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300 | 25,519,950 | In the first study the primary cognitive outcome of memory at six months did not reach significance , but there was significant improvement in overall cognitive function compared to placebo , with similar adverse events across groups .
The second study found no statistically significant difference between arms , with few adverse events .
There is supportive evidence that memantine may help prevent cognitive deficits for adults with brain metastases receiving cranial irradiation .
There is supportive evidence that donepezil may have a role in treating cognitive deficits in adults with primary or metastatic brain tumours who have been treated with cranial irradiation .
Further research that tries to minimise the withdrawal of consent , and subsequently reduce the requirement for imputation procedures , may offer a higher quality of evidence .There is no strong evidence to support any non-pharmacological interventions ( medical or cognitive/behavioural ) in the prevention or amelioration of cognitive deficits .
Non-r and omised studies appear promising but are as yet to be conclusive via translation into high quality evidence . | BACKGROUND Cognitive deficits are common in people who have received cranial irradiation and have a serious impact on daily functioning and quality of life .
The benefit of pharmacological and non-pharmacological treatment of cognitive deficits in this population is unclear .
OBJECTIVES To assess the effectiveness of interventions for preventing or ameliorating cognitive deficits in adult patients treated with cranial irradiation . | PURPOSE A prospect i ve , open-label phase II study was conducted to determine whether donepezil , a US Food and Drug Administration-approved reversible acetylcholinesterase inhibitor used to treat mild to moderate Alzheimer 's type dementia , improved cognitive functioning , mood , and quality of life ( QOL ) in irradiated brain tumor patients . PATIENTS AND METHODS Thirty-four patients received donepezil 5 mg/d for 6 weeks , then 10 mg/d for 18 weeks , followed by a washout period of 6 weeks off drug . Outcomes were assessed at baseline , 12 , 24 ( end of treatment ) , and 30 weeks ( end of wash-out ) . All tests were administered by a trained research nurse . RESULTS Of 35 patients who initiated the study , 24 patients ( mean age , 45 years ) remained on study for 24 weeks and completed all outcome assessment s. All 24 patients had a primary brain tumor , mostly low- grade glioma . Scores significantly improved between baseline ( pretreatment ) and week 24 on measures of attention/concentration , verbal memory , and figural memory and a trend for verbal fluency ( all P < .05 ) . Confused mood also improved from baseline to 24 weeks ( P = .004 ) , with a trend for fatigue and anger ( all P < .05 ) . Health-related QOL improved significantly from baseline to 24 weeks , particularly , for brain specific concerns with a trend for improvement in emotional and social functioning ( all P < .05 ) . CONCLUSION Cognitive functioning , mood , and health-related QOL were significantly improved following a 24-week course of the acetylcholinesterase inhibitor donepezil . Toxicities were minimal . We are planning a double blinded , placebo-controlled , phase III trial of donepezil to confirm these favorable results BACKGROUND To determine the protective effects of memantine on cognitive function in patients receiving whole-brain radiotherapy ( WBRT ) . METHODS Adult patients with brain metastases received WBRT and were r and omized to receive placebo or memantine ( 20 mg/d ) , within 3 days of initiating radiotherapy for 24 weeks . Serial st and ardized tests of cognitive function were performed . RESULTS Of 554 patients who were accrued , 508 were eligible . Grade 3 or 4 toxicities and study compliance were similar in the 2 arms . There was less decline in delayed recall in the memantine arm at 24 weeks ( P = .059 ) , but the difference was not statistically significant , possibly because there were only 149 analyzable patients at 24 weeks , result ing in only 35 % statistical power . The memantine arm had significantly longer time to cognitive decline ( hazard ratio 0.78 , 95 % confidence interval 0.62 - 0.99 , P = .01 ) ; the probability of cognitive function failure at 24 weeks was 53.8 % in the memantine arm and 64.9 % in the placebo arm . Superior results were seen in the memantine arm for executive function at 8 ( P = .008 ) and 16 weeks ( P = .0041 ) and for processing speed ( P = .0137 ) and delayed recognition ( P = .0149 ) at 24 weeks . CONCLUSIONS Memantine was well tolerated and had a toxicity profile very similar to placebo . Although there was less decline in the primary endpoint of delayed recall at 24 weeks , this lacked statistical significance possibly due to significant patient loss . Overall , patients treated with memantine had better cognitive function over time ; specifically , memantine delayed time to cognitive decline and reduced the rate of decline in memory , executive function , and processing speed in patients receiving WBRT . RTOG 0614 , Clinical Trials.gov number CT00566852 Limited research is available regarding the efficacy of psychostimulants in treating cognitive function in primary brain tumor patients . An open-label , r and omized , pilot trial examined both the general and differential efficacy of 4 weeks of methylpheni date ( MPH ) and modafinil ( MOD ) in 24 brain tumor patients . Participants completed cognitive tests and self-report measures of fatigue , sleep disturbance , mood and quality of life at baseline and after 4 weeks . Following stimulant treatment , there was evidence of a beneficial effect on test performance in speed of processing and executive function requiring divided attention . Patients with the greatest deficit in executive function at baseline appeared to derive the greatest benefit following stimulant therapy . Inconsistent , differential effects were found on a measure of attention in favor of MPH and on a measure of processing speed in favor of MOD . There was also evidence of a general beneficial effect on patient-reported measures of fatigue , mood , and quality of life , with no statistically significant differences between treatment arms in these measures over time . The results from this small pilot study should be interpreted with caution , but appear to warrant additional research , in larger study sample s , targeting fatigue , processing speed and executive function , and exploring different doses of stimulants . Future studies may also wish to explore the specific patient factors that may be associated with responsiveness to psychostimulant treatment Although their neurocognitive performance is one of the major concerns of patients with high- grade gliomas ( HGG ) and although neurocognitive deficits have been described to be associated with negative outcome , neurocognitive rehabilitation is usually not integrated into the routine care of patients with malignant gliomas . In this pilot trial , a weekly group training session for attention , verbal , and memory skills was offered to patients with HGG with pre and post-training evaluation . Eleven patients , six with glioblastoma multiforme and five with WHO grade III gliomas , median age 50 years , with a Karnofsky performance score of 80–100 participated in ten group training sessions of 90 min . For evaluation at baseline and after the training by a neuropsychologist not involved in care or training of the patients , Trail Making Tests A and B ( TMTA and TMTB ) , Hopkins Verbal Learning Test ( HVLT ) , and the Controlled Oral Word Association Test ( COWA ) were used . Comparison of mean group differences between baseline and at post-training evaluation after 12 weeks revealed improvement across all neurocognitive variables . The patients showed a great diversity in their performances , with worsening , improvement , and stabilization . However , a significant group difference was detected only for the HVLT ( score 19.6 ± 8.9 at baseline , 23.6 ± 8.8 after 12 weeks , P = 0.04 ) . This pilot study shows that neurocognitive training in patients with HGG is feasible as group training with weekly sessions and might be able to induce improvements in attention and memory skills BACKGROUND Fatigue , cognitive deficits , and depression are frequently reported but often undertreated symptoms that can profoundly affect daily life in patients with primary brain tumors ( PBTs ) . To evaluate the effects of the psychostimulant modafinil on fatigue , depression , health-related quality of life ( HRQOL ) , and cognitive functioning in PBT patients , we performed a multicenter , double-blind placebo-controlled crossover trial . METHODS Patients r and omly received either 6 weeks of treatment with modafinil ( up to 400 mg/day ) or 6 weeks with placebo . After a 1-week washout period , the opposite treatment was provided . Assessment s took place at baseline and immediately after the first and second condition . Patients completed self-report question naires on fatigue ( Checklist Individual Strength [ CIS ] ) , depression ( Center for Epidemiologic Studies Depression Scale [ CES-D ] ) , HRQOL ( Short-Form Health Survey [ SF-36 ] ) , and self-perceived cognitive functioning ( Medical Outcomes Study [ MOS ] ) . They also underwent comprehensive neurocognitive testing . RESULTS In total , 37 patients participated . Relative to baseline , patients reported lower fatigue severity ( CIS ) and better motivation ( CIS ) in both the modafinil ( P = .010 and P = .021 , respectively ) and the placebo condition ( P < .001 and P = .027 , respectively ) . The same held for physical health ( SF-36 Physical Component Summary score ; P = .001 and P = .008 , respectively ) , working memory ( P = .040 and P = .043 ) , and information processing capacity ( P = .036 and P = .040 ) . No improvement in depressive symptoms was found in either condition . CONCLUSIONS Modafinil did not exceed the effects of placebo with respect to symptom management . Patient accrual was slow , and relatively many patients dropped out during the trial , due mostly to side effects . Other , preferably nonpharmacologic intervention studies should be considered to improve symptom management of PBT patients Background Cerebral radiation necrosis is a serious complication of radiation treatment for brain tumors . Therapeutic options include corticosteroids , anticoagulation and hyperbaric oxygen with limited efficacy . Bevacizumab , an antibody against VEGF had been reported to reduce edema in patients with suspected radiation necrosis . We retrospectively review ed 6 patients with biopsy proven cerebral radiation necrosis treated with bevacizumab between 2006 and 2008 . Results Interval MRI follow-up demonstrated radiographic response in all patients with an average reduction of 79 % for the post gadolinium studies and 49 % for the FLAIR images . The initial partial radiographic response was noted for up to a mean follow-up time of 5.9 months ( 6 weeks to 18 months ) . Conclusion Bevacizumab appears to produce radiographic response and clinical benefits in the treatment of patients with cerebral radionecrosis PURPOSE Patients with gliomas often experience cognitive deficits , including problems with attention and memory . This r and omized , controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program ( CRP ) on cognitive functioning and selected quality -of-life domains in patients with gliomas . PATIENTS AND METHODS One hundred forty adult patients with low- grade and anaplastic gliomas , favorable prognostic factors , and both subjective cognitive symptoms and objective cognitive deficits were recruited from 11 hospitals in the Netherl and s. Patients were r and omly assigned to an intervention group or to a waiting-list control group . The intervention incorporated both computer-based attention retraining and compensatory skills training of attention , memory , and executive functioning . Participants completed a battery of neuropsychological ( NP ) tests and self-report question naires on cognitive functioning , fatigue , mental health-related quality of life , and community integration at baseline , after completion of the CRP , and at 6-month follow-up . RESULTS At the immediate post-treatment evaluation , statistically significant intervention effects were observed for measures of subjective cognitive functioning and its perceived burden but not for the objective NP outcomes or for any of the other self-report measures . At the 6-month follow-up , the CRP group performed significantly better than the control group on NP tests of attention and verbal memory and reported less mental fatigue . Group differences in other subjective outcomes were not significant at 6 months . CONCLUSION The CRP has a salutary effect on short-term cognitive complaints and on longer-term cognitive performance and mental fatigue . Additional research is needed to identify which elements of the intervention are most effective Patients with brain tumors may suffer from cognitive deficits caused by the disease and /or its treatment . Here , we review recent efforts in the research on prevention or treatment of cognitive deficits in these patients . We conclude that interest in this area is growing , but that method ological difficulties persist . In addition , we describe the recently completed first r and omized controlled trial on the effectiveness of cognitive rehabilitation that we conducted in patients with brain cancer . By reflecting on the method ological challenges experienced in our trial , we hope to assist others in planning and conducting future studies on both pharmacological treatments and cognitive rehabilitation programs for cognitive deficits in this patient population . We conclude with suggestions for future research directions Purpose : Analysis of the feasibility and effect of hyperbaric oxygen treatment ( HBO ) on cognitive functioning in patients with cognitive disorders after irradiation of the brain . Patients and Method : Seven patients with cognitive impairment after brain irradiation , with an interval of at least 1.5 years after treatment , were treated with 30 sessions of HBO in a phase I – II study . A comprehensive neuropsychological test battery was performed before treatment , at 3 and 6 months thereafter . Patients were r and omized into an immediate treatment group and a delayed treatment group . The delayed group had a second neuropsychological test at 3 months without treatment in that period and started HBO thereafter . Results : All eligible patients completed the HBO treatment and the extensive neuropsychological testing . One out of seven patients had a meaningful improvement in neuropsychological functioning . At 3 months there was a small , but not significant benefit in neuropsychological performance for the group with HBO compared to the group without HBO treatment . Six out of seven patients eventually showed improvement after HBO in one to nine ( median 2.5 ) of the 31 tests , although without statistical significance . Conclusion : HBO treatment was feasible and result ed in a meaningful improvement of congitive functioning in one out of seven patients . Overall there was a small but not significant improvement . Hintergrund : Es wurden die Durchführbarkeit und Wirksamkeit der hyperbaren Oxygenierung ( HBO ) auf die Gehirnfunktion bei Patienten mit kognitiven Störungen nach Hirnbestrahlung untersucht . Patientengut und Method e : In einer Phase-I/II-Studie wurden sieben Patienten mit kognitiven Störungen nach einem minimalen Intervall von 1,5 Jahren 30 HBO-Beh and lungen unterzogen . Neuropsychologische Tests wurden vor HBO sowie 3 und 6 Monate nach Abschluss der Beh and lung durchgeführt . Patienten wurden r and omisiert in eine sofortige und eine späte Beh and lungsgruppe . Die späte Beh and lungsgruppe wurde nach 3 Monaten zum zweiten Mal neuropsychologisch getestet ohne zwischenzeitliche HBO-Beh and lung . Nach diesem zweiten Test begann in dieser Gruppe die HBO . Ergebnisse : Alle Patienten konnten die vorgeschriebene HBO-Therapie und das umfangreiche neuropsychologische Testprogramm abschließen . Einer von sieben Patienten zeigte eine bedeutsame Verbesserung der neuropsychologischen Funktion . Die HBO-Gruppe zeigte i m Vergleich zu einer nicht mit HBO beh and elten Kontrollgruppe nach 3 Monaten eine leichte , statistisch nicht signifikante Verbesserung . Bei sechs der insgesamt sieben HBO-Patienten waren Verbesserungen nachweisbar in einem bis neun ( median 2,5 ) der 31 Tests , die statistisch jedoch nicht signifikant waren . Schlussfolgerung : HBO ist bei Patienten nach Hirnbestrahlung durchführbar und erzielte bei einem von sieben Patienten eine bedeutsame Verbesserung der kognitiven Funktion . Insgesamt zeigte sich eine leichte , statistisch nicht signifikante Verbesserung der getesteten Hirnfunktionen Ginkgo biloba has been reported to improve cognitive function in older adults and patients with Alzheimer ’s disease and multi-infa rct dementia . We conducted an open-label phase II study of this botanical product in symptomatic irradiated brain tumor survivors . Eligibility criteria included : life expectancy ≥30 weeks , partial or whole brain radiation ≥6 months before enrollment , no imaging evidence of tumor progression in previous 3 months , or stable or decreasing steroid dose , and no brain tumor treatment planned while on study . The Ginkgo biloba dose was 120 mg/day ( 40 mg t.i.d . ) for 24 weeks followed by a 6-week washout period . Assessment s performed at baseline , 12 , 24 ( end of treatment ) , and 30 weeks ( end of washout ) included KPS , Functional Assessment of Cancer Therapy-Brain ( FACT-Br ) , Profile of Mood States , Mini-Mental Status Exam , Trail Making Test Parts A ( TMT-A ) and B ( TMT-B ) , Digit Span Test , Modified Rey Osterrieth Complex Figure ( ROCF ) , California Verbal Learning Test Part II , and the F-A-S Test . Results : Of the 34 patients enrolled on study , 23 ( 68 % ) completed 12 weeks of treatment and 19 ( 56 % ) completed 24 weeks of treatment . There were significant improvements at 24 weeks in : executive function ( TMT-B ) ( p = 0.007 ) , attention/concentration ( TMT-A ) ( p = 0.002 ) , and non-verbal memory ( ROCF — immediate/delayed recall ) ( p = 0.001/0.002 ) , mood ( p = 0.002 ) , FACT-Br subscale ( p = 0.001 ) , and the FACT physical subscale ( p = 0.003 ) . Conclusions : Some improvement in quality of life and cognitive function were noted with Ginkgo biloba . However , treatment with Ginkgo biloba was associated with a high dropout rate PURPOSE To assess the impact of prophylactic cranial irradiation ( PCI ) on self-reported cognitive functioning ( SRCF ) , a functional scale on the European Organization for Research and Treatment of Cancer Core Quality of Life Question naire ( EORTC QLQ-C30 ) . METHODS AND MATERIAL S Radiation Therapy Oncology Group ( RTOG ) protocol 0214 r and omized patients with locally advanced non-small cell lung cancer to PCI or observation ; RTOG 0212 r and omized patients with limited-disease small cell lung cancer to high- or st and ard-dose PCI . In both trials , Hopkins Verbal Learning Test (HVLT)-Recall and -Delayed Recall and SRCF were assessed at baseline ( after locoregional therapy but before PCI or observation ) and at 6 and 12 months . Patients developing brain relapse before follow-up evaluation were excluded . Decline was defined using the reliable change index method and correlated with receipt of PCI versus observation using logistic regression modeling . Fisher 's exact test correlated decline in SRCF with HVLT decline . RESULTS Of the eligible patients pooled from RTOG 0212 and RTOG 0214 , 410 ( 93 % ) receiving PCI and 173 ( 96 % ) undergoing observation completed baseline HVLT or EORTC QLQ-C30 testing and were included in this analysis . Prophylactic cranial irradiation was associated with a higher risk of decline in SRCF at 6 months ( odds ratio 3.60 , 95 % confidence interval 2.34 - 6.37 , P<.0001 ) and 12 months ( odds ratio 3.44 , 95 % confidence interval 1.84 - 6.44 , P<.0001 ) . Decline on HVLT-Recall at 6 and 12 months was also associated with PCI ( P=.002 and P=.002 , respectively ) but was not closely correlated with decline in SRCF at the same time points ( P=.05 and P=.86 , respectively ) . CONCLUSIONS In lung cancer patients who do not develop brain relapse , PCI is associated with decline in HVLT-tested and self-reported cognitive functioning . Decline in HVLT and decline in SRCF are not closely correlated , suggesting that they may represent distinct elements of the cognitive spectrum Studies have proposed the involvement of oxidative stress and neuronal energy dysfunctions in the pathophysiology of bipolar disorder ( BD ) . This study evaluates plasma levels of the oxidative/energy metabolism markers , thiobarbituric acid reactive substances ( TBARS ) , superoxide dismutase ( SOD ) , catalase ( CAT ) , and neuron-specific enolase ( NSE ) during initial episodes of mania compared to controls in 75 subjects . Two groups of manic subjects ( unmedicated n=30 , and lithium-treated n=15 ) were age/gender matched with healthy controls ( n=30 ) . TBARS and antioxidant enzymes activity ( SOD and CAT ) were increased in unmedicated manic patients compared to controls . Conversely , plasma NSE levels were lower during mania than in the controls . In contrast , acute treatment with lithium showed a significant reduction in both SOD/CAT ratio and TBARS levels . These results suggest that initial manic episodes are associated with both increased oxidative stress parameters and activated antioxidant defenses , which may be related to dysfunctions on energy metabolism and neuroplasticity pathways . Antioxidant effects using lithium in mania were shown , and further studies are necessary to evaluate the potential role of these effects in the pathophysiology and therapeutics of BD Cognitive impairment is one of the most common neurological disorders in neuro-oncological patients and exerts a deep negative impact on quality of life interfering with familiar , social and career-related activities . To test the effectiveness of early cognitive rehabilitation treatment for in patients affected by primary brain tumors . Out of 109 consecutive patients enrolled in the study , 58 patients were r and omly assigned to a rehabilitation group or to a control group . The rehabilitation consisted of 16 one-hour individual sessions of therapist-guided cognitive training , spread over 4 weeks , combining computer exercises and metacognitive training . Patients in the control group received usual care without cognitive training . All patients were evaluated by means of a comprehensive neuropsychological battery at the admission ( T0 ) and after 4 weeks ( T1 ) . Patients in the rehabilitation group showed a significant improvement of cognitive functions . In particular , the domains that benefited most from the training were visual attention and verbal memory . The control group exhibited only a slightly , not statistically relevant , enhancement of cognitive performances . Cognitive rehabilitation for neuro-oncological in patients result ed in a significant enhancement of cognitive performances after the training , also providing a foundation for early administration . Future research should be aim ed to clarify the patients ’ characteristics that predict neuropsychological improvement , to identify the most effective elements in rehabilitative programs and to study the effects of treatment extension to everyday life PURPOSE To evaluate the effects of limited field conventional cerebral radiotherapy ( RT ) on cognitive functions of adults . METHODS AND MATERIAL S A prospect i ve neuropsychological study was performed on 17 patients who underwent conventional limited field RT for a low- grade glioma or for a good-prognosis anaplastic glioma . Results were compared with 14 control patients with low- grade gliomas who did not receive radiotherapy . RESULTS A transient significant decrease of performances for the Reaction Time test was observed at 6 months in the irradiated group with return to baseline values 12 months post-RT . Subsequently , no other significant changes were observed over a 48-month follow-up period in the irradiated and nonirradiated groups . Nonetheless , when the scores of each patient were considered over time instead of the mean values of the group , one irradiated patient ( 5.8 % ) experienced progressive deterioration while two irradiated patients ( 11.7 % ) experienced long-lasting improvement . Individual changes did not occur in the control group . CONCLUSION This study suggests that a transient early delayed drop of neuropsychological performances at 6 months is frequent following limited field conventional RT , but the risk of long-term cognitive dysfunction after irradiation is low , at least in the first 4 years after RT and when it is administered alone in young adults Background Up to 90 % of small cell lung cancer ( SCLC ) patients suffer cognitive dysfunction . Since donepezil and vitamin E have been somewhat successful in treating other dementias , this study tested the hypothesis that these agents can prevent cognitive decline in SCLC patients . Because accrual was poor , this trial also offered opportunities for suggesting other study design s for future clinical trials on cognitive dysfunction in this group of patients . Methods This double blind , placebo controlled trial tested oral donepezil 5 mg/day ( with dose escalation to 10 mg after 1 month ) and oral vitamin E 1,000 IU/day in SCLC patients after completion of all cancer therapy , including prophylactic cranial irradiation ( PCI ) . Cognition , adverse events , and quality of life were assessed throughout the study period . Results Only nine of 104 patients enrolled over 15 months ( four donepezil and vitamin E-treated versus five placebo-exposed ) , and thus no definitive conclusions could be drawn . Nonetheless , the only patient who manifested a precipitous decline in cognition was taking donepezil and vitamin E. There was also a slight trend of increased gastrointestinal side effects among donepezil and vitamin E-treated patients . There were no notable differences in cognitive stability , adverse events , or quality of life between treatment arms . Conclusion These preliminary findings do not provide enthusiasm for testing donepezil and vitamin E in the manner undertaken here for preventing cognitive dysfunction in SCLC patients . Eligibility criteria and timing of trial intervention are discussed as potential impediments to successful trial completion Radiotherapy is an important treatment modality for brain tumors and is the st and ard radical treatment for nasopharyngeal carcinoma ( NPC ) . However , the treatment is not free of side effects , and one possible neurologic sequela is the occurrence of temporal lobe radionecrosis ( TLN ) associated with cognitive dysfunction . Currently , there is no effective intervention to improve patients ' cognitive performance Whole brain radiation therapy ( WBRT ) is one of the most effective modalities for treatment of brain metastases . With increasing cancer control there is growing concern regarding the long-term effects of treatment . These effects are seen as white matter change ( WMC ) on brain MRI . Severity of WMC is implicated in cognitive and functional decline in many patient groups . Our objective was to identify clinical factors associated with greater accumulation of WMC following WBRT . Through retrospective review of serial MRIs obtained from 30 patients surviving greater than 1 year after WBRT , treated at a single institution between 2002 and 2007 , we calculated volumetric WMC over time using segmentation software . Changes related to tumor , secondary effects , surgery or radiosurgery were excluded . Factors that influenced the rate of WMC accumulation were identified through multivariate analysis . Following WBRT , patients accumulated WMC at an average rate of 0.07 % of total brain volume per month . In multivariate analyses , greater rates of accumulation were independently associated with older age ( β = 0.004 , p < .0001 ) , poor levels of glycemic control ( β = 0.048 , p < .0001 ) and hypertension diagnosis ( β = 0.084 , p < .0001 ) . Long-term survivors of cancer allow assessment of late effects of treatment modalities . Radiation injury appears to be related to a steady rate of white matter damage over time , as indicated by progressive accumulation of WMC . Our results suggest that rate of WMC accumulation is enhanced by parameters such as hyperglycemia and hypertension . This has significant clinical impact by clearly identifying hyperglycemia , steroid-induced hyperglycemia , and other vascular risk factors as targets for intervention to decrease WMC in patients receiving WBRT PURPOSE The quality of life ( QOL ) and neurocognitive function of patients with brain tumors are negatively affected by the symptoms of their disease and brain radiation therapy ( RT ) . We assessed the effect of prophylactic d-threo-methylpheni date HCl ( d-MPH ) , a central nervous system ( CNS ) stimulant on QOL and cognitive function in patients undergoing RT . METHODS AND MATERIAL S Sixty-eight patients with primary or metastatic brain tumors were r and omly assigned to receive d-MPH or placebo . The starting dose of d-MPH was 5 mg twice daily ( b.i.d . ) and was escalated by 5 mg b.i.d . to a maximum of 15 mg b.i.d . The placebo was administered as one pill b.i.d . escalating three pills b.i.d . The primary outcome was fatigue . Patients were assessed at baseline , the end of radiation therapy , and 4 , 8 , and 12 weeks after brain RT using the Functional Assessment of Cancer Therapy with brain and fatigue ( FACIT-F ) subscales , as well as the Center for Epidemiologic Studies Scale and Mini-Mental Status Exam . RESULTS The Mean Fatigue Subscale Score at baseline was 34.7 for the d-MPH arm and 33.3 for the placebo arm ( p = 0.61 ) . At 8 weeks after the completion of brain RT , there was no difference in fatigue between patient groups . The adjusted least squares estimate of the Mean Fatigue Subscale Score was 33.7 for the d-MPH and 35.6 for the placebo arm ( p = 0.64 ) . Secondary outcomes were not different between the two treatment arms . CONCLUSIONS Prophylactic use of d-MPH in brain tumor patients undergoing RT did not result in an improvement in QOL PURPOSE Because blocking vascular endothelial growth factor ( VEGF ) from reaching leaky capillaries is a logical strategy for the treatment of radiation necrosis , we reasoned that bevacizumab might be an effective treatment of radiation necrosis . PATIENTS AND METHODS Fifteen patients with malignant brain tumors were treated with bevacizumab or bevacizumab combination for their tumor on either a 5 mg/kg/2-week or 7.5 mg/kg/3-week schedule . Radiation necrosis was diagnosed in 8 of these patients on the basis of magnetic resonance imaging ( MRI ) and biopsy . MRI studies were obtained before treatment and at 6-week to 8-week intervals . RESULTS Of the 8 patients with radiation necrosis , posttreatment MRI performed an average of 8.1 weeks after the start of bevacizumab therapy showed a reduction in all 8 patients in both the MRI fluid-attenuated inversion-recovery ( FLAIR ) abnormalities and T1-weighted post-Gd-contrast abnormalities . The average area change in the T1-weighted post-Gd-contrast abnormalities was 48 % ( + /-22 SD ) , and the average change in the FLAIR images was 60 % ( + /-18 SD ) . The average reduction in daily dexamethasone requirements was 8.6 mg ( + /-3.6 ) . CONCLUSION Bevacizumab , alone and in combination with other agents , can reduce radiation necrosis by decreasing capillary leakage and the associated brain edema . Our findings will need to be confirmed in a r and omized trial to determine the optimal duration of treatment PURPOSE To determine the contribution of cognitive function in predicting the survival of patients with recurrent malignant brain tumors . PATIENTS AND METHODS A total of 80 patients with recurrent glioblastoma multiforme or anaplastic astrocytoma were seen for baseline evaluations before beginning a phase I or phase II clinical trial . Each patient received a battery of nine brief tests measuring cognitive function , ability to perform activities of daily living ( ADLs ) , and quality of life ( QOL ) . Tests were given monthly after treatment was begun . RESULTS Performance on a test of verbal memory was independently and strongly related to survival after accounting for age , Karnofsky performance status score , histology , and time since diagnosis . Models incorporating three of nine and all nine tests in the battery accounted for significantly more variance in survival than did the clinical variables alone . Measures of QOL and ADLs ( bathing , feeding , and so on ) were not independently related to survival , although they provide clinical information that is important for patient care . CONCLUSION These results indicate that a multifaceted assessment of cognition , QOL , and patient function is practical for brain tumor patients in clinical trials and can provide information regarding the relative risks versus benefits of new treatment regimens that supplements the information from the usual clinical variables Caregivers of patients with brain tumors frequently identify cognitive impairment in their loved ones as their greatest burden , but only one published study has examined a cognitive-rehabilitation intervention for adults with brain tumors . Emotional distress and poor quality of life ( QOL ) also have been identified as important issues , yet they have been excluded from most intervention studies that target coping and mood . The primary aim of this pilot study was to determine the feasibility and tolerability of a combined cognitive-rehabilitation and problem-solving-therapy intervention for patients with brain tumors and their caregivers . In all , 19 patient/caregiver pairs were enrolled and r and omized , and 13 pairs completed the 2-week trial . After receiving the intervention , 88 % of patients used the study -specific strategies , and 88 % indicated that they would recommend the intervention to other patients diagnosed with a brain tumor . The study intervention was described as " very helpful " or " somewhat helpful " by 88 % of study participants . Caregivers were similarly enthusiastic about the intervention . The results showed that patients with brain tumors who have cognitive impairment can participate meaningfully in a structured intervention , and they supported further research into the potential effectiveness of formal rehabilitation targeting cognitive and QOL symptoms for patients with brain tumors and their caregivers PURPOSE Patients with malignant glioma develop progressive neurobehavioral deficits over the course of their illness . These are caused both by the effects of the disease and the effects of radiation and chemotherapy . We sought to determine whether methylpheni date treatment would improve these patients ' neurobehavioral functioning despite their expected neurologic deterioration . PATIENTS AND METHODS Thirty patients with primary brain tumors underwent neuropsychologic assessment before and during treatment with methylpheni date . Ability to function in activities of daily living and magnetic resonance imaging ( MRI ) findings were also documented . Patients were assessed on 10 , 20 , and 30 mg of methylpheni date twice daily . RESULTS Significant improvements in cognitive function were observed on the 10-mg twice-daily dose . Functional improvements included improved gait , increased stamina and motivation to perform activities , and in one case , increased bladder control . Adverse effects were minimal and immediately resolved when treatment was discontinued . There was no increase in seizure frequency and the majority of patients on glucocorticoid therapy were able to decrease their dose . Gains in cognitive function and ability to perform activities were observed in the setting of progressive neurologic injury documented by MRI in half of the subjects . CONCLUSION This study demonstrated improved patient function in the setting of a progressive neurologic illness . Methylpheni date should be more widely considered as adjuvant brain tumor therapy This study investigated the specific patient factors that predict responsiveness to a cognitive rehabilitation program . The program has previously been demonstrated to be successful at the group level in patients with gliomas , but it is unclear which patient characteristics optimized the effect of the intervention at the individual level . Four categories of possible predictors of improvement were selected for evaluation : sociodemographic and clinical variables , self-reported cognitive symptoms , and objective neuropsychological test performance . Hierarchical logistic regression analyses were conducted , beginning with the most accessible ( sociodemographic ) variables and ending with the most difficult ( baseline neuropsychological ) to identify in clinical practice . Nearly 60 % of the participants of the intervention were classified as reliably improved . Reliable improvement was predicted by age ( p = .003 ) and education ( p = .011 ) . Additional results suggested that younger patients were more likely to benefit specifically from the cognitive rehabilitation program ( p = .001 ) , and that higher education was also associated with improvement in the control group ( p = .024 ) . The findings are discussed in light of brain reserve theory . A practical implication is that cognitive rehabilitation programs should take the patients ' age into account and , if possible , adapt programs to increase the likelihood of improvement among older participants PURPOSE To conduct a controlled trial of bevacizumab for the treatment of symptomatic radiation necrosis of the brain . METHODS AND MATERIAL S A total of 14 patients were entered into a placebo-controlled r and omized double-blind study of bevacizumab for the treatment of central nervous system radiation necrosis . All patients were required to have radiographic or biopsy proof of central nervous system radiation necrosis and progressive neurologic symptoms or signs . Eligible patients had undergone irradiation for head- and -neck carcinoma , meningioma , or low- to mid- grade glioma . Patients were r and omized to receive intravenous saline or bevacizumab at 3-week intervals . The magnetic resonance imaging findings 3 weeks after the second treatment and clinical signs and symptoms defined the response or progression . RESULTS The volumes of necrosis estimated on T(2)-weighted fluid-attenuated inversion recovery and T(1)-weighted gadolinium-enhanced magnetic resonance imaging scans demonstrated that although no patient receiving placebo responded ( 0 of 7 ) , all bevacizumab-treated patients did so ( 5 of 5 r and omized and 7 of 7 crossover ) with decreases in T(2)-weighted fluid-attenuated inversion recovery and T(1)-weighted gadolinium-enhanced volumes and a decrease in endothelial transfer constant . All bevacizumab-treated patients - and none of the placebo-treated patients -showed improvement in neurologic symptoms or signs . At a median of 10 months after the last dose of bevacizumab in patients receiving all four study doses , only 2 patients had experienced a recurrence of magnetic resonance imaging changes consistent with progressive radiation necrosis ; one patient received a single additional dose of bevacizumab and the other patient received two doses . CONCLUSION The Class I evidence of bevacizumab efficacy from the present study in the treatment of central nervous system radiation necrosis justifies consideration of this treatment option for people with radiation necrosis secondary to the treatment of head- and -neck cancer and brain cancer |
301 | 31,942,135 | This literature review reported that the usage of these e-cigarettes was high among this population and recorded a wide variety of reasons for using e-cigarettes .
Reducing tobacco use , considering e-cigarette as less harmful , less addictive , for pleasure and peer influence , lower cost and curiosity were the most commonly reported reasons . | Tobacco usage is harming the health , the treasury and the spirit of Saudi Arabia .
Every year , more than 7000 of its people are killed by tobacco-caused diseases .
Still , more than 20,000 children and 3,352,000 adults continue to use tobacco each day .
Likewise , the usage of electronic (e)-cigarette is also increasing ; this could be because of the publicity and marketing strategies adopted by the manufacturers of these products which are attracting the younger population .
This review was taken up to determine the usage and attitude toward e-cigarette smoking among the Saudi population through the analysis of literature . | Abstract Context : Electronic cigarettes ( e-cigarettes ) are becoming increasingly popular yet their effects on health remain unknown . Objective : To conduct the first comprehensive and st and ardized assessment of the acute impact of active and passive e-cigarette smoking on serum cotinine and lung function , as compared to active and passive tobacco cigarette smoking . Material s and methods : Fifteen smokers ( ≥15 cigarettes/day ; seven females ; eight males ) and 15 never-smokers ( seven females ; eight males ) completed this repeated- measures controlled study . Smokers underwent a control session , an active tobacco cigarette ( their favorite br and ) smoking session and an active e-cigarette smoking session . Never-smokers underwent a control session , a passive tobacco cigarette smoking session and a passive e-cigarette smoking session . Serum cotinine , lung function , exhaled carbon monoxide and nitric oxide were assessed . The level of significance was set at p ≤ 0.001 to adjust for multiple comparisons . Results : e-Cigarettes and tobacco cigarettes generated similar ( p > 0.001 ) effects on serum cotinine levels after active ( 60.6 ± 34.3 versus 61.3 ± 36.6 ng/ml ) and passive ( 2.4 ± 0.9 versus 2.6 ± 0.6 ng/ml ) smoking . Neither a brief session of active e-cigarette smoking ( indicative : 3 % reduction in FEV1/FVC ) nor a 1 h passive e-cigarette smoking ( indicative : 2.3 % reduction in FEV1/FVC ) significantly affected the lung function ( p > 0.001 ) . In contrast , active ( indicative : 7.2 % reduction in FEV1/FVC ; p < 0.001 ) but not passive ( indicative : 3.4 % reduction in FEV1/FVC ; p = 0.005 ) tobacco cigarette smoking undermined lung function . Conclusion : Regarding short-term usage , the studied e-cigarettes generate smaller changes in lung function but similar nicotinergic impact to tobacco cigarettes . Future research should target the health effects of long-term e-cigarette usage , including the effects of nicotine dosage INTRODUCTION Approximately 70 % of homeless youth smoke cigarettes , but their use of alternative tobacco products ( ATPs ) is unknown . This paper reports on ATP use among past-month smokers in Los Angeles County , including whether it differs by demographic characteristics , homelessness severity , past-year quit attempts , and readiness to quit smoking . Given the growing popularity of e-cigarettes , we also report on perceptions of harm and reasons for using this product . METHODS We surveyed 292 unaccompanied homeless youth who were r and omly sample d from street sites . Participants had smoked at least 100 cigarettes during their lifetime and 1 cigarette during the past month . RESULTS Seventy-two percent of youth reported past-month ATP use ( e-cigarettes = 51 % ; little cigars/cigarillos = 46 % ; hookah = 31 % ; other smokeless tobacco product = 24 % ; chewing tobacco/moist snuff = 19 % ) . Current ATP use was unrelated to most demographic characteristics or having a past-year quit attempt . However , youth who planned to quit smoking in the next 30 days were significantly less likely to report current use of hookahs , other smokeless tobacco products , or e-cigarettes . Among lifetime e-cigarette users , the most common reasons for use included not having to go outside to smoke ( 38 % ) and being able to deal with situations or places where they can not smoke ( 36 % ) ; it was less common to report using e-cigarettes to quit smoking ( 17%-18 % ) . DISCUSSION Dual use of ATPs among homeless youth smokers is common and is more likely among those who have no immediate plans to quit smoking . Effective and easily disseminable strategies for reducing all forms of tobacco use among homeless youth are urgently needed |
302 | 32,005,169 | However , no difference was found in CAL gain .
Moreover , no significant difference was observed in PPD and CAL at both 3 and 6 months post-treatment between FMD and FMSRP .
Adjunctive subgingival administration of XAN-CHX gel at individual selected sites in NSPT appears to provide slight benefits in PPD reduction compared to NSPT alone for CP . | BACKGROUND Subgingival applications of chlorhexidine ( CHX ) gel are commonly used as an adjunct in nonsurgical periodontal treatment ( NSPT ) for chronic periodontitis ( CP ) .
However , there is lack of systematic review and meta- analysis justifying the effects of adjunctive CHX gel on clinical outcomes .
The objective of this meta- analysis was to evaluate the efficacy of adjunctive subgingival administration of CHX gel in NSPT compared to NSPT alone for CP . | AIM The aim of this r and omized controlled clinical trial was to evaluate the clinical effects of chlorhexidine ( CHX ) application in a full-mouth disinfection ( FMD ) protocol in poorly controlled type-2 diabetic subjects with generalized chronic periodontitis . MATERIAL AND METHODS Thirty-eight subjects were r and omly assigned into FMD group ( n=19 ) : full-mouth scaling and root planing ( FMSRP ) within 24 h + local application of CHX gel + CHX rinses for 60 days or Control group ( n = 19 ) : FMSRP within 24 h + local application of placebo gel + placebo rinses for 60 days . Clinical parameters , glycated haemoglobin and fasting plasma glucose were assessed at baseline , 3 , 6 and 12 months post-therapies . RESULTS All clinical parameters improved significantly at 3 , 6 and 12 months post-therapies for both groups ( p < 0.05 ) . There were no significant differences between groups for any clinical parameters , and glycemic condition at any time-point ( p > 0.05 ) . CONCLUSIONS The treatments did not differ with respect to clinical parameters , including the primary outcome variable ( i.e. changes in clinical attachment level in deep pockets ) , for up to 12 months post-treatments Objectives : The aim of this study was to evaluate the efficacy of subgingivally administered xanthan-based chlorhexidine gel when used in the maintenance phase following scaling and root planing ( SRP ) in the treatment of chronic periodontitis . Material s and Methods : A r and omized , controlled , single-center study was conducted involving 92 sites in 46 systemically healthy patients suffering from moderate to advanced chronic periodontitis with isolated pockets . The selected sites were r and omized to two treatment arms : Group A ( SRP alone ) and Group B ( SRP + insertion of chlorhexidine gel after 1 month ) . The gingival index , plaque index , probing pocket depth ( PPD ) and clinical attachment level ( CAL ) were recorded at baseline and subsequently after 1 month and 3 months . Results : Both the groups showed significant reductions in PPD and CAL at both follow-up visits when compared with the baseline values ( P<0.001 ) . Conclusions : The results suggest that the application of xanthan based chlorhexidine gel following SRP in the maintenance phase might be beneficial in treatment of the chronic periodontitis in comparison to SRP alone . Greater improvements may be achieved when antimicrobial agents are used following SRP OBJECTIVES The beneficial effects of the one-stage , full-mouth disinfection remain controversial in the scientific literature . This might be due to the fact that an entire mouth disinfection with the use of antiseptics has been confused with a full-mouth scaling and root planing . This parallel , single blind RCT study aim ed to compare several full-mouth treatment strategies with each other . MATERIAL AND METHODS Seventy-one patients with moderate periodontitis were r and omly allocated to one of the following treatment strategies : scaling and root planing , quadrant by quadrant , at two-week intervals ( negative control , NC ) , full-mouth scaling and root planing within 2 consecutive days ( FRP ) , or three one-stage , full-mouth disinfection ( FM ) protocol s within 2 consecutive days applying antiseptics to all intra-oral niches for periopathogens using as antiseptics : chlorhexidine ( FMCHX ) for 2 months , amine fluoride/stannous fluoride for 2 months ( FMF ) , or chlorhexidine for 2 months followed by amine fluoride/stannous fluoride for another 6 months ( FMCHX+F ) . At baseline and after 2 , 4 , and 8 a series of periodontal parameters were recorded . RESULTS All treatment strategies result ed in significant ( p<0.05 ) improvements of all clinical parameters over the entire duration of the study . Inter-treatment differences were often encountered . The NC group nearly always showed significant smaller improvements than the two CHX groups . The differences between the FRP or FM groups , and the two CHX groups only sporadically reached a statistical significance . CONCLUSION These observations indicate that the benefits of the " OSFMD " protocol are partially due to the use of the antiseptics and partially to the completion of the therapy in a short time A report of a r and omized , controlled trial ( RCT ) should convey to the reader , in a transparent manner , why the study was undertaken and how it was conducted and analyzed . For example , a lack of adequately reported r and omization has been associated with bias in estimating the effectiveness of interventions ( 1 , 2 ) . To assess the strengths and limitations of an RCT , readers need and deserve to know the quality of its methods . Despite several decades of educational efforts , RCTs still are not being reported adequately ( 3 - 6 ) . For example , a review of 122 recently published RCTs that evaluated the effectiveness of selective serotonin-reuptake inhibitors as first-line management strategy for depression found that only 1 ( 0.8 % ) paper described r and omization adequately ( 5 ) . Inadequate reporting makes the interpretation of RCT results difficult if not impossible . Moreover , inadequate reporting borders on unethical practice when biased results receive false credibility . History of CONSORT In the mid-1990s , two independent initiatives to improve the quality of reports of RCTs led to the publication of the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement ( 7 ) , which was developed by an international group of clinical trialists , statisticians , epidemiologists , and biomedical editors . CONSORT has been supported by a growing number of medical and health care journals ( 8 - 11 ) and editorial groups , including the International Committee of Medical Journal Editors ( ICMJE , also known as the Vancouver Group ) ( 12 ) , the Council of Science Editors ( CSE ) , and the World Association of Medical Editors ( WAME ) . CONSORT is also published in Dutch , English , French , German , Japanese , and Spanish . It can be accessed on the Internet , along with other information about the CONSORT group ( 13 ) . The CONSORT statement comprises a checklist and flow diagram for reporting an RCT . For convenience , the checklist and diagram together are called simply CONSORT . They are primarily intended for use in writing , review ing , or evaluating reports of simple two-group , parallel RCTs . Preliminary data indicate that the use of CONSORT does indeed help to improve the quality of reports of RCTs ( 14 , 15 ) . In an evaluation ( 14 ) of 71 RCTs published in three journals in 1994 , allocation concealment was not clearly reported in 43 ( 61 % ) of the RCTs . Four years later , after these three journals required that authors reporting an RCT use CONSORT , the proportion of papers in which allocation concealment was not clearly reported had dropped to 39 % ( 30 of 77 ; mean difference , 22 % [ 95 % CI of the difference , 38 % to 6 % ] ) . The usefulness of CONSORT is enhanced by continuous monitoring of the biomedical literature ; this monitoring allows CONSORT to be modified depending on the merits of maintaining or dropping current items and including new items . For example , when Meinert ( 16 ) observed that the flow diagram did not provide important information about the number of participants who entered each phase of an RCT ( enrollment , treatment allocation , follow-up , and data analysis ) , the diagram could be modified to accommo date the information . The checklist is similarly flexible . This iterative process makes the CONSORT statement a continually evolving instrument . While participants in the CONSORT group and their degree of involvement vary over time , members meet regularly to review the need to refine CONSORT . At the 1999 meeting , the participants decided to revise the original statement . This report reflects changes determined by consensus of the CONSORT group , partly in response to emerging evidence on the importance of various elements of RCTs . Revision of the CONSORT Statement Thirteen members of the CONSORT group met in May 1999 with the primary objective of revising the original CONSORT checklist and flow diagram , as needed . The group discussed the merits of including each item in the light of current evidence . As in developing the original CONSORT statement , our intention was to keep only those items deemed fundamental to reporting st and ards for an RCT . Some items not considered essential may well be highly desirable and should still be included in an RCT report even though they are not included in CONSORT . Such items include approval of an institutional ethical review board , sources of funding for the trial , and a trial registry number ( as , for example , the International St and ard R and omized Controlled Trial Number [ IS RCT N ] used to register an RCT at its inception [ 17 ] ) . Shortly after the meeting , a revised version of the checklist was circulated to the group for additional comments and feedback . Revisions to the flow diagram were similarly made . All these changes were discussed when CONSORT participants met in May 2000 , and the revised statement was finalized shortly afterward . The revised CONSORT statement includes a 22-item checklist ( Table ) and a flow diagram ( Figure ) . Its primary aim is to help authors improve the quality of reports of simple two-group , parallel RCTs . However , the basic philosophy underlying the development of the statement can be applied to any design . In this regard , additional statements for other design s will be forthcoming from the group ( 13 ) . CONSORT can also be used by peer review ers and editors to identify reports with inadequate description of trials and those with potentially biased results ( 1 , 2 ) . Table . Checklist of Items To Include When Reporting a R and omized Trial Figure . Flow diagram of the progress through the phases of a r and omized trial ( enrollment , intervention allocation , follow-up , and data analysis ) . During the 1999 meeting , the group also discussed the benefits of developing an explanatory document to enhance the use and dissemination of CONSORT . The document is patterned on reporting of statistical aspects of clinical research ( 18 ) , which was developed to help facilitate the recommendations of the ICMJE 's Uniform Requirements for Manuscripts Su bmi tted to Biomedical Journals . Three members of the CONSORT group , with assistance from members on some checklist items , drafted an explanation and elaboration document . That document ( 19 ) was circulated to the group for additions and revisions and was last revised after review at the latest CONSORT group meeting . Changes to CONSORT 1 . In the revised checklist , a new column for Paper Section and Topic integrates information from the Subheading column that was contained in the original statement . 2 . The Was It Reported ? column has been integrated into a Reported on Page Number column , as requested by some journals . 3 . Each item of the checklist is now numbered , and the syntax and order have been revised to improve the flow of information . 4 . Title and Abstract are now combined in the first item . 5 . While the content of the revised checklist is similar to that of the original one , some items that previously were combined are now separate . For example , authors had been asked to describe primary and secondary outcome ( s ) measure(s ) and the minimum important difference(s ) , and indicate how the target sample size was projected . In the new version , issues pertaining to outcomes ( item 6 ) and sample size ( item 7 ) are separate , enabling authors to be more explicit about each . Moreover , some items request additional information . For example , for outcomes ( item 6 ) authors are asked to report any methods used to enhance the quality of measurements , such as multiple observations . 6 . The item asking for the unit of r and omization ( for example , cluster ) has been dropped because specific checklists have been developed for reporting cluster RCTs ( 20 ) and other design types ( 13 ) since publication of the original checklist . 7 . Whenever possible , new evidence is incorporated into the revised checklist . For example , authors are asked to be explicit about whether the analysis reported is by intention to treat ( item 16 ) . This request is based in part on the observations ( 21 ) that authors do not adequately describe and apply intention-to-treat analysis and that reports not providing this information are less likely to provide other relevant information , such as losses to follow-up ( 22 ) . 8 . The revised flow diagram depicts information from four stages of a trial ( enrollment , intervention allocation , follow-up , and analysis ) . The revised diagram explicitly includes the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers lets the reader know whether the authors have performed an intention-to-treat analysis ( 21 - 23 ) . Because some of the information may not always be known and to accommo date other information , the structure of the flow diagram may need to be modified for a particular trial . Inclusion of the participant flow diagram in the report is strongly recommended but may be unnecessary for simple trials , such as those without any participant withdrawals or dropouts . Discussion Specifically developed to guide authors about how to improve the quality of reporting of simple two-group , parallel RCTs , CONSORT encourages transparency with reporting of the methods and results so that reports of RCTs can be interpreted both readily and accurately . However , CONSORT does not address other facets of reporting that also require attention , such as scientific content and readability of RCT reports . Some authors , in their enthusiasm to use CONSORT , have modified the checklist ( 24 ) . We recommend against such modifications because they may be based on a different process than the one used by the CONSORT group . The use of CONSORT seems to reduce ( if not eliminate ) inadequate reporting of RCTs ( 14 , 15 ) . Potentially , the use of CONSORT should positively influence the manner in which RCTs are conducted . Granting agencies have noted this potential relationship and , in at least in one case ( 25 ) , have encouraged grantees to consider in their application how they have dealt with the CONSORT items . The evidence -based approach used to develop CONSORT has also been used Background : Local drug delivery agents can effectively deliver the antimicrobial drugs in bactericidal concentration , and have shown improved clinical outcomes when used as an adjunct to mechanical therapy . The aim of this study was to evaluate the efficacy of a xanthan-based chlorhexidine gel versus herbal extracts ’ gel as an adjunct to periodontal therapy in the treatment of chronic periodontitis . Material s and Methods : A total of 150 sites , age group of 30 - 50 years , periodontal pockets measuring 5 - 8 mm and diagnosed with chronic periodontitis were selected for the study . The selected sites were r and omized in five groups : Scaling and root planing ( SRP ) alone ( Group A ) , SRP + Chlosite gel ( Group B ) , SRP + Herbal gel ( Group C ) , Chlosite gel alone ( Group D ) and Herbal gel alone ( Group E ) . Clinical parameters such as Plaque Index , Gingival Index , probing pocket depth and clinical attachment level were recorded at baseline and 1- and 3-month intervals . Results : After 3 months , there were statistically significant reductions in all the clinical parameters for Groups B and C compared with Group A. There was no significant reduction in all clinical parameters between Group D and E where no mechanical therapy was performed . Conclusion : The results indicate that the local application of herbal gel can be comparably used as chlorhexidine gel in the treatment of chronic periodontitis as an adjunct to mechanical periodontal therapy The clinical effects of subgingivally placed 1 % chlorhexidine gel ( w/w ) and 40 % tetracycline ( w/w ) paste in periodontal pockets of 22 adult periodontitis patients were studied . The 2 agents were applied following scaling and root planing in pockets exceeding 4 mm . The patients were r and omly divided into 3 groups : ( a ) scaling and root planing ( SCRP ) only , the control group ; ( b ) corsodyl gel+SCRP ; ( c ) Tetracycline paste+SCRP . Gel or paste were gently applied using a syringe with a blunt needle until the selected pocket was overfilled . Evaluations were made of clinical parameters including the plaque index ( PI ) , gingival index ( GI ) , bleeding index ( GI-S ) , probing pocket depths , probing attachment levels and position of the gingival margin . The results suggested that all the treatment modalities were effective in producing statistically significant improvements in clinical parameters . It was concluded that the conventional treatment modalities were essential in the treatment of periodontal diseases , but in view of the structure of the periodontal pocket and adjacent complex root surface , subgingival drug application in certain cases , might also provide adjunctive improvement Context : Antimicrobial efficacy of subgingival chlorhexidine ( CHX ) application using two different vehicles of delivery . Aims : The aim was to evaluate the efficacy of CHX varnish and gel as an adjunct to scaling and root planing ( SRP ) in reducing microbial count within moderate to deep periodontal pockets . Setting s and Design : Experimental parallel mouth study . Subjects and Methods : A total of 30 subjects between the age groups 25 and 55 years having moderate to severe periodontitis , with pocket depth ≥ 5 mm were selected for the study . The selected patients were r and omized into three groups of 10 each . Subjects in Group 1 received SRP followed by subgingival application of CHX varnish , subjects in Group 2 received SRP followed by subgingival application of CHX gel , subjects in Group 3 received SRP alone . Subgingival plaque sample s were collected to estimate mean motile and nonmotile microbial counts using dark field microscopy at baseline , 1 week , 1 month , and 3 months . Results : After 3 months , there was statistically significant reduction in nonmotile microbial count in all the three groups . Motile microbial count was significantly reduced in all the three groups till 1 month from baseline . Only subjects in Group 1 who received subgingival CHXvarnish after SRP showed a significant reduction in motile microbial count till 3 months from baseline . Conclusions : Subgingival application of highly concentrated CHX varnish following SRP is beneficial in reducing microbial count in moderate to deep periodontal pockets AIM The aim of this study was to evaluate and compare the efficacy of subgingivally delivered 10 % doxycycline hyclate and xanthan based chlorhexidine gels when used as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis . METHODS AND MATERIAL S A r and omized , controlled , single center study was conducted involving 90 sites in 30 patients suffering from moderate to advanced chronic periodontitis . Each patient contributed three sites which were r and omized to three treatment groups : SRP + insertion of doxycycline gel [ SRP+DH ] , SRP + insertion of chlorhexidine gel [ SRP+CHX ] ) , and SRP alone [ SRP ] . Gingival index ( GI ) , plaque index ( PI ) , probing pocket depth ( PPD ) , and clinical attachment level ( CAL ) were recorded at baseline , 1 month , and 3 months post therapy . RESULTS All treatments showed significant reductions in PPD and CAL at 1 and 3 months when compared to baseline values ( p<0.001 ) . At 3 months , sites treated with SRP+DH and SRP+CHX showed an additional reduction in PPD of 0.86 + /- 1.0 mm and 0.66 + /- 1.58 mm , respectively , significantly greater than SRP alone ( p<0.02 ) . Differences in mean PPD reduction between SRP+DH and SRP+CHX were not significant ( p=0.46 ) . At 3 months , differences in relative CAL between both SRP+DH ( 0.80 + /- 0.92 ) and SRP+CHX ( 0.63 + /- 1.47 ) and SRP alone were statistically significant ( p<0.02 ) . Differences in relative CAL between SRP+DH and SRP+CHX were not significant ( p=0.54 ) . CONCLUSION The results suggest treatment with 10 % doxycycline hyclate and xanthan based chlorhexidine gels as an adjunct to SRP improves PPD and CAL patients with periodontitis compared to SRP alone . CLINICAL SIGNIFICANCE The use of local drug therapy may refocus the need for surgical periodontal therapy toward deeper pockets BACKGROUND / AIMS Recent studies reported significant additional clinical and microbiological improvements when severe adult periodontitis was treated by means of a " one-stage full-mouth " disinfection instead of a st and ard treatment strategy with consecutive root planings quadrant per quadrant . The one stage full-mouth disinfection procedure involves scaling and root planing of all pockets within 24 h in combination with an extensive application of chlorhexidine to all intra-oral niches such as periodontal pockets , tongue dorsum , tonsils ( chairside , and at home for 2 months ) . This study aims to examine the relative importance of the use of chlorhexidine in the one stage full-mouth disinfection protocol . METHODS Therefore , 3 groups of 12 patients each with advanced periodontitis were followed , both from a clinical and microbiological point of view , over a period of 8 months . The patients from the control group were scaled and root planed , quadrant per quadrant . at two-week intervals . The 2 other groups underwent a one stage full-mouth scaling and root planing ( all pockets within 24 h ) with ( Fdis ) or without ( FRp = full-mouth root planing ) the adjunctive use of chlorhexidine . At baseline and after 1 , 2 , 4 and 8 months , the following clinical parameters were recorded : plaque and gingivitis indices , probing depth , bleeding on probing and clinical attachment level . Microbiological sample s were taken from different intra-oral niches ( tongue , mucosa , saliva and pooled sample s from single- and multi-rooted teeth ) . The sample s were cultured on selective and non-selective media in order to evaluate the number of CFU/ml for the key-periodontopathogens . At baseline , an anonymous question naire was given to the patients to record the perception of each treatment ( post operative pain , fever , swelling etc . ) . RESULTS All 3 treatment strategies result ed in significant improvements for all clinical parameters , but the Fdis and FRp patients reacted always significantly more favourably than the control group , with an additional probing depth reduction of + /- 1.5 mm and an additional gain in attachment of + /- 2 mm ( for pockets > or = 7 mm ) . Also from a microbiological point of view both the FRp and Fdis patients showed additional improvements when compared to the control group , as well in the reduction of spirochetes and motile organisms as in the number of CFU/ml of the key-pathogens , especially when the subgingival plaque sample s were considered . The differences between FRp and Fdis patients were negligible . CONCLUSIONS These findings suggest that the benefits of a " one-stage full-mouth disinfection " in the treatment of patients suffering from severe adult periodontitis probably results from the full-mouth scaling and root planing within 24 h rather than the beneficial effect of chlorhexidine . The raise in body temperature the second day after the full-mouth scaling and root planing seems to indicate a Shwartzman reaction Aim : The aim of this study was to evaluate the clinical effectiveness of locally delivered xanthan-based Chlosite ® gel as an adjunctive therapy to scaling and root planing in treatment of chronic periodontitis . Material s and Methods : In a r and omized controlled clinical study , 30 patients were selected . Pocket depth between 5 and 7 mm was selected and each patient had two sites on the same side of the mouth . A total of 30 control sites were scaled and root planed and 30 test sites were scaled and root planed and Chlosite ® gel was added . The clinical parameters , probing depth ( PD ) , clinical attachment level ( CAL ) , plaque index ( PI ) and bleeding on probing ( BOP ) , gingival index were recorded at baseline , 6 weeks , 3 months and 6 months . Statistical Analysis : Paired/unpaired t-test was used , significance was placed at 5 % level of significance , i.e. , P < 0.05 was considered as a significant . Results : From baseline to a period of 6 months , significant difference was found between test and control group for PD , CAL , PI and BOP , P value being PD ( P = 0.002 ) , CAL index ( P = 0.014 ) , respectively . Conclusion : Subgingival injection of xanthan-based Chlosite ® gel adjunct with scaling and root planing appeared to cause significant improvement compared with scaling and root planing alone in persons with chronic periodontitis Aim : The aim of this study was to evaluate the effects of hyaluronan ( HA ) and chlorhexidine ( CHX ) gels as adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis . Material s and Methods : Sixty patients within the age group of 30 - 65 years recruited to participate in the study were r and omly equally divided into three groups . Complete SRP and subgingival debridement were performed within 6 h in all the patients . For control ( Group I ) patients , SRP was the only treatment modality given ; for Group II and III patients , at least 8 teeth with 4 - 8 mm probing pocket depth ( PPD ) were selected for subgingival application of HA gel and CHX gel , respectively . Clinical periodontal parameters such as gingival index , PPD , and clinical attachment level ( CAL ) were recorded at baseline and 3 months , whereas plaque index was recorded at baseline , 1 month , and 3 months . For measuring systemic/hematological parameters , blood sample s for laboratory tests for total leucocyte count ( TLC ) , differential leucocyte count ( DLC ) , and C-reactive protein ( CRP ) were obtained using st and ard 2-mL syringe from each subject in all the three groups at baseline , 24 h , and on the 1 month and 3 months post-baseline . Results : In all the three groups , a significant reduction in PPD and gain in CAL were observed between baseline and 3 months follow-up ( P < 0.05 ) ; however , at 3 months , change in PPD and CAL was more in Group II than Group III , but the difference was non-significant , and Group I ( control ) showed less changes in PPD and CAL than both experimental groups . Only one patient revealed positive value for CRP at baseline only , and hence could not be statistically analyzed . In all the three groups , the peak values for TLC count were observed at 24 h. At 1-month and 3-month intervals , a significant improvement in TLC and DLC counts was observed among the experimental ( HA gel/SRP and Xan-CHX gel ) groups as compared to control group ( SRP alone ) In a st and ard periodontal treatment strategy with consecutive root planings ( per quadrant at a one- to two-week interval ) , re-infection of a disinfected area might occur before completion of the treatment . This study examines , both clinical ly and microbiologically , whether a full-mouth disinfection within 24 hours significantly improves the outcome of periodontal treatment . Ten patients with advanced chronic periodontitis were r and omly allocated to a test and a control group . The patients from the control group received scalings and root planings as well as oral hygiene instructions per quadrant at two-week intervals . Full-mouth disinfection in the test group was sought by the removal of all plaque and calculus ( in two visits within 24 hours ) . In addition , at each of these visits , the tongue was brushed with a 1 % chlorhexidine gel for one min and the mouth rinsed with a 0.2 % chlorhexidine solution for two min . Furthermore , subgingival chlorhexidine ( 1 % ) irrigation was performed in all pockets . The recolonization of the pockets was retarded by oral hygiene and 0.2 % chlorhexidine rinses during two weeks . The clinical parameters were recorded , and plaque sample s were taken from the right upper quadrant at baseline and after one and two months . The test group patients showed a significantly higher reduction in probing depth for deep pockets at both follow-up visits ( p < 0.05 ) . At the one-month visit , differential phase-contrast microscopy revealed significantly lower proportions of spirochetes and motile rods in the test group ( p = 0.01 ) . Culturing showed that the test group harbored significantly fewer pathogenic organisms at one month ( p = 0.005 ) . At two months , the same sites harbored singificantly more " beneficial " bacteria ( p = 0.02 ) . Moreover , all sites of the test group initially harboring P. gingivalis ( 6/10 ) became negative after treatment . These findings suggest that it is possible to achieve a significant improvement of the treatment outcome ( both microbiologically and clinical ly ) with a one-stage full-mouth disinfection The clinical and microbiological effect of locally-applied chlorhexidine gel 2 % , amine fluoride gel 1.25 % , stannous fluoride gel 4 % or placebo gel in 40 periodontal pockets of 10 patients were studied . The gels were applied 3 x within 10 min . after mechanical debridement of the pockets . The treatment effect on the subgingival microflora was evaluated by microscopic and culture studies of the subgingival plaque sample s. In addition , supragingival plaque , bleeding after probing and probing pocket depth were scored . Examination were carried out before and during a period of 36 weeks after treatment . At the start , the cultured microflora consisted mainly of anaerobic Gram-positive bacteria . Following treatment , the clinical parameters were significantly reduced . Concomitantly , the % s of spirochetes , motile rods and non-motile rods decreased significantly . A significant decrease was also found in the total anaerobic count , whereas the facultative counts remained at the same level found before treatment . This suggested that the treatment result ed in a mainly facultative subgingival microflora . The % Gram-negative rods showed a significant reduction after treatment , but returned to base line at week 12 . Statistical analysis of the bacteriological and clinical examinations failed to demonstrate any significant differences between the 4 treatment groups . Thus , in comparison to the placebo gel , subgingival application of chlorhexidine gel 2 % , amine fluoride gel 1.25 % or stannous fluoride gel 4 % did not augment the effect of mechanical debridement on bacteriological and clinical parameters during the experimental period of 36 weeks . However the indicated treatments result ed in a facultative subgingival microflora which is compatible with the host BACKGROUND Conflicting data about the protocol of choice for non-surgical periodontal therapy with adjuvant use are still reported . This study aims to evaluate , through clinical and microbiologic parameters , the systemic use of azithromycin ( AZ ) and chlorhexidine ( CHX ) as adjuvants to non-surgical periodontal treatment performed by one-stage full-mouth disinfection ( FMD ) within 24 hours or conventional quadrant scaling ( QS ) in four weekly sections . METHODS In this r and omized controlled trial , 85 patients diagnosed with chronic periodontitis underwent different treatment protocol s , in six groups : three FMD groups and three QS groups , each with no adjuvants , with CHX , and with AZ . Clinical periodontal parameters were recorded , and total and quantitative bacterial counts of Aggregatibacter actinomycetemcomitans , Porphyromonas gingivalis , Tannerella forsythia , Treponema denticola , and Streptococcus oralis were measured with real-time polymerase chain reaction at baseline and 90 and 180 days after treatment . RESULTS In all groups , a significant reduction was observed in the percentage of periodontal diseased sites , gingival index , plaque index , and clinical attachment level gain at 90 days , demonstrating effectiveness of the treatment , independently of the adjuvant . The FMD with CHX group showed higher reduction in probing depth and percentage of periodontal diseases sites , as well as lower total bacterial count , than all the other groups at 180 days . CONCLUSIONS The adjuvant use of AZ did not provide any significant benefit , independently of the treatment protocol . The adjuvant use of CHX showed a more expressive and significant improvement in clinical and microbiologic parameters , especially in the FMD protocol , followed by QS This study evaluates the effect of subgingival irrigation with a 1 % chlorhexidine collagen gel in periodontal pockets as an adjunct procedure to scaling and root planing ( SRP ) . Thirty-seven sites with probing depth ( PD ) of 5 - 7 mm and BANA positive in 6 patients with chronic periodontal disease were selected . Sites were assigned to different treatment groups consisting of SRP only ( group 1 ) , SRP + irrigation with collagen gel ( group 2 ) , or SRP + irrigation with collagen gel containing 1 % chlorhexidine ( group 3 ) . Subgingival irrigation was performed after initial SRP and at 7 , 14 and 21 days . Clinical measurements including PD , plaque index ( PI ) , gingival index ( GI ) , gingival recession ( GI ) , bleeding on probing ( BOP ) and clinical attachment level ( CAL ) were performed at the selected sites at baseline , 60 and 90 days and the BANA test was performed on plaque sample s from the same sites at baseline and 90 days . There was an improvement in clinical parameters in all groups with a significantly greater decrease in GI and bleeding in the chlorhexidine group . There was a greater reduction of BANA positive sites in groups 2 and 3 . The authors concluded that 1 % chlorhexidine collagen gel is a promising adjunct to SRP in the treatment of adult periodontitis The clearance of a fluorescein gel applied with an irrigation technique in periodontal pockets was studied . In order to evaluate the time a drug remains in a periodontal pocket , the alteration in concentration of this drug in a given time period was investigated . After application of the gel in 4 pockets of 10 patients , sample s were taken from 1 of the 4 pockets at 5 , 10 , 20 and 40 min . The results show that in the 1st phase , directly after application , most of the gel disappeared from the pocket , while in the 2nd phase , the fluorescein gel is washed out with a calculated 50 % reduction time of 12.5 min . The rapid clearance of the gel observed after irrigation might provide a partial explanation of the minor effect of pocket irrigation on the subgingival microflora Abstract Objective : The aim of this study was to evaluate clinical efficacy of different chlorhexidine gluconate ( CHX ) preparations applied subgingivally as an adjunct to scaling and root planing ( SRP ) . Material and methods : A total of 120 periodontal pockets was included in this r and omized , controlled , split mouth design ed study . According to protocol s used in treatment , periodontal pockets were assigned to experimental and control groups as follows : CHX solution as an addition to SRP versus control SRP group ; CHX gel as an addition to SRP versus control SRP ; CHX chip as an addition to SRP versus control SRP group . Following clinical parameters were recorded at baseline , one and three months after the baseline : plaque index ( PI ) , probing pocket depth ( PPD ) , bleeding index ( BI ) and clinical attachment level ( CAL ) . Results : The most significant improvements were found concerning PI in CHX solution with SRP and CHX gel with SRP groups over controls at one month recall , as well as concerning BI and PPD in CHX chip with SRP group over SRP alone at three-month recall . Conclusion : Results of this study favour combination therapy using CHX chip as an adjunct to SRP due to greater improvements in BI and PPD compared to those obtained by SRP alone in the treatment of chronic periodontitis OBJECTIVES The present controlled , single-blind study was performed to assess and compare the clinical healing and the microbiological findings following repeated intrasulcular applications of 1 % metronidazole or 1 % chlorhexidine gels in persistent periodontal pockets previously treated by scaling and root planing ( SRP ) . MATERIAL AND METHODS Sixty-three systemically healthy subjects , 25 males and 38 females ( mean age 48.4+/-7.2 years ) , diagnosed for chronic periodontitis were enrolled in this study . They underwent SRP and received oral hygiene instructions ( OHI ) . Three months later , at baseline , a single persistent pocket with a probing depth ( PD ) of 5 - 9 mm was chosen as the experimental site in each patient ; the subjects were stratified into three matched experimental groups on the basis of the treatment to be performed , which consisted of the subgingival administration of 1 % metronidazole gel ( MG , n=19 ) , 1 % chlorhexidine gel ( CG , n=20 ) or placebo gel ( PG , n=24 ) . The treatments consisted of four repeated administrations of subgingival gels , each separated by 7 days , starting at the baseline . Clinical assessment was performed at the baseline and at the 180-day follow-up , after the end of treatment . For microbiological evaluations , subgingival plaque was sample d from the experimental sites at baseline , prior to the first subgingival gel administration , and at 7 , 15 , 30 and 90 days after the end of the treatment ( days 28 , 36 , 51 and 111 from baseline ) . RESULTS Plaque accumulation did not change significantly in all three groups . Bleeding on probing and clinical attachment levels reduced in the MGs and CGs only . PD was significantly reduced by the same amount in all experimental groups . In the MGs and CGs a remarkable reduction in the frequencies of detection of several periodontopathic micoorganisms was recorded after the treatment . The same was not seen for the PGs . CONCLUSIONS Subgingival administration of MG or CG , both at 1 % , may have a role in the management of persistent pockets during chronic periodontitis The short-term bactericidal effect of 2 % chlorhexidine gel , 4 % stannous fluoride gel or amine fluoride gel containing 1.25 % fluoride on the subgingival microflora was determined in 40 periodontal pockets of 10 patients . The antimicrobial gels or placebo gel were applied in 5 - 9 mm deep periodontal pockets 3 times within 10 min . Before and 30 min after the applications , sample s were taken of the subgingival microflora for determination of the total number of bacteria as well as the number of black pigmented Bacteroides . Reductions of the total number of bacteria were found in all test groups . The reductions found in the pockets treated with chlorhexidine gel or stannous fluoride gel were significantly greater than the reduction found in the pockets treated with a placebo gel . A significant reduction of black-pigmented Bacteroides was found after treatment with chlorhexidine gel or amine fluoride gel . It is concluded that 2 % chlorhexidine gel or 4 % stannous fluoride gel has a more than 99 % reduction effect on the microflora of periodontal pockets within 30 min after application This study aims to evaluate the oxidative stress changes in patients with chronic periodontitis ( CP ) undergoing non-surgical periodontal therapy alone , compared with non-surgical periodontal therapy with adjunctive systemic antibiotic therapy . Sixteen patients with CP , r and omly assigned into two equal groups , were treated either with scaling and root planing ( SRP ) + Amoxicillin + Metronidazole , each 500 mg , three times daily , for seven days ( test group ) , or with SRP + placebo for seven days ( control group ) . Venous blood and unstimulated saliva sample s were collected . Non-surgical periodontal therapy was performed simultaneously with antibiotics administration . Oxidative stress balance was evaluated by measuring derivatives of reactive oxygen metabolites ( d-ROMs ) and the biological antioxidant potential ( BAP ) in plasma . After the microscopic evaluation of the pathological aspect of the epithelial cells ( ECs ) , their number , viability and the presence of C-reactive protein ( CRP ) were reevaluated from saliva at seven days , while reduced glutathione ( GSH ) level , d-ROMs and BAP at three months . Wilcoxon and Kruskal-Wallis rank-tests were used for statistics . At three months , statistical significant reductions of mean periodontal pocket depth ( PPD ) and clinical attachment level ( CAL ) gains ( both p=0.01 ) were found in test group . Full-mouth plaque score ( FMPS ) decreased statistically significant in control group ( p=0.02 ) , d-ROMs decreased statistically significant in test group ( mean difference 116.24±107.6 U CARR , p=0.01 ) . Mean GSH , BAP level , number of ECs , their viability and CRP were statistically non-significant . In test group patients , oxidative stress status changed from a very high level to a medium one , suggesting that adjunctive use of antibiotics could have contributed to the reduction of reactive oxygen metabolites , along with significant clinical improvements BACKGROUND The use of locally delivered antibacterials containing chlorhexidine ( CHX ) was proposed to improve the effectiveness of non-surgical periodontal treatment . The present multicenter r and omized study investigated the effects of a xanthan-based chlorhexidine ( Xan-CHX ) gel used as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis . METHODS Ninety-eight systemically healthy subjects with moderate to advanced periodontitis were recruited in four centers ( 59 females and 39 males ; aged 24 to 58 years ) . For each subject , two experimental sites located in two symmetric quadrants were chosen with probing depths ( PD ) > or=5 mm and positive for bleeding on probing ( BOP ) . These two sites were r and omized at the split-mouth level with one receiving a single SRP treatment and the other receiving a single SRP + Xan-CHX gel treatment . Supragingival plaque , modified gingival index , PD , clinical attachment level ( CAL ) , and BOP were evaluated at baseline ( prior to any treatment ) and after 3 and 6 months . At the same times , subgingival microbiologic sample s and gingival crevicular fluid ( GCF ) were collected for the analysis of total bacterial counts ( TBCs ) , including the identification of eight putative periodontopathogens , and alkaline phosphatase ( ALP ) activity , respectively . RESULTS The Xan-CHX treatment group showed greater improvements compared to the SRP group for PD and CAL at 3 and 6 months ( P < 0.001 ) . The differences in PD reduction between the treatments were 0.87 and 0.83 mm at 3 and 6 months , respectively ( P < 0.001 ) ; for CAL , these were 0.94 and 0.90 mm , respectively ( P < 0.001 ) . Similar behavior was seen when the subgroup of pockets > or=7 mm was considered . The percentage of sites positive for BOP was similar between the treatments at each time point . For the comparisons between the treatment groups , no differences were seen in the TBCs and GCF ALP activity at baseline and 6 months ; in contrast , slightly , but significantly , lower scores were recorded for the Xan-CHX treatment group at 3 months ( P = 0.018 and P = 0.045 , respectively ) . Moreover , greater reductions in the percentages of sites positive for the eight putative periodontopathic bacteria were generally seen for the Xan-CHX treatment group compared to SRP alone . CONCLUSIONS The adjunctive use of Xan-CHX gel promoted greater PD reductions and CAL gains compared to SRP alone . These results were concomitant with better microbiologic and biochemical outcomes when Xan-CHX gel use was added to SRP , particularly up to 3 months after treatment BACKGROUND There are few r and omized , controlled clinical trials about the effect of non-surgical periodontal treatment on oral health-related quality of life ( OHRQL ) . This study aims to compare the effects of two different forms of non-surgical periodontal therapy , scaling and root planing ( SRP ) per quadrant and one-stage full-mouth disinfection ( FMD ) , on periodontal clinical parameters and OHRQL of patients with chronic periodontitis . METHODS In this r and omized , controlled clinical trial , the question naires Oral Impacts on Daily Performance ( OIDP ) and Oral Health and Quality of Life ( OHQoL ) were given to 90 patients divided into two groups : SRP ( n = 45 ) and FMD ( n = 45 ) . Periodontal clinical parameters recorded included probing depth , clinical attachment level , plaque index , and gingival index . For statistical analysis , χ(2 ) test , Fisher exact test , Mann-Whitney U test , and Wilcoxon test were used . Intention-to-treat analyses were performed at T0 ( baseline ) for periodontal clinical parameters , T1 ( 30 days after treatment ) for question naires , and T2 ( 180 days after treatment ) for both . RESULTS No significant differences were identified between the SRP and FMD groups in regard to OHQoL and OIDP scores when comparing the data of T1 and T2 . CONCLUSION Patients treated by both SRP and FMD showed improvement in all periodontal clinical parameters and OHRQL , with no significant differences between treatment groups |
303 | 32,274,173 | Dyspnea scores improved after aerobic and breathing exercises .
HRQL also improved after aerobic exercise training alone or combined with breathing exercises .
Aerobic training alone or combined with IMT or breathing exercises improved exercise capacity .
Conclusions Breathing exercises appears to complement exercise training towards improved dyspnea and HRQL in patients with IPF | Background Idiopathic pulmonary fibrosis ( IPF ) is a progressive disease associated with significant dyspnea and limited exercise capacity .
This systematic review aim ed to synthesize evidence of exercise interventions during pulmonary rehabilitation that aim to improve exercise capacity , dyspnea , and health-related quality of life ( HRQL ) in IPF patients . | BACKGROUND AND OBJECTIVE It is unclear whether the severity of functional limitation result ing from IPF affects the response to pulmonary rehabilitation . The aim of this study was to compare the outcomes of rehabilitation in patients with IPF , who were grouped according to the Medical Research Council ( MRC ) dyspnoea scale . METHODS Sixty-five subjects ( 46 , 71 % men ) with stable IPF were enrolled in an 8-week pulmonary rehabilitation programme . Subjects with MRC dyspnoea grade s 2 , 3 and 4 undertook a supervised outpatient programme , whereas subjects with MRC dyspnoea grade 5 participated in an unsupervised , home-based programme , with review every 2 weeks . The outcome measures included functional exercise capacity ( 6MWD ) , health status ( Medical Outcomes Study Short Form 36 ( SF-36 ) ) and dyspnoea ( transition dyspnoea index ) , which were measured at baseline and immediately after the programme . Hospitalizations for respiratory exacerbations were compared for the 12 months preceding and following the programme . RESULTS The number of subjects with MRC dyspnoea grade s 2 , 3 , 4 and 5 were 16 ( 25 % ) , 17 ( 26 % ) , 17 ( 26 % ) and 15 ( 23 % ) , respectively . There were differences between these groups in the magnitude of change in 6MWD , SF-36 and transition dyspnoea index ( all P < 0.05 ) . Specifically , subjects with MRC dyspnoea grade 2 or 3 demonstrated clinical ly and statistically significant improvements in 6MWD and SF-36 following rehabilitation ( all P < 0.05 ) . In contrast , for all measures , subjects with MRC dyspnoea grade 4 or 5 showed little or no improvement , or deteriorated following rehabilitation . Hospitalizations were reduced following rehabilitation only in subjects with MRC dyspnoea grade 2 , 3 or 4 ( P<0.05 ) . CONCLUSIONS The response to pulmonary rehabilitation in subjects with IPF varies depending on the MRC grade of dyspnoea , with little benefit being observed in subjects with severe functional limitation RATIONALE The 6-minute-walk test ( 6MWT ) is a practical and clinical ly meaningful measure of exercise tolerance with favorable performance characteristics in various cardiac and pulmonary diseases . Performance characteristics in patients with idiopathic pulmonary fibrosis ( IPF ) have not been systematic ally evaluated . OBJECTIVES To assess the reliability , validity , and responsiveness of the 6MWT and estimate the minimal clinical ly important difference ( MCID ) in patients with IPF . METHODS The study population included all subjects completing a 6MWT in a clinical trial evaluating interferon gamma-1b ( n = 822 ) . Six-minute walk distance ( 6MWD ) and other parameters were measured at baseline and at 24-week intervals using a st and ardized protocol . Parametric and distribution-independent correlation coefficients were used to assess the strength of the relationships between 6MWD and measures of pulmonary function , dyspnea , and health-related quality of life . Both distribution-based and anchor-based methods were used to estimate the MCID . MEASUREMENTS AND MAIN RESULTS Comparison of two proximal measures of 6MWD ( mean interval , 24 d ) demonstrated good reliability ( coefficient = 0.83 ; P < 0.001 ) . 6MWD was weakly correlated with measures of physiologic function and health-related quality of life ; however , values were consistently and significantly lower for patients with the poorest functional status , suggesting good construct validity . Importantly , change in 6MWD was highly predictive of mortality ; a 24-week decline of greater than 50 m was associated with a fourfold increase in risk of death at 1 year ( hazard ratio , 4.27 ; 95 % confidence interval , 2.57- 7.10 ; P < 0.001 ) . The estimated MCID was 24 - 45 m. CONCLUSIONS The 6MWT is a reliable , valid , and responsive measure of disease status and a valid endpoint for clinical trials in IPF BACKGROUND AND OBJECTIVE Although pulmonary rehabilitation is effective for patients with COPD , its efficacy in patients with IPF is unknown . The purpose of this study was to evaluate the effects of pulmonary rehabilitation in IPF . METHODS Thirty patients diagnosed with IPF , according to the consensus statement , were r and omly assigned to the rehabilitation group or the control group . The pulmonary rehabilitation mainly consisted of a 10-week programme of exercise training . Pulmonary function , blood gas analysis , 6MWD , dyspnoea rating with the baseline dyspnoea index and health-related quality of life score on the St George 's Respiratory Question naire were evaluated at baseline and after the programme . RESULTS Assessment of efficacy was carried out on 13 patients who completed the programme and 15 patients in the control group . There were no significant effects of the programme on measures of pulmonary function , values of arterial blood gas analysis or dyspnoea rating . Although there were some differences in the baseline 6MWD and total health-related quality of life score which were not statistically significant , marked improvements were observed in the 6MWD ( mean difference 46.3 m ( 95 % CI : 8.3 - 84.4 ) , P < 0.05 ) and the total health-related quality of life score ( -6.1 ( 95 % CI : -11.7 to -0.5 ) , P < 0.05 ) . CONCLUSIONS Pulmonary rehabilitation improves both exercise capacity and health-related quality of life in patients with IPF Background : Idiopathic pulmonary fibrosis ( IPF ) is a chronic , devastating , interstitial lung disease , with few therapeutic options . IPF is characterized by pulmonary restriction , dyspnea , hypoxemia , exercise intolerance and poor quality of life ( QOL ) . Objectives : We aim ed to examine the effect of exercise training ( ET ) on clinical outcomes in IPF patients . Methods : A r and omized controlled study included thirty-two IPF patients ( aged 68 ± 8 years ) who were allocated either to the ET group ( n = 15 ) , participating in a 12-week , twice-weekly 60-min supervised ET-based pulmonary rehabilitation program , or to a control group ( n = 17 ) continuing with regular medical treatment alone . Cardiopulmonary exercise test , 6-min walking distance ( 6MWD ) test , 30-second chair-st and test , pulmonary function tests , dyspnea and QOL were assessed at baseline and at the end of the 12-week intervention . Results : Significant differences were observed between the ET and the control groups in raw mean deltas ( Δ = post- - pre-intervention ) : Δ6MWD , 81 m , p < 0.001 ; ΔVO2 peak , 2.6 ml/kg/min , p = 0.002 ; Δwork rate , 22 W , p < 0.001 ; Δanaerobic threshold , 3.1 ml/kg/min , p < 0.001 , and ΔFVC % predicted , 6 % , p = 0.038 . Dyspnea , QOL and 30-second chair-st and were also improved significantly following the program . Conclusions : ET improves exercise tolerance , functional capacity , pulmonary function , dyspnea and QOL in patients with IPF , suggesting a short-term treatment efficacy for clinical improvement , and should be considered the st and ard care for IPF INTRODUCTION Idiopathic pulmonary fibrosis ( IPF ) is a severe chronic lung disease . Pulmonary rehabilitation could improve the quality of life of patients with this condition . METHODS We prospect ively evaluated the impact of an 8-week home-based pulmonary rehabilitation programme over 10 months in stable patients suffering from IPF . Exercise capacity , pulmonary function , dyspnoea and quality of life were analyzed before and after the rehabilitation programme . RESULTS Seventeen patients were included and 13 completed the study . Mean functional vital capacity ( FVC ) was 2.15±0.79L and mean diffusing capacity for carbon monoxide ( DLCO ) was 7.81±3.99mL/min/mmHg . Six patients were treated with low dose oral steroids ( 20mg/day of prednisone ) with or without immunosuppressive treatments ; six were taking part in therapeutic trials . Mean endurance time ( 7.4±9.1 min vs. 14.1±12.1 min ; P=0.01 ) , number of steps per minute on a stepper ( 322±97 vs. 456±163 ; P=0.026 ) , six-minute walk distance relative to heart rate ( HR ) ( 11±6 vs. 17±12 ; P=0.006 ) , exercise dyspnoea ( P=0.026 ) , sensation of physical limitation on the SF-36 ( 25%±26 vs. 49%±38 ; P=0.047 ) and four out of seven visual analogue scales were significantly improved after rehabilitation . In contrast , no significant difference was observed in resting pulmonary function or in other items on quality of life question naires . CONCLUSION A home-based programme of pulmonary rehabilitation is feasible in IPF patients . It significantly improved endurance parameters and physical limitation in this patient group without changing pulmonary function Background Patients with idiopathic pulmonary fibrosis ( IPF ) have severely limited exercise capacity due to dyspnea , hypoxemia , and abnormal lung mechanics . This pilot study was design ed to determine whether pulmonary rehabilitation were efficacious in improving the 6-min walk test ( 6-MWT ) distance , exercise oxygen uptake , respiratory muscle strength [ maximum inspiratory pressure ( MIP ) ] , and dyspnea in patients with IPF . Underlying physiological mechanisms and effects of the intervention were investigated . Methods Subjects were r and omly assigned to a 3-month pulmonary rehabilitation program ( n = 11 ) or to a control group ( n = 10 ) . All subjects initially underwent the 6-MWT and constant load exercise gas exchange studies . Results Subjects in the rehabilitation group increased treadmill exercise [ metabolic equivalent of task-minutes ] over the first 14 sessions . Beneficial effects on physical function result ed in those who completed rehabilitation . Subjects who completed the program increased cycle ergometer time and maintained exercise oxygen consumption ( exercise VO2 ) at the baseline level over 3 months , while the control group suffered a significant decrease in exercise VO2 . Rehabilitation subjects also increased their MIP . Plasma lactate doubled and brain natriuretic peptide levels increased significantly after exercise , as did the plasma amino acids glutamic acid , arginine , histidine , and methionine . These changes were associated with significant decreases in arterial oxygen saturation and increases in 15-F2t-isoprostanes after exercise . Conclusions Pulmonary rehabilitation effectively maintained exercise oxygen uptake over 3 months and lengthened constant load exercise time in patients with moderately severe IPF . Exercise endurance on cycle ergometry testing was limited by dyspnea and severe hypoxemia associated with systemic oxidant stress OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity BACKGROUND Pulmonary rehabilitation improves outcomes in patients with interstitial lung disease ( ILD ) , however it is unclear whether these effects are long lasting and which patients benefit most . METHODS Patients with ILD were recruited into this prospect i ve cohort study from three pulmonary rehabilitation programs . Patients completed functional assessment s ( 6-minute walk distance ( 6MWD ) , and 4-meter walk time ) and surveys ( quality of life , dyspnea , depression , and physical activity ) before rehabilitation , after rehabilitation , and at six months . Changes from baseline were compared using a paired t-test . Independent predictors of change in 6MWD and quality of life were determined using multivariate analysis . RESULTS Fifty-four patients were recruited ( 22 with idiopathic pulmonary fibrosis ) , 50 patients ( 93 % ) completed the rehabilitation program , and 39 returned for six-month follow-up . 6MWD improved 57.6 m immediately after rehabilitation ( 95 % confidence interval ( CI ) 40.2 - 75.1 m , p < 0.0005 ) , and remained 49.8 m above baseline at six months ( 95%CI 15.0 - 84.6 m , p = 0.005 ) . The majority of patients achieved the minimum clinical ly important difference for quality of life ( 51 % ) , dyspnea ( 65 % ) , and depression score ( 52 % ) immediately after rehabilitation , and improvements were still significant at 6-month follow-up for quality of life , depression , and physical activity . A low baseline 6MWD was the only independent predictor of improvement in 6MWD during rehabilitation ( r = -0.49 , p < 0.0005 ) . Change in 6MWD was an independent predictor of change in quality of life ( r = -0.36 , p = 0.01 ) . CONCLUSIONS Pulmonary rehabilitation improved multiple short- and long-term outcomes in patients with ILD . While all patients appear to benefit , ILD patients with a low baseline 6MWD had greater benefit from rehabilitation . CLINICAL TRIALS REGISTRATION NUMBER NCT01055730 ( clinical trials.gov ) BACKGROUND : Although pulmonary rehabilitation ( PR ) has been reported to improve exercise capacity in patients with idiopathic pulmonary fibrosis , it is unknown which exercise measurement is the most responsive for evaluation of PR efficacy . The purpose of this study was to compare the responsiveness of 5 exercise measurements by evaluating the efficacy of PR in subjects with idiopathic pulmonary fibrosis . METHODS : We conducted a prospect i ve observational study in which 53 subjects with idiopathic pulmonary fibrosis were enrolled . The PR group underwent a 10-week out-patient PR program . The control group was observed without any additional intervention , including PR . Five exercise measurements ( endurance time [ ET ] , peak work rate , peak oxygen consumption [ V̇O2 ] , 6-min walk distance , and incremental shuttle walk distance ) were evaluated at baseline and after 10 weeks . The effect size was used for the assessment of responsiveness . RESULTS : In each group , 24 subjects completed the 5 measurements at baseline and after 10 weeks . The changes in ET ( PR : 181.6 % ; control : −8.2 % ) , peak V̇O2 ( PR : 7.6 % ; control : −5.4 % ) , peak work rate ( PR : 15.1 % ; control : −5.1 % ) , 6-min walk distance ( PR : 6.0 % ; control : −3.8 % ) , and incremental shuttle walk distance ( PR : 9.1 % ; control : −5.1 % ) were significantly different between the groups after 10 weeks ( P < .05 ) . In the PR group , ET showed the most striking improvement among the 5 measurements ( P < .05 ) , and its effect size was as large as 2.96 , whereas those of the others were all < 0.5 . CONCLUSIONS : ET is the most responsive exercise measurement for evaluating PR efficacy in patients with idiopathic pulmonary fibrosis Background : The benefits of pulmonary rehabilitation in chronic obstructive pulmonary disease ( COPD ) are well recognized . However , whether individuals with idiopathic pulmonary fibrosis ( IPF ) benefit is less clear . Objectives : To evaluate the effects of pulmonary rehabilitation in subjects with IPF and compare their responses with a group of COPD subjects who underwent an identical program . Methods : For- ty-five subjects with IPF and 45 age- and Medical Research Council grade -matched COPD subjects were recruited . Subjects completed an 8-week outpatient pulmonary rehabilitation program . Dyspnea , peripheral muscle force , exercise capacity ( 6-min walk distance , 6MWD ) , activities of daily living , and health status ( 36-item short-form survey , SF-36 ) were assessed at baseline , immediately following and at 6 months following completion of the program . Results : Adherence to the program was similar in both groups . Significant improvements in dyspnea , muscle force , exercise capacity and ADL were observed in both groups ( all p < 0.05 ) ; however , the magnitude of improvement in all outcomes was less in the IPF group [ mean ( 95 % CI ) improvement in 6MWD , IPF 16.2 ( 7.1–25.4 ) ; COPD 53.1 ( 44.9–61.2 ) ] . All domains of SF-36 , with the exception of social function , improved ( all p < 0.05 ) in the COPD group ; however , there were no changes in SF-36 scores in the IPF group . The benefits were well maintained in the COPD group at 6 months , but , with the exception of the ADL score , the benefits were no longer present in the IPF group . Conclusions : Pulmonary rehabilitation in IPF produces only modest short-term gains in dyspnea , exercise capacity and ADL , but does not improve health status We studied interrelationships between exercise endurance , ventilatory dem and , operational lung volumes , and dyspnea during acute hyperoxia in ventilatory-limited patients with advanced chronic obstructive pulmonary disease ( COPD ) . Eleven patients with COPD ( FEV(1.0 ) = 31 + /- 3 % predicted , mean + /- SEM ) and chronic respiratory failure ( Pa(O(2 ) ) 52 + /- 2 mm Hg , Pa(CO(2 ) ) 48 + /- 2 mm Hg ) breathed room air ( RA ) or 60 % O(2 ) during two cycle exercise tests at 50 % of their maximal exercise capacity , in r and omized order . Endurance time ( T(lim ) ) , dyspnea intensity ( Borg Scale ) , ventilation ( V E ) , breathing pattern , dynamic inspiratory capacity ( IC(dyn ) ) , and gas exchange were compared . Pa(O(2 ) ) at end-exercise was 46 + /- 3 and 245 + /- 10 mm Hg during RA and O(2 ) , respectively . During O(2 ) , T(lim ) increased 4.7 + /- 1.4 min ( p < 0.001 ) ; slopes of Borg , V E , V CO(2 ) , and lactate over time fell ( p < 0.05 ) ; slopes of Borg-V E , V E-V CO(2 ) , V E-lactate were unchanged . At a st and ardized time near end-exercise , O(2 ) reduced dyspnea 2.0 + /- 0.5 Borg units , V CO(2 ) 0.06 + /- 0.03 L/min , V E 2.8 + /- 1.0 L/min , and breathing frequency 4.4 + /- 1.1 breaths/min ( p < 0.05 each ) . IC(dyn ) and inspiratory reserve volume ( IRV ) increased throughout exercise with O(2 ) ( p < 0.05 ) . Increased IC(dyn ) was explained by the combination of increased resting IRV and decreased exercise breathing frequency ( r(2 ) = 0.83 , p < 0.0005 ) . In conclusion , improved exercise endurance during hyperoxia was explained , in part , by a combination of reduced ventilatory dem and , improved operational lung volumes , and dyspnea alleviation BACKGROUND : Information on the benefits of pulmonary rehabilitation ( PR ) in patients with idiopathic pulmonary fibrosis ( IPF ) is growing , but PR 's effects on certain important outcomes is lacking . METHODS : We conducted a pilot study of PR in IPF and analyzed changes in functional capacity , fatigue , anxiety , depression , sleep , and health status from baseline to after completion of a st and ard , 6-week PR program . RESULTS : Six-min walk distance improved a mean ± st and ard error 202 ± 135 feet ( P = .01 ) from baseline . Fatigue Severity Scale score also improved significantly , declining an average 1.5 ± 0.5 points from baseline . There were trends toward improvement in anxiety , depression , and health status . CONCLUSIONS : PR improves functional capacity and fatigue in patients with IPF . ( Clinical Trials.gov registration NCT00692796 . Background Uncertainty exists regarding the clinical relevance of exercise training across the range of interstitial lung diseases ( ILDs ) . Objective To establish the impact of exercise training in patients with ILDs of differing aetiology and severity . Methods 142 participants with ILD ( 61 idiopathic pulmonary fibrosis ( IPF ) , 22 asbestosis , 23 connective tissue disease-related ILD ( CTD-ILD ) and 36 with other aetiologies ) were r and omised to either 8 weeks of supervised exercise training or usual care . Six-minute walk distance ( 6MWD ) , Chronic Respiratory Disease Question naire ( CRDQ ) , St George Respiratory Question naire IPF-specific version ( SGRQ-I ) and modified Medical Research Council dyspnoea score were measured at baseline , 9 weeks and 6 months . Measurements and main results Exercise training significantly increased 6MWD ( 25 m , 95 % CI 2 to 47 m ) and health-related quality of life ( CRDQ and SGRQ-I ) in people with ILD . Larger improvements in 6MWD , CRDQ , SGRQ-I and dyspnoea occurred in asbestosis and IPF compared with CTD-ILD , but with few significant differences between subgroups . Benefits declined at 6 months except in CTD-ILD . Lower baseline 6MWD and worse baseline symptoms were associated with greater benefit in 6MWD and symptoms following training . Greater gains were seen in those whose exercise prescription was successfully progressed according to the protocol . At 6 months , sustained improvements in 6MWD and symptoms were associated with better baseline lung function and less pulmonary hypertension . Conclusions Exercise training is effective in patients across the range of ILDs , with clinical ly meaningful benefits in asbestosis and IPF . Successful exercise progression maximises improvements and sustained treatment effects favour those with milder disease . Trial registration number Results , ACTRN12611000416998 Background Few data are available on the long-term effect of pulmonary rehabilitation ( PR ) and on long PR programs in interstitial lung diseases (ILD).We aim ed to evaluate the effects of PR on exercise capacity ( 6-Minute Walking Distance , 6MWD ; Peak Work Rate , Wmax ) , quality of life ( St George ’s Respiratory Question naire , SGRQ ) , quadriceps force ( QF ) and objective ly measured physical activity in ILD after the 6-month PR-program and after 1 year . Methods 60 patients ( 64 ± 11 years ; 62 % males ; 23 % with IPF ) were r and omly assigned to receive a 6 month-PR program or usual medical care . Results Exercise capacity , quality of life and muscle force increased significantly after the program as compared to control ( mean,95%CI[ll to ul ] ; 6MWD + 72,[36 to 108 ] m ; Wmax 19 , [ 8 to 29]%pred ; SGRQ − 12,[− 19 to − 6 ] points ; QF 10 , [ 1 to 18 ] % pred ) . The gain was sustained after 1 year ( 6MWD 73,[28 to 118 ] m ; Wmax 23 , [ 10 to 35]%pred ; SGRQ − 11,[− 18 to − 4 ] points ; QF 9.5 , [ 1 to 18 ] % pred ) . Physical activity did not change . Conclusions PR improves exercise tolerance , health status and muscle force in ILD . The benefits are maintained at 1-year follow-up . The intervention did not change physical activity . Trial registration Clinical trials.gov NCT00882817 Background : Although mainly described in patients with chronic obstructive pulmonary disease , pursed lip breathing ( PLB ) could prove useful in patients with interstitial lung disease ( ILD ) by improving exertional tachypnea and respiratory control . This prospect i ve , r and omized , crossover trial aim ed at evaluating the impact of PLB on dyspnea and walking distance in ILD patients . Methods : ILD patients with total lung capacity of < 80 % predicted were r and omized to 6-min walk tests using either PLB or usual breathing . Patients were crossed over for the second 6-min walk tests and served as their own controls . Ventilatory and metabolic variables were recorded using a portable metabolic cart and were compared at 1-min intervals . Results : Thirty-five patients were included ( mean forced vital capacity of 64 ± 10 % predicted ) . Use of PLB result ed in lower mean respiratory rates and larger tidal volumes ( both P < .001 ) , worsened dyspnea ratings ( post-6-min walk test Borg score : 5.2 ± 2.6 vs 4.2 ± 2.3 , P < .001 ) , and walking distance ( 403 ± 102 m vs 429 ± 93 m , P < .001 ) . Twenty-nine patients ( 83 % ) described PLB as less comfortable than usual breathing . Both groups had similar total ventilation and oxygen saturation ( all P > .05 ) , but PLB result ed in higher mean oxygen uptake ( 13.9 ± 3.6 vs 12.9 ± 3.2 mL/kg/min , P = .02 ) , even when corrected for walking distance ( P < .001 ) . Conclusion : In ILD patients , acute exposure to PLB did not improve exertional dyspnea , walking distance , or gas exchange , and was associated with higher metabolic dem and s than usual breathing . These results cast doubt on the usefulness of this technique in ILD patients and should be taken into account when tailoring pulmonary rehabilitation programs to this population |
304 | 25,180,438 | BTX-A application demonstrated no changes in the passive stiffness of spastic muscle .
In relation to functional level , the evidence of BTX-A effect was controversial . | OBJECTIVE This article aim ed to review the literature to verify the effect of botulinum toxin type A ( BTX-A ) on the intrinsic properties of spastic muscles and functionality in children with cerebral palsy ( CP ) . | Despite the lack of consensus of the role of spasticity in the observed motor disability in cerebral palsy ( CP ) , alleviation of spasticity remains a primary focus in the clinical management of these patients . The purpose s of this study were to : ( 1 ) quantify voluntary torque and passive resistance across speeds in the hamstrings and quadriceps muscle groups with respect to the presence of stretch responses and /or passive muscle stiffness in patients with CP compared to age-related children without disability , and ( 2 ) relate these parameters to each other and to functional performance , as measured by the Gross Motor Function Measure ( GMFM ) , in CP . Included were 23 subjects with CP , sub-grouped by the presence or absence of stretch responses as determined by electromyography , and 9 subjects without CP . Results indicated that peak torque was considerably greater in the comparison group than for each of the CP groups and resistance was greater in the CP group with spasticity compared to the nonspastic CP group in both muscles at all speeds . Stiffness differed between the spastic CP group and the comparison group only for the quadriceps at the fastest speed . Higher passive resistance torque and stiffness were correlated with decreased voluntary torque , particularly for the antagonists , and with lower GMFM scores . In conclusion , strength and motor function are related to the magnitude of resistance torque and stiffness in CP , although the small amount of variance explained reinforces the multidimensional nature of this disorder , and the challenges inherent in managing it Authors report the preliminary results of an open-label , prospect i ve study to evaluate a functional benefit of botulinum toxin type A injections in diparetic cerebral palsy patients , using gross motor function measure ( GMFM ) score . In a group of 14 children ( mean age 3.9 years , range 2 - 6 ) treated with Dysport 30 IU/kg , a statistically significant improvement ( P < 0.05 ) was noticed in both simple measurements ( Modified Ashworth Scale , Selective Motor Control , Passive Range of Movements , Physician Rating Scale and parental Clinical Global Impression ) and complex functions ( GMFM dimensions D and E ) after 1 and 3 months . However , the simple measurement scores decreased ( but not to the baseline ) after 3 months ; surprisingly , GMFM scores were still increasing ( 7.7 % change after 3 months and 11.3 % change after 6 months in nine patients ) . These results are in concordance with a few other data published to date . The study may support the concept of persistent functional gain in long-term treatment of spasticity caused by cerebral palsy with botulinum toxin type Botulinum neurotoxin type-A ( BoNT-A ) has been used in association with other interventions in the management of spasticity in children with cerebral palsy ( CP ) for almost two decades . This consensus statement is based on an extensive review of the literature by an invited international committee . The use of BoNT-A in the lower limbs of children with spasticity caused by CP is reported using the American Academy of Neurology Classification of Evidence for therapeutic intervention . R and omized clinical trials have been grouped into five areas of management , and the outcomes are presented as treatment recommendations . The assessment of children with CP and evaluation of outcomes following injection of BoNT-A are complex , and therefore , a range of measures and the involvement of a multidisciplinary team is recommended . The committee concludes that injection of BoNT-A in children with CP is generally safe although systemic adverse events may occur , especially in children with more physical limitations ( GMFCS V ) . The recommended dose levels are intermediate between previous consensus statements . The committee further concludes that injection of BoNT-A is effective in the management of lower limb spasticity in children with CP , and when combined with physiotherapy and the use of orthoses , these interventions may improve gait and goal attainment OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVES . The purpose of this work was to assess the effect of botulinum toxin A and occupational therapy compared with occupational therapy alone on body structure , activities participation , and self-perception in a sample of children ( aged 3–16 years ) with hemiplegic cerebral palsy recruited from a statewide register . PATIENTS AND METHODS . Participants of this single-blind , r and omized , controlled trial identified from a population -based cerebral palsy register received either an individually prescribed and localized injection of botulinum toxin A with 4 sessions of occupational therapy over 4 weeks ( intervention ) or occupational therapy alone ( control ) . Outcomes were assessed from 2 domains of the World Health Organization International Classification of Functioning , Disability , and Health : body structure ( Modified Ashworth Scale and Tardieu Scale ) and activities participation ( Assessment of Motor and Process Skills , Goal Attainment Scale , Pediatric Evaluation of Disability Inventory , and Pediatric Quality of Life Inventory ) . Self-perception was also measured . RESULTS . All of the participants ( intervention : n = 21 ; control : n = 22 ) provided data at baseline and 3 and 6 months . Mean age was 8.6 years ; 23 were boys and 20 were girls . At 3 months , children allocated to receive the intervention performed significantly better in terms of body structure and activities participation . They reported improvements in self-perception for the global self-worth domain . At 6 months , the differences between the intervention and control groups persisted for the measures of body structure but not for activities participation or self-perception . CONCLUSION . Botulinum toxin A injection combined with a low-intensity occupational therapy program achieves significant improvements in body structure , activity participation , and self-perception The purpose of this study was to compare the cumulative efficacy ( three treatment sessions ) of botulinum toxin A ( BTX-A ) alone , casting alone , and the combination of BTX-A and casting in the management of dynamic equinus in ambulatory children with spastic cerebral palsy ( CP ) . Thirty-nine children with spastic CP ( mean age 5y 10mo , range 3 to 9y ) were enrolled in the study . A multicenter , r and omized , double blind , placebo-controlled prospect i ve study was used . Children were r and omly assigned to one of three treatment groups : BTX-A only ( B ) , placebo injection plus casting ( C ) , or BTX-A plus casting ( B+C ) . The dosage for the BTX-A injections was 4U/kg per extremity . Assessment s were performed at baseline , 3 , 6 , 7.5 , and 12 months with a total of three treatments administered after the evaluations at baseline , 3 , and 6 months . Primary outcome measures were ankle kinematics , velocity , and stride length . Secondary outcome measures were ankle spasticity , strength , range of motion , and ankle kinetics . Group B made no significant change in any variable at any time . Groups C and B+C demonstrated significant improvements in ankle kinematics , spasticity , passive range of motion , and dorsiflexor strength . Results of this 1-year study indicate that BTX-A alone provided no improvement in the parameters measured in this study , while casting and BTX-A/casting were effective in the short- and long-term management of dynamic equinus in children with spastic CP OBJECTIVE To evaluate the changes in cortical somatosensory-evoked potentials ( SEPs ) after botulinum toxin type A injection to determine what effect spasticity has on cortical SEPs . DESIGN Intervention study and before-after trial . SETTING University-affiliated hospital in Korea . PARTICIPANTS Twelve children with spastic hemiplegic cerebral palsy ( CP ) , 7 children with spastic diplegic CP , and 8 patients with traumatic brain injury . INTERVENTION All participants had botulinum toxin type A injected into the muscles of the spastic limb . MAIN OUTCOME MEASURES SEPs were recorded before and 7 days after the botulinum toxin type A injection . Spasticity of the affected spastic limb was also measured . The short latency and amplitude of waves in SEPs were measured . The SEP results were divided into 3 groups : flat ( no evoked potential ) , abnormal ( evoked but delayed in latency ) , and normal ( clear waveform with normal latency ) . RESULTS The normal response of cortical SEP increased after injection . The SEPs exhibited more frequent improvement in the limbs , with greater improvement of spasticity in grade ( > 1.0 grade ) and in patients of younger age ( < 3y ) after injection ( P<.05 ) . CONCLUSION The observed improvement of cortical SEPs with associated reduction of spasticity that occurred after the botulinum toxin type A injection indicates that spasticity itself can be considered a factor affecting cortical SEPs Aim Stiffness and shortening of the calf muscle due to neural or mechanical factors can profoundly affect motor function . The aim of this study was to investigate non‐neurally mediated calf‐muscle tightness in children with cerebral palsy ( CP ) before and after botulinum toxin type A ( BoNT‐A ) injection Resistance training of the lower limbs is now commonly used in clinical practice in children and adolescents with spastic cerebral palsy ( CP ) . However , the effectiveness of this type of training is still disputed . The most recently published systematic review with meta- analysis included interventions such as electrical stimulation and resistance training and found insufficient evidence to support or refute the efficacy of these exercises in children with CP . Thus , the aim of this article is to evaluate the extent to which training protocol s from the most recent r and omized controlled trials are in keeping with the evidence for effective resistance training in children who are developing typically , as reflected in the training guidelines of the National Strength and Conditioning Association . Recommendations for resistance training protocol s , based on this evidence and appropriate to children with CP , are provided to help guide both future research and clinical practice for resistance training in children with CP It has been demonstrated that botulinum toxin type A ( BTX‐A ) injections reduce spasticity and improve muscle growth in children with spasticity . It has been postulated that BTX‐A allows the learning of more normal movement patterns . The aim of this study was to measure the effect of this treatment on functional ability , as measured by the Gross Motor Function Measure ( GMFM ) , in children with spastic hemiplegic cerebral palsy . Children of 3–13 years and meeting the selection criteria were r and omly allocated to the control or injection group using a matched pair design . A match constituted a child within 6 months of age with the same Modified Ashworth Score ( MAS ) for the gastroc‐soleus and within 10 % of the same goal scores on the Gross Motor Function Measure . Twelve matched pairs were enrolled . Outcomes were measured on enrolment and at 1 , 3 and 6 months post injection . The time course of the response to BTX‐A was assessed with measurements of the MAS , dynamic range of motion ( R1 ) and static muscle length ( R2 ) . Motor function was assessed using the 88‐item GMFM and parental satisfaction with a 10‐point visual analogue scale . Within pair comparisons of the GMFM using the Wilcoxon signed rank test indicated that the treatment group made significantly greater gains than controls at 3 months ( P=0.02 ) with even greater differences seen at 6 months ( P=0.004 ) . Using parametric statistics , the intrapair difference in proportional change of GMFM increased from 35 % ( 4 to 65 ) at 3 months to 52 % ( 17–87 ) at 6 months . Response to injection was confirmed by a decrease in MAS in the treatment group and very little change in controls . This difference was significant ( P=0.002 ) at 3 months and was attenuated but still significant ( P=0.016 ) at 6 months ; the difference in proportional change decreased from 44 % at 3 months to 22 % at 6 months . Changes in R1 reflected those of MAS in the treatment group and deteriorated significantly over the study period in controls . Parents of children in the treatment group were more satisfied than controls , but satisfaction scores did not correlate with changes in function or technical outcomes suggesting that this may be a placebo effect . The changes in GMFM correlated with changes in technical outcomes at 3 months , suggesting a causal relationship . The intrapair differences in GMFM continued to increase even after the local response to injection had started to wane BACKGROUND Cerebral palsy is the commonest cause of severe physical disability in childhood . For many years treatment has centred on the use of physiotherapy and orthotics to overcome the problems of leg spasticity , which interferes with walking and can lead to limb deformity . Intramuscular botulinum toxin ( BT-A ) offers a targeted form of therapy to reduce spasticity in specific muscle groups . AIMS To determine whether intramuscular BT-A can improve walking in children with cerebral palsy . DESIGN R and omised , double blind , placebo controlled trial . METHODS Forty patients with spastic diplegia or hemiplegia were enrolled . Twenty two received botulinum toxin and 18 received placebo . The primary outcome measure was video gait analysis and secondary outcome measures were gross motor function measure ( GMFM ) , physiological cost index ( PCI ) , and passive ankle dorsiflexion . RESULTS Video gait analysis showed clinical ly and statistically significant improvement in initial foot contact following BT-A at six weeks and 12 weeks compared to placebo . Forty eight per cent of BT-A treated children showed clinical improvement in VGA compared to 17 % of placebo treated children . The GMFM ( walking dimension ) showed a statistically significant improvement in favour of the botulinum toxin treated group . Changes in PCI and passive ankle dorsiflexion were not statistically significant . CONCLUSION The study gives further support to the use of intramuscular botulinum toxin type A as an adjunct to conventional physiotherapy and orthoses to reduce spasticity and improve functional mobility in children with spastic diplegic or hemiplegic cerebral palsy The objective of this study was to investigate the effects of botulinum toxin A ( BTA ) injection in reducing muscular spasticity and improving locomotor function in children with cerebral palsy . Thirty-eight children with spastic cerebral palsy who were undergoing regular physical therapy were enrolled . Twenty-eight of these received BTA injection at the hip adductors and /or gastrocnemius , while the other 10 , whose parents refused the BTA treatment protocol , served as the comparison group . The main outcome measures were : improvements in the severity of spasticity , walking distance , gross motor function ( as assessed with the Gross Motor Function Measure , GMFM ) , and gait pattern ( as assessed with the Physician Rating Scale , PRS ) , all measured 6 and 12 weeks after the start of BTA treatment . The severity of spasticity and walking distance at baseline did not differ significantly between the two groups . However , the severity of spasticity improved markedly in the BTA group , from 2.7 to 1.5 ( Modified Ashworth Scale ) at the hip adductor , and from 2.9 to 1.9 at the gastrocnemius at the 6-week follow-up . The walking distance improved from 46.17 m to 55.32 m at the 6-week follow-up , and to 66.6 m at the 12-week follow-up in the BTA group . Marked improvements in the quality of several gross motor functions were also noted in the BTA group . The improvements in spasticity , walking distance , and gross motor function were significantly greater in the BTA group than in the comparison group . The improvements in gait pattern did not differ significantly between the BTA and comparison groups . The findings of this study show BTA injection to be an effective treatment for reducing spasticity and improving gross motor function in children with spastic cerebral palsy . GMFM provides objective evidence regarding functional improvement after treatment in this patient population The present study was to compare the effects of combined therapy [ botulinum ( BTX ) plus physiotherapy ] with physiotherapy alone using diffusion tensor imaging ( DTI ) derived fractional anisotropy ( FA ) values of motor and sensory fiber bundles and clinical grade of the disability to see the value of BTX in term children with spastic diplegic cerebral palsy ( CP ) . Clinical ly diagnosed 36 children participated in the study . All these children were born at term , and had no history of seizures . The study was r and omly categorized into two groups : group I ( n=18 ) - physiotherapy alone and group II ( n=18 ) - physiotherapy plus BTX injection . Quantitative diffusion tensor tractography on all these children was performed on motor and sensory fiber bundles on baseline as well as after 6months of therapy . Motor function and clinical grade s were also measured by gross motor function measures ( GMFM ) scale on both occasions . We observed significant change in FA value in motor and sensory fiber bundle as well as in GMFM scores at 6months compared to baseline study in both the groups . However , delta change and relative delta change in FA values of sensory and motor fiber bundle as well as GMFM score between group I and group II was statistically insignificant . We conclude that addition of BTX to physiotherapy regimen does not influence the outcome at 6months with similar insult in children with term diplegic spastic CP . This information may influence management of diplegic CP especially in developing countries , where BTX is beyond the reach of these children Objective measures ( kinematics and kinetics ) were used to study prospect ively the effects of botulinum toxin A ( BTX/A ) on the gastro-soleus muscle in ambulant children with cerebral palsy . In this prospect i ve before and after trial , 15 children with diplegia and 10 children with hemiplegia were studied ( mean age 5 years 7 months , range 4 years to 9 years ) . A range of st and ardized clinical measures was undertaken but the emphasis for this report is on the three-dimensional gait analysis ( 3DGA ) results . All children showed improvements in sagittal ankle kinematics , as has been previously reported . Two new measures of ankle kinetics were devised : ankle moment quotient ( AMQ ) , and ankle power quotient ( APQ ) . Before intervention , ankle moments were characterized by a ' double bump ' ankle moment . A typical abnormal baseline ankle-power curve was triphasic with an initial trough of absorption followed by abnormal mid-stance power generation , instead of the usual A1 pattern , and reduced terminal stance power generation ( A2 ) . Three weeks after treatment with BTX/A alone there was a statistically significant improvement of AMQ and APQ ; some patients required potentiation of BTX/A with a short period of serial casts . Both groups ( BTX/A alone and BTX/A plus casting ) continued to show improvement in ankle kinetics from baseline after 12 and 24 weeks . This is the first study to demonstrate improvements in the typical abnormal ankle kinetics which we believe provides evidence of the ' biomechanical transformation of muscle ' OBJECTIVE Botulinum toxin A inhibits presynaptic release of acetylcholine at the neuromuscular junction and has reportedly been successful in the treatment of spastic disorders . This prospect i ve study attempted to determine whether botulinum toxin A injection result ed in clinical ly measurable gains for 4 mo . DESIGN Measurements were obtained from 32 children ( range , 1 - 18 yr ; average age , 6.9 yr ) with hemiplegic or quadriplegic cerebral palsy before and at 1 , 3 , and 4 mo after botulinum toxin A injections . Spasticity was measured using the Modified Ashworth Scale for 12 different joints . RESULTS Results showed that spasticity as measured by Ashworth scores for elbow and wrist extension clearly declined ( P < 0.02 ) by 1 mo after botulinum toxin A injection , and diminished spasticity continued for 3 - 4 mo . Caregivers reported improvement in subjectively rated management , appearance , and function . However , patient response to botulinum toxin A injection was not predictable . Age had no significant relationship to gains . CONCLUSIONS Further research is needed on the use of botulinum toxin A to diminish spasticity and improve function Rameckers EAA , Speth LAWM , Duysens J , Vles JSH , Smits-Engelsman BCM : Kinematic aim ing task : measuring functional changes in h and and arm movements after botulinum toxin-a injections in children with spastic hemiplegia . Am J Phys Med Rehabil 2007;86:538–547 . Objective : To describe different aspects of a kinematic aim ing task ( KAT ) as a quantitative way to assess changes in arm movements within 2 wks after botulinum toxin-A ( BTX-A ) injections in children with spastic hemiplegia . Design : Intervention study r and omized clinical trial ; follow-up within 4 wks after baseline measurement . Results : The KAT gave a high intraclass correlation on movement time , spread of end points ( END ) , and index of performance effective ( IP-E ) . After BTX-A , a significant increase of END and IP-E was shown if precision dem and in the KAT was high , whereas the inverse occurred when speed was more important . These functional changes coincided with a significant decrease of the maximum voluntary contraction of the flexor muscles of the forearm . Muscle tone measured with the Ashworth scale did show a nonsignificant decrease of muscle tone , as did the stretch restricted angle and the active and passive ranges of motion of the elbow and wrist . Conclusions : Muscle force decreased immediately after BTX-A , showing the direct effect of BTX-A. The KAT is an adequate , reproducible way to quantify functional changes after BTX-A in the upper limb . BTX-A has an inverse effect in the precision task when accuracy is important , and it has a positive effect when speed prevails Adductor spasticity in children with cerebral palsy ( CP ) impairs motor function and development . In a placebo-controlled , double-blind , r and omized multicentre study , we evaluated the effects of botulinum toxin A(BTX-A ) in 61 children ( 37 males , 24 females ; mean age 6 years 1 month [ SD 3y 1mo ] ) with CP ( leg-dominated tetraparesis , n=39 ; tetraparesis , n=22 ; GMFCS level I , n=3 ; II , n=6 ; III , n=17 ; IV , n=29 ; V , n=6 ) . Four weeks after treatment , a significant superiority of BTX-A was observed in the primary outcome measure ( knee-knee distance ' fast catch ' , p=0.002 ) , the Ashworth scale ( p=0.001 ) , and the Goal Attainment Scale ( p=0.037 ) The objective of this study was to determine whether the use of intramuscular botulinum toxin A ( BTX-A ) increases upper limb function and skills in the context of a specific therapy programme in children with hemiparetic cerebral palsy . Twenty children ( nine females , 11 males ) aged 4 to 16 years who were thought likely to benefit from BTX-A treatment were included . After matched pairs were made , on the basis of Zancolli grade and age , r and omization took place . All patients were given structured rehabilitation ( physiotherapy and occupational therapy three times a week for 6 months ) , and half of the patients received intramuscular BTX-A. No placebo injections were given in the control group . Participants were assessed at baseline , at 2 and 6 weeks , and at 3 , 6 , and 9 months after injection . The Ashworth scale , active range of motion of arm joints , the Melbourne assessment of upper limb function , the Pediatric Evaluation of Disability Inventory , and the nine-hole peg test were used for outcome measurement . Observers were blinded for treatment allocation only for scoring the Melbourne test . The children in the treatment group showed a clinical ly relevant increase in active dorsal flexion , and tone reduction of the wrist . For the functional outcome measures , no statistically significant differences between the groups could be demonstrated . Intramuscular BTX-A added to an intensive therapy programme reduces impairment for at least 9 months ; the effect on activity level is still uncertain |
305 | 28,458,581 | The IUD is a long-acting reversible contraceptive method that is suitable for use in all women undergoing CS . | BACKGROUND Women who undergo a cesarean section ( CS ) are in a unique position to receive the intrauterine contraceptive device ( IUD ) .
They may also want to use the IUD as a long-acting reversible contraceptive method provided the IUD is safe and effective in the presence of a CS scar . | OBJECTIVE To compare the expulsion rate of Nova-T380 , Multiload 375 , and Copper-T380A intrauterine contraceptive devices ( IUCDs ) inserted during cesarean delivery . METHODS A comparative r and omized study was conducted between January 1 , 2013 , and June 30 , 2014 , in three maternity centers in Egypt and Saudi Arabia . All women scheduled for an elective cesarean and accepting intraoperative insertion of an IUCD were r and omly allocated to receive the Nova-T380 ( group 1 ) , Multiload 375 ( group 2 ) , or Cu-T380A ( group 3 ) using a computer-generated table . Research ers and participants were not masked to the type of IUCD . Follow-up was for 1 year . The primary outcome was IUCD expulsion ( complete or partial [ i.e. displacement ] ) . RESULTS Each group contained 40 participants . At 1 year , expulsion had been reported for 5 ( 13 % ) women in group 1 , 2 ( 5 % ) in group 2 , and 6 ( 15 % ) in group 3 ( P>0.05 for all ) . The frequency of displacement was significantly lower in group 2 ( 5 [ 13 % ] participants ) than in group 1 ( 15 [ 38 % ] ; P=0.001 ) and group 3 ( 14 [ 35 % ] ; P=0.008 ) . CONCLUSION Despite a comparable risk of expulsion following IUCD insertion during cesarean delivery , the Multiload 375 device showed the lowest risk of displacement Intrauterine devices ( IUDs ) were applied in 554 women during cesarean sections and the results were compared with the event rates presented in 804 women who received the IUD vaginally immediately postpartum . The expulsion rates at one month were 4.1 for the IUD inserted during the cesarean section and 7.5 for the post partum IUD . The expulsion rates at three months were 10.9 and 16.4 respectively . In a third group of 240 women who had cesarean sections but did not accept the IUD for contraception , the rate of endometritis at one month result ed in 0.8 compared with 1.1 for the group of cesarean section with IUD . Almost two thirds of the cesarean sections in both groups were performed on emergency bases . The application of the transcesarean IUD is considered to be safe procedure for fertility control Abstract Objective To investigate whether sublingual misoprostol administered one hour before intrauterine device ( IUD ) insertion reduces failed insertions , insertion-related complications and pain in parous women delivered only by elective caesarean section ( CS ) . Methods Single-blind r and omised controlled trial conducted in Ismailia , Egypt , between July 2010 and December 2011 . Women who had never delivered otherwise than by elective CS and desirous of using an IUD were r and omly allocated to receive sublingually 400 μg misoprostol and 100 mg diclofenac ( misoprostol group ) or 100 mg diclofenac alone ( control group ) one hour before IUD insertion . Outcome measures were failed insertion , ease of insertion judged by the investigators , insertion-related complications , and patients ’ satisfaction . Results In all , 255 women ( 130 and 125 in the study and control groups , respectively ) had an IUD inserted . Seven insertions failed : five in the control group , and two in the study group . Ease of insertion and patients ’ satisfaction were comparable in both groups . Abdominal pain and nausea were the commonest side effects reported in the misoprostol group . Conclusion Sublingual administration of misoprostol one hour before IUD insertion in parous women with no previous vaginal delivery does not facilitate the procedure and may cause undesirable side effects . This approach is not recommended as a st and ard treatment OBJECTIVES To compare rates of Copper T380A intrauterine device ( IUD ) utilization and satisfaction with immediate versus delayed IUD insertion after cesarean delivery in Kampala , Ug and a. METHODS This study was a r and omized clinical trial of women undergoing cesarean section who desired an IUD in Kampala , Ug and a. Participants were r and omly assigned to IUD insertion at the time of cesarean delivery or 6weeks afterward . The primary outcome was IUD utilization at 6months after delivery . RESULTS Among 68 women who underwent r and omization , an IUD was inserted in 100 % ( 34/34 ) of the women in the immediate insertion group and in 53 % ( 18/34 ) in the delayed group . IUD use at 6 months was higher in the immediate insertion group ( 93 % vs. 50 % after delayed insertion ; p<.0001 ) . Infection and expulsion were rare and did not differ between groups . When we pooled both groups and looked at IUD users compared to nonusers , 91 % ( 39/43 ) of IUD users were satisfied or very satisfied with their contraceptive method compared to 44 % ( 11/25 ) of nonusers ( p<.0001 ) . Women who chose not to be in the study or had the IUD removed often did so because of perceived husb and or community disapproval . CONCLUSION The 6-month utilization of an IUD after immediate insertion was significantly higher than after delayed insertion without increased complications . Contraceptive satisfaction was significantly higher among IUD users than nonusers . Community and husb and attitudes influence IUD utilization and continuation in Kampala , Ug and a. IMPLICATION S This work is important because it shows the safety and efficacy of providing IUDs during cesarean section in a setting where access to any healthcare , including contraception , can be extremely limited outside of childbearing and the consequences of an unintended , closely spaced pregnancy after a cesarean section can be life threatening BACKGROUND The rate of unintended pregnancy in the United States is much higher than in other developed nations . Approximately half of unintended pregnancies are due to contraceptive failure , largely owing to inconsistent or incorrect use . METHODS We design ed a large prospect i ve cohort study to promote the use of long-acting reversible contraceptive methods as a means of reducing unintended pregnancies in our region . Participants were provided with reversible contraception of their choice at no cost . We compared the rate of failure of long-acting reversible contraception ( intrauterine devices [ IUDs ] and implants ) with other commonly prescribed contraceptive methods ( oral contraceptive pills , transdermal patch , contraceptive vaginal ring , and depot medroxyprogesterone acetate [ DMPA ] injection ) in the overall cohort and in groups stratified according to age ( less than 21 years of age vs. 21 years or older ) . RESULTS Among the 7486 participants included in this analysis , we identified 334 unintended pregnancies . The contraceptive failure rate among participants using pills , patch , or ring was 4.55 per 100 participant-years , as compared with 0.27 among participants using long-acting reversible contraception ( hazard ratio after adjustment for age , educational level , and history with respect to unintended pregnancy , 21.8 ; 95 % confidence interval , 13.7 to 34.9 ) . Among participants who used pills , patch , or ring , those who were less than 21 years of age had a risk of unintended pregnancy that was almost twice as high as the risk among older participants . Rates of unintended pregnancy were similarly low among participants using DMPA injection and those using an IUD or implant , regardless of age . CONCLUSIONS The effectiveness of long-acting reversible contraception is superior to that of contraceptive pills , patch , or ring and is not altered in adolescents and young women . ( Funded by the Susan Thompson Buffet Foundation . ) INTRODUCTION Short interconception period after caesarean section and its associated risk of increased morbidity , mortality and surgical interventions could be avoided by postplacental IUCD insertion during the procedure . Despite the safety reports on intracaesarean IUCD insertion , obstetricians are still hesitant to extend the benefit of this long acting reversible contraception to women undergoing operative delivery . OBJECTIVE To study the clinical outcome ( safety , efficacy , expulsion and continuation rates ) of postplacental Copper T 380A insertion in primiparous women undergoing caesarean section . MATERIAL S AND METHODS This study was a prospect i ve observational study , carried out in the Department of Obstetrics and Gynaecology , Sa fda rjung hospital , which is a tertiary care hospital of Northern India . Primiparous women who delivered by caesarean section over a period of six months ( July 2012 to December 2012 ) , willing for postplacental intracaesarean IUCD insertion , and willing to comply with the study protocol , were recruited for the study . All these subjects fulfilled the WHO St and ard Medical Criteria for PPIUCD insertion ; follow up visits were scheduled at 1 , 3 , 6 and 12 months . RESULTS A total of 300 primiparous women underwent postpartum intracaesarean insertion of Copper T 380A . The mean age of women included in the study was 23.12 ± 2.42 years . Most common postinsertion complication observed in the immediate postoperative period was febrile morbidity ( 2 % ) . Majority of women ( 94.33 % ) had hospital stay of less than 4 days . The common adverse events observed during follow-up of 12 months were menstrual complaints , excessive vaginal discharge and persistent pelvic pain . At the end of one year , there were 16 expulsions , 21 removals , and 2 pregnancies with gross cumulative expulsion , removal , failure and continuation rates of 5.33 % , 7 % , 0.67 % and 91 % , respectively . CONCLUSION Postplacental intracaesarean Copper T 380A insertion in primiparous women is a safe and effective method of reversible contraception , with low expulsion and high continuation rates A prospect i ve and cooperative study was done in 152 patients that were su bmi tted to cesarean section . Seventy eight patients received intrauterine device ( IUD ) T CU 220 during cesarean section , and the other 74 patients only got the cesarean section without IUD . The events that were analyzed during the puerperium were pain , bleeding and infection . We did n't find any difference in the results between both groups , these were analyzed with the help of the square chi ( X2 ) . These results suggest that with an adequate selection of the patients , the insertion of the IUD during the cesarean section is a secure and helpful method for the fertility control for patients with high risk of reproduction OBJECTIVE To present follow-up data for patients fitted with a copper intrauterine contraceptive device ( IUCD ) or the levonorgestrel intrauterine system ( IUS ) during cesarean delivery . METHODS Between March 2006 and December 2011 , a prospect i ve study was undertaken of women who were scheduled to have a repeat cesarean for a singleton pregnancy and had chosen to undergo intraoperative fitting of an IUCD or the IUS . Participants were followed up for up to 5 years using transvaginal ultrasonography , clinical evaluation , and a question naire . RESULTS Among 143 participants , 63 requested the IUCD and 80 the IUS . Misalignment was more common at 6 weeks with the IUS ( 37 [ 46.3 % ] patients ) than with the IUCD ( 22 [ 34.9 % ] ; P=0.06 ) . Spontaneous expulsion occurred in the IUCD group only ( 4 [ 6.3 % ] patients ) . No pregnancies were reported in the IUS group , whereas 4 ( 6.3 % ) women with the IUCD became pregnant . CONCLUSION Although misalignment of an IUCD or the IUS is fairly common after intraoperative insertion , the contraceptive performance and menstrual pattern are not affected . Therefore , there is no need to remove or replace a misaligned IUCD or IUS OBJECTIVES The safety and efficacy of a single-rod implantable contraceptive containing etonogestrel ( Implanontrade mark ) were investigated in a multicenter clinical trial . STUDY DESIGN Sexually active American women ( N=330 ) with apparently normal menstrual cycles used the implant for up to 2 years . All subjects recorded bleeding and /or spotting daily in a diary . Safety was assessed through adverse experiences ( AEs ) , laboratory tests and physical and gynecologic examinations . RESULTS Total exposure was 474 woman-years ( 6186 cycles ) , and 68 % of subjects had at least 1 year of exposure . No pregnancies occurred . The most common bleeding pattern observed throughout the study was infrequent bleeding , defined as less than three episodes of bleeding in a reference period ( excluding amenorrhea ) . The least common pattern was frequent bleeding , defined as more than five episodes of bleeding in a reference period . Infrequent , prolonged and frequent bleeding patterns were most common early in the study and declined thereafter . During the 3-month Reference Periods 2 - 8 ( Months 4 - 24 ) , the incidence of amenorrhea ranged from 14 % to 20 % . Forty-three subjects ( 13 % ) withdrew from the study because of bleeding pattern changes and 76 subjects ( 23 % ) discontinued because of other AEs . Other common AEs leading to discontinuation , besides bleeding irregularities , were emotional lability ( 6.1 % ) , weight increase ( 3.3 % ) , depression ( 2.4 % ) and acne ( 1.5 % ) . Use of Implanon ( etonogestrel subdermal implant , referred to herein as ENG implant ) for up to 2 years had no clinical ly significant effects on laboratory parameters , physical and pelvic examinations , vital signs or body mass index . The average length of time required for ENG implant insertion and that for removal were 0.5 and 3.5 min , respectively , and all the procedures were uncomplicated . The return to normal menstrual cycles and fertility was rapid after removal . CONCLUSIONS Implanon is a safe , highly effective and rapidly reversible new method of contraception OBJECTIVE : To compare intrauterine device ( IUD ) use at 6 months postpartum among women who underwent intracesarean delivery ( during cesarean delivery ) IUD placement compared with women who planned for interval IUD placement 6 or more weeks postpartum . METHODS : In this nonblinded r and omized trial , women who were undergoing a cesarean delivery and desired an IUD were r and omized to intracesarean delivery or interval IUD placement . The primary outcome was IUD use at 6 months postpartum . A sample size of 112 ( 56 in each group ) was planned to detect a 15 % difference in IUD use at 6 months postpartum between groups . RESULTS : From March 2012 to June 2014 , 172 women were screened and 112 women were r and omized into the trial . Baseline characteristics were similar between groups . Data regarding IUD use at 6 months postpartum were available for 98 women , 48 and 50 women in the intracesarean delivery and interval groups , respectively . A larger proportion of the women in the intracesarean delivery group were using an IUD at 6 months postpartum ( 40/48 [ 83 % ] ) compared with those in the interval group ( 32/50 [ 64 % ] , relative risk 1.3 , 95 % confidence interval 1.02–1.66 ) . Among the 56 women r and omized to interval IUD insertion , 22 ( 39 % ) of them never received an IUD ; 14 ( 25 % ) never returned for IUD placement , five ( 9 % ) women declined an IUD , and three ( 5 % ) had a failed IUD placement . CONCLUSION : Intrauterine device placement at the time of cesarean delivery leads to a higher proportion of IUD use at 6 months postpartum when compared with interval IUD placement . LEVEL OF EVIDENCE : BACKGROUND Immediate postplacental insertion of intrauterine devices ( IUDs ) during cesarean delivery could reduce a substantial barrier to access to long-term effective contraception . Initiating IUD use prior to discharge from the hospital postpartum eliminates a 6-week postpartum waiting period and an additional office visit . STUDY DESIGN This was a prospect i ve cohort study of 90 patients undergoing cesarean delivery . After delivery of the placenta , a copper T380A IUD was inserted into the endometrial cavity through the incision . The study participants were followed up at 6 weeks and 6 months postpartum . This study was conducted at the Weiler Division of the Montefiore Medical Center and at the Jacobi Medical Center in the Bronx , NY . RESULTS Forty-three ( 48 % ) women returned for their 6-week follow-up visits , and among those , no expulsions were recorded . Forty-two ( 47 % ) women were reached for phone follow-up at 6 months postpartum , and 80 % reported being " happy " or " very happy " with their IUD . CONCLUSIONS Immediate postplacental IUD insertion at the time of cesarean delivery is safe and acceptable |
306 | 29,256,085 | Discussion While limited by the number and variability of studies , the available research suggests that collaborative care for depression delivered by bilingual providers may be more effective than usual care among patients with LEP . | Background Patients with limited English proficiency ( LEP ) have high rates of depression , yet face challenges accessing effective care in outpatient setting s. We undertook a systematic review to investigate the effectiveness of the collaborative care model for depression for LEP patients in primary care . | This special article pays tribute to Wayne Katon , MD ( 1950 - 2015 ) with a Gedenkschrift , or review , of his prolific academic career . Abstract s of all of Dr. Katon 's Medline citations were review ed to develop a narrative of his seminal epidemiological and interventional research findings . Specifically , we describe : ( a ) how Dr. Katon 's clinical work and observational epidemiology and health services research informed and guided interventional studies ; ( b ) the evolution of multidisciplinary interventional trials from primary care-based psychiatric consultation to primary care-based collaborative care for depression to multicondition collaborative care ; and ( c ) how Dr. Katon 's research has informed the work of other leading research ers in the field of psychosomatic medicine and helped develop a new generation of research ers at the interface of psychiatry and primary care . For more than three decades , Dr. Katon led a multidisciplinary research team that conducted seminal epidemiological studies and r and omized trials and that influenced the thinking and research in the field of psychiatry in a number of areas : ( a ) the importance and impact of mental disorders presenting in primary care setting s and ( b ) the organization of effective multidisciplinary care for primary care patients with common mental disorders and comorbid medical conditions . Dr. Katon 's work revolutionized the care of psychiatric illnesses in primary care and other medical care setting s to the benefit of countless patients worldwide BACKGROUND Patients with depression and poorly controlled diabetes , coronary heart disease , or both have an increased risk of adverse outcomes and high health care costs . We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients . METHODS We conducted a single-blind , r and omized , controlled trial in 14 primary care clinics in an integrated health care system in Washington State , involving 214 participants with poorly controlled diabetes , coronary heart disease , or both and coexisting depression . Patients were r and omly assigned to the usual-care group or to the intervention group , in which a medically supervised nurse , working with each patient 's primary care physician , provided guideline -based , collaborative care management , with the goal of controlling risk factors associated with multiple diseases . The primary outcome was based on simultaneous modeling of glycated hemoglobin , low-density lipoprotein ( LDL ) cholesterol , and systolic blood-pressure levels and Symptom Checklist-20 ( SCL-20 ) depression outcomes at 12 months ; this modeling allowed estimation of a single overall treatment effect . RESULTS As compared with controls , patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels ( difference , 0.58 % ) , LDL cholesterol levels ( difference , 6.9 mg per deciliter [ 0.2 mmol per liter ] ) , systolic blood pressure ( difference , 5.1 mm Hg ) , and SCL-20 depression scores ( difference , 0.40 points ) ( P<0.001 ) . Patients in the intervention group also were more likely to have one or more adjustments of insulin ( P=0.006 ) , antihypertensive medications ( P<0.001 ) , and antidepressant medications ( P<0.001 ) , and they had better quality of life ( P<0.001 ) and greater satisfaction with care for diabetes , coronary heart disease , or both ( P<0.001 ) and with care for depression ( P<0.001 ) . CONCLUSIONS As compared with usual care , an intervention involving nurses who provided guideline -based , patient-centered management of depression and chronic disease significantly improved control of medical disease and depression . ( Funded by the National Institute of Mental Health ; Clinical Trials.gov number , NCT00468676 . ) OBJECTIVE To determine whether evidence -based socioculturally adapted collaborative depression care improves receipt of depression care and depression and diabetes outcomes in low-income Hispanic subjects . RESEARCH DESIGN AND METHODS This was a r and omized controlled trial of 387 diabetic patients ( 96.5 % Hispanic ) with clinical ly significant depression recruited from two public safety-net clinics from August 2005 to July 2007 and followed over 18 months . Intervention ( INT group ) included problem-solving therapy and /or antidepressant medication based on a stepped-care algorithm ; first-line treatment choice ; telephone treatment response , adherence , and relapse prevention follow-up over 12 months ; plus systems navigation assistance . Enhanced usual care ( EUC group ) included st and ard clinic care plus patient receipt of depression educational pamphlets and a community re source list . RESULTS INT patients had significantly greater depression improvement ( ≥50 % reduction in Symptom Checklist-20 depression score from baseline ; 57 , 62 , and 62 % vs. the EUC group 's 36 , 42 , and 44 % at 6 , 12 , and 18 months , respectively ; odds ratio 2.46–2.57 ; P < 0.001 ) . Mixed-effects linear regression models showed a significant study group – by – time interaction over 18 months in diabetes symptoms ; anxiety ; Medical Outcomes Study Short-Form Health Survey ( SF-12 ) emotional , physical , and pain-related functioning ; Sheehan disability ; financial situation ; and number of social stressors ( P = 0.04 for disability and SF-12 physical functioning , P < 0.001 for all others ) but no study group – by – time interaction in A1C , diabetes complications , self-care management , or BMI . CONCLUSIONS Socioculturally adapted collaborative depression care improved depression , functional outcomes , and receipt of depression treatment in predominantly Hispanic patients in safety-net clinics OBJECTIVE This study examines clinical predictors of symptom deterioration ( relapse/recurrence ) at the completion of a clinical intervention trial of depressed , low-income , predominantly Hispanic diabetes patients who were r and omized to socio-culturally adapted collaborative depression treatment or usual care and who no longer met clinical ly significant depression criteria at 12 months post-trial baseline . METHODS A sub-cohort of 193 diabetes patients with major depression symptoms at baseline , who were r and omized to a 12-month collaborative care intervention ( INT ) ( problem-solving therapy and /or pharmacotherapy , telephone symptom monitoring/relapse prevention , behavioral activation and patient navigation support ) or enhanced usual care ( EUC ) , and who did not meet major depression criteria at 12 months were subsequently observed over 18 to 24 months . RESULTS Post-trial depression symptom deterioration was similar between INT ( 35.2 % ) and EUC ( 35.3 % ) groups . Among the combined groups , significant predictors of symptom deterioration were baseline history of previous depression and /or dysthymia ( odds ratio [ OR ] = 2.66 ) , 12-month PHQ-9 score ( OR = 1.22 ) , antidepressant treatment receipt during the initial 12-months ( OR = 2.38 ) , 12-month diabetes symptoms ( OR = 2.27 ) , and new ICD-9 medical diagnoses in the initial 12 months ( OR = 1.11 ) ( R2 = 27 % ; max-rescaled R2 = 37 % ; likelihood ratio test , χ2 = 59.79 , df = 5 , P < 0.0001 ) . CONCLUSIONS Among predominantly Hispanic diabetes patients in community safety net primary care clinics whose depression had improved over 1 year , more than one-third experienced symptom deterioration over the following year . A primary care management depression care protocol that includes ongoing depression symptom monitoring , antidepressant adherence , and diabetes and co-morbid illness monitoring plus depression medication adjustment and behavioral activation may reduce and /or effectively treat depression symptom deterioration Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more CONTEXT Few depressed older adults receive effective treatment in primary care setting s. OBJECTIVE To determine the effectiveness of the Improving Mood-Promoting Access to Collaborative Treatment ( IMPACT ) collaborative care management program for late-life depression . DESIGN R and omized controlled trial with recruitment from July 1999 to August 2001 . SETTING Eighteen primary care clinics from 8 health care organizations in 5 states . PARTICIPANTS A total of 1801 patients aged 60 years or older with major depression ( 17 % ) , dysthymic disorder ( 30 % ) , or both ( 53 % ) . INTERVENTION Patients were r and omly assigned to the IMPACT intervention ( n = 906 ) or to usual care ( n = 895 ) . Intervention patients had access for up to 12 months to a depression care manager who was supervised by a psychiatrist and a primary care expert and who offered education , care management , and support of antidepressant management by the patient 's primary care physician or a brief psychotherapy for depression , Problem Solving Treatment in Primary Care . MAIN OUTCOME MEASURES Assessment s at baseline and at 3 , 6 , and 12 months for depression , depression treatments , satisfaction with care , functional impairment , and quality of life . RESULTS At 12 months , 45 % of intervention patients had a 50 % or greater reduction in depressive symptoms from baseline compared with 19 % of usual care participants ( odds ratio [ OR ] , 3.45 ; 95 % confidence interval [ CI ] , 2.71 - 4.38 ; P<.001 ) . Intervention patients also experienced greater rates of depression treatment ( OR , 2.98 ; 95 % CI , 2.34 - 3.79 ; P<.001 ) , more satisfaction with depression care ( OR , 3.38 ; 95 % CI , 2.66 - 4.30 ; P<.001 ) , lower depression severity ( range , 0 - 4 ; between-group difference , -0.4 ; 95 % CI , -0.46 to -0.33 ; P<.001 ) , less functional impairment ( range , 0 - 10 ; between-group difference , -0.91 ; 95 % CI , -1.19 to -0.64 ; P<.001 ) , and greater quality of life ( range , 0 - 10 ; between-group difference , 0.56 ; 95 % CI , 0.32 - 0.79 ; P<.001 ) than participants assigned to the usual care group . CONCLUSION The IMPACT collaborative care model appears to be feasible and significantly more effective than usual care for depression in a wide range of primary care practice OBJECTIVE This article describes the r and omized clinical trial methodology for a population -based study of oncology patients receiving cancer care in a public sector medical center . The primary goal is to test the effectiveness of socioculturally tailored collaborative care intervention in improving depression and quality of life outcomes among low-income ethnic minority patients with major depression and cancer . METHODS The Patient Health Question naire ( PHQ-9 ) depression scale was used to identify patients meeting criteria for major depression ( one cardinal depression symptom plus a PHQ-9 score of > or = 10 ) . Study -eligible patients were > /=90 days from cancer diagnosis who were receiving acute cancer treatment or follow-up care in oncology clinics . Patients with advanced disease limiting life expectancy to < 6 months , acutely suicidal or on antipsychotic medication were excluded . Allowing for attrition due to death or loss to follow-up , the study was powered at the 80 % level to detect a 20 % difference between study arms in the proportion of patients with > /=50 % reduction in PHQ-9 symptoms at 12 months . RESULTS Of 2330 patients screened , 23.2 % met criteria . An 82.4 % enrollment rate result ed in 446 primarily women being recruited and r and omized to intervention or usual care . CONCLUSION The study applies methods used in primary care depression trials with adaptations for oncology care clinics and for low-income minority patients In a pilot study , 55 low-income Latina patients with breast or cervical cancer and comorbid depression were r and omly assigned to receive collaborative care as part of the Multifaceted Oncology Depression Program or usual care . Relative to patients in the usual care condition , patients receiving collaborative care were more likely to show > or=50 % improvement in depressive symptoms as measured by the Personal Health Question naire ( OR=4.51 , 95 % CI=1.07 - 18.93 ) . Patients in the collaborative care program were also more likely to show improvement in emotional well-being ( increase of 2.15 ) as measured by the Functional Assessment of Cancer Therapy Scale than were those receiving usual care ( decrease of 0.50 ) ( group difference=2.65 , 95 % CI : 0.18 - 5.12 ) . Despite health system , provider , and patient barriers to care , these initial results suggest that patients in public sector oncology clinics can benefit from onsite depression treatment OBJECTIVE The aim of this study was to determine sustained effectiveness in reducing depression symptoms and improving depression care 1 year following intervention completion . METHOD Of 387 low-income , predominantly Hispanic diabetes patients with major depression symptoms r and omized to 12-month socioculturally adapted collaborative care ( psychotherapy and /or antidepressants , telephone symptom monitoring/relapse prevention ) or enhanced usual care , 264 patients completed 2-year follow-up . Depression symptoms ( Symptom Checklist-20 [ SCL-20 ] , Patient Health Question naire-9 [ PHQ-9 ] ) , treatment receipt , diabetes symptoms and quality of life were assessed 24 months postenrollment using intent-to-treat analyses . RESULTS At 24 months , more intervention patients received ongoing antidepressant treatment ( 38 % vs. 25 % , χ(2)=5.11 , df=1 , P=.02 ) ; sustained depression symptom improvement [ SCL-20 < 0.5 ( adjusted odds ratio=2.06 , 95 % confidence interval=1.09 - 3.90 , P=.03 ) , SCL-20 score ( adjusted mean difference -0.22 , P=.001 ) and PHQ-9 ≥50 % reduction ( adjusted odds ratio=1.87 , 95 % confidence interval = 1.05 - 3.32 , P=.03 ) ] . Over 2 years , improved effects were found in significant study group by time interaction for Short Form-12 mental health , Sheehan Disability Scale ( SDS ) functional impairment , diabetes symptoms , anxiety and socioeconomic stressors ( P=.02 for SDS ; P<.0001 for all others ) ; however , group differences narrowed over time and were no longer significant at 24 months . CONCLUSIONS Socioculturally tailored collaborative care that included maintenance antidepressant medication , ongoing symptom monitoring and behavioral activation relapse prevention was associated with depression improvement over 24 months for predominantly Hispanic patients in primary safety net care AIMS The association between Type 2 diabetes and depressive symptoms was examined prospect ively to assess possible causal relationships between the two diseases . METHODS A cohort of 971 men and women aged 50 and older from the adult population of Rancho Bernardo , California had an oral glucose tolerance test and completed the Beck Depression Inventory ( BDI ) at two clinic visits , 1984 - 87 and 1992 - 96 . RESULTS Depressive symptoms at baseline were associated with higher follow-up levels of non-fasting plasma glucose ( P = 0.001 ) and an increased risk of developing Type 2 diabetes [ odds ratio ( OR ) = 2.50 ; 95 % confidence interval ( CI ) = 1.29 - 4.87 ] , independent of sex , age , exercise and body mass index . Conversely , baseline non-fasting plasma glucose was not significantly associated with follow-up depressive symptoms and Type 2 diabetes at baseline was not significantly associated with the onset of BDI scores > or = 11 by the second visit ( OR = 0.73 ; 95 % CI = 0.41 - 1.30 ) . CONCLUSIONS Depressed mood is more likely to be a risk factor for Type 2 diabetes in older adults than the reverse Objective : This article describes design elements of the Multifaceted Depression and Diabetes Program ( MDDP ) r and omized clinical trial . The MDDP trial hypothesizes that a socioculturally adapted collaborative care depression management intervention will reduce depressive symptoms and improve patient adherence to diabetes self-care regimens , glycemic control , and quality -of-life . In addition , baseline data of 387 low-income , 96 % Hispanic , enrolled patients with major depression and diabetes are examined to identify study population characteristics consistent with trial design adaptations . Methods : The PHQ-9 depression scale was used to identify patients meeting criteria for major depressive disorder ( 1 cardinal depression symptom + a PHQ-9 score of > 10 ) from two community safety net clinics . Design elements included sociocultural adaptations in recruitment and efforts to reduce attrition and collaborative depression care management . Results : Of 1,803 diabetes patients screened , 30.2 % met criteria for major depressive disorder . Of 387 patients enrolled in the clinical trial , 98 % had Type 2 diabetes , and 83 % had glycated hemoglobin ( HbA1c ) levels ≥ 7 % . Study recruitment rates and baseline data analyses identified socioeconomic and clinical factors that support trial design and intervention adaptations . Depression severity was significantly associated with diabetes complications , medical comorbidity , greater anxiety , dysthymia , financial worries , social stress , and poorer quality -of-life . Conclusion : Low-income Hispanic patients with diabetes experience high prevalence of depressive disorder and depression severity is associated with socioeconomic stressors and clinical severity . Improving depression care management among Hispanic patients in public sector clinics should include intervention components that address self-care of diabetes and socioeconomic stressors PURPOSE To determine the effectiveness of the Alleviating Depression Among Patients With Cancer ( ADAPt-C ) collaborative care management for major depression or dysthymia . PATIENTS AND METHODS Study patients included 472 low-income , predominantly female Hispanic patients with cancer age > or= 18 years with major depression ( 49 % ) , dysthymia ( 5 % ) , or both ( 46 % ) . Patients were r and omly assigned to intervention ( n = 242 ) or enhanced usual care ( EUC ; n = 230 ) . Intervention patients had access for up to 12 months to a depression clinical specialist ( supervised by a psychiatrist ) who offered education , structured psychotherapy , and maintenance/relapse prevention support . The psychiatrist prescribed antidepressant medications for patients preferring or assessed to require medication . RESULTS At 12 months , 63 % of intervention patients had a 50 % or greater reduction in depressive symptoms from baseline as assessed by the Patient Health Question naire-9 ( PHQ-9 ) depression scale compared with 50 % of EUC patients ( odds ratio [ OR ] = 1.98 ; 95 % CI , 1.16 to 3.38 ; P = .01 ) . Improvement was also found for 5-point decrease in PHQ-9 score among 72.2 % of intervention patients compared with 59.7 % of EUC patients ( OR = 1.99 ; 95 % CI , 1.14 to 3.50 ; P = .02 ) . Intervention patients also experienced greater rates of depression treatment ( 72.3 % v 10.4 % of EUC patients ; P < .0001 ) and significantly better quality -of-life outcomes , including social/family ( adjusted mean difference between groups , 2.7 ; 95 % CI , 1.22 to 4.17 ; P < .001 ) , emotional ( adjusted mean difference , 1.29 ; 95 % CI , 0.26 to 2.22 ; P = .01 ) , functional ( adjusted mean difference , 1.34 ; 95 % CI , 0.08 to 2.59 ; P = .04 ) , and physical well-being ( adjusted mean difference , 2.79 ; 95 % CI , 0.49 to 5.1 ; P = .02 ) . CONCLUSION ADAPt-C collaborative care is feasible and results in significant reduction in depressive symptoms , improvement in quality of life , and lower pain levels compared with EUC for patients with depressive disorders in a low-income , predominantly Hispanic population in public sector oncology clinics OBJECTIVES We examined the feasibility and effectiveness of using culturally sensitive collaborative treatment ( CSCT ) to improve recognition , engagement , and treatment of depressed Chinese Americans in primary care . METHODS Chinese American patients in a primary care setting ( n = 4228 ) were screened for depression . The primary study outcome was treatment engagement rate , and the secondary outcome was treatment response . RESULTS Of the study participants , 296 ( 7 % ) screened positive for depression , 122 ( 41 % ) of whom presented for a psychiatric assessment ; 104 ( 85 % ) were confirmed with major depressive disorder , and 100 ( 96 % ) of these patients were r and omized into treatment involving either care management or usual care . Patients in the care management and usual care groups did not differ in terms of their outcomes . CSCT result ed in a nearly 7-fold increase in treatment rate among depressed patients in primary care . CONCLUSIONS CSCT is both feasible and effective in improving recognition and treatment engagement of depressed Chinese Americans . Care management may have limited effects on depressed patients treated by psychiatrists , given that these patients tend to have favorable responses in general OBJECTIVE This study assessed longer-term outcomes of low-income patients with cancer ( predominantly female and Hispanic ) after treatment in a collaborative model of depression care or in enhanced usual care . METHODS The r and omized controlled trial , conducted in safety-net oncology clinics , recruited 472 patients with major depression symptoms . Patients r and omly assigned to a 12-month intervention ( a depression care manager and psychiatrist provided problem-solving therapy , antidepressants , and symptom monitoring and relapse prevention ) or enhanced usual care ( control group ) were interviewed at 18 and 24 months after enrollment . RESULTS At 24 months , 46 % of patients in the intervention group and 32 % in the control group had a ≥50 % decrease in depression score over baseline ( odds ratio=2.09 , 95 % confidence interval=1.13 - 3.86 ; p=.02 ) ; intervention patients had significantly better social ( p=.03 ) and functional ( p=.01 ) well-being . Treatment receipt among intervention patients declined ( 72 % , 21 % , and 18 % at 12 , 18 , and 24 months , respectively ) ; few control group patients reported treatment receipt ( 10 % , 6 % , and 13 % , respectively ) . Significant differences in receipt of counseling or antidepressants disappeared at 24 months . Depression recurrence was similar between groups ( intervention , 36 % ; control , 39 % ) . Among patients with depression recurrence , intervention patients were more likely to receive treatment after 12 months ( 34 % versus 10 % ; p=.03 ) . At 24 months , attrition ( 262 patients , 56 % ) did not vary by group ; 22 % were deceased , 20 % declined further participation , and 14 % could not be located . CONCLUSIONS Collaborative care reduced depression symptoms and enhanced quality of life ; however , results call for ongoing depression symptom monitoring and treatment for low-income cancer survivors OBJECTIVE This study assessed treatment preferences among low-income Latino patients in public-sector primary care clinics and examined whether a collaborative care intervention that included patient education and allowed patients to choose between medication , therapy , or both would increase the likelihood that patients received preferred treatment . METHODS A total of 339 Latino patients with probable depressive disorders were recruited ; participants completed a baseline conjoint analysis preference survey and were r and omly assigned to receive the intervention or enhanced usual care . At 16 weeks , a patient survey assessed depression treatment received during the study period . Logistic regression models were constructed to estimate treatment preferences , examine patient characteristics associated with treatment preferences , and examine patient characteristics associated with a match between stated preference and actual treatment received . RESULTS The conjoint analysis preference survey showed that patients preferred counseling or counseling plus medication over antidepressant medication alone and that they preferred treatment in primary care over specialty mental health care , but they showed no significant preference for individual versus group treatment . Patients also indicated that individual education sessions , telephone sessions , transportation assistance , and family involvement were barrier reduction strategies that would enhance their likelihood of accepting treatment . Compared with patients assigned to usual care , those in the intervention group were 21 times as likely to receive preferred treatment . Among all participants , women , unemployed persons , those who spoke English , and those referred by providers were more likely to receive preferred treatment . CONCLUSIONS Collaborative care interventions that include psychotherapy can increase the likelihood that Latino patients receive preferred care ; however , special efforts may be needed to address preferences of working persons , men , and Spanish-speaking patients OBJECTIVE The objective of this study was to vali date the Chinese Bilingual version of the Patient Health Question naire ( CB-PHQ-9 ) for screening for depression among Chinese Americans in primary care . METHOD Chinese-American patients attending a primary care clinic were screened for major depressive disorder ( MDD ) using the CB-PHQ-9 . All patients who scored 15 or higher on the CB-PHQ-9 were interviewed using the Chinese-bilingual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , patient version . Eight percent of patients who scored less than 15 on the CB-PHQ-9 were r and omly selected and interviewed with the depression module of the Chinese-bilingual Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition , patient version . RESULTS During the study , 1940 unduplicated patients completed the CB-PHQ-9 . The CB-PHQ-9 had high internal consistency ( alpha = 0.91 ) , and the scores of each of its 9 items had moderate to moderately high correlations ( 0.52 - 0.85 ) with the total scores . The sensitivity and specificity of the CB-PHQ-9 for recognizing MDD were found to be 81 % and 98 % , respectively , and the area under the receiver operating characteristic curve was estimated to be 0.97 ( SE , 0.01 ) . CONCLUSION The CB-PHQ-9 is a valid and useful instrument for screening for MDD among Chinese Americans in primary care OBJECTIVE There have been few comparisons of the effectiveness of collaborative depression care between older versus younger adults with comorbid illness , particularly among low-income population s. DESIGN Intent-to-treat analyses are conducted on pooled data from three r and omized controlled trials that tested collaborative care aim ed at improving depression , quality of life , and treatment receipt . SETTING S Trials were conducted in oncology and primary care safety net clinics and diverse home healthcare programs . PARTICIPANTS Thous and eighty-one patients with major depressive symptoms and cancer , diabetes , or other comorbid illness . INTERVENTION Similar intervention protocol s included patient , provider , sociocultural , and organizational adaptations . MEASUREMENTS The Patient Health Question naire (PHQ)-9 depression , Short-Form Health Survey-12/20 quality of life , self-reported hospitalization , ER , intensive care unit utilization , and antidepressant , psychotherapy treatment receipt are assessed at baseline , 6 , and 12 months . RESULTS There are no significant differences in reducing depression symptoms ( p ranged 0.18 - 0.58 ) , improving quality of life ( t = 1.86 , df = 669 , p = 0.07 for physical functioning at 12 months , and p ranged 0.23 - 0.99 for all others ) patients aged between > /=60 years versus 18 - 59 years . Both age group intervention patients have significantly higher rates of a 50 % PHQ-9 reduction ( older : Wald chi[df = 1 ] = 4.82 , p = 0.03 ; younger : Wald chi[df = 1 ] = 6.47 , p = 0.02 ) , greater reduction in major depression rates ( older : Wald chi[df = 1 ] = 7.72 , p = 0.01 ; younger : Wald chi[df = 1 ] = 4.0 , p = 0.05 ) than enhanced-usual-care patients at 6 months and no significant age group differences in treatment type or intensity . CONCLUSION Collaborative depression care in individuals with comorbid illness is as effective in reducing depression in older patients as younger patients , including among low-income , minority patients . Patient , provider , and organizational adaptations of depression care management models may contribute to positive outcomes |
307 | 28,717,914 | Conclusions and relevance Based on the limited available evidence , suboptimal pre-operative HbA1c levels in patients with no prior history of diabetes predict post-operative complications and represent a potentially modifiable risk factor | Importance Pre-operative hyperglycemia is associated with post-operative adverse outcomes in diabetic and non-diabetic patients .
Current pre-operative screening includes r and om plasma glucose , yet plasma glycated hemoglobin ( HbA1c ) is a better measure of long-term glycemic control .
It is not clear whether pre-operative HbA1c can identify non-diabetic patients at risk of post-operative complications .
Objective The systematic review summarizes the evidence pertaining to the association of suboptimal pre-operative HbA1c on post-operative outcomes in adult surgical patients with no history of diabetes mellitus . | Background Supporting 21st century health care and the practice of evidence -based medicine ( EBM ) requires ubiquitous access to clinical information and to knowledge-based re sources to answer clinical questions . Many questions go unanswered , however , due to lack of skills in formulating questions , crafting effective search strategies , and accessing data bases to identify best levels of evidence . Methods This r and omized trial was design ed as a pilot study to measure the relevancy of search results using three different interfaces for the PubMed search system . Two of the search interfaces utilized a specific framework called PICO , which was design ed to focus clinical questions and to prompt for publication type or type of question asked . The third interface was the st and ard PubMed interface readily available on the Web . Study subjects were recruited from interns and residents on an inpatient general medicine rotation at an academic medical center in the US . Thirty-one subjects were r and omized to one of the three interfaces , given 3 clinical questions , and asked to search PubMed for a set of relevant articles that would provide an answer for each question . The success of the search results was determined by a precision score , which compared the number of relevant or gold st and ard articles retrieved in a result set to the total number of articles retrieved in that set . Results Participants using the PICO templates ( Protocol A or Protocol B ) had higher precision scores for each question than the participants who used Protocol C , the st and ard PubMed Web interface . ( Question 1 : A = 35 % , B = 28 % , C = 20 % ; Question 2 : A = 5 % , B = 6 % , C = 4 % ; Question 3 : A = 1 % , B = 0 % , C = 0 % ) 95 % confidence intervals were calculated for the precision for each question using a lower boundary of zero . However , the 95 % confidence limits were overlapping , suggesting no statistical difference between the groups . Conclusion Due to the small number of search es for each arm , this pilot study could not demonstrate a statistically significant difference between the search protocol s. However there was a trend towards higher precision that needs to be investigated in a larger study to determine if PICO can improve the relevancy of search results Purpose In diabetics , elevated preoperative hemoglobin A1c ( HbA1c ) levels are associated with increased complication rates after cardiac surgery . While many non-diabetics also have elevated HbA1c , the relationship with outcome in these patients is not well understood . Therefore , in a cohort of non-diabetic patients , we tested the hypothesis that preoperative HbA1c is associated with early mortality risk after cardiac surgery . Methods In this retrospective observational study , we accessed data from a prospect ively collected quality assurance data base for a cohort of 1,474 non-diabetic elective cardiac surgery patients with documented preoperative HbA1c levels . The relationship of HbA1c with death within 30 days of surgery was examined using logistic regression modeling . Acute kidney injury and infection were similarly assessed using multivariable linear and logistic regression . Results Thirty-one percent of patients ( n = 456 ) had elevated HbA1c values ( > 6.0 % ) . Patients with elevated HbA1c had higher fasting and peak intraoperative blood glucose values . Also , an elevated HbA1c level was independently associated with increased 30-day mortality ( odds ratio 1.53 per percent increase [ 1.24 - 1.91 ] ; P = 0.0005 ) . This relationship persisted even after “ borderline ” diabetics were excluded . Furthermore , acute kidney injury was associated with elevated baseline HbA1c ( P = 0.01 ) . No association was found between HbA1c and postoperative infection risk ( P = 0.48 ) . Conclusion In non-diabetics , an elevated preoperative HbA1c level ( > 6.0 % ) is independently associated with significantly greater early mortality risk after elective cardiac surgery . Our findings suggest that HbA1c may have value as a screening tool to identify high-risk non-diabetic cardiac surgery patients .RèsumèObjectifChez les diabétiques , des niveaux élevés d’hémoglobine A1c ( HbA1c ) préopératoire sont associés à une incidence accrue de complications après une chirurgie cardiaque . Alors que nombre de personnes non diabétiques ont également des niveaux élevés de HbA1c , la relation entre ces niveaux et le devenir de ces patients demeure mal comprise . Pour cette raison , dans une cohorte de patients non diabétiques , nous avons testé l’hypothèse selon laquelle la HbA1c préopératoire est associée à un risque de mortalité précoce après une chirurgie cardiaque . MéthodeDans cette étude observationnelle rétrospective , nous avons utilisé des données tirées d’une base de données d’assurance de la qualité récoltées de façon prospect i ve et portant sur une cohorte de 1474 patients non diabétiques devant subir une chirurgie cardiaque non urgente et do nt les niveaux préopératoires de HbA1c étaient documentés . La relation entre les niveaux de HbA1c et le décès dans les 30 jours suivant la chirurgie a été examinée à l’aide d’un modèle de régression logistique . Les lésions rénales aiguës et les infections ont été évaluées de la même façon à l’aide de modèles de régression logistique et linéaire multivariée . RésultatsTrente et un pour cent des patients ( n = 456 ) présentaient des valeurs de HbA1c élevées ( > 6,0 % ) . Chez les patients présentant des valeurs de HbA1c élevées , la glycémie était plus élevée à jeun et atteignait des valeurs maximales plus gr and es pendant l’opération . De plus , un niveau élevé de HbA1c était associé de façon indépendante à une mortalité accrue à 30 jours ( rapport de cotes 1,53 par augmentation de pour cent [ 1,24 - 1,91 ] ; P = 0,0005 ) . Cette relation est demeurée apparente même après l’exclusion des diabétiques « limite » du calcul . En outre , les lésions rénales aiguës étaient associées à des valeurs de HbA1c de base élevées ( P = 0,01 ) . Aucune association n’a été découverte entre la HbA1c et le risque d’infection postopératoire ( P = 0,48 ) . Conclusion Chez les personnes non diabétiques , un niveau préopératoire élevé de HbA1c ( > 6,0 % ) est associé de façon indépendante à un risque de mortalité précoce significativement plus élevé après une chirurgie cardiaque non urgente . Nos résultats suggèrent que le niveau de HbA1c pourrait être utile comme outil de dépistage afin d’identifier les patients de chirurgie cardiaque non diabétiques mais à risque élevé As the U.S. population ages , major surgical procedures are being performed in elderly patients with increasing frequency ( 1 ) , but few data are available to guide preoperative risk stratification . Several studies have described correlates of cardiac morbidity and mortality in patients undergoing noncardiac surgery ( 2 - 8 ) , but the number of elderly patients in most series has been small . Furthermore , few data are available on noncardiac complications , the overall complication rate , and length of stay . We describe the influence of age on perioperative complication and mortality rates in a large cohort of patients undergoing noncardiac surgery . As discussed elsewhere , age was not an independent correlate of major cardiac complications in this cohort ( 7 ) . This analysis tests the hypothesis that advanced age is a correlate of the overall rate of complications , after adjustment for functional status . Methods Patients All patients 50 years of age or older who underwent major nonemergent noncardiac procedures at Brigham and Women 's Hospital , Boston , Massachusetts , from 18 July 1989 to 28 February 1994 were eligible for the study . Major noncardiac procedures were defined as those with an expected length of stay of 2 or more days . Procedures were electively scheduled or were performed nonemergently during inpatient admissions . Eligibility criteria included the ability to speak English and adequate cognitive function to give informed consent . The enrollment and clinical data collection protocol s were approved by the institutional review board of Brigham and Women 's Hospital . The full study protocol included preoperative interviews by clinical study personnel ( physicians or research nurses ) . Of the 4315 patients who provided informed consent to participate , 621 ( 14.4 % ) did not provide consent before surgery for the serial interview portion of the study , which included interviews 1 and 6 months after surgery . Patients who were not interviewed before surgery were not excluded on the basis of age or clinical status , but solely according to the availability of study personnel . Data Collection The data collection protocol is described elsewhere ( 7 , 9 , 10 ) . In brief , patients who provided informed consent to the full study protocol underwent preoperative evaluation by clinical investigators ( physicians or research nurses ) using a structured data form . These evaluations included detailed medical histories , physical examinations , and laboratory tests . For patients who did not undergo this evaluation because they could not be approached or because they declined participation in the interview portion of the study , we obtained clinical data from the structured evaluation by the anesthesiologist found in the medical record . This data source was also used to obtain American Society of Anesthesiologists classification for all patients . Hence , prospect ively recorded clinical data were available for all patients . Consenting patients agreed to postoperative sampling of creatine kinase and , if total creatine kinase levels were elevated , measurement of creatine kinaseMB immediately after surgery , at 8 p.m. on the evening of surgery , and on the next two mornings . In all other enrolled patients , creatine kinaseMB was measured according to the physician 's orders . Among all participants , the mean ( SD ) number of cardiac enzyme sample s obtained was 4.0 2.2 . Electrocardiography was performed in the recovery room and on the first , third , and fifth postoperative days if the patient remained hospitalized . The Charlson Comorbidity Index , a weighted comorbidity score based on the number and the severity of 16 selected medical diseases , was used to quantify the burden of medical comorbid conditions ( 11 ) . The mean number of other common comorbid conditions in this population was calculated for all patients . Preoperative functional status was assessed in 3890 patients by performing structured interviews using the Specific Activity Scale , an ordinally scaled , four-class instrument based on metabolic expenditure in various personal care , housework , occupational , and recreational activities ( 12 , 13 ) . This group included 196 patients who consented to preoperative interviews but did not consent to the full study protocol , including long-term follow-up . Classification of Outcomes The occurrence of major cardiac events postoperatively was classified by a single review er who was blinded to preoperative clinical data and who evaluated only postoperative clinical information , including cardiac enzyme measurements , electrocardiograms , and clinical events . Myocardial infa rct ion was diagnosed on the basis of creatine kinaseMB levels and electrocardiographic findings ( 10 ) . Major cardiac complications were unstable angina ( postoperative typical chest pain associated with ischemic electrocardiographic changes ) , myocardial infa rct ion , cardiogenic pulmonary edema , documented ventricular tachycardia , ventricular fibrillation or primary cardiac arrest , and sustained complete heart block requiring pacemaker . Major noncardiac events were pulmonary embolism documented by autopsy , angiography , or a high-probability ventilationperfusion scan ; respiratory failure requiring intubation for more than 2 days or reintubation ; noncardiogenic pulmonary edema ; lobar pneumonia confirmed by chest radiography and requiring antibiotic therapy ; acute renal failure requiring dialysis ; or cerebrovascular accident with new neurologic deficit . In-hospital mortality was also recorded , and the combined end point of major cardiac or noncardiac complications or death was used in these analyses . Statistical Analysis To evaluate the impact of age on postoperative complications , we performed analyses in which age was considered as a continuous variable and as four categories ( 50 to 59 years , 60 to 69 years , 70 to 79 years , and 80 years ) . Because age was not linearly associated with the risk for outcomes , categorized age variables are used throughout this report . Univariate correlations between clinical characteristics and age category were analyzed by using the chi-square test and the Fisher exact test for categorical variables and a t-test or Wilcoxon test for continuous variables . Because several clinical and laboratory variables are associated with age and because it is difficult to exclude the association of age with the event of interest , we included all relevant clinical variables in the multivariate analysis . Logistic regression analysis was used to determine the independent association of age with postoperative complications while controlling for the presence of comorbid conditions , sex , ethnicity , functional status as measured by Specific Activity Scale class , type of procedure , and preoperative laboratory data . Patients for whom data on selected variables were missing were excluded from the model . Clinical ly relevant variables from the regression model were analyzed for potential interactions , and potentially significant interaction terms were considered in the regression models . A two-sided P value less than 0.05 was considered statistically significant in all analyses . Linear regression models were used to estimate the independent variation in length of stay attributable to age , controlling for sex , ethnicity , preoperative clinical characteristics , American Society of Anesthesiologists classification , type of procedure , postoperative events , and in-hospital mortality . The logarithmic transformation of length of stay was used because of the non-normal distribution of this variable . The percentage change in the geometric mean of length of stay in the final model was used to estimate the numbers of adjusted hospital days attributable to age groups . All analyses were performed by using SAS statistical software for Windows , version 6.12 ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in data collection and analysis or in subsequent decisions about publication of manuscripts . Results Patients The study sample constituted 4315 patients who had a mean age of 67 9 years ; 2096 patients ( 48 % ) were male and 3903 ( 90 % ) were white . Twenty-four percent ( 1015 patients ) were younger than 59 years , 38 % ( 1646 patients ) were 60 to 69 years of age , 31 % ( 1341 patients ) were 70 to 79 years of age , and 7 % ( 313 patients ) were older than 80 years of age . These patients undergoing elective surgery had a low prevalence of comorbid conditions , and 3187 ( 74 % ) patients had Charlson Comorbidity Index scores of 0 through 2 . The types of procedures performed were orthopedic ( 35 % ) , intrathoracic ( 12 % ) , abdominal ( 12 % ) , abdominal aortic aneurysm ( 5 % ) , other vascular ( 17 % ) , and other general surgical procedures ( 33 % ) . In the oldest age group , significantly fewer patients were male and nonwhite compared with the younger age groups ( Table 1 ) . The number of comorbid conditions and the average Charlson Comorbidity Index scores increased with increasing age . The distribution of Specific Activity Scale class and American Society of Anesthesiology class was also significantly worse in the older age groups ; a greater proportion of patients 70 to 79 years of age and 80 years of age was classified as class 3 or 4 . As expected , the type of surgical procedure performed varied among age groups . Higher percentages of older patients underwent orthopedic procedures , aortic aneurysm repair , and other vascular surgeries ( Table 1 ) . Table 1 . Patient Characteristics Perioperative Complications Major or fatal perioperative complications occurred in 44 ( 4.3 % ) patients younger than 59 years of age , 93 ( 5.7 % ) patients 60 to 69 years of age , 129 ( 9.6 % ) patients 70 to 79 years of age , and 39 ( 12.5 % ) patients 80 years of age or older ( P<0.001 ) ( Figure ) . Age was significantly associated with a higher risk for cardiogenic pulmonary edema , myocardial infa rct ion , ventricular arrhythmias , bacterial pneumonia , respiratory failure requiring intubation , and in-hospital mortality . All other major complications BACKGROUND The relationship of hyperglycemia to general surgery outcomes is not well-understood . We studied the association of operative day and postoperative day 1 ( POD1 ) blood glucose ( BG ) with outcomes after open colectomy for cancer . STUDY DESIGN We retrospectively analyzed the 2000 - 2005 Veterans Affairs Surgical Quality Improvement Program data base , linked with Veterans Affairs Decision Support System BG values . Median BG was categorized as hypoglycemic ( < 80 mg/dL ) ; normoglycemic ( BG 80 - 120 mg/dL ) ; or mildly ( BG 121 - 160 mg/dL ) , moderately ( BG 161 - 200 mg/dL ) , or severely ( BG > 200 mg/dL ) hyperglycemic . The relationship of BG to postoperative outcomes was assessed with multivariable logistic regression . RESULTS We identified 9,638 colectomies . We excluded 511 procedures for emergency status or preoperative coma , mechanical ventilation , or sepsis . After excluding patients without recorded BG , we analyzed operative day and POD1 BG in 7,576 and 5,773 procedures , respectively . On multivariable analysis , operative day moderate hyperglycemia was associated with surgical site infection ( odds ratio = 1.44 ; 95 % CI , 1.10 - 1.87 ) . POD1 severe hyperglycemia was associated with cardiac arrest ( odds ratio = 2.31 ; 95 % CI , 1.08 - 4.98 ) and death ( odds ratio = 1.97 ; 95 % CI , 1.23 - 3.15 ) . POD1 mild ( odds ratio = 2.20 ; 95 % CI , 1.05 - 4.60 ) , moderate ( odds ratio = 3.44 ; 95 % CI , 1.51 - 7.84 ) , and severe ( odds ratio = 3.94 ; 95 % CI , 1.64 - 9.58 ) hyperglycemia and hypoglycemia ( odds ratio = 6.74 ; 95 % CI , 1.75 - 25.97 ) were associated with myocardial infa rct ion . Associations were similar in diabetic and nondiabetic patients . CONCLUSIONS Even mild hyperglycemia was associated with adverse outcomes after colectomy , suggesting that a perioperative BG target of 80 to 120 mg/dL , although avoiding hypoglycemia , might be appropriate . R and omized clinical trials are needed to confirm these findings OBJECTIVE The aim was to formulate practice guidelines on the management of hyperglycemia in hospitalized patients in the non-critical care setting . PARTICIPANTS The Task Force was composed of a chair , selected by the Clinical Guidelines Subcommittee of The Endocrine Society , six additional experts , and a method ologist . EVIDENCE This evidence -based guideline was developed using the Grading of Recommendations , Assessment , Development , and Evaluation ( GRADE ) system to describe both the strength of recommendations and the quality of evidence . CONSENSUS PROCESS One group meeting , several conference calls , and e-mail communications enabled consensus . Endocrine Society members , American Diabetes Association , American Heart Association , American Association of Diabetes Educators , European Society of Endocrinology , and the Society of Hospital Medicine review ed and commented on preliminary drafts of this guideline . CONCLUSIONS Hyperglycemia is a common , serious , and costly health care problem in hospitalized patients . Observational and r and omized controlled studies indicate that improvement in glycemic control results in lower rates of hospital complications in general medicine and surgery patients . Implementing a st and ardized sc insulin order set promoting the use of scheduled basal and nutritional insulin therapy is a key intervention in the inpatient management of diabetes . We provide recommendations for practical , achievable , and safe glycemic targets and describe protocol s , procedures , and system improvements required to facilitate the achievement of glycemic goals in patients with hyperglycemia and diabetes admitted in non-critical care setting The American Diabetes Association ’s ( ADA ’s ) St and ards of Medical Care in Diabetes are published each year in a supplement to the January issue of Diabetes Care . The ADA ’s Professional Practice Committee develops the St and ards and up date s them annually , or more frequently online should it determine that new evidence or regulatory changes ( e.g. , drug approvals , label changes ) merit immediate incorporation . The St and ards include the most current evidence -based recommendations for diagnosing and treating adults and children with diabetes . ADA ’s grading system uses A , B , C , or E to show the evidence level that supports each recommendation . • A — Clear evidence from wellconducted , generalizable r and omized controlled trials that are adequately powered • B — Supportive evidence from well-conducted cohort studies • C — Supportive evidence from poorly controlled or uncontrolled studies • E — Expert consensus or clinical CONTEXT The impairment of insulin sensitivity , a marker of surgical stress , is important for outcomes . OBJECTIVE The aim was to assess the association between the quality of preoperative glycemic control , intraoperative insulin sensitivity , and adverse events after cardiac surgery . DESIGN AND SETTING We conducted a prospect i ve cohort study at a tertiary care hospital . SUBJECTS Nondiabetic and diabetic patients scheduled for elective cardiac surgery were included in the study . Based on their glycosylated hemoglobin A ( HbA(1c ) ) , diabetic patients were allocated to a group with good ( HbA(1c ) < 6.5 % ) or poor ( HbA(1c ) > 6.5 % ) glycemic control . INTERVENTION We used the hyperinsulinemic-normoglycemic clamp technique . MAIN OUTCOME MEASURES The primary outcome was insulin sensitivity measurement . Secondary outcomes were major complications within 30 d after surgery including mortality , myocardial failure , stroke , dialysis , and severe infection ( severe sepsis , pneumonia , deep sternal wound infection ) . Other outcomes included minor infections , blood product transfusions , and the length of intensive care unit and hospital stay . RESULTS A total of 143 nondiabetic and 130 diabetic patients were studied . In diabetic patients , a negative correlation ( r = -0.527 ; P < 0.001 ) was observed between HbA(1c ) and intraoperative insulin sensitivity . Diabetic patients with poor glycemic control had a greater incidence of major complications ( P = 0.010 ) and minor infections ( P = 0.006 ) . They received more blood products and spent more time in the intensive care unit ( P = 0.030 ) and the hospital ( P < 0.001 ) than nondiabetic patients . For each 1 mg x kg(-1 ) x min(-1 ) decrease in insulin sensitivity , the incidence of major complications increased ( P = 0.004 ) . CONCLUSIONS In diabetic patients , HbA(1c ) levels predict insulin sensitivity during surgery and possibly outcome . Intraoperative insulin resistance is associated with an increased risk of complications , independent of the patient 's diabetic state OBJECTIVE To assess the importance of diabetes , diabetes control , hyperglycemia , and previously undiagnosed diabetes in the development of surgical-site infections ( SSIs ) among cardiothoracic surgery patients . SETTING A 540-bed tertiary-care university-affiliated hospital . DESIGN Prospect i ve cohort and case-control studies . PATIENTS All patients having cardiothoracic surgery between November 1998 and September 1999 were eligible for participation . One thous and patients had preoperative hemoglobin A1c determinations . Seventy-four patients with SSIs were identified . RESULTS Diabetes ( odd ratio [ OR ] , 2.76 ; P<.001 ) and postoperative hyperglycemia ( OR , 2.02 ; P=.007 ) were independently associated with development of SSIs . Among known diabetics , elevated hemoglobin A1c values were not associated with a statistically significantly increased risk of infection ; the mean A1c value was 8.44 % among those with infections compared with 7.80 % for those without ( P=.09 ) . Forty-two ( 6 % ) of 700 patients without prior diabetes history had evidence of undiagnosed diabetes ; their infection rate was comparable to that of known diabetics ( 3/42 [ 7 % ] vs 17/300 [ 6 % ] ; P=.72 ) . An additional 30 % of nondiabetics had elevated hemoglobin A1c determinations or perioperative hyperglycemia . CONCLUSIONS Postoperative hyperglycemia and previously undiagnosed diabetes are associated with development of SSIs among cardiothoracic surgery patients . Screening for diabetes and hyperglycemia among patients having cardiothoracic surgery may be warranted to prevent postoperative and chronic complications of this metabolic abnormality Introduction Uncontrolled blood glucose is associated with a higher incidence of surgical site infections , greater utilization of re sources , and increased mortality . Preoperative screening for diabetes in elective surgical patients is not routinely performed . The purpose of this study was to examine blood glucose control in a preoperative surgical population . Methods Following ethics approval , adults presenting to the pre-surgical screening clinic in preparation for elective surgery were recruited . Data collection included a self-administered question naire on diabetic risk factors and blood glucose testing , including glycosylated hemoglobin ( HbA1c ) . Descriptive analyses were conducted . Results Seventy of the 402 participants ( 17.4 % ) had a previous diagnosis of diabetes ( diabetics ) . Among those without a history of diabetes ( n = 332 non-diabetics ) , 23.2 % ( n = 77 ) were considered very high risk for diabetes ( HbA1c = 6.0 - 6.4 % ) , and 3.9 % ( n = 13 ) had a provisional diagnosis of diabetes ( HbA1c ≥ 6.5 % ) . Fifty-six percent ( n = 39/70 ) of diabetics had suboptimal glycemic control ( HbA1c > 7.0 % ) , and 51.3 % ( n = 20/39 ) of this subgroup presumed their blood sugars were reasonably or very well controlled . Fifteen percent ( n = 2/13 ) of patients with a provisional diagnosis of diabetes ( HbA1c ≥ 6.5 % ) had an elevated r and om blood sugar ( RBS ) ( ≥ 11.1 mmol·L−1 ) , while 67 % ( n = 8/12 ) had an elevated fasting blood sugar ( FBS ) ( ≥ 7.0 mmol·L−1 ) . Forty-two percent ( n = 16/38 ) of suboptimally controlled diabetics ( HbA1c > 7.0 % ) had an elevated RBS ( ≥ 11.1 mmol·L−1 ) , and 86 % ( n = 31/36 ) had an elevated FBS ( ≥ 7.0 mmol·L−1 ) . Discussion Many elective surgical patients are at risk for unrecognized postoperative hyperglycemia and associated adverse outcomes . R and om blood sugar testing has limited value and HbA1c may be a more appropriate test for the preoperative assessment of diabetic patients .Résumé Introduction La glycémie non contrôlée est associée à une incidence plus élevée d’infections du site chirurgical , à une utilisation plus importante des res sources et à une augmentation de la mortalité . Le dépistage préopératoire du diabète chez les patients de chirurgie non urgente n’est pas systématique . L’objectif de cette étude était d’examiner le contrôle glycémique chez une population chirurgicale en période préopératoire . MéthodeAprès avoir obtenu l’accord du comité d’éthique , des adultes se rendant à la clinique de dépistage préchirurgical en préparation d’une chirurgie non urgente ont été recrutés . La collecte des données incluait un question naire auto-administré sur les facteurs de risque de diabète et un test de glycémie , y compris de l’hémoglobine glyquée ( HbA1c ) . Des analyses descriptives ont été réalisées . RésultatsUn diagnostic de diabète avait déjà été posé pour soixante-dix des 402 participants ( 17,4 % ) ( diabétiques ) . Parmi les patients sans antécédents de diabète ( n = 332 , non-diabétiques ) , 23,2 % ( n = 77 ) ont été évalués comme présentant un risque très élevé de diabète ( HbA1c = 6,0 - 6,4 % ) , et un diagnostic provisoire de diabète ( HbA1c ≥ 6,5 % ) a été posé pour 3,9 % ( n = 13 ) de ces patients . Le contrôle glycémique était sous-optimal chez 56 % ( n = 39/70 ) des diabétiques ( HbA1c > 7,0 % ) , et 51,3 % ( n = 20/39 ) de ce sous-groupe prenait pour acquis que leur glycémie était raisonnablement ou très bien contrôlée . Quinze pour cent ( n = 2/13 ) des patients ayant reçu un diagnostic provisoire de diabète ( HbA1c ≥ 6,5 % ) avaient une glycémie aléatoire élevée ( ≥ 11,1 mmol·L−1 ) , alors que 67 % ( n = 8/12 ) avaient une glycémie à jeun élevée ( ≥ 7,0 mmol·L−1 ) . Quarante-deux pour cent ( n = 16/38 ) des diabétiques mal contrôlés ( HbA1c > 7,0 % ) présentaient une glycémie aléatoire élevée ( ≥ 11,1 mmol·L−1 ) , et 86 % ( n = 31/36 ) une glycémie à jeun élevée ( ≥ 7,0 mmol·L−1 ) . Discussion De nombreux patients devant subir une chirurgie non urgente courent un risque d’hyperglycémie postopératoire non identifiée et de complications associées . Les tests de glycémie aléatoire ont une valeur limitée et le test de la HbA1c pourrait être mieux adapté pour évaluer les patients diabétiques en période préopératoire Objectives : To evaluate the significance of hyperglycemia in patients without a preoperative diagnosis of diabetes undergoing elective colorectal surgery . Methods : Preoperative and all postoperative blood glucose measurements were retrieved for 2628 consecutive patients undergoing elective colorectal resection within 2 years at 1 center . Nondiabetic patients were identified as those without a preoperative diagnosis of diabetes and /or based on HbA1C levels . The association between any elevated postoperative r and om glucose value ( hyperglycemia : > 125 mg/dL ) and level of elevation ( > 125 mg/dL or > 200 mg/dL ) within 72 hours of surgery in nondiabetic patients with 30-day mortality and infectious and noninfectious complications was assessed . Results : Evaluation of 16,404 postoperative glucose measurements for all 2447 nondiabetic patients who underwent surgery in 2010 and 2011 revealed that 66.7 % patients experienced hyperglycemia . Degree of hyperglycemia correlated with increasing American Society of Anesthesiologists class and surgical severity ( blood loss ) . Hyperglycemia was associated with infectious and noninfectious complications and mortality , the rates of these complications increasing parallel to the degree of hyperglycemia . Hyperglycemia was independently associated with septic complications ( P = 0.024 ) . Conclusions : Postoperative hyperglycemia is frequent after elective colorectal surgery in nondiabetic patients . Even a single postoperative elevated glucose value is adversely associated with morbidity and mortality ; this risk is related to the degree of glucose elevation . These findings strongly support monitoring of glucose values and early consideration of management strategies for glycemic control after surgery even in nondiabetic patients BACKGROUND Plasma Haemoglobin A1c ( HbA1c ) reflects ambient mean glycaemia over a 2 - 3 months period . Reports indicate that patients , with and without diabetes , with an elevated HbA1c have an increased risk of adverse outcome following surgical intervention . Our aim was to determine whether elevated plasma HbA1c level was associated with increased postoperative morbidity and mortality in patients undergoing vascular surgical procedures . METHODS Plasma HbA1c was measured prospect ively in 165 consecutive patients undergoing emergency and elective vascular surgical procedures over a 6-month period . Patients were categorized into four groups depending on whether their plasma HbA1c was < or = 6 % , 6.1 - 7 % , 7.1 - 8 % or > 8 % and clinical data was entered into a prospect ively maintained data base . Patients were also classified by diabetic status with suboptimal HbA1c in a patient without diabetes being > 6 to < or = 7 % and suboptimal HbA1c in a patient with diabetes being > 7 % . Patients with plasma HbA1c > 7 % were reclassified as having undiagnosed diabetes mellitus . Composite primary endpoints were all cause 30-day morbidity and mortality and all cause 6-month mortality . Composite secondary endpoints were procedure specific complications , adverse cardiac events , stroke , infection and mean length of hospital stay . RESULTS Of the 165 patients studied , 43 ( 26.1 % ) had diabetes and the remaining 122 ( 73.9 % ) did not . The mean age was 72 years and 59 % were male . Suboptimal HbA1c levels were found in 58 % patients without diabetes and in 51 % patients with diabetes . In patients without diabetes those with suboptimal HbA1c levels ( 6 - 7 % ) had a significantly higher incidence of overall 30-day morbidity compared to patients with HbA1c levels < or = 6 % ( 56.5 vs 15.7 % , p<0.001 ) . Similarly , for patients with diabetes those with suboptimal HbA1c levels ( HbA1c > 7 % ) had a significantly higher incidence of 30-day morbidity compared to those with HbA1c levels < or = 7 % ( 59.1 % vs 19 % , p=0.018 ) . Multivariate analysis revealed that a plasma HbA1c level of > 6 to < or = 7 % was a significant independent predictor of overall 30-day morbidity in patients without diabetes undergoing vascular surgical procedures . No difference in mortality , composite secondary endpoints , procedure specific complications , stroke or mean length of hospital stay was observed between any of the groups in the study . CONCLUSION Suboptimal HbA1c levels may hold prognostic significance in patients without diabetes undergoing vascular surgery |
308 | 27,583,824 | AUTHORS ' CONCLUSIONS Admission avoidance hospital at home , with the option of transfer to hospital , may provide an effective alternative to inpatient care for a select group of elderly patients requiring hospital admission . | BACKGROUND Admission avoidance hospital at home provides active treatment by healthcare professionals in the patient 's home for a condition that otherwise would require acute hospital inpatient care , and always for a limited time period .
This is the third up date of the original review .
OBJECTIVES To determine the effectiveness and cost of managing patients with admission avoidance hospital at home compared with inpatient hospital care . | AIMS The ' Hospital at home ' ( HaH ) model avoids hospital admission by transferring healthcare and treatment to the patient 's home . We aim ed to compare the effectiveness and direct healthcare costs of treating elderly patients with decompensated heart failure ( HF ) using HaH care vs. inpatient hospital care ( IHC ) in a cardiology unit . METHODS AND RESULTS Eighty patients aged over 65 years who presented at the emergency department with decompensated HF were r and omly assigned to IHC or HaH. All patients were studied for 1 year . Seventy-one patients completed the study , of these 34 were admitted to cardiology and 37 received HaH care . No significant differences were found in baseline characteristics , including comorbidity , functional status , and health-related quality of life . Clinical outcomes were similar after initial admission and also after the 12 months of follow-up . Death or re-admission due to HF or another cardiovascular event occurred in 19 patients in IHC and 20 in HaH ( P = 0.88 ) . Changes in functional status and health-related quality of life over the follow-up period were not significantly different . The average cost of the initial admission was 4502 + /- 2153 euro in IHC and 2541 + /- 1334 euro in HaH ( P < 0.001 ) . During 12 months of follow-up , the average expenditure was 4619 + /- 7679 euro and 3425 + /- 4948 euro ( P = 0.83 ) respectively . CONCLUSION Hospital at home care allows an important reduction in the costs during the index episode compared with hospital care , whilst maintaining similar outcomes with respect to cardiovascular mortality and morbidity and quality of life at 1 year follow-up OBJECTIVE : To test the cost effectiveness of Hospital in the Home compared to hospital admission for acute medical conditions BACKGROUND Hospitalization for acute illness is associated with higher rates of mortality and morbidity , as well as functional decline , for older patients . We have previously shown that treatment in Hospital in the Home ( HITH ) results in less confusion and fewer bowel and bladder problems for these patients . However , it is not clear what impact HITH has on physical and cognitive function . METHODS One hundred patients ( mean age 70 ) presenting to the emergency department and assessed by a senior doctor to require admission were r and omized to be treated in hospital or at home . We measured the Barthel index , Instrumental Activities of Daily Living ( IADL ) index , and Mental Status Question naire ( MSQ ) on admission and at discharge . RESULTS The HITH-treated group improved in the IADL and MSQ indices , whereas the hospital-treated group improved only in the MSQ . The improvement in IADL scores remained significant after adjusting for age , sex , living arrangements , development of confusion , and length of stay . CONCLUSIONS HITH offers a safe option for treatment of older patients with a functional advantage over in-hospital care BACKGROUND Although the hospital is the st and ard venue for short-term medical care , it may be hazardous for older persons . This study was performed to evaluate the feasibility and effectiveness of a physician-led hospital-at-home service for selected elderly patients with acute decompensation of chronic heart failure ( CHF ) . METHODS Prospect i ve , single-blind , r and omized controlled trial with 6-month follow-up for patients 75 years or older admitted to the hospital from April 1 , 2004 , through April 31 , 2005 , for acute decompensation of CHF . Patients were r and omly assigned to the general medical ward ( n = 53 ) or to the Geriatric Home Hospitalization Service ( GHHS ; n = 48 ) . The GHHS provides diagnostic and therapeutic treatments by hospital health care professionals in the home of the patient . RESULTS Patient mortality at 6 months was 15 % in the total sample , without significant differences between the 2 setting s of care . The number of subsequent hospital admissions was not statistically different in the 2 groups , but the mean ( SD ) time to first additional admission was longer for the GHHS patients ( 84.3 [ 22.2 ] days vs 69.8 [ 36.2 ] days , P = .02 ) . Only the GHHS patients experienced improvements in depression , nutritional status , and quality -of-life scores . CONCLUSIONS Substitutive hospital-at-home care is a viable alternative to traditional hospital inpatient care for elderly patients with acutely decompensated CHF . This type of care demonstrated clinical feasibility and efficacy in comparison with its alternative . Trial Registration clinical trials.gov Identifier : NCT00623571 BACKGROUND : The “ hospital-at-home ” model may provide adequate care without an adverse effect on clinical outcome , and is generally well received by users . Our objective was to compare hospital-at-home and in-patient hospital care for neuromuscular disease ( NMD ) patients with respiratory tract infections . METHODS : We conducted a prospect i ve r and omized controlled trial in a university teaching hospital offering secondary care service to a population of approximately 500,000 . We recruited selected NMD patients with respiratory tract infection for whom hospital admission had been recommended after medical assessment . Hospital-at-home was provided as an alternative to in-patient admission . The main outcome measures were need for hospitalization , treatment failure , time to recovery , death during the first 3 months following exacerbation , and cost of patient care . RESULTS : Among 59 consecutive NMD patients eligible for the study , 53 met the criteria for hospital-at-home . Twenty-six subjects were r and omized to home care and 27 to hospital care . No significant differences were found in treatment failure ( 8/26 vs 13/27 , P = .19 ) , time to recovery ( 8.9 ± 4.6 vs 9 ± 8.9 d , P = .21 ) , or mortality at 3 months ( 3/26 vs 4/27 deaths , P = .42 ) between the groups . Hospital-at-home failure was independently correlated with type of NMD ( P = .004 ) with an odds ratio of failure of 17.3 ( 95 % CI 2.1 to infinity ) for subjects with amyotrophic lateral sclerosis . The total and daily direct cost of patient healthcare was significantly lower for the subjects who were successfully treated at home , compared to the hospitalized individuals . CONCLUSIONS : Hospital-at-home is an effective alternative to hospital admission for selected NMD patients with respiratory tract infections OBJECTIVES To evaluate hospital readmission rates and mortality at 6-month follow-up in selected elderly patients with acute exacerbation of chronic obstructive pulmonary disease ( COPD ) . DESIGN Prospect i ve r and omized , controlled , single-blind trial with 6-month follow-up . SETTING San Giovanni Battista Hospital of Torino . PARTICIPANTS One hundred four elderly patients admitted to the hospital for acute exacerbation of COPD were r and omly assigned to a general medical ward ( GMW , n=52 ) or to a geriatric home hospitalization service ( GHHS , n=52 ) . MEASUREMENTS Measurements of baseline sociodemographic information ; clinical data ; functional , cognitive , and nutritional status ; depression ; and quality of life were obtained . RESULTS There was a lower incidence of hospital readmissions for GHHS patients than for GMW patients at 6-month follow-up ( 42 % vs 87 % , P<.001 ) . Cumulative mortality at 6 months was 20.2 % in the total sample , without significant differences between the two study groups . Patients managed in the GHHS had a longer mean length of stay than those cared for in the GMW ( 15.5+/-9.5 vs 11.0+/-7.9 days , P=.010 ) . Only GHHS patients experienced improvements in depression and quality -of-life scores . On a cost per patient per day basis , GHHS costs were lower than costs in GMW ( $ 101.4+/-61.3 vs $ 151.7+/-96.4 , P=.002 ) . CONCLUSION Physician-led substitutive hospital-at-home care as an alternative to inpatient care for elderly patients with acute exacerbations of COPD is associated with a substantial reduction in the risk of hospital readmission at 6 months , lower healthcare costs , and better quality of life Abstract Objectives : To compare the costs of admission to a hospital at home scheme with those of acute hospital admission . Design : Cost minimisation analysis within a pragmatic r and omised controlled trial . Setting : Hospital at home scheme in Leicester and the city 's three acute hospitals . Participants : 199 consecutive patients assessed as being suitable for admission to hospital at home for acute care during the 18 month trial period ( median age 84 years ) . Intervention : Hospital at home or hospital inpatient care . Main outcome measures : Costs to NHS , social services , patients , and families during the initial episode of treatment and the three months after admission . Results : Mean ( median ) costs per episode ( including any transfer from hospital at home to hospital ) were similar when analysed by intention to treat — hospital at home £ 2569 ( £ 1655 ) , hospital ward £ 2881 ( £ 2031 ) , bootstrap mean difference −305 ( 95 % confidence interval −1112 to 448 ) . When analysis was restricted to those who accepted their allocated place of care , hospital at home was significantly cheaper — hospital at home £ 2557 ( £ 1710 ) , hospital ward £ 3660 ( £ 2903 ) , bootstrap mean difference −1071 ( −1843 to −246 ) . At three months the cost differences were sustained . Costs with all cases included were hospital at home £ 3671 ( £ 2491 ) , hospital ward £ 3877 ( £ 3405 ) , bootstrap mean difference −210 ( −1025 to 635 ) . When only those accepting allocated care were included the costs were hospital at home £ 3698 ( £ 2493 ) , hospital ward £ 4761 ( £ 3940 ) , bootstrap mean difference −1063 ( −2044 to −163 ) ; P=0.009 . About 25 % of the costs for episodes of hospital at home were incurred through transfer to hospital . Costs per day of care were higher in the hospital at home arm ( mean £ 207 v £ 134 in the hospital arm , excluding refusers , P<0.001 ) . Conclusions : Hospital at home can deliver care at similar or lower cost than an equivalent admission to an acute hospital Objective : To assess the effectiveness of community-based rehabilitation for stroke patients who were not admitted to hospital in South London . Design : R and omized controlled trial . Setting : Patients ' homes in South London . Subjects : Stroke patients not admitted to hospital after a stroke . Intervention : Rehabilitation at home by rehabilitation team for up to three months or usual care . Main outcome measures : The primary outcome measure was the Barthel score . Secondary measures included the Motricity Index , Rivermead ADL , Hospital Anxiety and Depression score and Nottingham Health Profile . Results : Forty-three patients who remained at home were r and omized to rehabilitation team ( 23 ) or ‘ usual ’ care ( 20 ) . The mean number of physiotherapy sessions was three ( range 1–14 ) for the rehabilitation team group and two for the usual care group . Patients ( with a deficit ) in the rehabilitation arm of the trial were more likely to receive occupational , physical and speech therapy than those in the control arm ( p = 0.03 , 0.01 and 0.008 , respectively ) . For those patients actually receiving therapy , there was no evidence that the amount received differed between the groups . However , the number of patients in each of these comparisons was very small . The outcome for patients in the rehabilitation team arm of the trial was nonsignificantly higher ( 0.05 < p < 0.2 ) than for those in the control arm for the areas of Nottingham Health Profile , anxiety , depression , caregiver strain and the proportion of patients living at home . Based on the data observed here , a trial with approximately 150 patients in each arm would be needed to have adequate power to detect a 33 % difference between intervention and control groups in these outcomes . Conclusion : Community therapy support for patients not admitted to hospital is feasible but to determine whether it is cost- or clinical ly effective would require trials of adequate size Background and Purpose — Although stroke units reduce mortality and institutionalization , their comparative cost-effectiveness is unknown . Methods — Healthcare , social services , and informal care costs were compared for 447 acute stroke patients r and omly assigned to stroke unit , stroke team , or domiciliary stroke care . Prospect i ve and retrospective methods were used to identify re source use over 12 months after stroke onset . Cost-effectiveness and cost-utility analyses were undertaken . Results — Mean healthcare and social care costs over 12 months were £ 11 450 for stroke unit , £ 9527 for stroke team , and £ 6840 for domiciliary care . More than half the costs were for the initial episode of care . Institutionalization was a large proportion of follow-up costs . Inclusion of informal care increased costs considerably . When informal care was excluded , the incremental cost-effectiveness ratio per percentage point in deaths or institutionalizations avoided in the first year was £ 496 for the stroke unit over domiciliary care ; incremental cost per quality -adjusted life year quality -adjusted life year gained was £ 64 097 between these 2 groups . The stroke team was dominated by domiciliary care . Conclusions — Cost perspectives , especially those related to long-term and informal care , are important when stroke services are evaluated . Improved health outcomes in the stroke unit come at a higher cost Abstract Objectives : To compare “ hospital at home ” and hospital care as an inpatient in acute exacerbations of chronic obstructive pulmonary disease . Design : Prospect i ve r and omised controlled trial with three months ' follow up . Setting : University teaching hospital offering secondary care service to 350 000 patients . Patients : Selected patients with an exacerbation of chronic obstructive pulmonary disease where hospital admission had been recommended after medical assessment . Interventions : Nurse administered home care was provided as an alternative to inpatient admission . Main outcome measures : Readmission rates at two weeks and three months , changes in forced expiratory volume in one second ( FEV1 ) from baseline at these times and mortality . Results : 583 patients with chronic obstructive pulmonary disease referred for admission were assessed . 192 met the criteria for home care , and 42 refused to enter the trial . 100 were r and omised to home care and 50 to hospital care . On admission , FEV1 after use of a bronchodilator was 36.1 % ( 95 % confidence interval 2.4 % to 69.8 % ) predicted in home care and 35.1 % ( 6.3 % to 63.9 % ) predicted in hospital care . No significant difference was found in FEV1 after use of a bronchodilator at two weeks ( 42.6 % , 3.4 % to 81.8 % versus 42.1 % , 5.1 % to 79.1 % ) or three months ( 41.5 % , 8.2 % to 74.8 % versus 41.9 % , 6.2 % to 77.6 % ) between the groups . 37 % of patients receiving home care and 34 % receiving hospital care were readmitted at three months . No significant difference was found in mortality between the groups at three months ( 9 % versus 8 % ) . Conclusions : Hospital at home care is a practical alternative to emergency admission in selected patients with exacerbations of chronic obstructive pulmonary disease Abstract Objectives To compare the efficacy , safety , and acceptability of treatment with intravenous antibiotics for cellulitis at home and in hospital . Design Prospect i ve r and omised controlled trial . Setting Christchurch , New Zeal and . Participants 200 patients presenting or referred to the only emergency department in Christchurch who were thought to require intravenous antibiotic treatment for cellulitis and who did not have any contraindications to home care were r and omly assigned to receive treatment either at home or in hospital . Main outcome measures Days to no advancement of cellulitis was the primary outcome measure . Days on intravenous and oral antibiotics , days in hospital or in the home care programme , complications , degree of functioning and pain , and satisfaction with site of care were also recorded . Results The two treatment groups did not differ significantly for the primary outcome of days to no advancement of cellulitis , with a mean of 1.50 days ( SD 0.11 ) for the group receiving treatment at home and 1.49 days ( SD 0.10 ) for the group receiving treatment in hospital ( mean difference 0.01 days , 95 % confidence interval -0.3 to 0.28 ) . None of the other outcome measures differed significantly except for patients ' satisfaction , which was greater in patients treated at home . Conclusions Treatment of cellulitis requiring intravenous antibiotics can be safely delivered at home . Patients prefer home treatment , but in this study only about one third of patients presenting at hospital for intravenous treatment of cellulitis were considered suitable for home treatment OBJECTIVE To determine whether community management of mild to moderate community-acquired pneumonia ( CAP ) is as effective and acceptable as st and ard hospital management of CAP . DESIGN R and omised controlled trial . SETTING Christchurch , New Zeal and , primary and secondary care . PARTICIPANTS 55 patients presenting or referred to the emergency department at Christchurch Hospital with mild to moderately severe pneumonia , assessed using a vali date d pneumonia severity assessment score , from July 2002 to October 2003 . INTERVENTIONS Hospital treatment as usual or comprehensive care in the home delivered by primary care teams . MAIN OUTCOME MEASURES Primary : days to discharge , days on intravenous ( IV ) antibiotics , patient-rated symptom scores . Secondary : health status measured using level of functioning at 2 and 6 weeks , patient satisfaction . RESULTS The median number of days to discharge was higher in the home care group ( 4 days ; range , 1 - 14 ) than in the hospital groups ( 2 days ; range , 0 - 10 ; P = 0.004 ) . There was no difference in the number of days on IV antibiotics or on subsequent oral antibiotics . Patient-rated symptom scores at 2 and 6 weeks , median change in symptom severity from baseline to 6 weeks , and general functioning at 2 and 6 weeks did not differ between the groups . Patients in both groups were satisfied with their treatment , with a clear preference for community treatment ( P < 0.001 ) . CONCLUSIONS Mild to moderately severe CAP can be managed effectively in the community by primary care teams . This model of comprehensive care at home can be implemented by primary care teams with suitable funding structures This trial compared the cost of an integrated home-based care model with traditional inpatient care for acute chronic obstructive pulmonary disease ( COPD ) . 25 patients with acute COPD were r and omised to either home or hospital management following request for hospital admission . The acute care at home group costs per separation ( $ 745 , CI95 % $ 595-$895 , n = 13 ) were significantly lower ( p < 0.01 ) than the hospital group ( $ 2543 , CI95 % $ 1766-$3321 , n = 12 ) . There was an improvement in lung function in the hospital-managed group at the Outpatient Department review , decreased anxiety in the Emergency Department in the home-managed group and equal patient satisfaction with care delivery . Acute care at home schemes can substitute for usual hospital care for some patients without adverse effects , and potentially release re sources . A funding model that allows adequate re source delivery to the community will be needed if there is a move to devolve acute care to community providers BACKGROUND ' Hospital At Home ' schemes are set to increase in the United Kingdom ( UK ) in response to the NHS Plan . To date , little detailed work has been done on the acceptability of these schemes to patients and their carers . AIM To compare Hospital at Home patient and carer satisfaction with hospital care . DESIGN OF STUDY Pragmatic r and omised controlled trial . SETTING Consecutive patients assessed as suitablefor the Leicester Hospital at Home scheme were r and omised to Hospital at Home or one of three acute hospitals in the city . METHOD Patient satisfaction was assessed two weeks after r and omisation , or at discharge if later using a six-item question naire . Patients ' and carers ' views of the services were assessed by semistructured interviews . RESULTS One hundred and two patients were r and omised to Hospital at Home and 97 to hospital . Forty-eight ( 47 % ) patients in the Hospital at Home arm and 35 ( 36 % ) in the hospital arm completed the satisfaction question naire , representing 96 % and 85 % of those eligible , respectively . Total scores were significantly higher in the Hospital at Home ( median = 15 ) than in the hospital group ( median = 12 ) . ( P<0.001 , Mann-Whitney U-test . ) Responses to all six questions favoured Hospital at Home , with all but one of these differences being statistically significant . In the Hospital at Homegroup , 24 patients and 18 of their carers were interviewed ; in the hospital group 18 patients and seven of their carers were interviewed . Themes emerging from these interviews were that patients appreciated the more personal care and better communication offered by Hospital at Home and placed great value on staying at home , which was seen to be therapeutic . Patients largely felt safe in Hospital at Home , although some would have felt safer in hospital . Some patients and carers felt that better medical care would have been provided in hospital . Carers felt that the workload imposed by Hospital at Home was no greater than by hospital admission and that the relief from care duties at home would be counterbalanced by the added strain of hospital visiting . CONCLUSIONS Patient satisfaction was greater with Hospital at Home than with hospital . Reasons included a more personal style of care and a feeling that staying at home was therapeutic . Carers did not feel that Hospital at Home imposed an extra workload OBJECTIVES To describe the changes in activities of daily living ( ADL ) function occurring before and after hospital admission in older people hospitalized with medical illness and to assess the effect of age on loss of ADL function . DESIGN Prospect i ve observational study . SETTING The general medical service of two hospitals . PARTICIPANTS Two thous and two hundred ninety-three patients aged 70 and older ( mean age 80 , 64 % women , 24 % nonwhite ) . MEASUREMENTS At the time of hospital admission , patients or their surrogates were interviewed about their independence in five ADLs ( bathing , dressing , eating , transferring , and toileting ) 2 weeks before admission ( baseline ) and at admission . Subjects were interviewed about ADL function at discharge . Outcome measures included functional decline between baseline and discharge and functional changes between baseline and admission and between admission and discharge . RESULTS Thirty-five percent of patients declined in ADL function between baseline and discharge . This included the 23 % of patients who declined between baseline and admission and failed to recover to baseline function between admission and discharge and the 12 % of patients who did not decline between baseline and admission but declined between hospital admission and discharge . Twenty percent of patients declined between baseline and admission but recovered to baseline function between admission and discharge . The frequency of ADL decline between baseline and discharge varied markedly with age ( 23 % , 28 % , 38 % , 50 % , and 63 % in patients aged 70 - 74 , 75 - 79 , 80 - 84 , 85 - 89 , and > or = 90 , respectively , P < .001 ) . After adjustment for potential confounders , age was not associated with ADL decline before hospitalization ( odds ratio ( OR ) for patients aged > or = 90 compared with patients aged 70 - 74 = 1.26 , 95 % confidence interval ( CI ) = 0.88 - 1.82 ) . In contrast , age was associated with the failure to recover ADL function during hospitalization in patients who declined before admission ( OR for patients aged > or = 90 compared with patients aged 70 - 74 = 2.09 , 95 % CI = 1.20 - 3.65 ) and with new losses of ADL function during hospitalization in patients who did not decline before admission ( OR for patients aged > or = 90 compared with patients aged 70 - 74 = 3.43 , 95 % CI = 1.92 - 6.12 ) . CONCLUSION Many hospitalized older people are discharged with ADL function that is worse than their baseline function . The oldest patients are at particularly high risk of poor functional outcomes because they are less likely to recover ADL function lost before admission and more likely to develop new functional deficits during This study compares the costs and outcomes of domiciliary and hospital-based chemotherapy , using a prospect i ve r and omized cross-over design . Eighty-seven eligible patients were recruited from oncology services at two metropolitan hospitals in Sydney , Australia . Forty patients completed study evaluation requirements , having two months of chemotherapy in each location ( home and hospital ) . The domiciliary service was staffed by hospital-based oncology nurses . Marginal costs of domiciliary treatment over hospital treatment were estimated from the health service perspective . Home-based care was more expensive , largely due to extra nurse time . About half of the eligible patients ( n = 87 ) and 73 percent of the evaluated patients ( n = 40 ) preferred domiciliary care . Most evaluated patients and their informal carers were satisfied with the medical care provided , regardless of location . Patient needs were well met in either location , and no differences were found in quality of life . At current throughput rates , providing chemotherapy in the home was more expensive than providing it in hospital . However , if the dem and for chemotherapy were to exceed ward capacity by up to 50 percent , moving chemotherapy into the home could provide a less costly strategy for the expansion of a chemotherapy service without compromising patient outcomes PURPOSE For patients with cancer who have febrile neutropenia , relative costs of home versus hospital treatment , including unreimbursed costs borne by patients and families , are poorly characterized . We estimated costs from a r and omized trial of patients with low-risk febrile neutropenia for whom outpatient care was feasible , comparing inpatient treatment with discharge to home care after inpatient observation . METHODS We collected direct medical and self-reported indirect costs for 57 inpatient and 35 outpatient treatment episodes of patients enrolled in a r and omized trial from 1996 through 2000 . Charges from hospital bills were converted to costs using Medicare cost-to-charge ratios . Patients kept daily logs of out-of-pocket payments and time spent by informal caregivers providing care . Dollar amounts were st and ardized to June 2008 . RESULTS Mean total charges for the hospital arm were 49 % higher than for the home treatment arm ( $ 16,341 v $ 10,977 ; P < .01 ) . Mean estimated total costs for the hospital arm were 30 % higher ( $ 10,143 v $ 7,830 ; P < .01 ) . Inspection of sparse available data suggests that payments made were similar by treatment arm . In patients and their caregivers spent more out of pocket than their outpatient counterparts ( mean , $ 201 v $ 74 ; P < .01 ) . Informal caregivers for both treatment arms reported similar time caring and lost from work . CONCLUSION Home intravenous antibiotic treatment was less costly than continued inpatient care for carefully selected patients with cancer having febrile neutropenia without significantly increased indirect costs or caregiver burden OBJECTIVES To evaluate whether home treatment of elderly patients with acute uncomplicated first ischemic stroke is associated with different mortality rates and clinical outcomes from those of patients treated on a general medical ward ( GMW ) . DESIGN R and omized , controlled , single-blind trial . SETTING S. Giovanni Battista Hospital of Turin . PARTICIPANTS One hundred twenty elderly patients admitted to the emergency department of the hospital with first acute ischemic stroke were r and omized to home treatment from a geriatric home hospitalization service ( GHHS ) or to GMW treatment . MEASUREMENT Main outcome was cumulative survival at 6 months in the two groups . Residual functional impairment , neurological deficit , depression , morbidity , and admission to rehabilitation and long-term care facilities were considered as secondary outcomes in survivors . RESULTS One hundred twenty patients ( mean age 82 ; 54 men and 66 women ) were enrolled ( 60 in each study arm ) . The cumulative proportion of cases surviving at 6 months was 0.65 in the GHHS group and 0.60 in GMW group ( log-rank test P=.53 ) . Functional and neurological parameters were significantly improved in both GHHS and GMW patients , without significant differences between the two groups . Depression score was significantly better in home-treated patients ( P<.001 ) , who were more likely to remain at home at 6 months than hospital-treated patients and had a lower rate of select medical complications . CONCLUSION Home-treated elderly patients with ischemic stroke have better depressive scores and lower rates of admission to nursing homes . These results should prompt further studies to evaluate home hospitalization for elderly stroke patients Objective : To compare the safety , effectiveness , acceptability and costs of a hospital-at-home programme with usual acute hospital inpatient care . Method : Patients aged 55 years or over being treated for an acute medical problem were r and omized to receive either st and ard inpatient hospital care or hospital-at-home care . Follow-up was for 90 days after r and omization . Health outcome measures included physical and mental function , self-rated recovery , health status as assessed by the SF-36 , adverse events and readmissions to hospital . Acceptability was assessed using satisfaction surveys and the Carer Strain Index . Costs comprised hospital care , care in the home , community services , general practitioner services and personal health care expenses . Results : In all , 285 people were r and omized with a mean age of 80 years . There were no significant differences in health outcome measures between the two r and omized groups . Significantly more patients receiving care at home reported high levels of satisfaction , as did more of their relatives . Relatives of the care-at-home group also reported significantly lower scores on the Carer Strain Index . However , the mean cost per patient was almost twice for patients treated at home ( NZ$6524 ) as for st and ard hospital care ( NZ$3525 ) . A sensitivity analysis indicated that , if the service providing care in the home had been operating at full capacity , the mean cost per patient episode would have been similar for both modes of care . Conclusions : This hospital-at-home programme was found to be more acceptable and as effective and safe as inpatient care . While caring for patients at home was significantly more costly than st and ard inpatient care , this was largely due to the hospital-at-home programme not operating at full capacity In a controlled trial of a home-care service available for the first 6 months after acute stroke , 440 patients received the new service and 417 patients were in the control group . The trial group used more hospital bed days , had a slightly higher admission rate , and did not show better emotional adjustment to stroke than the control group . There was no difference between the 2 groups in stress on relatives . Functional recovery was equal in the 2 groups . A quarter of patients managed at home in each group were severely disabled . Providing a new service does not necessarily alter clinical decisions in the short term , and care should be taken before exp and ing domiciliary services to reduce hospital use A Geriatric Home Hospitalization Service ( GHHS ) has been operating in Torino at S. Giovanni Battista Hospital since 1985 . GHHS allows us to perform diagnostic and therapeutic interventions , which are usually made in hospital , also at home . GHHS team includes geriatricians , nurses , physiotherapists , social workers and counselors . Between February 1999 and April 2002 , the GHH Service conducted a r and omized controlled trial on 109 elderly , demented patients requiring admission to the Hospital Emergency Department (ED)for acute illnesses . Objective of the study was to identify the benefits of the care in a GHHScompared to a general medical ward ( GMW ) in reducing behavioral disturbances in elderly patients with advanced dementia and in lowering caregiver 's stress . Patients were r and omly assigned to GHHS ( 56 patients ) or to GMW ( 53 patients ) . Both groups were examined using the same protocol and were evaluated on admission and on discharge . All patients had a severe form of dementia as shown by the clinical dementia rating ( CDR ) scale mean value ( 3.7 + /- 0.9 ) with an important functional impairment and a relevant degree of comorbidity . The main reasons for hospitalization were infections , cerebrovascular accidents and malnutrition . Mortality of total sample was 19.3 % , without significant differences in the two setting s of care . On discharge , in GHHS patients there was a significant reduction of behavioral disturbances . The use of anti-psychotic drugs was significantly lower in GHHS patients compared to the GMW group ( p < 0.001 ) . The stress of caregivers on discharge was reduced only in GHHS group and not in the control ones . In conclusion , we can say that a GHHS continuous support allows us to reduce the family caregiver 's stress . When treated at home , demented patients do not have to change their environment or routine and it is possible to have a better control on behavioral disturbances Abstract Objective : To compare effectiveness of patient care in hospital at home scheme with hospital care . Design : Pragmatic r and omised controlled trial . Setting : Leicester hospital at home scheme and the city 's three acute hospitals . Participants : 199 consecutive patients referred to hospital at home by their general practitioner and assessed as being suitable for admission . Six of 102 patients r and omised to hospital at home refused admission , as did 23 of 97 allocated to hospital . Intervention : Hospital at home or hospital inpatient care . Main outcome measures : Mortality and change in health status ( Barthel index , sickness impact profile 68 , EuroQol , Philadelphia geriatric morale scale ) assessed at 2 weeks and 3 months after r and omisation . The main process measures were service inputs , discharge destination , readmission rates , length of initial stay , and total days of care . Results : Hospital at home group and hospital group showed no significant differences in health status ( median scores on sickness impact profile 68 were 29 and 30 respectively at 2 weeks , and 24 and 26 at 3 months ) or in dependency ( Barthel scores 15 and 14 at 2 weeks and 16 for both groups at 3 months ) . At 3 months ' follow up , 26 ( 25 % ) of hospital at home group had died compared with 30 ( 31 % ) of hospital group ( relative risk 0.82 ( 95 % confidence interval 0.52 to 1.28 ) ) . Hospital at home group required fewer days of treatment than hospital group , both in terms of initial stay ( median 8 days v 14.5 days , P=0.026 ) and total days of care at 3 months ( median 9 days v 16 days , P=0.031 ) . Conclusions : Hospital at home scheme delivered care as effectively as hospital , with no clinical ly important differences in health status . Hospital at home result ed in significantly shorter lengths of stay , which did not lead to a higher rate of subsequent admission . Key messages The effectiveness of hospital at home schemes for avoiding hospital admission has not been tested in a trial In this study patients suitable for hospital at home care were r and omised to hospital at home or hospital care and followed up for three months There were no clinical ly or statistically significant differences in outcome as measured by the sickness impact profile 68 , Barthel index , Philadelphia geriatric morale scale , and EuroQol Length of stay in care and total days of care were about 45 % less for patients r and omised to hospital at home For patients who meet the admission criteria , hospital at home schemes can provide an effective and acceptable alternative to hospital BACKGROUND Organised specialist care for stroke improves outcome , but the merits of different methods of organisation are in doubt . This study compares the efficacy of stroke unit with stroke team or domiciliary care . METHODS A single-blind , r and omised , controlled trial was undertaken in 457 acute-stroke patients ( average age 76 years , 48 % women ) r and omly assigned to stroke unit , general wards with stroke team support , or domiciliary stroke care , within 72 h of stroke onset . Outcome was assessed at 3 , 6 , and 12 months . The primary outcome measure was death or institutionalisation at 12 months . Analyses were by intention to treat . FINDINGS 152 patients were allocated to the stroke unit , 152 to stroke team , and 153 to domiciliary stroke care . 51 ( 34 % ) patients in the domiciliary group were admitted to hospital after r and omisation . Mortality or institutionalisation at 1 year were lower in patients on a stroke unit than for those receiving care from a stroke team ( 21/152 [ 14 % ] vs 45/149 [ 30 % ] ; p<0.001 ) or domiciliary care ( 21/152 [ 14 % ] vs 34/144 [ 24 % ] ; p=0.03 ) , mainly as a result of reduction in mortality . The proportion of patients alive without severe disability at 1 year was also significantly higher on the stroke unit compared with stroke team ( 129/152 [ 85 % ] vs 99/149 [ 66 % ] ; p<0.001 ) or domiciliary care ( 129/152 [ 85 % ] vs 102/144 [ 71 % ] ; p=0.002 ) . These differences were present at 3 and 6 months after stroke . INTERPRETATION Stroke units are more effective than a specialist stroke team or specialist domiciliary care in reducing mortality , institutionalisation , and dependence after stroke PURPOSE Febrile neutropenia commonly complicates cancer chemotherapy . Outpatient treatment may reduce costs and improve patient comfort but risk progression of undetected medical problems . PATIENTS AND METHODS By using our vali date d algorithm , we identified medically stable in patients admitted for febrile neutropenia ( neutrophils < 500/μL ) after chemotherapy and r and omly assigned them to continued inpatient antibiotic therapy or early discharge to receive identical antibiotic treatment at home . Our primary outcome was the occurrence of any serious medical complication , defined as evidence of medical instability requiring urgent medical attention . RESULTS We enrolled 117 patients with 121 febrile neutropenia episodes before study termination for poor accrual . We excluded five episodes as ineligible and three because of inadequate documentation of the study outcome . Treatment groups were clinical ly similar , but sociodemographic imbalances occurred because of block r and omization . The median presenting absolute neutrophil count was 100/μL. Hematopoietic growth factors were used in 38 % of episodes . The median neutropenia duration was 4 days ( range , 1 to 15 days ) . Five out patients were readmitted to the hospital . Major medical complications occurred in five episodes ( 8 % ) in the hospital arm and four ( 9 % ) in the home arm ( 95 % CI for the difference , -10 % to 13 % ; P = .56 ) . No study patient died . Patient-reported quality of life was similar on both arms . CONCLUSION We found no evidence of adverse medical consequences from home care , despite a protocol design ed to detect evidence of clinical deterioration . These results should reassure clinicians who elect to treat rigorously characterized low-risk patients with febrile neutropenia in suitable outpatient setting s with appropriate surveillance for unexpected clinical deterioration |
309 | 20,406,227 | Oxytocin is superior to misoprostol in hospitals .
Misoprostol substantially lowers PPH and severe PPH . | BACKGROUND Meta-analyses of postpartum blood loss and the effect of uterotonics are biased by visually estimated blood loss .
OBJECTIVES To conduct a systematic review of measured postpartum blood loss with and without prophylactic uterotonics for prevention of postpartum haemorrhage ( PPH ) . | Abstract Objective To evaluate whether routine administration of sublingual misoprostol 600 μg after delivery reduces postpartum haemorrhage . Design R and omised double blind placebo controlled trial . Setting Primary health centre in Bissau , Guinea-Bissau , West Africa . Participants 661 women undergoing vaginal delivery . Intervention Misoprostol 600 μg or placebo administered sublingually immediately after delivery . Main outcome measures Postpartum haemorrhage , defined as a loss of ≥ 500 ml and decrease in haemoglobin concentration after delivery . Results The incidence of postpartum haemorrhage was not significantly different between the two groups , the relative risk being 0.89 ( 95 % confidence interval 0.76 to 1.04 ) in the misoprostol group compared with the placebo group . Mean blood loss was 10.5 % ( −0.5 % to 20.4 % ) lower in the misoprostol group than in the control group . Severe postpartum haemorrhage of ≥ 1000 ml or ≥1500 ml occurred in 17 % ( 56 ) and 8 % ( 25 ) in the placebo group and 11 % ( 37 ) and 2 % ( 7 ) in the misoprostol group . Significantly fewer women in the misoprostol group experienced a loss of ≥1000 ml ( 0.66 , 0.45 to 0.98 ) or ≥ 1500 ml ( 0.28 , 0.12 to 0.64 ) . The decrease in haemoglobin concentration tended to be less in the misoprostol group , the mean difference between the two groups being 0.16 mmol/l ( −0.01 mmol/l to 0.32 mmol/l ) . Conclusion Sublingual misoprostol reduces the frequency of severe postpartum haemorrhage Oxytocin has been the oxytocic of choice for Active Management of Third Stage of Labor ( AMTSL ) [ 1 ] . Misoprostol would be a suitable alternative in low re source setting s where drug delivery is hampered by storage and problems of parenteral administration . In patients who are vomiting , unable to take medications or under anesthesia , rectal administration may be associated with fewer side effects and ease of administration [2].The use of additional uterotonics is significantly higher with rectal 400 mcg misoprostol than with oxytocin [ 3 ] . It is possible that a higher dose of rectal misoprostol may be more effective in reducing blood loss . A prospect i ve , double-blind , r and omized pilot study was undertaken in the Post Graduate Institute of Medical Education and Research ( PGIMER ) , Ch and igarh , India to determine the effectiveness and safety of rectal administration of 600 mcg misoprostol compared to oxytocin as part of the AMTSL in women at low risk for PPH . The study was approved by the ethical committee of the Institute . Two hundred women in spontaneous labor were recruited , and a written informed consent was Postpartum hemorrhage is the leading cause of maternal mortality in India , accounting for 25 - --30 % of all maternal deaths [ 1 ] . A large number of deliveries still occur at home , especially in rural areas . Injectable uterotonics are not necessarily applicable to these setting s , as their effective use requires safe administration and special storage to maintain stability . In this prospect i ve double blind r and omized study conducted in 2005 - 06 at the Postgraduate Institute of Medical Education and Research ( PGIMER ) , Ch and igarh , India , 200 women at low risk of PPH were r and omized to receive either two tablets of misoprostol ( 400 mcg ) sublingually or 1ml of methylergometrine ( 200 mcg ) intramuscularly at the delivery of anterior shoulder of baby . Identical looking placebo tablets and injections were used . Primary and secondary outcomes measured are shown in Table 1 . The duration of third stage , mean blood loss and need for additional oxytocics was similar in Postpartum hemorrhage ( PPH ) is a major cause of maternal mortality and morbidity worldwide . Uterine massage is thought to stimulate uterine contraction possibly through stimulation of local prostagl and in release and thus to reduce hemorrhage . The objective of the r and omized trial reported here was to determine the effectiveness of intermittent uterine massage after delivery of the placenta to reduce postpartum blood loss and the need for additional uterotonics . The study was conducted in the labor ward of the Department of Obstetrics and Gynecology Assiut University Hospital during June and July 2005 . ( excerpt A r and omised , controlled trial of 1429 women was carried out to compare ' active ' management of the third stage of labour , using i.v . Ergometrine 0.5 mg , with a method of ' physiological ' management , in women at ' low risk ' to haemorrhage . In the " active " management group a higher incidence of the following complications was found:- manual removal of placenta ( p less than 0.0005 ) , problems such as nausea ( p less than 0.0005 ) , vomiting ( p less than 0.0005 ) , and severe after-birth pains ( p less than 0.02 ) , hypertension ( p less than 0.0001 ) and secondary postpartum haemorrhage ( p less than 0.02 ) . The incidence of postpartum haemorrhage ( blood loss greater than 500 ml ) and postnatal haemoglobins less than 10 gm/100 were higher in the ' physiological ' group ( p less than 0.0005 , p less than 0.002 ) . No difference was found in the need for blood transfusion in either group . The routine use of i.v . Ergometrine 0.5 mg during the third stage of labour in women at ' low risk ' to haemorrhage does not appear to be necessary and has many adverse effects . Further studies comparing different methods of ' physiological ' management are recommended in order to reduce to a minimum the incidence of postpartum haemorrhage and anaemia Objective To compare intravenous oxytocin administration ( Partocon ® 10 IU ) with saline solution in the management of postpartum haemorrhage in the third stage of labour BACKGROUND Misoprostol , an inexpensive , stable , orally active prostagl and in analogue , has been suggested for use in the prevention of postpartum haemorrhage . Potential side-effects , however , need to be quantified . OBJECTIVE To compare the rate of postpartum shivering and pyrexia following oral misoprostol 600 micrograms and placebo . DESIGN A double-blind placebo-controlled trial . Women in labour were r and omly allocated to receive either misoprostol 600 micrograms orally or placebo after delivery . Conventional oxytocics were given immediately if blood loss was thought to be more than usual . Side-effects were recorded . Postpartum blood loss in the first hour was measured by collection in a special flat plastic bedpan . SETTING The labour ward of an academic hospital in Johannesburg , with 7,000 deliveries per annum . MAIN OUTCOME MEASURES Shivering and pyrexia . RESULTS The groups were well matched . Misoprostol use was associated with more shivering ( 44 % versus 11 % , relative risk ( RR ) 4.03 , 95 % confidence interval ( CI ) 2.85 - 5.70 ) , pyrexia > or = 37.8 degrees C ( 38 % v. 6 % , RR 6.23 , CI 3.89 - 9.97 ) , 1-hour systolic blood pressure > or = 140 mmHg ( 33 % v. 25 % , RR 1.32 , CI 1.03 - 1.70 ) , and diastolic blood pressure > or = 90 mmHg ( 10.5 % v. 3.0 % , RR 3.44 , CI 1.67 - 7.11 ) . There were no other significant differences . The study was not design ed to be large enough to assess a difference in blood loss > or = 1,000 ml ( 9 % v. 9.7 % , RR 0.93 , CI 0.56 - 1.53 ) . Possible effects on blood loss may have been obscured by the lesser use of additional oxytocics in the misoprostol group ( 14 % v. 18 % , RR 0.78 , CI 0.54 - 1.13 ) . CONCLUSIONS This study has shown the association of postpartum oral misoprostol 600 micrograms with shivering , pyrexia and hypertension . The increased blood pressure , as for the trend towards increased abdominal pain , may be secondary to the uterotonic effect of misoprostol . Large r and omised trials are needed to assess the effectiveness of misoprostol in the prevention of postpartum haemorrhage , against which the disadvantages demonstrated here can be weighed OBJECTIVE --To compare the effects on fetal and maternal morbidity of routine active management of third stage of labour and expectant ( physiological ) management , in particular to determine whether active management reduced incidence of postpartum haemorrhage . DESIGN --R and omised trial of active versus physiological management . Women entered trial on admission to labour ward with allocation revealed just before vaginal delivery . Five months into trial high rate of postpartum haemorrhage in physiological group ( 16.5 % v 3.8 % ) prompted modification of protocol to exclude more women and allow those allocated to physiological group who needed some active management to be switched to fully active management . Sample size of 3900 was planned , but even after protocol modification a planned interim analysis after first 1500 deliveries showed continuing high postpartum haemorrhage rate in physiological group and study was stopped . SETTING --Maternity hospital . PARTICIPANTS --Of 4709 women delivered from 1 January 1986 to 31 January 1987 , 1695 were admitted to trial and allocated r and omly to physiological ( 849 ) or active ( 846 ) management . Reasons for exclusion were : refusal , antepartum haemorrhage , cardiac disease , breech presentation , multiple pregnancy , intrauterine death , and , after May 1986 , ritodrine given two hours before delivery , anticoagulant treatment , and any condition needing a particular management of third stage . INTERVENTIONS --All but six women allocated to active management actually received it , having prophylactic oxytocic , cord clamping before placental delivery , and cord traction ; whereas just under half those allocated to physiological management achieved it . A fifth of physiological group received prophylactic oxytocic , two fifths underwent cord traction and just over half clamping of the cord before placental delivery . ENDPOINT -- Reduction in incidence of postpartum haemorrhage from 7.5 % under physiological management to 5.0 % under active management . MEASUREMENTS AND MAIN RESULTS --Incidence of postpartum haemorrhage was 5.9 % in active management group and 17.9 % in physiological group ( odds ratio 3.13 ; 95 % confidence interval 2.3 to 4.2 ) , a contrast reflected in other indices of blood loss . In physiological group third stage was longer ( median 15 min v 5 min ) and more women needed therapeutic oxytocics ( 29.7 % v 6.4 % ) . Apgar scores at one and five minutes and incidence of neonatal respiratory problems were not significantly different between groups . Babies in physiological group weighed mean of 85 g more than those in active group . When women allocated to and receiving active management ( 840 ) were compared with those who actually received physiological management ( 403 ) active management still produced lower rate of postpartum haemorrhage ( odds ratio 2.4;95 % CI1.6 to 3.7 ) . CONCLUSIONS --Policy of active management practised in this trial reduces incidence of postpartum haemorrhage , shortens third stage , and results in reduced neonatal packed cell volume Objective To compare the effect of intramuscular Syntometrine and Syntocinon in the management of the third stage of labour BACKGROUND Maternal mortality rates in India are estimated at 560/100,000 live births and postpartum hemorrhage ( PPH ) accounts for 35 - 56 % of these deaths . Given that 50 % of births in rural India occur at home , oral Misoprostol administered by minimally trained midwives may be an effective uterotonic agent for preventing PPH when the use of other uterotonics is not feasible . While the import for testing the effectiveness of this intervention may be readily obvious , the elements essential for the conduct of a scientific study in rural areas served by indigenous health workers may not be as evident . METHODS We present the design as well as the preparation and development of an ongoing NICHD sponsored U.S.-Indian collaborative r and omized , placebo-controlled , clinical trial ( RCT ) conducted in four Primary Health Center areas of Belgaum District , Karnataka , India . The primary goal of the trial is to assess the effectiveness of Misoprostol 600 microg orally in reducing the incidence of acute PPH ( > or = 500 mL ) in women delivering at home or in neighboring sub-centers . 1600 pregnant women will be r and omized to receive Misoprostol or placebo immediately post-delivery of the infant . However , beyond testing the scientific merit of the RCT , this study also tests the feasibility of having indigenous midwives regularly using Misoprostol in rural areas as well as the willingness of these communities to accept this intervention . In addition , this paper also explores the international and community collaborations necessary for the conduct of this study . FINDINGS It is necessary to have several critical elements in place , including international collaboration between the Indian and US research sites , funding through a private/public collaboration and trained scientists , as well as commitment from the community for the successful conduct of such a study . In the development and implementation of a RCT , careful attention must be paid to the training of field personnel involved in the delivery process and developing a data collection and monitoring system to ensure that information gathered is valid . CONCLUSIONS A joint U.S.-Indian collaboration to test the efficacy and the feasibility of an innovative method to reduce PPH can serve as collaborative model to develop additional interventions to improve maternal mortality and morbidity . If Misoprostol is shown to be sufficiently safe and efficacious in the prevention of PPH , the appropriate government agencies will be encouraged to make the drug available to midwives ( ANMs ) and rurally located physicians for whom parenteral medications are either not permitted or impractical and /or unavailable . Such a project can serve as a model applicable to rural setting s throughout the developing world for improving delivery practice s and reducing maternal mortality and morbidity . These are important public health concerns in India and other developing nations OBJECTIVES Our purpose was to compare the controlled cord traction technique with the minimal intervention technique for delivery of the placenta . The primary outcome was the incidence of postpartum hemorrhage . Secondary outcomes included duration of third stage of labor , frequency of retained placenta , hemorrhagic shock , the need for blood transfusion , and the need for uterotonic agents to control postpartum hemorrhage . STUDY DESIGN A total of 1648 women who were delivered vaginally were r and omly allocated during labor to the controlled cord traction group ( n = 827 ) or the minimal intervention group ( n = 821 ) . In the controlled cord traction group women received oxytocin , 10 units intramuscularly , with delivery of the baby 's anterior shoulder , after which the placenta was delivered actively by controlled cord traction ( Br and t- And rews method ) . In the minimal intervention group the placenta was delivered by maternal pushing . Continuous intravenous oxytocin was given after delivery of the placenta . Odds ratios with 95 % confidence intervals were calculated for each variable . RESULTS The overall incidence of postpartum hemorrhage was significantly lower in the controlled cord traction group ( 5.8 % vs 11 % ; odds ratio 0.50 , 95 % confidence interval 0.34 to 0.73 ) . The incidence of retained placenta ( > or = 30 minutes ) was 1.6 % in the controlled cord traction group and 4.5 % in the minimal intervention group ( odds ratio 0.31 , 95 % confidence interval 0.15 to 0.63 ) . Significantly more patients in the minimal intervention group required additional uterotonic agents to control hemorrhage ( 5.1 % vs 2.3 % ; odds ratio 0.44 , 95 % confidence interval 0.24 to 0.78 ) . CONCLUSION The controlled cord traction technique for delivery of the placenta results in a significantly lower incidence of postpartum hemorrhage and retained placenta , as well as less need for uterotonic agents , compared with the minimal intervention technique OBJECTIVE To compare current practice s for the active management of the third stage of labor ( AMTSL ) with the use of 600 mug of oral misoprostol . METHODS An operations research study was design ed to compare blood loss with current AMTSL practice s and misoprostol use . RESULTS Women in the misoprostol group were less likely to bleed 500 ml or more ( adjusted odds ratio , 0.30 ; 95 % confidence interval , 0.16 - 0.56 ) compared with those in the current practice s group . In the current practice s group 73 % women required interventions because of postpartum hemorrhage , compared with 11 % in the misoprostol group . CONCLUSION In situations where oxytocin and or ergometrine are not consistently and appropriately used during third stage of labor , misoprostol should be considered for inclusion in the AMTSL protocol BACKGROUND Postpartum haemorrhage is a major cause of maternal mortality in the developing world . Although effective methods for prevention and treatment of such haemorrhage exist -- such as the uterotonic drug oxytocin -- most are not feasible in re source -poor setting s where many births occur at home . We aim ed to investigate whether oral misoprostol , a potential alternative to oxytocin , could prevent postpartum haemorrhage in a community home-birth setting . METHODS In a placebo-controlled trial undertaken between September , 2002 , and December , 2005 , 1620 women in rural India were r and omised to receive oral misoprostol ( n=812 ) or placebo ( n=808 ) after delivery . 25 auxiliary nurse midwives undertook the deliveries , administered the study drug , and measured blood loss . The primary outcome was the incidence of acute postpartum haemorrhage ( defined as > or = 500 mL bleeding ) within 2 h of delivery . Analysis was by intention-to-treat . The trial was registered with the US clinical trials data base ( http://www . clinical trials.gov ) as number NCT00097123 . FINDINGS Oral misoprostol was associated with a significant reduction in the rate of acute postpartum haemorrhage ( 12.0 % to 6.4 % , p<0.0001 ; relative risk 0.53 [ 95 % CI 0.39 - 0.74 ] ) and acute severe postpartum haemorrhage ( 1.2 % to 0.2 % , p<0.0001 ; 0.20 [ 0.04 - 0.91 ] . One case of postpartum haemorrhage was prevented for every 18 women treated . Misoprostol was also associated with a decrease in mean postpartum blood loss ( 262.3 mL to 214.3 mL , p<0.0001 ) . Postpartum haemorrhage rates fell over time in both groups but remained significantly higher in the placebo group . Women taking misoprostol had a higher rate of transitory symptoms of chills and fever than the control . INTERPRETATION Oral misoprostol was associated with significant decreases in the rate of acute postpartum haemorrhage and mean blood loss . The drug 's low cost , ease of administration , stability , and a positive safety profile make it a good option in re source -poor setting Objective To assess the effectiveness of 600 μg oral misoprostol on postpartum haemorrhage ( PPH ) and postpartum anaemia in a low income country home birth situation OBJECTIVE To compare ( 1 ) visual estimation of postpartum blood loss with estimation using a specifically design ed blood collection drape and ( 2 ) the drape estimate with a measurement of blood loss by photospectrometry . METHODS A r and omized controlled study was performed with 123 women delivered at the District Hospital , Belgaum , India . The women were r and omized to visual or drape estimation of blood loss . A sub sample of 10 drape estimates was compared with photospectrometry results . RESULTS The visual estimate of blood loss was 33 % less than the drape estimate . The interclass correlation of the drape estimate to photospectrometry measurement was 0.92 . CONCLUSION Drape estimation of blood loss is more accurate than visual estimation and may have particular utility in the developing world . Prompt detection of postpartum hemorrhage may reduce maternal morbidity and mortality in low-re source setting OBJECTIVE To compare the effectiveness of 400 microg rectal misoprostol in 5 cm(3 ) of saline with oxytocin 10 IU , i.m . , in reducing bleeding during the third stage of labor . DESIGN A double blind , r and omized , clinical trial including 663 women with uncomplicated vaginal delivery who received misoprostol ( n=324 ) or oxytocin ( n=339 ) . MAIN OUTCOME MEASURES Changes in hemoglobin and hematocrit from before to 72 h postpartum ; blood loss during the third stage ; duration of the third stage of labor ; need for additional oxytocic drug ; frequency of requisition and of administration of blood ; changes in blood pressure ; and occurrence of side effects . RESULTS No significant differences were observed between groups , before and 72 h postpartum , in mean hemoglobin and hematocrit , on volume of blood loss and duration of third stage of labor . The incidence of shivering and mean temperature ( P<0.01 ) was significantly greater among women receiving misoprostol than oxytocin . CONCLUSIONS Misoprostol administered as a micro-enema , 400 microg in 5 ml of saline during the third stage of labor , appears to be as effective as oxytocin 10 IU , i.m . , but misoprostol produced more side effects than oxytocin AIM To compare vaginally administered misoprostol to rectally administered misoprostol and placebo in a prospect i ve r and omized placebo-controlled study . METHODS One hundred and fifty women with singleton vaginal deliveries were r and omized ( 50 women in each arm ) to receive 400-microg misoprostol tablets ( crushed and suspended in a microenema ) intravaginally , or 400-microg misoprostol tablets rectally , or two placebo lactose tablets rectally . The medication was administered immediately after delivery of the placenta . Women with profuse hemorrhage and delayed placental separation ( > 30 min ) were excluded . Our outcome measures were postpartum blood loss 1 h after administration , and change in hemoglobin and hematocrit values from baseline to postpartum day 1 . Analysis of variance and chi-squared tests were used to compare the outcome variables between groups . RESULTS One hundred and twenty-six women were available for analysis . Baseline characteristics were similar across the groups . The number of excluded subjects , the estimated blood loss , and the drop in hemoglobin and hematocrit values did not differ between the three groups ( P > 0.05 ) . CONCLUSIONS Misoprostol administered vaginally or rectally at a dosage of 400 microg following placental separation was not effective for decreasing postpartum bleeding in women without excessive hemorrhage Postpartum hemorrhage ( PPH ) is a major cause of morbidity and mortality in both developed and developing countries . Various pharmacologic agents including oxytocin ergot preparations and prostagl and in analogues such as 15-methyl prostagl and in F2a and prostagl and in E2 have been found to prevent PPH . However they are expensive associated with adverse effects and require parenteral administration . Misoprostol is a prostagl and in E1 analogue shown in several r and omized controlled trials to be effective in preventing PPH because of its strong uterotonic effects . Moreover misoprostol is inexpensive stable at room temperature and easy to administer . The present study compared the efficacy and side effects of 400 µg of rectal misoprostol with 125 µg of 15-methyl prostagl and in F2a in the prevention of PPH . ( excerpt OBJECTIVE To compare the efficacy of intravenous ergometrine , intramuscular oxytocin , and oral misoprostol in the control of postpartum hemorrhage . METHODS Mean blood loss , rates of blood loss between 500 and 1000 ml , hematocrit fall greater than 10 % , and need for additional oxytocic agents and nature and rates of adverse effects were assessed in this prospect i ve , r and omized , controlled study . RESULTS All outcomes were similar in the 3 groups . The main adverse effects in the misoprostol group were temperatures higher than 99 degrees F , which normalized within 2 h and shivering , which was mild and self-limiting . CONCLUSIONS Oral misoprostol is as effective as conventional oxytocic agents in preventing postpartum hemorrhage and can be recommended for use in low-re source setting Background . To compare sublingual misoprostol with intravenous syntometrine use during third stage of labor by measuring the blood loss Objectives . To determine the efficacy of intravenous oxytocin administration compared with intravenous methylergometrine administration for the prevention of postpartum hemorrhage ( PPH ) , and the significance of administration at the end of the second stage of labor compared with that after the third stage . Methods . A prospect i ve study was undertaken : two major groups ( oxytocin group and methylergometrine group ) of 438 women with singleton pregnancy and vaginal delivery were studied during a 15‐month period . These two groups were subdivided into three subgroups : 1 . intravenous injection ( two minutes ) group immediately after the delivery of the fetal anterior shoulder , 2 . intravenous injection ( two minutes ) group immediately after the delivery of the placenta , and 3 . drip infusion ( 20 min ) group immediately after the delivery of the fetal head . In each group , quantitative postpartum blood loss , frequencies of blood loss > 500 ml , and need of additional uterotonic treatment were evaluated . Results . As compared with methylergometrine , oxytocin administration was associated with a significant reduction in postpartum blood loss and in frequency of blood loss > 500 ml . The risk of PPH was significantly reduced with intravenous injection of oxytocin after delivery of the fetal anterior shoulder , compared with intravenous injection of oxytocin after expulsion of the placenta ( OR 0.33 , 95%CI 0.11–0.98 ) and intravenous injection of methylergometrine after delivery of the fetal anterior shoulder ( OR 0.31 , 95%CI 0.11–0.85 ) . Conclusions . Intravenous injection of 5 IU oxytocin immediately after delivery of fetal anterior shoulder is the treatment of choice for prevention of PPH in patients with natural course of labor Summary : A prospect i ve study was conducted to compare the accuracy of visual estimation of blood loss ( EBL ) at delivery with laboratory determination of measured blood loss ( MBL ) . It showed that EBL tends to be clouded by the conventional teaching that blood loss at delivery is usually between 200 to 300 mL. Women with MBL up to 150 mL were overestimated and the best correlation was in women with MBL between 150 to 300 mL. There was a tendency to underestimate blood loss when the MBL was between 301 to 500 mL. Of the 9 women with a primary postpartum haemorrhage , only one was correctly diagnosed as such and 3 women were estimated to have blood losses of at least 500 mL but the measured blood losses were all lower . It was concluded that visual estimation of blood loss is inaccurate , especially at the extremes of MBL and that primary postpartum haemorrhage is not detected by visual estimation of blood loss , unless there are associated signs of haemodynamic instability OBJECTIVE To compare the effect on post partum bloodloss of the postpartum prophylactic administration of oxytocin or sulprostone in low risk women having an expectant management of the third stage . DESIGN R and omized , placebo controlled , double-blind trial . SETTING Radboud University Hospital , Nijmegen ( 67 women ) and Lievensberg Hospital , Bergen op Zoom ( 10 women ) . PARTICIPANTS 77 women entered the trial ( three were excluded ) . INTERVENTIONS The intramuscular injection , immediately after the birth of the baby , of either oxytocin 5 IU , sulprostone 500 micrograms or 0.9 % saline . MAIN OUTCOME MEASURES Quantitative postpartum blood loss and length of third stage . RESULTS Postpartum blood loss was reduced almost equally , by about 35 % , by oxytocin ( P = 0.02 ) , or sulprostone ( P = 0.05 ) . The mean length of the third stage was shorter in both groups receiving the active treatment , this effect was significant in the sulprostone group ( P = 0.01 ) . CONCLUSION Prophylactic administration of oxytocin or sulprostone directly after delivery followed by expectant management of the third stage reduces post partum blood loss and shortens the third stage OBJECTIVE This study investigated the effectiveness of rectal misoprostol in preventing postpartum hemorrhage . STUDY DESIGN In a r and omized , placebo-controlled study , 550 women were r and omly allocated to rectally receive 400 microg misoprostol or nonidentical placebo after normal vaginal delivery . Any excessive bleeding was actively managed with conventional oxytocic agents . Blood loss was measured directly . RESULTS The baseline variables were similar . Blood loss of > or = 1000 mL occurred in 4.8 % ( 13/270 ) of the misoprostol group and 7 % ( 19/272 ) of the placebo group . Additional oxytocic therapy was required by 3.3 % and 4.7 % , respectively . No predominance of side effects , particularly shivering , was noted in the misoprostol group . CONCLUSIONS Postpartum use of 400 microg rectal misoprostol was well tolerated and associated with a statistically nonsignificant trend toward less postpartum hemorrhage . The early active management of excessive bleeding with conventional oxytocic agents may have reduced the potential of the study to detect differences between the groups OBJECTIVE To compare the efficacy and side effects of sublingual misoprostol and intravenous methylergometrine for active management of third stage of labor . METHOD One hundred twenty low risk pregnant women at term with spontaneous onset of labor were included in the study . The women were r and omized to receive either two tablets of misoprostol ( 200 microg/tablet ) sublingually or 1 ml of methylergometrine ( 200 microg ) intravenous injection , after the delivery of the anterior shoulder of the baby . The main outcome measures were : need for additional oxytocic drugs , blood loss > or=500 ml , change in hemoglobin levels and side effects . RESULTS Postpartum hemorrhage as defined by hemorrhage > or=500 ml occurred in 3.1 % of the women in the sublingual misoprostol group but none of the women in the methylergometrine group ( P > 0.05 ) . There was a need for additional oxytocic drugs in 5.0 % and 8.3 % after methylergometrine and misoprostol , respectively ( P > 0.05 ) . The change in hemoglobin levels at 24 h postpartum were 0.8 and 0.7 gm% in methylergometrine and misoprostol group , respectively(P > 0.05 ) . In the misoprostol group , 6.6 % women developed fever > or=38 degrees C and 21.6 % had shivering while in methylergometrine group none experienced these side effects . However , the incidence of other side effects like nausea , vomiting , headache and giddiness were similar in both groups . CONCLUSION Sublingual misoprostol appears to be as effective as intravenous methylergometrine in the prevention of postpartum hemorrhage . However , larger r and omized studies are needed to advocate its routine use OBJECTIVES A double blind r and omized controlled trial was performed at the tertiary hospital in Harare , Zimbabwe to compare oral misoprostol with intramuscular oxytocin in the management of third stage of labor . METHODS A total of 499 women were r and omized to receive either 400 microg misoprostol orally or 10 IU oxytocin intramuscularly . The incidences of postpartum hemorrhage and side effects were examined . RESULTS The demographic and labor characteristics were comparable . Postpartum hemorrhage occurred in 15.2 % of women given misoprostol and in 13.3 % of those given oxytocin ( P=0.534 ) . Measured blood loss of more than 1000 ml occurred in 3.7 % of the misoprostol group compared with 2 % in the oxytocin group ( P=0.237 ) . There was no significant difference in the need for additional oxytocic drugs or blood transfusion in women given misoprostol ( P values 0.137 and 0.600 , respectively ) . Significant side effects of misoprostol were shivering [ RR=1.32 ( 95 % CI 1.11 - 1.58 ) ; P=0.002 ) and a rise in temperature [ RR=2.02 ( 95 % CI 1.75 - 2.33 ) ; P<0.001 ] . CONCLUSIONS Oral misoprostol is as effective as intramuscular oxytocin in the prevention of PPH . Shivering and transient pyrexia were specific side effects of misoprostol . Misoprostol has potential in reducing the high incidence of PPH in developing countries |
310 | 12,917,988 | On a patient rather than per implant basis there were no statistically significant differences for failures , marginal bone level changes on intraoral radiographs and peri-implantitis between various implant systems .
REVIEW ER 'S CONCLUSIONS There was no evidence that any of the implant systems evaluated was superior to the other . | BACKGROUND Dental implants are available in different material s , shapes and with different surface characteristics .
In particular , numerous implant surface modifications have been developed for enhancing clinical performances .
OBJECTIVES To test the null hypothesis of no difference in clinical performance between various root-formed osseointegrated dental implant types . | BACKGROUND The aim of the present study was to compare the peri-implant soft tissue health status of implants supporting overdentures with bar attachments or ball attachments in the m and ible , as well as patient satisfaction with these attachment types . METHODS The study included a Dolder bar group with 18 cases ( 43 implants ) and a ball attachment group with 18 cases ( 51 implants ) . The mean function period in the Dolder bar group was 49 months ( range : 12 to 72 months ) and in the ball attachment group , the mean was 23 months ( range : 12 to 40 months ) . Implants were clinical ly evaluated by using a modified plaque index ( mPI ) , modified sulcus bleeding index ( mSBI ) , and probing depths . Patient satisfaction with the treatment was recorded using a question naire . RESULTS mPI , probing depth , and mSBI did not statistically differ between groups ( Mann-Whitney U test , P > 0.05 ) . Patient satisfaction was similar with both retentive systems . CONCLUSION Within the limits of this study , we concluded that there was no significant difference between the 2 attachment types used for implant-supported overdentures with respect to the soft tissue health status or patient satisfaction In earlier studies of Astra Tech and Brånemark System implants , high survival rates and small marginal bone changes have been demonstrated . The aim of this study was to compare the two systems , primarily with regard to marginal bone changes , but also with regard to other clinical variables of interest . The present paper describes the results after three years . Sixty-six patients were included in the study and r and omly assigned to treatment with Astra Tech implants ( n = 184 ) or Brånemark System implants ( n=187 ) . The marginal bone level was radiographically examined at fixture insertion , at abutment connection , at baseline ( delivery of the prosthetic construction ) and at 1- and 3-year follow-up examinations . Between fixture insertion and the baseline examination , the pattern of marginal bone resorption differed between the two systems . However , there was no significant marginal bone change between baseline and the 1-year examination or between the 1- and 3-year examinations . Nor were there any differences between the systems . The mean bone loss in the upper jaw between BL ( baseline ) and 3 years was 0.2 + /- 0.3 mm for Astra Tech implants and 0.2 + /- 0.1 mm for Brånemark System implants . The corresponding figures for the lower jaw were 0.3 + /- 0.2 mm and 0.2 + /- 0.1 mm . The survival rate of Astra Tech implants was significantly higher ( 98.9 % ) than for Brånemark System implants ( 95.2 % ) . However , five of the nine implant losses in the Brånemark group occurred in one patient . For that reason , this result must be interpreted with caution . The number of patients with implant losses did not differ significantly between the systems . Few complications were recorded up to 3 years Recent empirical evidence supports the importance of adequate r and omization in controlled trials . Trials with inadequate allocation concealment have been associated with larger treatment effects compared with trials in which authors reported adequate allocation concealment . While that provides empirical evidence of bias being interjected into trials , trial investigators rarely document the sensitive details of subverting the intended purpose of r and omization . This article relates anonymous accounts run the gamut from simple to intricate operations , from transillumination of envelopes to search ing for code in the office files of the principal investigator . They indicate that deciphering is something more frequent than a rate occurrence . These accounts prompt some method ological recommendations to help prevent deciphering . R and omized controlled trials appear to annoy human nature -- if properly conducted , indeed they should BACKGROUND Oral implant treatment ad modum Brånemark has been used for decades in the rehabilitation of edentate and partially dentate patients . Posterior jaw regions frequently exhibit bone of poor texture , and it is often difficult to obtain primary stability . Thus , it may prove beneficial to deviate from the original protocol and to use implants with a modified design , for example , with a slightly tapered geometry . PURPOSE The purpose of the investigation was to compare the early behavior of a modified ( prototype Mk IV , Brånemark System , Nobel Biocare AB , Gothenburg , Sweden ; test ) implant with that of the st and ard Brånemark implant ( control ) in regions of mainly type 4 bone . MATERIAL S AND METHODS Three Swedish centers participated , and a total of 44 patients were treated with oral implants for 39 maxillas and 5 m and ibles . The study focused on the most distal right and left implant sites ( 88 implants ) , which were r and omized to receive either a test or a control implant . Various parameters were recorded , such as registered insertion torque ( OsseoCare ) , Nobel Biocare AB ) , wobbling during insertion , primary and secondary stability ( as measured with resonance frequency ) , and marginal bone loss . The implants were followed up for 1 year . RESULTS The test implant more frequently required a higher insertion torque and showed a significantly higher primary stability than the control implant . This difference in stability leveled out over time , and test and control implants exhibited similar secondary stability at abutment operation and at the 1-year visit . Wobbling during insertion was rarely recorded for either of the implant design s. The 1-year cumulative success rate was 93.1 % for test implants and 88.4 % for control implants . CONCLUSIONS The modified implant design result ed in an increased primary stability , which may be important when placing implants in jaw regions of type 4 bone . However , independent of the achieved primary stability , successful implants tended to approach similar secondary stability in the two design s tested This paper describes the 5-year results of a comparative study between Astra Tech and Brånemark system implants . The aim was to compare the systems primarily with regard to bone level changes , and also with regard to other variables of interest . Sixty-six patients with edentulous jaws were included in the study . R and omisation schedules were used to allocate the patients to the two implant systems . 184 Astra Tech implants with a titanium-blasted surface and 187 Brånemark implants with a turned surface were used . The implants were inserted with a two-stage technique and the insertion followed the routines for the respective implant system . All patients were provided with full-arch fixed bridges . All patients were followed up with clinical and radiographic examinations from fixture insertion to the 5-year follow-up . The total mean bone level change in the upper jaw between fixture insertion and the 5-year examination was -1.74+/-0.45 mm at the Astra implants and -1.98+/-0.21 at the Brånemark implants . The corresponding values for the lower jaw were -1.06+/-0.19 for Astra and -1.38+/-0.17 for Brånemark . The major postoperative changes of the marginal bone level took place between fixture insertion and baseline . During this period , there was also a different pattern of bone remodelling between the implant systems . Between baseline ( prosthesis connection ) and the 5-year examination , the marginal bone level changes were small , with no difference between the implant systems . The implant stability was examined with the supraconstructions removed . At the 5-year examination , the survival rate for Astra Tech implants was 98.4 % and for the Brånemark implants it was 94.6 % . The difference was not statistically significant In a multicenter clinical trial treatment , the effects of overdentures on different implant systems in patients with severely resorbed m and ibles were compared 1 year after the insertion of new dentures . The implant systems used were the transm and ibular implant ( TMI ) , the IMZ ( IMZ ) , and the Brånemark system ( BRA ) . Treatment was r and omly assigned to 88 patients according to a balanced allocation method . Evaluation included peri-implant and radiographic parameters . According to the Delphi method a Clinical Implant Performance scale ( CIP ) was constructed based on all conceivable complications of the different implant systems . During the healing period , one IMZ and one BRA implant were lost , and one TMI implant was removed after functional loading . The results of the peri-implant and radiographic parameters and the CIP scale revealed no significant differences between the three implant systems STATEMENT OF PROBLEM Treatment of tooth loss in the anterior maxilla can involve difficult functional , esthetic , and psychologic problems , especially in young patients with otherwise good dentition . PURPOSE The purpose of this study was to provide a preliminary comparative evaluation of two implants ( ITI and Astra ) in single-tooth restorations . MATERIAL AND METHODS This prospect i ve study of 102 single-tooth replacements with 56 ITI and 46 Astra dental implants was performed in 82 patients at the Finnish Student Health Service Foundation . One Astra implant was lost before loading . The overall survival rate of the implants was 97.8 % for Astra implants and 100 % for the ITI system . After the initial healing period of at least 6 months , the remaining 101 implants ( 56 ITI , 45 Astra ) were free of periimplant infection and revealed no detectable mobility . Radiographs did not reveal signs of periimplant radiolucencies . All 101 implants received single-tooth crowns . RESULTS Periimplant parameters and acceptable implant function were examined and demonstrated satisfactory results with preestablished clinical parameters and radiographs at 1 year . During the observation time the mean marginal bone loss was 0.13 mm with Astra implants and 0.11 mm with ITI implants . Subjectively all patients were satisfied with their single-tooth restorations supported by either ITI or Astra dental implants . CONCLUSION The favorable results of this short-term study support the application of the two implant systems for single-tooth restorations , especially in the anterior region of the maxilla BACKGROUND Maintenance of the health and integrity of the bone-implant complex ( osseointegration ) has been shown to be essential for long term success of root-form , endosseous dental implants . If reliable clinical indicators of adequacy of the bone-implant complex existed , they could stimulate new and innovative early intervention research to arrest of reverse early deterioration of the bone-implant complex . In the absence of such indicators , this has been problematic . The Periotest may have the potential to provide this information by indirectly assessing the status of the bone-implant complex . However , little information is available that documents either the capability of the Periotest to reliably assess changes of the bone-implant complex or the " normal variations " in Periotest values ( PTVs ) for both HA-coated and non-coated implants . METHODS The purpose of this paper was to document changes in PTVs as influenced by various implant surfaces , implant design s , and bone densities . The mean PTVs recorded for each visit , for all implant types and bone densities , were combined to provide an overall average PTV ( A-PTV ) . The changes in stability ( PTVs ) were analyzed using a generalized linear model ( GLM ) with repeated measures ( Hotelling 's Trace ) . RESULTS The A-PTV for all implants over all visits was -3.5 . The mean PTVs ranged from -4.2 ( SD = 2.4 ) at uncovering to -3.9 ( SD = 2.9 ) at 60 months . All implants in bone qualities 1 and 2 ( BQ-1 and BQ-2 ) became more stable over time , while those in bone quality 3 or 4 ( BQ-3 and BQ-4 ) showed a slight decrease in stability . In BQ-1 , the mean PTVs increased from -4.7 at uncovering to -4.9 at 60 months . A similar increase in stability occurred in BQ-2 ( -4.1 at uncovering to -4.4 at 60 months ) . In BQ-3 , the stability of the implants decreased over time ( -3.6 at uncovering to -2.9 at 60 months ) , with similar changes recorded for BQ-4 ( -2.5 at uncovering to -1.0 at 60 months ) . When comparing the stability of all HA-coated with all non-coated implants , the HA implants became less stable ( -4.4 to -3.4 ) over time , while non-coated implants showed an improvement in stability ( -3.5 to -4.5 ) . The changes in stability found in BQ-1 , BQ-2 , and BQ-3 were similar , with HA implants becoming less stable and non-coated more stable . HA- and non-coated comparisons were not possible in BQ-4 since there were too few non-coated implants placed in this type of bone . The HA-coated screw showed a decrease in stability when compared to the non-coated screw . CONCLUSIONS Conclusions of the study are as follows : 1 ) PTVs are influenced by bone quality and surface coating of the implant ; 2 ) the PTVs at the time of uncovering provide the best estimate of a clinical ly acceptable PTV for that bone-implant complex ; 3 ) while the PTVs for any bone-implant complex may fluctuate + /- 1.0 around the uncovering PTV during routine healing and loading of the implant , a consistent shift toward a positive PTV that approaches " 0 " should be cause for concern that the bone-implant complex may be at risk of failure ; 4 ) HA-coated implants became slightly less stable ( more positive PTVs ) over time , while the non-coated implants became more stable ( more negative PTVs ) ; and 5 ) until a " critical PTV " can be accurately identified , it is suggested that a consistent shift in recorded PTVs that exceeds the + 3.0 value on the PTV scale should be viewed with concern for possible deterioration at the bone-implant complex S and blasted and acid-etched ( SLA ) implants were recently introduced to reduce the healing period between surgery and prosthesis . In this split-mouth study , SLA implants were compared to titanium plasma-sprayed ( TPS ) implants under loaded conditions one year after placement in 32 healthy patients , with comparable bilateral edentulous sites and no discrepancies in the opposing dentition . The surgical procedure was performed by the same operator and was identical at 68 SLA ( test ) and 68 TPS ( control ) sites . Tapping was never performed and primary stability was always achieved . Abutment connection was carried out at 35 Ncm 6 weeks postsurgery for test sites and 12 weeks for the controls , by the same dentist blind to the type of surface of the implant . In 4 of the 68 test sites the implant rotated slightly , patients reported minor pain and connection was not completed . Provisional restoration was fabricated and a new tightening was performed after six weeks . Similar gold-ceramic restorations were cemented on the same type of solid abutments on both sites . No implant was lost . Clinical measures and radiographic changes were recorded by the same operator , blind to the type of surface of the implant , 1 year post surgery . No significant differences were found with respect to presence of plaque ( 24 % vs. 27 % ) , bleeding on probing ( 24 % vs. 31 % ) , mean pocket depth ( 3.3 mm vs. 2.9 mm ) or mean marginal bone loss ( 0.65 mm vs. 0.77 mm ) . The results suggest that SLA implants are suitable for early loading at 6 weeks . Limited implant spinning may occasionally be found but , if properly h and led , it produces no detrimental effect on the clinical outcome The aim of this met analysis was to investigate possible differences in failure patterns among four different osseointegrated oral implant systems . Only systems with a supposed scientific validation , based on long-term follow-up studies , were selected for this analysis , i.e. the Branemark system , the Calcitek Integral system , the Interpore IMZ system and the Straumann ITI system . While several prospect i ve reports could be found on the Branemark system , only a few retrospective investigations concerning the ITI and the IMZ systems were available . No data on the Integral system could be employed . Despite these limitations , a substantial difference in failure patterns among various implant systems was observed . The Branemark implants showed a higher incidence of early failures , though sharply decreasing over time . On the contrary , IMZ implant characterized by rougher surfaces displayed a lower incidence of early failures , but showed constant or increased failure rates over time . For the ITI implants , for example , a higher prevalence of late failures , attributable to chronic bacterial infection ( peri-implantitis ) , was observed when compared to the Branemark system . With the exception of the latter implant system , prospect i ve long-term follow-up studies , using similar and well-defined success criteria , are needed for the others to confirm the current preliminary findings A new self-tapping Brånemark implant design ed for denser bone qualities was evaluated with regard to insertion technique , complications , marginal bone remodeling , and survival rate . Thirty patients , representing 21 m and ibles and 9 maxillae , participated in the study . In each patient both st and ard and self-tapping implants were placed , and a total of 179 implants , 88 self-tapping and 91 st and ard , were inserted . Thirteen of 62 m and ibular self-tapping implants reached their correct positions only after using the screw tap or the cylinder wrench for manual insertion . No such problems were noted when using st and ard fixtures after bone pre-tapping . In the maxillae , neither of the two implant design s presented any problems . One st and ard and one self-tapping fixture failed to osseointegrate . Radiolucencies were seen in the bone around the apical portion of two fixtures , one of each design . The mean marginal bone resorption after 1 year of follow-up was 0.5 to 0.6 mm for the two fixture types OBJECTIVE The purpose of this article was to present the preliminary results of a prospect i ve clinical trial comparing titanium plasma-sprayed versus hydroxyapatite-coated titanium plasma-sprayed cylinder ( press fit ) implants in different regions of the mouth . STUDY DESIGN Sixty-five subjects met the inclusion requirements . Surgery was done in two phases by four experienced surgeons . Implant placement and abutment connection were separated by 3 to 4 months in the m and ible , 6 to 7 months in the maxilla . Patients were assigned to either titanium plasma-sprayed or hydroxyapatite-coated implants on the day of surgery . Implant placement was not stratified for the region of the jaws . Outcome assessment was failure ( loss ) of an implant before or within 3 months of second phase surgery . RESULTS Three hundred fifty-two implants equally distributed between titanium plasma-sprayed and hydroxyapatite-coated titanium plasma-sprayed implants were placed in four different sites ; anterior maxilla , posterior maxilla , anterior m and ible , and posterior m and ible . There were a total of 15 failures ( 4.26 % ) . Overall , titanium plasma-sprayed implants showed a higher but not significant failure rate compared with hydroxyapatite-coated implants ( p = 0.06 ) . Although not statistically significant , we believe that a smoking history played an important role in the failure of implants . CONCLUSION This study suggests that an hydroxyapatite-coating of an implant allows superior initial integration when compared with a titanium plasma-sprayed surface BACKGROUND Step-wise reduction in loading protocol s is necessary to evaluate early loading of implants with m and ibular overdentures . PURPOSE To compare the success rates of two different dental implant systems following conventional or early loading protocol s in patients being rehabilitated with m and ibular overdentures . MATERIAL S AND METHODS Forty-eight edentulous participants were r and omly allocated to two different implant systems : one with a machined titanium implant surface ( Sterioss , Nobel Biocare , Yorba Linda , California , USA ) and the other with a roughened titanium surface ( Southern Implants , Irene , South Africa ) . For each system , the participants were further divided into control groups , in whom m and ibular implant overdentures and their respective matrices were inserted following a st and ard 12-week healing period , and test groups , in whom a 6-week healing period was followed prior to identical loading . Two unsplinted implants to support implant overdentures were placed in the anterior m and ible of all participants , using a st and ardized one-stage surgical procedure . Mobility tests and marginal bone levels , as well as peri-implant parameters , were evaluated at each baseline and 52 and 104 weeks after surgery . RESULTS There was no statistically significant difference in the success rates of the two systems in either control or test groups . At the 2-year evaluation , a success rate was found of 87.5 % and 70.8 % for the control and test Sterioss groups , respectively , and 83.3 % and 100 % for the control and test Southern Implants groups were observed . For the Sterioss groups , eight implants were lost at an early stage : seven in the test group and one in the control group . For the Southern Implants control and test groups , no failures were seen at any time interval . There were no significant differences in marginal bone loss , Periotest values , and peri-implant parameters between implant systems or between any of the control or test groups . CONCLUSIONS Early loading , with step-wise reductions in loading protocol s , of unsplinted machined Sterioss and roughened Southern Implants fixtures with m and ibular overdentures is possible for up to 2 years BACKGROUND A major reason for the success of modern dental implant systems has been the development of implant design s that enhance direct bone-implant interface . Surface roughness has been a factor in this success and different systems have utilized very different implant surface roughness . The major purpose of this study was to evaluate 2 similar implants with different surface roughness characteristics . METHODS Two similarly design ed , screw-type , commercially pure titanium implants , one dual acid-etched ( DAE ) and the other machined-surfaced ( MS ) , were compared in this prospect i ve , r and omized-controlled , multi-center study , in which a total of 97 patients were enrolled at a private dental practice or a university dental clinic . Both implant types were placed in each patient using a 2-stage approach with a conventional 4- to 6-month healing period . Implants supported fixed prostheses , hybrid prostheses , and overdentures as dictated by the individual patient 's need . All of the cases were followed using clinical and radiographic examinations . Criteria of success were the absence of peri-implant radiolucency , mobility , and persistent signs or symptoms of pain or infection . RESULTS Of the 432 implants ( 247 dual acid-etched , 185 machined-surfaced ) , 36 implants ( 12 dual acid-etched and 24 machined-surfaced ) have failed . The pre-loading integration success rate of the dual acid-etched implants ( 95.0 % ) was statistically higher ( P < 0.01 ) than the success rate of the machined-surfaced implants ( 86.7 % ) . At 36 months , the cumulative success rates ( CSR ) are 95.0 % for the dual acid-etched implants and 86.7 % for the machined-surfaced implants . CONCLUSIONS The difference in success rates is most likely attributed to the acid-etched surface characteristics . The greatest performance difference is observed in the conditions of poor quality or soft bone where the 3-year post-loading CSR are 96.8 % ( dual acid-etched ) and 84.8 % ( machined-surfaced ) BACKGROUND The aim of this study was to evaluate the clinical and radiographic changes in the peri-implant tissues around one-stage implants with different smooth neck portion lengths before and after functional prosthetic loading . METHODS Twelve one-stage implants were placed in adult patients with bilateral edentulous posterior m and ibular ridges . The sites were r and omly assigned into two groups of six each : group 1 : 2.8 mm neck implants and group 2 : neck implants . The parameters plaque index ( PI ) , gingival index ( GI ) , probing depth ( PD ) , gingival margin level ( GML ) , relative clinical attachment level ( r-CAL ) , and optical density ( OD ) were measured at loading ( 4 months ) and 12 months after implant placement . The radiographic parameter osseous level ( OL ) was measured at implant placement , loading , and at 12 months . Analysis of variance and the paired Student t test were used to detect difference over time and between groups . RESULTS The results showed significant differences ( P<0.05 ) for both groups for PD , r-CAL , and OL for intragroup comparisons over time . However , no significant differences were found for PI , GI , PD , GML , OD , and OL for between-group comparisons . CONCLUSION Bony loss occurred before loading , supporting the soft tissues and maintaining the biologic width irrespective of the smooth portion length PURPOSE Two treatment concepts for implant-supported bar retention of m and ibular overdentures-2 intramobile cylinder ( IMZ ) implants and a Dolder bar and 4 titanium plasma-sprayed ( TPS ) screw implants and an angulated bar-were compared in a r and omized controlled clinical trial with respect to postprosthetic efficacy and safety . MATERIAL S AND METHODS Four hundred twenty-five patients with edentulous m and ibles were enrolled ; 212 were r and omized to TPS implants ( control group ) and 213 to IMZ implants ( test group ) . Endpoints were occurrences of postprosthetic integration deficiency ( ID ) , functional deficiency ( FD ) , and complications . The trial was sized to detect a 10 % difference in 5-year ID-free postprosthetic system lifetime with a power of 80 % . RESULTS With 340 protocol -completed cases , the trial achieved its predetermined power . The 2 systems did not show statistically significant differences in occurrences of postprosthetic ID and FD ; 5-year occurrence-free postprosthetic system lifetime probabilities were estimated as 42.5 % with IMZ and 42.8 % with TPS , for ID ; and as 82.6 % with IMZ and 87.2 % with TPS , for FD . However , at 3 to 6 months after surgery , mean Periotest values were significantly higher ( P = .0001 without adjustment ) with IMZ implants ( 5.6 , SD 4.2 ) than with TPS implants ( 0.8 , SD 4.3 ) . TPS implants showed a higher incidence of inflammation and recession , while IMZ implants had a higher incidence of implant fracture after functional loading . DISCUSSION The system-wise approach overcomes potential bias with implant-wise analyses . A combination of radiographic and clinical criteria distinguishes between desirable integration and functional anchorage . The in situ survival rates at 5 years in this study ( 95 % for IMZ , 92 % for TPS ) match rates reported in the literature . CONCLUSION This study demonstrated equivalent efficacy of 2 IMZ cylinders and 4 TPS screws in implant-supported , bar-retained m and ibular overdentures and indicated a higher rate of complications with the TPS screw implants This report is based on a total of 2,955 implants of 6 different design s , r and omized and placed in 829 patients and followed for 48 months . Implant failure was defined as nonintegration at uncovering or removal due to mobility , persistent pain , infection , and evidence of radiographic bone loss . Failures were reported for 3 phases of treatment : implant placement to uncovering ( phase 1 ) , uncovering to loading ( phase 2 ) , and postloading ( phase 3 ) . Differences in survival were compared with Kaplan-Meier survival curves . The maxillary single tooth application result ed in 95.2 % survival for the hydroxyapatite-coated grooved implants . In the maxillary completely edentulous application , survival of hydroxyapatite grooved and screw implants were considerably better compared with the titanium screw implants . The hydroxyapatite-coated cylinder had better survival than the titanium basket and screw design s in the m and ibular completely edentulous application . The hydroxyapatite-coated cylinder and grooved implants in the maxillary posterior partially edentulous application had similar survival rates . The survival of the hydroxyapatite-coated cylinder exceeded that of the titanium basket in m and ibular posterior partially edentulous applications . Analyses by phase of treatment indicated a pattern of early failure for nonhydroxyapatite-coated implants compared with hydroxyapatite-coated implants . The implant with the highest survival at all phases of treatment was the hydroxyapatite-coated press-fit cylinder . Two hydroxyapatite-coated implant design s performed well in the challenging posterior maxillary region BACKGROUND Evidence -based reports are needed to support the application of a one-stage surgical protocol for unsplinted implants supporting m and ibular overdentures . PURPOSE To examine the feasibility and success of using two different dental implant systems ( originally design ed for two-stage operative technique ) using a one-stage operative procedure in patients being rehabilitated with implant m and ibular overdentures . MATERIAL S AND METHODS The study sample involved 24 edentulous subjects ( aged 55 - 80 yr ) r and omly allocated to two different implant systems , one with a machined titanium implant surface ( Steri-Oss , Nobel Biocare , Göteborg , Sweden ) and the other with a roughened titanium surface ( Southern Implants , Ltd. , Irene , South Africa ) . Two unsplinted implants to support implant overdentures were placed in the anterior m and ible of all patients , using a st and ardized one-stage surgical and prosthodontic procedure . Primary stability and bicortical anchorage of the implants was m and atory before healing abutments were connected at the time of implant placement . Implant overdentures and their respective matrices were inserted following a st and ard 12-week healing period . Data relating to mobility tests , radiographs , and peri-implant parameters were documented at 12 , 16 , and 52 weeks after surgery . RESULTS A success rate of 95.8 % for the Steri-Oss and 100 % for the Southern Implants was found , without any statistically significant differences in the marginal bone loss . Significant changes in Periotest values were observed for both types between 12 and 52 weeks ( p < .001 ) . Minor changes were observed in the peri-implant parameters evaluated . CONCLUSIONS These preliminary findings show a successful application of this one-stage approach for unsplinted implants supporting m and ibular overdentures with Steri-Oss and Southern Implant Systems Failure rates at second-stage surgery were reported for the ongoing Dental Implant Clinical Research Group studies of the Spectra-System ( Core-Vent Corporation , Las Vegas , NV ) implants . As of May 1995 , 69 implants failed out of 2,633 placed and uncovered . The overall failure rate was 2.6 % , with 3.6 % in bone quality 1 ( BQ-1 ) , 2.4 % in BQ-2 , 2.5 % in BQ-3 , and 3.1 % in BQ-4 . HA-coated cylinders had the lowest number of failures and titanium alloy baskets the highest . The basket design failed more often in the posterior jaw areas ; 9 of 32 clinical centers ( 28 % ) accounted for 72 % of these failures PURPOSE The aim of this study was to evaluate the feasibility of using a 2-stage implant system in a single-stage procedure and to study the impact of the microgap between the implant and the abutment . MATERIAL S AND METHODS Sixty edentulous patients ( Cawood class V or VI ) participated in this study . After r and omization , 20 patients received 2 IMZ implants placed in a single-stage procedure , 20 patients received 2 IMZ implants placed in the traditional 2-stage procedure , and 20 patients were treated with 2 ITI implants ( single-stage procedure ) . The implants were placed in the canine area of the m and ible . After 3 months , m and ibular overdentures were fabricated , supported by a bar- and -clip attachment . A st and ardized clinical and radiographic evaluation was performed immediately after prosthesis placement and after 12 and 24 months . RESULTS One IMZ implant of the 1-stage group and 1 IMZ implant of the 2-stage group were lost after 6 and 12 months , respectively . Apart from several significant but clinical ly irrelevant differences , the 3 groups did not appear to differ markedly with regard to clinical parameters during the evaluation period . The mean bone loss within the first 2 years of functioning ( 1.1 mm IMZ 1-stage , 0.8 mm IMZ 2-stage , 1.2 mm ITI ) was comparable for the 3 groups . DISCUSSION AND CONCLUSIONS The results of this study suggest that dental implants design ed for a submerged implantation procedure can also be used in a single-stage procedure and may be as predictable as when the same implants used in a 2-stage procedure or as 1-stage implants . Placement of the microgap at the crestal level in 2-stage implants did not appear to have an adverse effect on the amount of peri-implant bone loss at 2 years in this study population BACKGROUND Numerous new implant design s and material s have become available over the last decade , each with special cl aims of superiority in restoring complex cases . Differences in existing clinical data bases , study design s , and methods of determining failures/survival are seldom st and ardized , which complicates comparisons of clinical performance of these new design s. Little information is available concerning the changes in stability of various design s and material s following clinical loading . METHODS A total of 30 VA medical centers and 2 dental schools combined to form the Dental Implant Clinical Research Group ( DICRG ) . More than 2,900 implants were placed , restored and data gathered from the time of placement to 36 months . Implant stability from uncovering to 36 months and survival from placement to 36 months were determined . Survival was determined using two different approaches -- considering all implants removed at any time , regardless of the reason ( DICRG approach ) , and considering only those that were removed following loading of the prosthesis ( post-loading approach ) . Survival was also determined for each of the three phases of implant treatment -- phase 1 , from the time of placement to uncovering and abutment connection ; phase 2 , from uncovering to placement and loading of the prosthesis ; and phase 3 , from loading of the prosthesis to 36 months . RESULTS The two approaches to determining survival for each implant design and /or material included in the study showed differences in reported numbers ranging from 1.1 % to 21.7 % . The largest difference in survival was for the commercially pure titanium screw ( used in this study only in the maxillary completely edentulous applications ) , which showed a 21.7 % greater survival rate . With the DICRG approach , the hydroxyapatite (HA)-cylinder had the highest survival ( 97.5 % ) . When considering the post-loading approach , the titanium-alloy screw had the highest survival ( 99.4 % ) , with the HA-cylinder having the next highest survival ( 98.6 % ) . The HA-cylinder did not show increased stability from uncovering to 36 months , and the HA-grooved implant became less stable . CONCLUSIONS HA-coated implants demonstrated the highest survival rate ; 2 ) the post-loading analysis approach inflated survival ; 3 ) non-HA implants showed increased stability following loading ; 4 ) HA-coated implants showed a slight decrease or no change in stability ; and 5 ) the clinical significance of the changes in implant stability must be determined for the long-term BACKGROUND The purpose of this prospect i ve study is to compare the long-term outcome of immediately loaded implant-retained m and ibular overdentures supported by four screw-type one-piece transmucosal implants with that of four screw-type two-piece implants inserted in the interforaminal area of the m and ible and rigidly connected by a U-shaped curved MATERIAL S AND METHODS A prospect i ve pilot study was conducted with 10 patients receiving an implant-supported overdenture in the m and ible . The patients were r and omly assigned to two groups . In the control group ( five patients ) , four st and ard Brånemark implants ( MK II ; Nobel Biocare AB , Gothenburg , Sweden ) , 3.75 mm large and at least 10 mm long , were sited anterior to the mental foramina , and four st and ard abutments ( Nobel Biocare AB ) for bar construction were immediately screwed to the implants . In the test group ( five patients ) , four conical transmucosal implants ( Nobel Biocare AB ) , 3.75 mm large and at least 9 mm long in the threaded part , were sited anterior to the mental foramina . Immediately after implant placement , a U-shaped gold or titanium bar was fabricated and implants were immediately loaded ( within 24 h ) in both groups with an implant-retained overdenture . The patients were followed up for a minimum of 24 months . Implants were evaluated at the time of immediate loading and at 12 and 24 months after prosthetic loading , with the following parameters : modified plaque index ( MPI ) , modified bleeding index ( MBI ) , and probing depth ( PD ) . Periimplant bone resorption was evaluated on panoramic radiographs taken 12 and 24 months after the beginning of prosthetic loading . RESULTS No significant differences were found between the two groups with regard to MPI , MBI , PD , and periimplant bone resorption at 12 and 24 months . The cumulative success rate of implants according to the criteria proposed by Albrektsson and colleagues was 100 % in both groups after 2 years of functional loading . CONCLUSIONS Results from this study demonstrated that the success rate for immediately loaded m and ibular implants is similar to that obtained in cases of delayed loading and that there are no significant differences between results with two-piece implants and one-piece transmucosal implants BACKGROUND Many longitudinal studies of different implant systems have been published but few controlled r and omized investigations have been reported . A 1-year report of a comparative study of ITI Dental Implant System implants ( Straumann AG , Waldenburg , Switzerl and ) and Brånemark System implants ( Nobel Biocare AB , Gothenburg , Sweden ) has been published by the present authors . This paper is a 3-year follow-up of that r and omized study . PURPOSE The aim of the study was to compare the outcome of fixed partial prostheses supported by ITI or Brånemark implants . The outcome was evaluated primarily in terms of survival rates and changes in marginal bone level . MATERIAL AND METHODS The study group comprised 28 patients with anterior residual dentition in the maxilla . The patients were provided with two to four implants on each side of the dentition and were r and omly allocated to Brånemark implants or ITI implants ; 77 ITI implants and 73 Brånemark implants were inserted . After 6 months abutment connections were made to both ITI and Brånemark implants . All patients were provided with fixed partial prostheses of gold-ceramic . The patients were followed up annually with clinical and radiographic examinations for 3 years RESULTS Two Brånemark implants and two ITI implants were lost . The Brånemark implants were lost before loading whereas the ITI implants were lost because of periimplantitis . The survival rate for both groups was 97.3 % . The mean marginal bone level of the Brånemark implants was situated 1.8 mm from the reference point at both the baseline and the 3-year examinations . The corresponding values for the ITI implants were 1.4 mm at baseline and 1.3 mm after 3 years . There was no significant difference between the implant systems with regard to bone level or bone level change . A steady state of the marginal bone level was calculated to have been reached after 3 years for 95.5 % of the Brånemark implants and 87.1 % of the ITI implants . Periimplantitis ( infection including pus and bone loss ) was observed with seven ITI implants but with none of the Brånemark implants . This difference was statistically significant . CONCLUSIONS No statistically significant differences were found between the implants studied , except for the frequency of periimplantitis , which was higher for the ITI implants . The survival rates were high , and the marginal bone loss was small for both systems BACKGROUND Over the years , the definition of implant failure has varied , with some investigators accounting for all implants placed , while others discard failures that occurred before clinical loading . The influence of stresses transmitted to various bone densities , by different prosthetic appliances as well as the method used to determine failures , needs to be clearly understood . This paper reports on the influence of two different methods of determining 36-month survival of implants used to support different dental prostheses . METHODS More than 2,900 implants with six different design s were placed in 829 patients at 32 study centers and followed for 3 years . The first method of determining survival accounted for all failures from placement through 36 months , while the second method counted only failures from post-loading of the prosthesis to 36 months . Survival curves were used to determine differences in survival outcomes for the two methods . RESULTS For the maxillary single-tooth prosthetic application , implant survival from placement to 36 months was 94.7 % when all failures were counted and increased to 98.3 % with the post-loading method . For upper completely edentulous applications , implant survival was 85.3 % with all failures counted and 95.6 % with the post-loading method . This 10.3 % difference is clinical ly important . The survival for implants in lower completely edentulous applications increased by 4.4 % simply by using the post-loading approach . Implants used for upper posterior , partially edentulous applications involved only hydroxyapatite (HA)-coated implants , and the survival rates were similar ( 96.4 % for all implants and 98.2 % for the post-loading method ) . The difference in reported survival rates for implants in the lower posterior , partially edentulous application was 5.8 % . Since failures tended to occur in the earlier phases of treatment , the post-loading approach always result ed in more favorable survival data . With the post-loading approach , valuable information related to implant performance before loading is lost . In all comparisons , HA-coated implant survival was always better than non-HA implants . Clinical investigators should clearly state the method used for determining failures . For all implants included in the study , survival curves illustrated different failure patterns for each method of determining overall survival . CONCLUSION Reporting of implant survival rates based on the post-loading method provides more favorable survival rates ; however , accounting for all implants provides a more accurate method of determining survival The aim of this prospect i ve comparative study was to evaluate the condition of the peri-implant tissues of three different implant systems supporting a m and ibular overdenture . Ninety edentulous patients ( Cawood class V-VI ) participated in this study . After r and omization , 30 patients were treated with 2 Brånemark implants , 30 patients with 2 IMZ implants and 30 patients with 2 ITI implants . The implants were inserted in the canine region of the m and ible . After 3 months overdentures were fabricated supported by a round bar and clip attachment . A st and ardized clinical and radiographic evaluation was performed 0,6 and 12 months after insertion of the denture . The intraoral radiographs were made , using the long-cone technique with an aim ing device . Two implants were lost ( 1 Brånemark , 1 IMZ ) during the healing period . None of the patients showed any sensory change in lip or chin region . The pocket depth in the Brånemark group decreased significantly whereas the mucosa recession increased significantly in both the Brånemark as well as in the IMZ group . After 12 months , there was significantly less bone loss in the ITI group . From our study it was concluded that 2 ( Brånemark , IMZ or ITI ) implants placed in the interforaminal region connected with a bar supply a proper base for the support of a m and ibular overdenture in the ( Cawood V-VI ) edentulous patient . The ITI implant appears to be the implant of choice for m and ibular overdenture therapy , because only one operation is required for a comparable result PURPOSE Although no currently available technique for the measurement of osseointegration is entirely satisfactory , 3 clinical variables can be reasonably associated with the process : probing depth , micromobility , and crestal bone height . Micromobility can be quantified to some extent with the use of the Periotest , a commercially available instrument In this investigation , the influence of surface characteristics and geometry upon Periotest value ( PTV ) and probing depth measurements was studied . MATERIAL S AND METHODS In a multicenter trial , 120 healthy edentulous patients received 5 or 6 implants in the anterior m and ible and were followed for 3 years . A total of 634 implants were placed . Every patient received at least 1 implant of each of 3 types : threaded titanium plasma-sprayed ( TPS ) , threaded hydroxyapatite-coated ( HA ) , and cylindric HA-coated . A r and omization schedule assured that approximately equal numbers of each type of implant were placed and that they were uniformly distributed over the arch . RESULTS Of the 4 tested combinations of dependent and independent variables , the only statistically significant ( P < .05 ) effect was that of coating on PTV . At 1 year after prosthetic restoration , the mean PTV for HA-coated threaded implants was -5.36 + /- 1.24 , compared with -4.86 + /- 1.70 for TPS implants . This difference steadily declined in magnitude and significance , until , after 3 years , the groups were indistinguishable . DISCUSSION This study agrees with the previous observations that HA coating tends to accelerate the initial rate of osseointegration . The absence of a difference between threaded and cylindric implants confirms that the PTV responds to micromobility near the surface , on a scale much smaller than such gross geometric features . CONCLUSION On the basis of these results , one may conclude that HA-coated implants exhibit a more rapid decrease in micromobility than do TPS implants of identical geometry This study evaluated bone regeneration and osseointegration of hydroxyapatite ( HA ) coated and titanium plasma sprayed ( TPS ) implants placed in sockets immediately after extraction in 36 adults , mean age 55.2 years ( range 26 to 81 years ) . Twelve TPS and 10 HA-coated implants in 20 patients were grafted with demineralized freeze-dried bone allograft ( DFDBA ) , covered with a barrier material , and the facial flap coronally positioned to attain primary closure ( experimental ) . The remaining 11 TPS and 10 HA-coated implants were placed similarly , except that no DFDBA was used ( control ) . Osseous structures were measured at the initial placement and 6-month re-entry surgeries . At the 6-month re-entry , all implants placed were clinical ly osseointegrated . Bone resorption at the most coronal socket crest was -1.53 mm for the grafted group and -1.59 mm for the control group . Crestal bone apposition of 1.39 mm was noted at the most apical socket crest ( ASC ) for the grafted group , whereas crestal resorption of -0.11 mm was noted in the ungrafted control group ( P < 0.02 ) . Bone fill from the base of the deepest osseous defect was 5.68 mm for the grafted group and 3.18 mm for the control group ( P < 0.04 ) . Complete resolution of osseous defects occurred at 15 of 22 sites in the grafted group and at 9 of 21 sites in the control group . Clinical exposure of the barrier material and a subsequent inflammatory response at 27 of 43 sites , requires removal of the material prior to the 6-month re-entry and was associated with significantly more bone loss at the ASC sites ( P < 0.01 ) . There was no significant difference for any of the parameters when comparing the TPS with the HA-coated implants PURPOSE The purpose of this study was to compare the success of hydroxyapatite ( HA ) -coated and machined titanium ( Ti ) implants in a 5-year r and omized , controlled clinical trial conducted at 2 centers . MATERIAL S AND METHODS Each of 120 edentulous patients received HA-coated threaded , HA-coated cylindric , and machined Ti threaded implants in a r and omized design using 5 or 6 implants . Digital radiographs allowed for yearly measurements of bone loss . Calibrated clinicians also measured mobility , Gingival Index , Plaque Index , probing depth , and recession . A Kaplan-Meier analysis was used to compare the proportion of ailing implants ( defined as less than 2 mm of alveolar bone loss over 5 years ) for each type of implant design . The criteria employed to assess implant outcome included the need for successful implants to lose less than 2 mm of bone support over the 5 years following placement of the prosthesis . RESULTS This analysis revealed that 95.2 % of machined Ti threaded implants and 97.92 % of HA-coated threaded implants were successful , while 99.0 % of HA-coated cylindric implants experienced less than 2 mm of bone loss ( P < .06 ) . DISCUSSION All types of implants placed in this study had success rates above 95 % . CONCLUSION Over 5 years , the success rate tended to favor HA-coated implants BACKGROUND Because the life expectancy of individuals continues to increase , dentists providing dental implant treatment can expect to see an increasing number of patients with diabetes mellitus . Today , there are little data available concerning the clinical outcomes involving the use of implant treatment for patients with diabetes mellitus . There are three types of diabetes mellitus : Type 1 ( insulin dependent ) , Type 2 ( non-insulin dependent ) , and gestational . Because of possible complications from patients with diabetes mellitus , they are excluded from participation in most clinical studies of endosseous dental implant survival . METHODS This study attempted to determine if Type 2 diabetes represents a significant risk factor to the long-term clinical performance of dental implants , using the comprehensive DICRG data base . Diabetes was a possible exclusion criterion ; however , the final decision on Type 2 patients was left to the dental implant team at the research center . A total of 2,887 implants ( 663 patients ) were surgically placed , restored , and followed for a period of 36 months . Of these , 2,632 ( 91 % ) implants were placed in non-diabetic patients and 255 ( 8.8 % ) in Type 2 patients . Failures ( survival ) were compared using descriptive data . Possible clustering was also studied . RESULTS A model assuming independence showed that implants in Type 2 patients have significantly more failures ( P = 0.020 ) . However , if correlations among implants within the patient are considered , the significance level becomes marginal ( P = 0.046 ) . The experience of the surgeon did not produce a clinical ly significant improvement in implant survival . The use of chlorhexidine rinses following implant placement result ed in a slight improvement ( 2.5 % ) in survival in non-Type 2 patients and a greater improvement in Type 2 patients ( 9.1 % ) ; the use of preoperative antibiotics improved survival by 4.5 % in non-Type 2 patients and 10.5 % in Type 2 patients . The use of HA-coated implants improved survival by 13.2 % in Type 2 diabetics . CONCLUSION Type 2 diabetic patients tend to have more failures than non-diabetic patients ; however , the influence was marginally significant . These findings need to be confirmed by other scientific clinical studies with a larger Type 2 diabetic sample size The accuracy of determining marginal bone height changes around osseointegrated implants depends on the validity of comparing serial films and the reliability of the measurements . X-ray beam orientation changes can alter the validity of serial films . A human dry m and ible containing a Brånemark implant was irradiated + /- 12 degrees in the vertical plane at 1-degree intervals to the perpendicular to the long axis of the fixture . The thread width was recorded on both sides of each fixture image using a computer . Twenty-five r and omized unclassified images were remeasured and the vertical angle of the x-ray beam was estimated from the previous measurements to test for validity of comparing images . The reliability of measurements with altered image magnification and penumbra were calculated . The reliability of 24 repeated thread width measurements was a SD of 0.01 mm . Of the 25 unknown beam angulations , 32 percent matched correctly , 20 percent + /- 1 degree , 16 percent + /- 2 degrees , or 68 percent < or = + /- 2 degrees . Alteration from a short to a long cone technique was estimated to produce magnification errors similar to the reliability SD of 0.01 mm . Similarly the penumbra varied from 0.057 mm to 0.032 mm with short to long cones using a 1.0-mm focal spot . With a 0.6-mm focal spot , the smallest penumbra of 0.19 mm was twice the measurement reliability . This method demonstrated x-ray beam angulation and validity for comparing serial films can be estimated for the extreme variations but not accurately for + 9 to -6 degrees from a tangent to the fixture . ( ABSTRACT TRUNCATED AT 250 WORDS The aim of this study was to evaluate the feasibility of using a two-stage implant system in a single-stage procedure and to study the impact of the microgap at crestal level and to monitor the microflora in the peri-implant area . Forty edentulous patients ( Cawood & Howell class V-VI ) participated in this study . After r and omisation , 20 patients received two IMZ implants inserted in a single-stage procedure and 20 patients received two ITI implants . After 3 months , overdentures were fabricated , supported by a bar and clip attachment . A st and ardised clinical and radiographic evaluation was performed immediately after denture insertion and 6 and 12 months later . Twelve months after loading , peri-implant sample s were collected with sterile paper points and analysed for the presence of putative periodontal pathogens using culture techniques . One IMZ implant was lost due to insufficient osseointegration . With regard to the clinical parameters at the 12 months evaluation , significant differences for plaque score and probing pocket depth ( IMZ : mean 3.3 mm , ITI : mean 2.9 mm ) were found between the two groups . The mean bone loss in the first year of functioning was 0.6 mm for both groups . Prevotella intermedia was detected more often in the ITI group ( 12 implants ) than in the IMZ group ( three implants ) . Porphyromonas gingivalis was found in three patients . In one of these patients an implant showed bone loss of 1.6 mm between T0 and T12 . Some associations were found between clinical parameters and the target microorganisms in the ITI group . These associations were not present in the IMZ group . The short-term results indicate that two-stage implants inserted in a single-stage procedure may be as predictable as one-stage implants . The microgap at crestal level in nonsubmerged IMZ implants seems to have no adverse influence on the peri-implant microbiological colonisation and of crestal bone loss in the first year of functioning . The peri-implant sulcus can and does harbour potential periodontal pathogens without signs of peri-implantitis during the evaluation period of 1 year PURPOSE The aim of this prospect i ve r and omized clinical trial was to evaluate 10 years of treatment of patients receiving a m and ibular implant-retained overdenture ( IRO ) or a conventional complete denture ( CD ) . MATERIAL S AND METHODS One hundred twenty-one edentulous patients were treated with an IRO ( 2 endosseous implants , n = 61 ) or a conventional CD ( n = 60 ) . Clinical aspects and patient satisfaction were evaluated . One year after placement of the denture , unsatisfied patients of the CD group were given the opportunity to receive implants . RESULTS In the IRO group , 4 implants were lost during the first year and 4 implants were lost during the next 4 years . Between 5 and 10 years , no implants were lost ( survival rate : 93 % ) . In the CD group , 24 patients ( 40 % ) chose an IRO between 1 and 10 years . DISCUSSION Patients in the IRO group were significantly more satisfied than patients in the CD group after 1 year ( satisfaction score 8.3 versus 6.6 on a scale of 1 to 10 ) , after 5 years ( 7.4 versus 6.4 ) , and after 10 years ( 7.7 versus 6.8 ) . CONCLUSION The mean satisfaction score of the CD group ( including patients who later received implants ) was still lower than that of the IRO group , in spite of the opportunity for retreatment with IROs . Endosseous implants had a high survival rate after 10 years of follow-up Intramobile cylinder ( IMZ ) implants with either of two coatings , hydroxyapatite ( HA ) or titanium plasma-flame ( TPF ) , as distal abutments for combined tooth implant-supported restorations , were compared in 313 partially edentulous m and ibles with respect to postprosthetical failure patterns and complication frequencies in a r and omized multicenter clinical trial . Within the treatment protocol s , the two coatings do not show evidence of different efficacy with respect to occurrence of postprosthetical integration deficiency ( ID ) or functional deficiency ( FD ) . Statistical equivalence for an absolute effect of + /-15 % in event-free survival could only be demonstrated for FD , not for ID , however . Intent-to-treat and per- protocol population analyses gave consistent results . Hazards of occurrence of ID and FD , adjusted for years of follow-up , were estimated for ID as 7 % per year ( 95%CI 4 - 10 % per year ) with HA and 5 % per year ( 95%CI 3 - 7 % per year ) with TPF , and for FD as 5 % per year ( 95%CI 3 - 7 % per year ) with HA and 4 % per year ( 95%CI 2 - 6 % per year ) with TPF . The 5-year cumulative success rates for no ID were 69.5 % ( 95%CI 58 - 81 % ) with HA and 82.2 % ( 95%CI 74 - 91 % ) with TPF . With respect to frequencies of complications , there was no relevant statistically significant difference between the two coatings BACKGROUND The survival rate of oral implants in soft- quality bone has been demonstrated to be inferior to that of implants inserted in good- quality bone . A possible way to increase the survival rate in soft- quality bone may be to use a tapered implant . Such an implant has been developed and manufactured by Nobel Biocare AB , Gothenburg , Sweden . So far , there have been only a few publications regarding this implant . PURPOSE The aim of the study was to compare the outcome of using the tapered Brånemark System Mark IV fixture with the outcome of using earlier Brånemark fixtures in a controlled prospect i ve study . MATERIAL S AND METHODS The study was performed as a multicenter study including seven specialist centers . The material consisted of 40 patients in need of implant-supported bridges in the maxilla . Twenty-five patients belonged to the test group , in which the tapered Mark IV implants were inserted , and 15 patients belonged to the control group , in which Brånemark St and ard or Mark II implants were used . The patients were allocated to the test group or the control group according to r and omization schedules . The implants were inserted according to the guidelines for Brånemark implants . A two-stage surgical protocol was used , and abutment connection was made 6 months after fixture insertion . The test group comprised 97 Mark IV implants , and the control group made up 92 implants . The prosthetic procedure followed the guidelines for Brånemark implants , and all patients were provided with full fixed maxillary bridges . The patients were followed up with clinical and radiographic records for 1 year after loading . RESULTS The survival rate was 96.9 % for the Mark IV implants and 98.9 % for the control implants . There was no significant difference between the two groups . There was a mean marginal bone loss of 0.2 mm during the observation period , and there was no difference between test implants and control implants . CONCLUSIONS With regard to survival rate and marginal bone level changes , no differences could be demonstrated between the Mark IV tapered implant and the Brånemark implants used earlier . However , compared with earlier results of Brånemark implants in soft- quality bone , the Mark IV implant demonstrated an improved survival rate BACKGROUND Dental implants vary in design and surfaces . In addition , different surgical techniques have been used for implant insertion . The ITI Dental Implant System ( Straumann AG , Waldenburg , Switzerl and ) has always required a one-stage technique , whereas the Brånemark System ( Nobel Biocare AB , Gothenburg , Sweden ) requires a two-stage technique . PURPOSE The aim of this study is to compare the outcome of fixed partial bridges in the maxilla supported by both ITI and Brånemark implants in a split-mouth design . MATERIAL S AND METHODS Twenty-eight patients with a residual anterior dentition in the maxilla were included in this split-mouth study . The Brånemark implants were used on one side and the ITI implants on the other side of the residual dentition according to a r and omization procedure . A blocking size of four was used , giving equal probability of placing ITI or Brånemark implants in the right or left side of the jaw . The surgical and prosthetic procedures followed the guidelines given by the manufacturers . The prosthetic treatment with the two-implant systems was performed at the same time , and for that reason the healing period was 6 months for both systems . The observation period for all patients was 1 year after loading . RESULTS Two Brånemark implants ( in one patient ) were lost before loading , and one ITI implant was lost 1 year after loading . There was no significant difference in survival rate . Radiographic examination of the bone level was performed at the time of delivery of the bridge and after 1 year . The mean marginal bone level at baseline was situated 1.9 mm from the reference point for the Brånemark implants and 1.5 mm for the ITI implants . With regard to the insertion depth used , these bone levels indicate that bone loss had taken place before baseline . However , between baseline and the 1-year examination , there was no significant change of the marginal bone ( 0.2 + /- 0.08 mm at the Brånemark implants and 0.1 + /- 0.11 mm at the ITI implants ) . The difference between results with the two implants was not statistically significant . Crater-form bone destructions were seen at some ITI implants , indicating periimplantitis . However , at only two implants were there clinical signs of periimplantitis . CONCLUSIONS No significant difference in survival rate or in marginal bone change could be demonstrated between the two systems . At some ITI implants ( 18 % ) , crater-form bone loss was observed BACKGROUND Implant-supported single-tooth replacements are an increasingly used method to replace teeth , especially in young patients . Therefore , long-term validation of different treatment modalities with different implant systems is of great importance . PURPOSE The aim of the present study was to make a biologic , technical , and aesthetic evaluation of single-tooth replacement supported by the Astra Tech implant ( Astra Tech AB , Mölndal , Sweden ) during a 5-year period . MATERIAL S AND METHODS Twenty patients were divided into two consecutively treated groups . In group A the implants were placed " early " in the extraction sockets , and st and ard single-tooth abutments were used . In group B the implants were placed " delayed , " and preparable abutments were used . Clinical examinations including registration of plaque , bleeding , crown lengths , soft tissue marginal level , papilla height , complications , and radiography were performed yearly . At the 3-year control examination the patient and a dentist evaluated aesthetic appearance with a visual analog scale . RESULTS An implant survival rate of 100 % and a crown survival rate of 95 % over a period of 5 years were found . The mean loss of marginal bone adjacent to implants and neighboring teeth was less than 0.5 mm during the 5-year period , and there was no significant difference after crown placement between the treatment modality for group A and that for B. There were fewer clinical complications and repairs in group B than in group A. Soft tissue dimensions were more natural around implant crowns in group B as compared to group A , but this was not reflected in the patients ' satisfaction with aesthetic appearance . On the other h and the dentist judged the restorations in group B higher concerning aesthetics than in group A. CONCLUSION Implant-supported single-tooth replacement with the Astra Tech system is a reliable treatment result ing in a good 5-year prognosis and only few complications The loss of vertical bone height over time has been assessed radiographically as part of the Dental Implant Clinical Research Group studies . Radiographs were assessed from implant placement , uncovering surgeries , and recall appointments . Overall , the study implants experienced most peri-implant vertical bone loss in the first year after placement , followed by a dramatic decrease in bone loss rate through the subsequent study intervals . Stratified analysis of data up to 72 months after implant uncovering indicates different bone loss patterns by : 1 ) arch ; 2 ) jaw region ; 3 ) case type ; 4 ) bone quality ; 5 ) surface type ; 6 ) implant design ; 7 ) smoking status ; and 8) postoperative antibiotic treatment . These results will be used to build statistical mixed models to indicate which clinical factors are most predictive of peri-implant vertical bone loss , controlling for confounding and accounting for correlation of data over time and within study patients In a controlled clinical trial , treatment effects of m and ibular overdentures on two different implant-systems in edentulous patients were compared one year after insertion of the new dentures . The implant-systems used were the Brånemark system ( Brå ) and the IMZ-system . Treatment was r and omly assigned to 60 patients according to a balanced allocation method . Evaluation included peri-implant and radiographical parameters . According to the Delphi method a clinical implant performance scale ( CIP ) was constructed based on all conceivable complications of the different implant systems . During the osseointegration period , five Brå- and one IMZ-implants were lost . The results of one of the peri-implant parameters and the radiographical score showed significant differences considering the ( pseudo ) pocket probing depth ( Brå better than IMZ , P < 0.001 ) and the radiographic-score ( IMZ better than Brå , P < 0.003 ) . The results for the CIP-scale were less favourable for the Brå-group than for the IMZ-group ; however , these differences were not significant A classification of the edentulous jaws has been developed based on a r and omised cross-sectional study from a sample of 300 dried skulls . It was noted that whilst the shape of the basalar process of the m and ible and maxilla remains relatively stable , changes in shape of the alveolar process is highly significant in both the vertical and horizontal axes . In general , the changes of shape of the alveolar process follows a predictable pattern . Such a classification serves to simplify description of the residual ridge and thereby assist communication between clinicians ; aid selection of the appropriate surgical prosthodontic technique ; offer an objective baseline from which to evaluate and compare different treatment methods ; and help in deciding on interceptive techniques to preserve the alveolar process . An awareness of the pattern of resorption that takes place in various parts of the edentulous jaws , enables clinicians to anticipate and avert future problems BACKGROUND Maxillary implant overdentures opposing m and ibular two-implant overdentures are an underused treatment option for edentulous patients . Fewer implants , simple surgery , and short healing periods may increase patients ' acceptance of this treatment concept . PURPOSE To determine implant success , after overdenture loading , of three narrow-diameter roughened-surface implants placed in edentulous maxillas , using a one-stage surgical procedure , a 12-week healing period , and opposing m and ibular two-implant overdentures . MATERIAL S AND METHODS Forty edentulous participants with m and ibular two-implant overdentures were allocated to two groups with similar implant systems . Each group had three narrow-diameter roughened-surface implants placed into their edentulous maxillas in a one-stage surgical procedure . St and ardized intraoral radiography and implant stability tests were performed sequentially at surgery , at 12 weeks ( prior to loading ) , and at 64 weeks ( after 1 year of loading with maxillary overdentures ) . RESULTS One hundred seventeen implants were placed in 39 participants . After 1 year of loading , 15 implants had failed in 11 patients , 4 implants have been " put to sleep " in 3 patients , and 1 patient has died . Data on marginal bone loss and resonance frequency analysis showed no significant differences between the implant systems . The mean marginal bone loss was 1.30 mm ( + /- 0.44 mm ) from surgery to 12 weeks and 0.32 mm ( + /- 0.48 mm ) between 12 and 64 weeks with loading . The mean implant stability quotient and resonance frequency values showed a statistically significant improvement over time , at 56.05 ( 5,891 Hz ) , 57.54 ( 5,981 Hz ) , and 60.88 ( 6,167 Hz ) at surgery , 12 weeks , and 64 weeks , respectively . The overall success rate for all implants combined was 81 % , and the cumulative survival rate was 84.61 % . CONCLUSION In patients with m and ibular two-implant overdentures , three narrow-diameter roughened-surface implants can be placed in the edentulous maxilla , using a one-stage surgical procedure , and can be loaded within 12 weeks with overdentures for 1 year A multicenter clinical study of dental implants is being conducted by the Dental Implant Clinical Research Group to investigate the influence of implant design , application , and site on clinical performance and crestal bone . This article reports on the percentage of success up to implant uncovering for different implant design s and the distribution of failures across study sites . Data from 2,847 implants placed at 32 study sites were analyzed . Percentages of success up to implant uncovering were calculated for study implants overall , by implant design , by implant design within study strata , and according to individual study sites and quartile groupings of sites based on success . Comparisons were made , with chi-square and exact tests employed where appropriate . Differences were found between the different implant design s for the study overall , and between implant design s within the different study strata . Although some implant design s were found to have generally high success across study sites , some study sites design ated as having surgeons with less experience tended to have higher failure levels , and one implant design failed at higher rates in a subset of study sites . The percentage and distribution of implant failures varied across study sites and by implant design . These differences appeared to be in part related to the level of experience of the surgeons . Further investigation should focus on identification of factors that contribute to higher success in implant placement with different implant design In 50 partially edentulous patients , 133 ( 48 maxillary ; 85 m and ibular ) Astra Tech dental implants of 2 different surface textures ( machined ; TiO-blasted ) were alternately installed , supporting 52 fixed partial dentures ( FPDs ) . Before abutment connection 2 machined implants ( 1 m and ibular ; 1 maxillary ) were found to be non-osseointegrated and were replaced . Another implant could not be restored due to a technical complication . Two FPDs were remade because of technical complications , both because of abutment fractures . Thus , after 2 years in function , the cumulative survival rates were 97.7 % and 95.7 % for implants and prostheses , respectively . There was no statistically significant difference in survival rate between the 2 types of implants , 100 % ( TiO-blasted ) vs 95.3 % ( machined ) , P = 0.24 . After 2 years in function , when both jaw and type of implants were combined , the mean ( SD ) marginal bone loss was 0.24 ( 0.69 ) mm . No statistically significant difference in bone loss was found between the 2 types of implant after 2 years of loading , 0.04 ( 0.82 ) mm , P > 0.30 Immediate loading of dental implants can reduce treatment time and management concerns , thus increasing patient acceptance . This paper reports the authors ' preliminary experience with partially edentulous patients having received non-occlusally loaded provisional restorations within 24 hours of surgery , compared to patients treated according to an early loading protocol . The present data suggest that implant supported fixed partial prostheses can be immediately non-occlusally loaded and restored with a predictability similar to early loaded implants Survival rates from placement to 36 months were reported for the ongoing Dental Implant Clinical Research Group studies of root-form endosseous dental implants . Failure rates for all implants were similar in bone qualities 1 and 2 ( 6.2 % and 6.7 % , respectively ) and slightly higher in bone qualities 3 and 4 ( 8.5 % and 8.7 % , respectively ) . Hydroxyapatite (HA)-coated implants had an overall failure rate of 3.9 % over 36 months in all bone qualities combined , while non-coated implants had a 13.4 % failure rate for the same parameters . For each bone quality , there was a significant difference in implant survival for the non-coated implants ( P < 0.01 ) . The highest failure rates for non-coated implants were in bone qualities 3 and 4 ( 19.1 % and 25.5 % , respectively ) . No major difference in survival was found for HA-coated implants placed in each bone quality . Possible reasons for the differences in survival are discussed Vertical bone loss is being assessed radiographically as part of the Dental Implant Clinical Research Group studies through direct measurements on study radiographs taken longitudinally at surgery and recall appointments . Preliminary results and trends for the period between implant placement and 6 months after implant uncovering show more bone loss in implants that are 1 ) not coated with hydroxyapatite ; 2 ) placed in the maxilla ; 3 ) placed in anterior regions of the jaws ; 4 ) in completely edentulous cases ; and 5 ) placed in bone scored as having lower quality . Confounding relationships between predictor variables will require controlled statistical analyses when data collection is completed PURPOSE The aim of this prospect i ve clinical trial was to compare peri-implant clinical and radiographic parameters following the placement of nonsubmerged two- and one-stage implants . MATERIAL S AND METHODS Patients were r and omly assigned to the IMZ group ( 20 patients receiving two IMZ two-stage implants in a one-stage procedure ) or ITI group ( 20 patients receiving two ITI implants in the conventional one-stage procedure ) . The healing period was defined as an 18-week unloaded osseointegration period and a 1-year functional period during which maturation of bone took place . Twelve weeks after implant placement , fabrication of an overdenture with a bar-clip attachment system was started ; it was placed at 18 weeks . RESULTS None of the implants were lost during the osseointegration period ; one IMZ implant was removed during the functional period because of mobility . There was no significant difference in Gingival Index between the two groups at all evaluation periods . The mean bone loss during the functional period was 0.6 mm in both groups . A high number of healing abutments loosened in the IMZ group . CONCLUSION Clinical and radiographic parameters of two-stage implants placed in a one-stage procedure and one-stage implants are comparable during the healing period . Healing abutments of the IMZ implant system loosen easily BACKGROUND Clinical studies of dental implants tend to fall into two broad categories . Efficacy studies apply strict exclusion criteria under carefully controlled conditions to produce a narrow range of results . Effectiveness studies more closely model real-world treatment environments , with a more diverse patient sample and broader range of provider skills . In this multi-center study of more than 2,900 dental implants , study centers were grouped by implant survival scores in an attempt to draw attention to the influence of confounding variables associated with the treatment environment . METHODS Thirty-two study centers were ranked by implant survival scores at uncovering and assigned to three performance groups . Centers whose overall scores were within approximately one st and ard deviation of the mean were placed in the middle ( 70 % ) performance group ( MPG ) . The remaining centers were placed in either the top ( 15 % ) performance group ( TPG ) or the lower ( 15 % ) performance group ( LPG ) . Overall survival and survival by phase of treatment were recorded for each of six implant design s in each of the three performance groups . RESULTS From implant placement to 36 months , the TPG achieved survival rates from 100 % ( for 3 design s ) to 95.5 % ( for one design ) , with an average of 97 % for all design s. Increased variations in survival ( 97.2 % to 73 % ) occurred in the MPG , with larger variations ( 96.4 % to 48 % ) in the LPG . The HA-coated cylinder recorded consistently high survival scores ( over 95 % ) in all performance groups and all phases of treatment . Failures for other design s in the MPG and LPG were concentrated in the healing period ( placement to uncovering ) , except for the commercially pure titanium screw , which had the most failures between uncovering and prosthesis loading . CONCLUSIONS Implant design and treatment environment both play an important role in implant survival . Two design characteristics appear to enhance survival : 1 ) a surgical protocol involving minimal instrumentation at placement , and 2 ) hydroxyapatite ( HA ) coating . The HA-coated press-fit cylinder design was the least affected by the center 's performance BACKGROUND Immediate loading of osseointegrating implants shortens the treatment time and makes it possible to give the patient an esthetic appearance during the whole treatment period . A previous retrospective clinical study showed a success rate of 94.2 % after 1 year of immediate loading of fixed partial constructions in the maxilla supported by machined-surface implants . The recently introduced Brånemark System TiUnite ( Nobel Biocare AB , Gothenburg , Sweden ) surface has been shown to better maintain primary implant stability and to help achieve secondary stability earlier compared with the machined surface . PURPOSE The aim of the present study was to compare TiUnite and machined-surfaced Brånemark System implants when applying immediate loading of partial fixed bridges in the posterior m and ible . MATERIAL S AND METHODS Forty-four patients were r and omized for test and control therapy . In the test group , 22 patients received 66 Brånemark System TiUnite surface implants supporting 24 fixed partial bridges , all of which were connected on the day of implant insertion . In the control group , 22 patients received 55 Brånemark System machined-surface implants supporting 22 fixed partial bridges , which also were connected on the day of implant insertion . All constructions were two- to four-unit bridges . Bone quality and quantity were assessed . Radiographic examinations were performed on the day of surgery/loading and at the 1-year follow-up visit . RESULTS Three TiUnite and eight machined-surface implants failed during the first 7 weeks of loading . This result ed in a cumulative success rate of 95.5 % for TiUnite surface implants after 1 year of prosthetic load in the posterior m and ible . The corresponding cumulative success rate for machined-surface implants was 85.5 % . When using the machined-surface implants , the number of failed implants was significantly higher in smokers and in bone quality 4 sites . Such findings were not seen with the use of TiUnite implants , despite the fact that there were more smokers and more implants placed in bone quality 4 in this group . The marginal bone resorption after 1 year of loading was on average 0.9 mm ( SD 0.7 mm ) with the TiUnite implants and 1.0 mm ( SD 0.9 mm ) with the machined implants . CONCLUSIONS The present study demonstrated a 10 % higher success rate following immediate loading of partial fixed bridges in the posterior m and ible supported by TiUnite surface implants compared with success with machined implants . When using the machined implants , the number of failed implants was significantly higher in smokers and in bone quality 4 sites . Such findings were not seen following the use of TiUnite implants BACKGROUND Before early functional loading of unsplinted implants with m and ibular overdentures can become widespread , more clinical studies are needed to investigate the success of the approach . PURPOSE To evaluate the success rates of two types of roughened titanium surface implants with early 2-week functional loading of paired m and ibular interforaminal implants with overdentures . MATERIAL S AND METHODS R and om allocation divided 24 strictly selected edentulous participants into two groups , with each group to receive a different implant system ( ITI Dental Implant System , Straumann AG , Waldenburg , Switzerl and ; or Southern Implant System , Southern Implants , Irene , South Africa ) . Two implants were placed in the anterior m and ible of all participants using one-stage st and ardized surgical procedures . Previously constructed conventional m and ibular dentures ( opposing maxillary complete dentures ) were temporarily relined and worn by the participants for the first 2 weeks ; participants used a soft diet . Two weeks after implant surgery and following some mucosal healing , the m and ibular dentures had the tissue conditioner removed and the appropriate matrices included for an unsplinted prosthodontic design . RESULTS No implant from either group was lost . Resonance frequency analysis ( RFA ) indicated higher primary stability at surgery for the Southern group than for the ITI group , with a statistically significant difference between the groups throughout the study period . The drop in RF values between surgery and 6 weeks was significant and was greater for the Southern group . RFA also indicated stabilized osseointegration between 6 to 12 and 12 to 52 weeks , with no participant showing any decrease in those values over time . Participants with type 3 bone showed a significant improvement in RF values between 12 and 52 weeks , eventually matching those of participants with type 2 bone . There were no significant differences in marginal bone loss , periimplant parameters , or prosthodontic maintenance between the groups over the study period . CONCLUSIONS Using only strict patient selection criteria , 1-year follow-up data indicate that early functional loading of ITI and Southern implants with m and ibular two-implant overdentures is possible as early as 2 weeks after implant surgery PURPOSE The goal of this multicenter prospect i ve clinical trial was to compare clinical outcome and post-treatment care and patient satisfaction with different implant systems used for m and ibular overdenture treatment during a 6-year follow-up period . PATIENTS AND METHODS A total of 87 edentulous patients with a severely resorbed m and ible ( bone height , 8 to 15 mm ) received treatment involving either 2 Intra Mobiele Zylinder implants ( IMZ group , n = 41 ) ( Friedrichsfeld AG , Mannheim , Germany ) , 2 Brånemark implants ( Brå group , n = 17 ) ( Nobel Biocare AB , Gothenburg , Sweden ) or a Transm and ibular Implant ( TMI ; Krijnen Medical , Beesd , The Netherl and s ) ( TMI group , n = 29 ) . The evaluation involved clinical parameters , radiographs , surgical and prosthetic post-treatment care , clinical implant performance ( CIP scale ) , and patient satisfaction . RESULTS After 6 years , there was a significant difference in the mean plaque index : the mean plaque index of the TMI group was significantly higher than that of the IMZ and Brå groups . Other clinical parameters showed no significant differences . The implant survival rate of 97.5 % was noted in the IMZ group , 97.1 % in the Brå group , and 72.0 % in the TMI group . The CIP scale were significantly worse for the TMI group . CONCLUSION It was concluded that the IMZ and the Brånemark implant systems have a better survival rate and clinical implant performance than the TMI system . Based on these data , these systems should be the choice for the edentulous m and ible with a height between 8 and 15 mm The aim of this prospect i ve r and omized controlled clinical trial was to evaluate a set of clinical items and prosthetic aftercare of edentulous patients with a m and ibular overdenture retained by 2 IMZ implants or 2 Brånemark implants during a 5-years ' period . Patients were allocated to the IMZ group ( n = 29 ) or the Brånemark group ( n = 32 ) by a computerized balancing method . In the IMZ group 4 implants were lost during the 5-years ' follow-up ( survival rate : 93 % ) . In the Brånemark group 9 implants were lost ( survival rate : 86 % ) . All patients were re-operated successfully . Multiple prosthetic revisions were necessary in both groups , especially the precision attachment system in the overdenture was subject to frequent fracture or loosening . From this study can be concluded that there is no difference in clinical state , radiographical state , survival rate and clinical implant performance between the IMZ implant system and the Brånemark implant system supporting an overdenture on 2 implants after 5 years of follow-up OBJECTIVE A preliminary report from this study showed that hydroxyapatite-coated ( HA ) titanium plasma-sprayed ( TPS ) cylinder implants had fewer failures than TPS cylinder implants before prosthetic loading . The purpose of this article is to report the long-term success associated with the 2 systems . In addition , local and systemic factors that may influence the success or failure of the implants were analyzed . STUDY DESIGN Each of 65 subjects was r and omized to either HA-coated TPS or TPS cylinder implants . Loss of an implant was considered a failure . Failures were analyzed in terms of the coating of the implant , age and gender of the patient , location and length of the implant , opposing dentition , and smoking status . Data were statistically analyzed through use of chi-square tests . RESULTS Of 351 implants that were placed , 13 were lost before prosthetic loading and 17 were lost after prosthetic loading . The overall success rate was 92.8 % . Three hundred thirty-eight implants were prosthetically loaded . The implant success rate after prosthetic loading was 95.3 % . There was an overall nonsignificant higher failure rate for the TPS implants ( 8.0 % ) . Patient age and patient gender were nonsignificant variables . Ten-mm implants had a significantly higher failure rate ( 17.4 % ; chi-square , 1.00 ; P = .39 ) . Before prosthetic loading , more implants failed in the posterior m and ible ; after prosthetic loading , more implants failed in the anterior maxilla ( chi-square , 8.97 ; P = .03 ) . More implants failed when they were opposed by natural dentition or hybrids ( chi-square , 7.36 ; P = .007 ) . Smoking history was a significant factor ( chi-square , 5.2 ; P = .002 ) . CONCLUSIONS Statistically , there is little difference between the 2 systems . Local and systemic factors appear to play a greater role in implant failure than does the surface of the implant OBJECTIVES The aim of this prospect i ve comparative study was to evaluate the survival rate and the condition of the peri-implant tissues of the IMZ implant system ( two-stage cylindertype ) , the Brånemark implant system ( two-stage screwtype ) and the ITI implant system ( one-stage screwtype ) supporting a m and ibular overdenture during a 5-year follow-up period . MATERIAL AND METHODS Three groups of 30 edentulous patients were treated with two endosseous implants in the interforaminal region of the m and ible . Clinical and radiographic parameters were evaluated immediately after completion of the prosthetic treatment and after 1 , 2 , 3 , 4 and 5 years of functional loading . RESULTS The five-year survival rate is 98.3 % for the IMZ group , 98.3 % for the Brå group and 100 % for the ITI group . Mean scores on indices for plaque , calculus , gingiva and bleeding were very low at all evaluation periods . Mean marginal bone loss over a period of 5 years , was 1.4 mm for the IMZ group , 0.7 mm for the Brå group and 0.9 mm for the ITI group . CONCLUSION It is concluded that two implants placed in the interforaminal region , connected with a bar , supply a proper base for the support of a m and ibular overdenture in the edentulous patient . After 5 years no clinical ly relevant and statistically significant radiographic changes had developed between the three implant systems BACKGROUND Endosseous dental implants are used frequently , and many implant systems are available . The scientific documentation of the implant system presents a great variation , and it is often difficult to compare studies of different systems . PURPOSE The aim of this study was to compare two Swedish implant systems ( Astra Tech and Brånemark System implants ) , in a prospect i ve r and omized study . MATERIAL S AND METHODS Sixty-six patients were equally distributed between the two implant systems ; 184 Astra Tech and 187 Brånemark System implants were used . The patients have been followed annually with clinical and radiographic examinations . The results after 1 year are reported . RESULTS The abutment procedure was found to be easier and less time-consuming with Astra Tech than with Brånemark implants . The operation times in minutes ( mean + /- SEM ) were for the respective implant 35 + /- 4.0 and 51 + /- 4.8 in the maxilla and 32 + /- 3.8 and 43 + /- 2.4 in the m and ible . The differences in both cases were significant : p < .02 and p < .05 , respectively . The failure rate for Astra Tech implants was 0.5 % and for Brånemark implants 4.3 % . The difference was significant ( p < .05 ) ; however , taking into account that five of the eight implant losses in the Brånemark implant group occurred in one patient , an intraindividual correlation can not be excluded . Therefore , this result should be interpreted with caution . The marginal bone level changes were examined already from the fixture installation . The major bone loss was found between fixture installation and baseline . This bone loss was several times greater than the bone loss between the baseline and the 1-year follow-up . The total bone loss during the observation period did not differ significantly between the systems , but they had different resorption patterns . The bone loss in the upper jaw between baseline and 1-year follow-up was 0.22 + /- 0.14 and 0.03 + /- 0.09 mm for the Astra Tech and Brånemark implants , respectively . In the lower jaw , the loss was -0.31 for both systems . The frequency of plaque accumulation and bleeding on probing did not differ between the implant systems . CONCLUSIONS Abutment connection with Astra Tech implants was simpler than the corresponding surgery with Brånemark System implants and the survival rate of Astra Tech implants was higher than that of Brånemark system implants PURPOSE The aim of the present study was to evaluate whether there was a difference between machined and TiO(2)-blasted implants regarding survival rate and marginal bone loss during a 5-year observation period . MATERIAL S AND METHODS A total of 133 implants ( Astra Tech Dental Implants ; Astra Tech AB , Mölndal , Sweden ) were placed in 50 patients at 6 centers in 4 Sc and inavian countries . Forty-eight implants were installed in the maxilla and 85 implants in the m and ible . A r and omization and a stratification were done , so that each fixed partial prosthesis was supported by at least 1 machined and 1 TiO(2)-blasted implant . The implant-supported fixed partial prostheses ( ISFPP ) were fabricated within 2 months after postoperative healing . A total of 52 ISFPP ( 17 maxillary , 35 m and ibular ) were inserted . The patients were clinical ly examined once a year for 5 years . At the annual follow-up , biological as well as technical complications were recorded . RESULTS Of the 133 implants placed , 3 were reported as failed after 5 years of follow-up , result ing in an overall cumulative survival rate of 97.6 % . The cumulative implant survival rates were 100 % for the TiO(2)-blasted implants and 95.1 % for the machined implants . No significant difference in survival was , however , found between the machined and TiO(2)-blasted implants after 5 years . The mean marginal bone loss in the maxilla was 0.21 + /- 0.83 mm ( SD ) for the machined implants and 0.51 + /- 1.11 mm ( SD ) for the TiO(2)-blasted implants during the 5-year observation period . In the m and ible , the mean marginal loss was 0.22 + /- 1.13 mm for the machined implants and 0.52 + /- 1.07 mm for the TiO(2)-blasted implants from baseline to the 5-year examination . No significant difference in marginal bone loss between the 2 surface groups was found during the 5-year observation period . CONCLUSIONS The present study shows good 5-year results with small ISFPP in the m and ible , as well as in the maxilla . No significant differences were found in failure rate and marginal bone loss around implants with a machined rather than a TiO(2)-blasted surface . J Prosthodont 2001;10:2 - 7 BACKGROUND Comparatively few studies with at least 5 years of follow-up are available that describe the use of implants in prosthetic rehabilitation of partially edentulous patients . R and omized , controlled clinical studies that evaluated the effect of different surface design s of screw-shaped implants on the outcome of treatment are also sparse . OBJECTIVE To determine , in a prospect i ve r and omized , controlled clinical trial , the outcome of restorative therapy in periodontitis-susceptible patients who , following basic periodontal therapy , had been restored with implants with either a machined- or a rough-surface topography . MATERIAL AND METHODS Fifty-one subjects ( mean age , 59.5 years ) , 20 males and 31 females who , following treatment of moderate-to-advanced chronic periodontitis , required implant therapy for prosthetic rehabilitation were recruited . Seventeen of the patients were current smokers . Following the active treatment , all subjects were included in an individually design ed maintenance program . A total of 56 fixed partial dentures ( FPDs ) and a total of 149 screw-shaped , and self-tapping implants ( Astra Tech implants ) -- 83 in the maxilla and 66 in the m and ible -- were installed in a two-stage procedure . Each patient received a minimum of two implants and by r and omization every second implant that was installed had been design ed with a machined surface and the remaining with a roughened Tioblast surface . Abutment connection was performed 3 - 6 months after implant installation . Clinical and radiographical examinations were performed following FPD connection and once a year during a 5-year follow-up period . The analysis of peri-implant bone-level alterations was performed on subject , FPD and implant levels . RESULTS Four patients and four FPDs were lost to the 5 years of monitoring . One implant ( machined surface ) did not properly integrate ( early failure ) , and was removed at the time of abutment connection . Three implants were lost during function and a further eight implants could not be accounted for at the 5-year follow-up examination . The overall failure rate at 5 years was 5.9 % ( subject level ) , 5.3 % ( FPD level ) and 2.7 % ( implant level ) . Radiographic signs of loss of osseointegration were not found at any of the implants during the 5-year observation period . During the first year in function there was on average 0.33 ( SD , 0.61 ) mm loss of peri-implant marginal bone on the subject and FPD levels and 0.31 ( 0.81 ) mm on the implant level . During the subsequent 4 years , the peri-implant bone-level alterations were small . The calculated annual change in peri-implant bone level was -0.02 ( 0.15 ) on subject and FPD levels and -0.03 ( 0.20 ) on the implant level . Thus , the mean total bone-level change over the 5-year interval amounted to 0.41 mm on all three levels of analysis . In the interval between baseline and 5 years , the machined and the Tioblast implants lost on average 0.33 and 0.48 mm , respectively ( p>0.05 ) . CONCLUSION The present r and omized , controlled clinical trial that included partially edentulous periodontitis-susceptible subjects demonstrated that bone loss ( i ) during the first year of function as well as annually thereafter was small and ( ii ) did not vary between implants with machined- or rough-surface design In a r and omized prospect i ve study , two implant systems were compared in forty consecutive patients treated for m and ibular edentulism . The patients were r and omly allotted for treatment by the Brånemark two-stage ( submerged ) system ( BRS ) , or the ITI(R ) one-stage ( non-submerged ) system . In all , 102 Brånemark selftapping implants and 106 ITI hollow screw implants were installed and all patients were treated with full bridges . Biological and prosthodontic parameters , complications , success rates , clinical efficacy , patient satisfaction and re source requirements were evaluated . No differences were found in plaque accumulation , bleeding or complications during the follow-up period . The BRS group showed deeper periimplant sulcus , less attached mucosa , larger bridge-mucosa distance and higher Periotest values . Prosthetic complications were not related to the configuration of the implant systems . After 3 years , the cumulative success rates were 97.9 % and 96.8 % for the Brånemark and ITI systems , respectively ( difference not statistically significant ) . One implant in the BRS group had failed to osseointegrate at the time of abutment connection , and another was lost after 2 years due to progressive breakdown of bone . In the ITI group , three implants showed progressive bone loss after 1 - 3 years associated with periimplant infection . All 40 bridges were intact and remained stable throughout the study . There was general patient satisfaction , but about half the Brånemark patients reported difficulty in coping with the surgical procedures . Treatment time was similar for the two systems . It is concluded that both systems meet the current requirements for dental implant systems in the treatment of m and ibular edentulism Clinical data indicate different medium and long-term outcomes of endosseous implants for different implant configurations and in particular implant surfaces . The present study compares 2 very similar implant systems but with different surface characteristics in a split-mouth-r and omized design . The Astra-Tech ( A ) system ( Astra-Tech AB , Mölndal , Sweden ) consisted of selftapping TiO2-blasted screw-shaped implants made of commercially pure titanium , and the Brånemark ( B ) System ( Nobel Biocare , Gothenburg , Sweden ) comprised selftapping Mark II implants with machined surface irregularities . Throughout the 2-years ' observation period , no significant differences could be found concerning probing depths , presence of plaque or change in marginal bone level . A statistically significant difference in location of the marginal bone level in relation to the shoulder of the implant was found in favor of the A system both at baseline and after 2 years . Cumulative success rates of 100 % ( A ) and 97.7 % ( B ) were not statistically different . From a prosthetic point of view , more soldering points were needed for A compared to B to reach clinical acceptable fit . More years of observation are needed to compare the fate of the soft and hard tissues surrounding two different implant surfaces To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrollment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results |
311 | 30,630,442 | The most positive findings were associated with technology-based health interventions targeting SMBG as a behavioural outcome , with some benefits found for clinical and /or psychological diabetes self-management outcomes .
Technological interventions were well accepted by children and young people .
For the majority of included outcomes , clinical relevance was deemed to be little or none .
To produce clinical ly relevant outcomes , interventions may need to be delivered for at least 1 year and should consider targeting individuals with poorly managed diabetes . | Background The role of technology in the self-management of type 1 diabetes mellitus ( T1DM ) among children and young people is not well understood .
Interventions should aim to improve key diabetes self-management behaviours ( self-management of blood glucose , insulin administration , physical activity and dietary behaviours ) and prerequisites ( psychological outcomes and HbA1c ) highlighted in the UK guidelines of the National Institute for Health and Care Excellence ( NICE ) for management of T1DM .
The purpose was to identify evidence to assess the effectiveness of technological tools in promoting aspects of these guidelines amongst children and young people . | AIMS To assess Sweet Talk , a text-messaging support system design ed to enhance self-efficacy , facilitate uptake of intensive insulin therapy and improve glycaemic control in paediatric patients with Type 1 diabetes . METHODS One hundred and twenty-six patients fulfilled the eligibility criteria ; Type 1 diabetes for > 1 year , on conventional insulin therapy , aged 8 - 18 years . Ninety-two patients were r and omized to conventional insulin therapy ( n = 28 ) , conventional therapy and Sweet Talk ( n = 33 ) or intensive insulin therapy and Sweet Talk ( n = 31 ) . Goal - setting at clinic visits was reinforced by daily text-messages from the Sweet Talk software system , containing personalized goal -specific prompts and messages tailored to patients ' age , sex and insulin regimen . RESULTS HbA(1c ) did not change in patients on conventional therapy without or with Sweet Talk ( 10.3 + /- 1.7 vs. 10.1 + /- 1.7 % ) , but improved in patients r and omized to intensive therapy and Sweet Talk ( 9.2 + /- 2.2 % , 95 % CI -1.9 , -0.5 , P < 0.001 ) . Sweet Talk was associated with improvement in diabetes self-efficacy ( conventional therapy 56.0 + /- 13.7 , conventional therapy plus Sweet Talk 62.1 + /- 6.6 , 95 % CI + 2.6 , + 7.5 , P = 0.003 ) and self-reported adherence ( conventional therapy 70.4 + /- 20.0 , conventional therapy plus Sweet Talk 77.2 + /- 16.1 , 95 % CI + 0.4 , + 17.4 , P = 0.042 ) . When surveyed , 82 % of patients felt that Sweet Talk had improved their diabetes self-management and 90 % wanted to continue receiving messages . CONCLUSIONS Sweet Talk was associated with improved self-efficacy and adherence ; engaging a classically difficult to reach group of young people . While Sweet Talk alone did not improve glycaemic control , it may have had a role in supporting the introduction of intensive insulin therapy . Scheduled , tailored text messaging offers an innovative means of supporting adolescents with diabetes and could be adapted for other health-care setting s and chronic diseases OBJECTIVE The objective of this study was to compare the relative effectiveness of two modes of delivering Behavioral Family Systems Therapy for Diabetes ( BFST-D ) to improve adherence and glycemic control among adolescents with type 1 diabetes with suboptimal glycemic control ( HbA1c ≥9.0 % [ ≥74.9 mmol/mol ] ) : face to face in clinic ( Clinic ) and Internet videoconferencing ( Skype ) conditions . RESEARCH DESIGN AND METHODS Adolescents aged 12 to 18 years and at least one adult caregiver were r and omized to receive BFST-D via the Clinic or Skype condition . Participants completed up to 10 therapy sessions within a 12-week period . Changes in youth- and parent-reported adherence and glycemic control were compared before and after the intervention and at follow-up assessment . RESULTS Using an intent-to-treat analytic approach , no significant between-group differences were identified between the before , after , and follow-up assessment s. Groups were collapsed to examine the overall effects of BFST-D on adherence and glycemic control . Results identified that statistically significant improvements in adherence and glycemic control occurred from before to after the intervention ; improvements were maintained at 3-month follow-up . CONCLUSIONS Delivery of BFST-D via Internet-based videoconferencing is viable for addressing nonadherence and suboptimal glycemic control in adolescents with type 1 diabetes , potentially reducing important barriers to care for youth and families Being able to manage and adjust insulin doses is a key part of managing type-1 diabetes . Children and adolescents with type-1 diabetes mellitus often have serious difficulties with this dosage adjustment . Therefore , this paper aims to investigate the impact of using novel mobile , web and communication technologies in assisting their therapy and treatment . A trial was conducted in the north-eastern part of Germany to evaluate the impact of the “ Mobil Diab ” , a mobile diabetes management system , on the clinical outcome . 68 subjects aged between 8 and 18 years , divided r and omly into control and intervention groups , were included into the study . Metrics such as changes in the quality of metabolic control , changes in psychological parameters , usability and acceptance of the technology were used for evaluation purpose . Metabolic control was mainly assessed by the mean HbAlc . Analysis showed a good acceptance of the proposed system . An overall improvement in mean levels of HbA1c was observed , however further studies will be conducted to prove evidence of the weight and BMI improvements . Moreover , initial indications of positive impact on the improvement in psychological parameters were presumed based on the result of the conducted study . The system appeared to be an efficient and time saving tool in diabetes management Background While optimal blood glucose control is known to reduce the long-term complications associated with type 1 diabetes mellitus , adolescents often struggle to achieve their blood glucose targets . However , their strong propensity toward technology presents a unique opportunity for the delivery of novel self-management interventions . To support type 1 diabetes self-management in this population , we developed the diabetes self-management app bant , which included wireless blood glucose reading transfer , out-of-range blood glucose trend alerts , coaching around out-of-range trend causes and fixes , and a point-based incentive system . Objective The primary objective was to evaluate bant ’s effect on hemoglobin A1c ( HbA1c ) through a r and omized controlled trial ( RCT ) . Secondary measures ( eg , self-monitoring of blood glucose [ SMBG ] ) were also collected to assess bant ’s impact on the self-management behaviors of adolescents with type 1 diabetes . Methods We enrolled 92 adolescents into a 12-month RCT , with 46 receiving usual care and 46 receiving usual care plus bant . Clinical outcome data were collected at quarterly research visits via vali date d tools , electronic chart review , glucometer downloads , and semistructured interviews . App satisfaction was assessed at 6 and 12 months , and at trial end , users ranked bant components based on perceived usefulness . Mobile analytics captured frequency of blood glucose uploads , which were used to categorize participants into high , moderate , low , or very low engagement levels . Results Linear mixed models showed no changes in primary and secondary clinical outcomes . However , exploratory regression analysis demonstrated a statistically significant association between increased SMBG and improved HbA1c in the intervention group . For a subgroup of bant users taking SMBG ≥5 daily , there was a significant improvement in HbA1c of 0.58 % ( P=.02 ) , while the parallel subgroup in the control arm experienced no significant change in HbA1c ( decrease of 0.06 % , P=.84 ) . Although app usage did diminish over the trial , on average , 35 % ( 16/46 participants ) were classified as moderately or highly engaged ( uploaded SMBG ≥3 days a week ) over the 12 months . Conclusion Although primary analysis of clinical outcomes did not demonstrate differences between the bant and control groups , exploratory analysis suggested that bant may positively impact the use of SMBG data and glycemic control among youth . The next generation of bant will aim to remove barriers to use , such as deploying the app directly to personal devices instead of secondary research phones , and to explore the utility of integrating bant into routine clinical care to facilitate more frequent feedback . Future evaluations of mHealth apps should consider more robust research tools ( eg , Research Kit ) and alternative RCT study design s to enable more rapid and iterative evaluations , better suited to the nature of rapidly evolving consumer technology . Trial Registration Clinical Trials.gov NCT01899274 ; https:// clinical trials.gov/ct2/show/NCT01899274 ( Archived by WebCite at http://www.webcitation.org/6qWrqF1yw Aims : To investigate use of targeted self study material in type I diabetes patient education regarding dissemination , perceived patient benefit , and prevention of severe hypoglycaemia . Methods : In a r and omised 1:1:1 controlled study , 332 patients with type I diabetes ( aged 2.6–18.9 years ) were studied ; 313 completed clinical follow up , 261 completed endpoint question naire . The intervention group received videotapes and a brochure design ed to review skills for self control and treatment , aim ed at preventing severe hypoglycaemia . Two control groups received a videotape and brochure with general diabetes information , or traditional treatment only , respectively . Results : Yearly incidence of severe hypoglycaemia decreased from 42 % to 27 % in the intervention group , but not in controls . HbA1c remained unchanged . Levels of use ranged from 1 to 20 times ( median 2 ) ; 40–49 % had shown the material s to friends , relatives , school staff , sports coaches , etc ( there was little difference between intervention and control groups ) . Higher benefit and learning levels result ed from the intervention material , especially in patients with severe hypoglycaemia . Conclusions : Mass distributed pedagogical devices such as high quality video programmes and brochures may contribute to the prevention of severe hypoglycaemia . Such self study material s can reach high dissemination levels and constitute a cost effective complement to regular visits to a diabetes team and to other types of education . The findings may have implication s for other topics , other ages , and other diagnosis groups OBJECTIVE To evaluate the feasibility of an online interactive treatment environment for adolescents with type 1 diabetes , called Sugarsquare , to supplement usual care . RESEARCH DESIGN AND METHODS Sugarsquare provides easily accessible contact with the diabetes team , peer support , and treatment overview . Of 120 eligible patients , 62 adolescents aged 11 - 21 ( M = 15.23 , SD = 2.00 ) were assigned to a usual-care group ( n = 31 ) or a usual-care + intervention group ( n = 31 ) . Feasibility was assessed in terms of acceptability , dem and , practicability , integration , and efficacy in a 9-month study -period . RESULTS Assessment of acceptability and dem and revealed that 20 adolescents in the intervention group ( 65 % ) logged in at least once ; 16 adolescents ( 52 % ) logged in repeatedly . Usage result ed in 5795 page-views , 3580 chat-messages , 427 forum-messages , and in 40 private interactions between 11 adolescents ( 35 % ) and professionals . Assessment of practicability revealed that all 13 professionals ( 100 % ) accessed the intervention . Slow processing speed and security procedures formed obstacles for usage . Assessment of integration showed that international st and ards for diabetes care ( International Diabetes Federation/International Society for Pediatric and Adolescent Diabetes/American Diabetes Association ) were met . Assessment of efficacy revealed improvement in the intervention group in evaluation of care ( Patients ' Evaluation of Quality of Diabetes ) , F(1,30 ) = 5.35 , p < 0.05 , and quality of life , communication ( PedsQL ) , F(1,30 ) = 11.65 , p < 0.05 . The latter was correlated with posted chat-messages ( r = 0.42 , p < 0.05 ) . No between-group differences were found . CONCLUSIONS This study shows that Sugarsquare is feasible in adolescents with type 1 diabetes . It meets a dem and in adolescents and can support professionals when organizing on-going care according to international st and ards . Results are promising and next steps are a full-scale r and omized controlled trial and subsequent implementation in daily care Background : Poor management of type 1 diabetes mellitus ( T1DM ) may result in serious medical complications . Psychological intervention may improve adherence to medical regimens ; however , access to trained professionals is limited , particularly in rural communities . Telehealth interventions may address this by allowing families to access services at home ; however , little is known about the efficacy of such services . Method : This study presents results from a pilot trial of a r and omized waitlist controlled trial of Telehealth Behavioral Therapy ( TBT ) for youths with T1DM . Primary outcome measures were adherence to the diabetes regimen , glycemic control , and level of family discord . Thirty-two youths ( 23 female ) with T1DM ( aged 9 to 17 years ) and one parent or caregiver participated . Telehealth Behavioral Therapy sessions were conducted thrice weekly for 12 weeks by phone and lasted an average of 15 min each . Results : Results indicated that youths in treatment decreased their hemoglobin A1c by 0.74 compared to 0.09 in the waitlist , though this was not statistically significant . Youths in treatment reported increased unsupportive and decreased caring parental behaviors . Conclusion : Telehealth Behavioral Therapy improves access to knowledgeable providers and results in a clinical ly significant improvement in glycemic control . Despite some youths experiencing an increase in unsupportive parental behaviors , TBT is a promising method of service delivery that warrants further investigation OBJECTIVE To assess whether pedometers and text messaging increase physical activity in adolescents with type 1 diabetes . RESEARCH DESIGN AND METHODS A 12-week r and omized controlled trial was conducted . A total of 78 subjects participated in the trial ( mean ± SD age 14.4 ± 2.37 years , 36 [ 47 % ] male ) . Intervention participants wore an open pedometer and received regular motivational text messages . Control participants received usual care . Primary outcomes were daily step count ( 4-day closed pedometer ) and physical activity question naire . RESULTS Baseline median step count was 11,063 steps/day ( range 1,541–20,158 ) . At 12 weeks , mean daily step count reduced by 840 ( 95 % CI −1,947 to 266 ) in the control group and by 22 ( −1,407 to 1,364 ) in the intervention group ( P = 0.4 ) . Mean self-reported moderate or vigorous physical activity increased by 38.5 min/week in the control group and by 48.4 in the intervention group ( P = 0.9 ) . CONCLUSIONS A 12-week intervention using pedometers and text messaging as motivational tools in adolescents with type 1 diabetes did not increase physical activity AIM To study the long-term use of self- study material in type 1 diabetes patient education targeted at the prevention of severe hypoglycaemia . METHODS R and omized 1:1:1 control study in three local hospitals . We studied 332 type 1 diabetes patients from the geographic population , aged 2.6 - 18.9 y at entry . The intervention group received a videotape and brochure in which interviewed patients , parents and medical experts review ed in detail practical skills for self-control and treatment , with the aim of preventing severe hypoglycaemia . There were two control groups : one received a videotape and brochure with general diabetes information and the other only traditional treatment . Primary endpoints were severe hypoglycaemia needing assistance by another person and HbA1c . Dissemination , reading/viewing level , patients ' attitudes and extra contact with caregivers were also investigated . At 24 mo , 249 subjects provided data . RESULTS The yearly incidence of severe hypoglycaemia decreased at 24 mo from 42 % to 25 % ( difference 17 % , 95 % CI 3 - 31 , p = 0.0241 ) in the intervention group , but not in controls . HbA1c remained unchanged . Video use during months 13 - 24 was higher in the intervention group than in controls ( p = 0.0477 ) , ranging from 1 - 15 ( median 2 ) times , among 37 % of patients ( months 1 - 12 , 100 % ) . Higher future use was anticipated for intervention material ( p = 0.0003 ) . Extra caregiver contact was related to severe hypoglycaemia ( p = 0.0009 ) . The cost of the material was < EUR 10 per patient . CONCLUSION Mass-distributed pedagogical devices such as high- quality video programmes and brochures may reach high dissemination levels and , when targeted , contribute to the prevention of severe hypoglycaemia over a longer period of time , being a cost-effective complement to traditional care OBJECTIVE The purpose of the study was to evaluate the participation and preliminary efficacy of an Internet psychoeducational program ( Teens . Connect ) shown to be efficacious under controlled conditions compared with an open-access diabetes website for youth ( Planet D ) on the primary outcomes of A1C and quality of life ( QoL ) , and secondary outcomes of psychosocial and behavioral factors . RESEARCH DESIGN AND METHODS Teens with type 1 diabetes ( n = 124 , 11 - 14 yr ) from two clinical sites were r and omly prescribed one of the programs and completed baseline , 3-month and 6-month data . A1C was obtained from clinic records . Participation data included number of log ins , posts to the discussion board , and lessons completed ( Teens . Connect only ) . Descriptive and mixed model analyses were used . RESULTS Eighty-five percent ( 85 % ) of consented teens registered for their prescribed program . Satisfaction and log ins were similar between groups ( satisfaction ranged 3.3 - 3.5/5 ; mean log ins = 14/teen ) . Posts to the discussion forum were higher in Planet D ( mean = 28 vs. 19 ) . Participation in the Teens . Connect lessons was low , with only 69 % of teens completing any lesson . After 6 months there were no significant differences in A1C , QoL or secondary outcomes between groups . Teens in the Teens . Connect group reported lower perceived stress over time ( p < 0.01 ) . CONCLUSIONS Teens do not actively participate in an Internet psychoeducational program when they do not have frequent reminders , which may have contributed to a lack of treatment effect . Teens have many competing dem and s. Strategic implementation that includes targeted reminders and family support may be necessary to assure participation and improvement in health outcomes Aims The aim of the study was ( a ) to compare annual glycemic control in pediatric patients with type 1 diabetes mellitus ( T1DM ) who used a healthcare-funded continuous glucose monitoring system ( RT-CGMS ) to that of those who performed self-monitoring blood glucose ( SMBG ) only , in a real-life setting , and ( b ) to define parameters associated with compliance and glycemic control . Methods A total of 149 youth with T1DM ( 52.3 % females ) , mean age 11.8 ± 3.6 years , and 83 in the CGMS group were followed prospect ively for 12 months . Glycemic control parameters and compliance to RT-CGMS were assessed periodically . Results Glycemic parameters did not differ significantly between the groups during follow-up periods . The time spent with RT-CGMS decreased and only 38 % used it for more than 75 % of the time during the 12 months ( consistent users ) . Mean HbA1c decreased by 0.27 % in consistent users and increased by 0.21 % among intermittent users ( used RT-CGMS less than 75 % of time ) , p = 0.013 . Consistent users were younger 10 . 6 ± 4.2 vs. 12.5 ± 3.6 , p = 0.07 , and had higher frequency of SMBG at baseline , 10.6 ± 4.9 vs. 6.3 ± 2.8 , p = 0.011 . Conclusions The adoption of RT-CGMS was low , even in a healthcare system that funds its use . Caregivers should consider patient characteristics when recommending RT-CGMS use Introduction In this paper , we evaluated the feasibility of a telemedical ( TM ) support program and its effect on glycemic control in adolescents with type 1 diabetes mellitus ( T1DM ) . Thirty-six adolescents ( m=20 , median age at the start of the study : 15.3 years ( range : 10.7–19.3 years ) , median age at diagnosis : 9.3 years ( 2.1–13.8 years ) , median duration of disease : 6.4 years ( 1.0–12.8 years ) , HbA1c>8 % , all on intensified insulin therapy ) were r and omized in a crossover trial over 6 months ( 3 months with TM , 3 months with conventional support and paper diary ( PD ) ) . During the TM phase , the patients sent their data ( date , time , blood glucose , carbohydrate intake , insulin dosage ) via mobile phone , at least daily , to our server and diabetologists sent back their advice via short message service ( SMS ) once a week . Results Glycemic control improved during the TM phase , while it deteriorated during the PD phase : TM-PD group HbA1c ( % , median ( range ) ) : 9.05 ( 8–11.3 ) ( at 0 months ) , 8.9 ( 6.9–11.3 ) ( at 3 months ) , and 9.2 ( 7.4–12.6 ) ( at 6 months ) , and PD-TM group : 8.9 ( 8.3–11.6 ) , 9.9 ( 8.1–11 ) , and 8.85 ( 7.3–11.7 ) ( p<0.05 ) . Patients rated the TM support program to be a good idea . Technical problems with General Packet Radio Service ( GPRS ) data transmission led to data loss and decreased patient satisfaction . Conclusion Our telemedical support program , VIE-DIAB , proved to be feasible in adolescents and helped to improve glycemic control OBJECTIVE To determine whether the use of an Internet-based blood glucose monitoring system could improve glycemic control in adolescents with type 1 diabetes mellitus ( T1DM ) . METHODS In a r and omized , controlled clinical trial , a total of 70 adolescent subjects with T1DM were recruited . Subjects r and omized to the intervention group ( n = 36 ) were instructed to su bmi t their blood glucose levels weekly by Internet to the diabetes care team during a period of 6 months . Subjects r and omized to the control group ( n = 34 ) did not su bmi t results but were under routine follow-up . RESULTS At baseline , patients were 15.1 ± 2.6 years of age with mean HbA1c of 8.3 ± 1.3 % . At the 6-month follow-up period , no by-group differences in change from baseline to end of treatment HbA1c levels were detected . In the intervention group , 12/36 did not su bmi t blood glucose levels and were classified as non-compliant . In a secondary exploratory analysis in which non-compliant patients were omitted , HbA1c values in the compliant intervention group declined from 8.5 ± 1.7 % at baseline to 8.2 ± 1.2 % at 6 months , while in the control group HbA1c values increased from 8.2 ± 1.1 to 8.4 ± 1.1 % , this difference did not reach statistical significance . CONCLUSIONS An Internet-based blood glucose monitoring system was not associated with improved glycemic control in adolescents with T1DM . Identification of a sub-group of compliant subjects who may improve metabolic control by using this tool is needed OBJECTIVE To determine if scheduled telephone calls from a pediatric diabetes educator to children who have type 1 diabetes improve hemoglobin A1c ( HbA1c ) level , hospital admissions , diabetes knowledge , compliance , and psychological well-being . RESEARCH DESIGN AND METHODS A r and omized controlled trial of 123 young subjects ( mean age 11.9 yr , 69 male ) with type 1 diabetes ( mean duration 3.65 yr ) . For 7 months , the intervention group held bimonthly 15 - 30 min scheduled supportive telephone discussion s. The primary outcome was change in the HbA1c level . Admission rates and changes in diabetes knowledge , psychological parameters , compliance , and patient perception were measured . RESULTS There was no significant difference between the treatment and control groups either before or after the intervention . The mean HbA1c level in the control group increased from 8.32 to 8.82 % and in the intervention group from 8.15 to 8.85 % ( p = 0.24 ) . Both groups showed an increase in admissions of 0.2 per yr ( p = 0.57 ) . There was no improvement in diabetes knowledge ( p = 0.34 ) , compliance , or psychological function . The intervention group viewed their contact with the clinic as more helpful ( p = 0.003 ) . Analysis of family function did not reveal subgroups with statistically significant differences . A mean of 13 calls was made to each subject at a cost of 36 Australian dollars per child per month . CONCLUSIONS Scheduled bimonthly phone support does not improve the HbA1c level , admission rates , diabetes knowledge , psychological function , or self-management but is perceived by patients as helpful . Further study into the effects of more frequent but shorter periods of support for patients experiencing specific difficulties is needed The purpose of this study was to develop an Internet coping skills training program and to evaluate its feasibility and acceptability compared with an Internet education intervention for teenagers with type 1 diabetes . A multiphase mixed- methods design with focus groups , a r and omized pilot study , and a program evaluation was used . Teenagers with type 1 diabetes , parents , and health professionals were included in the development and evaluative phases along with the research and information technology team . The pilot study included 12 teenagers with type 1 diabetes ( mean [ SD ] age , 14.4 [ .90 ] years ; 58 % female ; mean [ SD ] duration of diabetes , 5.9 [ 3.0 ] years ) . Psychosocial data and HbA1c levels were collected at baseline and at 3 and 6 months . Results indicate that the development of a psychosocial Internet intervention was complex and required multiple iterations of development and evaluation . Results of this study also indicate the feasibility and acceptability of translating a group-based intervention for teenagers with type 1 diabetes to the Internet . Thus , this study demonstrates a systematic approach to Internet intervention development . Including teenagers with type 1 diabetes and a multidisciplinary professional team into the intervention design was critical to the success of this project Background : Increasingly various technologies are being tested to deliver behavioral health care . Delivering services via videoconferencing shows promise . Given that the patient-provider relationship is a strong predictor of patient adherence to medical regimens , addressing relationship quality when services are not delivered face-to-face is critical . To that end , we compared the therapeutic alliance when behavioral health care was delivered to youth with poorly controlled type 1 diabetes mellitus ( T1DM ) and their caregivers in-clinic with the same services delivered via Internet-based videoconferencing ( i.e. , Skype ™ ) . Methods : Seventy-one adolescents with poorly controlled T1DM ( hemoglobin A1c ≤9 % ) and one of their caregivers received up to 10 sessions of a family-based behavioral health intervention previously shown to improve adherence to diabetes regimens and family functioning ; 32 were r and omized to the Skype condition . Youth and caregivers completed the working alliance inventory ( WAI ) , a 36-item measure of therapeutic alliance , at the end of treatment . Additionally , the number of behavioral health sessions completed was tracked . Results : No significant differences in WAI scores were found for those receiving behavioral health care via Skype versus in-clinic . Youth WAI goal and total scores were significantly associated with the number of sessions completed for those in the clinic group . Conclusion : Behavioral health can be delivered to youth with T1DM via Internet-based videoconferencing without significantly impacting the therapeutic relationship . Thus , for those adolescents with T1DM who require specialized behavioral health care that targets T1DM management , Internet-based teleconferencing represents a viable alternative to clinic-based care Non-adherence with self-monitoring blood glucose ( SMBG ) among teenagers with type 1 diabetes can be a problem . The purpose of this study was to investigate the feasibility , acceptability , and preliminary efficacy of using Internet-based incentives to improve adherence with SMBG in non-adherent teenagers . Participants were r and omly assigned to contingent ( CS ; N = 23 ) , where they had to meet web camera-verified SMBG goals to earn incentives , or non-contingent ( NS ) groups ( N = 18 ) , where they earned incentives independent of adherence . Brief motivational interviewing ( MI ) was given prior to the intervention . Attrition was 15 % in the CS group . Participants and parents endorsed the intervention on all intervention dimensions . Daily SMBG increased after one MI session , and further increased when incentives were added , but significantly more for so for older participants . SMBG declined slowly over time , but only returned to baseline levels for younger NS participants . Internet-based incentive interventions are feasible , acceptable , and show promise for improving adherence with SMBG Adolescents with type 1 diabetes typically receive clinical care every 3 months . Between visits , diabetes-related issues may not be frequently reflected , learned , and documented by the patients , limiting their self-awareness and knowledge about their condition . We design ed a text-messaging system to help resolve this problem . In a pilot , r and omized controlled trial with 30 adolescents , we examined the effect of text messages about symptom awareness and diabetes knowledge on glucose control and quality of life . The intervention group that received more text messages between visits had significant improvements in quality of life |
312 | 31,393,083 | Skin-related adverse events such as hyperkeratosis , cutaneous squamous-cell carcinoma were less compared with monotherapy .
However , gastrointestinal events like nausea , diarrhea , and vomiting were at a higher frequency .
CONCLUSION Doublet BRAF and MEK inhibition achieved better survival outcomes over single-agent BRAF inhibition and occurred less skin-related events , but gastrointestinal events were more in combination therapy | BACKGROUND Melanoma is a potentially fatal malignancy with poor prognosis .
Several recent studies have demonstrated that combination therapy of BRAF and MEK inhibition achieved better curative effect and appeared less toxic effects .
We conducted a meta- analysis to evaluate the efficacy and safety between BRAF inhibition plus MEK inhibition combination therapy and BRAF inhibition monotherapy in melanoma patients . | BACKGROUND The combination of cobimetinib with vemurafenib improves progression-free survival compared with placebo and vemurafenib in previously untreated patients with BRAF(V600)-mutant advanced melanoma , as previously reported in the coBRIM study . In this Article , we report up date d efficacy results , including overall survival and safety after longer follow-up , and selected biomarker correlative studies . METHODS In this double-blind , r and omised , placebo-controlled , multicentre study , adult patients ( aged ≥18 years ) with histologically confirmed BRAF(V600 ) mutation-positive unresectable stage IIIC or stage IV melanoma were r and omly assigned ( 1:1 ) using an interactive response system to receive cobimetinib ( 60 mg once daily for 21 days followed by a 7-day rest period in each 28-day cycle ) or placebo , in combination with oral vemurafenib ( 960 mg twice daily ) . Progression-free and overall survival were primary and secondary endpoints , respectively ; all analyses were done on the intention-to-treat population . This study is registered with Clinical Trials.gov , number NCT01689519 , and is ongoing but no longer recruiting participants . FINDINGS Between Jan 8 , 2013 , and Jan 31 , 2014 , 495 eligible adult patients were enrolled and r and omly assigned to the cobimetinib plus vemurafenib group ( n=247 ) or placebo plus vemurafenib group ( n=248 ) . At a median follow-up of 14·2 months ( IQR 8·5 - 17·3 ) , the up date d investigator-assessed median progression-free survival was 12·3 months ( 95 % CI 9·5 - 13·4 ) for cobimetinib and vemurafenib versus 7·2 months ( 5·6 - 7·5 ) for placebo and vemurafenib ( HR 0·58 [ 95 % CI 0·46 - 0·72 ] , p<0·0001 ) . The final analysis for overall survival occurred when 255 ( 52 % ) patients had died ( Aug 28 , 2015 ) . Median overall survival was 22·3 months ( 95 % CI 20·3-not estimable ) for cobimetinib and vemurafenib versus 17·4 months ( 95 % CI 15·0 - 19·8 ) for placebo and vemurafenib ( HR 0·70 , 95 % CI 0·55 - 0·90 ; p=0·005 ) . The safety profile for cobimetinib and vemurafenib was tolerable and manageable , and no new safety signals were observed with longer follow-up . The most common grade 3 - 4 adverse events occurring at a higher frequency in patients in the cobimetinib and vemurafenib group compared with the vemurafenib group were γ-glutamyl transferase increase ( 36 [ 15 % ] in the cobimetinib and vemurafenib group vs 25 [ 10 % ] in the placebo and vemurafenib group ) , blood creatine phosphokinase increase ( 30 [ 12 % ] vs one [ < 1 % ] ) , and alanine transaminase increase ( 28 [ 11 % ] vs 15 [ 6 % ] ) . Serious adverse events occurred in 92 patients ( 37 % ) in the cobimetinib and vemurafenib group and 69 patients ( 28 % ) in the vemurafenib group . Pyrexia ( six patients [ 2 % ] ) and dehydration ( five patients [ 2 % ] ) were the most common serious adverse events reported in the cobimetinib and vemurafenib group . A total of 259 patients have died : 117 ( 47 % ) in the cobimetinib and vemurafenib group and 142 ( 58 % ) in the vemurafenib group . The primary cause of death was disease progression in most patients : 109 ( 93 % ) of 117 in the cobimetinib and vemurafenib group and 133 ( 94 % ) of 142 in the vemurafenib group . INTERPRETATION These data confirm the clinical benefit of cobimetinib combined with vemurafenib and support the use of the combination as a st and ard first-line approach to improve survival in patients with advanced BRAF(V600)-mutant melanoma . FUNDING F Hoffmann-La Roche-Genentech BACKGROUND Combined BRAF-MEK inhibitor therapy is the st and ard of care for BRAFV600-mutant advanced melanoma . We investigated encorafenib , a BRAF inhibitor with unique target-binding properties , alone or in combination with the MEK inhibitor binimetinib , versus vemurafenib in patients with advanced BRAFV600-mutant melanoma . METHODS COLUMBUS was conducted as a two-part , r and omised , open-label phase 3 study at 162 hospitals in 28 countries . Eligible patients were aged 18 years or older and had histologically confirmed locally advanced ( American Joint Committee on Cancer [ AJCC ] stage IIIB , IIIC , or IV ) , unresectable or metastatic cutaneous melanoma , or unknown primary melanoma ; a BRAFV600E or BRAFV600 K mutation ; an Eastern Cooperative Oncology Group ( ECOG ) performance status of 0 or 1 ; and were treatment naive or had progressed on or after previous first-line immunotherapy . In part 1 of the study , patients were r and omly assigned ( 1:1:1 ) via interactive response technology to receive either oral encorafenib 450 mg once daily plus oral binimetinib 45 mg twice daily ( encorafenib plus binimetinib group ) , oral encorafenib 300 mg once daily ( encorafenib group ) , or oral vemurafenib 960 mg twice daily ( vemurafenib group ) . The primary endpoint was progression-free survival by blinded independent central review for encorafenib plus binimetinib versus vemurafenib . Efficacy analyses were by intention-to-treat . Safety was analysed in patients who received at least one dose of study drug and one postbaseline safety assessment . The results of part 2 will be published separately . This study is registered with Clinical Trials.gov , number NCT01909453 , and EudraCT , number 2013 - 001176 - 38 . FINDINGS Between Dec 30 , 2013 , and April 10 , 2015 , 577 of 1345 screened patients were r and omly assigned to either the encorafenib plus binimetinib group ( n=192 ) , the encorafenib group ( n=194 ) , or the vemurafenib group ( n=191 ) . With a median follow-up of 16·6 months ( 95 % CI 14·8 - 16·9 ) , median progression-free survival was 14·9 months ( 95 % CI 11·0 - 18·5 ) in the encorafenib plus binimetinib group and 7·3 months ( 5·6 - 8·2 ) in the vemurafenib group ( hazard ratio [ HR ] 0·54 , 95 % CI 0·41 - 0·71 ; two-sided p<0·0001 ) . The most common grade 3 - 4 adverse events seen in more than 5 % of patients in the encorafenib plus binimetinib group were increased γ-glutamyltransferase ( 18 [ 9 % ] of 192 patients ) , increased creatine phosphokinase ( 13 [ 7 % ] ) , and hypertension ( 11 [ 6 % ] ) ; in the encorafenib group they were palmoplantar erythrodysaesthesia syndrome ( 26 [ 14 % ] of 192 patients ) , myalgia ( 19 [ 10 % ] ) , and arthralgia ( 18 [ 9 % ] ) ; and in the vemurafenib group it was arthralgia ( 11 [ 6 % ] of 186 patients ) . There were no treatment-related deaths except for one death in the combination group , which was considered possibly related to treatment by the investigator . INTERPRETATION Encorafenib plus binimetinib and encorafenib monotherapy showed favourable efficacy compared with vemurafenib . Overall , encorafenib plus binimetinib appears to have an improved tolerability profile compared with encorafenib or vemurafenib . Encorafenib plus binimetinib could represent a new treatment option for patients with BRAF-mutant melanoma . FUNDING Array BioPharma , Novartis The BRAF inhibitor , vemurafenib , has demonstrated improved progression-free and overall survival compared with chemotherapy in a r and omized trial , and represents a new st and ard of care in patients with advanced melanoma harboring a BRAF-V600 mutation . A BRAF-V600 mutation is identified in approximately half of patients with cutaneous melanoma , and is unequivocally a biomarker predictive of profound clinical benefit for these patients . However , acquired vemurafenib resistance is a major clinical challenge and therapy is not yet curative . A substantial body of translational research has been performed alongside clinical trials of vemurafenib , providing key insights into the molecular basis of response and resistance . This review summarizes the development of vemurafenib for the treatment of BRAF-V600 mutant melanoma and discusses how knowledge of critical signaling pathways will be applied for its optimal clinical use in future BACKGROUND Previously , a study of ours showed that the combination of dabrafenib and trametinib improves progression-free survival compared with dabrafenib and placebo in patients with BRAF Val600Lys/Glu mutation-positive metastatic melanoma . The study was continued to assess the secondary endpoint of overall survival , which we report in this Article . METHODS We did this double-blind phase 3 study at 113 sites in 14 countries . We enrolled previously untreated patients with BRAF Val600Glu or Val600Lys mutation-positive unresectable stage IIIC or stage IV melanoma . Participants were computer-r and omised ( 1:1 ) to receive a combination of dabrafenib ( 150 mg orally twice daily ) and trametinib ( 2 mg orally once daily ) , or dabrafenib and placebo . The primary endpoint was progression-free survival and overall survival was a secondary endpoint . This study is registered with Clinical Trials.gov , number NCT01584648 . FINDINGS Between May 4 , 2012 , and Nov 30 , 2012 , we screened 947 patients for eligibility , of whom 423 were r and omly assigned to receive dabrafenib and trametinib ( n=211 ) or dabrafenib only ( n=212 ) . The final data cutoff was Jan 12 , 2015 , at which time 222 patients had died . Median overall survival was 25·1 months ( 95 % CI 19·2-not reached ) in the dabrafenib and trametinib group versus 18·7 months ( 15·2 - 23·7 ) in the dabrafenib only group ( hazard ratio [ HR ] 0·71 , 95 % CI 0·55 - 0·92 ; p=0·0107 ) . Overall survival was 74 % at 1 year and 51 % at 2 years in the dabrafenib and trametinib group versus 68 % and 42 % , respectively , in the dabrafenib only group . Based on 301 events , median progression-free survival was 11·0 months ( 95 % CI 8·0 - 13·9 ) in the dabrafenib and trametinib group and 8·8 months ( 5·9 - 9·3 ) in the dabrafenib only group ( HR 0·67 , 95 % CI 0·53 - 0·84 ; p=0·0004 ; unadjusted for multiple testing ) . Treatment-related adverse events occurred in 181 ( 87 % ) of 209 patients in the dabrafenib and trametinib group and 189 ( 90 % ) of 211 patients in the dabrafenib only group ; the most common was pyrexia ( 108 patients , 52 % ) in the dabrafenib and trametinib group , and hyperkeratosis ( 70 patients , 33 % ) in the dabrafenib only group . Grade 3 or 4 adverse events occurred in 67 ( 32 % ) patients in the dabrafenib and trametinib group and 66 ( 31 % ) patients in the dabrafenib only group . INTERPRETATION The improvement in overall survival establishes the combination of dabrafenib and trametinib as the st and ard targeted treatment for BRAF Val600 mutation-positive melanoma . Studies assessing dabrafenib and trametinib in combination with immunotherapies are ongoing . FUNDING GlaxoSmithKline BACKGROUND Resistance to therapy with BRAF kinase inhibitors is associated with reactivation of the mitogen-activated protein kinase ( MAPK ) pathway . To address this problem , we conducted a phase 1 and 2 trial of combined treatment with dabrafenib , a selective BRAF inhibitor , and trametinib , a selective MAPK kinase ( MEK ) inhibitor . METHODS In this open-label study involving 247 patients with metastatic melanoma and BRAF V600 mutations , we evaluated the pharmacokinetic activity and safety of oral dabrafenib ( 75 or 150 mg twice daily ) and trametinib ( 1 , 1.5 , or 2 mg daily ) in 85 patients and then r and omly assigned 162 patients to receive combination therapy with dabrafenib ( 150 mg ) plus trametinib ( 1 or 2 mg ) or dabrafenib monotherapy . The primary end points were the incidence of cutaneous squamous-cell carcinoma , survival free of melanoma progression , and response . Secondary end points were overall survival and pharmacokinetic activity . RESULTS Dose-limiting toxic effects were infrequently observed in patients receiving combination therapy with 150 mg of dabrafenib and 2 mg of trametinib ( combination 150/2 ) . Cutaneous squamous-cell carcinoma was seen in 7 % of patients receiving combination 150/2 and in 19 % receiving monotherapy ( P=0.09 ) , whereas pyrexia was more common in the combination 150/2 group than in the monotherapy group ( 71 % vs. 26 % ) . Median progression-free survival in the combination 150/2 group was 9.4 months , as compared with 5.8 months in the monotherapy group ( hazard ratio for progression or death , 0.39 ; 95 % confidence interval , 0.25 to 0.62 ; P<0.001 ) . The rate of complete or partial response with combination 150/2 therapy was 76 % , as compared with 54 % with monotherapy ( P=0.03 ) . CONCLUSIONS Dabrafenib and trametinib were safely combined at full monotherapy doses . The rate of pyrexia was increased with combination therapy , whereas the rate of proliferative skin lesions was nonsignificantly reduced . Progression-free survival was significantly improved . ( Funded by GlaxoSmithKline ; Clinical Trials.gov number , NCT01072175 . ) BACKGROUND Combined BRAF and MEK inhibition , as compared with BRAF inhibition alone , delays the emergence of resistance and reduces toxic effects in patients who have melanoma with BRAF V600E or V600 K mutations . METHODS In this phase 3 trial , we r and omly assigned 423 previously untreated patients who had unresectable stage IIIC or stage IV melanoma with a BRAF V600E or V600 K mutation to receive a combination of dabrafenib ( 150 mg orally twice daily ) and trametinib ( 2 mg orally once daily ) or dabrafenib and placebo . The primary end point was progression-free survival . Secondary end points included overall survival , response rate , response duration , and safety . A preplanned interim overall survival analysis was conducted . RESULTS The median progression-free survival was 9.3 months in the dabrafenib-trametinib group and 8.8 months in the dabrafenib-only group ( hazard ratio for progression or death in the dabrafenib-trametinib group , 0.75 ; 95 % confidence interval [ CI ] , 0.57 to 0.99 ; P=0.03 ) . The overall response rate was 67 % in the dabrafenib-trametinib group and 51 % in the dabrafenib-only group ( P=0.002 ) . At 6 months , the interim overall survival rate was 93 % with dabrafenib-trametinib and 85 % with dabrafenib alone ( hazard ratio for death , 0.63 ; 95 % CI , 0.42 to 0.94 ; P=0.02 ) . However , a specified efficacy-stopping boundary ( two-sided P=0.00028 ) was not crossed . Rates of adverse events were similar in the two groups , although more dose modifications occurred in the dabrafenib-trametinib group . The rate of cutaneous squamous-cell carcinoma was lower in the dabrafenib-trametinib group than in the dabrafenib-only group ( 2 % vs. 9 % ) , whereas pyrexia occurred in more patients ( 51 % vs. 28 % ) and was more often severe ( grade 3 , 6 % vs. 2 % ) in the dabrafenib-trametinib group . CONCLUSIONS A combination of dabrafenib and trametinib , as compared with dabrafenib alone , improved the rate of progression-free survival in previously untreated patients who had metastatic melanoma with BRAF V600E or V600 K mutations . ( Funded by GlaxoSmithKline ; Clinical Trials.gov number , NCT01584648 . ) BACKGROUND B-rapidly accelerated fibrosarcoma ( BRAF ) inhibitor encorafenib alone and in combination with MEK inhibitor binimetinib improves survival in BRAF-mutated melanoma patients . So far , the range of cutaneous adverse events has been characterized only for established BRAF inhibitors ( vemurafenib , dabrafenib ) and MEK inhibitors ( trametinib , cobimetinib ) . OBJECTIVE The aim of this study was to investigate cutaneous adverse events emerging in melanoma patients treated with encorafenib and binimetinib . METHODS Patients treated with BRAF and MEK inhibitors in clinical trials at the University Hospital of Zurich were identified . Frequency and features of cutaneous adverse events as well as their management were assessed based on the prospect ively collected clinical and histopathological data . The events emerging during encorafenib and /or binimetinib therapy were compared to other BRAF and MEK inhibitors at the institution and in the literature . RESULTS The most frequent cutaneous adverse events observed in patients treated with encorafenib alone ( n = 24 ) were palmoplantar hyperkeratosis ( 54 % ) , palmoplantar erythrodysesthesia ( 58 % ) and alopecia ( 46 % ) . Drug-induced papulopustular eruptions prevailed in patients with binimetinib monotherapy ( n = 25 ) . The most frequent cutaneous adverse events in patients treated with encorafenib/binimetinib ( n = 49 ) were palmoplantar hyperkeratosis ( 10 % ) . CONCLUSION Compared to data published for established BRAFi , encorafenib monotherapy showed less hyperproliferative cutaneous adverse events . In contrast , palmoplantar hyperkeratosis and palmoplantar erythrodysesthesia seem to occur more often . The combination of encorafenib and binimetinib is well tolerated and induces few cutaneous adverse events BACKGROUND The combined inhibition of BRAF and MEK is hypothesized to improve clinical outcomes in patients with melanoma by preventing or delaying the onset of resistance observed with BRAF inhibitors alone . This r and omized phase 3 study evaluated the combination of the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib . METHODS We r and omly assigned 495 patients with previously untreated unresectable locally advanced or metastatic BRAF V600 mutation-positive melanoma to receive vemurafenib and cobimetinib ( combination group ) or vemurafenib and placebo ( control group ) . The primary end point was investigator-assessed progression-free survival . RESULTS The median progression-free survival was 9.9 months in the combination group and 6.2 months in the control group ( hazard ratio for death or disease progression , 0.51 ; 95 % confidence interval [ CI ] , 0.39 to 0.68 ; P<0.001 ) . The rate of complete or partial response in the combination group was 68 % , as compared with 45 % in the control group ( P<0.001 ) , including rates of complete response of 10 % in the combination group and 4 % in the control group . Progression-free survival as assessed by independent review was similar to investigator-assessed progression-free survival . Interim analyses of overall survival showed 9-month survival rates of 81 % ( 95 % CI , 75 to 87 ) in the combination group and 73 % ( 95 % CI , 65 to 80 ) in the control group . Vemurafenib and cobimetinib was associated with a nonsignificantly higher incidence of adverse events of grade 3 or higher , as compared with vemurafenib and placebo ( 65 % vs. 59 % ) , and there was no significant difference in the rate of study -drug discontinuation . The number of secondary cutaneous cancers decreased with the combination therapy . CONCLUSIONS The addition of cobimetinib to vemurafenib was associated with a significant improvement in progression-free survival among patients with BRAF V600-mutated metastatic melanoma , at the cost of some increase in toxicity . ( Funded by F. Hoffmann-La Roche/Genentech ; coBRIM Clinical Trials.gov number , NCT01689519 . ) BACKGROUND The BRAF inhibitors vemurafenib and dabrafenib have shown efficacy as monotherapies in patients with previously untreated metastatic melanoma with BRAF V600E or V600 K mutations . Combining dabrafenib and the MEK inhibitor trametinib , as compared with dabrafenib alone , enhanced antitumor activity in this population of patients . METHODS In this open-label , phase 3 trial , we r and omly assigned 704 patients with metastatic melanoma with a BRAF V600 mutation to receive either a combination of dabrafenib ( 150 mg twice daily ) and trametinib ( 2 mg once daily ) or vemurafenib ( 960 mg twice daily ) orally as first-line therapy . The primary end point was overall survival . RESULTS At the preplanned interim overall survival analysis , which was performed after 77 % of the total number of expected events occurred , the overall survival rate at 12 months was 72 % ( 95 % confidence interval [ CI ] , 67 to 77 ) in the combination-therapy group and 65 % ( 95 % CI , 59 to 70 ) in the vemurafenib group ( hazard ratio for death in the combination-therapy group , 0.69 ; 95 % CI , 0.53 to 0.89 ; P=0.005 ) . The prespecified interim stopping boundary was crossed , and the study was stopped for efficacy in July 2014 . Median progression-free survival was 11.4 months in the combination-therapy group and 7.3 months in the vemurafenib group ( hazard ratio , 0.56 ; 95 % CI , 0.46 to 0.69 ; P<0.001 ) . The objective response rate was 64 % in the combination-therapy group and 51 % in the vemurafenib group ( P<0.001 ) . Rates of severe adverse events and study -drug discontinuations were similar in the two groups . Cutaneous squamous-cell carcinoma and keratoacanthoma occurred in 1 % of patients in the combination-therapy group and 18 % of those in the vemurafenib group . CONCLUSIONS Dabrafenib plus trametinib , as compared with vemurafenib monotherapy , significantly improved overall survival in previously untreated patients with metastatic melanoma with BRAF V600E or V600 K mutations , without increased overall toxicity . ( Funded by GlaxoSmithKline ; Clinical Trials.gov number , NCT01597908 . ) |
313 | 31,579,502 | Staining was time associated ; the longer the study , the higher its reported incidence and severity .
The most frequently reported adverse effect was teeth staining . | Background Poor oral hygiene is strongly associated with oral and systemic diseases .
Alongside mechanical tooth cleaning , the adjunctive use of mouthrinses has been widely advocated .
Although research on the efficacy of various mouthrinse formulations is very active , there are a lack of conclusive data regarding their adverse effects . | The effects of topical ketorolac tromethamine mouthrinse ( 0.1 % ) on gingival crevicular fluid ( GCF ) prostagl and in E2 ( PGE2 ) concentrations were investigated in a 6-week , r and omized , double-blind , placebo-controlled , parallel group , single center study of 42 patients with moderately advanced chronic adult periodontitis . Following screening , GCF was sample d from 6 sites per subject with filter paper strips and PGE2 levels measured using an enzyme immunoassay kit . Only those subjects with mouth median GCF PGE2 concentrations > 30 ng/ml entered the rinsing phase . Eligible subjects were allocated placebo rinse in the first 2-week period ( days 0 through 14 ) , either ketorolac rinse ( test group , n = 21 ) or placebo rinse ( control group , n = 21 ) in the second 2-week period ( days 14 through 28 ) , and placebo rinse in the third 2-week period ( days 28 through 42 ) . Full mouth median GCF PGE2 concentrations were calculated for each subject at days 0 , 14 , 28 , and 42 , and group means were compared . From day 0 to day 14 , no significant changes in GCF PGE2 concentrations were detected in either study group ( P > 0.05 ) . Utilizing mean GCF PGE2 concentrations at days 0 and 14 as covariates , no significant differences were observed in adjusted mean PGE2 levels at days 28 and 42 between the study groups ( ANCOVA , P > 0.05 ) . A statistically significant increase in GCF PGE2 levels was noted at days 28 and 42 in the placebo group ( P < 0.01 ) , but not in the ketorolac group ( P > 0.05 ) , when compared to baseline , however . GCF PGE2 levels were further studied in a subset of volunteers ( n = 11 ) during a 12-hour period following first rinsing with mouthrinse ( active or placebo ) at day 14 . GCF was sample d 0 , 2 , 4 , 6 , 8 , and 12 hours post-rinsing . Mean PGE2 levels were higher in the placebo subgroup than in the ketorolac subgroup , and increased gradually over the 12-hour period in both subgroups . These data indicate that 1 ) 14 days of rinsing with 0.1 % ketorolac mouthrinse controlled the elevation of GCF PGE2 observed in the placebo group but did not actually reduce GCF PGE2 concentrations and 2 ) changes in GCF PGE2 levels were not detectable in the 12-hour period following first rinsing with ketorolac BACKGROUND Plaque control is the main method for preventing periodontal diseases . Chlorhexidine digluconate mouthrinse is widely recognized as helping to maintain plaque control . Most of these mouthrinses contain alcohol , making them impractical for many patients , including those with oral mucosal hypersensitivity . Mouthrinses without alcohol might cause fewer side effects , but also be less efficient . In this study , we evaluated the efficacy of a 0.12 % chlorhexidine mouthrinse without alcohol against one with 11 % ethanol and a placebo . METHODS This a double-blind , parallel group study with 96 patients who tested 3 mouthrinses containing 1 ) chlorhexidine digluconate 0.12 % sodium fluoride 0.05 % , and ethanol 11 % ( group 1 ; CHX-A ) ; 2 ) the same solution without alcohol ( group 2 ; CHX-NA ) ; and a placebo ( group 3 ; P ) . Plaque and bleeding indexes were recorded in all patients prior to treatment and at 14 and 28 days . RESULTS There were significant differences in plaque , gingivitis , and papilla bleeding indexes in both chlorhexidine rinses compared to placebo , but no differences between the 2 CHX products . CONCLUSIONS In this study , the alcohol-free rinse was as effective as one containing alcohol in controlling plaque and reducing gingival inflammation . Therefore , it would seem that its use can be recommended in all patients , but especially in patients for whom the use of alcohol is contraindicated OBJECTIVE To compare measures of dry mouth following extended use of an alcohol-based mouthrinse ( LISTERINE Antiseptic [ LA ] ) and a non-alcohol-based mouthrinse ( Crest Pro-Health Rinse [ CPH ] ) on healthy adults with " normal " salivary flow . METHODS This single-site , r and omized , observer-blinded , parallel study compared unstimulated whole salivary flow and perceived dryness following daily use at weeks 4 and 12 versus baseline . Noninferiority , between-treatment flow comparisons ( 0.15 mL/min margin ) , and between-treatment comparisons of the mean Bluestone Mouthfeel Question naire ( BMQ ) visual analog scale scores were made using analysis of covariance . RESULTS Measures of dry mouth were comparable between mouthrinses , as demonstrated by both noninferiority of LA versus CPH flow ( P < .001 ) and no significant differences between groups in the BMQ measures at 4 or 12 weeks . CONCLUSIONS Extended use of an alcohol-based mouthrinse is no more likely to cause reduction in salivary flow or perceived dryness in individuals with normal salivary flow compared with a non-alcohol-based mouthrinse ( CPH ) OBJECTIVES To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone . METHODS One hundred and sixty healthy volunteers were enrolled in the r and omized controlled trial . Participants were r and omly and equally assigned to four groups : ( i ) toothbrushing + rinsing ( 0.06 % CHX + 0.025 % NaF , alcohol-containing rinse , positive control ) ; ( ii ) toothbrushing + rinsing ( 0.06 % CHX + 0.025 % NaF , alcohol-free experimental rinse ) ; ( iii ) toothbrushing + rinsing ( 0.06 % CHX + 0.03 % CPC + 0.025 % NaF , alcohol-free experimental rinse ) ; ( iv ) toothbrushing alone ( negative control ) . At baseline , Quigley-Hein plaque index ( QHI ) , modified proximal plaque index ( MPPI ) , and papillary bleeding index ( PBI ) were recorded . All subjects brushed their teeth as usual during the study . Additionally , groups 1 - 3 rinsed twice daily . Eight weeks after baseline , indices were recorded again . anova with Bonferroni adjustment served for statistical analysis . RESULTS One hundred and fifty-five participants were included into final analysis ( i : n = 39 , 2 : n = 39 , 3 : n = 37 , 4 : n = 40 ) . Experimental rinses ( ii , iii ) reduced QHI and MPPI to a higher extent than the negative control ( iv ) , whereas no significant difference to the positive control was found . QHI : ( i ) 36.6 % , ( ii ) 32.3 % , ( iii ) 36.8 % , ( iv ) 21.6 % ; MPPI : ( i ) 11.9 % , ( ii ) 12.2 % , ( iii ) 13.6 % , ( iv ) 3.5 % . For PBI , no statistically significant difference was found between groups : ( i ) 80.2 % , ( ii ) 77.8 % , ( iii ) 76.5 % and ( iv ) 78.8 % . CONCLUSIONS With respect to QHI and MPPI , toothbrushing in combination with any rinse was more effective than toothbrushing alone . No statistically significant differences were found between the alcohol-free and the alcohol-containing control rinses BACKGROUND Non-alcoholic chlorhexidine mouthwashes are equally effective and have fewer potential risks than hydroalcoholic solutions . Nowadays , other active ingredients are added to these mouthwashes in an attempt to improve their effectiveness and reduce side effects . Following an experimental gingivitis model , this study examined three non-alcoholic commercial mouthwashes having 0.12 % chlorhexidine digluconate ( CHX ) in common . METHODS Using a double masked , cross-over design , 30 subjects underwent three consecutive experimental phases with three mouthwashes : CHX , CHX + 0.05 % sodium fluoride ( CHXNaF ) , and CHX + 0.05 % cetylpyridinium chloride ( CHX-CPC ) . In each one of these 21-day phases , the subjects discontinued all oral hygiene measures and were treated exclusively with the experimental mouthwash r and omly assigned ( an oral rinse twice a day ) . Each experimental phase was preceded by a 14-day washout period . Levels of gingivitis , dental plaque , supragingival calculus , and dental staining were assessed at baseline and end ( day 21 ) of experimental phases . RESULTS The evolution of gingival and dental staining indices did not show statistically significant differences between the treatments . Differences were noticed in the plaque index ( P = 0.0002 ) , with CHX-NaF the treatment with the greatest increase . Differences were also observed in the supragingival calculus index ( P = 0.0136 ) , with CHX-CPC showing a smaller increase . Tongue staining was more frequent with CHX-CPC ( P = 0.0141 ) . CONCLUSION In non-alcoholic 0.12 % chlorhexidine mouthwashes , the addition of other active ingredients does not produce beneficial effects , but may even reduce the antiplaque effectiveness or increase tongue staining PURPOSE To evaluate the effects of a novel mouthrinse containing 0.07 % high bioavailable cetylpyridinium chloride ( Crest Pro-Health Rinse ) on the development of gingivitis and plaque versus a placebo control over a period of 6 months . METHODS This was a r and omized , 6-month , placebo-controlled , parallel groups , double blind , single center clinical trial . One hundred thirty-nine generally healthy adults with mild-to-moderate gingivitis were enrolled in the study . Subjects were given Modified Gingival Index ( MGI ) , Gingival Bleeding Index ( GBI ) and Modified Quigley-Hein Plaque Index ( MQH ) examinations followed by a dental prophylaxis . Subjects were then r and omly assigned to either the cetylpyridinium chloride ( CPC ) rinse or placebo rinse and instructed to begin rinsing twice a day with 20 ml of their assigned mouthrinse for 30 seconds after brushing their teeth . Subjects were assessed for MGI , GBI and MQH scores after 3 and 6 months of product use . Oral hard and soft tissue examinations were also performed at all visits . RESULTS 124 subjects were evaluable at Month 3 and 119 at Month 6 . After 6 months , subjects rinsing with the CPC rinse showed 15.4 % less gingival inflammation , 33.3 % less gingival bleeding , and 15.8 % less plaque relative to the placebo group . All reductions were highly statistically significantly different ( P < 0.01 ) . Results were similar at 3 months . Both treatments were well-tolerated . CLINICAL SIGNIFICANCE This study demonstrates that the Crest Pro-Health 0.07 % CPC mouthrinse provided significant antiplaque and antigingivitis benefits when used twice daily for 6 months as an adjunct to toothbrushing PURPOSE To evaluate the effects of two experimental cetylpyridinium chloride ( CPC ) mouthrinses containing 0.075 % and 0.10 % CPC on the development of gingivitis and plaque versus a placebo control over a period of 6 months . METHODS This was a r and omized , single center , parallel group , double blind , positive and placebo controlled clinical trial . A 0.12 % chlorhexidine rinse served as the positive control for validation of the methodology . At the beginning of the trial , 366 subjects were balanced and r and omly assigned to treatment groups . Subjects received a dental prophylaxis and began rinsing twice a day with 15 ml of their assigned mouthwash for 30 seconds after brushing their teeth . Subjects were assessed for gingivitis and gingival bleeding by the Löe-Silness Gingival Index method and plaque by the Turesky modification of Quigley Hein Plaque Index at baseline and after 3 and 6 months of product use . Oral soft tissue health was also assessed . RESULTS After 3 and 6 months , subjects rinsing with either 0.075 % or 0.10 % CPC had significantly ( P < 0.0001 ) less gingivitis , gingival bleeding , and plaque , on average , than those on placebo . The 6-month mean reductions in gingivitis , gingival bleeding , and plaque for the 0.075 % and 0.10 % CPC rinses versus placebo were 23 % , 30 % and 17 % , and 20 % , 27 % and 19 % , respectively . There was no statistically significant difference in efficacy between the two CPC mouthrinses . Reductions at 3 months were similar to those seen at 6 months . Significant benefits were observed with chlorhexidine , thereby validating the study . CLINICAL SIGNIFICANCE This study clearly demonstrates that CPC mouthrinses formulated to deliver therapeutic benefits when used twice daily can significantly prevent the development of gingivitis , gingival bleeding , and plaque over a 6-month period Objectives Gingival bleeding following twice-daily use of 0.2 % w/v chlorhexidine digluconate mouthrinse with and without alcohol ( 0.2 % CHX-alcohol ; 0.2 % CHX-alcohol-free , respectively ) and brushing with a st and ard fluoride toothpaste was compared to brushing alone . Methods Three hundred and nineteen subjects with mild-to-moderate gingivitis ( with ≥16 gradable permanent teeth including four molars , bleeding after brushing and ≥20 bleeding sites ) completed this r and omised , examiner-blinded , parallel-group study . A prophylaxis was performed at baseline . Gingival Severity Index ( GSI ; primary objective ) , Gingival Index ( GI ) and Plaque Index ( PI ) were assessed at baseline and after 6 weeks of treatment . Adverse events ( AEs ) were recorded throughout the study . Results Between treatment differences at week 6 demonstrated significantly lower GSI for the 0.2 % CHX-alcohol and 0.2 % CHX-alcohol-free groups compared to brushing alone ( primary endpoint ; treatment difference −0.061 [ 95 % CI −0.081 , −0.041 ] and −0.070 [ 95 % CI −0.090 , −0.050 ] , respectively ; both p < 0.0001 ) . There were also significant reductions in GI and PI for the 0.2 % CHX-alcohol and 0.2 % CHX-alcohol-free groups compared to brushing alone ( all p < 0.0001 ) . The proportion of subjects reporting ≥1 treatment-related adverse events ( TRAEs ) was 27.8 % ( 0.2 % CHX-alcohol ) , 24.8 % ( 0.2 % CHX-alcohol-free ) and 3.7 % ( brushing alone ) . Conclusions Chlorhexidine mouthrinse with or without alcohol as an adjunct to brushing with regular fluoride toothpaste significantly reduces bleeding scores , plaque and gingival inflammation compared to brushing alone . TRAEs are characteristic of those associated with the use of chlorhexidine and are similar for both mouthrinses A double-blind , r and omised , 4-week clinical trial with parallel group design in 57 patients with gingivitis was conducted for study ing the antibacterial efficacy and safety of a delmopinol HCl aqueous solution 2 mg/ml ( 0.2 % w/v ) , which was used for unsupervised mouth-rinsing and compared with placebo and chlorhexidine digluconate 2 mg/ml ( 0.2 % w/v , Hibitane Dental , ICI Pharmaceuticals , UK ) . The plaque index and plaque wet weight were used to measure plaque formation , and gingival fluid flow and bleeding on probing to measure gingivitis . According to the reduction from baseline , chlorhexidine showed a significantly better effect on plaque formation than the placebo after 4 weeks treatment for both plaque measurements . Delmopinol exhibited significantly lower plaque index scores than placebo . The difference between chlorhexidine and delmopinol was not statistically significant for any of the plaque measurements . For gingivitis , no statistically significant differences were obtained between the effects of delmopinol , chlorhexidine and placebo . A transient anaesthetic sensation in the oral mucosa was experienced more clearly by the patients in the delmopinol group than by those using chlorhexidine or placebo rinses . Rinsing with chlorhexidine result ed in more staining of the teeth and tongue than did delmopinol and placebo . The placebo solution tasted better than the 2 active solutions . The results showed that rinsing with either delmopinol HCl aqueous solution 2 mg/ml or chlorhexidine digluconate 2 mg/ml 2x daily for 60 as a supplement to normal oral hygiene , following an initial professional tooth cleaning , leads to a lower plaque formation than rinsing with placebo . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVE The study compared two commercial chlorhexidine mouthrinses ( Chlorhexamed 0.1 % and Corsodyl 0.2 % ) for their effects on dental plaque and gingival inflammation , their side effects ( eg , tooth staining and mucosal irritation ) , and patient acceptance . METHOD AND MATERIAL S One hundred thirty healthy volunteers were r and omly distributed into two groups of 65 each . Each volunteer had gingivitis or chronic marginal periodontitis and used the rinse two times a day for 4 weeks . The sulcular bleeding index , approximal plaque index , gingival index , and a discoloration index were taken at baseline and once a week thereafter . The patients were question ed about taste disturbances , mucosal irritation , and their perception of the taste of the mouthrinse . RESULTS In both groups , after 4 weeks , the mean sulcular bleeding index , approximal plaque index , and gingival index scores had decreased significantly . The discoloration index had increased significantly in both groups . There were no statistically significant differences between the two mouthrinses in any of these measurements . There were no significant differences in side effects reported by the two groups . CONCLUSION The increase in concentration of chlorhexidine provided no clinical advantages or disadvantages OBJECTIVES The aim of this clinical , controlled double-blind trial was to evaluate the effectiveness and side effects of two different mouthrinses . METHOD AND MATERIAL S Ninety subjects with gingivitis ( or slight periodontitis ) were r and omly allocated to three groups : group 1 , Chlorhexamed ( 0.1 % chlorhexidine ) ; group 2 , Hexoral ( 0.1 % hexetidine ) ; and group 3 , a placebo-control compound . The subjects were instructed on how to use the mouthrinse . At baseline , as well as after 2 and 4 weeks , the Approximal Plaque Index ( API ) , the Bleeding Index ( BI ) , the Community Periodontal Index of Treatment Needs , the Gingival Index ( GI ) , and the Discoloration Index ( DI ) , were measured . Statistical analysis was carried out with the Kruskal-Wallis test , Fisher 's exact test , and Wilcoxon test . RESULTS In group 1 , the mean API improved significantly ( P < or = .001 ) after 4 weeks . The mean BI was reduced significantly , as was the GI . In group 2 , the mean API and the mean BI both decreased significantly , and a statistically significant reduction of the GI was also seen . In group 3 , significant improvements of the mean values of all parameters were documented after 4 weeks . When comparing group 3 with groups 1 and 2 , the difference in the reduction of the API was statistically significant ( P < .002 ) . No statistical difference could be shown when comparing groups 1 and 2 . Regarding the improved results of the BI and the GI , no statistically significant difference was found in the effectiveness of all 3 compounds . All 3 groups showed some increase in the mean DI after 4 weeks . Comparing groups 1 and 2 directly , the difference in the increase in the discoloration of the teeth was statistically significant ( P = .0035 ) . There was no statistical difference in the mean discoloration scores comparing groups 2 and 3 . CONCLUSION This double-blind clinical trial demonstrated Hexoral to be a useful alternative to Chlorhexamed mouthrinse , as well as one causing less discoloration OBJECTIVES An experimental gingivitis model was used to analyse the influence of alcohol in mouthwashes containing 0.15 % triclosan and zinc chloride on the formation of supragingival plaque , the development of gingivitis and the appearance of adverse events . MATERIAL AND METHODS Using a double-blind crossover design , 30 subjects underwent two consecutive experimental phases with two 0.15 % triclosan and zinc chloride mouthwashes , differentiated mainly by their excipient ( hydroalcoholic or aqueous ) . In each phase , the subjects discontinued all oral hygiene measures and were treated solely with the r and omly assigned experimental mouthwash for 21 days . Each experimental phase was preceded by a 14-day washout period in which , after receiving a complete oral prophylaxis , the subjects were instructed to perform thorough oral hygiene procedures . Gingivitis and plaque levels were assessed at the start and end of both the experimental phases . RESULTS The evolution of the gingivitis and plaque indices showed no statistically significant differences between both treatments . The mean gingival index increased from 0.30 to 0.38 with the non-alcoholic mouthwash and from 0.32 to 0.42 with the hydroalcoholic mouthwash . The respective changes in plaque index were from 0.88 to 1.93 and from 0.94 to 1.92 . The hydroalcoholic mouthwash produced a larger number of fresh symptoms ( p=0.033 ) , oral itching being the most reported . CONCLUSIONS Alcohol does not influence the effectiveness of a 0.15 % triclosan and zinc chloride mouthwash against gingivitis development and supragingival plaque formation . The absence of alcohol significantly decreases the incidence of adverse events produced by the mouthwash OBJECTIVE To evaluate the effectiveness of 0.07 % cetylpyridinium chloride ( CPC ) mouth rinse for reduction of gingival inflammation and inhibition of plaque compared to a vehicle control ( VC ) mouth rinse over a 6-month period . MATERIAL S & METHODS Participants ( n = 62 ) used their r and omly assigned product as adjunct to toothbrushing . Bleeding , plaque and staining scores were assessed at baseline , 3 and 6 months . Plaque and saliva sample s were taken at each assessment monitoring possible shifts in the composition of the microbiota . RESULTS A significant difference ( P = 0.002 ) in favour of the CPC mouth rinse , with respect to plaque scores , was found . Bleeding scores at 6 months were not significantly different ( P = 0.089 ) . However , when correcting for baseline values , a tendency towards a significant difference in bleeding scores at end trail was observed in favour of the CPC mouth rinse ( P = 0.061 ) . Regarding staining at 3 and 6 months , a small but significant difference ( 8.6 % and 10.4 % , respectively ) ( P < 0.0001 ) was observed with lower scores for the VC group . There was a significant reduction in total anaerobic count in the CPC group at 6 months ( P < 0.05 ) . The ratio of aerobes/anaerobes was markedly increased at 3 months , especially in the CPC group . No further differences were observed between groups at 6 months . CONCLUSIONS The use of 0.07 % CPC mouth rinse was significantly more effective in reducing plaque scores than the vehicle control . Bleeding scores were not different at 6 months . The test product was well accepted and did not cause any serious clinical side effects or negatively affected the microbiota Background Due to increasing resistance to antibiotics and rising incidence of oral diseases , there is a need for alternative treatment modalities to combat oral diseases . The aim of the present study was to access the effect of Aloe vera mouthwash on the dental plaque in the experimental period of 4 days and to compare it with the bench mark control chlorhexidine and placebo ( saline water ) . Material and Methods A total of 300 systemically healthy subjects were r and omly allocated into 3 groups : Aloe vera mouthwash group ( n=100 ) , control group (=100)-chlorhexidene group and saline water-Placebo ( n=100 ) . To begin with , Gingival index ( GI ) and plaque index ( PI ) were recorded . Then , baseline plaque scores were brought to zero by professionally cleaning the teeth with scaling and polishing . After r and omization of the participants into three groups they were refrained from regular mechanical oral hygiene measures . Subjects were asked to swish with respective mouthwash ( Aloe vera mouthwash , 0.2%chlorhexidine gluconate mouthwash , or normal saline ) as per therapeutic dose for 4 days . Results The results showed that Aloe vera mouthrinse is equally effective in reducing plaque as Chlorhexidine compared to placebo over a period of 4 days . There was a significant reduction on plaque in Aloe vera and chlorhexidine groups and no statistically significant difference was observed among them ( p>0.05 ) . Aloe vera mouthwash showed no side effects . Conclusion The results of the present study indicated that Aloe vera may prove an effective mouthwash due to its ability in reducing dental plaque The aim of the present study was to compare the effect on plaque growth and gingival response of Meridol ® , an amine/stannous fluoride solution , during a three-month investigation , with those of a placebo preparation as a negative control and a chlorhexidine solution as a positive control , in a double-blind study . After having their teeth professionally cleaned , 36 volunteers continued their usual oral hygiene for a period of two weeks . Their teeth were then polished again ( month 0 ) after which they rinsed twice daily ( morning and evening ) with one of the three mouthrinses in addition to their habitual toothcleaning . After three months of rinsing , plaque indices remained lowest in the chlorhexidine group , although the subjects using Meridol ® had indices significantly lower than those of individuals rinsing with the placebo solution . The gingival index scores in the Meridol ® group were higher than in the chlorhexidine group and lower than in the placebo group . The plaque vitality scores showed a bactericidal effect in vivo with chlorhexidine and Meridol ® during the entire experiment . The use of Meridol ® result ed in more toothstaining than with the placebo , but significantly less than with chlorhexidine . This study demonstrated that Meridol ® reduced plaque accumulation , retarded gingivitis development , possessed a definite bactericidal action , and produced only slight toothstaining AIM The effect of Ocimum gratissimum ( Og ) on the reduction of dental plaque and gingivitis was evaluated in a r and omized , parallel and double-blind clinical trial . MATERIAL S AND METHODS Subjects were r and omly allocated to the control group (n=10)-mouth rinse with no antiseptic agents ; CLX group (n=10)-mouth rinse containing chlorhexidine digluconate or Og group (n=10)-mouth rinse containing Ocimum gratissimum . Plaque ( PLI ) and bleeding ( BI ) indexes were assessed at days 0 and after 3 months . Subjects were asked to brush their teeth with a fluori date d dentifrice , three times a day , during a 90-day period . After each brushing they rinsed with one of the three mouth rinses during 1 minute . RESULTS There was a significant reduction on plaque and gingivitis in tests groups ( p < 0.05 ) , but no statistically significant difference was observed among them ( p > 0.05 ) . CONCLUSION Mouth rinse containing Og was effective as antiplaque and antigingivitis agent , in a similar manner that chlorhexidine digluconate . CLINICAL SIGNIFICANCE Research in treatment of chronic oral diseases using natural agents must be encouraged to verify which would be a useful addition to the current range of chemotherapeutic treatment options AIM To assess the efficacy of a 0.07 % cetylpyridinium chloride ( CPC ) mouth rinse in the control of plaque and gingival inflammation during a 6-month period . MATERIAL AND METHODS Adult subjects with moderate gingivitis were selected [ ≥40 % bleeding on marginal probing ( BOMP ) ] . After retrieving microbiological sample s and evaluating the clinical parameters ( plaque , BOMP and stain indexes ) , a professional prophylaxis was performed and subjects were r and omly assigned to the test ( CPC mouth rinse ) or to the placebo group . Subjects were re-assessed after 3 and 6 months . RESULTS A total of 67 patients ( 35 test , 32 placebo ) were included in the analysis . At 6 months , intra-group significant plaque reductions were observed in the test group ( 0.691 , p < 0.001 ) , but not in the placebo ( 0.181 , p = 0.653 ) . At 6 months , the mean BOMP values were lower in the test group ( p = 0.052 ) . Changes between baseline and 6 months were significantly higher in the test group both for plaque ( p = 0.002 ) and BOMP ( p = 0.037 ) when compared with the placebo . A microbiological impact was observed in the test group , especially for Prevotella intermedia . CONCLUSION The evaluated 0.07 % CPC-based mouth rinse , used three times per day adjunctively to mechanical tooth cleaning , prevents plaque accumulation and gingival inflammation , as compared to the placebo , for at least 6 months OBJECTIVE The objective of this r and omized , examiner-blind , parallel , controlled clinical study was to compare the antiplaque/antigingivitis efficacy of an essential oil-containing mouthrinse ( EO ) to a new 0.075 % cetylpyridinium chloride mouthrinse ( CPC ) using a two-week experimental gingivitis model with a 5 % hydroalcohol rinse serving as the negative control . METHODS After signing informed consents and completing baseline examinations , 185 subjects were r and omized into three groups . Subjects began supervised/recorded rinsing with 20 ml of their assigned rinse for 30 seconds twice daily for two weeks , with no mechanical oral hygiene permitted . Baseline and two-week assessment s were conducted as follows : Turesky Modification of the Quigley-Hein Plaque Index ( PI ) , Modified Gingival Index ( MGI ) , and the Gingival Bleeding Index ( BI ) . Analysis of efficacy variables ( i.e. , mean PI , mean MGI , mean BI , and proportion of bleeding sites derived from the BI ) was performed using a one-way analysis of covariance ( ANCOVA ) . RESULTS Among the 182 subjects who completed the study , the EO rinse showed statistically significant reductions compared to the negative control within the range previously reported in this model ; PI = 36.5 % ( p < 0.001 ) and MGI = 17.5 % ( p < 0.001 ) . A 43.2 % reduction in proportion of bleeding sites ( p < 0.001 ) was demonstrated . Mean PI , MGI , and proportion of bleeding sites at two weeks were statistically significantly lower for the EO rinse compared to the CPC rinse ( p < 0.001 ) , showing 27.7 % , 11.9 % , and 30.0 % reductions , respectively . CONCLUSION An EO rinse provided superior antigingivitis/antiplaque efficacy compared to a 0.075 % CPC rinse in this short-term clinical trial , and demonstrated efficacy within the range shown in previous studies using this model A double blind , r and omized , controlled study with three parallel treatment groups was done to evaluate the efficacy of a Terminalia chebula 10 % mouth rinse compared with chlorhexidine 0.12 % mouth rinse , applied two times daily for 2 weeks , in the treatment of dental plaque and gingivitis . Seventy-eight patients were included in the study . The efficacy variables were periodontal indices on days 0 , 7 and 14 after commencement of therapy . Twenty six patients received chlorhexidine mouth rinse , twenty six Terminalia chebula mouth rinse and twenty six received saline solution . The clinical parameters were significantly reduced by both chlorhexidine and Terminalia chebula mouth rinse although no significant difference was seen between the two groups ( P > 0.05 ) . This study demonstrated that Terminalia chebula mouth rinse is effective in reducing microbial plaque , gingival inflammation and neutralizing salivary The purpose of this 4-day plaque regrowth study was to assess the effect of N-chlorotaurine ( NCT ) mouth rinses on plaque inhibition and plaque vitality . Eighty volunteers participated in this investigator-blind , r and omized , clinical controlled study in parallel groups . No oral hygiene was permitted except rinsing with a 2 % or 3 % NCT mouth rinse , a positive or a negative control . Primary parameters were the plaque index ( Silness and Löe , Acta Odontol Sc and , 22:121–135 , 1964 ) and plaque vitality ( Netuschil et al. , J Clin Periodontol , 16:484–488 , 1989 ) after the final rinse . In addition , another plaque index ( Turesky et al. , J Periodontol , 41:41–43 , 1970 ) , plaque area , and bleeding on probing were recorded . All parameters were taken at baseline and day 5 . U test was applied on a 5 % error level . No differences in plaque inhibition were found between the two NCT formulations and the negative control . However , a statistically significant reduction of plaque vitality compared to the negative and positive control was observed . Discoloration of the tongue and unpleasant taste were recorded in participants in the NCT groups . NCT mouth rinses did not inhibit plaque regrowth , but they did reduce the vitality of plaque bacteria . Methods of prolonging the substantivity of the NCT mouth rinses should be investigated to enhance the antibacterial properties of these formulations PURPOSE This 6-month , examiner-blind , single center , r and omized , parallel group , controlled clinical trial compared the antiplaque/antigingivitis effects of an alcohol-free EO mouthrinse ( LISTERINE Zero ) to a negative control ( 5 % flavored , colored hydroalcohol ) and to an alcohol-free CPC-containing mouthrinse ( Colgate Plax ) . METHODS 337 gingivitis subjects were clinical ly examined to determine Modified Gingival Index ( MGI ) and Plaque Index ( PI ) at baseline , 3 and 6 months . The primary efficacy variables were mean MGI and mean PI at 6 months ( statistically analyzed by ANCOVA ) . After professional dental prophylaxis , subjects were r and omly assigned to 6-month twice daily unsupervised use of alcohol-free EO , alcohol-free CPC or a negative control rinse , in conjunction with normal brushing and flossing . Safety was monitored throughout the study . RESULTS 311 subjects completed the study . After 6 months of use , EO significantly reduced plaque ( 31.6 % ) and gingivitis ( 24.0 % ) compared to negative control . At 6 months , CPC also significantly reduced plaque ( 6.4 % ) and gingivitis ( 4.4 % ) compared to negative control . EO provided a 26.9 % decrease in plaque and a 20.5 % decrease in gingivitis compared to CPC ( P < 0.001 ) . All rinses were well tolerated . The alcohol-free EO mouthrinse demonstrated superior efficacy in reducing plaque and gingivitis over 6 months compared to both negative control and alcohol-free CPC mouthrinse OBJECTIVES AND METHODS A double-blind , r and omized , 6-month clinical trial with parallel group design in 162 patients with gingivitis divided into three rinsing groups was conducted in order to study the efficacy and safety of a flavoured solution of delmopinol hydrochloride 2 mg ml-1 ( 0.2 % w/v , Decapinol Mouthwash ) used for supervised mouthrinsing in one rinsing group , in comparison with chlorhexidine digluconate 2 mg ml-1 ( 0.2 % w/v , Hibitane Dental ) in a second rinsing group , and placebo in the third group . The criteria of the Plaque Index ( PI ) were used to assess plaque formation . Bleeding on probing ( BOP ) to the bottom of the pocket with a st and ard pressure was used as the primary gingivitis assessment . The occurrence of supragingival dental calculus and extrinsic tooth staining were also assessed . In addition , patients were asked to report adverse events at each visit . RESULTS Delmopinol and chlorhexidine exhibited lower scores of the mean PI and the BOP percentage than placebo , both at the 3-month and 6-month examinations . Furthermore , both active solutions showed a higher extent of staining of the teeth than placebo during these two observation periods . Rinsing with chlorhexidine result ed in more dental calculus than placebo after 6 months . Chlorhexidine showed lower scores for plaque formation and gingivitis development but higher scores of supragingival dental calculus ( after 6 months ) and tooth staining than did delmopinol . Both active solutions were reported by the patients --approximately to the same extent but more frequently than placebo -- to induce taste alterations and a transient anaesthetic sensation of the oral mucosa . However , subjective staining of the teeth and tongue was reported by 16 % of the delmopinol patients , but by 86 % of the patients rinsing with chlorhexidine for 6 months . Furthermore , 24 % of the patients in the chlorhexidine group , 9 % in the delmopinol group and 4 % in the placebo group wished to withdraw from treatment . CONCLUSIONS The results from this clinical trial indicate that supervised rinsing with 0.2 % delmopinol hydrochloride or with 0.2 % chlorhexidine digluconate twice daily for 60 s as a supplement to normal mechanical oral hygiene procedures result ed in less plaque formation and gingivitis than rinsing with placebo . Although chlorhexidine was more effective than delmopinol regarding plaque formation and gingivitis , it was considered by the patients as less tolerable The adjunctive use of antiplaque mouthrinses with normal oral hygiene procedures may produce a significant beneficial effect on gingival health . At present , numerous products are available with various cl aims for efficacy . Although for many of these products , well-controlled studies have been carried out comparing the products , against a negative control or placebo , very few studies have been carried out directly comparing the efficacy of one commercial product with another . In this observer-blind , 4-day plaque regrowth , crossover study , the efficacy of a commercial triclosan mouthrinse was compared to that of an essential oil mouthrinse and 2 placebo controls . Starting from zero plaque at the commencement of each trial period , 32 volunteers used only the allocated rinses as the method of oral hygiene over 4 days , and on the 5th day returned for measurement of plaque index and area . The essential oil rinse produced a plaque reduction of 52 % for plaque area and 17 % for plaque index compared to its placebo , whilst the triclosan rinse produced a 45 % reduction for plaque area and 12 % reduction for plaque index against its placebo . Analysis of variance and construction of 95 % confidence intervals showed that both active rinses significantly reduced plaque compared to their respective placebo . In addition , the essential oil rinse significantly reduced plaque compared to the triclosan rinse for plaque index but not for plaque area . The findings of this study would suggest that of the 2 rinses , the essential oil rinse would be expected to be more effective at reducing plaque formation in the longer term OBJECTIVE To compare the effects of an experimental mouth rinse containing 0.07 % cetylpyridinium chloride ( CPC ) ( Crest Pro-Health ) with those provided by a commercially available mouth rinse containing essential oils ( EOs ) ( Listerine ) on dental plaque accumulation and prevention of gingivitis in an unsupervised 6-month r and omized clinical trial . MATERIAL AND METHODS This double-blind , 6-month , parallel group , positively controlled study involved 151 subjects balanced and r and omly assigned to either positive control ( EO ) or experimental ( CPC ) mouth rinse treatment groups . At baseline , subjects received a dental prophylaxis procedure and began unsupervised rinsing twice a day with 20 ml of their assigned mouthwash for 30 s after brushing their teeth for 1 min . Subjects were assessed for gingivitis and gingival bleeding by the Gingival index ( GI ) of Löe & Silness ( 1963 ) and plaque by the Silness & Löe ( 1964 ) Plaque index at baseline and after 3 and 6 months of rinsing . At 3 and 6 months , oral soft tissue health was assessed . Microbiological sample s were also taken for community profiling by the DNA checkerboard method . RESULTS Results show that after 3 and 6 months of rinsing , there were no significant differences ( p=0.05 ) between the experimental ( CPC ) and the positive control mouth rinse treatment groups for overall gingivitis status , gingival bleeding , and plaque accumulation . At 6 months , the covariant ( baseline ) adjusted mean GI and bleeding sites percentages for the CPC and the EO rinses were 0.52 and 0.53 and 8.7 and 9.3 , respectively . Both mouth rinses were well tolerated by the subjects . Microbiological community profiles were similar for the two treatment groups . Statistically , a significant greater reduction in bleeding sites was observed for the CPC rinse versus the EO rinse . CONCLUSION The essential findings of this study indicated that there was no statistically significant difference in the anti-plaque and anti-gingivitis benefits between the experimental CPC mouth rinse and the positive control EO mouth rinse over a 6-month period Home-use studies on dentine hypersensitivity have most commonly involved toothpastes and rarely have mouthrinses been employed . Potassium and /or fluoride toothpastes have been shown effective in the treatment of dentine hypersensitivity . The aim of this study was to evaluate the effectiveness of a total formulation , containing potassium citrate , sodium fluoride , cetylpyridinium chloride mouthrinse compared to the base rinse minus actives in the reduction of dentine hypersensitivity . The study was a r and omised placebo controlled , double blind parallel design . At a screening visit , 90 adult subjects were recruited who were suffering from dentine hypersensitivity from at least 1 tooth responding to tactile stimulation ( 45gm pressure ) and had at least 2 teeth responding to evaporative stimulation ( air blast ) . During a washout period of 28 days and throughout the 56-day study period , subjects used a soft filament toothbrush and st and ard fluoride toothpaste . At baseline ( day 1 ) , threshold sensitivities to incremental tactile ( 10 g to 70 g ) and evaporative stimuli were determined . Gingival health was assessed by recording bleeding on probing at 25 g pressure at mesiobuccal and lingual sites . Plaque scores from buccal and lingual surfaces of disclosed teeth were also measured . Subjects then used the prescribed rinse , 10 ml for at least 30 s after brushing 2x per day returning on days 28 and 56 for rescoring of sensitivity , gingivitis and plaque . Data from 88 subjects were used with the intent to treat analyses and 83 in the completely evaluable analyses . Groups were well balanced for demographic data and product returns suggested good compliance . Both groups showed highly significant improvements in tooth sensitivity . The pattern was for greater improvement in the test compared to the control group ( statistically significant for the plaque score ) , whereas bleeding scores , already low , showed no change in either group . By definition , the placebo rinse could not have exerted any therapeutic action ; the study therefore provides clear direct evidence as to the magnitude ( 30%-40 % ) of the little studied , but assumed , placebo response in dentine hypersensitivity trials The purpose of the study was to compare the efficacy of four mouthrinses in clinical outcomes of changes in oral malodor measurements in a 4-week , r and omized , double-blind , longitudinal clinical trial in adults . The four rinses were coded as Products 1 , 2 , 3 , and 4 so that neither the examiners nor subjects had the knowledge of treatment . Of the four mouthrinses , two were commercially available mouthrinses with essential oils ( EO ) or chlorine dioxide plus zinc ( CD/Zn ) as active ingredients ( Products 1 and 4 ) , one mouthrinse was a formulation containing cetylpyridinium chloride ( Product 2 ) , and one was a placebo ( Product 3 ) . A total of 99 subjects who met the study criteria were assigned r and omly to one of the four groups . At three separate visits ( 0 , 2 , and 4 weeks ) , subjects received an examination of the oral soft tissues and were assessed for baseline oral malodor by two organoleptic judges and a laboratory instrument that measures oral malodor . Subjects were instructed to use the assigned rinse , and the measurements were performed again after 2 and 4 hours . Throughout the 4-week study period , each subject was asked to use the assigned rinse twice daily per the manufacturer 's recommended directions . The results showed that the four mouthrinses reduced oral malodor within 4 hours after a single usage , with Product 2 being the most effective and the placebo being the least effective . Daily use of EO , CD/Zn , and placebo rinses for up to 4 weeks did not reduce oral malodor from week 0 baseline values , and the effects on oral malodor were comparable among these three mouthrinses . Product 2 was the only mouthrinse that reduced oral malodor from baseline values after 2 and 4 weeks of daily use Previous reports have indicated that certain mouthrinses , even when used as directed can induce oral pain . In order to help determine the causal agent(s ) , various commercially available mouthrinses , as well as control solutions , were tested in a psychophysical study in which subjects rated categories of pain during and after mouthrinsing . More specifically , the studies tested the effects of ethanol concentration on induced pain . The results show that there is a direct relationship between ethanol content and the amount of induced pain . Furthermore , the amount of pain was found to increase with time of rinsing , and to slowly decrease after cessation of rinsing . Lastly , comparison of ethanol/water controls with a marketed product ( Clear Choice ) matched for ethanol content showed that , while ethanol was the key factor in mouthwash-induced oral pain , other presently unidentified agents can also add to the effect BACKGROUND The efficacy of an essential oil-containing antiseptic mouthrinse ( Listerine Antiseptic , Pfizer ) and an antiplaque/antigingivitis dentifrice ( Colgate Total , Colgate-Palmolive ) has been demonstrated in numerous double-blind clinical studies . This study was conducted to determine their comparative efficacy . METHODS Three hundred sixteen subjects with mild-to-moderate gingival inflammation and plaque received a dental prophylaxis and began their r and omly assigned brushing and rinsing regimen in an unsupervised setting . Subjects brushed for one minute and rinsed with 20 milliliters for 30 seconds twice daily for six months . The three groups were L ( control toothpaste/Listerine rinse ) , T ( Colgate Total toothpaste/control rinse ) and P ( control toothpaste/control rinse ) . RESULTS Subjects in the L and T groups demonstrated statistically significantly lower ( P < .001 ) Modified Gingival Index , or MGI ; Bleeding Index , or BI ; and Plaque Index , or PI , at both three and six months than subjects in the P group . The magnitude of reduction for the L group was 22.9 percent , 70 percent and 56.1 percent , respectively , and for the T group , 20.8 percent , 58 percent and 22.1 percent , respectively . Subjects in the L group were not different from subjects in the T group in regard to visual signs of gingivitis ( MGI ) , but were more effective ( P < .001 ) than subjects in the T group in experiencing reduced BI and PI . No product-related adverse events were reported . CONCLUSION Although the Listerine Antiseptic and Colgate Total antiplaque/antigingivitis products produced similar , clinical ly significant reductions in gingivitis ( as measured by MGI and BI ) , Listerine , when used in conjunction with a fluoride dentifrice and usual oral hygiene , provided a greater benefit in reducing plaque . CLINICAL IMPLICATION S When considering an antiplaque/antigingivitis product to recommend to patients , clinicians should consider Listerine Antiseptic , in conjunction with usual oral hygiene , if more rigorous plaque control is desired BACKGROUND Postsurgical mouthwashes are routinely used in clinical studies and also in daily clinical practice . Chlorhexidine gluconate ( CHX ) has long been the gold st and ard for supra-gingival chemical plaque control regimens . Amine fluoride/stannous fluoride ( AmF/SnF2 ) formulations have also been extensively studied and shown to have an antibacterial effect and be useful as antiplaque agents . The antibacterial effect of AmF/SnF2 and its minimal extrinsic tooth staining make it a possible alternative to CHX as an adjunct to periodontal surgical therapy . The aim of this double-blind , controlled clinical trial was to evaluate and compare the combined effect of an AmF/SnF2 or a CHX mouthwash and surgical periodontal therapy on periodontal parameters . METHODS Thirty-two patients with at least 3 pockets > or = 5 mm in the same quadrant were selected for this study , following a hygienic phase of therapy . They were r and omized into 2 treatment groups : surgical flap debridement and a postsurgical CHX mouthwash or surgical flap debridement and an AmF/SnF2 postsurgical mouthwash , performed twice daily for 3 weeks . Clinical measurements were taken at baseline and 3 and 12 weeks postsurgery . RESULTS Both treatment modalities result ed in significant improvements in probing depth and clinical attachment level . There was no significant difference between groups in any of the recorded parameters . Staining index at week 3 in the CHX group was significantly higher than in the AmF/SnF2 group ( P<0.05 ) . However these differences leveled down at 12 weeks . CONCLUSIONS Our results support the alternative use of an AmF/SnF2 mouthwash in plaque control management of patients following flap debridement surgery Oral mucosal effects of hydrogen peroxide mouth rinses were investigated in normal volunteers . Following a 2-week control period , 35 subjects were r and omly assigned to rinse with either normal saline , 1/4-strength hydrogen peroxide ( 0.75 % ) , or 1/2-strength hydrogen peroxide ( 1.5 % ) , 4 times daily for 2 weeks . Mucosal status , buccal microbial adherence , salivary flow rate ( SFR ) , and subjective reactions were assessed weekly . In the normal saline group , no significant changes were noted in any of the observed parameters and subjective reports were unremarkable . In both hydrogen peroxide groups , significant mucosal abnormalities were observed ( p < 0.001 ) and subjective complaints were numerous . Bacterial adherence was significantly reduced in the 1/4 hydrogen peroxide group but not in the 1/2 hydrogen peroxide group . Despite reports of dry mouth , SFRs were not altered significantly . Since hydrogen peroxide rinses are associated with mucosal abnormalities and elicit overwhelmingly negative subjective reactions in normal individuals , they are not recommended for oral care A double-blind , r and omized , 2-wk experimental gingivitis clinical trial with cross-over design in 14 dental students was conducted in order to study the efficacy and safety of delmopinol hydrochloride solution ( 2 mg/ml ) , used with no other oral hygiene procedures , in comparison with placebo . Plaque formation was measured by the Quigley & Hein Plaque Index and gingivitis was assessed by bleeding on probing according to Mühlemann & Son . Rinsing with delmopinol result ed in lower plaque scores compared to placebo . The development of gingivitis was weak during the 2-wk test periods , and thus no conclusive results were obtained . As in previous studies , the most frequent adverse event when rinsing with delmopinol was a transient anaesthetic sensation in the oral mucosa . The results showed that rinsing with delmopinol hydrochloride solution ( 2 mg/ml ) for 60 s twice daily with no other oral hygiene procedures led to less plaque formation than rinsing with placebo . This study also showed good tolerance and acceptability of mouthrinsing with delmopinol OBJECTIVE To investigate the clinical effect of a 0.1 % cetylpyridinium chloride(CPC ) rinse on the treatment of gingivitis and periodontitis . METHODS A multicenter , r and omized , parallel group trial was conducted . The eligible patients were divided r and omly into two groups . Subjects were assessed at the beginning and the end of a two-week period during which they rinsed with 0.1 % CPC or complex hibitane in addition to their usual oral hygiene procedures . The variation of PLI , SBI , GI , PD , pain , halitosis and adverse effects were observed before and after investigation . RESULTS After 14 days of treatment , in the CPC group , the decreasing rate of PLI was 63.0 % , the effective rate for gingivitis and periodontitis were 83.3 % , 36.7 % respectively , while those periodontal indices of control group were 49.5 % , 50 % and 16.7 % . After statistical analysis , the CPC group had significantly higher effective rates on gingivitis than the hibitane group ( P < 0.01 ) , at the same time , the effective rate was significantly different between two groups on periodontitis ( P < 0.05 ) . CONCLUSION The use of 0.1 % CPC rinse is effective in treating periodontal diseases OBJECTIVES The objective of the present r and omized controlled trial was to evaluate the efficacy of a mouthrinse containing a combination of AmF/SnF2 in controlling supragingival plaque accumulation and gingival inflammation during a 12-week period in patients affected by generalized aggressive periodontitis ( GAP ) . METHODS Eighteen subjects , six males and 12 females , mean age : 32.2 years , were evaluated . One-half of the patients was either prescribed an AmF/SnF2-containing mouthrinse ( test mouthrinse ) or a control mouthrinse in addition to mechanical plaque control for 12 weeks . After a 2-week wash-out period , the patients received the alternative mouthrinse . Before and after treatment plaque index ( PlI ) , gingival index ( GI ) , angulated bleeding index ( AngBI ) , tooth stain ( GMSI ) , and tongue stain were recorded . RESULTS Test mouthrinse result ed in a statistically significant decrease in PlI ( p = 0.029 ) and GI ( p = 0.017 ) . After treatment , PlI was significantly lower in test compared to control mouthrinse ( p = 0.027 ) . GMSI significantly increased post-treatment for both mouthrinse regimens ( p < 0.001 ) , a significantly higher score being observed for the test compared to control mouthrinse ( p = 0.002 ) . CONCLUSIONS The 12-week use of a AmF/SnF2-containing mouthrinse as an adjunct to conventional mechanical oral hygiene procedures in GAP patients was effective in controlling the amount of supragingival plaque deposits BACKGROUND The systemic use of non-steroidal anti-inflammatory drugs are associated with various side-effects like hepatotoxicity , blood dyscrasias , nephrotoxicity and gastric irritability . Among these , gastric irritability is the most common and the most important one , which should be taken care of . Therefore , it may be preferable to use a local formulation such as a mouthwash to treat the inflammatory conditions of the oral cavity . AIM To determine the efficacy and acceptability of 0.074 % diclofenac mouthwash in relieving pain and inflammation of post-periodontal surgery patients . MATERIAL S AND METHODS The study was design ed as a double-blind , placebo-controlled clinical trial . Twenty chronic periodontitis patients who were scheduled for full-mouth periodontal flap surgery were r and omized to receive either diclofenac mouthwash or placebo to rinse with 15 ml of solution daily for a period of 7 days . Modified gingival index ( Lobene 1986 ) was used to verify gingival inflammation and visual analog scale was used to assess pain . After the baseline measurements for all the parameters were recorded , spontaneous pain and burning were evaluated daily while redness and edema were recorded on the 3 rd and 7 th day from the day of treatment . RESULTS Data obtained were analyzed statistically using paired " t " test for intragroup comparison and unpaired " t"-test for intergroup comparison . Spontaneous pain was significantly reduced by diclofenac mouthwash . Other parameters , i.e. gingival inflammation and swelling , had not shown significant reduction in scores in either group , although the reduction was higher in the test group . CONCLUSION The new 0.074 % diclofenac mouthwash is an effective and tolerable medicinal product for post-surgical symptomatic relief Abstract . Objective and design : To examine the effectiveness of chlorhexidine mouthrinse ( CHX ) in addition to daily plaque control on gingival inflammation . Methods : Fifty gingivitis patients were r and omized to CHX or placebo groups . In addition to proper plaque control , CHX group rinsed with CHX , while placebo group rinsed with placebo mouthrinse for 4 weeks . Gingival crevicular fluid ( GCF ) sample s were collected and clinical parameters including plaque index ( PI ) , papillary bleeding index ( PBI ) , calculus index and probing depth ( PD ) were recorded at baseline and repeated at 4 week . GCF IL-1α , IL-1β , IL-1Ra , and IL-8 levels were determined by ELISA . Results : Whole mouth clinical parameters were significantly improved in both groups at 4 weeks . CHX group showed greater reduction in the mean PI scores than placebo at 4 weeks ( p < 0.05 ) . GCF IL-8 levels of anterior sites significantly reduced in CHX and placebo group at 4 weeks ( p < 0.05 ) . GCF IL-1α , IL-1β , IL-1Ra levels remained unchanged at 4 weeks in both groups . GCF cytokine levels of CHX group were similar to those of placebo at 4 weeks . Conclusions : Within the limitations of this study , CHX mouthrinse as adjuncts to daily plaque control could be useful in management of plaque-associated gingivitis , although ineffective on GCF cytokine levels OBJECTIVES This study aim ed to evaluate the clinical effects of 0.05 % sodium hypochlorite mouth rinse on supragingival biofilm and gingival inflammation . METHODS The study was performed as a controlled , r and omised , investigator-blinded , parallel group trial in 40 prison inmates . Following a preparatory period to obtain a plaque- and gingivitis-free dentition , tooth-brushing was substituted for 21 days by supervised twice daily rinsing with either 15 ml of fresh solution 0.05 % sodium hypochlorite or 15 ml of distilled water . Clinical outcomes were assessed using the Quigley-Hein Plaque Index ( QHPI ) , the Löe and Silness Gingival Index ( L&SGI ) and bleeding on probing . Adverse events were evaluated by question naire , visual examination and clinical photographs . RESULTS At day 21 , the average QHPI score had increased to 3.82 in the water rinse group and 1.98 in the sodium hypochlorite rinse group . The average L&SGI score had increased to 2.1 in the water rinse group and 1.0 in the sodium hypochlorite rinse group , and the average percentage of sites that bled on probing had increased to 93.1 % in the water rinse group and 56.7 % in the sodium hypochlorite rinse group . Differences were statistically significant ( P = 0.001 ) . A brown extrinsic tooth stain along the gingival margin appeared in 100 % of participants in the sodium hypochlorite rinse group and in 35.0 % of participants in the water rinse group ( P < 0.05 ) . CONCLUSIONS An oral rinse with 0.05 % sodium hypochlorite result ed in significant reductions in supragingival biofilm accumulation and gingival inflammation . Dilute sodium hypochlorite may represent an efficacious , safe and affordable antimicrobial agent in the prevention and treatment of periodontal disease OBJECTIVE P-113 , a 12 amino acid histatin-based peptide , was evaluated in a mouthrinse formulation for safety and efficacy in a phase 2 multi-center clinical study . METHOD 294 healthy subjects abstained from oral hygiene procedures and self-administered either 0.01 % P-113 , 0.03 % P-113 or placebo mouthrinse formulations twice daily over a 4-week treatment period . During this time , the safety , anti-gingivitis , and anti-plaque effects of P-113 were evaluated . RESULTS There was a significant reduction in the change from baseline to Day 22 in bleeding on probing in the 0.01 % P-113 treatment group of the intent to treat population ( p=0.049 ) . Non-significant trends in the reduction of the other parameters were observed in this population ( p > or = 0.159 ) . A sub-group of subjects which developed significant levels of disease within the four-week timeframe of the study was identified based on baseline gingival index scores > or = 0.75 . Significant findings were observed for bleeding on probing , gingival index and plaque index within this population ( p<0.05 ) . There were no treatment-related adverse events , and there were no adverse shifts in supragingival microflora during the study . Significant amounts of the peptide were retained in the oral cavity following rinsing . CONCLUSION These data suggest that P-113 mouthrinse is safe and reduces the development of gingival bleeding , gingivitis and plaque in the human experimental gingivitis model BACKGROUND A r and omized clinical trial was performed to test the efficacy of a fluori date d hydrogen peroxide-based mouthrinse on gingivitis and tooth whitening in a two-phase study . The first phase ( 28 days ) included the experimental gingivitis phase ; the second phase ( 5 months ) was the oral hygiene phase , which included rinsing . METHODS A total of 99 subjects were included in the study and were r and omly assigned to receive either placebo or test mouthrinse . Clinical measures were chosen to reflect the gingival health and tooth whiteness in an intent-to-treat study design . Statistical analyses of clinical parameters related to gingival health and tooth color were conducted , using the method of generalized estimating equations ( GEE ) , with an exchangeable working correlation to accommo date tooth-level data . Baseline differences between the groups were adjusted . Microbial sample s taken at the beginning and at the end of the study were analyzed by DNA-DNA hybridization technique , to determine whether there was any adverse shift in supragingival flora . RESULTS Eastman bleeding index , modified gingival index , intensity of stain , and extent of stain were significantly reduced in the test group at 6 months compared to baseline ( P < 0.05 ) . In contrast , only the Eastman bleeding index was significantly reduced in the control group ( P < 0.05 ) . The reduction in the index of gingival inflammation for the test group was significantly greater than for the control group ( P = 0.004 ) . Subjects using the test rinse were also six times more likely to exhibit an improvement in tooth color after 6 months than were subjects using placebo ( P = 0.002 ) . As a result of the clinical evaluations and microbial analysis , test mouthrinse was found to be safe during a 6-month period . CONCLUSION The results of this study indicate that the fluori date d hydrogen peroxide-based mouthrinse effectively whitens teeth and significantly reduces gingivitis The aim of this study was to investigate a possible dose-response effect of delmopinol hydrochloride , on the development of plaque and on the healing of gingivitis . 64 healthy male volunteers , aged 18 - 40 years with healthy gingivae and clean teeth , participated . During a 2-week period , the participants refrained from all oral hygiene and rinsed 2x daily with a placebo solution . On day 14 of the study , they received professional toothcleaning , and were r and omly assigned to 4 groups . For the following 2 weeks , they rinsed 2x daily for 1 min with 10 ml of 0.05 % ( 15 subjects ) , 0.1 % ( 17 ) or 0.2 % ( 16 ) delmopinol , respectively . 16 subjects rinsed with 0.2 % chlorhexidine . No oral hygiene procedures were performed during the test period . On days 0 , 14 and 28 , gingival bleeding index and the presence of stainable plaque were determined . Periodic identical photographs were used for planimetric determination of buccal plaque extension . No significant difference for the reduction in gingival bleeding index was found between 0.2 % delmopinol and chlorhexidine rinsing . The mean plaque index showed its most significant reduction on lingual surfaces of both upper and lower jaws when rinsing with 0.2 % delmopinol . Mean plaque extension was reduced by 23 % for 0.05 % , 39 % for 0.1 % and 55 % for 0.2 % delmopinol . A significant dose-response effect for 0.05 % , 0.1 % and 0.2 % delmopinol was found for gingival bleeding index , plaque index and plaque extension . The results show that delmopinol favors the healing of gingivitis and reduces plaque formation The purpose of this 3-week , double-blind study was to determine the effect of a stannous fluoride-containing mouthrinse on existing and developing dental plaque . A total of 55 subjects ( mean age = 31.42 yrs . ) received a professional prophylaxis in r and omly assigned contralateral quadrants and were then stratified into two balanced groups based on screening plaque scores : one group ( 27 subjects ) used the placebo rinse , the second group ( 28 subjects ) used the test mouthrinse ( 0.63 % diluted to 0.1 % stannous fluoride ) . Plaque index ( PI ) and stain index ( SI ) were scored at baseline , week 1 and week 3 . Gingival inflammation ( GI ) was monitored as a measure of product irritancy potential . The PI for the stannous fluoride rinse was significantly lower than the placebo , ( p < 0.0001 ) , for both prophied and unprophied sites with an average reduction of 29 % at week 1 and 28 % at week 3 . There was no statistically significant difference between the presence or absence of prophylaxis . Plaque indexes for both stannous fluoride and placebo showed significant reduction ( p < 0.0001 ) compared to baseline in all sites . Differences in staining potential between stannous fluoride and placebo were not significant ( p > 0.05 ) at any time during the study . The stain index for both stannous fluoride and placebo showed a non-significant increase from baseline in the prophied and unprophied sites . No irritancy was noted , although a trend towards lower GI scores was observed at 3 weeks for the stannous fluoride group . ( ABSTRACT TRUNCATED AT 250 WORDS Chlorhexidine and fluoride have valuable preventive roles in dental and oral diseases . There is also evidence that in caries prevention , together , they provide additive benefits . However , combined chlorhexidine/fluoride formulations have rarely been evaluated . The aim of this study was to determine whether a 0.12 % chlorhexidine , 100 ppm F- mouthrinse provided adjunctive oral hygiene benefits compared to a minus active control rinse . The study was a r and omised double-blind parallel design involving 102 subjects of whom 99 completed the 6 week experimental period . Subjects rinsed 2x per day for 1 min with 15 ml of the allocated rinse . Normal toothbrushing procedures were maintained throughout the study . At 6 weeks , plaque and gingivitis scores were significantly lower and the incremental reduction significantly larger in the active rinse group . However , as expected , toothstaining was significantly increased with the active rinse . It is apparent that this chlorhexidine/fluoride rinse could be used in those regimens recommended for other chlorhexidine formulations . The value of the formulation in caries prevention would seem worthy of further investigation A novel mouthrinse ( IND 61,164 ) containing essential oils and extracts from four plant species ( Melaleuca alternifolia , Leptospermum scoparium , Calendula officinalis and Camellia sinensis ) were tested . This study aim ed to evaluate the safety , palatability and preliminary efficacy of the rinse . Fifteen subjects completed the Phase I safety study . Seventeen subjects completed the Phase II r and omized placebo-controlled study . Plaque was collected , gingival and plaque indices were recorded ( baseline , 6 weeks , and 12 weeks ) . The relative abundance of two periodontal pathogens ( Actinobacillus actinomycetemcomitans , Tanerella forsythensis ) was determined utilizing digoxigenin-labeled DNA probes . ANCOVA was used at the p = 0.05 level of significance . Two subjects reported a minor adverse event . One subject withdrew from the study . Several subjects objected to the taste of the test rinse but continued treatment . Differences between gingival index , plaque index or relative abundance of either bacterial species did not reach statistical significance when comparing nine placebo subjects with eight test rinse subjects . Subjects exposed to the test rinse experienced no abnormal oral lesions , altered vital signs , changes in liver , kidney , or bone marrow function . Larger scale studies would be necessary to determine the efficacy and oral health benefits of the test rinse AIM This 3-month double-blind r and omized placebo-controlled study evaluated the clinical and microbial effects of an essential oil mouth rinse used as an adjunct to mechanical plaque control by patients in supportive periodontal care . MATERIAL AND METHODS Fifty patients were r and omly allocated to an essential oil group ( Listerine ( ® ) Coolmint ; Johnson & Johnson , New Brunswick , NJ , USA ) or placebo group to rinse twice per day as an adjunct to mechanical plaque control . At baseline and after 3 months , plaque index ( PI ) , gingivitis index ( GI ) , probing pocket depth , bleeding on probing ( BoP ) and clinical attachment level were registered . Subgingival plaque sample s were collected for the detection and quantification of Aggregatibacter actinomycetemcomitans , Porphyromonas gingivalis , Tannerella forsythia , Treponema denticola , Micromonas micros , Prevotella intermedia , Fusobacterium genus and Streptococcus mutans by means of real-time PCR ( qPCR ) . Patient 's compliance , satisfaction and side effects were registered . RESULTS Twenty-three patients in the essential oil group ( mean age : 57 ) and 21 in the placebo group ( mean age : 55 ) with acceptable oral hygiene at intake ( mean PI < 1.5 on a scale of 5 ) adhered to the study protocol . Gingivitis index , PI and BoP significantly reduced over time ( P ≤ 0.029 ) ; however , between group analyses revealed no significant differences . There was no significant change over time neither in detection frequency nor load for any of the microbiota . Daily rinsing with an essential oil rinse was found safe and perceived beneficial by the patients . CONCLUSION Patients in supportive periodontal care who are fairly compliant with oral hygiene may not benefit from additional mouth rinsing using an essential oil solution Chlorhexidine and phenolic mouthrinses have attracted considerable interest as adjuncts to oral hygiene . The aim of this study was to compare two well known proprietary mouthrinse products for their effects on plaque regrowth , the development of gingivitis and the formation of toothstaining . The study was a single-blind , r and omized , placebo-controlled , triple cross-over experimental , gingivitis design . A group of 15 volunteers with a very high st and ard of oral hygiene and gingival health used each rinse for 19 days in the absence of normal toothcleaning . Each period was separated by a 21 day washout . Plaque scores were significantly different between the rinses , being lowest with chlorhexidine and highest with saline . The plaque area increased 3-fold with the phenolic rinse and 6-fold with the saline rinse compared to the chlorhexidine rinse . Similarly , gingivitis increments were lowest with chlorhexidine and highest with saline but differences between rinses did not reach significance . Staining was significantly different between rinses , primarily due to minimal staining associated with the saline rinse . Staining occurred with both the chlorhexidine and phenolic mouthrinses . It is concluded that the 0.2 % chlorhexidine rinse offers greater oral hygiene benefits than the phenolic rinse . The question of indications and duration s of use of mouthwash products should be addressed OBJECTIVE This 6-month , examiner-blind , single-center , r and omized , parallel group clinical trial compared the antiplaque and antigingivitis effects of an essential oil-containing mouthrinse with zinc chloride and sodium fluoride ( EO ) to a 0.05 % cetylpyridinium chloride-containing mouthrinse ( CPC ) also with fluoride . METHOD AND MATERIAL S Four hundred and eight gingivitis subjects were monitored for the primary outcomes of modified Gingival Index ( MGI ) and Plaque Index ( PI ) at baseline and 3 and 6 months . Subjects were r and omly assigned to 6-month twice a day unsupervised use of EO , CPC , or negative control rinse in conjunction with normal brushing and flossing . RESULTS EO was always better than CPC at 3 and 6 months considering all parameters . All benefits allowed by EO increased from 3 to 6 months . CPC was better than the negative control at 3 and 6 months with respect to whole mouth plaque , and the proportion of more severe sites ( baseline scores ≥ 3 ) in PI and MGI . At 6 months , CPC did not differ from negative control in relation to whole mouth MGI reduction , proximal MGI reduction , and percentages of sites improved over baseline in PI and MGI . CONCLUSION This new EO mouthrinse provided superior clinical benefits to CPC and demonstrated increasing plaque and gingivitis reductions over 6 months . Our findings support the regular long-term use of the EO mouthrinse and selection over a 0.05 % CPC rinse for better efficacy OBJECTIVE To assess the clinical and microbiological efficacy of a 0.05 % chlorhexidine and 0.05 % cetyl-pyridinium chloride mouth rinse in supportive periodontal care ( SPC ) in patients with inadequate plaque control . MATERIAL AND METHODS The study was a r and omized , double-blinded , placebo-controlled clinical trial in patients with moderate to severe chronic periodontitis under SPC with an inadequate plaque control ( Turesky index > 1 ) . After supragingival prophylaxis and oral hygiene reinforcement , participants rinsed twice a day for 3 months with the test or placebo solutions , in addition to conventional hygiene . Primary clinical outcome variables included plaque and gingival indices . As secondary outcomes , periodontal and microbiological variables were studied . ancova and chi(2 ) tests were used to compare the variables . RESULTS Forty-seven patients ( 22 placebo and 25 test group ) participated . After 3 months , plaque levels increased in the placebo group , while diminished in the test group ( p<0.001 ) . Similar effects were found for bleeding on probing . The other clinical parameters did not show significant differences . Microbiological variables demonstrated inter-group significant reductions in subgingival counts of Fusobacterium nucleatum and Prevotella intermedia and a decrease of the total bacterial counts in saliva . CONCLUSIONS The tested mouth rinse demonstrated efficacy in reducing plaque and gingivitis , as well as in decreasing the microbial load in saliva and gingival sulcus An open , r and omized , controlled study with two parallel treatment groups was done to evaluate the efficacy of a Lippia sidoides essential oil ( EO ) 1 % mouthrinse compared with chlorhexidine 0.12 % mouthrinse , applied two times daily for 1 week , in the treatment of dental plaque and gingivitis . Fifty-five patients were included in the study . The efficacy variables were the colony count of Streptococcus mutans from the stimulated saliva and periodontal indices on days 0 , 7 and 30 after commencement of therapy . Twenty eight patients received chlorhexidine mouthrinse ( Periogard((R ) ) ) and 27 Lippia sidoides essential oil mouthrinse ( Cepakill((R ) ) ) . The clinical and microbiological parameters were significantly reduced by both mouthrinses . No significant difference was seen between the two groups ( p > 0.05 ) . There was a significant reduction in the colony count of S. mutans in both groups ( p < 0.05 ) . Chlorhexidine treatment reduced more efficiently than L. sidoides , however , no statistical difference was seen , the efficacy of both groups was similar ( p = 0.3 ) . The results indicate that Chlorhexidine mouthrinse reduced plaque index , gingival bleeding and the number of CFU ( colonies forming units ) more efficiently than L. sidoides but did not reach statistical significance . This study demonstrated that Lippia sidoides EO mouthrinse is effective in reducing microbial plaque and gingival inflammation BACKGROUND A variety of chemical agents have been evaluated relative to their abilities to inhibit dental plaque and to improve gingival health . Chlorhexidine gluconate is the best known and most widely used member of these agents , but its long-term use is compromised by different side effects , especially extrinsic tooth and tongue staining . Another agent , sanguinarine , which is currently used in both a mouthrinse and toothpaste , leads in some cases only to a transient burning sensation and could be used on a long-term basis . The purpose of this 14-week controlled clinical trial was to assess the effectiveness of a toothpaste and oral rinse containing sanguinaria extract after scaling , root planing and a chlorhexidine regimen . METHODS Sixty patients diagnosed as having adult periodontitis received initial periodontal therapy including scaling and root planing , followed by a 2-week oral care regimen which included rinsing with 0.2 % chlorhexidine gluconate oral rinse . Upon completion of this 2-week initial therapy phase , patients were r and omly assigned to either sanguinarine toothpaste and oral rinse or to control toothpaste and oral rinse without sanguinarine . Plaque ( modified Quigley-Hein index ) and gingivitis ( gingival index ) were measured prior to periodontal therapy , at the end of the chlorhexidine phase ( 2 weeks ) , and after 8 and 14 weeks . RESULTS Sanguinarine-containing toothpaste and oral rinse significantly inhibited the redevelopment of gingivitis through the 12 weeks following the chlorhexidine phase compared to the control toothpaste and rinse . Patients in the test group had 26 % fewer bleeding sites at 8 weeks , and 32 % fewer at 14 weeks , than the control group . CONCLUSIONS Our results support the combined use of chlorhexidine mouthrinse for a short term ( 2 weeks ) followed by sanguinaria mouthrinse and toothpaste up to 3 months in order to optimize the effectiveness of chlorhexidine without side effects . Further studies on the long-term effect of this combination should be established OBJECTIVES The objective of this study was to compare the antiplaque and antigingivitis effectiveness and the side-effect profiles of an essential oil-containing mouthrinse and a chlorhexidine-containing mouthrinse . MATERIAL AND METHODS One hundred and eight qualifying subjects , aged 20 - 57 years , were r and omized into three groups : essential oil mouthrinse ( ListerineAntiseptic ) ; 0.12 % chlorhexidine mouthrinse ( Peridex ) ; or 5 % hydroalcohol negative control . At baseline , subjects received a complete oral soft tissue examination and scoring of the Loe-Silness gingival index ( GI ) , Quigley-Hein plaque index ( PI ) , Volpe-Manhold calculus index ( CI ) , and Lobene extrinsic tooth stain index ( SI ) . Following a complete dental prophylaxis , subjects started rinsing twice daily with their respective mouthrinse as an adjunct to their usual mechanical oral hygiene procedures . One of the rinses on each weekday was supervised . Subjects were reexamined at 3 and 6 months . The treatment groups were compared with respect to baseline demographic and clinical variables . The primary efficacy variables were GI and PI . Intergroup differences for all clinical variables were tested at 3 and 6 months using appropriate statistical procedures . RESULTS All of the 108 r and omized subjects were evaluable at 3 months , and 107 subjects were evaluable at 6 months . There were no statistically significant differences among the three groups at baseline , with the exception that the control group PI was significantly lower than that of the essential oil group ( p<0.05 ) and the chlorhexidine group ( p<0.001 ) , and the essential oil mouthrinse group had a significantly greater number of subjects than the control group with body region SI scores > or = 1.0 ( p=0.021 ) . At 6 months , the essential oil and chlorhexidine mouthrinses produced statistically significant ( p<0.001 ) GI reductions of 14.0 % and 18.2 % , respectively , and statistically significant ( p<0.001 ) PI reductions of 18.8 % and 21.6 % , respectively , compared with the control and were not statistically significantly different from each other with respect to plaque and gingivitis reduction . The chlorhexidine mouthrinse group had significantly more calculus and extrinsic tooth stain than either the essential oil mouthrinse group or the control group . CONCLUSION This 6-month controlled clinical study demonstrated that the essential oil mouthrinse and the chlorhexidine mouthrinse had comparable antiplaque and antigingivitis activity . Insofar as side effects associated with the chlorhexidine mouthrinse may limit patient compliance , it is suggested that each product can have a distinct role in the management of patients with periodontal diseases BACKGROUND , AIMS Polyvinyl pyrrolidone ( PVP ) was shown in vitro to reduce chlorhexidine induced , dietary staining without affecting the uptake of the antiseptic to the test substrate . The aim of these studies in vivo was to determine whether PVP affected plaque and dietary staining by a low concentration chlorhexidine rinse . METHODS The plaque and stain studies used a double blind , r and omised 6 , treatment crossover design involving healthy subjects with a high st and ard of oral hygiene and gingival health . The rinse formulations under test were : ( A ) aqueous alcohol ( placebo control ) , ( B ) 0.03 % chlorhexidine , ( C ) 0.06 % chlorhexidine , ( D ) 0.06 % chlorhexidine+1.2 % PVP , ( E ) 0.06 % chlorhexidine+5 % PVP , ( F ) 0.06 % chlorhexidine+10 % PVP . In the plaque study , on day 1 of each period , subjects were rendered plaque free and then rinsed with 15 ml of the test rinse for 60 s. No further tooth cleaning was performed and subjects returned 24 h later for plaque scoring by area . In the stain study , on day 1 of each period , the tongue and teeth of each subject were rendered stain free . Subjects then rinsed under supervision for 60 s with 15 ml of the allocated rinse 8 x a day between 09:00 h and 17:00 h for 3 days . Immediately after each rinse with the test formulation , subjects rinsed for 120 s with 15 ml of warm black tea . Subjects were requested to also drink at least 5 cups of tea or coffee per day . On day 4 , stain was scored by area and intensity from design ated teeth and dorsum of the tongue . Washout periods were at least 7 days in both studies . RESULTS Plaque areas were greatest with placebo and least with 0.06 % chlorhexidine . Plaque scores increased with increasing concentrations of PVP in the 0.06 % chlorhexidine rinse and were significantly higher than 0.06 % chlorhexidine without PVP rinse . Tooth stain areas were comparable for placebo , 0.03 % and 0.06 % chlorhexidine rinses , but significantly reduced with the PVP/chlorhexidine rinses compared to the 0.06 % chlorhexidine rinse . Tooth stain intensity was significantly increased with 0.06 % chlorhexidine rinses compared to placebo and chlorhexidine/PVP rinses . Tongue stain area and intensity were significantly reduced with 5 % and 10 % PVP/chlorhexidine rinses compared to 0.06 % chlorhexidine rinse . CONCLUSION PVP , at the concentrations tested , reduced the stain propensity of a 0.06 % chlorhexidine rinse but at the expense of some loss of plaque inhibition BACKGROUND Gingivitis is a chronic inflammatory condition , result ing from gingival bacteria and bacterial byproducts . Antiplaque oral rinses reduce inflammation by removing or inhibiting plaque formation . The purpose of this pilot study was to examine the anti-inflammatory effects of HM-302 , a mouth rinse based on natural products , on gingival inflammation . METHODS A prospect i ve , double-blinded , r and omized parallel-group controlled trial involving 62 patients was conducted to assess efficacy and safety . During a 2-week period with no dental hygiene , subjects were r and omized to receive either the study rinse ( HM-302 ) ; a cetylpyridinium chloride ( CPC ) rinse ; an essential oils ( EO ) rinse ; or a water-only preparation . The gingival index ( GI ) , plaque index ( PI ) , and number of bleeding sites were measured at baseline and at the end of the study period . RESULTS Progression of gingival inflammation result ing from lack of dental hygiene was lowest in patients treated with the HM-302 rinse , and was significantly less marked than in patients treated with the water-only preparation . When compared to the CPC and EO treatments , HM-302 was the only mouth rinse that was significantlybetter than the control , with respect to both the change in absolute GI scores ( p = .006 ) and to the percent increase in GI scores ( p = .012 ) . No serious adverse effects were noted in any of the study groups . CONCLUSION HM-302 is a safe and effective treatment for preventing the development of gingival inflammation in an experimental gingivitis model . Further research is needed to evaluate its long-term effects BACKGROUND Studies with cetylpyridinium chloride ( CPC ) mouth rinses that range from 1 use to 6 months of use have documented the clinical efficacy of these formulations on supragingival plaque and gingivitis . OBJECTIVE The objective of the present study was to compare the effects of a commercially available mouth rinse containing 0.05 % CPC versus a fluoride mouth rinse on the anaerobic bacteria found in dental plaque . Antimicrobial effects on the organisms of the supragingival plaque , a natural biofilm , were determined after 1 use and after 14 days of use of each mouth rinse . METHODS After enrollment , adult subjects from China completed a 1-week washout period and provided baseline sample s of supragingival plaque for analysis of anaerobic bacteria . Subjects were r and omly assigned to receive a commercially available mouth rinse formulated with 0.05 % CPC or a fluoride mouth rinse . Subjects were assigned to each group according to a computer-generated r and omization sequence . They were instructed to rinse with 20 mL of either the CPC or the fluoride mouth rinse for 30 seconds . Microbiologic analyses of dental plaque sample s were conducted 12 hours after the first use of assigned mouth rinse . Subjects were instructed to continue twice-daily rinsing with their assigned mouth rinse for the next 14 days in addition to brushing their teeth with a commercial fluoride toothpaste . Dental plaque sample s for microbiologic analyses were collected on day 15 ; this was done 12 hours after the final use of the assigned mouth rinses . A dentist conducted oral examinations before each sample collection to evaluate hard and soft tissue health over the course of the study . RESULTS The study included 117 adults ( 62 females , mean age , 28.70 years ; 55 males , mean age , 30.41 years ) . Subjects rinsing with the CPC mouthwash ( n = 58 ; mean age , 29.41 years ) reported significant reductions in anaerobic bacteria versus those issued the fluoride rinse ( n = 59 ; mean age , 29.61 years ) 12 hours after 1 use and 12 hours after 14 days of use ( P < 0.001 ) . The mean percent reduction in anaerobic bacteria between the CPC mouth rinse and the fluoride mouth rinse was 29.98 % after 1 use and 57.90 % after 14 days of use . All enrolled subjects completed the study without any adverse events . CONCLUSION Use of the CPC mouth rinse was associated with significant reductions in the anaerobic bacteria of supragingival plaque compared with fluoride mouth rinse use in these adult subjects Delmopinol is a morpholinoethanol derivative which , in mouthrinses used in the absence of normal oral hygiene , has been shown effective in the inhibition of plaque and gingivitis . The aim of this study was to determine the adjunctive oral hygiene benefits and safety of delmopinol rinses when used alongside normal toothcleaning . This 6-month home use study was a placebo-controlled , double-blind , r and omised parallel design evaluating 0.1 % and 0.2 % delmopinol rinses and structured to conform with the ADA Council of Dental Therapeutics guidelines . A total of 450 dentate male and female subjects were recruited who had no relevant medical or pharmacotherapy histories determined from a full medical examination , including haematological and biochemical tests . Subjects had moderate levels of plaque and gingivitis . At baseline , 3 and 6 months subjects were scored for plaque , gingivitis , tooth stain and supragingival calculus , with plaque sample d for microbiological analysis . Additionally , oral mucosal examinations were performed and subjects question ed for adverse symptoms . Baseline special tests were repeated at the end of the study . After baseline examinations , the subjects received a professional prophylaxis , provided with the allocated mouthwash and instructed to use 10-ml volumes for 60 s 2 x daily and where appropriate after toothbrushing and meals . Demographic features of the 3 groups were similar and losses to trial were small . Adverse signs and symptoms included transitory numbness of the tongue , tooth and tongue staining , taste disturbance and rarely mucosal soreness and erosion . All local side-effects were less commonly reported at 6 compared to 3 months and only 6 subjects were withdrawn because of adverse event . No systemic effects attributable to the agent were observed and no significant shifts in haematological or biochemical parameters occurred . All groups showed considerable improvements in oral hygiene and gingival health with some significant differences in favour of 0.2 % delmopinol compared to placebo for gingivitis and more particularly plaque . Staining was also significantly increased in the delmopinol groups but not calculus . In the present study , a considerable Hawthorne effect occurred , which must in part explain why only a modestly significant effect was achieved PURPOSE To investigate the efficacy of various formulations of chlorhexidine 0.2 % ( CHX ) in terms of plaque and gingival bleeding control compared to each other and to saline rinse ( CTRL ) over a 35-day rinsing period . MATERIAL S AND METHODS Seventy subjects were r and omly allocated to one of 4 groups rinsing twice daily for 35 days . The different groups used CHX 0.2 % rinse with alcohol ( CHX1 ) and without alcohol ( CHX2 ) , with an antidiscolouration system ( CHX3 ) or saline rinse ( CTRL ) . Clinical examinations to evaluate full-mouth plaque scores ( FMPS ) and periodontal parameters were performed at baseline , 7 , 21 and 35 days . Tooth discolouration ( TD ) was measured at each time point using digital photographs and spectrophotometric analysis . RESULTS At 35 days , CTRL showed the highest levels of plaque . The mean changes in FMPS from baseline were 69.8 % ± 6.8 for CHX1 , 57.5 % ± 9.8 for CHX2 , 43.7 % ± 9.8 for CHX3 and 25.8 % ± 7.7 for CTRL . Statistically significant differences were demonstrated between CHX1 and CHX3 ( p = 0.02 ) , CHX2 vs CHX3 ( p ≤ 0.05 ) and CHX1/CHX2 vs CHX3 ( p < 0.05 ) . In contrast , CHX3 appeared more effective in reducing inflammatory indexes . TD increased over time in 60 % to 70 % of participants , although lighter staining was found in the CHX3 group . Greater FMPS reduction was observed in participants with staining vs without staining ( 26.0 % ± 12.3 , p = 0.04 ) . CONCLUSION Conventional CHX appeared more effective in terms of plaque reduction . Interestingly , the newest formulation showed a higher control of gingival inflammation . Staining was associated with lower plaque levels The effects of a magnesium monoperoxyphthalate ( MMPP ) mouth-rinse , with or without sodium lauryl sulphate ( SLS ) , and an MMPP dentifrice , on salivary counts of bacterial flora and yeasts , and on supragingival plaque scores were investigated in 131 healthy oral c and ida carriers over a 9 week double blind study . There were no changes in the salivary counts of bacteria studied ( anaerobes , streptococci , fusobacteria , Actinomyces , Viellonella ) in the test or placebo groups . A significant increase in salivary c and ida counts was seen in subjects using an MMPP rinse and dentifrice compared with placebo subjects and this phenomenon was not influenced by the presence of SLS . A significant reduction in plaque was seen in subjects using an MMPP rinse and dentifrice compared with placebo subjects . Frank c and idosis was observed in only 2 subjects ( 1 in the placebo rinse group and 1 in the MMPP dentifrice group ) but erythematous lesions , with subjective reports of soreness , dryness or burning sensation , were recorded and observed more frequently in the experimental groups than in the placebos , especially in those also using SLS . The substantial plaque reduction achieved with MMPP in the absence of tooth staining but with the increase in salivary C and ida counts suggests that further studies of MMPP are warranted BACKGROUND The aims of this clinical study were to evaluate the short-term subjective ( by means of question naire ) and objective ( by means of clinical examination ) side effects of 0.2 % chlorhexidine ( CHX ) mouthrinse without alcohol used as an adjunct to non-surgical periodontal treatment and to eluci date the relationship between the subjective and objective evaluations . METHODS This was a r and omized , double-blind , placebo-controlled clinical trial with two groups : 1 ) the test group , rinsing with the test product ( 0.2 % CHX without alcohol ) twice per day for 1 week , and 2 ) the control ( placebo ) group , rinsing with a placebo solution twice per day for 1 week . Following the start of rinsing , patients were subjectively and objective ly evaluated for the presence and severity of side effects ( pain , burning sensation , pruritus , dryness of mouth , taste disturbance , mucosal irritations , and discoloration of tooth and tongue surfaces ) at days 1 , 3 , and 7 of the rinsing period . The presence of subjective and objective side effects of the groups was compared via use of chi2 and Fisher exact tests . Analysis of the subjective and objective side effects within the evaluation periods was done by McNemar test . Spearman correlation analysis was used to assess the relationships between the subjective and objective side effects . RESULTS None of the patients in either group complained of dryness of the mouth . The most commonly reported side effect was the change in color of the labial and buccal mucosa , particularly of the gingiva , after day 3 of rinsing . There were significant ( r=0.308 to 0.835 ; P<0.05 ) correlations between the discolorations of tongue and tooth surfaces reported by the patients and clinical ly detected at all evaluation periods . There was a significant and positive relationship between the subjective side effects and the soft tissue irritations when the duration of rinsing increased . CONCLUSION Within the limits of this clinical evaluation , rinsing with 0.2 % alcohol-free CHX for 1 week caused more irritation to oral mucosa , greater burning sensation , and increased altered taste perception compared to the placebo rinse BACKGROUND The goal of this study is to evaluate the degree of staining and clinical efficacy of a chlorhexidine mouthwash with an antidiscoloration system ( ADS ) versus 0.2 % chlorhexidine mouthwash ( traditional ) . Secondary objectives are to evaluate the patient " compliance " factor according to patterns assigned by the clinician and to observe the side effects of the two mouthwashes . METHODS This comparative study is carried out on a sample of 15 non-smoking patients with chronic periodontitis at the Department of Periodontology , the International University of Catalunya , Barcelona , Spain . All patients used either 0.2 % chlorhexidine mouthwash ( control group = bottle B ) or chlorhexidine with ADS ( test group = bottle A ) for 15 days . Each patient first rinsed with a r and omly assigned mouthwash for 15 days followed by a 15-day washout period . Subsequently , each patient used a second mouthwash . Before each cycle , a full dental prophylaxis was performed . The plaque , gingival , and Brecx staining indexes were used . RESULTS The results showed less tooth staining with the test group ( P < 0.01 ) . No statistically significant differences were observed in plaque ( P = 0.1496 ) and gingival indexes ( P = 0.1688 ) . Eighty-eight percent of patients followed the instructions outlined in the protocol . In terms of other adverse effects , two patients reported a bad taste with both mouthwashes . CONCLUSIONS The test group with ADS had less staining than the control group during a usage period of 15 days . However , the two mouthwashes seemed to be equally effective as antiplaque and antigingivitis agents OBJECTIVE The aim of this experimental gingivitis study was to assess the efficacy and safety of two new chlorhexidine ( CHX ) mouthrinses . MATERIAL AND METHODS Ninety volunteers participated in this investigator-blind , r and omized , clinical -controlled trial in parallel groups . During the treatment period , no oral hygiene measures except rinsing with non-alcoholic 0.2 % CHX or 0.2 % CHX/0.055 % sodium fluoride mouthrinses , a positive control , or a negative control were permitted . The primary parameter was the gingival index ; the secondary parameters were plaque index , discolouration index , and bleeding on probing . Clinical examinations were conducted 14 days before the start of the study , at baseline , and after 7 , 14 , and 21 days . The two sample t-test , anova , and ancova were used for the statistical analysis . RESULTS No difference in efficacy was found between the two new CHX formulations and the positive control . On day 21 , statistically significantly less gingival inflammation and plaque accumulation compared with placebo were observed . Besides discolouration and taste irritations , no adverse events were recorded . CONCLUSION The two new CHX mouthrinses were able to inhibit plaque re-growth and gingivitis . Neither the omission of alcohol nor the supplementation with sodium fluoride had weakened the clinical efficacy of CHX with respect to the analysed clinical parameters Experimental mouthrinses containing 0.4 % zinc sulphate and 0.15 % triclosan , which differed in base formulations were compared to a commercially available non-active control mouthrinse . Following baseline clinical examinations for plaque , gingival bleeding and calculus , the volunteers were provided with a dental prophylaxis and given oral hygiene instruction , stratified into 3 groups and given 1 of 3 mouthrinses . Further clinical assessment s were performed after 4 , 16 and 28 weeks . Salivary mutans streptococci were also monitored during the study . At 4 weeks , plaque and calculus scores in all groups were low compared to baseline . During the remainder of the study , these improvements were not maintained and both plaque and calculus levels increased in all groups . Plaque was significantly lower ( P < 0.05 ) than in the control at all time points . Calculus was significantly lower ( P < 0.05 ) than in the control at all time points . Calculus was significantly lower at week 28 for experimental mouthrinse group 2 . Gingival bleeding also decreased in the initial 4 weeks but increased thereafter in the control group . In contrast , gingival bleeding was significantly ( P < 0.05 ) lower in the two experimental groups than in the control group . No significant changes in mutans streptococci were observed OBJECTIVES The aim of this study was to evaluate DNA damage and cytokinetic defects , proliferative potential and cell death caused by the frequent use of mouthrinses containing chlorhexidine , triclosan and essential oils in ethanolic solution , compared to a placebo mouthwash . STUDY DESIGN This double-blind , prospect i ve , r and omized clinical trial included 80 Caucasian patients . Subjects were divided into four groups : Group I used a mouthrinse , Triclosan ; Group II used physiological saline ; Group III used chlorhexidine ; Group IV a mouthrinse with essential oils in ethanolic solution . All subjects used the mouthrinses for two weeks ( 15 ml , twice a day , rinsing for 30s ) . Two cell sample s per subject were collected , before and after mouthrinse use ( on day 0 and day 15 ) . Sample s were processed as follows : cell collection from cheeks with a cytobrush ; cell centrifuge ; slide preparation , fixation and staining ; and fluorescent microscope analysis . 2000 exfoliated cells were screened for nuclear abnormalities , particularly the presence of micronuclei by means of cytome assay . RESULTS No significant differences between study times ( before and after use of mouthwash ) were identified for any of the variables studied ( p>0.05 ) . Differences between mouthrinse groups were also compared but no significant differences were found ( p>0.05 ) . CONCLUSIONS This study did not observe any genotoxic effect result ing from mouthrinse use OBJECTIVES the aim of this study was to evaluate the effects of the use of a mouth rinse and dentifrice with cetylpyridinium chloride ( CPC ) in patients with gingivitis . METHODS the study was design ed as a 1-month , double-blind , parallel , r and omized clinical trial comparing a negative control regimen ( minus active ingredients dentifrice and mouth rinse ) with the test products ( dentifrice and mouth rinse with 0.05 % CPC ) in terms of plaque and gingival indexes ( PI , GI ) , patient-based and microbiological outcome variables . The comparisons in relation to the main outcome variables ( PI and GI ) were made by means of the t-test , either unpaired or paired for the intergroup and intragroup comparisons , respectively . RESULTS no differences were detected at baseline . Both groups showed statistically significant decreases in GI ( 0.17 - 0.19 ) , without intergroup differences . The PI demonstrated a significant decrease of -0.12 in the test group and minor changes in the negative control group ( increase of + 0.01 ) . Differences between groups showed a tendency towards statistical significance . A limited impact was observed for microbiological variables in both groups . CONCLUSION the results of this study show limited benefits of the evaluated formulations as adjuncts to unsupervised oral hygiene in reducing plaque accumulation , and no effect on gingivitis Abstract Background : The aim of this study was to compare the efficacy , safety , antiplaque and antigingivitis properties of a herbal mouthwash with chlorhexidine mouthwash . Methods : A double-blinded r and omized clinical trial was conducted among 72 undergraduate students with age group 18–24 years . They were r and omly divided into three mouthwash group with 24 participants in each group . Group A ( herbal ) , Group B ( chlorhexidine ) and Group C ( normal saline).The Turesky et al. 1970 plaque index and Loe and Silness 1963 gingival index was recorded . Student ’s t-test and one-way ANOVA were used to test the significance . Results : A statistically highly significant difference was obtained between mouthwash B and C ( p=0.00 ) and a significant difference between mouthwash A and C ( p=0.004 ) , showing that chlorhexidine was superior to herbal mouthwash and saline . However , there was a nonsignificant difference between mouthwash A and B ( p=0.435 ) showing that herbal and chlorhexidine mouthwash was equally effective in reducing plaque and gingivitis . Conclusions : The efficacy of herbal mouthwash was equally effective in reducing plaque and gingivitis as compared to chlorhexidine mouthwash and may be considered as a good alternative . The chlorhexidine mouthwash was reported with many side effects which limits its acceptability and long-term use , whereas the presently tested herbal mouthwash had no side effects apart from mild burning sensation The aim of this r and omized , double-blind , cross-over pilot study was to evaluate the effect on plaque formation and patient experience of rinsing after periodontal surgery using chlorhexidine solution with or without alcohol . Twenty patients refrained from tooth brushing after surgery and used two mouth rinses . Ten patients used alcohol-based ( AB ) 0.1 % and another ten used alcohol-free ( AF ) 0.12 % chlorhexidine ( CHX ) . Sutures were removed after 2 weeks and teeth were cleaned ; thereafter , the two groups shifted solution . Plaque at operated teeth was recorded at 2 and 4 weeks ( Quigley-Hein Index ) . Patient experience was assessed with a visual analogue scale ( 0 - 10 ) . Mean ( SD ) plaque indices at 2 and 4 weeks were 1.0 ( 0.8 ) and 1.1 ( 1.0 ) for AB CHX and 1.1 ( 0.7 ) and 0.8 ( 0.7 ) for AF CHX , respectively ( no significant differences between solutions ) . At 2 weeks , between-group differences in taste experience of the solutions differed non-significantly : 6.1 ( 2.8 ) for AB and 6.0 ( 2.3 ) for AF . At 4 weeks , values were 4.6 ( 2.5 ) for AB and 6.9 ( 3.3 ) for AF- patients tended to prefer AF ( p = 0.050 ) . Taste change over the study period was equal for both groups : -37 ( 3.3 ) for AB and 3.4 ( 2.3 ) for AF at 2 weeks and slightly higher at 4 weeks 4.9 ( 2.8 ) and 4.5 ( 2.5 ) for AB and AF , respectively . Smarting was low in both groups : 2.2 ( 3.2 ) and 1.3 ( 2.2 ) for AB and 1.0 ( 1.5 ) and 1.9 ( 2.0 ) for AF at 2 and 4 weeks , respectively . To conclude , alcohol-free and alcohol-based chlorhexidine showed the same plaque inhibitory effect in periodontal patients after periodontal surgery . Both rinses were well tolerated by the patients PURPOSE This r and omized , single center , examiner-blind , controlled , parallel-group , 6-month clinical study compared the antiplaque/antigingivitis potential of an essential oil ( EO ) versus a 0.07 % cetylpyridinium chloride (CPC)-containing mouthrinse . A 5 % hydroalcohol solution was included as a control group . METHODS 354 healthy volunteers ( 18 - 71 years of age ) were enrolled in this clinical trial ; 338 subjects completed the study . At baseline , 1- , 3- , and 6-month visits , subjects received an oral examination , gingivitis ( MGI ) , gingival bleeding ( BI ) and plaque assessment s ( PI ) . Following r and omization , subjects received a prophylaxis and began brushing twice daily with the provided fluoride toothpaste and rinsing twice daily with 20 mL of the assigned mouthrinse for 30 seconds . RESULTS All rinses were well tolerated by the subjects , with the exception of extrinsic tooth stain complaints in 13 subjects in the CPC group between the 3- and 6-month exams . Statistically significant reductions in gingivitis , bleeding and plaque were observed for both EO and CPC at all post-baseline time-points when compared to the negative control . At 6 months MGI and PI were reduced by 42.6 % and 42.0 % for EO and by 17.1 % and 13.9 % respectively , for CPC vs. control . When compared to CPC , EO was statistically significantly superior at all post-baseline time-points . EO showed increasing reductions in MGI of 10.5 % , 20.3 % and 30.7 % as well as reductions in PI of 12.7 % , 23.7 % and 32.6 % at 1 , 3 and 6 months , respectively . When analyzing the number of healthy sites ( MGI scores of 0 or 1 ) , the beneficial effect of the EO-containing mouthrinse is 45.8 % greater than using a CPC-containing mouthrinse and 59.8 % greater than placebo PURPOSE To compare the safety and the antiplaque and antigingivitis efficacy of two oral rinses . METHODS A r and omized , double-blind , parallel groups , single-center study was conducted to evaluate the safety and efficacy of a high bioavailable , alcohol-free 0.07 % cetylpyridinium chloride ( CPC ) rinse ( Crest Pro-Health Rinse ) and a positive control rinse containing essential oils ( EO ) and 21.6 % ethyl alcohol ( Cool Mint Listerine ) . Seventy-eight healthy adults were enrolled in a modified experimental gingivitis clinical trial . Four weeks before the baseline visit , subjects received a prophylaxis and were instructed to brush twice daily in a manner to approach optimum gingival health . At the end of the 4-week period , subjects were r and omly assigned to treatment and instructed to use 20 ml of their assigned product for 30 seconds after brushing twice daily during a 21-day treatment phase . Plaque removal by brushing was prevented during the treatment phase for one m and ibular quadrant ( experimental gingivitis region ) by means of a specially-manufactured tooth shield . Safety and efficacy measurements were obtained at baseline and at the end-of-treatment using the Modified Gingival Index ( MGI ) , Gingival Bleeding Index ( GBI ) , and Modified Quigley-Hein Plaque Index ( MQH ) . At all visits , an oral soft tissue examination was performed for each subject . The efficacy data obtained in the experimental gingivitis region were analyzed with analysis of covariance . RESULTS Seventy-five subjects completed the study and were included in the data analyses . No statistically significant differences were detected between the two treatment groups for MGI , GBI or MQH measures . Results were similar for shielded interproximal sites . Both treatments were well-tolerated . CLINICAL SIGNIFICANCE This r and omized , controlled comparative clinical trial demonstrated that rinsing twice daily with the experimental alcohol-free 0.07 % CPC rinse provides antiplaque and antigingivitis efficacy similar to that of the positive control EO rinse , a recognized antiplaque and antigingivitis mouthrinse that contains alcohol OBJECTIVE To evaluate the clinical and microbiological activity of a new mouth rinse formulation , used as an adjunct to oral hygiene , for patients in supportive periodontal care . PATIENTS AND METHODS This was a r and omized , placebo-controlled clinical trial with two groups : test group , rinsing twice per day with the test product ( with 0.05 % chlorhexidine and 0.05 % cetylpyridinium chloride ) ; and control group , rinsing with a placebo . Treated chronic periodontitis patients were included , and two visits were rendered , baseline , and after 15 days . Clinical outcome variables included plaque and gingival indices , and probing pocket depth . Subgingival sample s were processed by culturing . Patient-based variables and adverse effects were also assessed . Outcome variables were compared by t-test , chi2 , and Mann-Whitney test . RESULTS The results belonged to 33 patients . Plaque and gingival indices , and the log of bacterial total counts were reduced in the test group ( p < or = 0.01 ) , but differences between groups were only statistically significant ( p < 0.05 ) for plaque and bacterial counts . A significant reduction in the proportions of flora ( p < 0.05 ) and frequency of detection ( p = 0.01 ) of Porphyromonas gingivalis was observed in the test group . CONCLUSIONS The newly formulated mouth rinse demonstrated short-term plaque-inhibitory activity . This was associated with a reduction in the total load of anaerobic subgingival microflora A recently reported six-month gingivitis study demonstrated that in subjects with gingivitis , a triclosan/pyrophosphate dentifrice provided supragingival plaque control . The level of plaque reduction was comparable with that reported for other triclosan-containing dentifrices ; however , no reductions in gingivitis were observed for triclosan/pyrophosphate relative to the negative control . One possible explanation of this result is that the Hawthorne effect in the study was too great to allow the detection of a treatment benefit for the triclosan product . In order to further explore the relevance of these results , three independent clinical studies were undertaken utilizing design s based on a 21-day experimental gingivitis model in which Hawthorne effects are minimized , in part due to the absence of toothbrushing . In each model , a pre- study prophylaxis was followed by a three-week period of oral hygiene instruction to establish optimum baseline gingival health in study participants . The studies varied in enrollment ; 120 , 33 and 32 subjects completed treatment on studies 1 , 2 , and 3 , respectively . In study 1 , test articles were dentifrice products ( 0.28 % triclosan/5 % pyrophosphate/0.145 % sodium fluoride , 0.2 % triclosan/0.5 % zinc citrate/0.112 % sodium fluoride , 0.145 % sodium fluoride and 0.15 % sodium monofluorophosphate ) applied neat and undiluted via a performed tooth shield ( that prevents mechanical tooth-brushing at the test sites in the oral cavity ) in a partial mouth design . In study 2 , test articles were also dentifrice products ( 0.28 % triclosan/5 % pyrophosphate/0.243 % sodium fluoride , 0.3 % triclosan/2 % Gantrez copolymer/0.24 % sodium fluoride and 0.243 % sodium fluoride ) but administered to subjects in the form of 1:3 aqueous slurry rinses . Lastly , in study 3 , test articles were all mouthrinses ( 0.12 % chlorhexidine , 0.045 % triclosan in ethanol plus respective vehicle placebos ) . Clinical assessment s to quantify the test articles ' effects on the development of plaque and gingivitis were conducted at baseline ( studies 1 , 2 and 3 ) , day 7 ( studies 2 and 3 ) , day 14 ( studies 2 and 3 ) and day 21 ( studies 1 , 2 and 3 ) . In study 1 , no statistically significant treatment effects were observed between the test articles and controls for plaque or gingivitis development . In study 2 , no statistically significant treatment effects were observed at any time point between test products for the development of gingivitis . At days 7 and 14 , there were no significant differences between test products and control for plaque development as well . At day 21 , the group rinsing with the triclosan/pyrophosphate/sodium fluoride slurry had significantly less plaque accumulation than the group rinsing with the triclosan/copolymer/sodium fluoride slurry ( p < 0.05 ) ; however , neither of the groups using test products containing triclosan was significantly different for plaque development from the group using the sodium fluoride control test article . In addition , aspartate aminotransferase activity in gingival crevicular fluid was assayed at days 0 and 21 ; no between-group differences were found at either of these time points , though day 21 AST activities were higher than those at baseline . In study 3 , statistically significant treatment differences in plaque regrowth and gingivitis were observed at day 21 for the chlorhexidine rinse versus all other rinses ( p < 0.05 ) . No other statistically significant treatment effects were observed between test compounds at any other time points . The results benchmark the anti-plaque and anti-gingivitis benefit for a range of triclosan-based product forms against positive and negative controls in a three different experimental gingivitis models , a design considered predictive of clinical efficacy in longer-term investigations . It is concluded that dentifrice products containing triclosan do not possess sufficient antimicrobial activity to suppress plaque and gingivitis development in the absence of normal oral hygiene , and that relative to chlorhexidine , triclosan itself offers only modest efficacy for the prevention of plaque accumulation and therefore the delayed onset of gingivitis BACKGROUND Chlorhexidine ( CHX ) rinsing after periodontal surgery is common . We assessed the clinical and microbiological effects of two CHX concentrations following periodontal surgery . MATERIAL S AND METHODS In a r and omized , controlled clinical trial , 45 subjects were assigned to 4 weeks rinsing with a 0.05 CHX/herbal extract combination ( test ) or a 0.1 % CHX solution . Clinical and staining effects were studied . Subgingival bacteria were assessed using the DNA-DNA checkerboard . Statistics included parametric and non-parametric tests ( p<0001 to declare significance at 80 % power ) . RESULTS At weeks 4 and 12 , more staining was found in the control group ( p<0.05 and p<0.001 , respectively ) . A higher risk for staining was found in the control group ( crude OR : 2.3:1 , 95 % CI : 1.3 to 4.4 , p<0.01 ) . The absolute staining reduction in the test group was 21.1 % ( 9 5 % CI : 9.4 - 32.8 % ) . Probing pocket depth ( PPD ) decreases were significant ( p<0.001 ) in both groups and similar ( p=0.92 ) . No rinse group differences in changes of bacterial counts for any species were found between baseline and week 12 . CONCLUSIONS The test CHX rinse result ed in less tooth staining . At the study endpoint , similar and high counts of periodontal pathogens were found The aim of this study was to test the effect of a rinse with 0.05 % sodium fluoride and 0.05 % chlorhexidine on plaque and gingival inflammation compared with a placebo without these agents . In a double-blind study , 47 adults with > 20 teeth and a CPITN score > 1 but < 4 were r and omised into test and control groups . After baseline assessment s for plaque , bleeding and stain , teeth were professionally cleaned . Subjects were asked to rinse for 30 s with 10 ml of the respective test or placebo rinse after normal oral hygiene for 8 weeks . 39 subjects completed the study . There was no significant difference in the 2 groups at baseline with respect to either plaque or bleeding scores . After scaling and 8 weeks use of the test rinse , there were significant reductions ( p < 0.001 ) in both plaque and bleeding . The control group showed no significant reduction in plaque scores after 8 weeks , but a significant ( p < 0.05 ) reduction in bleeding . However , this reduction was significantly greater ( p < 0.001 ) in the test group than in the control . The test group had a significantly greater ( p < 0.05 ) stain score than the control at baseline . After scaling and rinsing for 8 weeks , stain scores were lower for both groups compared to baseline but reached significance ( p < 0.05 ) only for the control group . It is concluded that , as an adjunct to normal oral hygiene , the chlorhexidine/fluoride rinse had a significant inhibitory effect on plaque and bleeding but its effect on staining is uncertain This double-blind , r and omised , 6-month clinical trial with parallel group design in 68 subjects with gingivitis was conducted to study the effects on the oral flora of delmopinol hydrochloride 2 mg/ml ( 0.2 % w/v , Decapinol Mouthwash ) , when used for partly supervised mouthrinsing in comparison with placebo and chlorhexidine digluconate 2 mg/ml ( 0.2 % w/v , Hibitane Dental , ICI Pharmaceuticals , UK ) . Apart from estimating the total cultivable microbial dental plaque flora and salivary flora , analyses were focused on bacterial groups associated with gingivitis/periodontitis and dental caries . Furthermore , the presence of staphylococci , gram-negative enteric bacteria and yeasts in saliva were evaluated . The minimal inhibitory concentration ( MIC ) was determined for isolates belonging to the predominating micro-organisms in sample s of both dental plaque and saliva . In relation to the findings in the placebo group , the use of delmopinol during the rinsing period did not produce an undesirable shift in the bacterial population s considered to be related to dental caries or periodontal diseases . These groups remained virtually unchanged during the study . In relation to the observations in the placebo group , slight reductions in the total cultivable plaque and salivary flora were observed during the study and no change was found in the ratio total anaerobically/aerobically cultivable microbial flora . Furthermore , no increased growth in staphylococci , enteric bacteria or yeasts was observed in the saliva sample s. The pattern of changes taking place in the composition of the plaque and salivary microbial flora in sample s from the participants rinsing with chlorhexidine were in most aspects similar to that observed in the delmopinol group . In the delmopinol group , no microbiologically significant changes were observed over time in the MIC-values for the isolates , neither in the plaque nor in the saliva sample s , which indicates that no adaptation to delmopinol had taken place during the rinsing period . Similar observations were made for the plaque isolates in sample s from the participants in the chlorhexidine group . On the other h and , when gram-positive and catalase-negative cocci from the saliva sample s of the latter group were tested against chlorhexidine , 4 - 6 times higher MIC-values were obtained at 3 and 6 months both when compared to baseline and in comparison with the other two rinsing groups ( p<0.01 or p<0.05 ) . Neither delmopinol nor chlorhexidine showed any residual effect on the studied microbial groups in the plaque and the saliva sample s 3 months after the end of treatment . In conclusion , delmopinol was accompanied by a composition of the plaque and salivary flora associated with healthy conditions in the oral cavity In vitro studies and early clinical trials have shown promising results for Delmopinol HCl solution as an effective mouth rinse for reducing experimentally induced gingivitis in the absence of mechanical plaque control . The efficacy of Decapinol mouthwash 2 mg/mL ( Delmopinol HCl ) in preventing gingivitis in a double-blind , r and omized clinical study with parallel group design was studied . Forty-seven healthy young adults were r and omly assigned to the Delmopinol or placebo groups . After an initial period of four weeks of intensive oral hygiene including bi-weekly professional cleaning of the teeth and oral hygiene instruction , all subjects achieved a low degree of gingivitis or a plaque score close to zero . At baseline , Bleeding on Probing , Modified Gingival Index and Plaque Index were recorded and the teeth were professionally cleaned . All forms of plaque control were then suspended and subjects were supervised in a one-minute rinsing of Decapinol mouthwash 2 mg/mL or placebo twice daily . Measurements of efficacy variables were then repeated after two and three weeks treatment and adverse events were recorded . After the study period of three weeks all previous plaque control measures were resumed . At week four , all subjects were reassessed for the resolution of gingival inflammation and where residual gingival inflammation persisted , appropriate treatment was given . Only mild and short-lasting adverse events were noted for the use of Delmopinol in the study period . However , for all teeth sites measured , significant differences between Delmopinol and placebo groups were found in Bleeding on Probing ( p < 0.05 ) and Plaque Index ( p < 0.0005 ) . ( ABSTRACT TRUNCATED AT 250 WORDS A double-blind , r and omised , 6-month clinical trial with parallel group design in 149 patients with gingivitis was conducted to study the efficacy and safety of delmopinol hydrochloride 2 mg/ml ( 0.2 % w/v , Decapinol Mouthwash ) used for partly supervised mouthrinsing in comparison with chlorhexidine digluconate 2 mg/ml ( 0.2 % w/v , Hibitane Dental , ICI Pharmaceuticals , UK ) and placebo as an addition to normal oral hygiene . Assessment s of efficacy were performed using the plaque index and bleeding on probing ( BOP ) . Delmopinol showed 22 % lower plaque index scores than placebo after 3 months ( p<0.01 ) and 13 % lower scores after 6 months . The corresponding figures for chlorhexidine were 38 % ( p<0.001 ) and 38 % ( p<0.001 ) after 3 and 6 months , respectively . Bleeding on probing was reduced for delmopinol in comparison with placebo by 11 % after 3 months and by 18 % ( p<0.05 ) after 6 months . For chlorhexidine the corresponding figures were 18 % ( p<0.01 ) and 22 % ( p<0.01 ) after 3 and 6 months , respectively . While chlorhexidine showed greater plaque reduction than delmopinol ( p<0.01 at 6 months ) , no statistically significant difference was reached between these two solutions regarding BOP . Both active solutions showed an increased amount of dental calculus in comparison with placebo . A transient anaesthetic sensation in the oral mucosa and taste affection were commonly reported adverse events in both the delmopinol and the chlorhexidine groups . The number of patients withdrawn from treatment due to adverse events or lack of cooperation was 7 in the chlorhexidine group , 4 in the placebo group and 1 in the delmopinol group . The results showed that rinsing with either 0.2 % delmopinol hydrochloride or 0.2 % chlorhexidine digluconate twice daily for 60 secs for 6 months results in less plaque formation and gingivitis than rinsing with placebo . Mouthrinsing with the 0.2 % delmopinol hydrochloride solution was well accepted in this study UNLABELLED The use of chlorhexidine ( CHX ) has been recommended for a number of clinical applications including plaque control in the post-operative period . However , the use of CHX is burdened by some side effects that could affect the compliance of the patient . The aim of this clinical trial was to evaluate the side effects , the staining in particular , the patient acceptance , and the efficacy of a 0.2 % CHX mouthwash containing an anti discoloration system ( ADS ) compared with a 0.2 % CHX alone , after periodontal flap surgery . MATERIAL AND METHODS This single-centre , cross-over , triple-blind r and omized clinical trial was carried out on 48 consecutive patients . After periodontal flap surgery , the patients were prescribed to rinse two times per day for 1 min for 1 week with 10 ml of test or control CHX , contained in anonymous bottles coded K or M and assigned r and omly . No brushing and interdental cleaning of the surgical area was allowed . At week 1 , after suture removal , patients received full-mouth prophylaxis and were given a second anonymous bottle , reversing the products , with the same instructions as at baseline . Patients resumed tooth-brushing but not interdental cleaning . At the end of week 2 , prophylaxis was repeated , mouth rinsing was discontinued and patients resumed normal oral hygiene . At weeks 1 and 2 , the following variables were recorded : presence of pigmentation , gingival parameters at the surgically treated sites ( gingival inflammation , tissue inflammation around the sutures , gingival swelling and presence of granulation tissue ) , patient perception and acceptance of the 2 mouthwashes . RESULTS Forty-seven patients completed the study . The difference between treatments related to gingival variables was not statistically significant . The test CHX caused consistently less pigmentations than the control CHX in all the evaluated areas of the dental surfaces ( odds ratio (OR)=0.083 p<0.0001 in the incisal area , OR=0.036 p<0.0001 in the approximal area and OR=0.065 p<0.0001 in the gingival area ) . The CHX ADS was found to be more tolerated by patients than the control mouthwash and to cause less food alteration , less alterations to the perception of salt and to be less irritant for the oral tissues . CONCLUSIONS ( 1 ) CHX ADS caused less pigmentation , was burdened by less side effects and was more agreeable than the control CHX ; ( 2 ) CHX ADS was as effective as CHX without ADS in reducing gingival signs of inflammation in the post-surgical early healing phase ; ( 3 ) the use of CHX ADS could be of value in treatment protocol s in which the patient compliance with a CHX mouthwash prescription is relevant BACKGROUND Chlorhexidine ( CHX ) 0.2 % solution , still the golden st and ard as mouthrinse for the prevention of plaque formation and development of gingivitis , has some limited side-effects such as extrinsic tooth staining , poor taste , taste disturbance , sensitivity changes in tongue , pain , and the content of alcohol . These side effects led to the search of new formulations . METHODS In this double-blind , r and omised , cross-over study , 16 young dental students with a healthy periodontium , abolished all means of mechanical plaque control during 4 experimental periods of 11 days ( separated from each other by a washout period of 3 weeks ) . During each experimental period , they rinsed 2x daily with one of the following mouthrinses in a r and omised order : CHX 0.2 % + alcohol ( Corsodyl ) , CHX 0.12 % + alcohol ( Perio . Aid ) , CHX 0.12 % + sodium fluoride 0.05 % ( Cariax Gingival ) and CHX 0.12 % + CPC 0.05 % ( Perio . Aid , new formulation ) . After 7 and 11 days of undisturbed plaque formation , clinical parameters were recorded , question naires completed and plaque sample s ( supragingivally and saliva ) collected . RESULTS The CHX 0.12 % + alcohol and the CHX 0.12 % + CPC 0.05 % formulations were as efficient as the CHX 0.2 % mouthrinse in retarding de novo plaque formation ( proven by clinical observations as well as by anaerobic and aerobic culture data ) , and always superior ( p<0.001 ) to the CHX 0.12 % + sodium fluoride 0.05 % solution . The subjective ratings were in favour of the new CHX formulation when compared with the other CHX formulations , especially for taste ( p<0.05 ) . CONCLUSIONS The results of this study demonstrated the potential of a new CHX 0.12 % + CPC 0.05 % non-alcoholic formulation as an effective anti-plaque and anti-inflammatory agent with reduced unpleasant subjective side-effects OBJECTIVE To evaluate the effect of a mouth-rinse formulation combining benzydamine hydrochloride and cetylpyridinium chloride ( BNZ+CPC ) in preventing de novo plaque formation , in comparison with CPC and placebo mouth rinses . PATIENTS AND METHODS This was a controlled , observer-blind , cross-over study . In this model of plaque re-growth , subjects received a session of oral prophylaxis and were directed to withdraw oral hygiene measures for the next 4 days , using only the mouth rinse assigned . The outcome parameters were the plaque index ( PlI ) and gingival index ( GI ) . In addition , microbiological evaluation of the subgingival microflora , by means of culture , was performed , as well as patient-based variables . Data analysis was carried out using anova for Latin-square design . RESULTS The analysis of variance showed a significant statistical difference between the BNZ+CPC association and placebo ( p<0.0001 ) . No differences between CPC and placebo were detected considering multiple comparisons between treatments . The 90 % confidence interval of the differences between BNZ+CPC and CPC showed no equivalence between treatments , being the PlI lower in the BNZ+CPC group . No significant difference between groups in GI was observed . Mean anaerobic colony-forming units ( CFU ) demonstrated a significant increase between visits in all groups ( p<0.001 ) and differences among groups were not significant . Subjects treated with BNZ+CPC frequently reported " tingling mouth " and " numbness mouth " . CONCLUSION Within the limitations of the study model , the BNZ+CPC combination showed a statistically significant plaque-inhibitory capacity , as compared with the placebo mouth rinse , and an additive effect as compared with CPC . No relevant clinical or microbiological adverse effects were detected The effectiveness of amine fluoride and stannous fluoride in the prophylaxis of caries and gingivitis is well-known from the literature . The aim of this study was to assess whether these agents could be recommended for long-term use . Under conditions of a clinical double-blind study , the influence of an amine/stannous fluoride rinse on gingivitis , plaque accumulation and the composition of the supragingival plaque was tested over a period of 7 months . 102 persons with signs of chronic gingivitis participated in the study . Gingival indices ( GI , SBI ) and plaque indices ( PlI , API ) were recorded at baseline , after 3.5 and 7 months . The composition of the supragingival plaque was evaluated by dark-field microscopy . During the 7 months , the GI decreased in the test group from 1.36 to 0.95 , and the SBI from 52.0 % to 29.3 % . The PlI fell from 1.17 to 0.68 , and the API from 61.3 % to 50.6 % ( p < 0.001 ) . No significant changes were recorded in the control group . In the test group , the proportion of cocci in the plaque increased from 58.4 % to 68.9 % ( p < 0.001 ) while the proportion of rods and other plaque bacteria underwent a significant decrease ( p < 0.001 ) . The microflora was stable in the control group throughout the study period . No side-effects of the drug were reported by the prob and s. The results suggest that long-term use of the amine/stannous fluoride rinse is of benefit to gingival health Mouthwashes containing 0.3 % or 0.15 % triclosan in combination with 1.5 % sodium lauryl sulfate ( SLS ) produced a significant reduction in plaque formation in a test panel of 11 students who refrained from oral hygiene during the test periods , during which they rinsed twice daily with different mouthwashes . Pl . I. was evaluated after each test period . A mouthwash containing only 1.5 % SLS inhibited plaque to almost the same degree . In both cases , the major effect was on the buccal/lingual surfaces , where score 2 was changed to score 0 . Addition of triclosan appeared to reduce the untoward side-effects of mouth-washes containing SLS alone ( i.e. desquamation and a burning sensation in the mouth ) OBJECTIVE To assess the antiplaque/antigingivitis efficacy of a hexetidine-containing mouthwash . METHODS This examiner-blind , parallel group , controlled clinical study examined the effectiveness of a hexetidine ( 0.1 % ) mouthwash both in inhibiting the development of supragingival plaque and in reducing gingivitis . One hundred and thirty-four adult subjects completed the 2-week experimental gingivitis model study . Following baseline examinations , which included plaque index , modified gingival index and gingival bleeding index , subjects received a full dental prophylaxis . Subjects were r and omly assigned to one of three mouthwashes ( hexetidine 0.1 % , chlorhexidine 0.12 % ( positive control ) or a 5 % hydroalcohol negative control ) and commenced three times daily supervised rinsing as their sole method of oral hygiene . All indices were rescored after 2 weeks . RESULTS Compared to the negative control group , the hexetidine group demonstrated a statistically significant inhibition and reduction of supragingival plaque and gingival inflammation with reductions of 6.3 % , 33.5 % and 56 % for gingivitis , plaque and gingival bleeding , respectively . The results of the chlorhexidine group were used to vali date the study . CONCLUSION The study confirms the efficacy of a hexetidine rinse in reducing supragingival plaque and gingival inflammation BACKGROUND AND OBJECTIVE Chlorhexidine ( CHX ) is the most tested and leading oral antiseptic agent . Zinc as an active ingredient has shown additive and synergistic effect and when Sodium fluoride ( NaF ) was used it failed to show added effectiveness and the combined effect of NaF and Zinc chloride ( ZnCl2 ) both as active ingredients has never been evaluated . The present study assessed the effectiveness of active ingredients and to compare the frequency of adverse events occurring with traditional CHX and CHX+NaF+ZnCl2 . MATERIAL AND METHODS A r and omized double blind crossover trial was executed with 24 subjects participating in two consecutive experimental phases of 21 days each with CHX and CHX+NaF+ZnCl2 mouth rinses . Each individual was assessed for gingivitis , plaque , supragingival calculus and extrinsic stains at baseline and after experimental phase and adverse events experienced were recorded . RESULTS There was a significant difference ( p = 0.014 ) between the two experimental mouth rinses for their effectiveness on gingivitis . In the CHX group , the gingival score on D21 was significantly greater by 0.13 than DO while with CHX+NaF+ZnCl2 there was a decrease in gingival score by 0.09 which was insignificant . No significant difference was observed between the interventions for plaque accumulation and formation of extrinsic stains . The difference in the mean calculus score at baseline and after experimental phase was 1.47 for CHX+NaF+ZnCl2 in contrast to 1.93 among CHX group . Oral itching , oral soreness , apthous ulcers and dryness were reported by many subjects while burning sensation was reported by very few volunteers . There was no significant difference for occurrence of adverse events between the two experimental mouthrinses . CONCLUSIONS CHX+NaF+ZnCl2 mouth rinse was found to be significantly more effective in the reduction of gingivitis and supragingival calculus . No significant difference was found for the occurrence of dental plaque , extrinsic stains and adverse events between the interventions STATEMENT OF PROBLEM Antimicrobial mouthrinses have become an important part of comprehensive dental care . However , mouthrinses that contain alcohol have been shown to be detrimental to patients undergoing radiation therapy for head and neck cancer , to some immunocompromised patients , to families with small children , and to persons sensitive to alcohol . PURPOSE This study evaluated the effectiveness of alcohol-free , 0.12 % chlorhexidine mouthrinse in reducing microbial levels when compared with commercially available 0.12 % chlorhexidine ( CHX ) and essential oils mouthrinses . MATERIAL AND METHODS This study consisted of both in vitro and in vivo investigations . The double-blind study included 32 subjects r and omly assigned to 3 groups , equalized according to the indices tested . One group ( n = 11 ) received essential oils rinse ; the second group ( n = 11 ) received CHX ; and the last group ( n = 10 ) received the alcohol-free CHX . Subjects were asked not to use any mechanical means of oral hygiene for 21 days . The in vitro part of the study consisted of Streptococcus mutans strip tests . RESULTS Mean plaque scores for both CHX products decreased after 21 days , whereas the mean for the essential oils increased . Bleeding and gingival index scores for all 3 groups increased , which may be due to the initially healthy tissues of the participants . Relative microbial growth for S mutans for both the CHX products decreased to 0 after 21 days , whereas the counts for the essential oils group remained varied OBJECTIVES To assess the effectiveness of three different mouthrinses -- chlorhexidine , triclosan + sodium fluoride and chlorhexidine + triclosan + sodium fluoride + zinc chloride -- on plaque , calculus , gingivitis and stains and to evaluate the occurrence of adverse effects with these three treatments . METHODS Forty-eight healthy subjects participated in a double-blind , r and omized , parallel experiment and were r and omly allocated to any one of the three experimental mouthrinses : group A ( 0.2 % chlorhexidine ( CHX ) gluconate ) , group B ( 0.03 % triclosan + 0.025 % sodium fluoride ( NaF ) + 12 % ethyl alcohol ) or group C ( 0.2 % CHX + 0.3 % triclosan + 0.3 % NaF + 0.09 % Zn chloride ( ZnCl(2 ) ) . All the subjects were assessed for gingivitis , plaque , supragingival calculus and extrinsic stains at baseline and at the end of the 21-day experimental period . RESULTS There was a significant difference ( P = 0.046 ) in the effectiveness for the prevention of gingivitis and plaque , with subjects of group A and group C presenting least and highest gingival and plaque scores , respectively . Significant differences ( P = 0.03 ) were observed for the accumulation of supragingival calculus where the deposition of calculus in group A was nearly double that of the group B , and group B was most effective in the prevention of supragingival calculus . Highest deposition of extrinsic stains was in the group A followed by group C and group B. There was no significant difference between the three treatments for adverse events ' occurrence . CONCLUSIONS CHX mouthrinse was most effective in controlling plaque and gingivitis but caused greatest deposition of extrinsic stains . Supragingival calculus deposition was least in triclosan + NaF group followed by CHX + triclosan + NaF + ZnCl(2 ) and CHX . More than half of the subjects reported adverse events during the experimental phase |
314 | 21,975,777 | The intervention was found to have limited impact on weight loss ( about 2 kg or less ) and other outcome measures .
There was no conclusive evidence for sustainable weight loss .
However , TTM SOC and a combination of physical activity , diet and other interventions tended to produce significant outcomes ( particularly change in physical activity and dietary intake ) .
TTM SOC and a combination of physical activity , diet and other interventions result ed in minimal weight loss , and there was no conclusive evidence for sustainable weight loss . | BACKGROUND Obesity is a global public health threat .
The transtheoretical model stages of change ( TTM SOC ) model has long been considered a useful interventional approach in lifestyle modification programmes , but its effectiveness in producing sustainable weight loss in overweight and obese individuals has been found to vary considerably .
OBJECTIVES To assess the effectiveness of dietary and physical activity interventions based on the transtheoretical model , to produce sustainable weight loss in overweight and obese adults . | OBJECTIVE To assess the process variables involved in a weight loss program for African-American adolescent girls . Several process variables have been identified as affecting success in in vivo weight loss programs for adults and children , including program adherence , self-efficacy , and social support . The current study sought to broaden the underst and ing of these process variables as they pertain to an intervention program that is presented using the Internet . It was hypothesized that variables such as program adherence , dietary self-efficacy , psychological factors , and family environment factors would mediate the effect of the experimental condition on weight loss . RESEARCH METHODS AND PROCEDURES Participants were 57 adolescent African-American girls who joined the program with one obese parent ; family pairs were r and omized to either a behavioral or control condition in an Internet-based weight loss program . Outcome data ( weight loss ) are reported for the first 6 months of the intervention . RESULTS Results partially supported the hypotheses . For weight loss among adolescents , parent variables pertaining to life and family satisfaction were the strongest mediating variables . For parental weight loss , changes in dietary practice s over the course of 6 months were the strongest mediators . DISCUSSION The identification of factors that enhance or impede weight loss for adolescents is an important step in improving weight loss programs for this group . The current findings suggest that family/parental variables exert a strong influence on weight loss efforts for adolescents and should be considered in developing future programs Thirty-nine U.S. Air Force enlisted men participated in a r and omized controlled study that evaluated an experimental program design ed to enhance fitness . Subjects were assigned to either a treatment ( access to the program ) or control ( no access to program ) group for 6 months . To improve treatment group fitness ( as measured by VO2 , subjects received individually tailored information ( based on a behavior change model ) via the Internet to encourage adoption of positive diet and exercise behaviors . Results showed no significant effect in improving fitness in treatment . However , significant effects were observed for secondary outcomes such as weight ( controls , + 1.0 kg vs. treatment , -2.2 kg , p < 0.05 ) , body mass index ( + 0.3 kg/m2 vs. -0.7 kg/m2 , p < 0.05 ) , and percent body fat ( + 0.6 % vs. -1.5 % , p < 0.001 ) . The data suggest that the individually tailored exercise information was not effective in encouraging sufficient exercise intensity to impact fitness . However , the dietary tailored information appears to have encouraged the adoption of more positive nutritional practice s as demonstrated by the beneficial effects reflected in secondary outcomes Background Our aim was to compare the effects of a Paleolithic ( ' Old Stone Age ' ) diet and a diabetes diet as generally recommended on risk factors for cardiovascular disease in patients with type 2 diabetes not treated with insulin . Methods In a r and omized cross-over study , 13 patients with type 2 diabetes , 3 women and 10 men , were instructed to eat a Paleolithic diet based on lean meat , fish , fruits , vegetables , root vegetables , eggs and nuts ; and a Diabetes diet design ed in accordance with dietary guidelines during two consecutive 3-month periods . Outcome variables included changes in weight , waist circumference , serum lipids , C-reactive protein , blood pressure , glycated haemoglobin ( HbA1c ) , and areas under the curve for plasma glucose and plasma insulin in the 75 g oral glucose tolerance test . Dietary intake was evaluated by use of 4-day weighed food records . Results Study participants had on average a diabetes duration of 9 years , a mean HbA1c of 6,6 % units by Mono-S st and ard and were usually treated with metformin alone ( 3 subjects ) or metformin in combination with a sulfonylurea ( 3 subjects ) or a thiazolidinedione ( 3 subjects ) . Mean average dose of metformin was 1031 mg per day . Compared to the diabetes diet , the Paleolithic diet result ed in lower mean values of HbA1c ( -0.4 % units , p = 0.01 ) , triacylglycerol ( -0.4 mmol/L , p = 0.003 ) , diastolic blood pressure ( -4 mmHg , p = 0.03 ) , weight ( -3 kg , p = 0.01 ) , BMI ( -1 kg/m2 , p = 0.04 ) and waist circumference ( -4 cm , p = 0.02 ) , and higher mean values of high density lipoprotein cholesterol ( + 0.08 mmol/L , p = 0.03 ) . The Paleolithic diet was mainly lower in cereals and dairy products , and higher in fruits , vegetables , meat and eggs , as compared with the Diabetes diet . Further , the Paleolithic diet was lower in total energy , energy density , carbohydrate , dietary glycemic load , saturated fatty acids and calcium , and higher in unsaturated fatty acids , dietary cholesterol and several vitamins . Dietary GI was slightly lower in the Paleolithic diet ( GI = 50 ) than in the Diabetic diet ( GI = 55 ) . Conclusion Over a 3-month study period , a Paleolithic diet improved glycemic control and several cardiovascular risk factors compared to a Diabetes diet in patients with type 2 diabetes . Trial registration Clinical Trials.gov NCT00435240 OBJECTIVES To identify diabetes-related characteristics of individuals at different stages of readiness to change to healthy , low-fat eating . RESEARCH DESIGN AND METHODS Stage-based differences in demographic , eating-related , health care utilization , and psychosocial factors were examined in a sample of 768 overweight ( BMI > 27 kg/m(2 ) ) individuals with diabetes enrolled in a r and omized behavioral intervention trial . RESULTS Stage-based differences occurred for type 1 diabetic participants on percent of calories from fat and number of daily vegetable servings . For type 2 diabetic participants , sex , disease-specific quality of life , percent calories from fat , and number of daily vegetables servings differed across stages . Those in action stages were more likely to be female and have a better quality of life and healthier eating habits . Type 2 diabetic insulin-requiring participants in action stages were more likely to be married . Social support was highest for those in the contemplation stage and lowest for those in the action stage . Type 2 diabetic participants on pills in the action stages were older , had a lower BMI , ate more fruit , were nonsmokers , recently attended diabetes education , had a better quality of life and social support , and had less stress . One anomalous finding for type 2 diabetic participants was that precontemplators scored similarly to those in action stages . CONCLUSIONS These data vali date the Transtheoretical Model , where those in the action stages displayed healthier eating . They also indicate that demographic and psychosocial factors may mediate readiness to change diet . Precontemplators were a heterogeneous group and may need individually tailored interventions Data from two r and omized clinical trials ( RCT ) were used to examine the extent to which a health promotion intervention affected changes in growth trajectories of psychosocial constructs and if so , whether these constructs in turn explained changes in physical activity ( PA ) . PA and psychosocial measures on 842 overweight adults in the United States were collected in two RCTs evaluating Internet-based behavior change interventions with assessment s at baseline , 6 and 12 months . A physical activity latent variable at 12 months was created using indicators of self-reported walking and leisure time activities . Intervention-mediated effects on PA at 12 months were found via latent growth curves representing self-efficacy and behavioral strategies , where increasing growth curves across time were associated with higher PA values at 12 months . These findings provide some evidence that web-based self-help intervention programs worked through targeted behavior change constructs to influence physical activity levels in overweight adults Background Successfully transferring the findings of expensive and tightly controlled programmes of intensive lifestyle modification to the primary care setting is necessary if such knowledge is to be of clinical utility . The objective of this study was to test whether intensive lifestyle modification , shown previously in tightly-controlled clinical trials to be efficacious for diabetes risk-reduction among high-risk individuals , can reduce cardiovascular risk factor levels in the primary care setting . Methodology / Principal Findings The Swedish Björknäs study was a r and omized controlled trial conducted from 2003 to 2006 with follow-up on cardiovascular risk factors at 3 , 12 , 24 and 36 months . A total of 151 middle-aged men and women at moderate- to high-risk of cardiovascular disease from northern Sweden were r and omly assigned to either an intensive lifestyle intervention ( n = 75 ) or control ( n = 76 ) group . The intervention was based broadly on the protocol of the Diabetes Prevention Program . The three-month intervention period was administered in the primary care setting and consisted of supervised exercise sessions and diet counselling , followed by regular group meetings during three years . The control group was given general advice about diet and exercise and received st and ard clinical care . Outcomes were changes in anthropometrics , aerobic fitness , self-reported physical activity , blood pressure , and metabolic traits . At 36 months post-r and omisation , intensive lifestyle modification reduced waist circumference ( −2.2 cm : p = 0.001 ) , waist-hip ratio ( −0.02 : p<0.0001 ) , systolic blood pressure ( −4.9 mmHg : p = 0.036 ) , and diastolic blood pressure ( −1.6 mmHg : p = 0.005 ) , and improved aerobic fitness ( 5 % ; p = 0.038 ) . Changes in lipid or glucose values did not differ statistically between groups . At 36 months , self-reported time spent exercising and total physical activity had increased more in the intervention group than in the control group ( p<0.001 ) . Conclusion / Significance A program of intensive lifestyle modification undertaken in the primary health care setting can favourably influence cardiovascular risk-factor profiles in high-risk individuals . Trial Registration Clinical Trials.gov Background Research on the motivational model proposed by Self-Determination Theory ( SDT ) provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors , and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation . Although obesity is notoriously difficult to reverse and its recidivism is high , adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term . The purpose s of this study are twofold : i ) to describe a 3-year r and omized controlled trial ( RCT ) aim ed at testing a novel obesity treatment program based on SDT , and ii ) to present the rationale behind SDT 's utility in facilitating and explaining health behavior change , especially physical activity/exercise , during obesity treatment . Methods Study design , recruitment , inclusion criteria , measurements , and a detailed description of the intervention ( general format , goals for the participants , intervention curriculum , and main SDT strategies ) are presented . The intervention consists of a 1-year group behavioral program for overweight and moderately obese women , aged 25 to 50 ( and pre-menopausal ) , recruited from the community at large through media advertisement . Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team ( 30 2 h sessions in total ) , and go through a program covering most topics considered critical for successful weight control . These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines . Comparison group receive a general health education curriculum . After the program , all subjects are follow-up for a period of 2 years . Discussion Results from this RCT will contribute to a better underst and ing of how motivational characteristics , particularly those related to physical activity/exercise behavioral self-regulation , influence treatment success , while exploring the utility of Self-Determination Theory for promoting health behavior change in the context of obesity . Trial Registration Clinical Trials Gov. Identifier Research on the conceptualization of adherence to treatment has not addressed a key question : Is adherence best defined as being a uni-dimensional or multi-dimensional behavioral construct ? The primary aim of this study was to test which of these conceptual models best described adherence to a weight management program . This ancillary study was conducted as a part of the POUNDS LOST trial that tested the efficacy of four dietary macronutrient compositions for promoting weight loss . A sample of 811 overweight/obese adults was recruited across two clinical sites , and each participant was r and omly assigned to one of four macronutrient prescriptions : ( 1 ) Low fat ( 20 % of energy ) , average protein ( 15 % of energy ) ; ( 2 ) High fat ( 40 % ) , average protein ( 15 % ) ; ( 3 ) Low fat ( 20 % ) , high protein ( 25 % ) ; ( 4 ) High fat ( 40 % ) , high protein ( 25 % ) . Throughout the first 6 months of the study , a computer tracking system collected data on eight indicators of adherence . Computer tracking data from the initial 6 months of the intervention were analyzed using exploratory and confirmatory analyses . Two factors ( accounting for 66 % of the variance ) were identified and confirmed : ( 1 ) behavioral adherence and ( 2 ) dietary adherence . Behavioral adherence did not differ across the four interventions , but prescription of a high fat diet ( vs. a low fat diet ) was found to be associated with higher levels of dietary adherence . The findings of this study indicated that adherence to a weight management program was best conceptualized as being multi-dimensional , with two dimensions : behavioral and dietary adherence BACKGROUND The increasing prevalence of overweight and obesity underscores the need for evidence -based , easily disseminable interventions for weight management that can be delivered on a population basis . The Transtheoretical Model ( TTM ) offers a promising theoretical framework for multiple behavior weight management interventions . METHODS Overweight or obese adults ( BMI 25 - 39.9 ; n=1277 ) were r and omized to no-treatment control or home-based , stage-matched multiple behavior interventions for up to three behaviors related to weight management at 0 , 3 , 6 , and 9 months . All participants were re-assessed at 6 , 12 , and 24 months . RESULTS Significant treatment effects were found for healthy eating ( 47.5 % versus 34.3 % ) , exercise ( 44.90 % versus 38.10 % ) , managing emotional distress ( 49.7 % versus 30.30 % ) , and untreated fruit and vegetable intake ( 48.5 % versus 39.0 % ) progressing to Action/Maintenance at 24 months . The groups differed on weight lost at 24 months . Co-variation of behavior change occurred and was much more pronounced in the treatment group , where individuals progressing to Action/Maintenance for a single behavior were 2.5 - 5 times more likely to make progress on another behavior . The impact of the multiple behavior intervention was more than three times that of single behavior interventions . CONCLUSIONS This study demonstrates the ability of TTM-based tailored feedback to improve healthy eating , exercise , managing emotional distress , and weight on a population basis . The treatment produced a high level of population impact that future multiple behavior interventions can seek to surpass BACKGROUND There is a paucity of r and omised controlled trials of weight management in primary care . AIM To ascertain the feasibility of a full trial of a nurse-led weight-management programme in general practice . DESIGN OF STUDY Factorial r and omised control trial . SETTING Primary care , UK . METHOD A total of 123 adults ( 80.3 % women , mean age 47.2 years ) with body mass index > or = 27 kg/m(2 ) , recruited from eight practice s , were r and omised to receive structured lifestyle support ( n = 30 ) , structured lifestyle support plus pedometer ( n = 31 ) , usual care ( n = 31 ) , or usual care plus pedometer ( n = 31 ) for a 12-week period . RESULTS A total of 103 participants were successfully followed up . The adjusted mean difference in weight in structured support compared to usual care groups was -2.63 kg ( 95 % confidence interval [ CI ] = -4.06 to -1.20 kg ) , and for pedometer compared to no pedometer groups it was -0.11 kg ( 95 % CI = -1.52 to 1.30 kg ) . One in three participants in the structured-support groups ( 17/50 , 34.0 % ) lost 5 % or more of their initial weight , compared to less than one in five ( 10/53 , 18.9 % ) in usual-care groups ; provision of a pedometer made little difference ( 14/48 , 29.2 % pedometer ; 13/55 , 23.6 % no pedometer ) . Difference in waist circumference change between structured-support and usual-care groups was -1.80 cm ( 95 % CI = -3.39 to -0.20 cm ) , and between the pedometer and no pedometer groups it was -0.84 cm ( 95 % CI = -2.42 to 0.73 cm ) . When asked about their experience of study participation , most participants found structured support helpful . CONCLUSION The structured lifestyle support package could make substantial contributions to improving weight-management services . A trial of the intervention in general practice is feasible and practicable OBJECTIVES We tested a community-based intervention design ed to reduce cardiovascular disease risk in sedentary midlife and older women who were overweight or obese . METHODS In a r and omized controlled trial conducted in 8 counties in Arkansas and Kansas , counties were assigned to the intervention ( a 12-week twice-weekly heart health program ) group or to the delayed-intervention control group . Ten to fifteen women were selected from each site , and participants ' weight , waist circumference , diet , physical activity , and self-efficacy were measured before and after the intervention . Data were analyzed with multiple regressions . RESULTS Compared with the control group , participants in the intervention group had a significant decrease in body weight ( -2.1 kg ; 95 % confidence interval [ CI ] = -3.2 , -1.0 ) , waist circumference ( -2.3 in ; 95 % CI = -4.2 , -0.5 ) , and energy intake ( -390 kcal/day ; 95 % CI = -598 , -183 ) ; an increase in activity ( + 1637 steps/day ; 95 % CI = 712 , 2562 ) ; and an increase in self-efficacy for dietary and physical activity behaviors . CONCLUSIONS Our results suggest that a community-based program can improve self-efficacy , increase physical activity , and decrease energy intake , result ing in decreased waist circumference and body weight among at-risk women OBJECTIVE To investigate the effects of intensive counseling on eating behavior and weight loss and maintenance and their associations . METHODS A r and omized weight loss counseling intervention with follow-up of 18 months , conducted between 2002 - 2004 at Oulu University Hospital , Finl and included obese adults ( n=82 , body mass index > 27 kg/m(2 ) ) . Subjects were r and omized into 1 ) intensive counseling and 2 ) short-term counseling . Forty-nine subjects who completed the study were included . Eating behavior was repeatedly assessed by the Three Factor Eating Question naire-18 and Binge Eating Scale . RESULTS Eating behavior improved in both groups . Effect of counseling was -5.0+/-5.7 kg compared with -2.4+/-2.5 kg in the control group ( p<0.05 between the groups ) during the first 6 months . At 18 months the weight loss results were -2.6+/-6 kg and -0.7+/-3.5 kg , respectively ( NS ) . Success in weight loss maintenance is associated with improved eating behavior ( p<0.05 ) . By contrast , failure in weight loss is associated with high scores of uncontrolled eating and binge eating symptoms at the baseline ( p<0.05 ) . CONCLUSIONS Both intensive and short-term interventions improved eating behavior and weight loss but there was no difference between the two modes of intervention . The association between the improvement of eating behaviour and the success of weight loss suggests a causal relationship which however should be confirmed in a prospect i ve study focusing specifically on this aspect OBJECTIVE To describe the stages of change that take place over 18 months , using the criterion of fat intake < or = 30 % of total energy to define effective action and to investigate the effect of a single dietary feedback report on dietary fat reduction . DESIGN Subjects were r and omly assigned to experimental or control conditions and assessed at 0 , 6 , 12 , and 18 months for fat intake and stage of change . Subjects in the experiment group received 1 feedback report at baseline ; all subjects received a report at 12 months . SUBJECTS Potential subjects ( n = 614 ) were recruited by mail from a r and om sample of nonsmoking adults ( 32 % response rate ) . Subjects were excluded if consuming < or = 30 % of energy from fat or if pregnant or lactating ( n = 145 ) . Although 83 % of subjects ( n = 389 ) completed the 18-month study , only 296 provided complete data for all time points . The study was restricted to these 296 . INTERVENTION Dietary feedback reports plus brief educational material s were provided following the experiment design . ANALYSES Repeated measures analysis of variance with fat intake ( percent of energy from fat ) as the dependent variable and baseline stage and condition as independent variables . In addition , t tests were used to compare groups at specific time points . RESULTS There was a main effect for time ( F3,286 = 39 , P < .0001 ) and baseline stage ( F3,286 = 24 , P < .0001 ) , but no effect of feedback . There was a time-by-feedback interaction ( F4,286 = 4.7 , P < .01 ) . There was a short-term effect of feedback over 6 months ( t = 3.8 , P < .001 ) , but this effect was not significant at other time points . About 9 % to 12 % of subjects in the precontemplation or contemplation stages , 24 % of subjects in the preparation stage , and 40 % of unclassified subjects at baseline progressed to the action stage by 18 months . Between 12 and 18 months , subjects progressing at least 1 stage reduced their fat intake to a greater extent than subjects who failed to progress ( t = 5.1 , P < .0001 ) . IMPLICATION S Interventions targeted to stage of change have the potential for accelerating the rate of change for dietary fat reduction , but reaching the goal of fat intake < or = 30 % of total energy may require more intensive interventions than a single dietary feedback report Background To our knowledge , no studies have evaluated whether weight loss can be promoted in overweight adults through the use of an intervention that is largely based on daily SMS ( Short Message Service : text ) and MMS ( Multimedia Message Service : small picture ) messages transmitted via mobile phones . Objective This paper describes the development and evaluation of a text message – based intervention design ed to help individuals lose or maintain weight over 4 months . Methods The study was a r and omized controlled trial , with participants being exposed to one of the following two conditions , lasting 16 weeks : ( 1 ) receipt of monthly printed material s about weight control ; ( 2 ) an intervention that included personalized SMS and MMS messages sent two to five times daily , printed material s , and brief monthly phone calls from a health counselor . The primary outcome was weight at the end of the intervention . A mixed-model repeated- measures analysis compared the effect of the intervention group to the comparison group on weight status over the 4-month intervention period . Analysis of covariance ( ANCOVA ) models examined weight change between baseline and 4 months after adjusting for baseline weight , sex , and age . Results A total of 75 overweight men and women were r and omized into one of the two groups , and 65 signed the consent form , completed the baseline question naire , and were included in the analysis . At the end of 4 months , the intervention group ( n = 33 ) lost more weight than the comparison group ( −1.97 kg difference , 95 % CI −0.34 to −3.60 kg , P = .02 ) after adjusting for sex and age . Intervention participants ’ adjusted average weight loss was 2.88 kg ( 3.16 % ) . At the end of the study , 22 of 24 ( 92 % ) intervention participants stated that they would recommend the intervention for weight control to friends and family . Conclusions Text messages might prove to be a productive channel of communication to promote behaviors that support weight loss in overweight adults . Trial Registration Clinical trials.gov NCT00415870 ; http:// clinical trials.gov/ct2/show/NCT00415870 ( Archived by WebCite at http://www.webcitation.org/5dnolbkFt OBJECTIVE To assess the effects of stage-matched nutrition counseling on stages of change and fat intake . DESIGN Controlled clinical trial . SETTING 9 family practice s in a family medicine practice network . PARTICIPANTS 143 patients at elevated cardiovascular risk , aged 40 to 70 years . INTERVENTION Intervention patients received stage-matched counseling from their family physician and a dietitian . Control patients received usual care . MAIN OUTCOME MEASURES Stages of change and fat intake were measured at baseline and after 6 and 12 months . ANALYSIS Chi-squared tests , t tests , and regression analyses ( alpha = .05 ) were conducted . RESULTS More patients in the intervention group than in the control group were in the postpreparation stage after 6 months ( 70 % vs 35 % ; P < .01 ) but not after 12 months ( 70 % vs 55 % ; P = .10 ) . Between 0 and 12 months , the reduction in total fat intake ( -5.6 % kcal vs -2.4 % kcal ) was largest in the intervention group . CONCLUSIONS AND IMPLICATION S Stage-matched nutrition counseling promotes movement through stages of change , result ing in a reduced fat intake . Our results partly support stages of change as a tool for behavior change . Movement across stages of change was not an intermediating factor in the intervention effects . Research should focus on feasible ways to keep patients in the postpreparation stage The aim of the project was to reach inactive people through primary care offices and motivate them to become more active for health purpose s. Physical activity question naires based on the transtheoretical model ( TM ) of behaviour change were h and ed out to every person entering one of five primary care offices . All inactive people were entered into a r and omised controlled trial ( RCT ) . Individuals assigned to the feedback group were given feedback from their physician concerning their physical activity level . In addition , the advice plus group received further advice and stage matched leaflets and was offered a 45-min counselling session . Changes in physical activity behaviour were measured 7 weeks as well as 14 months after the intervention . Physicians and patients alike reacted positively to the project . Ninety percent of patients entering the primary care offices were willing to participate . Ninety percent of inactive people agreed to be entered into the RCT . The follow-up rate in this trial was 82 % at 14 months . At 7 weeks , 35 % of patients in the feedback group were now classified as active and 38 % of patients in the advice plus group . At 14 months , 47 % of the subjects in both groups were active . Inactive people can be reached effectively through primary care offices . Patients receiving feedback from their physician concerning their physical activity level improved their behaviour to the same extent as patients who were given further advice and written material s , and were offered a counselling session BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial , diabetes incidence in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups . On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) OBJECTIVE To compare health benefits achieved in a transtheoretical model-chronic disease ( TM-CD ) minimal intervention for obesity vs. augmented usual care ( AUC ) . RESEARCH METHOD AND PROCEDURES This was a 2-year , r and omized clinical trial with overweight or obese men and women from 15 primary care sites . AUC ( n = 336 ) included dietary and exercise advice , prescriptions , and three 24-hour dietary recalls every 6 months . TM-CD care ( n = 329 ) included AUC elements plus " stage of change " ( SOC ) assessment s for five target behaviors every other month , mailed SOC and target behavior-matched workbooks , and monthly telephone calls from a weight-loss advisor . Weight change was the primary outcome . RESULTS Repeated measures models under the missing at r and om assumption yielded nonsignificant adjusted differences between the AUC and TM-CD groups for weight change , waist circumference , energy intake or expenditure , blood pressure , and blood lipids . The pattern of change over time suggested that TM-CD participants were trying harder to impact target behaviors during the first 6 to 12 months of the trial but relapsed afterward . Sixty percent of trial participants maintained their baseline weights for 18 to 24 months . DISCUSSION A combination of mailed patient material s and monthly telephone calls based on the transtheoretical model and some elements of chronic disease care is not powerful enough , relative to AUC , to alter target behaviors among overweight primary care patients in an obesogenic environment . AUC may be sufficient to maintain weights among at-risk primary care patients BackgorundMixed hyperlipidemia is common in patients with diabetes . Statins , the choice drugs , are effective at reducing lipoproteins that contain apolipoprotein B100 , but they fail to exert good control over intestinal lipoproteins , which have an atherogenic potential . We describe the effect of prescription omega 3 fatty acids on the intestinal lipoproteins in patients with type 2 diabetes who were already receiving fluvastatin 80 mg per day . Methods Patients with type 2 diabetes and mixed hyperlipidemia were recruited . Fasting lipid profile was taken when patients were treated with diet , diet plus 80 mg of fluvastatin and diet plus fluvastatin 80 mg and 4 g of prescription omega 3 fatty acids . The intestinal lipoproteins were quantified by the fasting concentration of apolipoprotein B48 using a commercial ELISA . Results The addition of 4 g of prescription omega 3 was followed by significant reductions in the levels of triglycerides , VLDL triglycerides and the triglyceride/HDL cholesterol ratio , and an increase in HDL cholesterol ( P < 0.05 ) . Fluvastatin induced a reduction of 26 % in B100 ( P < 0.05 ) and 14 % in B48 ( NS ) . However , the addition of omega 3 fatty acids enhanced this reduction to 32 % in B100 ( NS ) and up to 36 % in B48 ( P < 0.05 ) . Conclusion Our preliminary findings therefore suggest an additional benefit on postpr and ial atherogenic particles when omega 3 fatty acids are added to st and ard treatment with fluvastatin OBJECTIVE To develop and evaluate the long-term effectiveness of an intervention program , based on preaction-stage-oriented change processes of the Transtheoretical Model of Behavior Change , that could be delivered in a group setting to help participants lower dietary fat intake . DESIGN An enhanced version of the nonequivalent control group experimental design was used . Entire sections of an undergraduate introductory nutrition science course were assigned to an experimental , pretest/posttest control , or posttest-only control group . Daily fat intake and stage of change of the experimental and pretest/posttest control groups were determined at the pretest and posttest and 1-year later at a follow-up test . Every 1 to 2 weeks during the study , stage of change of the experimental group was assessed . Daily fat intake of the experimental group was assessed at study midpoint . Daily fat intake and stage of change of the posttest-only control group was determined at the posttest . Pretest results were used to place participants of the experimental and pretest/posttest control groups in either the preaction stage ( i.e. , precontemplation , contemplation , or preparation ) or the action/maintenance stage . SUBJECTS/ SETTING The sample consisted of 38 , 30 , and 42 undergraduate students who were assigned to the experimental , pretest/posttest control , and posttest-only control groups , respectively . INTERVENTION The experimental group participated in a group-based , dietary fat intake intervention that included a series of 11 lessons taught over a 14-week period . Each lesson was based on 1 or 2 of the preaction-stage-oriented change processes of the Transtheoretical Model . MAIN OUTCOME MEASURES Data were evaluated to determine the effects of the intervention program on long-term dietary fat reduction and stage of change progression . STATISTICAL ANALYSIS PERFORMED Analysis of variance , repeated- measures analysis of variance , and paired t tests . RESULTS For pretest and posttest dietary fat intake scores , stage and time were significant , and there was a significant time-by-stage interaction . Time was significant for pretest and posttest stage scores . Subjects in the preaction-stage experimental group significantly increased their mean stage of change and reduced their fat intake between the pretest and posttest ; these changes persisted for 1 year . Pretest/posttest control group participants who began in a preaction stage also significantly increased their mean stage and reduced fat intake by the posttest , but these changes did not endure until the follow-up test . APPLICATIONS/ CONCLUSIONS This intervention program produced an enduring , significant reduction in mean dietary fat consumption and a significant progression in mean stage of change of subjects in the experimental group who were in the preaction stage . It may be appropriate to design group interventions to use preaction stage processes rather than the more traditionally used action and maintenance stages change processes The Prevention and Reduction of Obesity through Active Living ( PROACTIVE ) is a r and omised controlled trial to evaluate the effectiveness of a behaviourally based physical activity and diet composition programme to prevent and reduce obesity and related comorbidities in a primary healthcare setting . 491 abdominally obese men and women 25–75 years of age who were patients of primary care physicians were r and omly assigned to either a usual care group ( N = 242 ) or a behavioural intervention group ( N = 249 ) . Those in usual care received general advice from the physician regarding the merits of physical activity and a healthy diet as a strategy for obesity reduction . Those in the behavioural intervention group received an individually design ed counselling programme from a specially trained health educator , with respect to physical activity , diet and obesity reduction . The study was design ed to provide 95 % power in both men and women to detect a 2 % ( 2 cm ) difference in waist circumference and 80 % power to identify a 15 % reduction in the prevalence of the metabolic syndrome , the two primary outcomes . PROACTIVE is the first behavioural intervention study to assess the effects of physical activity and diet on abdominal obesity and associated metabolic risk factors in a primary healthcare setting , include a generalised sample of men and women and examine long-term ( 24 months ) effects . PROACTIVE has the potential to provide the basis for changing clinical practice ( primary care ) with respect to the prevention and reduction of obesity and related health risks . The purpose of this report is to present and discuss the rationale , design and methods of PROACTIVE OBJECTIVE In this r and omized controlled study , a st and ardized motivation intervention was compared with a relaxation intervention with regard to its effectiveness in decreasing dropout rates and increasing physical activity in a sample of obese patients . METHOD Thirty-eight obese participants were r and omly assigned to a one-session motivation or relaxation intervention . Thereafter , both groups participated in an 8-week aerobic program . Adherence , physical activity , motivational stage of change , and body mass index ( BMI ) were assessed during intervention and at 3- and 6-month follow-ups . RESULTS During the aerobic program , the motivation group showed significantly fewer dropouts but comparable adherence if only completers were considered . Moreover , their weekly minutes of physical activity increased over time before leveling off , whereas steady decreases were observed in the relaxation group . For motivational stage of change and BMI , no significant group differences were observed . DISCUSSION The importance and efficacy of motivational interventions in enhancing the high dropout rates in obesity treatment is underlined OBJECTIVE To test the feasibility of the " Rolling Store , " an innovative food-delivery intervention , along with a nutrition education program to increase the consumption of healthy foods ( fruits and vegetables ) to prevent weight gain in African American women . METHODS Forty eligible African American women were enrolled in the study and r and omized to intervention or control groups . A trained peer educator and a Rolling Store operator implemented the study protocol at a local community center . RESULTS The program retention rate was 93 % . Participants in the intervention group lost a mean weight of 2.0 kg , while participants in the control group gained a mean weight of 1.1 kg at six months . Overall participants showed a mean decrease in weight of -.4 kg ( st and ard deviation 3.0 kg ) , but the intervention group lost significantly more weight and had a decreased body mass index at six months . In the intervention group , the average number of servings consumed per day of fruits/ fruit juice and vegetables significantly increased at six months . CONCLUSIONS The Rolling Store , at least on the small scale on which it was implemented , is a feasible approach to producing weight loss and improvements in healthy eating when combined with an educational program in a small community center A match-mismatch test was conducted to test the transtheoretical model applied to fruit intake . Precontemplators and contemplators were r and omly assigned to receive a web-based individualized precontemplation feedback ( PCF ) , contemplation feedback ( CF ) or action feedback ( AF ) letter promoting fruit intake . Immediately and 1 week after reading this letter , post-test measures were obtained . Fruit intake increased significantly between pre- and post-test in contemplators , but not in precontemplators . No differences between the feedback conditions were found in fruit intake , stage progression , use or credibility of the feedback in precontemplators and contemplators . In precontemplators , also no differences between the conditions were found in personal relevance of the feedback . Contemplators , however , rated AF as more personally relevant than PCF or CF . To conclude , the present study failed to show superiority of stage-matched information in the promotion of fruit intake Physical activity interventions targeting social and physical environments of the urban poor hold promise in improving health outcomes in underserved communities . This study r and omly assigned overweight , sedentary , economically disadvantaged adults to one of three intervention conditions at The Hope and Healing Center , a large inner-city health facility providing numerous options for exercise . Within the tenets of Social Action Theory , the Health Opportunities with Physical Exercise ( HOPE ) trial will test the efficacy of two behavior change models , social support and patient-provider interaction , to increase physical activity . In addition to a st and ard care condition , in which patients have open access to Hope and Healing physical activity programming , patients were assigned to one of two behavior change interventions . Those assigned to patient-peer receive face-to-face , systematic and scheduled encouragement from study -trained ' peer ' interventionists at the facility . Patients assigned to patient-provider receive face-to-face , systematic and scheduled encouragement provided by study -trained ' provider ' interventionists also at the facility . The primary outcomes of change in exercise behavior will be documented by self-reported physical activity and confirmed by fitness testing at baseline , 6 , 12 and 24 months during the 1 year of active intervention and 1 year of relapse prevention follow-up . Intervention conditions will be compared on psychosocial mediators including motivational appraisal s , ratings of social support , rapport , problem solving and self-efficacy for overcoming barriers to increased physical activity . Novel aspects of this intervention include : ( 1 ) delivery of socially based physical activity interventions to an economically disadvantaged urban population , ( 2 ) reduction of environmental barriers to be physically active and ( 3 ) emphasis on social interactions influencing health habit change . Results of this study have the potential to identify mechanisms of behavior change that could be adopted by physical activity interventions aim ed at reducing sedentary behavior and health disparities in high-risk , underserved population OBJECTIVE To evaluate effect of exercise consultation on physical activity and result ant physiological and biochemical variables at 6 months in people with type 2 diabetes . RESEARCH DESIGN AND METHODS A total of 70 inactive people with type 2 diabetes were given st and ard exercise information and were r and omized to receive an exercise consultation ( n = 35 ) or not ( n = 35 ) . Exercise consultation , based on the transtheoretical model , combines motivational theory and cognitive behavioral strategies into an individualized intervention to promote physical activity . Changes from baseline to 6 months were assessed in 1 ) physical activity ( 7-day recall , accelerometer , cardiorespiratory fitness , stage , and processes of change ) , 2 ) physiological variables ( blood pressure and BMI ) , and 3 ) biochemical variables ( HbA(1c ) , lipid profile , and fibrinogen ) . RESULTS Between-group differences were recorded for the change in minutes of moderate activity ( P < 0.001 ) and activity counts ( P < 0.001 ) per week . Experimental participants recorded an increase in activity counts per week and minutes of moderate activity per week ( P < 0.001 ) . The control group recorded no significant changes . More experimental participants increased stage of change ( chi(2 ) = 22.6 , P < 0.001 ) . Between-group differences were recorded for the change in total exercise duration and peak gradient ( P < 0.005 ) , HbA(1c ) ( P = 0.02 ) , systolic BP ( P = 0.02 ) , and fibrinogen ( P = 0.03 ) . CONCLUSIONS Exercise consultation increased physical activity and improved glycemic control and cardiovascular risk factors in people with type 2 diabetes Objective : To examine the effects of 17 weeks of physical exercise and micronutrient supplementation on the psychological wellbeing of 139 independently living , frail , elderly subjects ( inactive , body mass index ≤25 or experiencing weight loss ) . Methods : Participants ( mean ( SD ) age 78.5 ( 5.7 ) ) were r and omly assigned to : ( a ) comprehensive , moderate intensity , group exercise ; ( b ) daily micronutrient enriched foods ( 25–100 % recommended daily amount ) ; ( c ) both ; ( d ) neither . A social programme and identical regular foods were offered as attention control and placebo . Results : At baseline , moderate to low but significant correlations were found between general wellbeing scores and physical fitness ( r = 0.28 ) , functional performance ( r = 0.37 ) , and blood concentrations of pyridoxine ( r = 0.20 ) , folate ( r = 0.25 ) , and vitamin D ( r = 0.23 ) ( all p values ≤0.02 ) , but not with physical activity levels and other blood vitamin concentrations . General wellbeing score and self rated health were not responsive to 17 weeks of exercise or nutritional intervention . Conclusion : Psychological wellbeing in frail elderly people was not responsive to 17 weeks of intervention with exercise and /or micronutrient enriched foods . The moderate but significant correlations between wellbeing and physical fitness and several blood vitamin concentrations at baseline suggest that changes in wellbeing may occur after long term interventions OBJECTIVE To test the efficacy in promoting brisk walking of two theory-based interventions that incorporate implementation intentions and text message ( Short Message Service ; SMS ) reminders directed at one 's walking-related plans or goals . DESIGN Participants ( N = 149 ) were r and omized to one of three conditions ( implementation intention + SMS plan reminder , implementation intention + SMS goal reminder , control ) before completing measures at baseline and follow-up 4 weeks later . At follow-up , the experimental groups were given a surprise recall task concerning their plans . All participants completed an equivalent goal recall task . MAIN OUTCOME MEASURES Vali date d self-report measures of physical activity and measures of implementation intention and goal recall , weight , and waist-to-hip ratio . RESULTS Both intervention groups increased their brisk walking relative to the control group , without reducing other physical activity . The goal reminder group lost the most weight . The SMS plan reminder group recalled more of their plans than the SMS goal reminder group , but the latter were more successful in goal recall . CONCLUSION Both interventions can promote brisk walking in sedentary population s. Text messages aid the recall of , and could enhance interventions that target , implementation intentions and goals BACKGROUND In the U.S. , Latinos report particularly high levels of inactivity and related chronic illnesses and are in need of intervention . Thus , the purpose of the current study was to culturally and linguistically adapt an empirically supported , individually tailored physical activity print intervention for Latinos and then conduct an RCT of the modified program . DESIGN An RCT was conducted . SETTING / PARTICIPANTS The sample included 93 overweight/obese ( 80 % ) Latinas with low income and acculturation . INTERVENTION Data were collected in 2007 - 2008 and analyzed by intent-to-treat in 2009 . Participants were r and omly assigned to either ( 1 ) a culturally and linguistically adapted physical activity intervention ( Seamos Activas ) or ( 2 ) a wellness contact control condition . MAIN OUTCOME MEASURES Self-report physical activity , as measured pre- and post-intervention ( 6 months , 87 % retention ) by the 7-Day Physical Activity Recall . RESULTS Moderate-intensity ( or greater ) physical activity increased from an average of 16.56 minutes/week ( SD=25.76 ) at baseline to 147.27 ( SD=241.55 ) at 6 months in the intervention arm ( n=45 ) , and from 11.88 minutes/week ( SD=21.99 ) to 96.79 ( SD=118.49 ) in the wellness contact control arm ( n=48 ) . No between-group differences were seen in overall physical activity . Intervention participants reported significantly greater increases in cognitive ( F[1 , 91]=9.53 , p=0.003 ) and behavioral processes of change ( F[1 , 91]=8.37 , p=0.005 ) and available physical activity supplies and equipment at home ( F[1 , 91]=4.17 , p=0.04 ) than control participants . CONCLUSIONS Results supported the hypothesized feasibility , acceptability , and preliminary efficacy of individually tailored physical activity print interventions among Latinas . Although more research is needed to corroborate these findings , such high-reach , low-cost approaches have great potential to positively affect public health . TRIAL REGISTRATION NCT00724165 An estimated 60 % of individuals prescribed lipid-lowering medications are nonadherent . Failure to adhere increases morbidity , mortality , healthcare utilization , and healthcare costs . This study examined the effectiveness of a population -based , individualized Transtheoretical Model ( TTM ) expert system intervention to improve adherence and increase exercise and diet in a r and omized 18-month trial involving 404 adults . Compared to usual care , treatment participants who started in a pre-action stage were significantly more likely to be in the Action and Maintenance ( A/M ) stages for adherence at end of treatment ( 55.3 % versus 40 % , z = 2.11 , p < 0.05 , h = 0.31 ) and at 18-months ( 56 % versus 37.8 % , z = 2.38 , p < 0.01 , h = 0.36 ) . The treatment group scored significantly better on two measures of adherence at six and 12 months post-treatment ( all p < 0.05 , odds ratios [ OR ] 1.49 - 3.67 ) . Among those who began in A/M , treatment participants were significantly more likely to remain in A/M at 18 months ( 85.2 % versus 55.6 % , z = 2.63 , p < 0.01 , h = 0.67 ) . Those receiving treatment were significantly more likely to progress to A/M for exercise and dietary fat reduction ( 43.3 % versus 24.7 % for exercise , and 24.7 % versus 12.5 % for diet ) . TTM expert system interventions can have a significant impact on entire population s for adherence . Results for dietary fat and exercise suggest covariation of treatment effects Purpose . The objectives of this study were to develop a stage-of-change classification system and to determine the degree to which various adult subgroups have adopted the behavioral changes necessary to achieve a low-fat and /or high-fiber diet as recommended by the Dietary Guidelines for Americans . Design . The study used a mail survey r and omly sent to 7110 adults . Setting . The survey was conducted in 11 states and the District of Columbia . Subjects . The r and om sample included males and females over age 18 . Of the eligible respondents , 3198 ( 51.5 % ) were included in this analysis , with 2004 and 2066 unambiguously classified into stages of change for fat and fiber , respectively . Measures . Stage of change was defined by an algorithm based on self-reported intent and behaviors to limit fat and /or increase fiber . Results . 45 % of the respondents were classified as being in action/maintenance for fat and 38 % for fiber . Women , older adults , individuals with advanced education , persons with diet-related chronic disease , people with higher levels of relevant nutrition knowledge and attitudes , and persons who indicated that health concerns were a primary influence on their diet were more likely to be in action/maintenance than other respondents . Conclusions . The algorithm in this study presents a model that more closely reflects the proportions of the adult population that have achieved low-fat diets and classifies a greater proportion in the preparation stage than classification systems in previous studies OBJECTIVES We examined whether adding behavioral weight loss strategies could improve the outcomes of a community weight loss campaign . METHODS Shape Up RI is a 12-week , online , team-based program for health improvement in Rhode Isl and . In study 1 , we r and omly assigned participants to the st and ard Shape Up RI program or to the program plus video lessons on weight loss . In study 2 , we r and omly assigned participants to the st and ard program or to the program plus video lessons ; daily self-monitoring of weight , eating , and exercise ; and computer-generated feedback . RESULTS Adding video lessons alone ( study 1 ) did not result in significantly improved weight loss ( 2.0 ±2.8 kg vs 1.4 ±2.9 kg ; P = .15 ) . However , when the video lessons were supplemented with self-monitoring and feedback ( study 2 ) , the average weight loss more than doubled ( 3.5 ±3.8 kg vs 1.4 ±2.7 kg ; P < .01 ) , and the proportion of individuals achieving a weight loss of 5 % or more tripled ( 40.5 % vs 13.2 % ; P < .01 ) . Participants in study 2 su bmi tted self-monitoring records on 78 % of days , and adherence was significantly related to outcome . CONCLUSIONS Adding behavioral strategies to community campaigns may improve weight loss outcomes with minimal additional cost BACKGROUND There is increasing interest in developing interventions to promote physical activity ( PA ) that do not involve face-to-face contact with health professionals . We developed a fully automated PA counseling system ( telephone-linked communication , TLC-PA ) that was delivered via telephone . DESIGN A r and omized , controlled trial with 298 adult , sedentary members ( mean age , 45.9 years ; 72 % women ; 45 % white ; and 45 % African American ) of a multi-site medical practice . The comparison group ( TLC-Eat ) received an automated intervention promoting healthy eating , which was also delivered via telephone . INTERVENTION The TLC-PA promoted moderate-intensity PA ( MI-PA ) based on the transtheoretical model of behavior change and social cognitive theory . The system was available to participants for 6 months . MAIN OUTCOMES Energy expenditure in MI-PA , proportion of participants who met recommendations for MI-PA , and motivational readiness for PA . MEASURES Self-reports of PA behavior and motivational readiness at baseline , 3 months , and 6 months . RESULTS At 3 months , intention-to-treat analyses showed that the TLC-PA group was more likely to meet recommendations for MI- or vigorous-intensity PA ( VI-PA ) compared to the TLC-Eat group ( TLC-PA=26 % vs TLC-Eat=19.6 % , p=0.04 ) . Among study completers , TLC-PA subjects reported significantly higher daily kilocalorie energy expenditure in MI-PA ( 2.3 kcal/kg/d vs 2.0 kcal/kg/d , p=0.02 ) ; a larger proportion met recommendations for MI- or VI-PA ( 31.2 % vs 21.3 % , p=0.02 ) and were in more advanced stages of motivational readiness than TLC-Eat subjects ( TLC-PA=52.5 % vs TLC-Eat=42.2 % , p=0.04 ) . Results were not maintained at 6 months . The proportion of TLC-PA users decreased significantly over the intervention period . CONCLUSIONS A fully automated counseling system had positive short-term effects on PA among sedentary adults . Lack of maintenance of effects may be due to a decrease in the number of participants who continued to use the system Purpose To examine predictors of exercise adherence in breast cancer survivors . Methods Seventy-five breast cancer survivors were r and omly assigned to exercise ( n = 37 ) or usual care ( n = 38 ) . Demographic , prognostic , physiologic , and psychosocial information was collected at baseline and 6 months . The exercise goal was 30 min of exercise 5 days/week for 6 months . Results Women r and omized to exercise participated in moderate-intensity recreational exercise for 123 ± 52 min/week ( 81 % of the prescribed 150 min/week ) over 6 months . Baseline variables associated with better adherence were lower body mass index ( BMI ) , smaller waist circumference , higher amounts of physical activity 6 months prior to enrollment , being in the preparation vs. contemplation Stage of Change and higher FACT-B breast cancer subscale score . After adjusting for these variables , lower BMI and higher Stage of Change continued to be associated with better adherence ( p < 0.05 ) . Conclusions Future studies of exercise and breast cancer prognosis should target obese women for participation , as well as women just beginning to contemplate participation and its benefits after a cancer diagnosis Context People who are obese have difficulty changing their lifestyle to lose weight . Contribution This trial compared 5 ways of providing support for lifestyle modification . It found that high-frequency telephone contact with a dietitian led to the same weight loss as in-person contact and more weight loss than with low-frequency or e-mail contact or no contact at all . Caution Many patients withdrew , and most were women . Implication Telephone contacts with dietitians are as effective as in-person appointments for helping patients lose weight , and both are more effective than education or occasional dietitian contact . The Editors Despite substantial increases in awareness of the disease burden associated with excess weight , the prevalence of obesity continues to increase ( 1 , 2 ) . Lifestyle modification , which includes a low-calorie diet , increased physical activity , and behavioral treatment , continues to be the cornerstone of weight management ( 3 ) . However , the inability of most patients to sustain long-term lifestyle changes makes pharmacotherapy an attractive option . In one trial , the addition of sibutramine , 15 mg/d , to a lifestyle modification program result ed in weight loss at 12 months that was nearly twice that of each treatment alone ( 4 ) . Academic medical centers typically produce the best weight-loss results by combining intensive behavioral modification programs with pharmacotherapy in a structured setting that requires patients to attend weekly individual or group behavioral treatment sessions led by dietitians or behavioral psychologists . Despite the additional benefits of combining interventions , primary care practitioners , the principal providers of obesity treatment ( 5 ) , frequently prescribe medications but offer minimal lifestyle counseling . Possible reasons for omitting lifestyle counseling may be little or no training in behavioral counseling ; inability to dedicate time for ongoing counseling ; lack of multidisciplinary staff ; inadequate infrastructure ; and costs associated with more frequent visits , which are seldom covered by medical insurance . As a result , investigators have begun to explore alternative methods of providing lifestyle modification , such as telephone contact or Internet- and e-maildelivered interventions , which could decrease the dem and s of onsite behavioral programs , improve patient adherence , and reduce costs ( 69 ) . However , to our knowledge , no study has directly compared these different methods of delivering and reinforcing the behavioral modification program . Thus , we aim ed to examine the effect of 5 methods of delivering a lifestyle modification program in combination with the weight-loss medication sibutramine . We hypothesized that high-frequency face-to-face meetings with a dietitian would produce the greatest weight loss , whereas self-help would be associated with the least . Weight loss with telephone and e-mail interventions were expected to fall between these 2 groups . Methods Study Design This was a 6-month , open-label study . We assigned participants to 1 of 5 intervention groups by using a computer-generated r and omization schedule consisting of r and omly permuted blocks . Block length was 5 . All groups received the same drug treatment , sibutramine , 10 mg/d , and a st and ardized lifestyle modification program for weight loss that included a printed manual and access to a weight-loss Web site . The method of delivering the lifestyle modification program varied among the intervention groups in frequency and type of contact with a dietitian . High frequency was weekly contact during the first 3 months and every other week during the following 3 months , and low frequency was monthly contact . The type of contact with the dietitian was either face-to-face or by telephone or e-mail . One group had no contact with a dietitianonly self-help with the lifestyle manual and access to the weight-loss Web site . We r and omly assigned patients to high-frequency face-to-face counseling ( HF-F2F ) , low-frequency face-to-face counseling ( LF-F2F ) , high-frequency telephone counseling ( HF-TEL ) , high-frequency e-mail counseling ( HF-EMAIL ) , and self-help ( SELF ) ( Figure 1 ) . Figure 1 . Study flow diagram . AE= adverse event ; HF-EMAIL= high-frequency e-mail counseling ; HF-F2F= high-frequency face-to-face counseling ; HF-TEL= high-frequency telephone counseling ; LF-F2F= low-frequency face-to-face counseling ; SELF= self-help . * High frequency was weekly contact during weeks 1 to 12 and every other week during weeks 13 to 24 . Low frequency was monthly contact . Participants defaulted at their request or were lost to follow-up . Study Sample Participants were to be men and women age 25 to 60 years who had a body mass index of at least 30 kg/m2 but less than 40 kg/m2 . Participants had their own physicians for routine medical care and received screening for trial eligibility after responding to advertisements placed in the community . They had to be eligible to receive sibutramine ( per the U.S. package insert ) , adhere to study -related procedures , and have access to the Internet and e-mail . We excluded participants if they had uncontrolled blood pressure ( 140/90 mm Hg ) ; type 1 or 2 diabetes ; coronary heart disease ; chronic congestive heart failure ; stroke ; substantial metabolic , hepatic , or renal disease ; current cancer ; or gastric bypass surgery . We also excluded persons who in the past 6 months had lost 10 % or more of their initial weight , participated in a structured weight-loss program , or taken weight-loss drugs . We excluded women who were pregnant or breastfeeding , and women of childbearing potential had to use adequate contraception . The first participant visit took place in August 2004 , and the last participant was seen in April 2005 . The study was conducted at 12 U.S. research centers comprising mostly nonacademic , independent clinics that had experience running clinical trials with obese patients . Local ethics committees approved the trial . Outcomes and Measurements The study 's primary outcome was 6-month change in body weight . Secondary outcomes were 6-month changes in waist circumference ; lipid , glucose , and insulin levels ; blood pressure ; weight-related symptoms ; and quality of life . We obtained measurements of body weight , blood pressure , and pulse rate at baseline and at the end of weeks 2 , 4 , 12 , and 24 . We took waist circumference and biochemical measurements ( fasting lipid , glucose , and insulin levels ) at baseline and at the end of weeks 12 and 24 . We did safety laboratory measurements ( serum chemistry , hematology , and urinalysis ) at screening and at the end of the study . We assessed patient-reported quality of life and symptom distress at baseline and at 24 weeks by using vali date d measures : the Impact of Weight on Quality of Life-Lite ( IWQOL-Lite ) ( 10 ) and the Weight-Related Symptoms Measure ( WRSM ) ( 11 ) . We used percentage of contact participationcalculated as actual divided by expected contactas a measure of adherence to the intervention for the groups with dietitian contacts . We scheduled high-frequency groups for 18 contacts and low-frequency groups for 7 contacts . Lifestyle Modification Program We adapted the behavioral strategies and the support material s from the Diabetes Prevention Program ( www.bsc.gwu.edu/dpp/manuals.htmlvdoc ) . Study dietitians had st and ardized lifestyle and Web site training before participating in the trial and received ongoing support through monthly teleconferences led by a senior dietitian and regular teleconferences with the Web site developer . Caloric Intake We instructed all participants to adopt a 750 kcal/ddeficit diet with a minimum intake of 1000 kcal/d for women and 1200 kcal/d for men . We estimated daily caloric requirements at baseline by using the HarrisBenedict formula and adjusted downward if patients lost 9.1 kg during treatment . The macronutrient composition of the diet consisted of 15 % protein , 30 % ( or less ) fat , and 55 % carbohydrate . Physical Activity Recommendations We recommended walking as the primary method of physical activity . We gave all participants a pedometer and recommended increasing their number of steps per day by approximately 500 steps each week . We encouraged participants to build to a goal of 10000 steps per day . Behavioral Recommendations Behavioral treatment strategies included goal setting , self-monitoring ( including weekly weighing and completion of daily food intake and physical activity logs ) , stimulus control , enlisting the support of family and friends , use of problem-solving skills to overcome barriers , cognitive restructuring , and coping with slips and lapses . Support Material s All participants received the same support material s , which were a lifestyle modification manual ( both in print and electronic format ) and access to an interactive weight-loss Web site application . We encouraged participants to log on to the Web site at least once a week . Statistical Analysis We selected the sample size to provide the study with 80 % power to detect a 1.5 % difference in weight loss between any 2 of the 5 groups on the basis of a 2- sample t test at the 5 % level ( 2-sided ) assuming a common SD of 2.6 % . The primary statistical analysis used a mixed-model repeated- measures approach for longitudinal data . The mixed-model analysis included intervention , visit , and the intervention-by-visit interaction as fixed factors and baseline body weight as a covariate . We found clinical center to be an insignificant factor and removed it from the final model . This was a modified intention-to-treat analysis because it included all r and omly assigned participants who had a baseline measurement and at least 1 postbaseline measurement of body weight , and participants were considered members of the intervention group in which they were r and omly assigned , regardless of adherence . We did not follow participants who withdrew prematurely , but we used their partial data in the analysis . All 10 pairwise comparisons among the 5 intervention groups were to be OBJECTIVE This r and omized controlled trial tested a tailored , telephone-based physical activity coaching intervention for a predominantly African American group of women with severe obesity and mobility disability . METHODS We recruited 92 clinic patients from the University of Illinois at Chicago Medical Center referred by their physicians during 2004 - 2007 and r and omized participants to one of three groups -- awareness(informational brochure , no coaching ) , lower support ( phone coaching only ) and higher support ( phone coaching plus monthly exercise support group)--to determine the efficacy of a tailored coaching intervention on key health outcomes , which included body weight and body mass index , blood pressure , cholesterol , physical activity ( barriers and self-reported activity ) , movement and mobility , general health , and social support . RESULTS The higher support group had the greatest reduction in Body Mass Index ( BMI ) ( 7.4 % ) compared with a 0.2 % and 1.6 % increase in BMI for the lower support and awareness groups , respectively ( pb.01 ) . Both the higher and lower support groups had a greater increase in physical activity scores ( 39 % and 30 % , respectively)compared with a decline of 13 % in the awareness group ( pb.05 ) . CONCLUSION Providing phone-based coaching and monthly in-person exercise support group sessions appear to be an effective approach for reducing body weight and increasing physical activity among severely obese , disabled adults residing in difficult social environments OBJECTIVE According to the Transtheoretical Model ( TM ) , tailoring interventions to patients ' readiness to change can enhance patient progress and help patients use therapeutic re sources more effectively . However , tailoring an intervention depends on accurate assessment of patients ' stage of change ( SOC ) . This study describes a multi-item algorithm of SOC ( M-SOC ) for weight loss-related behaviors that attempts to overcome some of the conceptual and method ological difficulties encountered in previously SOC assessment s. RESEARCH METHODS Data were collected from participants r and omly assigned to the treatment arm of a clinical trial comparing a TM-based , cognitive-behavioral intervention with enhanced usual care for weight loss . RESULTS The stair-step relationships hypothesized by the TM between assessed SOC and key behavioral measures were found for all algorithms ( p < 0.05 ) , indicating that the M-SOC algorithm performs as well as single item algorithms . However , 50 % fewer patients were classified in action or maintenance for dietary fat intake and portion control ( p < 0.05 ) by the multiple-item algorithms , providing staging more consistent with the clinical presentation of obese individuals . In addition , logistic regression analyses indicated that the single-item algorithms were not sufficient predictors of these behavioral domains . DISCUSSION To the extent that treatment is guided by assessed SOC , there is potential for a considerable variability in interventions with different approaches to staging . For weight-loss interventions that target portion control and decreased fat intake , the multi-item SOC algorithms seem to be better guides for matching treatments to SOC The purpose of the present study was to examine the relationship between patterns of meal replacement ( MR ) adherence and changes in outcomes during a behaviorally-oriented weight loss program . Data from the present study are based on sixty female participants ( age : 29 - 62 years , BMI : 27.99 - 37.50 kg/m(2 ) ) . Participants were r and omized into either a control or experimental condition , which tested the use of MRs during weight loss maintenance . Outcome measures included body weight , depression , physical activity , cognitive restraint , disinhibition , hunger , and binge eating collected at four assessment points . Within the experimental condition , we further examined adherence to MRs and its relationship with the outcome measures . We found evidence of differences at baseline on some measures ( e.g. , weight , physical activity and depression ) while on others ( cognitive restraint , disinhibition , and hunger ) , differences that emerged over the course of treatment . Further research is necessary to determine if there are measures associated with successful MR use that can be detected at baseline and if MR adherence itself leads to changes in eating behavior PURPOSE Physical activity has been associated with a decreased risk for breast cancer . Mechanisms for this association may involve hormonal pathways . The Physical Activity for Total Health study is testing the effect of a 1-yr moderate intensity physical activity intervention on the endogenous sex hormone profile of postmenopausal women in a r and omized controlled study . METHODS Women ( N = 168 ) who are aged 55 - 75 yr , not using sex hormones , sedentary , nonsmokers , have no endocrine-related disease or cancer , and with body mass index of 25.0 or greater , are eligible . Women are recruited through mass mailings and media advertising and are r and omized to either a 1-yr moderate intensity aerobic and strength training exercise program ( monitored group exercise sessions plus home exercise ) or a control program ( stretching classes ) . RESULTS Serum hormones to be assayed at baseline and at the end of the study include : total estrone , total estradiol , free estradiol , percent bioavailable estradiol , estrone sulfate , sex hormone binding globulin , albumin , testosterone , free testosterone , and rostenedione , dehydroepi and rosterone , dehydroepi and rosterone sulfate , insulin , glucose , and triglycerides . Other outcome measures include : the ratio of urinary 2-hydroxyestrone : 16alpha-hydroxyestrone ( an estrogen metabolite ratio that may be associated with risk for breast cancer ) , weight , body mass index , total fat mass , and body fat distribution ( waist : hip circumference ratio , DEXA scan , and abdominal fat measured by computed tomography ) . CONCLUSION This study is the first to examine the effect of change in physical activity level on sex hormones in postmenopausal women . It will provide insight into possible mechanisms through which physical activity might be associated with reduced risk of breast cancer OBJECTIVE This study was design ed to compare the initial efficacy of Motivational Interviewing ( MI ) , Online Transtheoretical Model (TTM)-tailored communications and a brief Health Risk Intervention ( HRI ) on four health risk factors ( inactivity , BMI , stress and smoking ) in a worksite sample . METHOD A r and omized clinical trial assigned employees to one of three recruitment strategies and one of the three treatments . The treatment protocol included an HRI session for everyone and in addition either a recommended three TTM online sessions or three MI in person or telephone sessions over 6 months . At the initial post-treatment assessment at 6 months , groups were compared on the percentage who had progressed from at risk to taking effective action on each of the four risks . RESULTS Compared to the HRI only group , the MI and TTM groups had significantly more participants in the Action stage for exercise and effective stress management and significantly fewer risk behaviors at 6 months . MI and TTM group outcomes were not different . CONCLUSION This was the first study to demonstrate that MI and online TTM could produce significant multiple behavior changes . Future research will examine the long-term impacts of each treatment , their cost effectiveness , effects on productivity and quality of life and process variables mediating outcomes BACKGROUND & AIM The optimal diet for type III hyperlipoproteinemia is unknown . We examined blood lipids and body weight following low or high glycemic index diets in comparison with a lipid-lowering diet . MATERIAL S AND METHODS Sixteen overweight/obese men completed a cross-over study where they followed a st and ard lipid-lowering diet , a high and a low glycemic index diet , each lasting 4 weeks . Measurements were obtained at the end of each diet intervention . RESULTS The lipid-lowering diet reduced significantly LDL cholesterol , and apolipoprotein B by 24 % , and 17 % , whereas high glycemic index increased LDL cholesterol with 21 % . The low glycemic index diet reduced ( p<0.05 ) total and LDL cholesterol and apolipoprotein B compared with the lipid-lowering diet . A moderate weight loss ( p<0.05 ) was achieved after the lipid-lowering diet compared with baseline : 1.4 ( -3.6 - 0.2 ; median , 95 % CI ) kg and similar to that after high glycemic index diet . A low glycemic index diet result ed in 2.4 ( -3.9 - 1.4 ) kg weight loss compared with the high glycemic index diet ( p<0.05 ) . CONCLUSION A low glycemic index diet may be superior to that of a st and ard lipid-lowering diet in type III hyperlipoproteinemia OBJECTIVE To examine changes in motivation and the relationship of motivation to adherence to self-monitoring and weight loss in a 16-week Internet behavioral weight-loss intervention . DESIGN Two-group r and omized design . SETTING This study was conducted over the Internet . PARTICIPANTS Sixty-six women , ages 22 - 65 , with a body mass index ( BMI ) between 25 and 40 , and with a home computer with Internet access , participated . INTERVENTION These data are from an Internet behavioral weight-loss program in which all participants received a face-to-face initial session followed by the 16-week Internet program . MAIN OUTCOME MEASURES Adherence to self-monitoring and weight loss were the main outcome measures . ANALYSIS Linear regression and mediation analysis using the Baron and Kenny method were conducted . RESULTS Autonomous motivation increased initially and remained high for those who ultimately achieved a 5 % weight loss , but declined over time for participants who did not achieve a 5 % weight loss . Autonomous motivation at 4 weeks was a predictor of adherence to self-monitoring and 16-week weight loss . Adherence mediated the relationship between autonomous motivation and weight loss . CONCLUSIONS AND IMPLICATION S These results suggest that autonomous motivation may be a promising intervention target for promoting program procedure adherence and weight loss OBJECTIVES We used a participatory process to develop an obesity intervention appropriate for elementary school personnel . METHODS A r and omized controlled trial included 16 school worksites ( 8 intervention , 8 control ) . Intervention schools formed committees to develop and implement health promotion activities for employees . Anthropometric and self-report data were collected at baseline and postintervention ( 2 years later ) . The primary outcome measures were body mass index ( BMI ) , waist-hip ratio , physical activity , and fruit and vegetable consumption . RESULTS After adjustment for age , ethnicity , and job classification , employees in intervention schools reduced their BMI by an average of 0.04 kg/m2 , and those in control schools increased their BMI by an average of 0.37 kg/m2 . Comparisons for waist-hip ratio , weekly physical activity minutes , and fruit and vegetable consumption were not significant . CONCLUSIONS The participatory process appeared to be an effective means for stimulating change . The intervention may have slowed and perhaps reversed the tendency of adults to gain weight progressively with age Purpose . To assess the effectiveness of applying behavior change theory to a physical activity intervention for obese , sedentary women . Design . A 48-week r and omized controlled trial . Subjects were r and omized to one of two intervention groups . Setting . A university classroom and a local health club . Subjects . Fifty-eight sedentary , obese women . Interventions . A 24-week theory-based physical activity program that aims to change the way subjects think and behave in relation to physical activity ( treatment group , n = 29 ) and a traditionally structured exercise program ( control group , n = 29 ) . Measures . Question naires on physical activity , stage of change , processes of change , and self-efficacy were completed at baseline , 24 weeks , and 48 weeks . Results . Twenty-seven of the 29 participants in the treatment group and 17 participants in the control group completed the study . Analysis of variance revealed significant and positive changes in measures of eight processes of change , self-efficacy , physical activity , and cardiorespiratory fitness in the treatment group at 24 weeks . All but one of these changes were maintained at 48 weeks . In the control group , significant changes occurred in only two processes of change , and no change occurred in self-efficacy , physical activity , or cardiorespiratory fitness at 24 or 48 weeks . Conclusion . A theory-based intervention is more likely to change the way obese women think and behave in relation to physical activity than a traditional exercise program that does not incorporate behavior change theory PURPOSE The efficacy of a home-based physical activity ( PA ) intervention for early-stage breast cancer patients was evaluated in a r and omized controlled trial . PATIENTS AND METHODS Eighty-six sedentary women ( mean age , 53.14 years ; st and ard deviation , 9.70 years ) who had completed treatment for stage 0 to II breast cancer were r and omly assigned to a PA or contact control group . Participants in the PA group received 12 weeks of PA counseling ( based on the Transtheoretical Model ) delivered via telephone , as well as weekly exercise tip sheets . Assessment s were conducted at baseline , after treatment ( 12 weeks ) , and 6 and 9 month after baseline follow-ups . The post-treatment outcomes are reported here . RESULTS Analyses showed that , after treatment , the PA group reported significantly more total minutes of PA , more minutes of moderate-intensity PA , and higher energy expenditure per week than controls . The PA group also out-performed controls on a field test of fitness . Changes in PA were not reflected in objective activity monitoring . The PA group was more likely than controls to progress in motivational readiness for PA and to meet PA guidelines . No significant group differences were found in body mass index and percent body fat . Post-treatment group comparisons revealed significant improvements in vigor and a reduction in fatigue in the PA group . There was a positive trend in intervention effects on overall mood and body esteem . CONCLUSION The intervention successfully increased PA and improved fitness and specific aspects of psychological well-being among early-stage breast cancer patients . The success of a home-based PA intervention has important implication s for promoting recovery in this population Research on the effect of email-delivered , pedometer-based interventions on walking behavior and transtheoretical model ( TTM ) constructs is lacking . Therefore , the purpose of this study was to compare the effectiveness of two email-delivered , pedometer-based interventions design ed to increase walking and TTM construct scores among insufficiently active women . Participants were r and omly assigned to one of two 6-week intervention groups . Both groups wore pedometers , su bmi tted step logs , and received weekly email reminders . One group also received in the emails suggested strategies based on TTM for increasing physical activity . Of the 74 women who began the study , 56 ( age=41.5+/-7.6 years ; body mass index=31.2+/-6.6kg/m(2 ) ; 86 % Caucasian ) completed the International Physical Activity Question naire and TTM question naires at baseline and post-intervention . Participants in both groups combined increased weekly time spent walking ( p=0.002 ) and their scores on TTM cognitive processes , behavioral processes , pros , and cons changed ( p < or = 0.001 ) from baseline to post-intervention . The changes in walking and TTM scores did not differ between groups ( p>0.05 ) . The results of this study indicate that email-delivered , pedometer-based interventions may impact walking and most TTM scores among insufficiently active women . Although preliminary , the findings provide additional evidence that this low-cost method of intervening may be an effective approach to combat physical inactivity in women BACKGROUND African American women are at increased risk for CVD morbidity and mortality relative to white women . Physical inactivity and poor dietary habits are modifiable health behaviors shown to reduce CVD risk . Community health centers have the potential to reach large numbers of African Americans to modify their risk for CVD , yet few lifestyle counseling interventions have been conducted in this setting . METHODS The HHER Lifestyle trial is a r and omized controlled trial to compare the effects of a st and ard care intervention ( provider counseling , nurse goal setting , and educational material s ) to a comprehensive intervention ( st and ard care intervention plus 12 months of telephone counseling and tailored print material s ) on changes in physical activity and dietary fat consumption in financially disadvantaged African American women at 6 and 12 months . Secondary outcomes are body mass index , central adiposity , and total cholesterol . Potential mediators of outcome are self-efficacy for overcoming barriers , social support , and decisional balance . RESULTS African American women ( N=266 ; 130 st and ard care , 136 comprehensive intervention ) 35 years and older from nine clinics within two community health centers were enrolled . Most participants were overweight or obese with existing chronic health conditions . CONCLUSION The HHER Lifestyle trial is unique in that it targets financially disadvantaged African American women from community health centers , incorporates a st and ard care intervention into a routine clinical appointment , and includes a comprehensive process evaluation . The design will permit further research examining the added effect of regular telephone counseling and tailored print material s to a primary care provider and nurse intervention BACKGROUND Poor long-term success observed with current weight-control strategies stresses the relevance to explore new weight management approaches . OBJECTIVE To assess the effects of a Health-At-Every-Size ( HAES ) intervention on eating behaviors , appetite sensations , metabolic and anthropometric variables , and physical activity levels in women at 6-month and 1-year postintervention . DESIGN R and omized controlled trial ; measurements at baseline , at the end of the intervention period ( 4 months ) , and at 6-month and 1-year postintervention ( 10 months and 16 months , respectively ) . Intervention and testing took place from September 2003 to August 2006 . PARTICIPANTS / SETTING Premenopausal overweight/obese women ( n=144 ; mean age of 42.3+/-5.6 years ) , recruited from free-living , general community . INTERVENTION Women were r and omly assigned to : HAES group ( n=48 ) , social support group ( n=48 ) , or control group ( n=48 ) . MAIN OUTCOME MEASURES Eating behaviors ( restraint , disinhibition , and susceptibility to hunger ) , appetite ratings ( desire to eat , hunger , fullness , and prospect i ve food consumption ) , anthropometric and metabolic variables ( body mass index , waist and hip circumferences , blood lipid levels , and blood pressure ) , and engagement in moderate to intense physical activity ( energy cost > or = 1.2 k cal x kg(-1 ) x 15 minutes(-1 ) [ > or = 4.8 metabolic equivalents ] ) . STATISTICAL ANALYSES PERFORMED Changes for each dependent variable were assessed by linear mixed models according to a group ( HAES vs social support vs control ) by time ( baseline vs 4 months vs 10 months vs 16 months ) split-plot design . RESULTS Situational susceptibility to disinhibition and susceptibility to hunger significantly decreased over time in both HAES group ( -0.9+/-0.2 and -1.3+/-0.5 , respectively ) and the social support group ( -0.4+/- 0.2 and -1.4+/-0.5 , respectively ) . Although eating behavior scores observed at 16 months did not differ between HAES and social support groups ( situational susceptibility to disinhibition : 2.5+/-0.2 in HAES group vs 2.7 + /- 0.2 in social support group ; susceptibility to hunger : 4.2+/-0.5 in both groups ) , they were lower in these groups than scores noted in the control group ( 3.3+/-0.2 for situational susceptibility to disinhibition and 5.9+/-0.5 for susceptibility to hunger ) . CONCLUSIONS These results suggest that , when compared to a control group , an HAES approach could have long-term beneficial effects on eating behaviors related to disinhibition and hunger . In addition , our study did not show distinctive effects of the HAES approach in comparison to a social support intervention Background / objectives : Weight loss in obesity can reduce morbidity and mortality and benefits persist as long as weight loss is maintained . Weight maintenance is difficult in the long term and new strategies need to be developed to achieve this goal . We aim ed to evaluate the efficacy of substituting a low-calorie diet formula for a meal in a weight loss program during the maintenance phase . Methods : R and omized paralleled clinical trial including 62 adult patients with at least a 5 % weight loss with diet alone for 6 months , r and omized to two groups : daily replacement of one meal with a low-calorie diet formula , or dieting alone for another 6 months ( weight maintenance phase ) . Results : Weight maintenance or further weight loss occurred in 83.9 % of patients in the intervention group , whereas only in 58.1 % in the control group ( P=0.025 ) . As a whole , patients in the intervention group lost a further 3.2±3.7 % of initial weight compared with a 1.3±3.6 % in the control group ( P=0.030 ) . Body fat mass diminished in both groups , with no differences between them ( 1.6±3.5 vs 1.0±9.3 kg , respectively , P=0.239 ) , and the same happened with free fat mass ( 0.9±3.3 vs 0.4±6.7 kg , respectively , P=0.471 ) . A multivariate logistic regression analysis ( R 2=0.114 , P=0.023 ) retained only the intervention as a predictor of the achievement of weight maintenance with an odds ratio ( 95 % confidence interval ) of 3.756 ( 1.138–12.391 ) . Conclusions : Substitution of a low-calorie diet formula for a meal is an effective measure for weight loss maintenance compared with dieting alone OBJECTIVE To develop an algorithm that defines a person 's stage of change for fat intake < or = 30 % of energy . The Stages of Change Model describes when and how people change problem behaviors ; change is defined as a dynamic variable with five discrete stages . DESIGN A stage of change algorithm for determining dietary fat intake < or = 30 % of energy was developed using one sample and was vali date d using a second sample . SUBJECTS Sample 1 was a r and om sample of 614 adults who responded to mailed question naires . Sample 2 was a convenience sample of 130 faculty , staff , and graduate students . STATISTICS Subjects in sample 1 were initially classified in a stage of change using an algorithm based on their behavior related to avoiding high-fat foods . Dietary markers were selected for a Behavioral algorithm using logistic regression analyses . Sensitivity , specificity , and predictive value of the Behavioral algorithm were determined , then compared between sample s using the Z test . RESULTS The following dietary markers predicted intake < or = 30 % of fat ( chi 2 = 131 ; P < .0001 ) : low-fat cheese , breads without added fat , chicken without skin , low-calorie salad dressing , and vegetables for snacks . The specificity of the Behavioral algorithm was vali date d ; the algorithm classified subjects consuming > 30 % of energy from fat with 93 % specificity in sample 1 and 87 % in sample 2 ( Z = 1.36 ; P > .05 ) . Predictive value was also vali date d ; 64 % and 58 % of subjects meeting the behavioral criteria had fat intakes < or = 30 % of energy ( Z = 1.1 ; P > .05 ) . The algorithm was not sensitive , however ; most subjects with fat intakes < or = 30 % of energy from fat failed to meet the behavioral criteria . The sensitivity differed between sample s 1 and 2 ( 44 % and 27 % , respectively ; Z = 3.84 ; P < .0001 ) . APPLICATIONS The Behavioral algorithm determines stage of change for fat reduction to < or = 30 % of energy in population s with high fat intakes . The algorithm could be used in dietary counseling to tailor interventions to a patient 's stage of change Objective : To estimate the current burden of mortality attributable to excess weight in the European Union ( EU ) . Methods : Prevalence of overweight ( body mass index , BMI 25–29.9 kg/m2 ) and obesity ( BMI ≥30 kg/m2 ) were based on self-reported data from a survey with sample s representative of the 15 EU Member States in 1997 . Primary source of relative risk ( RR ) of death by BMI was the first American Cancer Prevention Study ( CPS I ) . Additional calculations were performed to account for effect of smoking ( using CPS I data for non- or never-smokers ) , for pre-existing illness ( using the second CPS , CPS II , data for healthy never-smokers ) and using RRs derived from European rather than US data ( using data from a meta- analysis of prospect i ve studies ) . Mortality attributable to excess weight was calculated by combining the prevalences of overweight and obesity , the RRs , and the number of deaths in the EU countries . Results : Annual deaths attributable to overweight and obesity totalled approximately 279 000 when RRs for all subjects were used . When RRs for nonsmokers only were applied to the entire population , about 304 000 deaths were attributable to excess weight . In analyses using RRs which controlled for both smoking and history of disease , the number of deaths attributable to excess weight was estimated at about 337 000 based on European data and at about 401 000 based on US data . In the EU , therefore , a minimum of 279 000 deaths were attributable to excess weight ( 7.7 % of all deaths , varying from 5.8 % for France through 8.7 % for the UK ) . More attributable deaths occurred among the obese ( 175 000 ) than among the overweight ( 104 000 ) . Around 70 % were cardiovascular disease deaths ( 195 000 ) and 20 % cancer deaths ( 53 000 ) . Conclusion : Mortality attributable to excess weight is a major public health problem in the EU . At least one in 13 annual deaths in the EU are likely to be related to excess weight . Sponsorship : This study has been partially funded by Madrid Regional Authority ( Comunidad de Madrid ) grant no. 08.4/0011/2000 Evidence is lacking regarding effective and sustainable weight loss approaches for use in the primary care setting . We conducted a 12-week r and omized controlled trial to evaluate the short-term efficacy of a web-based weight loss intervention among 101 primary care patients with obesity and hypertension . Patients had access to a comprehensive website that used a moderate-intensity weight loss approach design ed specifically for web-based implementation . Patients also participated in four ( two in-person and two telephonic ) counseling sessions with a health coach . Intent-to-treat analysis showed greater weight loss at 3 months ( -2.56 kg ; 95 % CI -3.60 , -1.53 ) among intervention participants ( -2.28 + /- 3.21 kg ) , relative to usual care ( 0.28 + /- 1.87 kg ) . Similar findings were observed among intervention completers ( -3.05 kg ; 95 % CI -4.24 , -1.85 ) . High rates of participant retention ( 84 % ) and website utilization were observed , with the greatest weight loss found among those with a high frequency of website logins ( quartile 4 vs. 1 : -4.16 kg ; 95 % CI -1.47 , -6.84 ) . The intervention 's approach promoted moderate weight loss at 12 weeks , though greater weight loss was observed among those with higher levels of website utilization . Efficacious web-based weight loss interventions can be successfully offered in the primary care setting The stages of change construct , which addresses the readiness to change , has only recently been applied to dietary behavior , such as fat consumption . This article describes the application of the stages of change construct to dietary fat and fiber consumption and examines the association of dietary stages to eating practice s and related demographic and psychosocial factors in a large , geographically diverse population of workers . We present results from the baseline survey of 17,121 employees in the Working Well Trial . We assessed stage from an algorithm based on seven items and measured dietary intake with an 88-item food frequency question naire . Findings indicated that a greater proportion of the population has actively tried to reduce fat intake than to consume more fiber . Stage of change was associated with fat , fiber , and fruit and vegetable intake in a stepwise manner , as predicted . In multivariate analyses that controlled for demographic characteristics , stage of change predicted between 8 and 13 % of the variance in dietary intake , and more than demographic variables . These findings have implication s for the design of nutrition interventions and for the evaluation of intermediate outcomes OBJECTIVES This study assessed stages of change in fat intake , physical activity , and cigarette smoking during a r and omized controlled trial of behavioral counseling . METHODS Twenty general practice s ( primary health care centers ) were r and omized to lifestyle counseling by behavioral methods or to usual health promotion . A total of 883 patients were selected for the presence of 1 or more of the following risk factors : cigarette smoking , high cholesterol , or a combination of a high body mass index and low physical activity . Stage of change ( precontemplation , contemplation , preparation , and action/maintenance ) was assessed at baseline and after 4 and 12 months . RESULTS The odds of moving to action/maintenance for behavioral intervention vs control patients at 4 months were 2.15 ( 95 % confidence interval [ CI ] = 1.30 , 3.56 ) for fat reduction , 1.89 ( 95 % CI = 1.07 , 3.36 ) for increased physical activity , and 1.77 ( 95 % CI = 0.76 , 4.14 ) for smoking cessation . The likelihood of achieving action/maintenance was related to baseline stage for all 3 behaviors . CONCLUSIONS Brief behavioral counseling based on advice matched to stage of readiness for change may be valuable in encouraging healthy lifestyles among patients in primary care at raised risk of cardiovascular disease Secular trends towards earlier puberty , possibly caused by new environmental triggers , provide a basis for periodic evaluation of the influence and interaction of genetic and environmental effects on pubertal timing . In such studies , a practical marker that reflects timing of puberty in both genders needs to be used . We investigated genetic and environmental influences on pubertal timing by using change in the relative height between early and late adolescence ( HD : SDS , height difference in st and ard deviations ) as a new marker of pubertal timing . HD : SDS correlated well with age at peak height velocity in a population of men and women with longitudinal growth data . In 2,309 twin girls and 1,828 twin boys , HD : SDS was calculated between height SDs at age 11.5 and 17.5 , and 14.0 and 17.5 years , respectively . Quantitative genetic models for twin data were fitted to estimate the genetic contribution to HD : SDS . We also investigated whether the same genetic factors influenced individual differences between HD : SDS and development of secondary sex characteristics prospect ively collected by pubertal development scale ( PDS ) . Genetic effects contributed to 86 and 82 % of the variance in HD : SDS in girls and boys , respectively , when using the same model including additive genetic and specific environmental factors . In girls , 30 % and in boys , 49 % of the genetic factors affecting PDS and HD : SDS were the same . Future comparison of the results of periodic evaluations allows estimation of possible changes in the effects of environment on timing of puberty . In such studies , HD : SDS can be used as a practical marker of pubertal timing . Am . J. Hum . Biol . , 2008 . © 2008 Wiley‐Liss , A major national health campaign has recently been initiated to promote consumption of 5 or more servings of fruits and vegetables each day . This paper investigates psychosocial factors related to fruit and vegetable consumption to underst and better who might be receptive and who might resist the national 5-A-Day campaign . We studied 405 adult respondents to a r and om-digit dial telephone survey . Applying the Transtheoretical Model , respondents were classified by stage of readiness to adopt the practice of eating 5 or more fruits and vegetables each day . Logistic regression models were developed for persons consuming 2 or fewer servings daily and for persons in the Precontemplation stage . Education was directly related to fruit and vegetable intake and indirectly related to being in the Precontemplation stage . Males were twice as likely as females to be in the Precontemplation stage and eat fewer than 2 servings a day . Of special interest , respondents with children at home were at greater risk of eating 2 or fewer servings a day than those without children at home ( OR=1.63 ; 95 % CI , 1.06–2.52 ) . These results imply that stage of readiness to change should be considered as well as other factors in planning interventions for increasing fruit and vegetable consumption OBJECTIVES This study examined whether weight gain with age could be prevented through the use of a low-intensity intervention . METHODS Participants , 228 men and 998 women recruited from diverse sources , were r and omized to one of the following groups : ( 1 ) no-contact control , ( 2 ) education through monthly newsletters , or ( 3 ) education plus incentives for participation . All participants were weighed and completed question naires about behaviors and attitudes related to weight at baseline and annually for 3 years thereafter . RESULTS Individuals in intervention groups reported favorable changes over time in frequency of weighting and healthy dieting practice s relative to those in the control group . These behavior changes were in turn related to a reduced rate of weight gain over time . However , weight gain over 3 years did not differ significantly by treatment group . CONCLUSIONS This low-intensity educational approach to weight gain prevention sustained interest over a lengthy time period and was associated positively with behavior change , but it was not strong enough to significantly reduce weight gain with age This report provides a further analysis of the first year weight losses in the Look AHEAD ( Action for Health in Diabetes ) study and identifies factors associated with success . Participants were a total of 5,145 men and women with type 2 diabetes who were recruited at 16 sites and r and omly assigned to an intensive lifestyle intervention ( ILI ) or a control condition , Diabetes Support and Education ( DSE ) . During year 1 , participants in ILI received comprehensive diet and physical activity counseling in a total of 42 group and individual sessions , compared with three educational sessions for DSE participants . As reported previously , at the end of the year , ILI participants lost 8.6 % of initial weight , compared to 0.7 % for DSE ( P < 0.001 ) . Within the ILI group , all racial/ethnic groups achieved clinical ly significant weight losses ( > 5.5 % ) , although there were significant differences among groups . For the year , ILI participants attended an average of 35.4 treatment sessions and reported exercising a mean of 136.6 min/week and consuming a total of 360.9 meal replacement products . Greater self-reported physical activity was the strongest correlate of weight loss , followed by treatment attendance and consumption of meal replacements . The use of orlistat , during the second half of the year , increased weight loss only marginally in those ILI participants who had lost < 5 % of initial weight during the first 6 months and chose to take the medication thereafter as a toolbox option . The lifestyle intervention was clinical ly effective in all subsets of an ethnically and demographically diverse population BACKGROUND Few studies have examined the long-term adherence to a yearlong exercise intervention among postmenopausal women . We examined the patterns of adherence to a yearlong exercise intervention and the influence of demographic , physiologic , and psychosocial variables on patterns of adherence among 173 sedentary , overweight , postmenopausal women . METHODS We collected demographic , physical activity ( PA ) , physiologic , psychosocial , and medical history information at baseline and 12 months . The exercise prescription consisted of at least 45 min of moderate-intensity exercise 5 days/week for 12 months . We calculated several adherence variables . Associations between baseline variables and adherence levels were assessed in bivariate analyses and in multiple regression models . RESULTS Women r and omized to the exercise group ( N = 87 ) participated in moderate-intensity sports or recreational PA on 3.7 + /- 1.4 days/week ( 79 % of the prescribed 5 days/week ) for 171 + /- 88 min/week ( 87 % of the prescribed 225 min/week ) over the yearlong trial period . Sixty-eight percent of the exercisers had a yearlong average PA level exceeding the national recommendation of 150 min/week . Being in the preparation stage vs. the contemplation stage of the transtheoretical model and a history of participating in any sports or recreational PA were significant predictors of adherence . CONCLUSIONS Our findings provide important information for the design of future PA interventions and health promotion programs Weight change over 3 years was examined in a large and heterogeneous sample of women as a function of stage of change for weight control . Women were classified into Precontemplation , Contemplation , Preparation , and Action stages on the basis of reports of current and past weight control behaviors and future intentions . Stage of change did not predict success in weight control . Mean weight changes over 3 years were 1.1 kg , 1.0 kg , 2.1 kg , and 2.3 kg for Precontemplation , Contemplation , Preparation , and Action stages , respectively . The findings call into question the generality of the stages-of-change classification system across behavioral domains PURPOSE Patients with breast cancer on adjuvant chemotherapy can experience weight gain and concurrent losses in muscle mass . Exercise interventions can prevent these changes , but time and travel pose barriers to participation . The Survivor Training for Enhancing Total Health ( STRENGTH ) trial assessed the feasibility and impact of 2 home-based interventions . PATIENTS AND METHODS Ninety premenopausal patients with breast cancer on adjuvant chemotherapy were r and omized to a calcium-rich diet ( CA ) intervention ( attention control ) or to 2 experimental arms : a CA + exercise ( EX ) arm or a CA + EX and high fruit and vegetable , low-fat diet ( FVLF ) arm . Exercise arms included aerobic and strength-training exercises . Body composition , weight status , waist circumference , dietary intake , physical activity , quality of life , anxiety , depression , serum lipids , sex hormone binding globulin , insulin , proinsulin , C-reactive protein , interleukin-1B , and tumor-necrosis factor receptor-II were measured at baseline and at 6-month follow-up . RESULTS Accrual targets were achieved and modest attrition was observed ( 8.8 % ) . Self-reports suggest increased calcium intakes in all arms , and higher fruit and vegetable and lower fat intake in the CA + EX + FVLF arm ; no differences in physical activity were observed . While measures of adiposity were generally lower in the CA + EX + FVLF arm , the only significant difference was in percentage of body fat ( arms and legs ) ; change in scores ( mean + /- st and ard deviation ) were + 0.7 % + /- 2.3 % ( CA ) ; + 1.2 % + /- 2.7 % ( CA + EX ) ; and + 0.1 % + /- 2 % ( CA + EX + FVLF ; P = .047 ) . Lean body mass was largely preserved , even in the control arm ( net gain of 452 g + /- 2395 g ) . No differences were observed in other endpoints . CONCLUSION Diet and exercise interventions can prevent weight gain and adverse body composition changes , but more research is needed to determine optimally effective interventions that can be implemented during active treatment and that promote adherence OBJECTIVE To evaluate whether an intervention of foods high in soluble fiber from psyllium and /or oats plus a telephone-based , personalized behavior change support service improves serum lipids and elicits cholesterol-managing lifestyle changes vs usual care . DESIGN 7-week r and omized , controlled intervention . SUBJECTS/ SETTING 150 moderately hypercholesterolemic men and women , age range 25 to 70 years . INTERVENTION The intervention group consumed 4 servings/day of high-fiber foods and had weekly telephone conversations with a personal coach who offered support and guidance in making lifestyle changes consistent with the National Cholesterol Education Program 's ( NCEP ) cholesterol-lowering guidelines . The usual care group received a h and out describing the NCEP Step-1 diet . MAIN OUTCOME MEASURES Serum lipids and lipoproteins and self-reported lifestyle changes . STATISTICAL ANALYSES For physiologic and dietary changes , mixed linear models for repeated measures were applied . Models were simplified using analysis of covariance where age in years was the covariate . Traditional general linear models were used to assess lifestyle changes . RESULTS In the intervention group total cholesterol ( TC ) decreased 5.6 % , low-density lipoprotein ( LDL ) cholesterol 7.1 % , LDL/high-density lipoprotein ( HDL ) cholesterol ratio 5.6 % , and triglycerides ( TG ) 14.2 % ( P<.0167 ) ; decreases in TC and LDL were significantly different from the usual care group . In the usual care group TC decreased 1.9 % , LDL 1.2 % , LDL/HDL 1.9 % , and TG 4.4 % ( all not significant ) . The intervention group also reported an increase in their knowledge , ability , and confidence to make cholesterol-managing diet and exercise changes compared with the usual care group ( P<.05 ) . The intervention group had a greater decrease in energy intake from saturated fat ( -1.6 % ) and increase in soluble fiber intake ( 7.3 % ) than the usual care group ( P<.05 ) . The intervention group reported an increase in exercise vs the usual care group ( P<.05 ) . Both intervention and control groups had a minimal reduction ( < 1 % ) in body weight compared with baseline ( P<.0167 ) . APPLICATIONS/ CONCLUSIONS A 7-week intervention that includes both functional foods and individualized , interactive support for behavior change could be an effective model for dietitians to use with patients at risk for CVD , pending results of long-term studies OBJECTIVE This study compared diabetes Treatment As Usual ( TAU ) with Pathways To Change ( PTC ) , an intervention developed from the Transtheoretical Model of Change ( TTM ) , to determine whether the PTC intervention would result in greater readiness to change , greater increases in self-care , and improved diabetes control . RESEARCH DESIGN AND METHODS Participants were stratified by diabetes treatment and r and omized to treatment with PTC or TAU as well as being r and omized regarding receipt of free blood testing strips . The PTC consisted of stage-matched personalized assessment reports , self-help manuals , newsletters , and individual phone counseling design ed to improve readiness for self-monitoring of blood glucose ( SMBG ) , healthy eating , and /or smoking cessation . A total of 1029 individuals with type 1 and type 2 diabetes who were in one of three pre-action stages for either SMBG , healthy eating , or smoking were recruited . RESULTS For the SMBG intervention , 43.4 % of those receiving PTC plus strips moved to an action stage , as well as 30.5 % of those receiving PTC alone , 27.0 % of those receiving TAU plus strips , and 18.4 % of those receiving TAU alone ( P < 0.001 ) . For the healthy eating intervention , more participants who received PTC than TAU ( 32.5 vs. 25.8 % ) moved to action or maintenance ( P < 0.001 ) . For the smoking intervention , more participants receiving PTC ( 24.3 % ) than TAU ( 13.4 % ) moved to an action stage ( P < 0.03 ) . In intention-to-treat ( ITT ) analysis of those receiving the SMBG intervention , PTC result ed in a greater reduction of HbA(1c ) than TAU , but this did not reach statistical significance . However , in those who moved to an action stage for the SMBG and healthy eating interventions , HbA(1c ) was significantly reduced ( P < 0 0.001 ) . Individuals who received the healthy eating intervention decreased their percentage of calories from fat to a greater extent ( 35.2 vs. 36.1 % , P = 0.004 ) , increased servings of fruit per day ( 1.89 vs. 1.68 , P = 0.016 ) , and increased vegetable servings ( 2.24 vs. 2.06 , P = 0.011 ) but did not decrease weight . However , weight loss for individuals who received the healthy eating intervention and who increased SMBG frequency as recommended was significantly greater , with a 0.26-kg loss in those who remained in a pre-action SMBG stage but a 1.78-kg loss in those performed SMBG as recommended ( P < or= 0 . 01 ) . CONCLUSIONS This study demonstrates that this intervention has the potential of positively impacting the health of broad population s of individuals with diabetes , not just the minority who are ready for change OBJECTIVE To examine the effects of ad libitum diets with three distinct levels of fat intake for the prevention of weight gain in sedentary , normal-weight and overweight men and women . METHODS AND PROCEDURES Three hundred and five participants were r and omized to one of three diets . The diets targeted < 25 % of energy from fat ( low fat ( LF ) ) , between 28 and 32 % of energy from fat ( moderate fat ( MF ) ) , or > 35 % of energy from fat ( high fat ( HF ) ) . Participants consumed two meals per day on weekdays and one meal per day on weekends in a university cafeteria over a 12-week period . Energy and nutrient content of cafeteria foods were measured by digital photography . All meals and snacks consumed outside the cafeteria were measured by dietary recall . All analysis of energy and nutrient content was completed using Nutrition Data System for Research ( NDS-R ) version 2005 . RESULTS Two hundred and sixty participants completed the study . LF gained 0.1 + /- 3.1 kg , MF gained 0.8 + /- 2.5 kg , and HF gained 1.0 + /- 2.2 kg and there was no gender or age effect . Longitudinal mixed modeling indicated a significant difference among the groups in weight over time ( P = 0.0366 ) . When adjusting for total energy intake , which was a significant predictor of weight over time , the global effect for the group was eliminated . Thus , increasing weight was a function of increasing energy but not increasing percentage of fat intake . DISCUSSION Energy intake , but not percentage of energy from fat , appears responsible for the observed weight gain . LF diets may contribute to weight maintenance and HF diets may promote weight gain due to the influence of fat intake on total energy intake The Maryl and Women , Infants and Children ( WIC ) 5-A-Day Promotion Program examined the effect of a multifaceted nutrition intervention on changing the fruit and vegetable consumption of low-income women in the WIC program in Maryl and . The sample consisted of 3,122 participants ( 1,443 intervention and 1,679 control ) with a mean age of 27.2 . Fifty-six percent were Black/African American . This article focuses on the effect of the intervention on the stages of change of the participants . Intervention participants showed significantly greater positive movement through the stages than control participants . Stages of change were measured for two specific target behaviors : eating five servings of fruits and vegetables a day and eating more servings of fruit and vegetables a day . Results demonstrated significant differences in the stage status of intervention and control women and in movement through the stages . The effectiveness of the intervention across groups depended on which staging measure was used The aim of this study was to evaluate the efficacy of an Internet-based weight-loss program for men in an assessor blinded r and omized controlled trial . In total , 65 overweight/obese male staff and students at the University of Newcastle ( mean ( s.d . ) age = 35.9 ( 11.1 ) years ; BMI = 30.6 ( 2.8 ) ) were r and omly assigned to either ( i ) Internet group ( n = 34 ) or ( ii ) control group ( information only ) ( n = 31 ) . Both groups received one face-to-face information session and a program booklet . Internet group participants used the study website to self-monitor diet and activity with feedback provided based on participants ' online entries on seven occasions over 3 months . Participants were assessed at baseline , 3- , and 6-month follow-up for weight , waist circumference , BMI , blood pressure , resting heart rate , objective ly measured physical activity , and self-reported total daily kilojoules . Intention-to-treat analysis revealed significant weight loss of 5.3 kg ( 95 % confidence interval ( CI ) : -7.3 , -3.3 ) at 6 months for the Internet group and 3.5 kg ( 95 % CI : -5.5 , -1.4 ) for the control group . A significant time effect was found for all outcomes but no between-group differences . Per- protocol analysis revealed a significant group-by-time interaction ( P < 0.001 ) , with compliers losing more weight at 6 months ( -9.1 kg ; 95 % CI -11.8 , -6.5 ) than noncompliers ( -2.7 kg ; 95 % CI -5.3 , -0.01 ) and the control group ( -4.2 kg ; 95 % CI -6.2 , -2.2 ) . Simple weight-loss interventions can be effective in achieving statistically and clinical ly significant weight loss in men . The Internet is a feasible and effective medium for weight loss in men but strategies need to be explored to improve engagement in online programs PURPOSE This pilot study was to assess the feasibility of the health-related lifestyle self-management ( HeLM ) intervention as a strategy to decrease cardiovascular risk following acute coronary syndrome . METHODS Participants in this r and omised controlled trial were recruited from a tertiary teaching hospital in metropolitan Sydney Australia . The multifaceted HeLM intervention , using the principles of the transtheoretical model , involved the use of bibliotherapy , a structured evidence -based approach to cardiovascular risk reduction , a communication strategy with general practitioners , three supportive telephone calls to participants and provision of behavioural prompts and a health record diary . Differences in behavioural and clinical outcomes between the HeLM intervention group ( n=29 ) and the st and ard cardiac rehabilitation group ( n=22 ) were assessed . RESULTS A total of 125 participants screened were eligible for participation in the study . Fifty-one participants , mean age 57 years ( + /-8.78 ) were r and omised . At the 8-week follow-up , participants in the HeLM intervention group had a reduced systolic blood pressure compared to the st and ard care group ( 120.3 S.D. : 16.3 vs. 126.4 S.D. : 14.6 ) . There were no significant differences in diastolic blood pressure and cholesterol levels between the two groups . Participants in both the intervention and control group had a reduction in waist circumference although when compared to baseline values , women in the HeLM intervention group had a greater reduction compared to those receiving st and ard care . Patients reported high levels of satisfaction with this intervention . CONCLUSIONS Findings support the feasibility of implementing the health-related lifestyle self-management intervention for risk factor modification in patients with acute coronary syndrome . An adequately powered r and omised controlled trial is required to test the impact of the intervention on cardiovascular risk reduction |
315 | 32,190,365 | This remained apparent in both single- and multi-strain probiotic interventions as well as synbiotic formulations .
However , evidence regarding prebiotics was scarce .
There were no significant inter-group differences in terms of the frequency of adverse events . | Treatments that target alterations in gut microbiota may be beneficial for patients with irritable bowel syndrome ( IBS ) . | Abstract Objective . The effect of probiotics on IBS symptoms has been mixed , but remains an intriguing treatment option with appeal to the patient . Material and methods . Patients fulfilling the Rome II criteria were r and omized double-blind to a daily intake of 500 ml of fermented milk containing at least 5 × 107 CFU/ml of Lactobacillus paracasei ssp paracasei F19 , Lactobacillus acidophilus La5 and Bifidobacterium lactis Bb12 or an equal volume of acidified milk for 8 weeks . Symptoms were assessed at baseline and weekly using a disease-specific vali date d symptom rating scale ( IBS-SSI ) . The predefined primary outcome measure was patient reported adequate symptom relief . Adherence to study protocol were assessed by performing stool sample s at the of the treatment period . Results . Eight-one patients were screened . Sixty-four patients were r and omized ; 18 patients did not complete the study due to protocol violations or withdrew due to lack of effect . Fifty-two patients ( 13 males ) completed the study as per protocol ; mean age was 51.3 years ( range 29–67 ) . The proportion of patients reporting adequate symptom relief increased in both patient groups , but there was not any statistical difference between the groups . IBS-SSI scores did not differ statistically between the groups at the end of the treatment period , but improved during the study period in both groups . Conclusions . During this 8-week trial gastrointestinal symptoms improved . However , there was no difference between treatment with fermented milk containing probiotics or acidified milk . The effect of probiotics on IBS symptoms remains uncertain and further studies are warranted BACKGROUND Micro-inflammation is considered an element in the pathogenesis of irritable bowel syndrome ( IBS ) . High-sensitivity C reactive protein ( hs-CRP ) was previously shown to be higher in IBS compared to healthy controls , albeit within the normal range . Since probiotics may suppress micro-inflammation in the gut , we tested if they reduce symptoms and inflammatory markers ( hs-CRP and fecal calprotectin ( FC ) in diarrhea-predominant IBS ( IBS-D ) . The aim of this study was to assess the clinical and laboratory effects of BIO-25 , a multispecies probiotic , in women with IBS-D. METHODS A double-blind , placebo-controlled study . Following a 2-week run-in , eligible women were assigned at r and om to a probiotic capsule or an indistinguishable placebo , twice daily for 8 weeks . IBS symptoms and stool consistency were rated daily by Visual Analogue Scales ( VAS ) and the Bristol Stool Scale ( BSS ) . High-sensitivity C reactive protein was tested at baseline , 4 and 8 weeks . FC was tested at baseline and 8 weeks . KEY RESULTS One hundred and seventy-two IBS-D patients were recruited and 107 eligible patients were allocated to the intervention ( n=54 ) or placebo ( n=53 ) group . All symptoms improved in both groups with no significant difference between them in symptom improvement , hs-CRP or FC levels . CONCLUSIONS & INFERENCES An 8-week treatment with BIO-25 improved symptoms in women with IBS-D , but was not superior to placebo . This rigorously design ed and executed study supports the findings of other studies that did not demonstrate superiority of probiotics over placebo in IBS . High quality clinical studies are necessary to examine the efficacy of other specific probiotics in IBS-D patients since data are still conflicting AIM To determine the effects of Lactobacillus acidophilus NCFM on irritable bowel syndrome ( IBS ) symptoms and quality of life ( QoL ) . METHODS In this r and omized triple-blind trial , adult IBS volunteers who were recruited according to Rome III criteria received 109 or 1010 colony-forming units of NCFM or placebo daily for 12 wk . IBS Symptom Severity Score ( IBS-SSS ) , which constituted the primary outcome , and secondary outcomes , including individual IBS symptoms , IBS-related QoL question naire , anxiety and depression , defecation frequency , and stool consistency , were assessed at baseline at the end of the 8-wk run-in period , after 4 and 12 wk of intervention , and after a 4-wk washout . RESULTS A total of 340 of 391 r and omized volunteers completed the trial . IBS-SSS improved over 12 wk of treatment in all treatment groups , decreasing by a mean ± SD of 44.0 ± 80.2 , 50.8 ± 82.4 , and 48.3 ± 72.2 in the placebo , active low-dose , and active high-dose groups , respectively . Similarly , secondary outcomes did not differ between treatment groups . However , in a post hoc analysis of volunteers with moderate to severe abdominal pain at baseline ( VAS > 35/100 ) , the treatment significantly reduced the sensation of abdominal pain . Pain scores fell by 20.8 ± 22.8 , 29.4 ± 17.9 , and 31.2 ± 21.9 in the placebo , active low-dose , and active high-dose groups , respectively ( P value for placebo vs combined active doses = 0.0460 ) . CONCLUSION NCFM alleviates moderate to severe abdominal pain , consistent with earlier observations of this strain mitigating visceral pain through increased analgesic receptor expression Background Current knowledge suggests that small intestinal overgrowth participates in the pathogenesis of irritable bowel syndrome . It is question able if this association is modulated by intake of proton pump inhibitors ( PPIs ) . Methods In a prospect i ve study , quantitative cultures of duodenal aspirates were performed for aerobic species in 897 consecutive patients undergoing upper GI tract endoscopy . SIBO was defined as equal to or more than 103 cfu/ml . The effect of PPI intake on the relationship between SIBO and IBS was the primary endpoint . Results Analysis among patients without any history of PPI intake ( n = 713 ) showed that odds ratio ( OR ) for IBS in the event of SIBO was 5.63 ( 3.73–8.51 , p < 0.0001 ) ; this was 4.16 ( 1.91–9.06 ) when analysis was done among patients with history of PPI intake ( n = 184 , p : 0.498 between patients without and with PPI intake ) . Multiple logistic regression analysis found that factors independently associated with SIBO were age above or equal to 60 years ( OR : 2.36 ) , body mass index more than or equal to 22 kg/m2 ( OR : 0.60 ) , presence of IBS ( OR : 6.29 ) , type 2 diabetes mellitus ( OR : 1.59 ) and gastritis ( OR : 0.47 ) . Conclusions The association between IBS and SIBO was completely independent from PPI intake . Although gastritis was protective against SIBO , results show that PPI intake can not prime SIBO Irritable bowel syndrome ( IBS ) is a common disorder in gastrointestinal system and impairs the quality of life of the patients . Clostridium butyricum ( CB ) is a probiotics that has been used in several gastrointestinal diseases . The efficacy of CB in treating IBS is still unknown . This prospect i ve , multi-centre , r and omized , double-blind , placebo-controlled trial aim ed to assess the efficacy and safety of CB in treating diarrhea-predominant IBS ( IBS-D ) and analyze the fecal microbiota after treatment . Two hundred patients with IBS-D were recruited and were given CB or placebo for 4 weeks . End points included change from baseline in IBS symptoms , quality of life , stool consistency and frequency . Compared with placebo , CB is effective in improving the overall IBS-D symptoms ( −62.12 ± 74.00 vs. −40.74 ± 63.67 , P = 0.038 ) as well as quality of life ( 7.232 ± 14.06 vs. 3.159 ± 11.73 , P = 0.032 ) and stool frequency ( −1.602 ± 1.416 vs. −1.086 ± 1.644 , P = 0.035 ) . The responder rates are found higher in CB compared with the placebo ( 44.76 % vs. 30.53 % , P = 0.042 ) . The change in fecal microbiota was analyzed and function pathways of CB in treating IBS-D were predicted . In conclusion , CB improves overall symptoms , quality of life and stool frequency in IBS-D patients and is considered to be used as a probiotics in treating IBS-D clinical ly BACKGROUND : Probiotic bacteria exhibit a variety of properties , including immunomodulatory activity , which are unique to a particular strain . Thus , not all species will necessarily have the same therapeutic potential in a particular condition . We have preliminary evidence that Bifidobacterium infantis 35624 may have utility in irritable bowel syndrome ( IBS ) . OBJECTIVES : This study was design ed to confirm the efficacy of the probiotic bacteria B. infantis 35624 in a large-scale , multicenter , clinical trial of women with IBS . A second objective of the study was to determine the optimal dosage of probiotic for administration in an encapsulated formulation . METHODS : After a 2-wk baseline , 362 primary care IBS patients , with any bowel habit subtype , were r and omized to either placebo or freeze-dried , encapsulated B. infantis at a dose of 1 × 106 , 1 × 108 , or 1 × 1010 , cfu/mL for 4 wk . IBS symptoms were monitored daily and scored on to a 6-point Likert scale with the primary outcome variable being abdominal pain or discomfort . A composite symptom score , the subject 's global assessment of IBS symptom relief , and measures of quality of life ( using the IBS-QOL instrument ) were also recorded . RESULTS : B. infantis 35624 at a dose of 1 × 108 cfu was significantly superior to placebo and all other bifidobacterium doses for the primary efficacy variable of abdominal pain as well as the composite score and scores for bloating , bowel dysfunction , incomplete evacuation , straining , and the passage of gas at the end of the 4-wk study . The improvement in global symptom assessment exceeded placebo by more than 20 % ( p < 0.02 ) . Two other doses of probiotic ( 1 × 106 and 1 × 1010 ) were not significantly different from placebo ; of these , the 1 × 1010 dose was associated with significant formulation problems . No significant adverse events were recorded . CONCLUSIONS : B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS . At a dosage level of 1 × 108 cfu , it can be delivered by a capsule making it stable , convenient to administer , and amenable to widespread use . The lack of benefits observed with the other dosage levels of the probiotic highlight the need for clinical data in the final dosage form and dose of probiotic before these products should be used in practice Background The treatment of Irritable bowel syndrome ( IBS ) is still challenging . Partially hydrolyzed guar gum ( PHGG ) is a known prebiotic fiber . To assess the effects of PHGG on clinical symptoms of IBS patients in a prospect i ve r and omized double blind placebo-controlled study . Methods Suitable IBS patients were recruited into an 18-week-long study ( 2 weeks of run-in , 12 weeks of treatment and 4 weeks of follow-up ) . They were blindly r and omized to receive 6 gr of PHGG or placebo . Treatment efficacy was evaluated by the Francis Severity IBS score , the IBS quality -of-life scores and scored parameters of weekly journal of symptoms . Deltas of changes between the final and baseline scores were compared between two groups . Results Of 121 patients who underwent r and omization , 108 patients ( 49 in the PHGG group and 59 in the placebo group ) had all the data needed for intention-to-treat analysis . A 12-week administration of PHGG led to a significant improvement of journal bloating score in the PHGG group versus placebo ( −4.1±13.4 versus −1.2±11.9 , P=0.03 ) , as well as in bloating+gasses score ( −4.3±10.4 versus −1.12±10.5 , P = 0.035 ) . The effect lasted for at least 4 weeks after the last PHGG administration . PHGG had no effect on other journal reported IBS symptoms or on Severity and Quality of life scores . There were no significant side effects associated with PHGG ingestion . The rate of dropouts was significantly higher among patients in the placebo group compared with the PHGG group ( 49.15 % versus 22.45 % , respectively , P = 0.01 ) . Conclusions The results of this study support the administration of 6 g/day PHGG for IBS patients with bloating . Trial registration BACKGROUND Interest in fructooligosaccharides as a health-promoting food component is increasing . Fructooligosaccharides are mainly indigestible and large amounts in the colon may provoke gastrointestinal symptoms . OBJECTIVE The symptoms of irritable bowel syndrome ( IBS ) may be provoked by large quantities of carbohydrates in the colon . The objective of this study was to determine whether regular consumption of fructooligosaccharides worsens gastrointestinal symptoms in patients with IBS . DESIGN A multicenter , prospect i ve , r and omized , double-blind , placebo-controlled parallel group comparison was conducted at 24 sites . The study consisted of a 2-wk , single-blind run-in phase and a 12-wk , double-blind comparative phase . Subjects were r and omly assigned to receive 20 g fructooligosaccharides powder/d ( n = 52 ) or a placebo ( n = 46 ) . Efficacy was based on the patients ' overall response to treatment at completion of the study and on the severity and duration of individual symptoms ( abdominal distension , abdominal rumbling , abnormal flatulence , and abdominal pain ) . RESULTS Data from 96 patients ( 16 men and 80 women ) were analyzed . After 4 - 6 wk of treatment , IBS symptoms improved more in the placebo group than in the fructooligosaccharide group . After completion of the study , there were no significant differences between the 2 groups : symptoms improved in 58 % of the fructooligosaccharide group and in 65 % of the placebo group and symptoms worsened in 8 % of the fructooligosaccharide group and in 13 % of the placebo group . CONCLUSION Although symptoms worsened in patients with IBS at the onset of treatment with 20 g fructooligosaccharides/d , continuous treatment for 12 wk result ed in no worsening of symptoms Abstract Aim : We aim ed to evaluate the efficacy of a synbiotic containing Bacillus Coagulans in treatment of IBS . Background : Some studies have shown the efficacy of probiotics in the treatment of irritable bowel syndrome ( IBS ) . Patients and methods : Adult IBS patients ( n=85 ) were r and omized to receive a synbiotic containing Bacillus Coagulans or placebo for 12 weeks . Frequency of IBS symptoms including abdominal pain ( scored 1 to 7 ) , and diarrhea and constipation ( scored 1 to 5 ) was evaluated before and after the intervention and then after nine months follow-up . Results : Twenty-three patients in the synbiotic group and 33 patients in the placebo group completed the study ( age = 39.8±12.7 years , 78.6 % female ) . After treatment , more reduction in abdominal pain frequency was observed with synbiotic compared with placebo ( score reduction 4.2±1.8 vs. 1.9±1.5 , P<0.001 ) . Diarrhea frequency was decreased in the synbiotic group , but not in the placebo group ( score reduction 1.9±1.2 vs. 0.0±0.5 , P<0.001 ) . Decrease in constipation frequency was the same between the two groups ( score reduction 0.9±1.2 vs. 0.8±1.1 , P=0.561 ) . After nine months follow-up , abdominal pain frequency was decreased ( P=0.016 ) , constipation frequency was increased ( P<0.001 ) , and diarrhea frequency remained unchanged in the synbiotic group ( P=1.000 ) . In the placebo group , abdominal pain frequency was increased ( P<0.001 ) , constipation frequency remained unchanged ( P=0.553 ) , and diarrhea frequency was increased ( P<0.001 ) . Conclusion : Bacillus Coagulans improves abdominal pain and diarrhea in IBS patients . Further studies on a larger sample of patients are warranted The exact pathogenesis of diarrhea-dominant irritable bowel syndrome ( IBS ) is not known , but the abnormal microbiota of the gastrointestinal tract is considered to be one of the important contributing factors as in other gastrointestinal diseases such as inflammatory bowel disease , antibiotic-associated diarrhea , and colorectal cancer as well as systemic diseases . Though diverse trials of probiotics had been continued in the treatment of diarrhea-IBS , only a few proved by r and omized clinical trial . To prove the efficacy of Lactobacillus gasseri BNR17 isolated from breast milk in patients with diarrhea-IBS , prospect i ve , r and omized , placebo controlled clinical trial was done including health related- quality of life analysis , colon transit time , and the changes of fecal microbiota . BNR17 significantly improved the symptoms of diarrhea compared to control group . Health related-QOL analysis showed significant improvement of abdominal pain , distension , disturbed daily life , and mean defecation frequency with BNR17 . On comparative CTT before and after BNR17 , 6 out of 24 subjects showed significant correction of rapid colon transit pattern , while only 2 out of 24 in placebo ( p<0.01 ) . Upon fecal microbiota analysis , BNR17 significantly increased B. fecalis , E. rectale , C. aerofaciens , F. prausnitzil and B. steroris . Conclusively , Lactobacillus gasseri BNR17 can be a potential probiotics to ameliorate diarrhea-IBS Purpose The aim of this study is to test in a double-blinded , r and omised placebo-controlled study the effects of a commercially available multi-strain symbiotic mixture on symptoms , colonic transit and quality of life in irritable bowel syndrome ( IBS ) patients who meet Rome III criteria . Background There is only one other double-blinded RCT on a single-strain symbiotic mixture in IBS . Methods This is a double-blinded , r and omised placebo-controlled study of a symbiotic mixture ( Probinul , 5 g bid ) over 4 weeks after 2 weeks of run-in . The primary endpoints were global satisfactory relief of abdominal flatulence and bloating . Responders were patients who reported at least 50 % of the weeks of treatment with global satisfactory relief . The secondary endpoints were change in abdominal bloating , flatulence , pain and urgency by a 100-mm visual analog scale , stool frequency and bowel functions on vali date d adjectival scales ( Bristol Scale and sense of incomplete evacuation ) . Pre- and post-treatment colonic transit time ( Metcalf ) and quality of life ( SF-36 ) were assessed . Results Sixty-four IBS patients ( symbiotic n = 32 , 64 % females , mean age 38.7 ± 12.6 years ) were studied . This symbiotic mixture reduced flatulence over a 4-week period of treatment ( repeated- measures analysis of covariance , p < 0.05 ) . Proportions of responders were not significantly different between groups . At the end of the treatment , a longer rectosigmoid transit time and a significant improvement in most SF-36 scores were observed in the symbiotic group . Conclusions This symbiotic mixture has shown a beneficial effect in decreasing the severity of flatulence in IBS patients , a lack of adverse events and a good side-effect profile ; however , it failed to achieve an improvement in global satisfactory relief of abdominal flatulence and bloating . Further studies are warranted BACKGROUND This study assesses the potential effect of Lactobacillus reuteri as a single strain probiotic preparation ( Biogaia ® ) on irritable bowel syndrome ( IBS ) . METHODS Patients diagnosed with IBS who fulfilled Rome III criteria and consented to participate in this study were r and omized to receive either the probiotic or an identical placebo once daily for four weeks . Patients used a question naire to record any symptoms and adverse reactions over a one-week run-in period and during the final two weeks of intervention . For each group , we calculated the differences between mean scores of the variables and compared the results between groups . RESULTS Frequency of defecation increased in the Biogaia ® group and decreased in the placebo group meaningfully . But There were no significant difference in the two groups in other terms of bloating , sense of urgency for defecation , abdominal pain , stool shape , quality of defecation , sense of incomplete evacuation , and treatment satisfaction . CONCLUSION The frequency of defecation increased in the Biogaia ® group and decreased in the placebo group , however this study did not classify patients according to diarrhea or constipated subgroups , the efficacy of this drug is not clear . Hence Lactobacillus reuteri was not better than placebo in controlling IBS symptoms in this study . However , considering the significant placebo effect in IBS patients , it may be necessary to conduct studies with larger numbers of participants to better assess the possible beneficial effects of Biogaia Abstract Objective . Meta-analyses have indicated effect of probiotics on irritable bowel syndrome ( IBS ) . However , few long-term trials have been conducted and uncertainty remains as to effectiveness and long-term effect in a primary care setting . We aim ed to investigate the effect of probiotics compared with placebo in the management of IBS in primary care during a 6-month treatment period and with a 6-month follow-up . Material and methods . We r and omized IBS patients fulfilling Rome III criteria to receive two capsules twice daily either containing placebo or a probiotic mixture of Lactobacillus paracasei ssp paracasei F19 , Lactobacillus acidophilus La5 and Bifidobacterium Bb12 in an amount of 1.3 × 1010 CFU per capsule . Primary endpoint was proportion of responders defined as patients reporting adequate relief ( AR ) at least 50 % of the time in the 6-month treatment period . Secondary outcomes were proportions of patients reporting AR at different time points , and change in gastrointestinal symptoms and health-related quality of life ( HrQOL ) from baseline to 6 and 12 months . Results . A total of 131 patients were included in this study . The proportion of responders in the treatment period was 52 % ( 35/67 ) in the probiotic group versus 41 % ( 26/64 ) in the placebo group , p = 0.18 . Overall we found no difference between the groups in change in gastrointestinal symptoms after treatment . Patients improved in HrQOL , but with no statistically significant difference between the groups . Conclusion . During a 6-month treatment period , we were not able to detect a positive effect of probiotic when compared with placebo Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVES Irritable bowel syndrome ( IBS ) is a common diagnosis in gastroenterology . Its etiology is unknown and therapeutic options limited . Trials suggest probiotics may be beneficial . The aim of this study was to assess the symptomatic efficacy of Lactobacillus plantarum 299 v ( L. plantarum 299 v ) for the relief of abdominal pain in patients with IBS fulfilling Rome II criteria . METHODS This study was conducted in a referral hospital . Trial participants were r and omized to receive either two capsules of L. plantarum 299 v at a dosage of 5 × 10(9 ) cfu per capsule or placebo daily for 8 wk . Severity of abdominal pain was assessed using a visual analog scale at each visit and a quality -of-life IBS ( QoL-IBS ) question naire was also completed . RESULTS There was no significant difference in abdominal pain relief between the study and placebo groups ( P = 0.800 ) . There was also no difference in QoL- IBS scores between the groups ( P = 0.687 ) . Both groups had a significant improvement in abdominal pain scores over the study period , from an average of 251.55 to 197.90 ( P < 0.0001 ) indicating a large placebo effect . CONCLUSION An 8-wk treatment with L. plantarum 299 v did not provide symptomatic relief , particularly of abdominal pain and bloating , in patients fulfilling the Rome II criteria BACKGROUND Irritable bowel syndrome ( IBS ) is a common disorder in Iran with challenging treatment . Although trials have suggested that probiotics alleviate the complaints of patients with minimal side effects , they have not been investigated in Iranian adults . METHODS In a r and omized double-blind study , 108 eligible IBS patients ( Rome III Criteria ) aged 20 - 70 years who referred consecutively to a clinical center in Tehran with abdominal bloating from 2010 to 2012 received a combination probiotics or placebo twice daily for 4 weeks . The objective was to evaluate the efficacy and safety of a multi-strain probiotics combination . One week prior to and throughout the treatment , the participants recorded their abdominal symptoms on a daily basis , using visual analogue scale and reported satisfactory relief of general symptoms at the end of each week . Adverse events were evaluated by self-reporting and physical examination . Continuous variables were analyzed by independent t-test and chi-square was used for binomials . RESULTS The baseline characteristics were balanced ( 60 % female , mean age 36.7 ± 11.5 ) . A total of 97 ( 51 intervention , 46 control ) completed the treatment . Intention to treat analysis was done on 108 allocated subjects . 85 % of the probiotic group reported satisfactory relief of general symptoms compared with 47 % in the control group ( P < 0.01 ) . A reduction in abdominal bloating and pain with probiotic was superior to placebo [ -13.0 vs. -3.7 ( P < 0.01 ) , -8.2 vs. -2.1 ( P = 0.02 ) , respectively ] . No severe adverse drug reaction was seen in either group . CONCLUSIONS A 4-week period of treatment with the combination probiotics twice daily was safe , well tolerated , and effective in our patients . Further investigation is recommended for other subgroups of IBS . Trial Registration : I RCT .ir I RCT 2012071010230N1 Background Irritable bowel syndrome ( IBS ) is a common functional gastrointestinal disorder characterized by recurrent abdominal pain and /or discomfort . Probiotics have been reported to benefit IBS symptoms but the level of benefit remains quite unclear . Objective This study was design ed to assess the benefit of Saccharomyces cerevisiae I-3856 on IBS symptoms . Methods A r and omized , double blind , placebo-controlled trial has been performed in 379 subjects with diagnosed IBS . Subjects were r and omly supplemented with the probiotics ( 1000 mg ) or placebo for 12 weeks . Question naires ( gastrointestinal symptoms , stools , wellbeing , and quality of life ) were completed . Primary endpoint was percentage of responders defined as having a 50 % decrease in the weekly average “ intestinal pain/discomfort score ” for at least 4 out of the last 8 weeks of the study . Results There was no overall benefit of S. cerevisiae I-3856 on IBS symptoms and wellbeing in the study population . Moreover , S. cerevisiae I-3856 was not statistically significant predictor of the responder status of the subjects ( p > 0.05 ) . Planned subgroup analyses showed significant effect in the IBS-C subjects : improvement of gastrointestinal symptoms was significantly higher in active group , compared to placebo , on abdominal pain/discomfort and bloating throughout the study and at the end of the supplementation . Conclusions In this study , S. cerevisiae I-3856 at the dose of 1000 mg per day does not improve intestinal pain and discomfort in general IBS patients . However , it seems to have an effect in the subgroup with constipation which needs further studies to confirm ( NCT01613456 in Clinical Trials.gov registry ) Background Irritable Bowel Syndrome ( IBS ) is a common condition characterised by pain , distension and altered bowel habit . Evidence suggests functional foods containing probiotics improve gastrointestinal transit , however , data are limited by short follow-up periods and evaluation in selected population s. Methods A multi-centre , r and omized , double blind , controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element ( IBS – Constipation or IBS – Mixed profile ) . Set in 13 general practice s within central Engl and . Individuals meeting the ROME III criteria for IBS , aged 18–65 completed a pre- study diary . Eligible individuals were r and omized to consume dairy ‘ yoghurt ’ products which either did or did not contain active probiotics twice daily and to complete a daily diary . Primary outcome was subjective global assessment of symptom relief at week 4 . Other outcomes comprised , IBS symptom scores , pain , bloating and flatulence levels , stool frequency , stool consistency , ease of bowel movement and quality of life . Results 179 were r and omized ( 91 active , 88 placebo ) . 76 ( 43 active , 33 placebo ) completed the study . No significant between group differences existed at 4 weeks ( 57 % active vs 53 % placebo , reported adequate relief ( p = 0.71 ) ) . By week 8 , 46 % active vs 68 % placebo reported adequate relief ( p = 0.03 ) . This was sustained at week 12 . Conclusions Significant improvements were reported for most outcomes in all trial participants but improvement did not differ by group . This trial does not provide evidence for effectiveness of a probiotic in IBS , in variance with a body of published literature and review conclusions . Differential drop out may however cloud interpretation of data .UK Trial registration IS RCT Background / Aims Small intestinal bacterial overgrowth ( SIBO ) is considered to be involved in the pathogenesis of functional gastrointestinal disorders ( FGID ) . However , the prevalence and clinical conditions of SIBO in patients with FGID remain to be fully eluci date d. Here , we examined the frequency of SIBO in patients with refractory FGID . Methods We prospect ively enrolled patients with refractory FGID based on Rome III criteria . A glucose hydrogen breath test ( GHBT ) was performed using a gas analyzer after an overnight fast , with breath hydrogen concentration measured at baseline and every 15 minutes after administration of glucose for a total of 3 hours . A peak hydrogen value ≥ 10 ppm above the basal value between 60 and 120 minutes after administration of glucose was diagnosed as SIBO . Results A total of 38 FGID patients , including 11 with functional dyspepsia ( FD ) , 10 with irritable bowel syndrome ( IBS ) , and 17 with overlapping with FD and IBS , were enrolled . Of those , 2 ( 5.3 % ) were diagnosed with SIBO ( one patient diagnosed with FD ; the other with overlapping FD and IBS ) . Their symptoms were clearly improved and breath hydrogen levels decreased to normal following levofloxacin administration for 7 days . Conclusions Two patients initially diagnosed with FD and IBS were also diagnosed with SIBO as assessed by GHBT . Although the frequency of SIBO is low among patients with FGID , it may be important to be aware of SIBO as differential diagnosis when examining patients with refractory gastrointestinal symptoms , especially bloating , as a part of routine clinical care Background / Aims Despite numerous r and omized clinical trials and meta-analyses , there is no increased evidence for the efficacy of probiotics in the treatment of irritable bowel syndrome ( IBS ) . We review this evidence , identify and analyse the reasons for this lack of evidence and propose method ological improvements for future studies . Methods Based on a literature search , we identified 56 papers that matched the purpose of our analyses . Twenty-seven studies used multi-species bacterial preparations and 29 used single-strain probiotics . They were analysed regarding patients included , treatment duration , probiotic dosage , and outcome measures . Results Trials in both groups suffered from heterogeneity with respect to probiotic concentration , duration of treatment , and other method ological issues ( crossover design and underpowered studies ) . This heterogeneity did not allow the application of a meta-analytic approach and a systematic review was therefore performed instead . Multi-strain preparations combined 2 to 8 different bacterial subspecies , mostly lactobacilli or bifidobacteria , and used variable lengths of treatments . Overall , more than 50 % of trials presented negative outcomes . The majority of the single-strain probiotic trials employing lactobacilli or Saccharomyces were negative , whereas trials employing bifidobacteria showed positive results . Conclusions The heterogeneity of the studies of probiotics in IBS questions the value of meta-analyses . The use of different bacterial strains and different mixtures of these strains , as well as different dosages , are the main contributors to this heterogeneity . Current data provides limited evidence for the efficacy of a small number of single-strain probiotics in IBS ( mostly bifidobacteria ) and sound studies following strict trial guidelines ( Food and Drug Administration and European Medicines Agency guidelines for clinical trials ) are needed . We summarised and proposed some method ological issues for future studies in the field Background : Short‐chain fructooligosaccharides ( scFOS ) have beneficial effects in subjects with minor digestive complaints , but the potential mechanisms involved have not been eluci date d. The aim of the study was to evaluate changes in rectal sensitivity related to the clinical effects of scFOS in a selected group of patients with irritable bowel syndrome ( IBS ) and rectal hypersensitivity . Methods : In 79 IBS patients ( defined by Rome III criteria ) with rectal hypersensitivity ( defined as discomfort threshold ≤44 g ) a parallel , placebo‐controlled , r and omized , and double‐blind study was performed to assess the effects of dietary supplementation ( 5 g d−1 ) with scFOS vs placebo for 4 weeks on rectal sensitivity ( primary outcome : tolerance to increasing wall tension applied by a tensostat ) , clinical outcomes ( IBS , anxiety/depression and quality of life scores ) and composition of fecal microbiota . Key Results : Rectal discomfort threshold , and IBS and quality of life scores , significantly improved during treatment , but in a similar manner in both scFOS and placebo groups ; a post‐hoc analysis showed that the effect of scFOS on rectal sensitivity was more pronounced in constipation‐predominant‐IBS patients ( P=.051 vs placebo ) . Contrary with placebo , scFOS significantly reduced anxiety scores and increased fecal Bifidobacteria ( P<.05 for both ) without modifying other bacterial groups . Conclusions & Interfences : The effect of scFOS on anxiety may be related to modulation of the gut microbiota ; demonstration of effects of scFOS on rectal sensitivity may require higher doses and may depend on the IBS subgroup . & NA ; Our aim was to evaluate the effects of short‐chain fructooligosaccharides ( scFOS ) on rectal sensitivity , fecal microbiota , and symptoms in patients with irritable bowel syndrome . Rectal sensitivity improved with scFOS and placebo alike ; however , scFOS , but not placebo , significantly increased fecal Bifidobacteria and reduced anxiety score . Figure . No caption available Background : The clinical effect of probiotics on irritable bowel syndrome ( IBS ) is still controversial . Aims : We aim ed to evaluate the effects of a probiotic mixture on IBS symptoms and the composition of fecal microbiota in patients with diarrhea-dominant IBS ( D-IBS ) . Methods : Fifty patients with D-IBS were r and omized into placebo or probiotic mixture ( Lactobacillus acidophilus , Lactobacillus plantarum , Lactobacillus rhamnosus , Bifidobacterium breve , Bifidobacterium lactis , Bifidobacterium longum , and Streptococcus thermophilus 1.0 × 1010 CFU ) groups . Treatment was taken daily for 8 weeks . The primary outcome was adequate relief ( AR ) of overall IBS symptoms , which was assessed weekly for 10 weeks . A responder was defined as a patient who experienced AR for at least half of the 10-week study period . Secondary outcomes included the effects on individual symptoms , stool parameters , and IBS quality of life . The fecal flora compositions were analyzed by polymerase chain reaction denaturing gradient gel electrophoresis ( DGGE ) . Results : The proportion of AR was consistently higher in the probiotics group than in the placebo group throughout the 10-week period ( P<0.05 ) . The proportion of responders was significantly higher in the probiotics group than in the placebo group ( 48 % vs. 12 % , P=0.01 ) . Stool consistency improved significantly in the probiotics group compared with the placebo group . Percent changes in individual symptom scores were similar in the 2 groups , but IBS quality of life improvement tended to be higher in the probiotics group . Comparison of denaturing gradient gel electrophoresis profiles of fecal flora showed that the concordance rate between bacterial compositions before and after treatment was significantly higher in the probiotics group than in the placebo group ( 69.5 % vs. 56.5 % , P=0.005 ) . Conclusions : The probiotic mixture was effective in providing AR of overall IBS symptoms and improvement of stool consistency in D-IBS patients , although it had no significant effect on individual symptoms . The therapeutic effect of probiotics is associated with the stabilization of intestinal microbiota OBJECTIVES The purpose of this study was to evaluate the effects of a probiotic combination on symptoms in patients with irritable bowel syndrome ( IBS ) . METHODS We investigated the efficiency of a probiotic dietary supplement , containing four strains of lactic acid bacteria , on symptoms of IBS . One hundred and sixteen patients with IBS fulfilling the Rome II criteria were r and omized in a parallel group , double-blind study to receive a placebo or a probiotic combination ( 1 x 10(10 ) cfu once daily ) for four weeks . The symptoms that were monitored weekly included discomfort , abdominal pain , and stool frequency and quality . Quality of life was assessed before and at the end of the treatment using the SF36 and FDD- quality -of-life question naires . RESULTS One hundred subjects completed the study ( 48 probiotic combination , 52 placebo ) . The probiotic combination was not superior to the placebo in relieving symptoms of IBS ( 42.6 versus 42.3 % improvement ) . However , the decrease of abdominal pain between the first and the fourth week of treatment was significantly higher in probiotic treated patients ( -41.9 versus -24.2 % , P=0.048 ) . Interesting findings from the IBS sub-groups were also observed such as a lower pain score at end point in patients with alternating bowel habits ( P=0.023 ) and an increase of stool frequency in the constipated sub-group from the first week of probiotic treatment ( P=0.043 ) . CONCLUSIONS The probiotic combination was not significantly superior to the placebo in relieving symptoms of IBS . Despite the apparent high placebo response , interesting findings from IBS sub-groups were observed in the field of abdominal pain and stool frequency Background Probiotics confer health benefits to the host . However , its clinical effect on irritable bowel syndrome ( IBS ) is controversial . Aims This study was aim ed to evaluate the effects of Saccharomyces boulardii on quality of life ( QOL ) and symptoms in patients with diarrhea-predominant IBS or mixed-type IBS . Methods Sixty-seven patients with IBS were r and omized either to receive S. boulardii at 2 × 1011 live cells as a daily dose ( n=34 ) , or placebo ( n=33 ) for 4 weeks . IBS-QOL was assessed at the beginning and end of the treatment phase . IBS-related symptoms , bowel movement frequency , and stool consistency were recorded on a daily basis and assessed each week . Results The overall improvement in IBS-QOL was higher in S. boulardii group than placebo ( 15.4 % vs 7.0 % ; P<0.05 ) . All eight domains of IBS-QOL were significantly improved in S. boulardii group ; however , placebo group only showed improvements in dysphoria and health worry . Composite scores for IBS symptoms were significantly reduced in both groups to a similar extent . Bowel frequency and stool consistency did not change in either group . Conclusions S. boulardii improved IBS-QOL better than placebo but was not superior for individual symptoms in patients with diarrhea-predominant IBS or mixed-type IBS OBJECTIVE : The influence of the gastrointestinal ( GI ) microflora in patients with irritable bowel syndrome ( IBS ) has not been clearly eluci date d. This study was undertaken to see if patients with IBS have an imbalance in their normal colonic flora , as some bacterial taxa are more prone to gas production than others . We also wanted to study whether the flora could be altered by exogenous supplementation . In a previous study we have characterized the mucosa-associated lactobacilli in healthy individuals and found some strains with good colonizing ability . Upon colonization , they seemed to reduce gas formation . METHODS : The study comprised 60 patients with IBS and a normal colonoscopy or barium enema . Patients fulfilling the Rome criteria , without a history of malabsorption , and with normal blood tests underwent a sigmoidoscopy with biopsy . They were r and omized into two groups , one receiving 400 ml per day of a rose-hip drink containing 5 × 107 cfu/ml of Lactobacillus plantarum ( DSM 9843 ) and 0.009 g/ml oat flour , and the other group receiving a plain rose-hip drink , comparable in color , texture , and taste . The administration lasted for 4 wk . The patients recorded their own GI function , starting 2 wk before the study and continuing throughout the study period . Twelve months after the end of the study all patients were asked to complete the same question naire regarding their symptomatology as at the start of the study . RESULTS : All patients tolerated the products well . The patients receiving Lb . plantarum had these bacteria on rectal biopsies . There were no major changes of Enterobacteriaceae in either group , before or after the study , but the Enterococci increased in the placebo group and remained unchanged in the test group . Flatulence was rapidly and significantly reduced in the test group compared with the placebo group ( number of days with abundant gas production , test group 6.5 before , 3.1 after vs 7.4 before and 5.6 after for the placebo group ) . Abdominal pain was reduced in both groups . At the 12-month follow-up , patients in the test group maintained a better overall GI function than control patients . There was no difference between the groups regarding bloating . Fifty-nine percent of the test group patients had a continuous intake of fermented products , whereas the corresponding figure for the control patients was 73 % . CONCLUSIONS : The results of the study indicate that the administration of Lb . plantarum with known probiotic properties decreased pain and flatulence in patients with IBS . The fiber content of the test solution was minimal and it is unlikely that the fiber content could have had any effect . This type of probiotic therapy warrants further studies in IBS patients Introduction This preliminary study aim ed to investigate the effects of the probiotic Saccharomyces boulardii on proinflammatory and anti-inflammatory cytokines in patients with diarrhea-dominant irritable bowel syndrome ( IBS-D ) . The other objectives were to document any clinical improvement as judged by symptoms , quality of life , and histology . Patients and methods This was a r and omized , double blind , placebo-controlled trial in which S. boulardii , 750 mg/day , or placebo was administered for 6 weeks in IBS-D patients , in addition to ispaghula husk st and ard treatment . Results Thirty-seven patients received S. boulardii and 35 patients received the placebo . As compared with placebo , the S. boulardii group showed a significant decrease in blood and tissue levels of proinflammatory cytokines interleukin-8 ( IL-8 ) and tumor necrosis factor-&agr ; ( P<0.001 ) and an increase in anti-inflammatory IL-10 levels , as well as an increase in the tissue IL-10/IL-12 ratio ( P<0.001 ) . No significant change in the blood and tissue levels of cytokines was found in the placebo group . Bowel-related IBS-D symptoms reported in the patients ’ daily diary improved in both groups . However , overall improvement in the quality of life was more marked in the S. boulardii group . Although baseline histological findings were mild , an improvement was observed in the probiotic group in the lymphocyte and neutrophil infiltrates ( P=0.017 and 0.018 ) , epithelial mitosis ( P=0.003 ) , and intraepithelial lymphocytes ( P=0.024 ) . No serious adverse events were found in either group . Conclusion S. boulardii with ispaghula husk was superior to placebo with ispaghula husk in improving the cytokine profile , histology , and quality of life of patients with IBS-D. These preliminary results need to be confirmed in a well-powered trial AIM To assess the symptomatic efficacy of Lactobacillus plantarum 299v ( L. plantarum 299v ) ( DSM 9843 ) for the relief of abdominal symptoms in a large subset of irritable bowel syndrome ( IBS ) patients fulfilling the Rome III criteria . METHODS In this double blind , placebo-controlled , parallel- design ed study , subjects were r and omized to daily receive either one capsule of L. plantarum 299v ( DSM 9843 ) or placebo for 4 wk . Frequency and intensity of abdominal pain , bloating and feeling of incomplete rectal emptying were assessed weekly on a visual analogue scale while stool frequency was calculated . RESULTS Two hundred and fourteen IBS patients were recruited . After 4 wk , both pain severity ( 0.68 + 0.53 vs 0.92 + 0.57 , P < 0.05 ) and daily frequency ( 1.01 + 0.77 vs 1.71 + 0.93 , P < 0.05 ) were lower with L. plantarum 299v ( DSM 9843 ) than with placebo . Similar results were obtained for bloating . At week 4 , 78.1 % of the patients scored the L. plantarum 299v ( DSM 9843 ) symptomatic effect as excellent or good vs only 8.1 % for placebo ( P < 0.01 ) . CONCLUSION A 4-wk treatment with L. plantarum 299v ( DSM 9843 ) provided effective symptom relief , particularly of abdominal pain and bloating , in IBS patients fulfilling the Rome III criteria BACKGROUND We aim ed to evaluate clinical symptoms in subjects with irritable bowel syndrome receiving Saccharomyces cerevisiae in a r and omized double-blind placebo-controlled clinical trial . METHODS Overall , 179 adults with irritable bowel syndrome ( Rome III criteria ) were r and omized to receive once daily 500 mg of Saccharomyces cerevisiae , delivered by one capsule ( n = 86 , F : 84 % , age : 42.5 ± 12.5 ) , or placebo ( n = 93 , F : 88 % , age : 45.4 ± 14 ) for 8 weeks followed by a 3-week washout period . After a 2-week run-in period , cardinal symptoms ( abdominal pain/discomfort , bloating/distension , bowel movement difficulty ) and changes in stool frequency and consistency were recorded daily and assessed each week . A safety assessment was carried out throughout the study . RESULTS The proportion of responders , defined by an improvement of abdominal pain/discomfort , was significantly higher ( p = 0.04 ) in the treated group than the placebo group ( 63 % vs 47 % , OR = 1.88 , 95 % , CI : 0.99 - 3.57 ) in the last 4 weeks of treatment . A non-significant trend of improvement was observed with Saccharomyces cerevisiae for the other symptoms . Saccharomyces cerevisiae was well tolerated and did not affect stool frequency and consistency . CONCLUSION Saccharomyces cerevisiae is well tolerated and reduces abdominal pain/discomfort scores without stool modification . Thus , Saccharomyces cerevisiae may be a new promising c and i date for improving abdominal pain in subjects with irritable bowel syndrome Background : Evidence has shown beneficial effects of probiotics in the treatment of irritable bowel syndrome ( IBS ) ; however , there is still a lack of data in this regard . We evaluated the efficacy of a multi-strain probiotic compound on IBS symptoms and quality -of-life ( QOL ) . Material s and Methods : Adult IBS patients ( n0=132 ) were r and omized to receive a probiotic compound containing seven bacteria species including Lactobacillus strains , Bifidobacterium strains and Streptococcus thermophiles or similar placebo , twice daily after a meal for 14 consecutive days . Improvement of IBS symptoms was assessed in categories of abdominal pain and distension and improvement of bowel habit . Improvement in patients QOL was assessed by the IBS-QOL instrument . Patients were evaluated for symptoms and QOL at baseline and then 1 month after completion of the treatment . Results : After treatment , there was a decrease in abdominal pain and distension severity in both probiotic and the placebo groups ( P<0.001 ) , but there was no difference between the two groups in this regard ( P>0.05 ) . Improvement in bowel habit was observed in 33.3 % of the probiotic and 36.5 % of the placebo group ( P = 0.910 ) . There was no significant difference between the two groups in QOL after the treatment ( P > 0.05 ) . Conclusions : We found no beneficial effects over placebo for a 2-week treatment with the above mentioned multi-strain probiotic compound in the treatment of IBS . Further , trials are yet required before a clear conclusion in this regards A combination of Lactobacillus acidophilus CL1285 , Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 was compared to placebo for relief of symptoms of irritable bowel syndrome ( IBS ) . A total of 113 subjects at 3 clinical sites were r and omised in a 2:1 ratio and followed for 12 weeks . Subjects ingested either 2 capsules of active study product , containing 50 × 109 cfu of live organisms , or 2 placebo capsules daily . Endpoints included improvement in abdominal pain , days of pain , distention , stool consistency and frequency , quality of life ( QOL ) , and adequate relief ( AR ) of IBS symptoms . IBS subtypes constipation ( IBS-C ) , diarrhoea ( IBS-D ) , and mixed ( IBS-M ) were evaluated separately ; the effect of gender was also examined . For all efficacy endpoints improvement of 30 % or more vs placebo was considered clinical ly significant . With the exception of pain intensity and AR , the endpoints demonstrated a therapeutic advantage of active over placebo for IBS symptoms in at least some subject subgroups . The IBS-D and female subgroups showed the largest and most consistent effects . Stool frequency and consistency were evaluated in the IBS-C and IBS-D subgroups , and improvement of active vs placebo was noted in both . QOL improvement was seen overall and in specific domains . Adverse events ( AEs ) were limited to 7 subjects ; all were of mild or moderate intensity except one , severe cramping . Four AEs in the same subject in the placebo group were judged to be related to study product ; these resolved by the end of study . There were no serious AEs Objectives : Beneficial therapeutic effect of probiotics has been reported in children with the irritable bowel syndrome ( IBS ) but not consistently in other functional abdominal pain-related disorders . The aim of the present study was to investigate the effect of Lactobacillus reuteri DSM 17938 in the treatment of functional abdominal pain ( FAP ) and IBS in children . Methods : Children ( age 4–18 years ) referred to pediatric gastroenterologist at Children 's Hospital Zagreb from May 2012 to December 2014 , diagnosed as FAP or IBS , were r and omized to receive L reuteri DSM 17938 108 CFU daily or placebo . The study was a prospect i ve , r and omized , double-blind , placebo-controlled parallel study . Symptoms were evaluated using Wong-Baker FACES pain rating scale for pain and Bristol scale for stool shape and consistence . Results : Data were analyzed for 55 children ( 26 in the intervention group and 29 in the placebo group ) . Children in the intervention group had significantly more days without pain ( median 89.5 vs 51 days , P = 0.029 ) . Abdominal pain was less severe in children taking probiotics during the second month ( P < 0.05 ) and fourth month ( P < 0.01 ) . The 2 groups did not differ in the duration of abdominal pain , stool type , or absence from school . Both groups experienced significant reduction in the severity of abdominal pain from first to fourth month , with the reduction more prominent in the intervention group ( P < 0.001 vs P = 0.004 ) . Conclusions : Administration of L reuteri DSM 17938 was associated with a possible reduction of the intensity of pain and significantly more days without pain in children with FAP and IBS |
316 | 29,516,003 | Diets with an increased proportion of carbohydrates decreased IMF proportions ; however , increasing caloric intake with carbohydrates increased IMF .
Starvation diets increased IMF stores , and hypocaloric diets did not result in any IMF proportion changes .
Conclusion This systematic review suggests that high-fat diets and diets with caloric intake increased above the amount required to maintain BMI with carbohydrates , and short-term starvation diets are associated with increases in IMF content . | Background There is an increasing trend in the consumption of poor- quality diets worldwide , contributing to the increase of non-communicable diseases .
Diet directly influences physiological composition and subsequently physical health .
Studies have shown that dietary macronutrient and energy content can influence the proportion of intramuscular fat ( IMF ) , which mediates various metabolic and endocrine dysfunction .
The purpose of this systematic review was to identify evidence in the literature assessing the association between different dietary interventions on the proportion of IMF in humans . | Type 2 diabetes is a global public health crisis that threatens the economies of all nations , particularly developing countries . Fueled by rapid urbanization , nutrition transition , and increasingly sedentary lifestyles , the epidemic has grown in parallel with the worldwide rise in obesity . Asia 's large population and rapid economic development have made it an epicenter of the epidemic . Asian population s tend to develop diabetes at younger ages and lower BMI levels than Caucasians . Several factors contribute to accelerated diabetes epidemic in Asians , including the “ normal-weight metabolically obese ” phenotype ; high prevalence of smoking and heavy alcohol use ; high intake of refined carbohydrates ( e.g. , white rice ) ; and dramatically decreased physical activity levels . Poor nutrition in utero and in early life combined with overnutrition in later life may also play a role in Asia 's diabetes epidemic . Recent advances in genome-wide association studies have contributed substantially to our underst and ing of diabetes pathophysiology , but currently identified genetic loci are insufficient to explain ethnic differences in diabetes risk . Nonetheless , interactions between Westernized diet and lifestyle and genetic background may accelerate the growth of diabetes in the context of rapid nutrition transition . Epidemiologic studies and r and omized clinical trials show that type 2 diabetes is largely preventable through diet and lifestyle modifications . Translating these findings into practice , however , requires fundamental changes in public policies , the food and built environments , and health systems . To curb the escalating diabetes epidemic , primary prevention through promotion of a healthy diet and lifestyle should be a global public policy priority BACKGROUND The consumption of sucrose-sweetened soft drinks ( SSSDs ) has been associated with obesity , the metabolic syndrome , and cardiovascular disorders in observational and short-term intervention studies . Too few long-term intervention studies in humans have examined the effects of soft drinks . OBJECTIVE We compared the effects of SSSDs with those of isocaloric milk and a noncaloric soft drink on changes in total fat mass and ectopic fat deposition ( in liver and muscle tissue ) . DESIGN Overweight subjects ( n = 47 ) were r and omly assigned to 4 different test drinks ( 1 L/d for 6 mo ) : SSSD ( regular cola ) , isocaloric semiskim milk , aspartame-sweetened diet cola , and water . The amount of intrahepatic fat and intramyocellular fat was measured with (1)H-magnetic resonance spectroscopy . Other endpoints were fat mass , fat distribution ( dual-energy X-ray absorptiometry and magnetic resonance imaging ) , and metabolic risk factors . RESULTS The relative changes between baseline and the end of 6-mo intervention were significantly higher in the regular cola group than in the 3 other groups for liver fat ( 132 - 143 % , sex-adjusted mean ; P < 0.01 ) , skeletal muscle fat ( 117 - 221 % ; P < 0.05 ) , visceral fat ( 24 - 31 % ; P < 0.05 ) , blood triglycerides ( 32 % ; P < 0.01 ) , and total cholesterol ( 11 % ; P < 0.01 ) . Total fat mass was not significantly different between the 4 beverage groups . Milk and diet cola reduced systolic blood pressure by 10 - 15 % compared with regular cola ( P < 0.05 ) . Otherwise , diet cola had effects similar to those of water . CONCLUSION Daily intake of SSSDs for 6 mo increases ectopic fat accumulation and lipids compared with milk , diet cola , and water . Thus , daily intake of SSSDs is likely to enhance the risk of cardiovascular and metabolic diseases . This trial is registered at clinical trials.gov as NCT00777647 Twenty one healthy untrained male subjects were r and omized to follow a high-fat diet ( HFD ; 55 - 60E% fat , 25 - 30E% carbohydrate , and 15E% protein ) or a normal diet ( ND ; 25 - 35E% fat , 55 - 60E% carbohydrate , and 10 - 15E% protein ) for 2(1/2 ) wk . Diets were isocaloric and tailored individually to match energy expenditure . At 2(1/2 ) wk of diet , one 60-min bout of bicycle exercise ( 70 % of maximal oxygen uptake ) was performed . Muscle biopsies were obtained before and after the diet , immediately after exercise , and after 3-h recovery . Insulin sensitivity ( hyperinsulinemic-euglycemic clamp ) and intramyocellular triacylglycerol content did not change with the intervention in either group . Indexes of mitochondrial density were similar across the groups and intervention . Mitochondrial respiratory rates , measured in permeabilized muscle fibers , showed a 31 ± 11 and 26 ± 9 % exercise-induced increase ( P < 0.05 ) in state 3 ( glycolytic substrates ) and uncoupled respiration , respectively . However , in HFD this increase was abolished . At recovery , no change from resting respiration was seen in either group . With a lipid substrate ( octanoyl-carnitine with or without ADP ) , similar exercise-induced increases ( 31 - 62 % ) were seen in HFD and ND , but only in HFD was an elevated ( P < 0.05 ) respiratory rate seen at recovery . With HFD complex I and IV protein expression decreased ( P < 0.05 and P = 0.06 , respectively ) . A fat-rich diet induces marked changes in the mitochondrial electron transport system protein content and in exercise-induced mitochondrial substrate oxidation rates , with the effects being present hours after the exercise . The effect of HFD is present even without effects on insulin sensitivity and intramyocellular lipid accumulation . An isocaloric high-fat diet does not cause insulin resistance Consumption of simple carbohydrates has markedly increased over the past decades , and may be involved in the increased prevalence in metabolic diseases . Whether an increased intake of fructose is specifically related to a dysregulation of glucose and lipid metabolism remains controversial . We therefore compared the effects of hypercaloric diets enriched with fructose ( HFrD ) or glucose ( HGlcD ) in healthy men . Eleven subjects were studied in a r and omised order after 7 d of the following diets : ( 1 ) weight maintenance , control diet ; ( 2 ) HFrD ( 3.5 g fructose/kg fat-free mass ( ffm ) per d , + 35 % energy intake ) ; ( 3 ) HGlcD ( 3.5 g glucose/kg ffm per d , + 35 % energy intake ) . Fasting hepatic glucose output ( HGO ) was measured with 6,6 - 2H2-glucose . Intrahepatocellular lipids ( IHCL ) and intramyocellular lipids ( IMCL ) were measured by 1H magnetic resonance spectroscopy . Both fructose and glucose increased fasting VLDL-TAG ( HFrD : + 59 % , P < 0.05 ; HGlcD : + 31 % , P = 0.11 ) and IHCL ( HFrD : + 52 % , P < 0.05 ; HGlcD : + 58 % , P = 0.06 ) . HGO increased after both diets ( HFrD : + 5 % , P < 0.05 ; HGlcD : + 5 % , P = 0.05 ) . No change was observed in fasting glycaemia , insulin and alanine aminotransferase concentrations . IMCL increased significantly only after the HGlcD ( HFrD : + 24 % , NS ; HGlcD : + 59 % , P < 0.05 ) . IHCL and VLDL-TAG were not different between hypercaloric HFrD and HGlcD , but were increased compared to values observed with a weight maintenance diet . However , glucose led to a higher increase in IMCL than fructose It is currently believed that intramyocellular triglyceride ( IMTG ) accumulation and insulin resistance are a consequence of dietary fat ingestion and /or the elevated circulating lipid levels associated with chronic fat surplus . The purpose of this study was to compare the effect of short‐term starvation versus low‐carbohydrate (CHO)/high‐fat diet on IMTG accumulation and the development of insulin resistance in physically fit men . Intramyocellular triglyceride content , measured as intramyocellular lipid ( IMCL ) by proton magnetic resonance spectroscopy ( 1H‐MRS ) , and glucose tolerance/insulin sensitivity , assessed by frequently sample d intravenous glucose tolerance test ( IVGTT ) , were determined after 67 h of : ( a ) water‐only starvation ( S ) ; and ( b ) very low‐CHO/high‐fat diet ( LC ) . These diets had in common significant restriction of CHO availability but large differences in fat content . All results were compared with those measured after a mixed CHO diet ( C ) . Dietary interventions were administered by cross‐over design . The level of dietary‐induced IMTG accumulation ( P= 0.46 ) , insulin resistance ( P= 0.27 ) and glucose intolerance ( P= 0.29 ) was not different between S and LC treatments . Intramyocellular triglyceride content and insulin sensitivity were negatively correlated ( r=−0.63 , P < 0.01 ) . Therefore , whilst insulin resistance may be due to fat accumulation at a cellular level , in the integrated human organism this outcome is not exclusively a function of dietary fat intake . The comparable level of IMTG accumulation and insulin resistance following S and LC may suggest that these metabolic perturbations are largely a consequence of the increased lipolytic response associated with CHO restriction OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity PURPOSE This study evaluated whether lowering IMCL stores via 3-d consumption of very-low-fat ( LFAT ) diet impairs endurance performance relative to a moderate-fat diet ( MFAT ) , and whether such a diet unfavorably alters lipid profiles . METHODS Twenty-one male and female endurance-trained runners followed a controlled diet and training regimen for 3 d prior to consuming either a LFAT ( 10 % fat ) or MFAT ( 35 % fat ) isoenergetic diet for another 3 d in r and om crossover fashion . On day 7 , runners followed a glycogen normalization protocol ( to equalize glycogen stores ) and then underwent performance testing ( 90-min preload run at 62 + /- 1 % VO2max followed by a 10-km time trial ) on the morning of day 8 . Muscle biopsies obtained from vastus lateralis before and after performance testing were analyzed for IMCL ( via electron microscopy ) and glycogen content ( via enzymatic methodology ) . RESULTS Despite approximately 30 % lower IMCL ( 0.220 + /- 0.032 % LFAT , 0.316 + /- 0.049 % MFAT ; P = 0.045 ) and approximately 22 % higher muscle glycogen stores at the start of performance testing ( P = 0.10 ) , 10-km performance time was not significantly different following the two diet treatments ( 43.5 + /- 1.4 min LFAT vs 43.7 + /- 1.2 min MFAT ) . However , LFAT produced less favorable lipid profiles ( P < 0.01 ) by increasing fasting triglycerides ( baseline = 84.9 + /- 8.6 ; LFAT = 118.7 + /- 10.0 mg.dL(-1 ) ) and the total cholesterol : HDL cholesterol ratio ( baseline = 3.42 + /- 0.13:1 ; LFAT = 3.75 + /- 0.20:1 ) , whereas MFAT lowered triglycerides ( baseline = 97.5 + /- 12.2 ; MFAT = 70.9 + /- 7.1 mg.dL(-1 ) ) and the total cholesterol : HDL cholesterol ratio ( baseline = 3.47 + /- 0.18:1 ; MFAT = 3.33 + /- 0.14:1 ) . CONCLUSION The results suggest that reducing IMCL via 3-d consumption of a LFAT diet does not impair running performance lasting a little over 2 h ( compared with 3-d consumption of a MFAT diet plus 1-d glycogen normalization ) , but that even short-term consumption of a LFAT diet may unfavorably alter serum lipids , even in healthy , endurance-trained runners OBJECTIVE The purpose of this article was to determine the relationships among total body fat , visceral adipose tissue ( VAT ) , fat cell size ( FCS ) , ectopic fat deposition in liver ( intrahepatic lipid [ IHL ] ) and muscle ( intramyocellular lipid [ IMCL ] ) , and insulin sensitivity index ( S(i ) ) in healthy overweight , glucose-tolerant subjects and the effects of calorie restriction by diet alone or in conjunction with exercise on these variables . RESEARCH DESIGN AND METHODS Forty-eight overweight volunteers were r and omly assigned to four groups : control ( 100 % of energy requirements ) , 25 % calorie restriction ( CR ) , 12.5 % calorie restriction + 12.5 % energy expenditure through structured exercise ( CREX ) , or 15 % weight loss by a low-calorie diet followed by weight maintenance for 6 months ( LCD ) . Weight , percent body fat , VAT , IMCL , IHL , FCS , and S(i ) were assessed at baseline and month 6 . RESULTS At baseline , FCS was related to VAT and IHL ( P < 0.05 ) but not to IMCL . FCS was also the strongest determinant of S(i ) ( P < 0.01 ) . Weight loss at month 6 was 1 + /- 1 % ( control , mean + /- SE ) , 10 + /- 1 % ( CR ) , 10 + /- 1 % ( CREX ) , and 14 + /- 1 % ( LCD ) . VAT , FCS , percent body fat , and IHL were reduced in the three intervention groups ( P < 0.01 ) , but IMCL was unchanged . S(i ) was increased at month 6 ( P = 0.05 ) in the CREX ( 37 + /- 18 % ) and LCD ( 70 + /- 34 % ) groups ( P < 0.05 ) and tended to increase in the CR group ( 40 + /- 20 % , P = 0.08 ) . Together the improvements in S(i ) were related to loss in weight , fat mass , and VAT , but not IHL , IMCL , or FCS . CONCLUSIONS Large adipocytes lead to lipid deposition in visceral and hepatic tissues , promoting insulin resistance . Calorie restriction by diet alone or with exercise reverses this trend |
317 | 28,771,220 | Results showed that many of the interventions were associated with changes in health outcomes irrespective of the source type , the outcome or intervention type ( source , path or infrastructure ) .
For road traffic sources and the annoyance outcome , the expected effect-size can be estimated from an appropriate exposure – response function , though the change in annoyance in most studies was larger than could be expected based on noise level change | This paper describes a systematic review ( 1980–2014 ) of evidence on effects of transport noise interventions on human health .
The sources are road traffic , railways , and air traffic .
Health outcomes include sleep disturbance , annoyance , cognitive impairment of children and cardiovascular diseases . | Introduction This study hypothesised that a reduction of sound during the night using earplugs could be beneficial in the prevention of intensive care delirium . Two research questions were formulated . First , does the use of earplugs during the night reduce the onset of delirium or confusion in the ICU ? Second , does the use of earplugs during the night improve the quality of sleep in the ICU ? Methods A r and omized clinical trial included adult intensive care patients in an intervention group of 69 patients sleeping with earplugs during the night and a control group of 67 patients sleeping without earplugs during the night . The research ers were blinded during data collection . Assignment was performed by an independent nurse research er using a computer program . Eligible patients had an expected length of stay in the ICU of more than 24 hours , were Dutch- or English-speaking and scored a minimum Glasgow Coma Scale of 10 . Delirium was assessed using the vali date d NEECHAM scale , sleep perception was reported by the patient in response to five questions . Results The use of earplugs during the night lowered the incidence of confusion in the studied intensive care patients . A vast improvement was shown by a Hazard Ratio of 0.47 ( 95 % confidence interval ( CI ) 0.27 to 0.82 ) . Also , patients sleeping with earplugs developed confusion later than the patients sleeping without earplugs . After the first night in the ICU , patients sleeping with earplugs reported a better sleep perception . Conclusions Earplugs may be a useful instrument in the prevention of confusion or delirium . The beneficial effects seem to be strongest within 48 hours after admission . The relation between sleep , sound and delirium , however , needs further research .Trial registration Current Controlled Trials IS RCT To determine whether the Cheers for Ears Program on noise induced hearing loss prevention was effective in improving current knowledge of noise impact of personal listening devices on hearing , and in changing self-reported listening behavior of primary school students aged between 9 years and 13 years . A survey study was implemented at participating primary schools . Schools represented various levels of socio-economic status . Informed consent ( parents and teachers ) and informed assent ( pupils ) were obtained . All pupils participated in two interactive sessions ( the second 6 weeks after first ) and only those who provided assent and consent were surveyed at three points during the study : Prior to the first session ( baseline ) , directly post-session and at 3 months post-session . A total of 318 pupils were surveyed . The median age of the participants was 11 years ( nearly 50 % of the total cohort ) . Significant changes are reported in their knowledge about hearing and in listening behavior of the participants as measured by pre- and post-measurement . The changes in behaviors were stable and sustained at 3 months post-intervention survey point and the success of the program can be attributed to the multimodal interactive nature of the sessions , the spacing of the sessions and the survey points . Wide-ranging support from schools and departments also played a role . The pilot Cheers for Ears Program is effective in increasing knowledge on the harmful effects of noise and therefore , it may prevent future noise-induced hearing loss BACKGROUND Sleep deprivation may contribute to impaired immune function , ventilatory compromise , disrupted thermoregulation , and delirium . Noise levels in intensive care units may be related to disturbed sleep patterns , but noise reduction has not been tested in this setting . OBJECTIVE To measure the effect of a noise reduction intervention on the sleep of healthy subjects exposed to simulated intensive care unit noise . METHODS After digital audiotape recording of noise and development of the noise reduction intervention , 5 nocturnal 8-hour periods of sleep were measured in 6 paid , healthy volunteers at 7-day intervals in a sleep disorders center . Polysomnographic data were collected by experienced sleep disorders technicians and scored by certified raters . After the first 3 quiet nights , earplugs were r and omly assigned to be worn on the fourth and fifth nights during exposure to the recorded noise . Sound pressure levels were measured during all 5 nights . RESULTS Sleep architecture and sound measurements on quiet nights did not differ significantly . Sound levels were significantly lower on quiet nights than on noise nights . Exposure to the noise increased the number of awakenings , percentage of stage 2 sleep , and rapid eye movement latency and decreased time asleep , sleep maintenance efficiency index , and percentage of rapid eye movement sleep . Earplugs worn during exposure to the noise produced a significant decrease in rapid eye movement latency and an increase in the percentage of rapid eye movement sleep . CONCLUSION The results provide a reasonable basis for testing the effects of earplugs on the sleep of critically ill subjects Before the opening of the new Munich International Airport and the termination of the old airport , children near both sites were recruited into aircraft-noise groups ( aircraft noise at present or pending ) and control groups with no aircraft noise ( closely matched for socioeconomic status ) . A total of 326 children ( mean age = 10.4 years ) took part in three data - collection waves , one before and two after the switch-over of the airports . After the switch , long-term memory and reading were impaired in the noise group at the new airport . and improved in the formerly noise-exposed group at the old airport . Short-term memory also improved in the latter group after the old airport was closed . At the new airport , speech perception was impaired in the newly noise-exposed group . Mediational analyses suggest that poorer reading was not mediated by speech perception , and that impaired recall was in part mediated by reading Background : It has been suggested that noise exposure increases the risk of hypertension . Road traffic is the dominant source of community noise exposure . Objective : To study the association between exposure to residential road traffic noise and hypertension in an urban municipality . Methods : The study population comprised r and omly selected subjects aged 19–80 years . A postal question naire provided information on individual characteristics , including diagnosis of hypertension . The response rate was 77 % , result ing in a study population of 667 subjects . The outdoor equivalent traffic noise level ( Leq 24 h ) at the residence of each individual was determined using noise-dispersion models and manual noise assessment s. The individual noise exposure was classified in units of 5 dB(A ) , from < 45 dB(A ) to > 65 dB(A ) . Results : The odds ratio ( OR ) for hypertension adjusted for age , smoking , occupational status and house type was 1.38 ( 95 % confidence interval ( CI ) 1.06 to 1.80 ) per 5 dB(A ) increase in noise exposure . The association seemed stronger among women ( OR 1.71 ; 95 % CI 1.17 to 2.50 ) and among those who had lived at the address for > 10 years ( OR 1.93 ; 95 % CI 1.29 to 2.83 ) . Analyses of categorical exposure variables suggested an exposure – response relationship . The strongest association between exposure to traffic noise and hypertension was found among those with the least expected misclassification of true individual exposure , as indicated by not having triple-glazed windows , living in an old house and having the bedroom window facing a street ( OR 2.47 ; 95 % CI 1.38 to 4.43 ) . Conclusion : The results of our study suggest an association between exposure to residential road traffic noise and hypertension BACKGROUND AND PURPOSE There is disagreement in the literature about the importance of sleep disruption from intensive care unit ( ICU ) environmental noise . Previous reports have assumed that sleep disruption is produced by high-peak noise . This study aim ed to determine whether peak noise or the change in noise level from baseline is more important in inducing sleep disruption . We hypothesized that white noise added to the environment would reduce arousals by reducing the magnitude of changing noise levels . PATIENTS AND METHODS Four subjects underwent polysomnography under three conditions : ( 1 ) baseline , ( 2 ) exposure to recorded ICU noise and ( 3 ) exposure to ICU noise and mixed-frequency white noise , while one additional subject completed the first two conditions . Baseline and peak noise levels were recorded for each arousal from sleep . RESULTS A total of 1178 arousals were recorded during these studies . Compared to the baseline night ( 13.3+/-1.8 arousals/h ) the arousal index increased during the noise ( 48.4+/-7.6 ) but not the white noise/ICU noise night ( 15.7+/-4.5 ) ( P<0.004 ) . The change in sound from baseline to peak , rather than the peak sound level , determined whether an arousal occurred and was the same for the ICU noise and white noise/ICU noise condition ( 17.7+/-0.4 versus 17.5+/-0.3 DB , P=0.65 ) . CONCLUSIONS Peak noise was not the main determinant of sleep disruption from ICU noise . Mixed frequency white noise increases arousal thresholds in normal individuals exposed to recorded ICU noise by reducing the difference between background noise and peak noise BACKGROUND Exposure to noise in a critical care unit may trigger a response by the sympathetic nervous system , thereby increasing cardiovascular work in patients recovering from cardiac surgery . OBJECTIVE To investigate the effects of a music intervention given twice on the first postoperative day on noise annoyance , heart rate , and arterial blood pressure in subjects with high ( n = 22 ) and low ( n = 18 ) sensitivity to noise . METHODS A prospect i ve , quasi-experimental , repeated- measures design was used . Based on results of power analysis , the sample size was 40 . Subjects were recruited preoperatively , and their sensitivity to noise was assessed . On the first postoperative day , repeated- measures data were collected on levels of noise annoyance and physiological variables during 15 minutes of baseline and 15 minutes of music intervention on two occasions . Subjects completed a follow-up question naire regarding their perceptions of the noise in the critical care unit and the music intervention . RESULTS Repeated- measures analysis of variance showed that subjects had lower levels of noise annoyance during music intervention than at baseline . Heart rate and systolic blood pressure decreased during the music intervention compared with baseline . Diastolic blood pressure decreased during the music intervention from baseline during time 2 , but not time 1 . Subjects with high baseline scores of noise sensitivity preoperatively had higher baseline levels of noise annoyance in the critical care unit the first postoperative day . Subjects rated the music intervention as highly enjoyable regardless of their baseline noise sensitivity or noise annoyance . CONCLUSION Results of this study support the idea that noise annoyance is a highly individual phenomenon , influenced by a transaction of personal and environmental factors . Use of a music intervention with cardiac surgery patients during the first postoperative day decreased noise annoyance , heart rate , and systolic blood pressure , regardless of the subject 's noise sensitivity The Norwegian facade insulation study includes one pre-intervention and two post-intervention surveys . The facade-insulating measures reduced indoor noise levels by 7 dB on average . Before the intervention , 43 % of the respondents were highly annoyed by noise . Half a year after the intervention , the proportion of respondents who were highly annoyed by road traffic noise had been significantly reduced to 15 % . The second post-intervention study ( 2 yr after the first post-intervention study ) showed that the proportion of highly annoyed respondents had not changed since the first post-intervention study . The reduction in the respondents ' self-reported sleep disturbances ( due to traffic noise ) also remained relatively stable from the first to the second post-intervention study . In the control group , there were no statistically significant differences in annoyance between the pre-intervention and the two post-intervention studies . Previous studies of traffic changes have reported that people " overreact " to noise changes . This study indicated that when considering a receiver measure , such as facade insulation , the effect of reducing indoor noise levels could be predicted from exposure-response curves based on previous studies . Thus no evidence of an " overreaction " was found OBJECTIVE To determine if Critical Care Unit ( CCU ) sound levels suppress rapid eye movement ( REM ) sleep . DESIGN Posttest-only control group experimental design . SETTING Sleep laboratory located in a university neurologic institute . SUBJECTS Seventy paid ( $ 40 ) women who had no hearing or sleep problems . PROCEDURES Subjects were r and omly assigned to a noise or quiet ( control ) group while attempting to sleep overnight in the laboratory . Noise-condition subjects heard an audiotape recording of CCU nighttime sounds . The audiotape recording was withheld from the control group . RESULTS Subjects in the noise condition showed poorer REM sleep on seven of 10 measures . These included REM activity and shorter REM duration s throughout the night and during the first and second halves of the night as well as a longer interval between the first and second REM cycles . The majority of the t test results were significant at the 0.001 level or better . CONCLUSIONS Although generalization of the results to CCU patients is limited ( because of the use of laboratory subjects ) , the results provided convincing support for a causal relationship between CCU sound levels and suppression of REM sleep Abstract Objective : To evaluate the effectiveness of four NIHL prevention interventions at improving knowledge , attitudes , and intended behaviors regarding sound exposure and appropriate use of hearing protective strategies in children . Design : A r and omized trial of the four interventions with a non-intervention comparison group . Question naires were completed prior to , immediately after , and three months after each intervention . Study : Interventions included : ( 1 ) A classroom presentation by older-peer educators , ( 2 ) A classroom presentation by health professionals , ( 3 ) . Exploration of a museum exhibition , and ( 4 ) . Exploration of an internet-based virtual museum . A comparison group received no intervention . Study sample : Fifty-three fourth grade classrooms ( 1120 students ) participated in the study . Results : All interventions produced significant improvements but the number of improvements decreased over time . In terms of effectiveness , the classroom programs were more effective than the internet-based virtual exhibit , which was more effective than the visit to the museum exhibition . Self-reported exposures indicated that as many as 94.5 % of participants were at risk for NIHL . Conclusions : Interpersonal , interactive educational interventions such as the classroom program are more effective and have longer impact than self-directed learning experiences for NIHL and tinnitus prevention , however each may have an important role in promoting hearing health in elementary school students |
318 | 21,942,932 | Conclusions Previous conclusions of a lack of efficacy for cognitive training in MCI may have been influenced by not clearly defining the intervention .
Our systematic review found that cognitive exercises can produce moderate-to-large beneficial effects on memory-related outcomes . | Background Effective non-pharmacological cognitive interventions to prevent Alzheimer 's dementia or slow its progression are an urgent international priority .
The aim of this review was to evaluate cognitive training trials in individuals with mild cognitive impairment ( MCI ) , and evaluate the efficacy of training in memory strategies or cognitive exercises to determine if cognitive training could benefit individuals at risk of developing dementia . | Background : Cognitive decline leads to disability and increased health care expenditures . Methods : Effectiveness of an intervention to stimulate multiple cognitive domains was determined using a format combining traditional and computer-based activities ( Integrated Cognitive Stimulation and Training Program ) , 45 minutes a day , 2 days a week , for 6 weeks . Nonimpaired , mildly , and moderately-impaired participants > age 65 ( n = 32 ) were r and omly allocated into a control or experimental group . Using a repeated measures design participants were tested again postintervention and at 8 weeks follow-up . Results : Statistically significant improvement on Dementia Rating Scale scores occurred for mildly and moderately impaired treatment participants ( n = 15 ) . Statistical significance was demonstrated on subscales of the WMS-III : Logical Memory I and Logical Memory II . Conclusion : Blending computer-based with traditional cognitive stimulation activities shows promise in preserving cognitive function in elders . Future studies to explore efficacy in larger , more diverse sample s are needed One of the defining differences between mild cognitive impairment ( MCI ) and dementia is the degree of independence in everyday activities . Effecting memory-related behavioural change in MCI could help maintain daily function and prolong the time before onset of dependency . However , it is well known that changing previously well-established behaviours is difficult to achieve . We conducted a r and omised controlled trial to evaluate the effectiveness of a multidisciplinary group-based intervention programme in changing everyday memory behaviour in individuals with amnestic MCI . The intervention provided evidence d-based memory training and lifestyle education to optimise memory behaviour . Fifty-four participants were r and omly assigned to treatment or waitlist-control conditions . Consistent with our primary goal , treatment participants showed an increase in memory- strategy knowledge and use from pre-test to immediate post-test , and these gains were maintained at three-month post-test relative to waitlist controls . There were no group differences in memory beliefs or on laboratory tests of objective memory performance . The increase in memory- strategy knowledge and use was associated with the degree of participation in the programme . Individuals with MCI , therefore , can acquire and maintain knowledge about memory strategies and , importantly , can change their everyday memory behaviour by putting this knowledge into practice . This incorporation of practical memory strategies into daily routines could potentially provide the means for maintaining functional independence by individuals with MCI , an issue to be addressed in future research We performed a pilot r and omized , controlled trial of intensive , computer-based cognitive training in 47 subjects with mild cognitive impairment . The intervention group performed exercises specifically design ed to improve auditory processing speed and accuracy for 100 min/d , 5 d/wk for 6 weeks ; the control group performed more passive computer activities ( reading , listening , visuospatial game ) for similar amounts of time . Subjects had a mean age of 74 years and 60 % were men ; 77 % successfully completed training . On our primary outcome , Repeatable Battery for Assessment of Neuropsychological Status total scores improved 0.36 st and ard deviations ( SD ) in the intervention group ( P=0.097 ) compared with 0.03 SD in the control group ( P=0.88 ) for a nonsignificant difference between the groups of 0.33 SD ( P=0.26 ) . On 12 secondary outcome measures , most differences between the groups were not statistically significant . However , we observed a pattern in which effect sizes for verbal learning and memory measures tended to favor the intervention group whereas effect sizes for language and visuospatial function measures tended to favor the control group , which raises the possibility that these training programs may have domain-specific effects . We conclude that intensive , computer-based mental activity is feasible in subjects with mild cognitive impairment and that larger trials are warranted This study aim ed to determine the efficacy of cognitive training in a 10-week r and omised controlled study involving 22 individuals presenting with mild cognitive impairment of the amnestic type ( MCI-A ) . Participants in the experimental group ( n = 11 ) learned face – name associations using a paradigm combining errorless ( EL ) learning and spaced retrieval ( SR ) whereas participants in the control group ( n = 11 ) were trained using an errorful ( EF ) learning paradigm . Psycho-educational sessions on memory were also provided to all participants . After neuropsychological screening and baseline evaluations , the cognitive training took place in 6 sessions over a 3-week period . The post-training and follow-up evaluations , at one and four weeks respectively , were performed by research assistants blind to the participant 's study group . The results showed that regardless of the training condition , all participants improved their capacity to learn face – name associations . A significant amelioration was also observed in participant satisfaction regarding their memory functioning and in the frequency with which the participants used strategies to support memory functions in daily life . The absence of difference between groups on all variables might be partly explained by the high variability of scores within the experimental group . Other studies are needed in order to verify the efficacy of EL learning and SR over EF in OBJECTIVE The authors evaluated the efficacy of a new cognitive rehabilitation program on memory and functional performance of mildly impaired Alzheimer disease ( AD ) patients receiving a cholinesterase inhibitor . METHODS Twenty-five participants in the Cognitive Rehabilitation ( CR ) condition participated in two 45-minute sessions twice per week for 24 total sessions . CR training included face-name association tasks , object recall training , functional tasks ( e.g. , making change , paying bills ) , orientation to time and place , visuo-motor speed of processing , and the use of a memory notebook . Nineteen participants in the Mental Stimulation ( MS ) condition had equivalent therapist contact and number of sessions , which consisted of interactive computer games involving memory , concentration , and problem-solving skills . RESULTS Compared with the MS condition , participants in CR demonstrated improved performance on tasks that were similar to those used in training . Gains in recall of face-name associations , orientation , cognitive processing speed , and specific functional tasks were present post-intervention and at a 3-month follow-up . CONCLUSION A systematic program of cognitive rehabilitation can result in maintained improvement in performance on specific cognitive and functional tasks in mildly impaired AD patients Background : Memory disturbance , deficient concentration , and fatigue are symptoms seen in amnestic mild cognitive impairment ( MCI ) as well as in mild traumatic brain injury ( TBI ) . The aim of this study was to assess if an established rehabilitation program commonly used in TBI can aid MCI patients to develop compensatory memory strategies that can improve their cognition , occupational performance , and quality of life ( QoL ) . Methods : Fifteen patients with MCI participated in the program 2 days per week for 8 weeks . Cognitive function , occupational performance , and self-perceived QoL were assessed at baseline , at the end of the intervention , and at follow-up after 6 months . Results : Significant improvements were seen in cognitive processing speed , occupational performance , and in some of the QoL domains . Conclusion : As this goal -oriented rehabilitation program in MCI result ed in some improvements in cognition , occupational performance , and QoL , further r and omized controlled studies are warranted Normal aging is associated with progressive functional losses in perception , cognition , and memory . Although the root causes of age-related cognitive decline are incompletely understood , psychophysical and neuropsychological evidence suggests that a significant contribution stems from poorer signal-to-noise conditions and down-regulated neuromodulatory system function in older brains . Because the brain retains a lifelong capacity for plasticity and adaptive reorganization , dimensions of negative reorganization should be at least partially reversible through the use of an appropriately design ed training program . We report here results from such a training program targeting age-related cognitive decline . Data from a r and omized , controlled trial using st and ardized measures of neuropsychological function as outcomes are presented . Significant improvements in assessment s directly related to the training tasks and significant generalization of improvements to nonrelated st and ardized neuropsychological measures of memory ( effect size of 0.25 ) were documented in the group using the training program . Memory enhancement appeared to be sustained after a 3-month no-contact follow-up period . Matched active control and no-contact control groups showed no significant change in memory function after training or at the 3-month follow-up . This study demonstrates that intensive , plasticity-engaging training can result in an enhancement of cognitive function in normal mature adults Dementia is a highly invalidating condition and , given the progressive aging of the population , one of the major issues that health systems will have to face in future years . Recently there has been an increase in the potential of diagnostic tools and pharmacological treatments for dementia ; moreover , considerable interest has been expressed regarding non pharmacological interventions . However , the current evidence in support of non pharmacological treatments in patients affected by dementia still does not allow to draw definitive conclusions on what is the most effective treatment to apply , largely because of method ological difficulties and limitations of the studies so far carried out due to the complex nature of the disease . To address this need , we carried out a single blind r and omized controlled study on the efficacy of computer cognitive rehabilitation in patients with mild cognitive decline . We here present preliminary data on 11 patients with diagnosis of Alzheimer 's Disease ( AD ) and mild cognitive decline r and omly assigned to treatment ( a ) or control ( b ) condition ( i.e. specific vs. aspecific treatment ) . The specific treatment ( a ) consisted in a cycle of 12 individual sessions of computer exercises , while the control condition ( b ) consisted in sessions of semi-structured interviews with patients , conducted with the same frequency and time period as ( a ) . Cognitive , behavioural and functional assessment was performed by an expert evaluator , blinded to the patients ' group allocation . Preliminary results show a significant performance decline only in the control group at the 9-month follow-up compared to both baseline and the 3-month follow-up . Our results suggest that computer based cognitive training in patients with AD and mild cognitive decline is effective at least in delaying the continuous progression of cognitive impairment in AD Background : Positive effects are reported for memory training for healthy older adults , and yet there is limited information about the benefit of cognitive intervention for older adults with increasing memory difficulties — mild cognitive impairment . Objective : To investigate the usefulness of an early cognitive intervention for the memory difficulties experienced by people with amnestic mild cognitive impairment . Methods : Using a r and omised control design , 52 participants with amnestic mild cognitive impairment and their family partners were r and omly assigned to a cognitive intervention ( memory rehabilitation group ) or waitlist ( control group ) . Participants were assessed on primary measures of everyday memory ( prospect i ve memory ) and memory strategies at 2 weeks ’ and 4 months ’ follow-up ; secondary measures of contentment with memory and the family participants ’ knowledge of memory strategies were also assessed . Results : Everyday memory , measured by performance on prospect i ve memory tasks , significantly improved following intervention , although self- appraisal of everyday memory did not demonstrate a similar intervention effect . Knowledge and use of memory strategies also significantly increased following intervention . Furthermore , family knowledge of memory strategies increased following intervention . There was a strong trend towards improvement in contentment with memory immediately following intervention , but this effect was not significant . Conclusions : Early intervention for memory difficulties in amnestic mild cognitive impairment , using cognitive rehabilitation in compensatory strategies , can assist in minimising everyday memory failures as evaluated by performance on prospect i ve memory tasks and knowledge of memory strategies BACKGROUND Memory complaints and decline in cognitive function are common in the elderly . Cognitive intervention has been shown to be beneficial in Alzheimer 's disease ( AD ) . However , few community-based cognitive intervention programs are available in Hong Kong . The aim of this project is to examine and compare the feasibility , acceptability , and clinical outcome of a cognitive intervention program for older patients with mild cognitive impairment and mild dementia using telemedicine versus a conventional face-to-face method . METHODS Community-dwelling older subjects with mild dementia or mild cognitive impairments were recruited from a community center . A total of 12 sessions of assessment and cognitive intervention were conducted via videoconferencing or by face-to-face method . Assessment included : Cantonese version of Mini Mental State Examination ( C-MMSE ) , Cantonese version of Rivermead Behavioural Memory test ( C-RBMT ) and Hierarchic Dementia Scale ( HDS ) . RESULTS Twenty-two clients were recruited . There was significant and comparable cognitive improvement in clients in both treatment arms . The videoconference arm was highly accepted by the clients and the community center . Overall compliance rate of participants was above 95 % . CONCLUSIONS Telemedicine was a feasible , effective and acceptable means in providing cognitive assessment and intervention to older persons with mild cognitive deficits . Promoting such a program to other community setting s would further enhance the accessibility of dementia service to the community ' Mild cognitive impairment ' ( MCI ) in older adults refers to a significant decline in memory function but not other cognitive functions . Pharmacological and non-pharmacological treatments for MCI are needed . The present r and omized clinical trial tests the efficacy of a cognitive and behavioral treatment to improve memory performance and participants ' attitudes about their memory . A multi-faceted intervention that included education about memory loss , relaxation training , memory skills training , and cognitive restructuring for memory-related beliefs was compared to a no-treatment control condition . Outcomes included memory performance and appraisal s of memory function and control . Results indicate that the treated group had significantly better memory appraisal s than controls at the end of treatment and at a six-month follow-up . There were no differences between groups on memory performance at post-test but at follow-up the trained individuals showed a trend toward better word list recall than controls . Findings suggest that individuals with MCI can benefit from multi-component memory enhancement training . Further development of such training programs and tests of their efficacy alone and in combination with medications are needed Background and aims : Cognitive training programs have been developed for Alzheimer ’s disease patients and the health ] ; elderly ) population . Collective cognitive stimulation programs have been shown to be efficient for subjects with memory complaint . The aim of this study was to evaluate the benefit of such cognitive programs in population s with Mild Cognitive Impairment ( MCI ) . Methods : Twelve patients with MCI and twelve cognitively normal elders were administered a cognitive stimulation program . Cognitive performance ( Logical Memory , Word paired associative learning task , Trail Making Test , verbal fluency test ) were collected before and after the intervention . A gain score [ ( post-score — pre-score)/pre-score ] was calculated for each variable and compared between groups . Results : The analysis revealed a larger intervention size effect in MCI than in normal elders ’ performances on the associative learning task ( immediate recall : p<0.05 , delayed recall : p<0.01 ) . The intervention was more beneficial in improving associative memory abilities in MCI than in normal subjects . At the end of the intervention , the MCI group had lower results than the normal group only for the delayed recall of Logical Memory . Conclusions : Although further studies are needed for more details on the impact of cognitive stimulation programs on MCI patients , this intervention is effective in compensating associative memory difficulties of these patients . Among non-pharmacological interventions , cognitive stimulation therapy is a repeatable and inexpensive collective method that can easily be provided to various population s with the aim of slowing down the rate of decline in elderly persons with cognitive impairment PURPOSE To compare the efficacy of cognitive training ( CT ) and cognitive stimulation ( CS ) programs for the community elderly with subjective memory complaints ( SMC ) . METHOD The single-blind non-r and omized controlled study was applied . The numbers of CT and CS participants were 14 and 11 . The mean ages of CT and CS participants were 68.71 and 70.36 . Memory training and problem solving strategies were applied in the CT group . There were ten 2-hourly sessions of CT , held twice weekly . CS group met once weekly in a 1.5-h class for eight classes . Cognitive performance tests of general cognitive performance , verbal memory and executive function were measured before/after the training and at 6 months follow-up . RESULTS In both training conditions , the general cognitive performance were enhanced . The CT group showed improvement in the verbal memory test . The CS group did not trigger any training effect in the verbal memory test but the executive function . All cognitive progresses remained at follow-up . CONCLUSION Both cognitive training and cognitive stimulation programs showed training effects and remained until 6 months Cognitive disorders in elderly individuals frequently have a basis in neurodegenerative or vascular brain diseases , which typically evolve over a long period of time . By the time a diagnosis of dementia is made , the individual has often suffered some deficits in cognition over many years . The predementia phase of cognitive impairment has been of much recent interest because research ers focus on strategies to prevent dementia . There are also many conditions such as brain trauma , cerebral infection , cerebrovascular disease , neoplasia , or depression , in which decline in cognition is incontrovertible but insufficiently disabling to justify a diagnosis of dementia . Some of these individuals do not have a predementia cognitive syndrome but a subthreshold one , i.e. , their cognitive impairment , while clinical ly significant , is often nonprogressive and , therefore , not a prodrome of dementia . Nosologists , epidemiologists , clinicians , and clinical research ers have all struggled with defining this syndrome , especially in the last 2 decades . A plethora of terms has emerged , some of which include Benign or Malignant Senescent Forgetfulness , Age-Associated Memory Impairment , Aging-Associated Cognitive Decline , Cognitive Impairment Not Dementia , Mild Neurocognitive Disorder , and Question able Dementia with a Clinical Dementia Rating ( CDR ) scale rating of 0.5 . The term that has achieved the most widespread usage is Mild Cognitive Impairment ( MCI ) , originally proposed in 1988 , for which diagnostic criteria were first described in 1999 . More than a decade after these criteria were proposed , the construct of MCI remains imprecise , with considerable variability in studies examining its prevalence estimates , the heterogeneity in its clinical features , and its variable predictive value for dementia . The publication of consensus criteria by an international working group on MCI made some headway toward resolving the discrepancies , but many difficulties remain in its operationalization . The use of MCI , both in clinical work and research , has , however , been widespread , and there has been an exponential increase in publications related to MCI in recent years . Neurology service providers in the United States reported frequently using the MCI diagnosis for diagnostic and billing purpose s , and most use cholinesterase inhibitors and other drugs at least sometimes for these patients . Thus , despite remaining uncertainties , the concept of MCI has importantly served to focus our attention on the early and prodromal stages of cognitive decline . There are many reasons for the highly variable use of MCI and related terms . The 1999 criteria for MCI focused on it as a prodrome of Alzheimer disease , with an emphasis on memory impairment that does not equally apply to other types of dementia . The original and revised definitions of MCI were intended more as guidelines for experienced clinicians and clinician research ers than as operational criteria in and of themselves . Population studies have operationalized these definitions in different ways and applied them retrospectively or prospect ively |
319 | 22,788,118 | The patterns that emerged were persisting normoglycaemia , transient hyperglycaemia , persisting hyperglycaemia and delayed hyperglycaemia . | AIM This article presents the results of a systematic review of descriptive cohort studies on the dynamics of glycaemia among adults admitted to hospital with acute stroke .
BACKGROUND Hyperglycaemia is common among adults admitted to hospital with stroke . | BACKGROUND AND PURPOSE Hyperglycemia at the time of ischemic stroke is associated with increased mortality and morbidity . Animal studies suggest that infa rct expansion may be responsible . The influence of persisting hyperglycemia after stroke has not previously been examined . We measured the blood glucose profile after acute ischemic stroke and correlated it with infa rct volume changes using T2- and diffusion-weighted MRI . METHODS We recruited 25 subjects within 24 hours of ischemic stroke symptoms . Continuous glucose monitoring was performed with a glucose monitoring device ( CGMS ) , and 4-hour capillary glucose levels ( BGL ) were measured for 72 hours after admission . MRI and clinical assessment s were performed at acute ( median , 15 hours ) , subacute ( median , 5 days ) , and outcome ( median , 85 days ) time points . RESULTS Mean CGMS glucose and mean BGL glucose correlated with infa rct volume change between acute and subacute diffusion-weighted MRI ( r > or=0.60 , P<0.01 ) , acute and outcome MRI ( r=0.56 , P=0.01 ) , outcome National Institutes of Health Stroke Scale ( NIHSS ; r > or=0.53 , P<0.02 ) , and outcome modified Rankin Scale ( mRS ; r > or=0.53 , P=0.02 ) . Acute and final infa rct volume change and outcome NIHSS and mRS were significantly higher in patients with mean CGMS or mean BGL glucose > or=7 mmol/L. Multiple regression analysis indicated that both mean CGMS and BGL glucose levels > or=7 mmol/L were independently associated with increased final infa rct volume change . CONCLUSIONS Persistent hyperglycemia on serial glucose monitoring is an independent determinant of infa rct expansion and is associated with worse functional outcome . There is an urgent need to study normalization of blood glucose after stroke Background and Purpose — We aim ed to analyze the frequency of persistent hyperglycemia ( PH ) , its implication s for outcome , and to document the inpatient management of hyperglycemia . Methods — Post hoc analysis of the GLIAS ( Glycemia in Acute Stroke ) study , a multicenter , prospect i ve , and observational cohort study of 476 acute ischemic stroke patients . Capillary finger-prick glucose was determined on admission and during the first 48 hours . We defined PH was defined as at least 2 values ≥155 mg/dL. Outcome ( modified Rankin Scale ) was evaluated at 3 months . Results — PH developed in 117 patients ( 24.7 % ) . PH was associated with poorer outcome ( modified Rankin Scale score > 2 : 56.2 % vs 28.1 % ; P<0.01 ) and higher mortality ( 26.7 % vs 5.9 % ; P<0.01 ) than those with glycemia < 155 mg/dL. PH ≥155 mg/dL was associated with a 4-fold increase in the odds of poor outcome at 3 months ( odds ratio , 4.7 ; 95 % confidence interval , 2.2–10.2 ) after adjustment for age , gender , hypertension , diabetes , stroke severity , admission glycemia , and infa rct volume . Only 20 % of patients with hyperglycemia ≥155 mg/dL received insulin on admission , with a progressive increase in the use of insulin during the following 48 hours . However , 114 ( 39.1 % ) out of 291 patients who received corrective treatment for hyperglycemia still had levels ≥155 mg/dL. Conclusions — PH ≥155 mg/dL is a common observation in acute ischemic stroke patients that is associated with poorer outcome and higher mortality . Almost 40 % of patients maintained levels ≥155 mg/dL despite corrective treatment Objective : To analyze the frequency , clinical characteristics , and predictors of symptomatic intracerebral hemorrhage ( ICH ) after intraarterial ( IA ) thrombolysis with recombinant pro-urokinase ( r-proUK ) in acute ischemic stroke . Method : The authors conducted an exploratory analysis of symptomatic ICH from a r and omized , controlled clinical trial of IA thrombolysis with r-proUK for patients with angiographically documented occlusion of the middle cerebral artery within 6 hours from stroke onset . Patients ( n = 180 ) were r and omized in a ratio of 2:1 to either 9 mg IA r-proUK over 120 minutes plus IV fixed-dose heparin or IV fixed-dose heparin alone . As opposed to intention to treat , this analysis was based on “ treatment received ” and includes 110 patients given r-proUK and 64 who did not receive any thrombolytic agent . The remaining six patients received out-of- protocol urokinase and were excluded from analysis . The authors analyzed central ly adjudicated ICH with associated neurologic deterioration ( increase in NIH Stroke Scale [ NIHSS ] score of ≥4 points ) within 36 hours of treatment initiation . Results : Symptomatic ICH occurred in 12 of 110 patients ( 10.9 % ) treated with r-proUK and in two of 64 ( 3.1 % ) receiving heparin alone . ICH symptoms in r-proUK – treated patients occurred at a mean of 10.2 ± 7.4 hours after the start of treatment . Mortality after symptomatic ICH was 83 % ( 10/12 patients ) . Only blood glucose was significantly associated with symptomatic ICH in r-proUK – treated patients based on univariate analyses of 24 variables : patients with baseline glucose > 200 mg/dL experienced a 36 % risk of symptomatic ICH compared with 9 % for those with ≤200 mg/dL ( p = 0.022 ; relative risk , 4.2 ; 95 % CI , 1.04 to 11.7 ) . Conclusions : Symptomatic ICH after IA thrombolysis with r-proUK for acute ischemic stroke occurs early after treatment and has high mortality . The risk of symptomatic ICH may be increased in patients with a blood glucose > 200 mg/dL at stroke onset Background and Purpose — Evidence is accumulating regarding the prognostic influence of hyperglycemia in patients with acute ischemic stroke . However , the level associated with poor outcome is unknown . Our objectives were to establish the capillary glucose threshold with the highest predictive accuracy of poor outcome and to evaluate its hypothetical value in influencing functional outcome by adjusting for other well-known prognostic factors in acute stroke . Methods — The authors conducted a multicenter , prospect i ve , and observational cohort study of 476 patients with ischemic stroke within less than 24 hours from stroke onset . Capillary finger-prick glucose and stroke severity were determined on admission and 3 times a day during the first 48 hours . Poor outcome ( modified Rankin Scale > 2 ) was evaluated at 3 months . Results — The receiver operating characteristic curves showed the predictive value of maximum capillary glucose at any time within the first 48 hours with an area under the curve of 0.656 ( 95 % CI , 0.592 to 0.720 ; P<0.01 ) and pointed to 155 mg/dL as the optimal cutoff level for poor outcome at 3 months ( 53 % sensitivity ; 73 % specificity ) . This point was associated with a 2.7-fold increase ( 95 % CI , 1.42 to 5.24 ) in the odds of poor outcome after adjustment for age , diabetes , capillary glucose on admission , infa rct volume , and baseline stroke severity and with a 3-fold increase in the risk of death at 3 months ( hazard ratio , 3.80 ; 95 % CI , 1.79 to 8.10 ) . Conclusions — Hyperglycemia ≥155 mg/dL at any time within the first 48 hours from stroke onset , and not only the isolated value of admission glycemia , is associated with poor outcome independently of stroke severity , infa rct volume , diabetes , or age Background : In patients with acute ischaemic stroke , hyperglycaemia has been retrospectively associated with negative outcome . There is an ongoing discussion as to which treatment algorithm , if any , provides the most effective prospect i ve intervention . Here we test the safety and feasibility of an intravenous insulin-only infusion protocol design ed for pragmatic routine clinical use . Methods : 40 ischaemic stroke patients with onset < 24 h ago , admitted to our stroke unit , were r and omized either to the study regimen ( 50 IU insulin in 50 ml 0.9 % saline solution applied intravenously via a perfusor pump ) , with the aim of reaching and maintaining blood glucose levels between 4.44 mmol/l ( 80 mg/dl ) and 6.11 mmol/l ( 110 mg/dl ) , or were treated with insulin subcutaneously if concentrations were above 11.10 mmol/l ( 200 mg/dl ) . Treatment was continued for 5 days . Primary outcome was the number of hypoglycaemic ( < 3.33 mmol/l ; < 60 mg/dl ) and severe hyperglycaemic ( > 16.65 mmol/l ; > 300 mg/dl ) events . Results : Hypoglycaemic events were significantly more common in patients treated intensively ( total n = 25 ; incidence rate ratio , IRR = 5.3 ; 95 % CI = 1.2–22.4 ; p < 0.05 ) . Symptomatic events were rare ( total n = 5 ) . Severe hyperglycaemia was associated with conventional treatment ( IRR = 4.9 ; 95 % CI = 1.5–15.9 ; p < 0.05 ) . Though those treated intensively attained near-normoglycaemic levels quicker and had significantly lower blood glucose levels over the study period ( 6.49 ± 2.19 mmol/l vs. 8.01 ± 3.06 mmol/l ; 95 % CI = –1.78 to –1.28 , p < 0.0005 ) , treatment imposes considerable strain on both patients and caregivers . Conclusions : The intensive intravenous insulin infusion protocol effectively lowers blood glucose levels with an increased risk of manageable hypoglycaemic events . However , a highly motivated and trained staff seems essential , limiting feasibility outside of specialty care setting BACKGROUND diabetes mellitus not only increases the risk of ischaemic stroke two- to four-fold but also adversely inXuences prognosis . The prevalence of recognised diabetes mellitus in acute stroke patients is between 8 and 20 % , but between 6 and 42 % of patients may have undiagnosed diabetes mellitus before presentation . Post-stroke hyperglycaemia is frequent and of limited diagnostic value and the oral glucose tolerance test assumes that the patient is clinical ly stable and eating normally . There is a need for a simple and reliable method to predict new diabetes mellitus in acute stroke patients . OBJECTIVES to determine the prevalence of unrecognised diabetes mellitus and impaired glucose tolerance on hospital admission and 12 weeks later in acute stroke patients with post-stroke hyperglycaemia > or = 6.1 mmol/l . To measure the accuracy of hyperglycaemia and elevated glycosylated haemoglobin concentration in predicting the presence of unrecognised diabetes mellitus at 12 weeks . DESIGN acute ( < 24 hours ) stroke patients ( cerebral infa rct ion and primary intracerebral haemorrhage ) with admission hyperglycaemia between 6.0 and 17 mmol/l and without a previous history of insulin-treated diabetes mellitus who were r and omised into the Glucose Insulin in Stroke Trial between October 1997 and May 1999 were studied . The Glucose Insulin in Stroke Trial is a r and omised controlled trial investigating the benefits of maintaining euglycaemia in acute stroke patients with mild to moderate hyperglycaemia . At 12 weeks , survivors underwent a 75 g oral glucose tolerance test . The positive predictive value and negative predictive value of admission plasma glucose > or = 6.1 mmol/l and elevated glycosylated haemoglobin concentration in predicting the presence of diabetes mellitus were used to estimate the prevalence of unrecognised diabetes mellitus in a consecutive series of 582 acute stroke admissions . RESULTS 582 consecutive acute stroke patients were assessed for eligibility for the Glucose Insulin Stroke Trial , of whom 83 ( 14 % ) had recognised diabetes mellitus . One hundred and forty-two patients were r and omised and 62 underwent a 3-month oral glucose tolerance test , of whom 26 ( 42 % ) had normal glucose tolerance , 23 ( 37 % ) had impaired glucose tolerance and 13 ( 21 % ) had diabetes mellitus . Admission plasma glucose > or = 6.1 mmol/l and glycosylated haemoglobin > or = 6.2 % predicted the presence of previously unrecognised diabetes mellitus at 12 weeks with a positive predictive value of 80 % and negative predictive value of 96 % . The estimated prevalence of unrecognised diabetes mellitus in the total series of acute stroke admissions was 16 - 24 % . CONCLUSIONS one-third of all acute stroke patients may have diabetes mellitus . For patients presenting with post-stroke hyperglycaemia , impaired glucose tolerance or diabetes mellitus is present in two-thirds of survivors at 12 weeks . Admission plasma glucose > or = 6.1 mmol/l combined with glycosylated haemoglobin > or = 6.2 % are good predictors of the presence of diabetes mellitus following stroke Background : Hyperglycaemia on presentation with acute ischaemic stroke ( AIS ) is associated with poor outcome , but intervention is unproven . We investigated the safety and tolerability of one method of glycaemic control . Methods : Patients within 24 h of AIS and plasma glucose 8–20 mmol/l were r and omised to receive either rigorous glycaemic control ( RC ) or st and ard management ( SM ) for 48 h. RC comprised i.v . insulin at a variable rate adjusted for target glucose concentration of 5–8 mmol/l , and intravenous crystalloid . The SM group received intravenous crystalloid alone in an open-label design . Results : Thirteen patients were r and omised to RC and 12 to SM ( age 75 ± 6.2 years ; 40 % male ; 20 % lacunar stroke ; time to treatment 8 ± 6.1 h ; plasma glucose 10.6 ± 0.9 mmol/l ; known diabetes 52 % ; NIHSS 8 , range 2–28 ) . The glucose concentration-time curve was reduced in the RC group ( AUC 324 ± 15 versus 385 ± 28 h·mmol/l , p = 0.04 ) . By 48 h , plasma glucose in both groups was 6.8 ± 1.1 and 7.5 ± 1.3 mmol/l respectively , but mean hourly insulin requirements in the RC group had dropped from 3.25 ± 0.32 units to 1.25 ± 0.5 units ( p < 0.01 ) . One transient episode of hypoglycaemic symptoms occurred in the RC group . Conclusion : Glycaemic control with sliding scale insulin for 48 h is feasible and well-tolerated after AIS . Treatment after 48 h may be unnecessary Several reports indicate that mild hyperglycemia ( plasma glucose level [ PGL ] ≥7.0 and ≤10.0 mmol/L [ ≥126 and ≤180 mg/dL ] ) is associated with poor prognosis in nondiabetic patients who sustain acute ischemic stroke ( AIS ) . Insulin therapy to maintain PGL < 7.0 mmol/L ( < 126 mg/dL ) has been reported to be beneficial in critically ill patients , but the safety and efficacy of this approach in patients with AIS are not well established . In a prospect i ve , open-label study , 50 consecutive nondiabetic patients with AIS admitted within 12 hours of ictus and with a PGL ≥7.0 and ≤10.0 mmol/L ( ≥126 and ≤180 mg/dL ) were r and omized to receive either a 24-hour intravenous ( IV ) insulin infusion ( ISI ) adjusted to maintain PGL within 4.5 - 7.0 mmol/L ( 81 - 126 mg/dL ) ( ISI group ; n=26 ) or treatment with subcutaneous insulin if PGL was > 10.0 mmol/L ( > 180 mg/dL ) ( control group [ CG ] ; n=24 ) . Patients ' neurologic status was assessed based on National Institutes of Health Stroke Scale ( NIHSS ) score at admission , 24 hours and 30 days . The 2 groups did not differ in terms of risk factors for stroke . The mean PGL measured at admission was 8.25±0.9 mmol/L ( 149±16 mg/dL ) in the ISI group and 8.1±0.8 mmol/L ( 146±14 mg/dL ) in the CG ( P=.8 ) . After 24 hours , these values dropped to 4.9±0.5 mmol/L ( 88±9 mg/dL ) and 5.5±0.45 mmol/L ( 99±8 mg/dL ) , respectively ( P < .01 ) . Two patients from the ISI group ( 8 % ) required IV glucose infusion for symptomatic hypoglycemia . There was no significant between-group difference in neurologic status at admission ( median NIHSS score , 10±3 vs 10±2 ) and 24 hours later ( 8±2 vs 9±3 ) . At 30 days , the median NIHSS score was 4±3 in the ISI group and 7±4 in the CG ( P=.04 ) . Our findings indicate that in nondiabetic AIS patients with mild hyperglycemia , IV insulin therapy aim ed at maintaining strict glycemic control ( PGL 4.5 - 7.0 mmol/L [ 81 - 126 mg/dL ] ) is relatively safe and may improve stroke outcome Background : In patients with acute ischaemic stroke and hyperglycaemia , prolonged strict glycaemic control may improve clinical outcome . The question is how to achieve this prolonged strict glycaemic control . In this study , the efficacy and safety of two regimens with different basal to meal related insulin ratio are described . Methods : 33 patients with ischaemic stroke and hyperglycaemia at admission were r and omised in an open design to receive : ( 1 ) conventional glucose lowering therapy , ( 2 ) strict glucose control with predominantly basal insulin using intravenous insulin or ( 3 ) strict glucose control with predominantly meal related insulin using subcutaneous insulin in the first 5 days after stroke . The target range of glucose control for the last two groups was 4.4–6.1 mmol/l . 16 consecutive patients without hyperglycaemia at admission were included to serve as normoglycaemic controls . Results : The median area under the curve ( AUC ) in the meal related insulin group was 386 mmol/l × 58 h ( range 286–662 ) for days 2–5 , and did not differ from the hyperglycaemic control group ( median AUC 444 mmol/l × 58 h ; range 388–620 ) . There was also no difference in median AUC of the basal insulin group ( 453 mmol/l × 58 h , range 347–629 ) and the hyperglycaemic control group on days 2–5 . In the first 12 hours , glucose profiles were lower in the groups treated with strict glucose control ; median AUC was 90 mmol/l × 12 h ( range 77–189 ) for the hyperglycaemic control group versus 81 mmol/l × 12 h ( range 60–118 ) for the meal related insulin group ( p = 0.03 ) and 74 mmol/l × 12 h ( range 52–97 ) for the basal insulin group ( p = 0.008 ) . Conclusion : In intermittently fed ischaemic stroke patients , strict glycaemic control between day 2 and day 5 with two different basal bolus regimens did not result in lower glucose profiles due to postpr and ial hyperglycaemia . Continuous enteral feeding may therefore be needed to achieve prolonged strict glycaemic control in acute stroke patients Autonomic nervous system dysfunction is a common complication of ischemic stroke . Clinical and experimental data indicate hemispheric lateralization in the control of autonomic activity . The insular cortex has also been shown to play a crucial role in the central autonomic network . The aim of this study was to assess cardio-autonomic dysfunction in patients with ischemic insular versus non-insular cortex infa rct ion , and to demonstrate a possible lateralization in autonomic activity mediated by the insular cortex . Sympathetic function was prospect ively assessed by determining plasma norepinephrine and epinephrine in 15 patients with left-hemisphere ( LH ; four insular infa rct ion ) , and 14 with right-hemisphere ( RH ) middle cerebral artery ( MCA ) stroke ( five insular infa rct ion ) . Systolic and diastolic blood pressure and heart rate were recorded during the first 5 days after stroke . Sympathetic activity was significantly higher in insular than in non-insular infa rct ion ( p < 0.05 ) with concomitantly elevated cardiovascular parameters in insular stroke patients . The pathological activation of the sympathetic nervous system was most excessive in RH-stroke involving the insular cortex ( p < 0.05 ) . Our data indicate a hemispheric lateralization in autonomic activity which is mediated by the right-sided insular cortex . Patients with RH stroke involving the insular cortex are most susceptible to develop cardio-autonomic dysfunction Controversy exists whether acute hyperglycemia is causally associated with worse stroke outcome or simply reflects a more severe stroke . In reversible ischemia models , hyperglycemia is associated with lactic acidosis and conversion of penumbral tissue to infa rct ion . However , the relationship between hyperglycemia , lactic acidosis , and stroke outcome has not been explored in humans . Sixty‐three acute stroke patients were prospect ively evaluated with serial diffusion‐weighted and perfusion‐weighted magnetic resonance imaging and acute blood glucose measurements . Patients with hypoperfused at‐risk tissue were identified by acute perfusion‐diffusion lesion mismatch . As a sub study , acute and subacute magnetic resonance spectroscopy was performed in the 33 most recent patients to assess the relationship between acute blood glucose and lactate production in the ischemic region . In 40 of 63 patients with acute perfusion‐diffusion mismatch , acute hyperglycemia was correlated with reduced salvage of mismatch tissue from infa rct ion , greater final infa rct size , and worse functional outcome . These correlations were independent of baseline stroke severity , lesion size , and diabetic status . Furthermore , higher acute blood glucose in patients with perfusion‐diffusion mismatch was associated with greater acute‐subacute lactate production , which , in turn , was independently associated with reduced salvage of mismatch tissue . In contrast , acute blood glucose levels in nonmismatch patients did not independently correlate with outcome measures , nor was there any acute‐subacute increase in lactate in this group . Acute hyperglycemia increases brain lactate production and facilitates conversion of hypoperfused at‐risk tissue into infa rct ion , which may adversely affect stroke outcome . These findings support the need for r and omized controlled trials of aggressive glycemic control in acute stroke Background Hyperglycemia at the time of acute ischemic stroke has been linked to worse outcome in both human and animal studies . Objective To describe the prevalence and severity of hyperglycemia on hospital admission among acute ischemic stroke patients , to examine the independent relationship of admission hyperglycemia to all-cause mortality , and to document the inpatient management of hyperglycemia . Methods Patients hospitalized with acute ischemic stroke at one hospital from July 1993 to June 1998 ( n = 656 ) were identified . Demographic data , diagnoses , and blood glucose ( BG ) values were retrieved from the electronic medical record system . Admission stroke severity , fingerstick BG results , and new diabetes diagnoses were obtained by chart review . Hyperglycemia was defined as admitting r and om serum BG ≥ 130 mg/dL. Hazard ratios ( HR ) for 30-day , 1-year , and 6-year mortality were calculated using multivariable Cox regression models . Results Hyperglycemia at admission to hospital was present in 40 % of patients with acute stroke . Patients with hyperglycemia were more often women and more likely to have prior diagnoses of diabetes and heart failure . Almost all of these patients remained hyperglycemic during their hospital stay ( mean BG = 206 mg/dL ) , and 43 % received no inpatient hypoglycemic drugs . Hyperglycemic patients had longer hospital stay ( 7 vs 6 days , p = 0.015 ) and higher inpatient hospital charges ( $ 6,611 vs $ 5,262 , p < 0.001 ) . Hyperglycemia independently increased the risk for death at 30 days ( HR 1.87 , p ≤ 0.01 ) , 1 year ( HR 1.75 , p ≤ 0.01 ) , and 6 years after stroke ( HR 1.41 , p ≤ 0.01 ) . Conclusions Admitting hyperglycemia was common among patients with acute ischemic stroke and was associated with increased short- and long-term mortality and with increased inpatient charges . Inpatient blood glucose management was suboptimal in this hospital . A trial of intensive treatment of hyperglycemia should be considered BACKGROUND Hyperglycemia on admission increases the risk of death in patients with acute stroke . It remains unclear whether glucose normalisation after admission is associated with improved survival . The goal of the study was to determine the relationship between postadmission glucose levels and mortality in stroke patients with and without admission hyperglycemia . METHODS 302 patients with first-ever ischemic stroke and without prior diagnosis of diabetes mellitus were enrolled . R and om plasma glucose level was measured on admission and fasting glucose on day 1 , 2 , 3 , 5 and 7 . Hyperglycemia on admission was defined as glucose level > or = 7.8 mmol/L. Postadmission hyperglycemia was diagnosed if mean postadmission fasting glucose level was > or = 6.1 mmol/L. RESULTS After multivariable adjustment , postadmission hyperglycemia was associated with higher risk of death regardless of admission glucose levels ( HR : 1.80 , 95%CI : 1.39 - 2.86 , P<0.01 ) . Postadmission hyperglycemia increases risk of death in both patients with admission hyperglycemia ( HR : 4.83 , 95%CI : 1.93 - 12.06 , P<0.01 ) and those with admission normoglycemia ( HR : 1.64 , 95%CI : 1.06 - 2.54 , P=0.03 ) . In patients with admission hyperglycemia glucose normalisation after admission was associated with reduced risk of death compared to those with persistent hyperglycemia ( HR : 0.21 , 95%CI : 0.08 - 0.52 ) . The patients who were normoglycemic on day 1 and developed hyperglycemia on next days had increased risk of death compared to persistent normoglycemic patients ( HR : 1.55 , 95%CI : 1.01 - 2.39 , P=0.04 ) . CONCLUSIONS Postadmission , but not admission , hyperglycemia is associated with increased risk of death . Glucose normalisation after admission is associated with better survival |
320 | 27,759,881 | Available evidence does not provide clinicians with reliable guidelines for treating periapical lesions . | BACKGROUND When primary root canal therapy fails , periapical lesions can be retreated with or without surgery .
Root canal retreatment is a non-surgical procedure that involves removal of root canal filling material s from the tooth , followed by cleaning , shaping and obturating of the canals .
Root-end resection is a surgical procedure that involves exposure of the periapical lesion through an osteotomy , surgical removal of the lesion , removal of part of the root-end tip , disinfection and , commonly , retro grade sealing or filling of the apical portion of the remaining root canal .
This review up date s one published in 2008 .
OBJECTIVES To assess effects of surgical and non-surgical therapy for retreatment of teeth with apical periodontitis .
To assess effects of surgical root-end resection under various conditions , for example , when different material s , devices or techniques are used . | Innovations in periradicular surgery for failed treatment of ortho grade root canal disease have been well-documented . We know of no prospect i ve studies that have compared success rates of conventional methods with these presumed advances . In this prospect i ve r and omised trial we compare the use of an ultrasonic retrotip with a microhead bur in the preparation of a retro grade cavity . Outcome was estimated clinical ly by estimation of pain , swelling , and sinus , and radiographically by looking at infill of bone and retro grade root filling 2 weeks and 6 months postoperatively . Both methods used other surgical techniques including microinstruments to place the retro grade root filling . The success rate of the ultrasonic method was higher ( all patients , n=26 ) than that of the microhead method ( n=19 of 21 ) . A larger study with longer follow up is required to consoli date this evidence OBJECTIVE R and omized clinical prospect i ve study to evaluate the application of MTA and IRM as retro grade sealers in surgical endodontics . STUDY DESIGN One hundred single-rooted teeth were surgically treated . After r and omization , MTA or IRM was used as a retrosealer . Radiographs were taken 1 week , 3 months , and 1 year postoperatively . Assessment was performed by 2 independent assessors 1 year after surgery . Both treatment groups were homogeneous in their composition , and clinical features and radiographic findings were classified according to Rud 's classification . RESULTS Complete healing was observed in 64 % of the MTA-treated teeth vs 50 % of the IRM-treated teeth . Incomplete healing was seen in 28 % ( MTA ) vs 36 % ( IRM ) , and unsatisfactory in 6 % ( MTA ) vs 14 % ( IRM ) . Only 1 failure was seen ( MTA ) . No statistically significant differences were found between the 2 retrofilling material s. CONCLUSION As root-end filling material s in this clinical prospect i ve r and omized design on single rooted teeth , MTA and IRM had the same clinical effectiveness This article covers a 4-year study that reports 320 cases in which endodontic surgery was performed for residual apical lesions or lesions that could not be treated in a conventional way . Four groups of 80 teeth each were formed and they were followed up after a 12-month interval . The first group comprised cases treated with a micro bur , retro grade filling and IRM ; the second , cases treated at the apical and radicular portions with a CO2 laser ; the third , cases in which the retro grade cavity was prepared with an ultrasonic device instead of a micro bur ; and the fourth group comprised cases treated in a similar way to the second group , i.e. , cases treated at the apical and radicular portions , but with a CO2 laser instead of a micro bur . After 12 months , the results showed a better prognosis with ultrasonic treatment . Regardless of technique , the CO2 laser did not improve the healing process OBJECTIVE To evaluate the pain experience following root-end resection and filling with Mineral Trioxide Aggregate or Intermediate Restorative Material . STUDY DESIGN Referred adult patients recruited using strict entry criteria were r and omly allocated to receive either material . A st and ardized surgical technique was employed . Postoperative instructions and a pain question naire were given to each patient to record the severity of their pain at 3 time intervals-3 - 5 hours , 24 hours , and 48 hours after surgery-on a st and ard visual analog scale ( VAS ) . Patients were also asked to record consumption of any self-prescribed analgesics , the type , and dosage . RESULTS At 3 - 5 hours after surgery , regardless of the material used , 90 % of all patients experienced some level of postoperative pain . Twenty-four hours after surgery 82 % of patients experienced pain , as did 72 % after 48 hours . Thirty-seven percent of patients did not take any analgesics at all . In order of popularity , the analgesics taken were ibuprofen , acetaminophen , and acetaminophen plus codeine phosphate . The VAS measurements were reduced over time in both treatment groups ( P < .001 ) . There was no statistically significant difference in the proportion of subjects taking analgesics in each treatment group . Patients who used analgesics showed higher median VAS measurements at all time periods ( P < .05 ) . CONCLUSIONS There was no significant difference in the pain experienced by both treatment groups . The postoperative pain was of a relatively short duration , at its maximum intensity early in the postoperative period but progressively decreased with time . Even if pain relief medication was needed , nonprescription analgesics were adequate and effective OBJECTIVES This prospect i ve r and omized study compared the outcome of retreatment and surgical intervention in root canal treated teeth with nonhealing periradicular pathosis . STUDY DESIGN One such tooth from each of 38 patients was r and omly allotted to retreatment or root-end resection and root-end filling . Treatment outcome after 1 year was evaluated and compared clinical ly and radiographically . RESULTS The success rate for surgery was higher than for conventional retreatment , but the difference was not statistically significant . CONCLUSIONS For management of nonhealing periradicular pathosis associated with root canal treated teeth , surgical intervention should be considered as an alternative to retreatment . In cases with a similar prognosis for both modes of treatment , the choice should be governed by consideration of intrinsic and extrinsic factors INTRODUCTION The purpose of the present study was to evaluate the clinical outcomes of endodontic microsurgery when super ethoxy-benzoic acid ( Super EBA ; Harry J. Bosworth , Skokie , IL ) and mineral trioxide aggregate ( MTA ) were used as root-end filling material s in a prospect i ve r and omized controlled study . METHODS Of the 388 teeth eligible for endodontic microsurgery , 128 teeth were excluded from the study , and 260 teeth were r and omly assigned to either the Super EBA group or the MTA group with equal numbers using the " minimization method . " Endodontic microsurgical procedures were performed according to the Yonsei protocol reported in a previous study and were carried out by a single operator . The patients were followed up at 3 , 6 , and 12 months . The primary outcome measure was the change in the apical bone density at 12 months , and the secondary outcome measures were the presence of clinical symptoms or abnormal findings at 12 months . RESULTS A total of 192 teeth were examined at the 12-month follow-up ; 102 teeth were in the Super EBA group , and 90 were in the MTA group . The overall success rate was 94.3 % , with a success rate of 95.6 % ( 86/90 teeth ) for MTA and 93.1 % ( 95/102 teeth ) for Super EBA . The statistical analysis of the success rate results did not show any significant difference between the groups ( P = .472 ) . CONCLUSIONS In this prospect i ve r and omized controlled study , there was no significant difference in the clinical outcomes of endodontic microsurgery when Super EBA and MTA were used as root-end filling material OBJECTIVE The purpose of this study was to evaluate the potential benefit of an ultrasonic device in apical surgery on the outcome of treatment . STUDY DESIGN A r and omized prospect i ve design was used in a st and ardized treatment protocol . Patients were allocated to treatment with an ultrasonic device ( P-Max Newtron ) or treatment with a bur in an otherwise similar protocol . One year after treatment the results were evaluated by 2 oral and maxillofacial surgeons who were blinded for the therapy . RESULTS Out of a total group of 399 patients who were included in the study , adequate follow-up could be obtained in 290 patients . The overall success rate in the ultrasonic group was 80.5 % and in the group treated with a bur 70.9 % ( P = .056 ) . In molars , the difference in success rate was significant ( P = .02 ) . CONCLUSION The use of an ultrasonic device in apical surgery improved the outcome of treatment . In molars this effect was significant AIM To assess the success rate of the root-end filling material , Mineral Trioxide Aggregate ( MTA ) . METHODOLOGY Referred adult patients were recruited using strict entry criteria and r and omly allocated to receive MTA or IRM . A st and ardized surgical technique was employed : the root end was resected perpendicularly and a root-end cavity was prepared ultrasonically and filled . A radiograph taken immediately after surgery was compared with those taken at 12 and 24 months . Customised film holders and the paralleling technique were used ; radiographs were assessed by two trained observers using agreed criteria . The results from 122 patients ( 58 in IRM group , 64 in MTA group ) after 12 months and 108 patients ( 47 in IRM group , 61 in MTA group ) for the 24-month review period were analysed using the chi2 test . RESULTS The highest number of teeth with complete healing at both times was observed when MTA was used . When the numbers of teeth with complete and incomplete ( scar ) healing , and those with uncertain and unsatisfactory healing were combined , the success rate for MTA was higher ( 84 % after 12 months , 92 % after 24 months ) compared with IRM ( 76 % after 12 months , 87 % after 24 months ) . However , statistical analysis showed no significant difference in success between material s ( P > 0.05 ) at both 12 and 24 months . CONCLUSIONS In this study , the use of MTA as a root-end filling material result ed in a high success rate that was not significantly better than that obtained using IRM AIM To compare healing responses to periosteal sliding grafts and polyglactin 910 periodontal mesh used as guided tissue regeneration ( GTR ) material s/techniques when both periapical and periradicular bone loss are present . METHODOLOGY Thirty patients with suppurative chronic apical periodontitis with apicomarginal communication were selected and allocated r and omly into two groups according to the barrier technique to be used during periradicular surgery : periosteal graft group ( n = 15 ) and bioabsorbable membrane group ( n = 15 ) . Clinical and radiological evaluations were completed prior to surgery , a week later and every 3 months after surgery up to 12 months to measure the periodontal pocket depth ( PD ) , clinical attachment level ( CAL ) , gingival margin position ( GMP ) , size of periapical lesion , percentage reduction of the periapical rarefaction , and periapical healing . RESULTS Both groups showed highly significant ( P < 0.001 ) reductions in periodontal PD , CAL and size of periapical lesion at 12 months whilst GMP was unaltered . No significant difference between the experimental groups was evident for these parameters , or for the percentage reduction of size of the periapical lesion and clinical -radiographic healing . CONCLUSION Guided tissue regeneration applied to apicomarginal defects using sliding periosteal grafts and use of bioabsorbable membranes led to similar enhancements of the clinical outcome of periradicular surgery in terms of periapical healing , gain of periodontal support , PD reduction and minimal recession of the gingival margin The purpose of this prospect i ve clinical study was to assess the rate of healing of periapical bony defects created at the time of endodontic periapical surgery by measuring the densitometric ratio change in periapical osseous tissues , after periapical endodontic surgery was performed , by using or not using Guidor bioresorbable membrane material . Periapical surgeries were performed on 25 patients where nonsurgical root canal therapy had failed and a periapical lesion was present . For inclusion in the study , the osseous defect to be analyzed had to be confined to the apical area , with bone covering the entire root surface coronally , and an intact lingual cortical plate had to be present . A series of radiographs at the 3- , 6- , and 12-month recalls were compared with the radiograph taken immediately after surgery by using digital imaging and a densitometric ratio that gave a numerical estimation of osseous healing . Using repeated-measure ANOVA , it was shown that there was no statistical difference between the rate of healing in those cases where a Guidor resorbable membrane was used and those cases where no membrane was used . The results suggest that placement of a guided tissue membrane over the bony opening created during an endodontic periapical surgical procedure has no beneficial effect on the rate of healing and the added expense to the patient would not be warranted in these cases PURPOSE The introduction of microsurgical instruments and magnification devices has brought advantages in root-end management and the application of root-end filling material s. The main purpose of this prospect i ve clinical study was to monitor the outcome of ultrasonic root-end preparation using magnification loupes or an endoscope . Tooth location and the presence of post restoration were also examined as potentially affecting the outcome . MATERIAL S AND METHODS Teeth treated surgically showed a periradicular lesion of strictly endodontic origin . A total of 59 patients were included in the study , according to specific selection criteria . Following the reflection of a full mucoperiosteal tissue flap , residual soft tissues were curetted , root ends were resected , and root-end cavities were prepared ultrasonically with a zirconium nitrate tip , and zinc oxide EBA-reinforced cement root-end fillings were placed . Thirty-two root-end management procedures were performed using magnification loupes and 39 using an endoscope . All cases followed for a period of 1 year were classified into 3 groups ( success , uncertain healing , and failure ) according to radiographic and clinical criteria . RESULTS Of the 71 teeth evaluated at 1-year follow-up , 67 teeth ( 92.95 % ) successfully healed , 3 teeth had uncertain healing , and 2 failed . In the group using endoscopy , 94.9 % of successful healing was achieved , while for the other group , 90.6 % was recorded . We found no statistically significant differences in treatment results related to the arch ( P = .20 ) , post restoration ( P = .21 ) , or type of magnification device ( P = .08 ) . CONCLUSIONS In the present study , adherence to a strict endodontic surgical protocol and the use of modern surgical endodontic procedures , together with visual magnifications , result ed in an overall high success rate AIM This r and omized , controlled , clinical study was design ed to evaluate the adjunctive effect of calcium sulphate grafts on the surgical treatment of through and through periradicular lesions . METHODOLOGY Twenty patients each with one tooth showing evidence radiologically of a periradicular lesion wider than 10 mm , with lack of both buccal and lingual cortical bony plates and an indication for surgery were selected for the study . Ten teeth were treated with apicectomy , root-end filling and grafting of the bone defect with calcium sulphate prior to suturing ( test group ) . The other 10 teeth received the same surgical therapy but no grafting with calcium sulphate ( control group ) . The outcome of the healing process was evaluated at 6 and 12 months radiographically following the criteria reported by Rud and And reasen . RESULTS At the six- and 12-month evaluation the test group had seven teeth with complete healing and two with incomplete healing , whilst the control group showed three teeth with complete healing , five with incomplete healing and one with unsatisfactory healing . One tooth in each group had to be extracted because of a vertical fracture that occurred during the follow-up period . CONCLUSIONS The results of the study demonstrate that the addition of calcium sulphate as a bone graft during the conventional surgical treatment of through and through lesions improves the clinical outcome . Histological analysis is desirable to investigate the quality of tissues formed using the two surgical procedures AIM To compare healing after root-end resection with a root-end filling of mineral trioxide aggregate ( MTA ) or smoothing of the ortho grade gutta-percha ( GP ) root filling . METHODOLOGY Forty-four patients ( consisting of 52 teeth with periapical infection ) , average age of 54.6 years ( range 30 - 77 ) participated in a r and omized clinical trial ( RCT ) comparing the MTA and GP treatment methods . Radiographs produced 1-week and 12 months post-operatively were compared after blinding for treatment method , and healing was assessed as complete , incomplete , uncertain , or unsatisfactory . RESULTS Six teeth were not available for the 12-month follow-up : three teeth ( GP ) had been re-operated because of pain and two teeth ( one GP , one MTA ) had been extracted because of root fracture ( these five teeth were classified as failures ) . One patient ( GP ) was not available for recall . In the GP group , seven teeth ( 28 % ) showed complete healing , six teeth ( 24 % ) incomplete healing , six teeth ( 24 % ) uncertain healing and two teeth ( 8 % ) unsatisfactory healing after 1 year . In the MTA group , 22 teeth ( 85 % ) showed complete healing , three teeth ( 12 % ) incomplete healing , and none were scored as uncertain or unsatisfactory healing after 1 year . The difference in healing between the GP and the MTA groups was significant ( P < 0.001 ) . CONCLUSIONS The results from this RCT emphasize the importance of placing a root-end filling after root-end resection . Teeth treated with MTA had significantly better healing ( 96 % ) than teeth treated by smoothing of the ortho grade GP root filling only ( 52 % ) OBJECTIVE The aim of this study was to evaluate the healing outcome after periapical surgery with an ultrasonic cleaning technique in conjunction with the use of either of 2 different retro grade root-filling material s in teeth with apical periodontitis . STUDY DESIGN One hundred sixty teeth in 139 consecutive patients were r and omly allocated into 2 groups receiving either IRM or thermoplasticized gutta-percha ( GP ) with AH Plus sealer as a retro grade root-end seal . The patients were review ed 12 months after surgery . The results were analyzed with Fisher exact test . RESULTS One hundred forty-seven teeth in 131 patients were review ed . Radiologic evaluation and clinical examination showed an 85 % success rate for the IRM group and 90 % for GP group . There was no statistical significance between the 2 groups . CONCLUSION Both tested material s , IRM and GP , are suitable as retro grade root-end filling material s in conjunction with ultrasonic root-end preparation according to the results of the healing outcome after 12 months follow-up PURPOSE The aim of the present prospect i ve , r and omized , controlled , clinical study was to compare the outcomes of periradicular surgery of the maxillary first molar tooth using the vestibular approach between 2 preoperative radiologic evaluation methods : cone beam computed tomography ( CBCT ) and conventional radiography . PATIENTS AND METHODS Periradicular surgery was applied to the maxillary first molar tooth in 40 patients . The patients were divided into 2 groups . The patients in group 1 underwent examination and preoperative planning with CBCT , and the patients in group 2 underwent examination and preoperative planning with conventional radiography . The outcomes of the treatment were evaluated radiographically and clinical ly , and the data were analyzed statistically . RESULTS The mean operative time was significantly shorter in group 1 than in group 2 . According to the radiographic and clinical healing criteria used in the present study , the healing of patients in group 1 was rated as a success in 35 % , an improvement in 40 % , and a failure in 25 % . In the group 2 patients , healing was rated as a success in 42.1 % , an improvement in 31.6 % , and a failure in 26.3 % . Sinus membrane elevation was performed in 92.3 % of all patients . Sinus membrane perforation occurred in 20 % of the patients in group 1 and 36.8 % of the patients in group 2 . CONCLUSIONS Periradicular surgery of maxillary first molars using a vestibular approach is a viable treatment method with a low complication rate . Preoperative CBCT examination demonstrated positive contributions to the treatment outcomes INTRODUCTION The aim of the present controlled clinical trial was to compare 2 incision techniques , papilla base incision ( PBI ) and sulcular incision ( IS ) , evaluating changes in papilla and recession height over a 12-month period . METHODS A total of 24 subjects requiring endodontic surgery on a single tooth were enrolled . PBI was used in 1 group and IS in the other group . The primary outcomes were changes in gingival recession of the tooth affected by periapical lesions and the mesial and distal teeth and the mesial and distal papilla height using the treated tooth as the reference . Outcome variables were assessed at baseline and 12 months after the surgical intervention . Statistical analysis was performed by a blinded operator through appropriate tests , with significance set at a P value equal to .05 . RESULTS In the PBI group , the papilla height at the 12-month follow-up in the mesial and distal aspect decreased 0.10 ± 0.32 mm and 0.10 ± 0.32 mm , respectively , and 0.23 ± 0.68 mm and 0.25 ± 0.40 mm , respectively , in the IS group without any significant differences . There were no differences found for recession change values between groups . CONCLUSIONS The PBI and IS approaches in endodontic surgery showed similar results in terms of papilla height preservation and recession changes Endodontic retreatment decision-making must include an appraisal of the costs of the different strategies proposed . In addition to direct costs , postoperative discomfort may have other consequences in terms of time off work , unscheduled visits and suffering . To establish a foundation for the appraisal of such indirect and intangible costs the present study was set up in which patients ' assessment s of pain and swelling after surgical and nonsurgical retreatment procedures were recorded . Ninety-two patients with 95 root-filled incisors and canine teeth exhibiting apical periodontitis were included in the study . The mode of retreatment was r and omly assigned . Each day during the first post-treatment week patients assessed their degree of swelling and pain on horizontal 100-mm visual analog scales ( VAS ) . The scales ranged from " no swelling " to " very severe swelling " and " no pain " to " intolerable pain " , respectively . Consumption of self-prescribed analgesics and time off work were also recorded . Significantly more patients reported discomfort after surgical retreatment than after nonsurgical procedures . High pain scores were most frequent on the operative day while swelling reached its maximum on the first postoperative day followed by progressive decrease both in frequency and magnitude . Postoperative symptoms associated with nonsurgical retreatment were less frequent but reached high VAS values in single cases . Analgesics were significantly more often consumed after periapical surgery . Patients reported absence from work mainly due to swelling and discoloration of the skin . This was found to occur only after surgical retreatment . Conclusively , surgical retreatment result ed in more discomfort and tended to bring about greater indirect costs than nonsurgical retreatment PURPOSE A healthy gingival condition after endodontic surgery may depend on adequate soft tissue management . The aim of this study was to compare 2 incision techniques , papilla base incision ( PBI ) and intrasulcular flap ( IS ) , which are currently used in endodontic surgery . MATERIAL S AND METHODS In the present nonr and omized controlled clinical trial , patients requiring endodontic surgery on a single tooth were enrolled . PBI was used in 1 group and IS was used in the other group . The primary outcomes were changes in periodontal probing depth , gingival recession , and height of the interproximal mesial and distal papillae . Outcome variables were assessed preoperatively and 6 months after surgery . Between-group differences were evaluated through appropriate statistical analysis , with significance set at a P value equal to .05 . RESULTS Each group was composed of 12 patients and the 2 groups were comparable at baseline . Two weeks after surgery , papilla height decreased significantly in the IS group ( 2.05 and 1.80 mm at the mesial and distal aspects , respectively ) , whereas no significant decrease in papilla height was observed in the PBI group ( 0.10 and 0.20 mm ) . No statistically significant difference between groups was observed after 6 months . No significant difference between groups was found for gingival recession or probing depth at any follow-up time . CONCLUSIONS Better soft tissue preservation in the early postoperative period was achieved using the PBI approach compared with the IS approach . The PBI can be recommended for endodontic surgical procedures involving esthetic regions INTRODUCTION The aim of the study was to compare the healing responses of platelet-rich plasma ( PRP ) , PRP + a collagen sponge , and a collagen membrane used as guided tissue regeneration ( GTR ) material s for the treatment of apicomarginal defects . METHODS Thirty patients with suppurative chronic apical periodontitis and apicomarginal communication were selected and allocated r and omly into three groups according to the barrier technique to be used during periradicular surgery : the collagen membrane group , the PRP group , and the PRP + collagen sponge group . Clinical and radiographic measurements were determined at baseline and every 3 months after surgery up to 1 year . Cases were defined as healed when no clinical signs or symptoms were present , and radiographs showed complete or incomplete ( scar tissue ) healing of previous radiolucencies . RESULTS The PRP and PRP + collagen sponge groups depicted 83.33 % and 88.89 % healing , respectively , in terms of combined clinical -radiographic healing as compared with 80 % in the collagen membrane group . All the three treatments showed highly significant ( P < .05 ) reductions in the periodontal pocket depth ( PD ) , the clinical attachment level ( CAL ) , the gingival margin position ( GMP ) , the size of the periapical lesion , the percentage reduction of the periapical rarefactions , and periapical healing . No significant differences between the three groups were evident for these parameters ( P > .05 ) . CONCLUSIONS GTR applied to apicomarginal defects using PRP or PRP + collagen sponge lead to similar enhancements of the clinical outcome of periradicular surgery in terms of periapical healing , gain of periodontal support , PD reduction , and PRP may be an alternative treatment for GTR membrane in the treatment of apicomarginal defects OBJECTIVE This study evaluated the treatment outcome after periapical surgery with the use of 2 different retro grade root-filling material s and the influence of 3 pre- and perioperative variables on the periapical healing . STUDY DESIGN Two hundred six teeth in 164 patients were r and omly allocated to receive either IRM or Super-EBA as a retro grade root-end seal . The teeth were review ed 12 months after surgery . The influence of lesion size , lesion type , and ortho grade root filling quality on healing was analyzed . RESULTS One hundred ninety-four teeth in 153 patients were review ed . Radiologic evaluation and clinical examination revealed 91 % success rate for the IRM group and 82 % for the Super-EBA group . There was no statistical significance in the healing outcome between the 2 groups ( Fisher exact test ) . The analyzed pre- and perioperative variables had no significant influence on the treatment outcome ( Z test ) . CONCLUSIONS Both retro grade material s tested in this study can serve as a root-end seal in periapical infected teeth , according to the results of the healing outcome after 12 months ' follow-up OBJECTIVES The purpose of this prospect i ve study was to evaluate a possible clinical benefit of LLLT in endodontic surgery . STUDY DESIGN Seventy-two endosurgery cases on incisors and premolars were included to the study and were split r and omly into an LLLT test group , a placebo group , and a control group . In the LLLT group , irradiation was performed intraoperatively and postoperatively 1 , 3 , and 7 days after surgery . In the placebo group , irradiation was performed without laser activation . In the control group , neither LLLT nor placebo therapy was used . Swelling , wound healing , and pain were evaluated by a blinded investigator 1 , 3 , and 7 days postoperatively . RESULTS No statistically relevant differences between the LLLT and the placebo groups were found . Patients in the control group reported on statistically relevant stronger pain . CONCLUSION In routine endodontic surgery cases , LLLT does not achieve a significant clinical benefit . Further , the results indicate a prominent placebo effect of the soft laser therapy AIM To assess the treatment results up to 1 year after endodontic treatment of apical periodontitis using a silicone-based sealer in comparison with Grossman 's sealer , and to compare the results at 3 months after treatment with the 12-month follow-up to assess the prognostic value of a 3-month control . METHODOLOGY A total of 199 teeth were treated at three centres . The sealer was r and omly chosen at the time of filling . Treatment results were evaluated clinical ly and radiographically 3 and 12 months after root-canal filling . The periapical status was evaluated using the periapical index ( PAI ) . RESULTS AND CONCLUSIONS Average PAI scores decreased from 3.43 at start to 2.21 at 12 months for Grossman 's sealer and from 3.40 to 2.26 for the silicon-based material . No significant difference between the groups at start or any of the follow ups was seen . The 3-month control was adequate in establishing significant healing in both groups . The improvement of the periapical condition continued at the 12-month examination AIM To determine the value of clindamycin prophylaxis in the prevention of postoperative wound infections in patients undergoing endodontic surgery . METHODOLOGY This study included 256 patients undergoing endodontic surgery in a prospect i ve double-blind placebo-controlled trial comparing oral administration of an oral placebo versus a preoperative 600 mg dose of clindamycin . After r and omization the study medication was administered orally 1 h before surgery in a double-blind fashion . For a period of 4 weeks the postoperative course was observed according to clinical parameters of infection . Primary end-point was infection at the surgical site . RESULTS The mean age of the study population was 44.4 years ( SD 11.4 , range 18 - 82 years ) with a sex distribution of 147 females ( 47.4 % ) and 109 males ( 42.6 % ) . Mean age of the patients in the clindamycin group was 44.7 years ( SD 12.0 ) , and the mean age in the placebo group was 44.1 years ( SD 10.8 ) ( P = 0.49 ) . In the clindamycin group , the mean duration of surgery was 32.3 min ( SD 8.8 ) and in the placebo group the mean duration of surgery was 32.5 min ( SD 8.4 ) ( P = 0.89 ) . Two infections [ 1.6 % ; 95 confidence interval ( CI ) : 0.48 - 4.72 ] were identified in the clindamycin group and four ( 3.2 % ; 95 CI : 0.42 - 1.33 ) in the placebo group ( P = 0.448 ) . CONCLUSIONS No statistically significant difference was found between clindamycin prophylaxis and placebo with regard to the prevention of postoperative infection in endodontic surgical procedures PURPOSE The purpose of this prospect i ve clinical trial was to monitor the outcomes of periradicular surgery in large periapical lesions with or without guided tissue regeneration ( GTR ) and anorganic bovine bone . MATERIAL S AND METHODS All teeth in the study revealed a periradicular lesion measuring at least 10 mm . A total of 63 teeth in 44 patients were included according to specific selection criteria . In the test group , after root end filling was completed , the defect was filled with anorganic bovine bone and was covered with a resorbable collagen membrane . In the control group , neither graft nor membrane was used . RESULTS A total of 59 teeth in 41 patients were evaluable at 1-year follow-up . Of these , 24 teeth belonged to the test group and 35 to the control group . Overall , 46 teeth ( 78 % ) had successfully healed , 10 ( 16.9 % ) demonstrated uncertain healing , and 3 exhibited treatment failure . Investigators found no statistically significant differences in outcome between test and control groups . CONCLUSIONS The present study showed that the use of GTR in association with anorganic bovine bone in the treatment of patients with large periradicular lesions of strictly endodontic origin has no beneficial effect on outcome INTRODUCTION The purpose of this prospect i ve , r and omized controlled trial was to evaluate the healing outcomes of platelet-rich fibrin ( PRF ) in periapical surgeries involving apicomarginal defects and to compare these results with surgeries not using any guided tissue regeneration techniques . METHODS Thirty patients with suppurative chronic apical periodontitis and apicomarginal communication were r and omly assigned to either the PRF or the control group . Clinical and radiographic parameters including pocket depth ( PD ) , clinical attachment level , gingival marginal position , size of periapical lesion , and percentage reduction of the periapical radiolucency were recorded at baseline and at an interval of 3 months for a period of 12 months . RESULTS The overall success rate was 83.33 % , with a success rate of 86.66 % ( 13 of 15 teeth ) for PRF group and 80 % ( 12 of 15 teeth ) for control group . Both the groups exhibited a significant reduction in PD , clinical attachment level , gingival marginal position , and size of periapical lesion at 12-month period . No significant differences were observed between the 2 groups for these parameters except PD , which showed a statistically significant reduction in the PRF group ( P < .05 ) . CONCLUSIONS The adjunctive use of regenerative techniques may not promote healing of apicomarginal defects of endodontic origin A total of 67 teeth in 64 patients were treated with apicectomy and retro grade fillings . They were r and omized to receive fillings of amalgam or glass ionomer cement in a comparative clinical study . Healing was evaluated clinical ly and radiographically after 1 and 5 years . Evaluation showed no difference in healing capacity between the two material s. Overall success rates in both groups were registered as 90 % at 1 year and 85 % at 5 years . Contamination with blood or saliva during insertion of the filling material did not affect healing adversely . The study shows that the 5-year follow-up result can be predicted in more than 95 % of the cases at the 1-year follow-up . It can be concluded that glass ionomer cement is a valid alternative to amalgam as an apical sealant after apicectomy with equally good long-term clinical results INTRODUCTION The aim of apical surgery is to hermetically seal the root canal system after root-end resection , thereby enabling periradicular healing . The objective of this nonr and omized prospect i ve clinical study was to report results of 2 different root-end preparation and filling methods , ie , mineral trioxide aggregate ( MTA ) and an adhesive resin composite ( Retroplast ) . METHODS The study included 353 consecutive cases with endodontic lesions limited to the periapical area . Root-end cavities were prepared with sonic microtips and filled with MTA ( n = 178 ) , or alternatively , a shallow concavity was prepared in the cut root face , with subsequent placement of an adhesive resin composite ( Retroplast ) ( n = 175 ) . Patients were recalled after 1 year . Cases were defined as healed when no clinical signs or symptoms were present and radiographs demonstrated complete or incomplete ( scar tissue ) healing of previous radiolucencies . RESULTS The overall rate of healed cases was 85.5 % . MTA-treated teeth demonstrated a significantly ( P = .003 ) higher rate of healed cases ( 91.3 % ) compared with Retroplast-treated teeth ( 79.5 % ) . Within the MTA group , 89.5%-100 % of cases were classified as healed , depending on the type of treated tooth . In contrast , more variable rates ranging from 66.7%-100 % were found in the Retroplast group . In particular , m and ibular premolars and molars demonstrated considerably lower rates of healed cases when treated with Retroplast . CONCLUSIONS MTA can be recommended for root-end filling in apical surgery , irrespective of the type of treated tooth . Retroplast should be used with caution for root-end sealing in apical surgery of m and ibular premolars and molars Healing capacity after apicectomy was investigated in a r and omized clinical study of 105 teeth apically sealed with either amalgam or glass ionomer cement . The results were evaluated clinical ly and radiographically after 1 year . The success rate was high for both material s : 91 % for amalgam and 89 % for glass ionomer cement . Contamination with moisture and blood adversely affected the outcome for both material s and was significantly more frequent in unsuccessful cases The purpose of this prospect i ve , r and omized , clinical study was to monitor the outcome of periradicular surgery , in which either a surgical microscope or an endoscope was used as a magnification device . A total of 113 teeth in 70 patients were included in the study , according to specific selection criteria . The choice of endoscope or surgical microscope was made using a r and omized table . One hundred cases were followed for at least 2 years . Of these , 59 root-end management procedures were performed using a microscope and 41 using an endoscope . At the 2-year follow-up they were classified into three groups ( success , uncertain healing and failure ) according to radiographic and clinical criteria . After a 2-year follow-up , 91 teeth ( 91 % ) healed successfully . In the group using an endoscope 90 % of successful healing was achieved , while 92 % of success was recorded for the group using a microscope . No statistically significant difference was found in the treatment results relating to the type of magnification device . The type of magnification device used did not seem to affect the outcome of endodontic surgery The purpose of this prospect i ve study was to assess the outcome of periradicular surgery with or without guided tissue regeneration ( GTR ) for the treatment of through- and -through lesions . Thirty-four teeth were included according to specific selection criteria . In the test group ( using GTR ) , after root-end filling , the defects were filled with anorganic bovine bone and covered with a resorbable collagen membrane . Healing was assessed according to specific criteria and grade d as successful , doubtful , or failed . In the control group , neither grafts nor membranes were used . After 1 year , 31 teeth were evaluated . Of these , 22 ( 71 % ) healed successfully , 6 ( 19 % ) showed doubtful healing , and 2 were recorded as failures . The outcomes of the defects treated with GTR ( 88 % successful ) were significantly better than those of the control group ( 57 % successful ) . The present study showed that the use of GTR associated with anorganic bovine bone in the treatment of through- and -through lesions may positively affect the healing process Information of " success " rates after surgical or nonsurgical endodontic retreatment is abundant but inconclusive . Reported healing frequencies vary between 45 % and 90 % . The present study was design ed to find any systematic difference between the methods . Nonsurgical and surgical retreatment was r and omly assigned to 95 endodontically " failed " cases . The outcome of the procedures was clinical ly and radiographically recorded , and followed for 4 years . At the 12-month recall , a statistically significant ( p < 0.05 ) higher healing rate was observed for cases surgically retreated . At the final 48-month examination , no such difference was found . These findings may be explained by ( a ) slower healing dynamics in the nonsurgical group and ( b ) the event of late " failures " in the surgical group . Within the latter category , four cases classified as healed after 1 yr failed at the final follow-up . Conclusively , this study failed to show any systematic difference in the outcome of surgical and nonsurgical endodontic retreatment . Surgical retreatment seems to result in more rapid periapical bone fill , but also may imply a higher risk of " late failures . " From a scientific point of view , the length of the follow-up period is very important and may strongly influence the conclusions made AIM To monitor the quality of life of patients after periradicular surgery when two different flap design s were used . METHODOLOGY Forty patients with teeth having a periradicular lesion of endodontic origin were included according to specific selection criteria . Patients were r and omly assigned to two groups . In one group a sulcular incision ( SI ) with complete papilla mobilization was made , and in the other group a papilla-base incision ( PBI ) was used . Periradicular surgery was performed using a surgical microscope . Parameters related to life quality were recorded daily in the first week post-surgery using a question naire . Pain was evaluated with a 0 - 100 visual analog scale ( VAS ) . Other symptoms ( swelling , bleeding and nausea ) , plus functions ( chewing , speaking , sleeping , daily routine and work ) were assessed using a five-point scale . Analgesic intake was recorded . Fisher 's test and unpaired t-test were used to assess the difference between groups . RESULTS The VAS score for pain , and the scores for swelling , chewing and phonetic impairment , peaked on days 1 and 2 postoperatively . A significant difference in favour of the PBI group was found for chewing and swelling in the first 4 days . Starting from day 3 post-surgery , the PBI group reported a significantly more rapid decrease in pain levels and analgesics use than the SI group ( P < 0.05 ) . The other parameters were similar in the two groups . CONCLUSIONS The papilla-base incision technique may be preferred as reduction of pain levels , swelling and drug intake were more rapid in the first week postoperatively compared with cases in which a sulcular incision was used INTRODUCTION Control of postoperative discomfort might enhance the patient 's quality of life and treatment acceptance . The aim of the present r and omized single-blind study was to evaluate whether the use of platelet concentrate during endodontic surgery might have a favorable impact on pain and other factors related to patient 's quality of life during the first week after surgery . METHODS Eighteen patients with periapical lesion were treated with modern endodontic surgical procedure ( control group ) . In another 18 patients , in adjunct to surgical procedure , platelet concentrate was applied on the root end in liquid form , within the bone defect in clot form , and over the suture in liquid form ( test group ) . All patients completed a question naire for evaluation of main symptoms and daily activities during the first week after surgery . The outcomes of the question naires of the 2 groups were statistically compared . RESULTS The test group showed significantly less pain and swelling , fewer analgesics taken , and improved functional activities as compared with the control group . CONCLUSIONS The adjunct of platelet concentrate to the endodontic surgical procedure produced significant beneficial effect to patients ' quality of life during the early postoperative stage |
321 | 18,637,031 | Thus , using Thal/Dex results in an improved response rate in relapsed/refractory MM , with a toxicity rate comparable to thalidomide monotherapy | Thalidomide monotherapy in relapsed/refractory multiple myeloma ( MM ) has a response rate of 30 % .
The combination of thalidomide with dexamethasone ( Thal/Dex ) is expected to improve responses , but it is unknown if the combination increases the rate of adverse events . | BACKGROUND Thalidomide is effective in approximately 30 % of patients with refractory multiple myeloma . Dexamethasone is active in 25 % of patients with disease resistant to alkylating agents . We investigated the combination of thalidomide with dexamethasone as salvage treatment for heavily pretreated patients with multiple myeloma , in order to assess its efficacy and toxicity . PATIENTS AND METHODS Forty-four patients with refractory myeloma were treated with thalidomide , 200 mg p.o . daily at bedtime , with dose escalation to 400 mg after 14 days , and dexamethasone , which was administered intermittently at a dose of 20 mg/m2 p.o . daily for four days on day 1 - 4 , 9 - 12 , 17 - 20 , followed by monthly dexamethasone for four days . Patients ' median age was 67 years . All patients were resistant to st and ard chemotherapy , 77 % were resistant to dexamethasone-based regimens and 32 % had previously received high-dose therapy . RESULTS On an intention-to-treat basis twenty-four patients ( 55 % ) achieved a partial response with a median time to response of 1.3 months . The thalidomide and dexamethasone combination was equally effective in patients with or without prior resistance to dexamethasone-based regimens and in patients with or without prior high-dose therapy . Toxicities were mild or moderate and consisted primarily of constipation , morning somnolence , tremor , xerostomia and peripheral neuropathy . The median time to progression for responding patients is expected to exceed 10 months and the median survival for all patients is 12.6 months . CONCLUSION The combination of thalidomide with dexamethasone appears active in patients with refractory multiple myeloma . If this activity is confirmed , further studies of this combination as second-line treatment for patients resistant to conventional chemotherapy , and as primary treatment for patients with active myeloma , should be considered We report the results of a non‐r and omized phase II study of low‐dose thalidomide plus low‐dose dexamethasone therapy in 66 patients with refractory multiple myeloma . The overall response rate ( near complete , partial and minimal response ) was 63.6 % , and progression‐free and overall survival periods were 6.2 and 25.4 months . In adverse events , the incidence of peripheral neuropathy and deep vein thrombosis was lower than the data reported in USA and Europe . On the other h and , leukopenia was observed in 41 % of patients , including 11 % of those with Grade 3 . Leukopenia was closely related to pretreatment pancytopenia , especially thrombocytopenia . The incidence of adverse events related to dexamethasone was low . In conclusion , low‐dose thalidomide plus low‐dose dexamethasone therapy was as effective as high‐dose thalidomide plus high‐dose dexamethasone therapy in patients with refractory multiple myeloma . Leukopenia is one of the most serious adverse events in Japanese patients , especially in patients with pretreatment pancytopenia PURPOSE The efficacy of low-dose thalidomide ( THAL ) plus dexamethasone ( DEX ) has been evaluated in myeloma . The clinical outcome of patients treated with THAL-DEX was compared with that of a control group treated with conventional chemotherapy ( CC ) . EXPERIMENTAL DESIGN A total of 120 relapsed/refractory patients to one ( 52 % ) , or two or more(48 % ) lines of chemotherapy were treated with THAL 100mg/day ( continuous ) and DEX 40 mg ( days 1 - 4 of each month ) . Their clinical outcome was compared to a control group of 120 patients frequency matched for serum beta2-microglobulin levels and Durie and Salmon clinical stage . Clinical characteristics were homogeneous in the two groups . RESULTS In patients treated after one line of chemotherapy , THAL-DEX significantly improved outcome . Median progression-free survival ( PFS ) was superior in THAL-DEX group versus CC group ( 17 months versus 11 months , P = 0.0024 ) . The median survival for THAL-DEX patients has not to been reached , but the probabilities of survival at 3 years were 60 % after THAL-DEX and 26 % after CC ( P = 0.0016 ) . The clinical outcome of patients receiving THAL-DEX or CC after two or more lines of chemotherapy , was similar . In the THAL-DEX group , the medianPFS was 11 months compared to 9 months in the CC group ( P = NS ) . No differences in overall survival ( OS ) were observed ( median OS 19 months for both THAL-DEX and CC ) . CONCLUSIONS As first salvage regimen , THAL-DEX was superior to CC , as second or third salvage regimen , it was equivalent to CC . THAL-DEX is not myelotoxic . It postpones the delivery of effective salvage chemotherapy . This might explain the survival benefit The aim of this study was the evaluation of the effect of intermediate doses of thalidomide with dexamethasone ( Thal/Dex ) on disease course and bone disease in patients with refractory/relapsed myeloma who were under zoledronic acid therapy . We studied 35 patients , who received thalidomide at a dose of 200 mg/daily . We measured , pre- , 3 and 6 months post-treatment soluble receptor activator of nuclear factor-κB lig and ( sRANKL ) , osteoprotegerin ( OPG ) , osteopontin ( OPN ) , markers of bone resorption and formation . Before treatment , patients had increased levels of sRANKL/OPG ratio , bone resorption markers and OPN , while they had suppressed bone formation . The pretreatment sRANKL/OPG ratio correlated with the extent of bone disease . Thal/Dex administration result ed in a significant reduction of sRANKL/OPG ratio , and bone resorption . Bone formation , OPG and OPN did not show any alteration . Changes of sRANKL/OPG ratio correlated with changes of bone resorption markers . Thal/Dex was given for a median time of 10 months and the median follow-up period was 22 months . The response rate was 65.7 % . The median survival was 19.5 months . β2-microglobulin , type of response and International Staging System predicted for survival . These results suggest that the combination of intermediate dose of Thal/Dex is effective in patients with refractory/relapsed myeloma and improves abnormal bone remodeling through the reduction of sRANKL/OPG ratio The aim of this study was to assess the side effects and the efficacy of thalidomide alone or in combination with dexamethasone in relapsed multiple myeloma ( MM ) and to evaluate possible predictive factors for response rate and survival . Twenty-nine pretreated patients were enrolled , including 13 patients with a relapse after high-dose chemotherapy . The median number of relapses was 3 ( range : 1–7 ) . Twenty-two patients received thalidomide in combination with dexamethasone and seven patients thalidomide alone . The dosage of thalidomide was 400 mg/day and the dosage of dexamethasone 20 mg/m2 daily for 4 consecutive days every 3 weeks . Cycles of dexamethasone were given until maximal decline of myeloma protein was achieved , whereas therapy with thalidomide was maintained until disease progression . Responses occurred in 62 % of patients , including 5 ( 17 % ) complete remissions and 13 ( 45 % ) partial remissions . The median event-free survival ( EFS ) was 7.2 months and the median overall survival ( OS ) 26.1 months . In multivariate analysis , pretreatment serum levels of soluble interleukin-2 receptor ( sIL-2R ) were a significant prognostic factor for EFS , and those of β2-microglobulin ( β2 M ) and sIL-2R for OS . Serum levels of sIL-2R significantly increased after 3 weeks of treatment in 89 % of patients , possibly representing lymphocyte activation induced by thalidomide . Two patients died of septic complications within 3 months after starting treatment with thalidomide and dexamethasone and one patient of herpes encephalitis after 26 months of treatment with thalidomide alone . Also , one case of pneumonia and one case of deep venous thrombosis of the lower limb occurred . Other side effects were somnolence , peripheral neuropathy , and bradycardia occurring in 35 , 55 , 38 and 55 % of patients , respectively . The combination of thalidomide and dexamethasone is an effective therapy in heavily pretreated myeloma patients with a high response rate and acceptable toxicities . A powerful predictive factor both for EFS and OS was the pretreatment serum level of sIL-2R PURPOSE Although thalidomide ( Thal ) was introduced successfully in the treatment of multiple myeloma ( MM ) , the optimal Thal dosage and schedule are still controversial . The aim of this study was to analyze whether the effect of Thal in MM is dose dependent and whether the outcome might be improved when the Thal dosage is adjusted to parameters reflecting body size . EXPERIMENTAL DESIGN From December 1998 to March 2001 , 83 patients with relapsed MM were enrolled in a clinical Phase II trial and treated with a maximum Thal dosage of 400 mg daily . We performed a retrospective analysis and studied the effect of the cumulative 3-month Thal dosage on progression-free survival and overall survival ( OS ) together with age and the pretreatment levels of beta2-microglobulin , C-reactive protein , albumin , and hemoglobin in a Cox regression model . RESULTS After a median follow-up time of 17 months ( range , 1 - 30 months ) , the estimated 12-month progression-free survival and OS were 45 % ( SE = 6 % ) and 86 % ( SE = 4 % ) for the whole patient group . After backward selection , hemoglobin ( P = 0.002 ) and the cumulative 3-month Thal dosage ( P = 0.002 ) were the remaining factors for OS . The effect on OS could not be improved when the cumulative 3-month Thal dosage was adjusted to parameters reflecting body size such as height , weight , body surface area , or body mass index in comparison with Thal alone . CONCLUSIONS Our retrospective analysis demonstrates that the cumulative 3-month Thal dosage is one of the major prognostic factors for OS , supporting the hypothesis of a dose-dependent effect of Thal in relapsed MM |
322 | 25,822,171 | These studies suggest that providing free ITNs probably increases ITN ownership when compared to subsidized ITNs or ITNs offered at full market price .
Five studies examined the effect of price on ITN ownership and found moderate-certainty evidence that ownership was highest among the groups who received the ITN free versus those who purchased the ITN at any cost .
In economic terms , this means that dem and for ITNs is elastic with regard to price .
Educational interventions for promoting ITN use have an additional positive effect .
However , the impact of different types or intensities of education is unknown | BACKGROUND Malaria is a life-threatening parasitic disease and 40 % of the world 's population lives in areas affected by malaria .
Insecticide-treated bednets ( ITNs ) effectively prevent malaria , however , barriers to their use have been identified .
OBJECTIVES To assess the evidence on the effectiveness of available strategies that focus on delivery and appropriate use of ITNs . | Short-run subsidies for health products are common in poor countries . How do they affect long-run adoption ? We present a model of technology adoption in which people learn about a technology 's effectiveness by using it ( or observing others using it ) for some time , but people quit using it too early if they face higher-than-expected usage costs ( e.g. , side effects ) . The extent to which one-off subsidies increase experimentation , and thereby affect learning and long-run adoption , then depends on people 's priors on these usage costs . One-off subsidies can also affect long-run adoption through reference-dependence : People might anchor around the subsidized price and be unwilling to pay more for the product later . We estimate these effects in a two-stage r and omized field experiment in Kenya . We find that , for a new technology with a lower usage cost than the technology it replaces , short-run subsidies increase long-run adoption through experience and social learning effects . We find no evidence that people anchor around subsidized prices Background Since 2002/03 , an estimated 4.7 million nets have been distributed in the Southern Nations , Nationalities and Peoples Region ( SNNPR ) among an at risk population of approximately 10 million people . Evidence from the region suggests that large-scale net ownership rapidly increased over a relatively short period of time . However , little is known about how coverage is being maintained given that the last mass distribution was in 2006/2007 . This study sought to determine the status of current net ownership , utilization and rate of long lasting insecticide-treated nets ( LLIN ) loss in the previous three years in the context of planning for future net distribution to try to achieve sustainable universal coverage . Methods A total of 750 household respondents were interviewed across malarious , rural kebeles of SNNPR . Households were r and omly selected following a two-stage cluster sampling design where kebeles were defined as clusters . Kebeles were chosen using proportional population sampling ( PPS ) , and 25 households within 30 kebeles r and omly chosen . Results Approximately 67.5 % ( 95%CI : 64.1–70.8 ) of households currently owned at least one net . An estimated 31.0 % ( 95%CI 27.9–34.4 ) of all nets owned in the previous three years had been discarded by owners , the majority of whom considered the nets too torn , old or dirty ( 79.9 % : 95%CI 75.8–84.0 ) . Households reported that one-third of nets ( 33.7 % ) were less than one year old when they were discarded . The majority ( 58.8 % ) of currently owned nets had ‘ good ’ structural integrity according to a proportionate Hole Index . Nearly two-thirds of households ( 60.6 % ) reported using their nets the previous night . The overriding reason for not using nets was that they were too torn ( 45.7 % , 95 % CI 39.1–50.7 ) . Yet , few households are making repairs to their nets ( 3.7 % , 95 % CI : 2.4–5.1 ) . Conclusions Results suggest that the life span of nets may be shorter than previously thought , with little maintenance by their owners . With the global move towards malaria elimination it makes sense to aim for sustained high coverage of LLINs . However , in the current economic climate , it also makes sense to hark back to simple tools and messages on the importance of careful net maintenance , which could increase their lifespans Background Insecticide-treated bed nets ( ITNs ) have been shown to reduce morbidity and mortality due to malaria in sub-Saharan Africa . Strategies using incentives to increase ITN use could be more efficient than traditional distribution campaigns . To date , behavioural incentives have been studied mostly in developed countries . No study has yet looked at the effect of incentives on the use of ITNs . Reported here are the results of a cluster r and omized controlled trial testing household-level incentives for ITN use following a free ITN distribution campaign in Madagascar . Methods The study took place from July 2007 until February 2008 . Twenty-one villages were r and omized to either intervention or control clusters . Households in both clusters received a coupon redeemable for one ITN . After one month , intervention households received a bonus for ITN use , determined by visual confirmation of a mounted ITN . Data were collected at baseline , one month and six months . Both unadjusted and adjusted results , using cluster specific methods , are presented . Results At baseline , 8.5 % of households owned an ITN and 6 % were observed to have a net mounted over a bed in the household . At one month , there were no differences in ownership between the intervention and control groups ( 99.5 % vs. 99.4 % ) , but net use was substantially higher in the intervention group ( 99 % vs. 78 % ) , with an adjusted risk ratio of 1.24 ( 95 % CI : 1.10 to 1.40 ; p < 0.001 ) . After six months , net ownership had decreased in the intervention compared to the control group ( 96.7 % vs. 99.7 % ) , with an adjusted risk ratio of 0.97 ( p < 0.01 ) . There was no difference between the groups in terms of ITN use at six months ; however , intervention households were more likely to use a net that they owned ( 96 % vs. 90 % ; p < 0.001 ) . Conclusions Household-level incentives have the potential to significantly increase the use of ITNs in target households in the immediate-term , but , over time , the use of ITNs is similar to households that did not receive incentives . Providing incentives for behaviour change is a promising tool that can complement traditional ITN distribution programmes and improve the effectiveness of ITN programmes in protecting vulnerable population s , especially in the short-term Long-lasting insecticidal nets ( LLINs ) have been advocated as an effective tool against malaria transmission . However , success of this community based intervention largely depends on the knowledge and practice regarding malaria and its prevention . According to the national strategy plan on evaluation of LLINs ( Olyset nets ) , this study was conducted to determine the perceptions and practice s about malaria and to improve use of LLINs in Bashagard district , one of the important foci of malaria in southeast Iran . The study area comprised 14 villages that were r and omized in two clusters and design ated as LLINs and untreated nets . Each of households in both clusters received two bed nets by the free distribution and delivery . After one month quantitative data collection method was used to collect information regarding the objectives of the study . On the basis of this information , an educational program was carried out in both areas to increase motivation for use of bed nets . Community knowledge and practice regarding malaria and LLIN use assessed pre- and post-educational program . The data were analyzed using SPSS ver.16 software . At baseline , 77.5 % of respondents in intervention and 69.4 % in control area mentioned mosquito bite as the cause of malaria , this awareness increased significantly in intervention ( 90.3 % ) and control areas ( 87.9 % ) , following the educational program . A significant increase also was seen in the proportion of households who used LLINs the previous night ( 92.5 % ) compared with untreated nets ( 87.1 % ) . Educational status was an important predictor of LLINs use . Regular use of LLIN was considerably higher than the targeted coverage ( 80 % ) which recommended by World Heaths Organization . About 81.1 % and 85.3 % of respondents from LLIN and control areas reported that mosquito nuisance and subsequent malaria transmission were the main determinants of bed net use . These findings highlight a need for educational intervention in implementation of long-lasting insecticidal nets ; this should be considered in planning and decision-making in the national malaria control program during the next campaigns of LLINs in Iran A group-r and omized controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) was conducted in an area of high perennial malaria transmission in western Kenya to test the effect of ITNs on all-cause mortality in children 1 - 59 months of age . Child deaths were monitored over a two-year period by biannual household census in Asembo ( 1997 - 1998 ) and in Gem ( 1998 - 1999 ) . Overall , 1,722 deaths occurred in children 1 - 59 months followed for 35,932 child-years . Crude mortality rates/1,000 child-years were 51.9 versus 43.9 in control and ITN villages in children 1 - 59 months old . The protective efficacy ( PE ) ( 95 % confidence interval ) adjusted for age , study year , study site , and season was 16 % ( 6 - 25 % ) . Corresponding figures in 1 - 11- and 12 - 59-month-old children in control and ITN villages were 133.3 versus 102.3 , PE = 23 % ( 11 - 34 % ) and 31.1 versus 28.7 , PE = 7 % ( -6 - 19 % ) . The numbers of lives saved/1,000 child-years were 8 , 31 , and 2 for the groups 1 - 59 , 1 - 11 , and 12 - 59 months old , respectively . Stratified analysis by time to insecticide re-treatment showed that the PE of ITNs re-treated per study protocol ( every six months ) was 20 % ( 10 - 29 % ) , overall and 26 % ( 12 - 37 % ) and 14 % ( -1 - 26 % ) in 1 - 11- and 12 - 59-month-old children , respectively . ITNs prevent approximately one in four infant deaths in areas of intense perennial malaria transmission , but their efficacy is compromised if re-treatment is delayed beyond six months Insecticide-treated nets ( ITNs ) are effective in substantially reducing malaria transmission . Still , ITN coverage in sub-Saharan Africa ( SSA ) remains extremely low . Policy makers are concerned with identifying the most suitable delivery mechanism to achieve rapid yet sustainable increases in ITN coverage . Little is known , however , on the comparative costs of alternative ITN distribution strategies . This paper aim ed to fill this gap in knowledge by developing such a comparative cost analysis , looking at the cost per ITN distributed for two alternative interventions : subsidized sales supported by social marketing and free distribution to pregnant women through antenatal care ( ANC ) . The study was conducted in rural Burkina Faso , where the two interventions were carried out alongside one another in 2006/07 . Cost information was collected prospect ively to derive both a financial analysis adopting a provider 's perspective and an economic analysis adopting a societal perspective . The average financial cost per ITN distributed was US$ 8.08 and US$ 7.21 for sales supported by social marketing and free distribution through ANC , respectively . The average economic cost per ITN distributed was US$ 4.81 for both interventions . Contrary to common belief , costs did not differ substantially between the two interventions . Due to the district 's ability to rely fully on the use of existing re sources , financial costs associated with free ITN distribution through ANC were in fact even lower than those associated with the social marketing campaign . This represents an encouraging finding for SSA governments and points to the possibility to invest in programmes to favour free ITN distribution through existing health facilities . Given restricted budgets , however , free distribution programmes are unlikely to be feasible Many severe health risks in developing countries could be substantially reduced with access to appropriate preventive measures . However , the associated costs are often high enough to restrict access among poor households , and free provision through public health campaigns is often not financially feasible . We describe findings from the first large-scale cluster r and omized controlled trial in a developing country context that evaluates the uptake of a health-protecting technology , insecticide-treated bednets ( ITNs ) , through micro-consumer loans , as compared to free distribution and control conditions . Numerous studies have shown that widespread , regular use of ITNs is one the most effective preventive measures against malaria . However , ownership rates remain very low in most malarious areas , including our study areas in rural Orissa ( India ) . Despite the un-subsidized price , 52 percent of sample households purchased at least one ITN , leading to 16 percent of individuals using a treated net the previous night , relative to only 2 percent in control areas where nets were not offered for sale . However , the increase fell significantly short of the 47 percent previous-night usage rate achieved with free distribution . Most strikingly , we find that neither micro-loans nor free distribution led to improvements in malaria and anemia prevalence , measured using blood tests . We examine and rule out several plausible explanations for this latter finding . We conjecture that insufficient ITN coverage is the most likely explanation , and discuss implication s for public health policy Background ITN use is generally poor in Nigeria among all categories of people . Although use of ITNs has been shown to reduce malarial morbidity and mortality , this measure needs to be supported by an adequate healthcare system providing ITN possibly at the household level . This study was therefore design ed to determine the effect of health education on the uptake of ITN among nursing mothers in rural communities in Nigeria . Methods The study design was a quasi-experimental study carried out in Ijebu North Local Government Area of Ogun State . A multistage r and om sampling technique was used in choosing the required sample s for this study and a semi- structured question naire was used to collect relevant information . The intervention consisted of a structured educational programme based on a course content adapted from the national malaria control programme . A total of 400 respondents were recruited into the study with 200 each in both the experimental and control groups and were followed up for a period of 3 months when the knowledge and uptake of ITN was reassessed . Result There was no significant difference ( P > 0.05 ) observed between the experimental and control groups in terms of socio-dermographic characteristics such as age , marital status , religion , and income . The ITN ever users in experimental group were 59 [ 29.5 % ] and 138 [ 72.6 % ] in pre and post intervention period , respectively ( p value = 0.0001 ) . These proportions of ITN ever users were 55 [ 27.5 % ] and 57 [ 31.6 % ] in control group , during the pre and post intervention periods ( p = 0.37 ) . Post health education intervention , degree of change in knowledge of ITN re-treatment [ 37.0 % ] and mounting [ 33.5 % ] , readiness to use if given free [ 30.5 % ] and belief in efficacy [ 36.9 % ] improved significantly in the experimental group while there was no significant change in the control group [ p = 0.84 , 0.51 , 0.68 & 0.69 respectively ] . Majority [ 89 % ] of the respondents were willing to buy ITN for between US$ 1.5 to US$ 3.0 . There was no statistically significant change ( P > 0.05 ) despite intervention in the amount the respondents were willing to pay to own an ITN in both the experimental and control groups . Conclusion The study concludes that the use of ITN in the study population was significantly increase by health education and that the free distribution of ITN may not guarantee its use . Uptake of ITN can be significantly improved in rural areas if the nets are made available and backed up with appropriate health education intervention Background Long-lasting insecticide-treated bed nets ( LLITN ) have demonstrated significant impact in reducing malaria-related childhood morbidity and mortality . However , utilization of LLITN by under-five children is not satisfactory in many sub-Saharan African countries due to behavioural barriers . Previous studies had focused on the coverage and ownership of LLITN . The effect of skill-based training for household heads on LLITN utilization had not yet been investigated . A cluster-r and omized trial on the effect of training of household heads on the use of LLITN was done in Ethiopia to fill this knowledge gap . Methods The study included 22 ( 11 intervention and 11 control ) villages in southwest Ethiopia . The intervention consisted of tailored training of household heads about the proper use of LLITN and community network system . All households in each group received free LLITN . Data were collected at baseline , six and 12 months of the follow up periods . Utilization of LLITN in the control and intervention villages was compared at baseline and follow up periods . Results A total of 21,673 ; 14,735 and 13,758 individuals were included at baseline , sixth and twelfth months of the project period . At the baseline survey , 47.9 % of individuals in the intervention villages and 68.4 % in the control villages reported that they had utilized LLITN the night before the survey . At the six month , 81.0 % of individuals in the intervention villages and 79.3 % in the control villages had utilized LLITN . The utilization of LLITN in all age groups in the intervention villages was increased by 17.7 percentage point ( 95 % CI 9.7 - 25.6 ) at sixth month and by 31.0 percentage point ( 95 % CI 16.9 - 45.1 ) at the twelfth month . Among under-five children , the LLITN utilization increased by 31.6 percentage point ( 95 % CI 17.3 - 45.8 ) at the sixth month and 38.4 percentage point ( 95 % CI 12.1 - 64.7 ) at the twelfth months of the project period . Conclusion Household level skill-based training has demonstrated a marked positive effect in the utilization of LLITN . The effect of the intervention steadily increased overtime . Therefore , distribution of LLITN should be accompanied by a skill-based training of household heads to improve its utilization . Trail registration Australian New Zeal and Clinical Trials Registry ( ACTR number : ACTRN12610000035022 ) Background Long-lasting insecticide-treated bed nets ( LLITN ) have demonstrated a significant effect in reducing malaria-related morbidity and mortality . However , barriers on the utilization of LLITN have hampered the desired outcomes . The aim of this study was to assess the effect of community empowerment on the burden of malaria and anaemia in under-five children in Ethiopia . Methods A cluster r and omized trial was done in 22 ( 11 intervention and 11 control ) villages in south-west Ethiopia . The intervention consisted of tailored training of household heads about the proper use of LLITN and community network system . The burden of malaria and anaemia in under-five children was determined through mass blood investigation at baseline , six and 12 months of the project period . Cases of malaria and anaemia were treated based on the national protocol . The burden of malaria and anaemia between the intervention and control villages was compared using the complex logistic regression model by taking into account the clustering effect . Eight Focus group discussion s were conducted to complement the quantitative findings . Results A total of 2,105 household heads received the intervention and the prevalence of malaria and anaemia was assessed among 2410 , 2037 and 2612 under-five children at baseline , six and 12 months of the project period respectively . During the high transmission/epidemic season , children in the intervention arm were less likely to have malaria as compared to children in the control arm ( OR = 0.42 ; 95%CI : 0.32 , 0.57 ) . Symptomatic malaria also steadily declined in the intervention villages compared to the control villages in the follow up periods . Children in the intervention arm were less likely to be anaemic compared to those in the control arm both at the high ( OR = 0.84 ; 95%CI : 0.71 , 0.99 ) ) and low ( OR = 0.73 ; 95%CI : 0.60 , 0.89 ) transmission seasons . Conclusion Training of household heads on the utilization of LLITN significantly reduces the burden of malaria in under-five children . The Ministry of Health of Ethiopia in collaboration with other partners should design similar strategies in high-risk areas to control malaria in Ethiopia . Trial registration Australia and New Zeal and Clinical Trials Register ( ANZCTR ) : Background Insecticide-treated nets ( ITNs ) are effective tools for malaria prevention and can significantly reduce severe disease and mortality due to malaria , especially among children under five in endemic areas . However , ITN coverage and use remain low and inequitable among different socio-economic groups in sub-Saharan Africa , particularly in Nigeria . Several strategies have been proposed to increase coverage and use and reduce inequity in Nigeria , including free distribution campaigns recently conducted by the Nigerian federal government . Using data from the first post-campaign survey , the authors investigated the effect of the mass free distribution campaigns in achieving equity in household ownership and use of ITNs . Methods A post-campaign survey was undertaken in November 2009 in northern Nigeria to assess the effect of the campaigns in addressing equity across different socio-economic groups . The survey included 987 households r and omly selected from 60 clusters in Kano state . Using logistic regression and the Lorenz concentration curve and index , the authors assessed equity in ITN coverage and use . Results ITN ownership coverage increased from 10 % before the campaigns to 70%-a more than fivefold increase . The campaigns reduced the ownership coverage gap by 75 % , effectively reaching parity among wealth quintiles ( Concentration index 0.02 , 95 % CI ( -0.02 ; 0.05 ) versus 0.21 95%CI ( 0.08 ; 0.34 ) before the campaigns ) . ITN use ( individuals reporting having slept under an ITN the night before the survey visit ) among individuals from households owning at least one ITN , was 53.1 % with no statistically significant difference between the lowest , second , third and fourth wealth quintiles and the highest wealth quintile ( lowest : odds ratio ( OR ) 0.87 , 95 % confidence interval ( CI ) ( 0.67 ; 1.13 ) ; second : OR 0.85 , 95 % CI ( 0.66 ; 1.24 ) ; third : OR 1.10 95 % CI ( 0.86 ; 1.4 ) and fourth OR 0.91 95 % CI ( 0.72 ; 1.15 ) . Conclusion The campaign had a significant impact by increasing ITN coverage and reducing inequity in ownership and use . Free ITN distribution campaigns should be sustained to increase equitable coverage . These campaigns should be supplemented with other ITN distribution strategies to cover newborns and replace aging nets The fifth , and probably last , large-scale , group-r and omized , controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) showed that ITNs are efficacious in reducing all-cause post-neonatal mortality in an area of intense , perennial malaria transmission . The trial helped to define pregnant women and infants as target groups for this intervention in high transmission setting s. High population coverage with ITNs in both target and non-target groups may be critical to enhance health and survival in pregnant women and infants . The proportion of households with ITNs ( coverage ) , the proportion of individuals properly deploying ITNs each night ( adherence ) , and the proportion of nets properly treated with insecticide ( treatment ) are the three key determinants of effectiveness of large-scale ITN programs . These three simple outcomes should serve as the basis for program objectives and monitoring and evaluation efforts . Coverage effects and economic analysis support the proposition that ITNs may be viewed as a public good , worthy of public support . Research should continue to improve the intervention tools ( the net , the insecticide , and methods for durable treatment and re-treatment ) and their deployment Background Relatively few programmes have attempted to actively engage the private sector in national malaria control efforts . This paper evaluates the health impact of a large-scale distribution of insecticide-treated nets ( ITNs ) conducted in partnership with a Zambian agribusiness , and its cost-effectiveness from the perspective of the National Malaria Control Programme ( NMCP ) . Methods The study was design ed as a cluster-r and omized controlled trial . A list of 81,597 cotton farmers was obtained from Dunavant , a contract farming company in Zambia ’s cotton sector , in December 2010 . 39,963 ( 49 % ) were r and omly selected to obtain one ITN each . Follow-up interviews were conducted with 438 farmers in the treatment and 458 farmers in the control group in June and July 2011 . Treatment and control households were compared with respect to bed net ownership , bed net usage , self-reported fever , and self-reported confirmed malaria . Cost data was collected throughout the programme . Results The distribution effectively reached target beneficiaries , with approximately 95 % of households in the treatment group reporting that they had received an ITN through the programme . The average increase in the fraction of household members sleeping under an ITN the night prior to the interview was 14.6 percentage points ( p-value < 0.001 ) . Treatment was associated with a 42 percent reduction in the odds of self-reported fever ( p-value < 0.001 ) and with a 49 percent reduction in the odds of self-reported malaria ( p-value 0.002 ) . This was accomplished at a cost of approximately five US$ per ITN to Zambia ’s NMCP . Conclusions The results illustrate that existing private sector networks can efficiently control malaria in remote rural regions . The intra-household allocation of ITNs distributed through this channel was comparable to that of ITNs received from other sources , and the health impact remained substantial Adherence with permethrin-treated bed net ( ITN ) use and their proper deployment was directly observed in 2,178 individuals ( 784 households ) participating in a large-scale trial of ITNs on child mortality in western Kenya . The ITNs were distributed free of charge to ensure high coverage , result ing in a ratio of 1.46 persons per ITN . Approximately 30 % of ITNs present were unused . The overall percentage adherence was 72.3 % . The probability of adherence by individuals depended strongly on age ( relative risk [ RR ] = 0.86 , 95 % confidence limit [ CL ] = 0.78 - 0.94 ) , in which children less than five years of age were less likely to use ITNs than older individuals , and temperature , in which ITNs were more likely to be used in periods of cooler weather . A marginally significant diminution in adherence during the second year of the project was also observed ( RR = 0.83 , 95 % CL = 0.68 - 1.01 ) . Mosquito numbers , relative wealth , number of house occupants , and the educational level of the head of the household had no effect on adherence . In unstructured question ing of house residents , excessive heat was often cited as a reason for not deploying the child 's ITN . The most important reason for non-adherence was disruption of sleeping arrangements , indicating that ITNs were not readily redeployed in the face of shifting sleeping patterns due to visitors , funerals , house construction , and other events . Challenges faced by health education programs to maximize adherence with ITN use are discussed Background It is well established that insecticide-treated bed nets ( ITNs ) , in particular long-lasting , insecticidal nets ( LLINs ) , can be used as one of the primary interventions for effective malaria control . A consistent gap between net ownership and use has been observed , indicating that factors exist that prevent an owned mosquito net from being used . One approach used in the context of LLIN campaigns is a post-distribution , door-to-door visit of households with educational messages and to physically assist with hang-up of nets . Methods A cluster r and omized trial was conducted in the Plateaux Region of Togo to evaluate the effectiveness of different approaches to post-LLIN campaign home visits ( number of visits and timing ) by volunteers to enhance LLIN hang-up and utilization . Results It was found that , in general , households that received intervention visits , particularly the most recent intervention visit , had levels of use that were typically 5 to 10 % higher than the control households , while access did not differ among control and intervention households . Eight months post-campaign , ITN use by all individuals , children under five years and women of reproductive age was 11.3 to 14.4 percentage points greater in the study arm that received all three intervention visits than in the control communities . In households that received one or two additional door-to-door visits , the majority of respondents indicated that the volunteer provided new information during the visit regarding the use and importance of ITNs despite having received previous multiple visits . Conclusions The impact of the interventions appears to have been primarily through the delivery and reinforcement of key behaviour-c hange c ommunication ( BCC ) messages regarding the importance of using an ITN and its care . Regardless of whether the respondents in fact received new information or had forgotten earlier information , this suggests that regular visits from community agents are useful in reinforcing key BCC messages Background Malaria is currently the most important cause of death and disability in children aged under 5 years in Africa . A health education interventional study of this nature is essential in primary control of an endemic communicable disease such as malaria . This study was therefore design ed to determine the effect of health education on the home management of Malaria among the caregivers of children under 5 years old in Ogun State , Nigeria . Methods The study design was a quasi-experimental study carried out in Ijebu North Local Government Area of Ogun State . A multistage r and om sampling technique was used in choosing the required sample s for this study and a semi-structured question naire was used to collect relevant information . The intervention consisted of a structured educational program based on a course content adapted from the national malaria control program . A total of 400 respondents were recruited into the study , with 200 each in both the experimental and control groups , and were followed up for a period of 3 months when the knowledge and uptake of insecticide treated net was reassessed . Results There was no statistically significant differences observed between the experimental and control groups in terms of sociodemographic characteristics such as age ( P = 0.99 ) , marital status ( P = 0.48 ) , religion ( P = 0.1 ) , and income ( P = 0.51 ) . The majority in both the experimental ( 75.0 % ) and control ( 71.5 % ) groups use arthemisinin-based combination therapy as first line home treatment drugs pre intervention . Post health education intervention , the degree of change in the knowledge of referral signs and symptoms in the experimental group was 52.8 % ( P < 0.0001 ) while it was 0.2 % in the control group ( P = 0.93 ) . Tepid sponging improved by 45.0 % , paracetamol use by 55.3 % , and the use of herbs and other drugs were not significantly influenced in the experimental ( P = 0.65 and 0.99 ) and control group ( P = 0.89 and 0.88 ) , respectively . Furthermore , there was a 55.7 % ( P = 0.001 ) increase in the proportion of respondents using the correct dose of arthemisinin-based combination therapy in the home management of malaria and 23.9 % ( P < 0.001 ) in the proportion using it for the required time . Conclusions The study concludes that there is a shift in the home management of malaria with the use of current and effective antimalarial drugs . It also demonstrated the effect of health education on the promptness of appropriate actions taken among the respondents for early diagnosis and treatment . Early diagnosis and appropriate treatment can be guaranteed if caregivers are knowledgeable on prompt actions to be taken in the home management of malaria Background Insecticide-impregnated bed nets ( ITNs ) have been shown to be a highly effective tool against malaria in the endemic regions of sub-Saharan Africa ( SSA ) . There are however different opinions about the role of ITN social marketing and ITN free distribution in the roll-out of ITN programmes . The objective of this study was to evaluate the effects of free ITN distribution through antenatal care services in addition to an ITN social marketing programme in an area typical for rural SSA . Methods A cluster-r and omised controlled ITN trial took place in the whole Kossi Province in north-western Burkina Faso , an area highly endemic for malaria . Twelve clusters were assigned to long-term ITN ( Serena br and ) social marketing plus free ITN ( Serena br and ) distribution to all pregnant women attending governmental antenatal care services ( group A ) , and 13 clusters to ITN social marketing only ( group B ) . The intervention took place during the rainy season of 2006 and thereafter . The trial was evaluated through a representative household survey at baseline and after one year . Serena ITN household ownership was the primary outcome measure . Findings A total of 1052 households were visited at baseline in February 2006 and 1050 at follow-up in February 2007 . Overall Serena ITN household ownership increased from 16 % to 28 % over the study period , with a significantly higher increase in group A ( 13 % to 35 % ) than in group B ( 18 % to 23 % ) ( p<0.001 ) . Interpretation The free distribution of ITNs to pregnant women through governmental antenatal care services in addition to ITN social marketing substantially improved ITN household ownership in rural Burkina Faso . Trial registration Controlled-Trials.com IS RCT Background This paper presents results from an evaluation of the effect of a community health worker ( CHW ) –based , interpersonal communication campaign ( IPC ) for increasing insecticide-treated mosquito net ( ITN ) use among children in Luangwa District , Zambia , an area with near universal coverage of ITNs and moderate to low malaria parasite prevalence . Methods A quasi-experimental community r and omized control trial was conducted from 2008 to 2010 . CHWs were the unit of r and omization . Cross-sectional data were collected from houses in both 2008 and 2010 using simple r and om sampling of a complete household enumeration of the district . A difference-in -differences approach was used to analyse the data . Results ITN use among children < 5 years old in households with ≥1 ITN increased overall from 54 % in 2008 to 81 % in 2010 ( χ2 = 96.3 , p < 0.01 ) ; however , there was no difference in increase between the treatment and control arms in 2010 ( p > 0.05 ) . ITN use also increased among children five to 14 years old from 37 % in 2008 to 68 % in 2010 . There was no indication that the CHW-based intervention activities had a significant effect on increasing ITN use in this context , over and above what is already being done to disseminate information on the importance of using an ITN to prevent malaria infection . Discussion ITN use increased dramatically in the district between 2008 and 2010 . It is likely that IPC activities in general may have contributed to the observed increase in ITN use , as the increased observed in this study was far higher than the increase observed between 2008 and 2010 malaria indicator survey ( MIS ) estimates . Contamination across control communities , coupled with linear settlement patterns and subsequent behavioural norms related to communication in the area , likely contributed to the observed increase in net use and null effect in this study Background In Ethiopia , the utilization of long-lasting insecticide-treated bed nets ( LLITN ) is hampered by behavioural factors such as low awareness and negative attitude of the community . The aim of this study was to present the design and baseline results of a cluster r and omized trial on the effect of training of household heads on the use of LLITN . Methods This baseline survey was undertaken from February to March , 2009 as part of a r and omized cluster trial . A total of 11 intervention and 11 control Gots ( villages ) were included in the Gilgel Gibe Field Research Centre , south-west Ethiopia . House to house visit was done in 4135 households to collect information about the use of LLITN and socio-demographic variables . For the diagnosis of malaria and anaemia , blood sample s were collected from 2410 under-five children and 242 pregnant women . Results One fourth of the households in the intervention and control Gots had functional LLITN . Only 30 % of the observed LLITN in the intervention and 28 % in the control Gots were hanged properly . Adults were more likely to utilize LLITN than under-five children in the control and intervention Gots . The prevalence of malaria in under-five children in the intervention and control Gots was 10.5 % and 8.3 % respectively . The intervention and control Gots had no significant difference concerning the prevalence of malaria in under-five children , [ OR = 1.28 , ( 95%CI : 0.97 , 1.69 ) ] . Eight ( 6.1 % ) pregnant women in the intervention and eight ( 7.2 % ) in the control Gots were positive for malaria ( P = 0.9 ) . Children in the intervention Gots were less likely to have anaemia than children in the control Gots , [ OR = 0.75 , ( 95%CI : 0.62 , 0.85 ) ] . Conclusion The availability and utilization of LLITN was low in the study area . The prevalence of malaria and anaemia was high . Intervention strategies of malaria should focus on high risk population and vulnerable groups The impact of insecticide (permethrin)-treated bed nets ( ITNs ) on malaria in pregnancy was studied in a rural area in western Kenya with intense perennial malaria transmission . All households in 40 of 79 villages were r and omized to receive ITNs by January 1997 . The ITNs were distributed in control villages two years later . Complete data on birth outcome were available on 2,754 ( 89.6 % ) of 3,072 deliveries . Women ( n = 780 ) were followed monthly throughout pregnancy in 19 of 79 villages . Among gravidae 1 - 4 , ITNs were associated with reductions of 38 % ( 95 % confidence interval [ CI ] = 17 - 54 % ) in the incidence of malaria parasitemia and 47 % ( 95 % CI = 6 - 71 % ) in the incidence of severe malarial anemia ( hemoglobin level < 8 g/dL with parasitemia ) during pregnancy . At the time of delivery , mean hemoglobin levels were 0.6 g/dL ( 95 % CI = 0.01 - 1.2 g/dL ) higher , the prevalence of placental or maternal malaria was reduced by 35 % ( 95 % CI = 20 - 47 % ) , and the prevalence of low birth weight was reduced by 28 % ( 95 % CI = 2 - 47 % ) in gravidae 1 - 4 from ITN villages . No beneficial impact was observed in gravidae five or higher . In areas of intense perennial malaria transmission , permethrin-treated bed nets reduce the adverse effect of malaria during the first four pregnancies As part of a community-based , group-r and omized , controlled trial of insecticide-treated bed nets ( ITNs ) in an area with intense malaria transmission in western Kenya , a birth cohort ( n = 833 ) was followed monthly until the age of 24 months to determine the potential beneficial and adverse effects of reduced malaria exposure during pregnancy and infancy . Malaria transmission and morbidity were comparable pre-intervention . The ITNs reduced malaria attack rates ( force of infection ) in infancy by 74 % , and delayed the median time-to-first parasitemia ( 4.5 to 10.7 months ; P < 0.0001 ) . The incidence of both clinical malaria and moderate-severe anemia ( hemoglobin level < 7 g/dL ) were reduced by 60 % ( P < 0.001 for both ) . Protective efficacy was greatest in infants less than three months old and similar in older infants and one-year-old children . Efficacy was lowest in the dry season . Infants from ITN villages experienced better height and weight gain . In areas of intense perennial malaria transmission , ITNs substantially reduce exposure to malaria and subsequent malaria-associated morbidity in children less than 24 months old . Reduced malaria exposure during infancy did not result , with continued ITN use , in increased malaria morbidity in one-year-old children A community r and omized pre-test/post-test design was used to compare the knowledge and behaviors of microfinance clients receiving malaria education ( n=213 ) to those receiving diarrhea education ( n=223 ) and to non-client controls ( n=268 ) . Comparisons assessed differences at follow-up as well as within-group changes over time . At follow-up , malaria clients had significantly better malaria knowledge than comparison groups : 48.4 % of malaria clients were able to identify groups most vulnerable to malaria compared with 39.2 % of diarrhea clients ( P=0.044 ) and 37.7 % of non-clients ( P=0.024 ) . Malaria clients were more likely than diarrhea clients ( P=0.024 ) ( P<0.001 ) and non-clients ( P=0.028 ) ( P=0.004 ) to report that insecticide-treated nets ( ITNs ) provide the best protection against malaria , and to agree that pregnant women should use ITNs , respectively . Between baseline and follow-up , malaria clients were most likely to : improve in knowledge of malaria complications during pregnancy ; to own at least one bed net ; and to report at least one child or woman of reproductive age sleeping under a bed net . Malaria clients also experienced the greatest increases in ITN ownership/use ( 9 % vs. 2.9 % and 6.7 % among diarrhea clients and non-clients ) . Results indicate that , although significant barriers to malaria control remain , a malaria education program provided by microfinance institutions can effectively contribute to community and national malaria initiatives During a r and omized controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) in an area with intense malaria transmission in western Kenya , we monitored 20,915 sick child visits ( SCVs ) by children less than five years of age visiting seven peripheral health facilities . The SCVs were monitored over a four-year period both before ( 1995 - 1996 ) and during the intervention ( 1997 - 1998 ) . Results are used to estimate the effect of ITNs on the burden of malaria in this community and to evaluate the potential role of these facilities in assessment of the impact of large-scale public health interventions . Compared with baseline , a 27 % greater reduction in the incidence of SCVs was seen in ITN villages than in control villages ( 37 % versus 10 % ; P = 0.049 ) . A similar reduction was observed in SCVs diagnosed as malaria ( 35 % reduction in ITN villages versus 5 % reduction in controls ; P = 0.04 ) . Two-hundred sixteen SCVs per 1,000 child-years were prevented ; three-fourths of these were in children less than 24 months old . As a consequence of lack of laboratory facilities , severe anemia was rarely ( < 2 % ) diagnosed , regardless of intervention status . No effect of ITNs on the incidence of respiratory tract infections , diarrhea , and other commonly diagnosed childhood illnesses was observed . The ITNs reduced the number of SCVs due to malaria , but had no effect on other illnesses . Routine statistics from these facilities provided useful information on trends in malaria incidence , but underestimated the burden of severe anemia To investigate the effectiveness of scaling-up existing bednet distribution campaigns , a r and omised controlled trial with 516 farming households in Katete District , a rural area with highly endemic malaria in Zambia 's Eastern Province , was evaluated . In the trial , selected farmers were assigned to bednet programmes that allowed them to obtain additional bednets for free or at subsidised prices through agricultural loan programmes . On average , 2.4 nets were distributed in the free distribution group and 0.9 in the net loan group . The marginal health impact of additional nets appears large , reducing the odds of self-reported all-cause morbidity by 40 - 42 % and the odds of self-reported confirmed malaria by 53 - 60 % R and omized controlled trials in sub-Saharan Africa have shown that permethrin-treated bed nets and curtains reduce all-cause child mortality by 15 - 33 % in areas with low or high but seasonal malaria transmission . This report describes the study site for a community-based , group-r and omized , controlled trial in an area of high and year-round malaria transmission in western Kenya . We outline the development of the human and physical infrastructure required to conduct this trial and discuss some of the difficulties encountered and lessons learned in conducting it A study of mothers ' perceptions regarding bed nets and malaria was conducted before and after a r and omized controlled trial of insecticide (permethrin)-treated bed nets ( ITNs ) in western Kenya . Awareness about the trial and the rationale for bed net use increased by the end of the trial . Knowledge that mosquitoes caused malaria also increased ; however , a higher proportion of mothers from control , rather than intervention villages , cited this ( 44.4 % versus 27.9 % ; P < 0.001 ) . Mothers from intervention villages were more knowledgeable about the use and maintenance of bed nets and re-treatment with insecticide . Both groups specified advantages of ITNs . Mothers from intervention villages noted practical advantages such as protection against bedbugs and falling roof debris . Few ( < 1 % ) mothers indicated that ITNs protected children against malaria . Intervention homes used significantly fewer mosquito coils , insect spray , medicines , and burned cow dung less often compared with those in control villages . Mothers were willing to pay approximately 4.5 U.S. dollars for a regular bed net , but only 10.5 U.S. cents ( intervention ) and 0.036 ( control ) for re-treating a bed net . This study suggests that , despite two years of experience of use , bed nets and insecticides would not be purchased as a household priority in this impoverished rural community A community-based r and omized , controlled trial of permethrin impregnated bednets was carried out in a rural area of northern Ghana , between July 1993 and June 1995 , to assess the impact on the mortality of young children in an area of intense transmission of malaria and no tradition of bednet use . The district around Navrongo was divided into 96 geographical areas and in 48 r and omly selected areas households were provided with permethrin impregnated bednets which were re-impregnated every 6 months . A longitudinal demographic surveillance system was used to record births , deaths and migrations , to evaluate compliance and to measure child mortality . The use of permethrin impregnated bednets was associated with 17 % reduction in all-cause mortality in children aged 6 months to 4 years ( RR = 0.83 ; 95 % CI 0.69 - 1.00 ; P = 0.05 ) . The reduction in mortality was confined to children aged 2 years of younger , and was greater in July-December , during the wet season and immediately after ( RR = 0.79 ; 95 % CI 0.63 - 1.00 ) , a period when malaria mortality is likely to be increased , than in the dry season ( RR = 0.92 , 95 % CI 0.73 - 1.14 ) . The ready acceptance of bednets , the high level of compliance in their use and the subsequent impact on all-cause mortality in this study has important implication s for programmes to control malaria in sub-Saharan Africa The impact of insecticide (permethrin)-treated bed nets ( ITNs ) on the health of adolescent schoolgirls was investigated during a community-based , r and omized , controlled trial of ITNs in western Kenya . Two school-based cross-sectional surveys were conducted to determine the prevalence of malaria and anemia in 644 schoolgirls 12 - 18 years old in a rural area with intense perennial malaria transmission . In 12- and 13-year-old schoolgirls , ITNs were associated with a reduced prevalence of all cause anemia ( hemoglobin level < 12 g/dL , 16.9 % versus 31.4 % , adjusted odds ratio [ OR ] = 0.38 , 95 % confidence interval [ CI ] = 0.21 , 0.69 % ) and a 0.34 g/dL ( 95 % CI = 0.02 , 0.66 ) increase in mean hemoglobin concentrations . No beneficial effect on all-cause anemia ( adjusted OR = 0.79 , 95 % CI = 0.43 , 1.45 ) or hemoglobin concentrations ( difference in mean = 0.14 g/dL , 95 % CI = -0.24 , 0.53 ) was evident in older girls . In all age groups , no effect was found on malaria parasite prevalence or density , clinical malaria , all-cause morbidity , st and ard measures of nutritional status and growth , or the use of antimalarials and other medications . ITNs approximately halved the prevalence of mild anemia in young , school-attending , non-pregnant , adolescent girls , but had no impact in older girls or on other malaria-associated morbidity or nutritional status |
323 | 10,571,710 | In simple clinical scenarios , results expressed in relative risk reduction or gain terms were viewed most positively by doctors .
: While a framing effect may exist , particularly when results are presented in terms of proportional or absolute measures of gain or loss , it appears highly susceptible to modification , and even neutralization , by other factors that influence doctors ’ decision making . | OBJECTIVE : The presentation format of clinical trial results , or the “ frame , ” may influence perceptions about the worth of a treatment .
The extent and consistency of that influence are unclear .
We undertook a systematic review of the published literature on the effects of information framing on the practice s of physicians . | BACKGROUND Medical practice patterns change in response to a variety of stimuli , one of which may be the publication of the results of r and omized clinical trials . We assessed the temporal association between the publication of clinical trials on myocardial infa rct ion and changes in treatment practice s for this disorder . METHODS We analyzed the use of aspirin before and after myocardial infa rct ion and that of calcium antagonists after myocardial infa rct ion in 2231 survivors of myocardial infa rct ion enrolled in the Survival and Ventricular Enlargement ( SAVE ) study over a three-year period ( from January 1987 through January 1990 ) . The proportion of patients using these treatments was analyzed before and after the publication date s of three clinical trials : the Physicians ' Health Study , published in January 1988 , which supported the use of aspirin to prevent a first myocardial infa rct ion ; the Second International Study of Infa rct Survival ( ISIS-2 ) , published in August 1988 , which supported the use of aspirin after myocardial infa rct ion ; and the Multicenter Diltiazem Postinfa rct ion Trial , published in August 1988 , which reported a deleterious effect of diltiazem in some patients after myocardial infa rct ion . RESULTS The use of aspirin before myocardial infa rct ion increased from 16.2 percent to 23.9 percent between January 1987 and January 1990 ( P less than 0.001 ) . Enrollment in the study after the publication of the Physicians ' Health Study independently predicted aspirin use before myocardial infa rct ion ( odds ratio , 1.43 ; 95 percent confidence interval , 1.11 to 1.85 ) . The use of aspirin after myocardial infa rct ion increased from 38.8 percent to 71.9 percent ( P less than 0.001 ) during the three-year study period . Enrollment in the study after the publication of ISIS-2 independently predicted the use of aspirin after myocardial infa rct ion ( odds ratio , 2.28 ; 95 percent confidence interval , 1.89 to 2.76 ) . The use of calcium antagonists after myocardial infa rct ion decreased from 57.1 percent to 33.1 percent ( P less than 0.001 ) during the study period . Enrollment in the study after the publication of the Multicenter Diltiazem Postinfa rct ion Trial independently predicted the use of calcium antagonists after myocardial infa rct ion ( odds ratio , 0.47 ; 95 percent confidence interval , 0.39 to 0.57 ) . CONCLUSIONS These observations suggest that r and omized clinical trials have a measurable influence on medical practice patterns In recent years , clinical decisions about treatment have been increasingly guided by the findings of r and omized clinical trials . These trials use the strongest type of study design for treatment assessment . They offer the best approach to reducing bias and balancing the distribution of known or unknown patient attributes that could threaten the internal validity of the study ( 1 ) . The quantitative measures of risk reduction used to report r and omized clinical trials describe the collective experience of the participants in the trial . To apply the results of such trials in clinical practice , physicians must translate the concepts and measures used to describe groups of patients into a language that can inform the decisions of an individual patient . A clinical vignette illustrates the tensions inherent in this process of translation . You are caring for a 74-year-old man whose blood pressure averages approximately 175/85 mm Hg . He has type 2 diabetes mellitus that is controlled by oral medications . On the basis of the findings of a r and omized clinical trial , the Systolic Hypertension in the Elderly Program ( SHEP ) ( 2 ) , you believe that treatment with antihypertensive medication will reduce his risk for a cardiovascular event . The patient asks you , If I take this medication , how will it help me ? ( The Table provides data from the SHEP trial to inform your answer . ) Table . Measures of Treatment Efficacy from the Systolic Hypertension in the Elderly Program ( SHEP ) Trial Three problems impede an accurate response to your patient 's seemingly simple question . First , reports of r and omized clinical trials do not usually account for individual characteristics that modify the effect of treatment ( 3 ) . Second , clinicians and patients often have difficulty interpreting quantitative data about risk and risk reduction ( 4 , 5 ) . Finally , the results of treatment studies can be expressed , or framed , in different ways ; this can influence how both physicians and patients perceive the efficacy of treatment ( 6 ) . You suspect that diabetes increases your patient 's risk for cardiovascular disease . He may therefore receive more benefit from treatment of hypertension . In the SHEP trial , as in most r and omized clinical trials , some participants had risk factors that increased their likelihood of a cardiovascular event ; 13 % of enrolled patients were current smokers , 10 % had a personal history of diabetes , and 5 % had previous myocardial infa rct ion ( 2 ) . However , this particular trial provides only the average estimated benefit for all participants rather than an estimate that takes your patient 's diabetes into account . Interpreting the Data The measures of risk reduction in a r and omized clinical trial are calculated from two proportions : the proportion of patients in the control group with an adverse outcome ( P C ) and the proportion of patients in the treatment group with the same adverse outcome ( P T ) . These proportions can be used to calculate two measures of treatment effect : relative risk reduction and absolute risk reduction . Formulas for both calculations are provided in the Table . The relative risk reduction is the traditional method of reporting the findings of a r and omized clinical trial . To describe to your patient the reduction in all cardiovascular events observed in the SHEP trial by using the relative risk reduction , you could say , Taking antihypertensive medications for 5 years will reduce your risk for stroke or cardiac event by 30 % . Because the event rate appears in both the numerator and the denominator of the relative risk reduction , it cancels out of their ratio ( 3 ) . As a result , the same relative risk reduction can be observed for adverse outcomes that occur at much different rates . For example , the relative risk reduction for all adverse cardiovascular events in the SHEP trial ( 30 % ) was approximately the same as the relative risk reduction for a fatal stroke ( 29 % ) , even though 12.2 % of treated patients experienced some type of cardiovascular event and only 0.4 % had a fatal stroke ( Table ) . Laupacis and colleagues ( 7 ) proposed that clinical decisions about treatment should incorporate the reciprocal of the absolute risk reduction , calculated as 1/(P C P T ) , which they termed the number needed to treat . The number needed to treat to prevent any cardiovascular event in the SHEP trial was 19 , roughly 30-fold less than the number needed to treat to prevent a fatal stroke ( Table ) . You could describe the number needed to treat to your patient by saying , About 19 persons need to be treated for hypertension for 5 years to prevent one stroke or cardiac event . The number needed to treat has become the st and ard for presenting the results of r and omized clinical trials in ACP Journal Club ( 8) . Framing the Effectiveness of Treatment The relative risk reduction and number needed to treat frame therapeutic decisions differently . The number needed to treat unambiguously assumes the population perspective because it explicitly states the number of people who must be treated and for what length of time to protect one person . Although the relative risk reduction is also a population statistic , it seems to promise a benefit that is individual , large , and immediate . In studies of hypothetical treatment decisions , physicians ( 9 - 12 ) and patients ( 13 , 14 ) viewed treatments more favorably when benefits of these treatments were framed in terms of relative risk reduction . In a question naire study of 235 physicians ( 9 ) , 49 % of respondents reported that they would be more likely to prescribe a lipid-lowering drug with a relative risk reduction of 24 % than a drug with an absolute risk reduction of 0.4 % , even though both statistics were calculated from the Lipid Research Clinics Coronary Primary Prevention Trial ( 15 ) . In another question naire study that used data from the Helsinki Heart Study ( 16 ) , 88 % of patients indicated that they would be willing to take a medication that caused a 34 % relative risk reduction in heart attacks . However , only 31 % of patients said that they would take this medication when the same information was expressed as a number needed to treat ( 71 persons needed to be treated for 5 years to prevent one heart attack ) ( 14 ) . Thus , in hypothetical cases , physicians and patients seem more likely to promote or accept treatment when it is framed in individual terms rather than in population terms . Little research has assessed the content of actual clinical conversations about risk . In one study , discussion s about risk occurred in 26 % of audiotaped primary care office visits ( 17 ) . Only 3.4 % of risk discussion s were quantitative ; relative risk reduction was used in those conversations . The physician usually told the patient that an adverse outcome was certain unless the patient adopted the recommended treatment ; in other words , that P C = 1 ( 17 ) . These limited clinical data support studies of hypothetical treatment decisions ( 9 - 14 ) by suggesting that physicians may deliberately or unconsciously choose to discuss the benefits of a treatment by using a framing strategy that does not provide neutral information but is intended to guide the treatment choices of their patients . The Language of Population s : From Groups to Subgroups You could estimate the benefits of hypertension treatment for your patient more precisely if information were available about the subgroup of diabetic patients enrolled in the SHEP trial . A valid subgroup analysis of a r and omized clinical trial identifies characteristics of prognostic importance before data analysis , then compares outcomes between treated patients and controls within the subgroup of patients who have these characteristics ( 18 ) . Subgroup analyses can provide useful information to guide decision making when the subgroups are large , the subgroup analyses are specified in advance , and the statistical analysis is appropriately conservative ( 19 , 20 ) . Although the initial SHEP study ( 2 ) did not evaluate the effect of treatment of hypertension in persons with diabetes , a subsequent SHEP report found that the cumulative incidence of adverse cardiovascular events at 5 years among the subgroup of diabetic persons who received antihypertensive drugs was 21.4 % compared with 31.5 % among diabetic persons receiving placebo ( 21 ) . When the formulas in the Table are used , these findings represent a relative risk reduction of 32 % and a number needed to treat of 10 . Thus , as we would expect to find in clinical practice , diabetic patients in the SHEP trial were at greater risk for adverse events and received more benefit from treatment of hypertension . With this additional information , you could say to your patient , On average , 19 patients need to be treated for hypertension for 5 years to prevent a stroke or cardiac event . For persons with diabetes , only 9 to 10 patients need to be treated for the same period to achieve the same benefit . In a similar way , you could use other single risk factorsor your overall assessment of your patient 's risk for a cardiovascular event if he does not receive antihypertensive medicationto modify the average estimate of treatment benefit from the SHEP trial . A full discussion of this process , which is called Bayesian reasoning , is beyond the scope of this paper , but the literature contains excellent introduction s ( 22 , 23 ) . In a busy clinical practice , neither the findings of the SHEP trial itself nor the additional data necessary to further particularize the benefits of treatment are readily available . Computerized decision support systems to provide such information in real time are being developed ( 24 ) . Problems of statistical power limit the applicability of subgroup analyses in r and omized clinical trials to individual decisions . The sample size for a r and omized clinical trial is calculated to provide a precise estimate of the average treatment effect . Nevertheless , estimates of the relative risk reduction or the number needed to treat from any study retain statistical uncertainty , which can In the third of a series of four articles the authors show the calculation of measures of association and discuss their usefulness in clinical decision making . From the rates of death or other " events " in experimental and control groups in a clinical trial , we can calculate the relative risk ( RR ) of the event after the experimental treatment , expressed as a percentage of the risk without such treatment . The absolute risk reduction ( ARR ) is the difference in the risk of an event between the groups . The relative risk reduction is the percentage of the baseline risk ( the risk of an event in the control patients ) removed as a result of therapy . The odds ratio ( OR ) , which is the measure of choice in case-control studies , gives the ratio of the odds of an event in the experimental group to those in the control group . The OR and the RR provide limited information in reporting the results of prospect i ve trials because they do not reflect changes in the baseline risk . The ARR and the number needed to treat , which tells the clinician how many patients need to be treated to prevent one event , reflect both the baseline risk and the relative risk reduction . If the timing of events is important -- to determine whether treatment extends life , for example -- survival curves are used to show when events occur over time The results of a r and omized clinical trial can be reported using relative and /or absolute estimators of treatment effect . These various measures convey different information , and the choice can influence the physician 's appreciation of the size of treatment effect and , subsequently , treatment decisions . We compare the estimators with respect to the clinical ly relevant information conveyed to physicians , and identify which clinical questions can and can not be answered directly by each . We also identify opportunities for misinterpretation when one estimator is substituted for another , or when an estimator is mislabeled . Clinical ly important questions are addressed most directly by reporting both relative and absolute effects using relative risk and its complement , relative risk reduction , and risk difference and its reciprocal , number needed to treat . This is true of estimates of treatment effect derived from a single trial and also from meta- analysis of a group of trials . Because the control group 's risk affects the numerical value of the odds ratio , the odds ratio can not substitute for the risk ratio in conveying clinical ly important information to physicians . This is especially important when large treatment effects are shown in trials carried out in population s at high baseline risk OBJECTIVE To determine whether situations involving multiple options can paradoxically influence people to choose an option that would have been declined if fewer options were available . DESIGN Mailed survey containing medical scenarios formulated in one of two versions . PARTICIPANTS Two groups of physicians : members of the Ontario College of Family Physicians ( response rate = 77 % ; n = 287 ) and neurologists and neurosurgeons affiliated with the North American Symptomatic Carotid Endarterectomy Trial ( response rate = 84 % ; n = 352 ) . One group of legislators belonging to the Ontario Provincial Parliament ( response rate = 32 % ; n = 41 ) . INTERVENTION The basic version of each scenario presented a choice between two options . The exp and ed version presented three options : the original two plus a third . The two versions otherwise contained identical information and were r and omly assigned . OUTCOME MEASURES Participants treatment recommendations . RESULTS In one scenario involving a patient with osteoarthritis , family physicians were less likely to prescribe a medication when deciding between two medications than when deciding about only one medication ( 53 % vs 72 % ; P < .005 ) . Apparently , the difficulty in deciding between the two medications led some physicians to recommend not starting either . Similar discrepancies were found in decisions made by neurologists and neurosurgeons concerning carotid artery surgery and by legislators concerning hospital closures . CONCLUSIONS The introduction of additional options can increase decision difficulty and , hence , the tendency to choose a distinctive option or maintain the status quo . Awareness of this cognitive bias may lead to improved decision making in complex medical situations OBJECTIVE To compare clinicians ' ratings of therapeutic effectiveness when different trial end points were presented as percent reductions in relative compared with absolute risk and as numbers of patients treated to avoid one adverse outcome . DESIGN Survey , with r and om allocation of two question naires . SETTING Toronto teaching hospitals . RESPONDENTS Convenience sample of 100 faculty and housestaff in internal medicine and family medicine . INTERVENTION One question naire presented results for three end points of the Helsinki Heart Study as separate drug trials using only absolute differences in events ; the other showed the same end points as relative differences . Both question naires included a fourth " trial , " showing person-years of treatment needed to prevent one myocardial infa rct ion . MAIN OUTCOME MEASURE The " trials " were each rated on an 11-point scale , from treatment " harmful " to " very effective . " RESULTS Respondents ' ratings of effectiveness varied with the end point . Controlling for end point , ratings of effectiveness by the 50 participants receiving absolute event data were lower than those by 50 participants responding to relative risk reductions ( P < 0.001 ) ; however , no end-point difference was more than 0.6 scale points . For a " trial " reporting that 77 persons were treated for 5 years to prevent one myocardial infa rct ion , mean ratings were 2.3 or 1.8 scale points lower , respectively ( both P < 0.001 ) , than when the same data were shown as relative or absolute risk reductions . CONCLUSIONS Clinicians ' views of drug therapies are affected by the common use of relative risk reductions in both trial reports and advertisements , by end-point emphasis , and , above all , by underuse of summary measures that relate treatment burden to therapeutic yields in a clinical ly relevant manner BACKGROUND Evidence -based medicine requires general practitioners ( GPs ) to act upon the results of clinical trials . Clinical trial evidence may be difficult to underst and and apply in practice . AIM To investigate whether GPs were unduly influenced in managing hypertension in the elderly by the ways in which benefits of trial results were presented , and to establish whether their current treatment of an elderly hypertensive patient was broadly in line with recent clinical trial evidence . METHOD Seventy-three GPs attending a refresher course were given a written question naire containing data from one clinical trial of treatment of hypertension in the elderly presented in four different ways ( absolute risk reduction , relative risk reduction , difference in event-free patients , and number of patients who had to be treated in order to prevent one clinical event ) , as if from four different trials . The effect of each presentation on treatment preferences was assessed using Likert scales . The results were analysed to determine whether the method of presentation of results influenced decision making . A clinical scenario was presented to investigate their current treatment preferences in an elderly hypertensive . RESULTS All GPs returned completed question naires . Relative risk reduction was the only presentation which was significantly different from the others , and was the most likely to influence prescribing . In free-text comments , 75 % of GPs admitted having problems underst and ing statistics commonly found in medical journals . More than 90 % conformed with recent clinical trial evidence for the management of hypertension . CONCLUSION GPs were most influenced by relative risk reduction , and were unaware of how the presentation of research results could affect treatment decisions . Most GPs freely admitted to difficulty in comprehending medical statistics . Almost all of the GPs expressed treatment decisions which were broadly in line with clinical evidence Recent changes in the medical marketplace that limit access to specialty care have spurred much debate about the quality of care provided by generalists and specialists [ 1 ] . Previous research has compared generalists ' and specialists ' knowledge and practice s with regard to diseases such as rheumatoid arthritis and myocardial infa rct ion , for which it can be reasonably argued that specialists have greater expertise [ 2 - 4 ] . However , the relative expertise of generalists and specialists in primary prevention , which is particularly central to primary care practice , is unknown . Previous research has suggested that some patients may not accept primary preventive therapy if presented with information about the true risk for disease at baseline and about the actual benefits of therapy [ 5 ] . Furthermore , the value of a preventive intervention to an individual person may differ from expert consensus that is based on population studies [ 6 - 9 ] . Given these findings , physicians should transmit accurate knowledge to patients about the extent to which they are at risk for cardiovascular disease , so that patients can make informed decisions . In our study , we surveyed practicing family physicians , general internists , and cardiologists to assess their quantitative perceptions of baseline cardiovascular risk and of the benefit of drug therapy for two groups of patients who frequently receive primary preventive therapy : middle-aged men with hypercholesterolemia and elderly persons with isolated systolic hypertension . We also examined a tertiary prevention intervention [ 10 ] : coronary artery bypass graft surgery in patients with stable angina and left main coronary stenosis . Because generalists are responsible for most primary prevention , we expected that their estimates of risk at baseline and after therapy would be more accurate than cardiologists ' estimates for the primary preventive interventions , but less accurate for the tertiary care intervention . Methods Question naire The question naire consisted of written case simulations of patients with hypercholesterolemia , isolated systolic hypertension , and chronic stable angina with left main coronary stenosis whose clinical characteristics were representative of the average person in well-publicized clinical trials ( Table 6 ) . The hypercholesterolemia case simulation ( or scenario ) was extrapolated from the Lipid Research Clinics and Helsinki trials [ 11 , 12 ] ; physicians were asked to give unprompted estimates of 5-year risk for myocardial infa rct ion with and without lipid-lowering drug therapy . In the section of the question naire dealing with the isolated systolic hypertension scenario , which was derived from the Systolic Hypertension in the Elderly Program trial [ 13 ] , physicians were asked to give estimates of 5-year risk for stroke with and without antihypertensive drug therapy . In the section that provided the left main coronary stenosis scenario , which was extrapolated from the Veterans Administration Cooperative Study of Surgery for Coronary Arterial Occlusive Disease and the Collaborative Study in Coronary Artery Surgery [ 14 , 15 ] , physicians were asked to estimate 3-year survival with and without coronary artery bypass graft surgery . The correct answers were taken from the results of the studies from which each scenario was derived . Respondents were asked not to consult the literature when completing the question naire , but simply to give their best estimates . Appendix Table * The physicians were also asked whether they would generally recommend therapy for such a patient ( yes or no ) . They rated their confidence in their estimates and their familiarity with the relevant medical literature on 7-point Likert-type scales ( for example , 1 equals not at all confident ; 7 equals very confident ) . Finally , respondents reported their age , sex , practice setting , specialty ( cardiology , general internal medicine , or family practice ) , and the year in which they graduated from medical school . Sample Selection and Survey Procedure Sampling was done in two stages . First , an addressing company contracted by the American Medical Association ( AMA ) drew a self-weighted , nationally representative , systematic sample of 6000 practicing physicians ( 2417 family physicians , 2901 general internists , and 682 cardiologists ) from the AMA masterfile of all licensed physicians . Second , after dividing the first-stage sample into the three specialty groups , we selected three separate simple r and om sample s of 199 family physicians , 200 general internists , and 200 cardiologists to form our mailed sample ( Table 1 ) . For the cholesterol scenario , using a two- sample t-test , a st and ard deviation of 8 percentage points from a pilot study , and a 50 % response rate , 200 physicians in each group would have given us more than 90 % power ( equals 0.05 ) to detect a difference of 4 percentage points between the groups ' estimates . We mailed the two-page survey three times between September 1993 and February 1994 , and a reminder postcard was sent 2 weeks after the second mailing . Table 1 . Demographic Characteristics of Physicians in the Population and the Sample , by Specialty * Analysis Self-reported specialty was compared with the specialty category in the AMA masterfile , with a percent agreement of 91 % . Because the AMA specialty category was used for demographic comparison with the nonrespondents and overall population , we used the specialty design ation from the AMA masterfile . The sex of all nonrespondents was inferred on the basis of first name when possible , before the names were deleted . Sex could not be determined in 2 % of instances . Characteristics of the AMA masterfile population were estimated from 1993 year-end data [ 16 ] . Absolute risk reduction was calculated as the difference between estimated risk at baseline and after therapy . Relative risk reduction was the absolute risk difference divided by the baseline risk . Accuracy was defined as the absolute value of the difference between the physician 's estimate and the estimate from the literature , with lower numbers indicating greater accuracy . Because the estimates and accuracy were not normally distributed , we present median estimates with interquartile ranges ( the range between the 25th and 75th percentiles ) . Across specialty groups , we generated differences in medians with confidence intervals , and used the Mann-Whitney U test [ 17 ] . Similarly , within each specialty group , we compared the differences in medians between those who would and those who would not recommend treatment . To compare respondents ' and nonrespondents ' sex and geographic region , we used the Cochran-Mantel-Haenszel chi-square statistic for contingency tables stratified by specialty [ 18 ] . For analyses of categorical variables across specialty groups , we did chi-square tests and calculated confidence intervals . Across specialty groups , we also used analysis of variance to generate differences in means and confidence intervals for comparisons of 1 ) confidence in estimates and 2 ) familiarity with the relevant literature [ both of which were measured on 7-point Likert-type scales ] , as well as 3 ) years since graduation from medical school . The relation between these three variables and accuracy was assessed using the Spearman rank correlation coefficient , with confidence intervals generated using the Fisher Z transformation . For clarity , 95 % CIs are given throughout . Because of multiple comparisons , we defined statistical significance at the P 0.005 level ( two-tailed ) and noted trends at the P 0.05 level . Results Respondents and Nonrespondents We received responses from 232 ( 40 % ) of 579 eligible physicians . Of the 20 ineligible physicians , 15 did not have a forwarding address and 5 were retired or deceased . Another 5 surveys were illegible , leaving 227 for analysis . Thus , 84 ( 44 % ) of 191 eligible family physicians , 77 ( 40 % ) of 194 general internists , and 66 ( 34 % ) of 194 cardiologists responded ( Table 1 ) . The available demographic characteristics of respondents were reasonably similar to those of nonrespondents and of the AMA masterfile population ( Table 1 ) . Estimates and Treatment Recommendations For both primary prevention scenarios , cardiologists gave lower , more accurate estimates of baseline risk and absolute risk reduction than either general internists or family physicians , although these estimates were inflated and widely distributed for all three specialties ( Table 2 ) . For example , 27 % of general internists and more than 30 % of family physicians estimated that the 5-year absolute risk reduction for myocardial infa rct ion in the cholesterol scenario was greater than 10 % , a 10-fold overestimate , compared with only 14 % of cardiologists . Similarly , for the systolic hypertension scenario , half of the family physicians and general internists gave two- to threefold overestimates of the 5-year risks for stroke both with and without antihypertensive therapy , whereas most of the cardiologists better approximated the estimate from the literature . Despite differing perceptions of baseline risk and absolute risk reduction , the specialties did not differ significantly as to estimates of relative risk reduction for the primary prevention scenarios . Table 2 . Estimates of Baseline Risk , Absolute Risk Reduction , and Relative Risk Reduction , by Specialty * For the left main coronary stenosis case , cardiologists gave lower estimates of baseline survival and greater estimates of its improvement with surgery ( Table 2 ) than general internists and family physicians , but no differences in accuracy ( the absolute value of the difference between the physician 's estimate and the estimate from the literature ) were seen across the specialties . For example , for the absolute improvement in survival after bypass surgery , no differences in median accuracy were noted between cardiologists and either family physicians ( point estimate for the difference in medians , 0 ; 95 % CI , 1 to 5 ) or general internists ( point estimate , 0 ; CI , 5 to 3 ) . BACKGROUND The respective roles of generalist and specialist physicians in the care of patients is currently a matter of debate . Information is limited about the knowledge and practice s of generalist and specialist physicians regarding conditions that both groups treat , such as myocardial infa rct ion . METHODS We therefore surveyed 1211 cardiologists , internists , and family practitioners in the states of New York and Texas about four treatments demonstrated by r and omized clinical trials to be associated with improved survival after myocardial infa rct ion ( thrombolytic therapy , immediate and long-term use of aspirin , and long-term use of beta-blockers ) and two treatments for which such evidence is lacking ( diltiazem for patients with pulmonary congestion and prophylactic lidocaine ) . We asked physicians about the effect of each treatment on survival and the likelihood that they would prescribe each class of drugs . RESULTS For the four beneficial treatments , the cardiologists believed more strongly than the internists and family physicians that survival was improved by the treatment , and they were more likely to prescribe these drugs ( P < 0.001 ) . For example , 94.1 percent of cardiologists said they were very likely to prescribe thrombolytic agents to treat an acute myocardial infa rct ion , as compared with 82.0 percent of internists and 77.3 percent of family practitioners . Conversely , for the two treatments for which trials showed no evidence of a survival benefit , cardiologists were less likely than internists and family practitioners to think there was such a benefit and less likely to prescribe the drugs ( P < 0.001 ) . For example , 4.7 percent of cardiologists reported that they were very likely to use prophylactic lidocaine , as compared with 13.1 percent of internists , and 16.5 percent of family practitioners . When we used logistic regression to adjust for potential confounders , all the differences between the cardiologists and the internists and family practitioners remained significant ( P < 0.02 ) . CONCLUSIONS Internists and family practitioners are less aware of or less certain about key advances in the treatment of myocardial infa rct ion than are cardiologists . This finding underscores the need to improve the dissemination of information from clinical trials to generalist physicians , particularly if they are to have an enlarged role in the evolving health care system Clinical trials may lead to conflicting results . We studied how different ways of reporting results affected physicians ' recommendations . A question naire distributed to 148 general practitioners presented results of a clinical trial where a reduction of cardiac events and an increase of mortality was reported . Results were shown in four different ways -- relative risk reduction , absolute risk reduction , percentages of event-free patients , number needing to be treated to prevent an event -- as if they derived from different trials . A fifth presentation was the reduced rate of cardiac events along with the increased rate of mortality . Physicians were asked to estimate how much they would be willing to prescribe each drug . The mean agreement of physicians ' decisions was 77 (28)% for relative risk reduction , 24 (28)% for absolute risk reduction , 37 (37)% for different percentages event-free patients , 34 (34)% for number need to treat , and 23 (28)% for events reduction and mortality for increase ( p < 0.001 relative risk vs others ) . The method of reporting trial results and the completeness of information in the case of controversial results affects physicians willingness to prescribe R and omized clinical trials of cardiac rehabilitation following myocardial infa rct ion have typically demonstrated a lower mortality in treated patients , but with a statistically significant reduction in only one trial . To overcome the problem of not being able to detect small but clinical ly important benefits in mortality in r and omized clinical trials of exercise and risk factor rehabilitation after myocardial infa rct ion with small numbers of patients , we carried out a meta- analysis on the combined results of ten r and omized clinical trials that included 4347 patients ( control , 2145 patients ; rehabilitation , 2202 patients ) . The pooled odds ratios of 0.76 ( 95 % confidence intervals , 0.63 to 0.92 ) for all-cause death and of 0.75 ( 95 % confidence intervals , 0.62 to 0.93 ) for cardiovascular death were significantly lower in the rehabilitation group than in the control group , with no significant difference for nonfatal recurrent myocardial infa rct ion . These results suggest that , for appropriately selected patients , comprehensive cardiac rehabilitation has a beneficial effect on mortality but not on nonfatal recurrent myocardial infa rct ion In a r and omized , double-blind five-year trial , we tested the efficacy of simultaneously elevating serum levels of high-density lipoprotein ( HDL ) cholesterol and lowering levels of non-HDL cholesterol with gemfibrozil in reducing the risk of coronary heart disease in 4081 asymptomatic middle-aged men ( 40 to 55 years of age ) with primary dyslipidemia ( non-HDL cholesterol greater than or equal to 200 mg per deciliter [ 5.2 mmol per liter ] in two consecutive pretreatment measurements ) . One group ( 2051 men ) received 600 mg of gemfibrozil twice daily , and the other ( 2030 men ) received placebo . Gemfibrozil caused a marked increase in HDL cholesterol and persistent reductions in serum levels of total , low-density lipoprotein ( LDL ) , and non-HDL cholesterol and triglycerides . There were minimal changes in serum lipid levels in the placebo group . The cumulative rate of cardiac end points at five years was 27.3 per 1,000 in the gemfibrozil group and 41.4 per 1,000 in the placebo group -- a reduction of 34.0 percent in the incidence of coronary heart disease ( 95 percent confidence interval , 8.2 to 52.6 ; P less than 0.02 ; two-tailed test ) . The decline in incidence in the gemfibrozil group became evident in the second year and continued throughout the study . There was no difference between the groups in the total death rate , nor did the treatment influence the cancer rates . The results are in accord with two previous trials with different pharmacologic agents and indicate that modification of lipoprotein levels with gemfibrozil reduces the incidence of coronary heart disease in men with dyslipidemia OBJECTIVE : To determine whether the way in which information on benefits and harms of long-term hormone replacement therapy ( HRT ) is presented influences family physicians ’ intentions to prescribe this treatment . DESIGN : Family physicians were r and omized to receive information on treatment outcomes expressed in relative terms , or as the number needing to be treated ( NNT ) with HRT to prevent or cause an event . A control group received no information . SETTING : Primary care . PARTICIPANTS : Family physicians practicing in the Hunter Valley , New South Wales , Australia . INTERVENTION : Estimates of the impact of long-term HRT on risk of coronary events , hip fractures , and breast cancer were summarized as relative ( proportional ) decreases or increases in risk , or as NNT . MEASUREMENTS AND MAIN RESULTS : Intention to prescribe HRT for seven hypothetical patients was measured on Likert scales . Of 389 family physicians working in the Hunter Valley , 243 completed the baseline survey and 215 participated in the r and omized trial . Baseline intention to prescribe varied across patients —it was highest in the presence of risk factors for hip fracture , but coexisting risk factors for breast cancer had a strong negative influence . Overall , a larger proportion of subjects receiving information expressed as NNT had reduced intentions , and a smaller proportion had increased intentions to prescribe HRT than those receiving the information expressed in relative terms , or the control group . However , the differences were small and only reached statistical significance for three hypothetical patients . Framing effects were minimal when the hypothetical patient had coexisting risk factors for breast cancer . CONCLUSIONS : Information framing had some effect on family physicians ’ intentions to prescribe HRT , but the effects were smaller than those previously reported , and they were modified by the presence of serious potential adverse treatment effects Abstract Objective : To determine whether the reporting of study results by using reductions in relative or absolute risk and the number needed to treat affects the views of physicians about the effectiveness of drugs to lower lipid concentrations and decisions about treatment . Design : R and om allocation of two question naires presenting the results of three end points of the Helsinki heart study as results from separate trials by using reduction in either relative or absolute20risk . In both question naires one end point was also presented by showing person years of treatment20needed to prevent one myocardial infa rct ion . The effectiveness of lipid lowering drugs was assessed for all end points on an 11 point scale . For each study result the likelihood to treat hypercholesterolaemia of 7.5 mmol/l in a healthy man had to be indicated on a seven point scale . Subjects : R and om sample of 802 internists and general practioners representative of providers of primary care in Switzerl and . Results - The response rate was 69.6 % ( 558 ) . For the prevention of fatal and non-fatal myocardial infa rct ion the mean ratings of effectiveness of lipid lowering drugs were 0.45 ( 95 % confidence interval 0.21 to 0.69 ) and 1.39 ( 1.09 to 1.68 ) scale points lower when the reduction of absolute risk or number needed to treat were reported instead of the relative risk reduction ( both P<0.001 ) . Physicians receiving trial results for identical end points in form of absolute reduction of risk or number needed to treat were less inclined to treat hypercholesterolaemia ( both P<0.001 ) . Conclusions : Physicians ' views of the effectiveness of lipid lowering drugs and the decision to prescribe such drugs is affected by the predominant use of reduction of relative risk in trial reports and advertisements |
324 | 26,691,270 | DISCUSSION In keeping with the adult literature , cross-sectional studies of children and adolescents consistently report associations with eating pathology .
There is some evidence from prospect i ve studies that insecure attachment may be a risk factor for the development of eating pathology in adolescence .
The literature on mentalization and eating pathology suggests that adolescents with anorexia nervosa may have difficulties in recognizing emotions . | OBJECTIVE Insecure attachment and mentalizing difficulties have been associated with eating pathology in adulthood .
However , it is unclear whether eating pathology is associated with attachment or mentalization in children .
The aim of this study is to systematic ally review the literature in this emerging field . | Community-based prospect i ve studies are needed to shed light on mechanisms that may influence development of eating disorders and identify variables that could serve as potential targets for prevention efforts . In this paper we examine level of weight preoccupation and other variables prospect ively associated with age of onset of eating disorder symptoms over a 3-year interval in a community sample ( N = 939 ) of young adolescent girls . 3.6 % ( 32/887 ) experienced onset of symptoms over the interval . Only one factor , a measure of Weight Concerns , was significantly associated with onset ( p < .001 ) . Girls scoring in the highest quartile on the measure of Weight Concerns had the shortest survival time ( 12 % incidence by age 14.5 ) and those scoring in the lowest quartile had the highest survival time ( 2 % incidence by age 14.5 ; p < .001 ) . This finding is consistent with both theoretical and clinical perspectives and represents one of the first prospect i ve demonstrations of a linkage between weight and body shape concerns and later onset of eating disorder symptoms . An underst and ing of the independent variables that predispose girls to development of symptoms is a useful step towards the establishment of a rational basis for the choice of a prevention intervention target The purpose of this study was to conduct an assessment of binge eating severity among obese persons . Two question naires were developed . A 16-item Binge Eating Scale was constructed describing both behavioral manifestations ( e.g. , eating large amounts of food ) and feeling/cognitions surrounding a binge episode ( e.g. , guilt , fear of being unable to stop eating ) . An 11-item Cognitive Factors Scale was developed measure two cognitive phenomena thought to be related to binge eating : the tendency to set unrealistic st and ards for a diet ( e.g. , eliminating " favorite foods " ) and low efficacy expectations for sustaining a diet . The results showed that the Binge Eating Scale successfully discriminated among persons judged by trained interviewers to have either no , moderate or severe binge eating problems . Significant correlation between the scales were obtained such that severe bingers tended to set up diets which were unrealistically strict while reporting low efficacy expectations to sustain a diet . The discussion highlighted the differences among obese persons on binge eating severity and emphasized the role of cognitions in the relapse of self control of eating BACKGROUND The long-term outcome of anorexia nervosa is insufficiently research ed . AIMS To study prospect ively the long-term outcome and prognostic factors in a representative sample of people with teenage-onset anorexia nervosa . METHOD Fifty-one people with anorexia nervosa , recruited by community screening and with a mean age at onset of 14 years were compared with 51 matched comparison individuals at a mean age of 32 years ( 18 years after disorder onset ) . All participants had been examined at ages 16 years , 21 years and 24 years . They were interviewed for Axis I psychiatric disorders and overall outcome ( Morgan-Russell assessment schedule and the Global Assessment of Functioning ) . RESULTS There were no deaths . Twelve per cent ( n=6 ) had a persisting eating disorder , including three with anorexia nervosa . Thirty-nine per cent of the anorexia nervosa group met the criteria for at least one psychiatric disorder . The general outcome was poor in 12 % . One in four did not have paid employment owing to psychiatric problems . Poor outcome was predicted by premorbid obsessive-compulsive personality disorder , age at onset of anorexia nervosa and autistic traits . CONCLUSIONS The 18-year outcome of teenage-onset anorexia nervosa is favourable in respect of mortality and persisting eating disorder OBJECTIVE We examined whether mentalization-based treatment for adolescents ( MBT-A ) is more effective than treatment as usual ( TAU ) for adolescents who self-harm . METHOD A total of 80 adolescents ( 85 % female ) consecutively presenting to mental health services with self-harm and comorbid depression were r and omly allocated to either MBT-A or TAU . Adolescents were assessed for self-harm , risk-taking and mood at baseline and at 3-monthly intervals until 12 months . Their attachment style , mentalization ability and borderline personality disorder ( BPD ) features were also assessed at baseline and at the end of the 12-month treatment . RESULTS MBT-A was more effective than TAU in reducing self-harm and depression . This superiority was explained by improved mentalization and reduced attachment avoidance and reflected improvement in emergent BPD symptoms and traits . CONCLUSIONS MBT-A may be an effective intervention to reduce self-harm in adolescents This study examines the relationship between attachment strategies and symptom reporting among college women . Sixty-one college women were selected who reported high or low levels of depressive and eating disorder symptoms . The Adult Attachment Interview ( AAI ) was administered , and interview transcripts were rated with the Attachment Interview Q-Sort . The results indicated that women with hyperactivating AAI strategies were prone to reporting elevated levels of depressive symptoms , whereas women with deactivating strategies were prone to reporting elevated levels of eating-disorder symptoms , when depression was statistically controlled . These findings support the hypothesis that secondary or defensive attachment strategies predispose individuals toward different forms of symptom expression |
325 | 22,878,028 | Physicians and nurses seem equally capable of providing face-to-face communication-related BCTs in primary care .
Behavioral counseling , motivational interviewing , education and advice all seem effective communication-related BCTs .
However , BCTs were also found in less successful studies .
Furthermore , based on existing literature , one primary care profession does not seem better equipped than the other to provide face-to-face communication-related BCTs .
PRACTICE IMPLICATION S There is evidence that behavioral counseling , motivational interviewing , education and advice can be used as effective communication-related BCTs by physicians and nurses . | OBJECTIVES To systematic ally review the literature on the relative effectiveness of face-to-face communication-related behavior change techniques ( BCTs ) provided in primary care by either physicians or nurses to intervene on patients ' lifestyle behavior . | BACKGROUND Physical activity promotion is a priority , but contribution of physicians ' interventions is unclear . The effectiveness of the PEPAF ( " Experimental Program for Physical Activity Promotion " ) , which was implemented exclusively by physicians in routine primary care from October 2003 to December 2004 , was assessed . METHODS Fifty-six Spanish family physicians were r and omized to either the intervention ( n = 29 ) or st and ard care ( n = 27 ) arm of the trial . The physicians recruited 4317 physically inactive patients ( 2248 for intervention and 2069 for control protocol s ) from a systematic sample after assessing their physical activity in routine practice . Intervention physicians provided advice to all patients and a physical activity prescription to the subgroup attending an additional appointment ( 30 % ) . The main outcome measure was the change in physical activity measured by blinded nurses using the 7-Day Physical Activity Recall . Secondary outcomes included cardiorespiratory fitness and health-related quality of life . RESULTS At 6 months , intervention patients increased physical activity more than controls ( adjusted difference , 18 min/wk [ 95 % confidence interval , 6 - 31 min/wk ] ; metabolic equivalent tasks x hours per week , 1.3 [ 95 % CI , 0.4 - 2.2 ] ) . The proportion of the population achieving minimal physical activity recommendations was 3.9 % higher in the intervention group ( 1.2%-6.9 % ; number needed to treat , 26 ) . No differences were found in secondary outcomes . The effect of intervention was positively modified in subjects older than 50 years ( P < or = .01 ) and in the prescription subgroup ( P < .001 ) . CONCLUSIONS Family physicians were effective for increasing physical activity of primary care patients . Overall clinical effect was small but relevant for population public health . Within the intervention program , clinical ly relevant effects were seen in patients receiving a physical activity prescription . Trial Registration clinical trials.gov Identifier : NCT00131079 Objectives Primary : To compare the effectiveness of intensive group and individual interventions for smoking cessation in a primary health care setting ; secondary : to identify the variables associated with smoking cessation . Methods Three-pronged clinical trial with r and omisation at the individual level . We performed the following : an intensive individual intervention ( III ) , an intensive group intervention ( IGI ) and a minimal intervention ( MI ) . Included in the study were smokers who were prepared to quit smoking . Excluded from the study were individuals aged less than 18 years or with severe mental conditions or terminal illnesses . The outcome measure was continued abstinence at 12 months confirmed through CO-oximetry ( CO ) . The analysis was based on intention to treat . Results In total , 287 smokers were recruited : 81 in the III , 111 in the IGI , and 95 in the MI . Continued abstinence at 12 months confirmed through CO was 7.4 % in the III , 5.4 % in the IGI , and 1 % in the MI . No significant differences were noted between III and MI on the one h and , and between IGI and MI on the other [ RR 7.04 ( 0.9 - 7.2 ) and RR 5.1 ( 0.6 - 41.9 ) , respectively ] . No differences were noted between IGI and III [ RR 0.7 ( 0.2 - 2.2 ) ] . In multivariate analysis , only overall visit length showed a statistically significant association with smoking cessation . Conclusions The effectiveness of intensive smoking interventions in this study was lower than expected . No statistically significant differences were found between the results of individual and group interventions .Trial registration numberIS RCT Moderate to severe chronic kidney disease ( CKD ) is associated with increased cardiovascular risk . Usually nephrologists are primarily responsible for the care of CKD patients . However , in many cases treatment goals , as formulated in guidelines , are not met . The addition of a nurse practitioner might improve the quality of care . The Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse Practitioners ( MASTERPLAN ) study is a r and omized controlled multicenter trial , aim ed at investigating whether a multifactorial approach in patients with moderate to severe CKD ( stage 3 and 4 ) to achieving treatment goals using both a polydrug strategy and lifestyle treatment either with or without the addition of a nurse practitioner will reduce cardiovascular risk and slow the decline of kidney function . Patients ( n=793 ) have been r and omized to nurse care or physician care . In the nurse-care arm of the study , nurse practitioners use flowcharts to address risk factors requiring drug and /or lifestyle modification . They have been trained to coach patients by motivational interviewing with the aim of improving patient self-management . At baseline , both treatment groups show equal distributions with regard to key variables in the study . Moreover , in only 1 patient were all risk factors within the limits as defined in various guidelines , which underscores the relevance of our initiative OBJECTIVE To determine if lifestyle improved at a short term through an intervention to involve patients in cardiovascular risk management by the practice nurse . METHODS The IMPALA study ( 2006 , the Netherl and s ) was a cluster-r and omised controlled trial involving 25 general practice s and 615 patients who were eligible for cardiovascular risk management . The intervention consisted of ( 1 ) individual 10-year cardiovascular risk assessment , ( 2 ) risk communication , ( 3 ) use of a decision aid and ( 4 ) adapted motivational interviewing , applied by practice nurses in two consultations . Outcomes were smoking , alcohol , diet , physical activity and the secondary outcomes risk perception , anxiety , confidence about the decision and satisfaction with the communication , measured at baseline and after 12 weeks . RESULTS Patients of both groups improved their lifestyle , but no relevant significant differences between the groups were found . Intervention group patients improved in terms of the appropriateness of risk perception , although not significantly . Intervention group patients improved significantly in terms of appropriateness of anxiety and were more satisfied with the communication compared to control group patients . CONCLUSION The intervention seems to have improved the patients ' risk perception , anxiety and satisfaction with the communication , which are important conditions for shared decision making . However , we found no additional effect of the intervention on lifestyle Background : Promoting physical activity is an important public health strategy for long-term reductions in incidence or severity of clinical disease . Benefits to health-related quality of life ( HRQL ) and subjective well-being may be as important and take less time to accrue . Purpose : We examined the HRQL benefits of a social-cognitive-theory-based intervention of the Activity Counseling Trial ( ACT ) , both directly in terms of changes in physical fitness and indirectly from increased self-efficacy associated with the intervention . Methods : In ACT , 395 female and 479 male inactive patients ages 35 to 75 years were r and omized to one of : physician advice , advice plus behavioral counseling during primary care visits , or advice plus behavioral counseling that also included telephone contact and behavioral classes . Participants were assessed at baseline , 6 months , and 24 months . HRQL was assessed as perceived quality of life , perceived stress , depression , and general health . Satisfaction with function and appearance , self-efficacy , and social support were also assessed . Results : At 24 months women who received counseling or assistance had significant reductions in daily stress and improvements in satisfaction with body function compared to those receiving advice only . Men had reductions in daily stress across all treatment arms . These results mirrored V02max changes observed per group . Change in barriers self-efficacy was significantly associated with reductions in daily stress at 24 months . Conclusions : Patient benefit from ACT intervention was mediated by enhanced cardiorespiratory fitness and by barriers self-efficacy The goal of evidence -based medicine is ultimately to improve patient outcomes and quality of care . Systematic review s of the available published evidence are required to identify interventions that lead to improvements in behavior , health , and well-being . Authoritative literature review s depend on the quality of published research and research reports . The Consoli date d St and ards for Reporting Trials ( CONSORT ) Statement ( www.consort-statement.org ) was developed to improve the design and reporting of interventions involving r and omized clinical trials ( RCTs ) in medical journals . We describe the 22 CONSORT guidelines and explain their application to behavioral medicine research and to evidence -based practice . Additional behavioral medicine-specific guidelines ( e.g. , treatment adherence ) are also presented . Use of these guidelines by clinicians , educators , policymakers , and research ers who design , report , and evaluate or review RCTs will strengthen the research itself and accelerate efforts to apply behavioral medicine research to improve the processes and outcomes of behavioral medicine practice Background : There is an alarming prevalence of obesity and sedentariness in Western countries . An ideal context for health promotion and preventive medicine seems to be the setting of primary care provided by the general practitioner ( GP ) . Purpose : Therefore , this study evaluated the impact of GPs’brief physical activity counseling for overweight and obese patients . Methods : Individuals recruited during routine physician visits were r and omly split into an experimental ( n = 48 ) group that received the Patient-centered Assessment and Counseling for Exercise ( PACE ) protocol , and a usual-care control ( n = 48 ) group . Body mass index ( BMI ) and abdominal girth were assessed as objective biometrical parameters . Patients in the experimental group self-reported their readiness for physical activity and self-efficacy . Results : The experimental group had significantly better BMI and abdominal girth compared with the control group after a 5- to 6-month follow-up . Furthermore , the experimental group progressed in their stage of physical activity readiness and increased their self-efficacy . Conclusions : The GPs’counseling for physical activity using the PACE protocol influenced mediators and biometrical outcomes in an Italian primary care context PURPOSE the purpose of this study was to compare selected diabetes care processes and outcomes of nurse practitioners ( NPs ) and physicians ( MDs ) in the primary care of adults with type 2 diabetes . METHODS Adults with type 2 diabetes and no regular source of primary care were enrolled from the emergency room and r and omized to an NP or MD practice . Chart review s were conducted to assess processes of care ; patient interviews and hemoglobin Al C ( Al C ) testing were performed to measure patient outcomes . RESULTS NPs were more likely than MDs to document provision of general diabetes education and education about nutrition , weight , exercise , and medications . They were more likely to document patient height , urinalyses results , and Al C values . No differences were found in documenting current medications ; alcohol , illicit drug , or tobacco use ; depression ; weight and blood pressure ; foot and cardiovascular exams ; blood glucose and creatinine testing ; or referral to ophthalmologists . No differences were found in patient outcomes . CONCLUSIONS This study provides preliminary evidence of interdisciplinary differences in the processes of care employed by primary care NPs and MDs in caring for patients with type 2 diabetes . NPs documented the provision of diabetes education and selected monitoring tests more frequently than MDs ; however , these differences were not reflected in 6-month patient outcomes Objective To evaluate whether nurse run clinics in general practice improve secondary prevention in patients with coronary heart disease . Design R and omised controlled trial . Setting A r and om sample of 19 general practice s in northeast Scotl and . Patients 1173 patients ( 685 men and 488 women ) under 80 years with working diagnoses of coronary heart disease , but without terminal illness or dementia and not housebound . Intervention Nurse run clinics promoted medical and lifestyle aspects of secondary prevention and offered regular follow up . Main outcome measures Components of secondary prevention assessed at baseline and one year were : aspirin use ; blood pressure management ; lipid management ; physical activity ; dietary fat ; and smoking status . A cumulative score was generated by counting the number of appropriate components of secondary prevention for each patient . Results There were significant improvements in aspirin management ( odds ratio 3.22 , 95 % confidence interval 2.15 to 4.80 ) , blood pressure management ( 5.32 , 3.01 to 9.41 ) , lipid management ( 3.19 , 2.39 to 4.26 ) , physical activity ( 1.67 , 1.23 to 2.26 ) and diet ( 1.47 , 1.10 to 1.96 ) . There was no effect on smoking cessation ( 0.78 , 0.47 to 1.28 ) . Of six possible components of secondary prevention , the baseline mean was 3.27 . The adjusted mean improvement attributable to intervention was 0.55 of a component ( 0.44 to 0.67 ) . Improvement was found regardless of practice baseline performance . Conclusions Nurse run clinics proved practical to implement in general practice and effectively increased secondary prevention in coronary heart disease . Most patients gained at least one effective component of secondary prevention and , for them , future cardiovascular events and mortality could be reduced by up to a third STUDY OBJECTIVE : To study the clinical and cost outcomes of providing nutritional counselling to patients with one or more of the following conditions : overweight , hypertension and type 2 diabetes . DESIGN : The study was design ed as a r and om controlled trial . Consecutive patients were screened opportunistically for one or more of the above conditions and r and omly allocated to one of two intervention groups ( doctor/dietitian or dietitian ) or a control group . Both intervention groups received six counselling sessions over 12 months from a dietitian . However , in the doctor/dietitian group it was the doctor and not the dietitian who invited the patient to join the study and the same doctor also review ed progress at two of the six counselling sessions . SETTING : The study was conducted in a university group general practice set in a lower socioeconomic outer suburb of Perth , Western Australia . PATIENTS : Of the 273 patients r and omly allocated to a study group , 198 were women . Age ranged from 25 to 65 years . Seventy eight per cent of patients resided in the lower two socioecnomic quartiles , 56 per cent described their occupation as home duties and 78 per cent were partnered . RESULTS : Both intervention groups reduced weight and blood pressure compared with the control group . Patients in the doctor/dietitian group were more likely to complete the 12 month programme than those in the dietitian group . Patients in the doctor/dietitian group lost an average of 6.7 kg at a cost of $ A9.76 per kilogram , while the dietitian group lost 5.6 kg at a cost of $ A7.30 per kilogram . CONCLUSION : General practitioners , in conjunction with a dietitian , can produce significant weight and blood pressure improvement by health promotion methods Chronic obstructive pulmonary disease ( COPD ) is disabling , with symptoms such as chronic cough , phlegm , wheezing , shortness of breath and increased infections of the respiratory passage . The aim was to examine the effects of a structured educational intervention programme at a nurse-led primary health care clinic ( PHCC ) on quality of life ( QoL ) , knowledge about COPD and smoking cessation in patients with COPD . This study had an experimental design in which 52 patients with COPD from a Swedish primary care setting were r and omized into two groups ( intervention or control ) . Both groups received st and ard care but patients in the intervention group were also offered two visits to a nurse specialized in COPD care . The purpose of the visits was to increase the patients ' self-care ability and their knowledge about COPD . The study was approved by the local Research Ethics Committee . Data were collected using two question naires , one pertaining to knowledge about COPD and smoking habits and St. George 's Respiratory Question naire , addressing how QoL was affected by the patients ' respiratory symptoms . The intervention and control groups answered both question naires on their first and last visits to the PHCC . A statistically significant increase was noted in the intervention group on QoL , the number of patients who stopped smoking and patients ' knowledge about COPD at the follow-up , 3 - 5 months after intervention . However , a confounding factor may have been that one of the research ers ( Eva Osterlund Efr aims son ) , as a nurse in the PHCC , performed the intervention . This implies that patients were in a dependent relationship which may have affected the responses in a favourable direction . Our findings show that conventional care alone did not have an effect on patients ' QoL and smoking habits . Instead , the evidence suggests that a structured programme with self-care education is needed to motivate patients for life-style changes BACKGROUND The multiprofessional teams in Finnish health centres are well placed to carry out interventions aim ed at the prevention of cardiovascular diseases . AIM To evaluate the effectiveness of an individually tailored multifactorial lifestyle intervention in primary care for individuals at high risk for cardiovascular disease . DESIGN OF STUDY A r and omised controlled trial was conducted over 24 months with interim assessment s at six and 12 months . SETTING A health centre in Finl and with a patient population of 11,000 . METHOD One hundred and fifty adults aged 18 to 65 years old with existing cardiovascular disease or multiple risk factors were r and omised to active multiprofessional risk factor intervention or to st and ard care . The main outcome measure was a change in cardiovascular risk-factor score . Secondary outcomes were changes in blood pressure , weight , body-mass index , serum cholesterol , blood glucose , smoking cessation , and exercise habits . RESULTS The cardiovascular risk score decreased by 28 % in the intervention group ( 23 % in the control group ) , body weight decreased by 3.7 % ( 2 % ) and total cholesterol decreased by 10.8 % ( 6.5 % ) , while time engaged in exercise increased by 39 % ( 43 % ) . Differences were not significant . CONCLUSIONS Cardiovascular risk levels of high-risk individuals decreased in both intervention and control groups . Primary care prevention should be targeted to high-risk persons . Long-term follow-up studies are needed Abstract Objective : To measure the effect of brief behavioural counselling in general practice on patients ' consumption of fruit and vegetables in adults from a low income population . Design : Parallel group r and omised controlled trial . Setting : Primary health centre in a deprived , ethnically mixed inner city area . Participants : 271 patients aged 18 - 70 years without serious illness . Intervention : Brief individual behavioural counselling based on the stage of change model ; time matched nutrition education counselling . Main outcome measures : Self reported number of portions of fruit and vegetables eaten per day , plasma β carotene , α tocopherol , and ascorbic acid concentrations , and 24 hour urinary potassium excretion . Assessment at baseline , eight weeks , and 12 months . Results : Consumption of fruit and vegetables increased from baseline to 12 months by 1.5 and 0.9 portions per day in the behavioural and nutrition groups ( mean difference 0.6 portions , 95 % confidence interval 0.1 to 1.1 ) . The proportion of participants eating five or more portions a day increased by 42 % and 27 % in the two groups ( mean difference 15 % , 3 % to 28 % ) . Plasma β carotene and α tocopherol concentrations increased in both groups , but the rise in β carotene was greater in the behavioural group ( mean difference 0.16 µmol/l , 0.001 µmol/l to 1.34 µmol/l ) . There were no changes in plasma ascorbic acid concentrations or urinary potassium excretion . Differences were maintained when analysis was restricted to the 177 participants with incomes £ 400 ( € 596 , $ 640 ) a week . Conclusions : Brief individual counselling in primary care can elicit sustained increases in consumption of fruit and vegetables in low income adults in the general population . What is already known on this topic Brief interventions can be effective in increasing consumption of fruit and vegetables Biomarkers and intention to treat analyses have seldom been used in such interventions , and few studies have targeted low income population s What this study adds Compared with nutritional counselling , brief behavioural counselling carried out by nurses in primary care led to greater increases in fruit and vegetable intake and in plasma β carotene concentration Favourable effects were observed in low income adults living in a deprived inner city OBJECTIVE To evaluate three strategies for promoting physical activity ( PA ) in a primary care setting . METHOD Data were collected between 2002 and 2004 from 136 patients attending two general practice s in Brisbane , Australia . Inactive patients ( 50 - 70 years ) were r and omly allocated to one of three hierarchical intervention groups : the general practitioner ( GP ) group received ' brief ' advice ; the GP+ES group also received behavior change advice from an exercise scientist ( ES ) ; and the GP+ES+P group also received a pedometer . Self-reported PA and its determinants were measured at baseline and weeks 12 and 24 . Cardio-respiratory variables were measured at baseline and week 12 . RESULTS Overall , mean PA time increased by 84 and 128 min/week at weeks 12 and 24 ( p<.01 ) with no significant group differences . Small improvements in blood pressure and post-exercise heart rate were observed . At week 24 , the GP+ES+P group were more likely to report meeting PA guidelines than the GP group ( OR=2.39 95 % CI : 1.01 , 5.64 ) . CONCLUSION PA levels can be increased in mid- to older-age adults , either by brief advice from motivated GPs alone , or from collaboration between GPs and ESs . The most intense intervention ( GP+ES+P ) showed the most promising results BACKGROUND The U.S. Congress m and ated evaluations , initiated in 1989 , to determine whether extending Medicare benefits to include preventive services would improve health status , reduce costs of care , and improve health risk behaviors of beneficiaries . METHODS The Johns Hopkins Medicare Preventive Services Demonstration was a r and omized trial in which Medicare beneficiaries were assigned either to an intervention group that was offered yearly preventive visits for 2 years and optional counseling visits to their primary care provider or to a control group that received usual care . This report describes the effect of the intervention over a period of 2 years on smoking , problem alcohol use , and sedentary lifestyle . RESULTS Differences were observed between the intervention and control groups in the extent to which changes occurred in smoking and problem alcohol use , but none of the differences was statistically significant . The proportion of smokers who quit was higher in the intervention group than in the control group ( 24.2 vs 17.9 % , P = 0.09 ) . However , a higher proportion of problem drinkers in the control group improved ( 67.1 vs 57.0 % , P = 0.183 ) . There was virtually no difference between the intervention and the control groups in the proportion with improvement in sedentary lifestyle . CONCLUSIONS This study demonstrates the difficulty of bringing about health behavior change in older patients in the course of a yearly preventive visit for 2 years with their primary care physician when the visit encompasses screening and immunizations , as well as health behavior counseling directed by the physician . Further study is required to determine whether a more intense program of counseling for health behavior change among older persons by their primary care providers would be effective Efficacy and costs of 3 levels of medical-behavioral treatment intensity in conjunction with nicotine replacement therapy ( NRT ) were compared in 240 one-pack-a-day smokers : ( a ) a low-intensity ( LI ) group that received 8 weeks of NRT ( n = 80 ) and 1 advice and education ( A&E ) session with a nurse practitioner ( NP ) ; ( b ) a moderate-intensity ( MI ) group that was provided NRT and 4 A&E sessions with an NP ( n = 80 ) ; and ( c ) a high-intensity ( HI ) group that received treatment combining NRT , 4 A&E sessions , and 12 weeks of individualized cognitive-behavioral therapy ( n = 80 ) . Biochemically confirmed abstinence rates at 9 , 26 , and 52 weeks posttreatment initiation were highest for the HI ( 45 % , 37 % , 35 % ) group , followed by the LI ( 35 % , 30 % , and 27 % ) and MI ( 27 % , 12 % , 12 % ) groups . Group differences approached statistical significance at 9 weeks and were statistically significant at both 26 and 52 weeks . The cost of LI treatment was $ 308 , that of MI was $ 338 , and the HI treatment cost was $ 582 Background : Research on the translation of efficacious lifestyle change programs to prevent type 2 diabetes into community or clinical setting s is needed . Objective : The objective of this study was to examine the reach , implementation , and efficacy of a 6-month lifestyle program implemented in primary care by nurse practitioners ( NPs ) for adults at risk of type 2 diabetes . Methods : The NP sites ( n = 4 ) were r and omized to an enhanced st and ard care program ( one NP and one nutrition session ) or a lifestyle program ( enhanced st and ard care and six NP sessions ) . These NPs recruited adults at risk of diabetes from their practice ( n = 58 ) , with an acceptance rate of 70 % . Results : The program reached a diverse , obese , and moderately low income sample . The NPs were able to successfully implement the protocol s. The average length of the program was 9.3 months . Attendance was high ( 98 % ) , and attrition was low ( 12 % ) . The NPs were able to adopt the educational , behavioral , and psychosocial strategies of the intervention easily . Motivational interviewing was more difficult for NPs . Mixed-model repeated- measures analysis indicated significant trends or improvement in both groups for nutrition and exercise behavior . Participants of the lifestyle program demonstrated trends for better high-density lipoprotein ( HDL ) and exercise behavior compared with the enhanced st and ard care participants . Twenty-five percent of lifestyle participants met treatment goals of 5 % weight loss compared with 11 % of st and ard care participants . Discussion : A lifestyle program can be implemented in primary care by NPs , reach the targeted population , and be modestly successful . Further research is indicated OBJECTIVE To compare health benefits achieved in a transtheoretical model-chronic disease ( TM-CD ) minimal intervention for obesity vs. augmented usual care ( AUC ) . RESEARCH METHOD AND PROCEDURES This was a 2-year , r and omized clinical trial with overweight or obese men and women from 15 primary care sites . AUC ( n = 336 ) included dietary and exercise advice , prescriptions , and three 24-hour dietary recalls every 6 months . TM-CD care ( n = 329 ) included AUC elements plus " stage of change " ( SOC ) assessment s for five target behaviors every other month , mailed SOC and target behavior-matched workbooks , and monthly telephone calls from a weight-loss advisor . Weight change was the primary outcome . RESULTS Repeated measures models under the missing at r and om assumption yielded nonsignificant adjusted differences between the AUC and TM-CD groups for weight change , waist circumference , energy intake or expenditure , blood pressure , and blood lipids . The pattern of change over time suggested that TM-CD participants were trying harder to impact target behaviors during the first 6 to 12 months of the trial but relapsed afterward . Sixty percent of trial participants maintained their baseline weights for 18 to 24 months . DISCUSSION A combination of mailed patient material s and monthly telephone calls based on the transtheoretical model and some elements of chronic disease care is not powerful enough , relative to AUC , to alter target behaviors among overweight primary care patients in an obesogenic environment . AUC may be sufficient to maintain weights among at-risk primary care patients BACKGROUND Previous reports indicate risk factors and lifestyle behaviors may deteriorate early after completion of a cardiac rehabilitation program ( CRP ) . We hypothesized that a modest risk factor and lifestyle management intervention after a CRP would significantly reduce overall cardiovascular risk using the Framingham risk score compared with usual care after 4 years . METHODS Patients with ischemic heart disease ( n = 302 ) were r and omized after a CRP to either usual care or intervention ( exercise sessions , telephone follow-ups , counseling sessions , and reports to the participants ' family physicians ) . The Framingham risk score , risk factors , and lifestyle behaviors were compared after 4 years . RESULTS Data were available for 130 intervention and 119 usual care participants . The intervention result ed in 15.5 hours of direct participant contact . Framingham score , total cholesterol , low-density lipoprotein cholesterol , and systolic blood pressure were significantly improved in the intervention group after adjusting for baseline factors . There were no significant differences with respect to lifestyle factors between the groups . CONCLUSIONS A modest risk factor and lifestyle management intervention result ed in a significant reduction to global risk compared with usual care and should be considered after CRP Abstract Objective : To assess the long term effectiveness of the “ green prescription ” programme , a clinician based initiative in general practice that provides counselling on physical activity . Design : Cluster r and omised controlled trial . Practice s were r and omised before systematic screening and recruitment of patients . Setting : 42 rural and urban general practice s in one region of New Zeal and . Subjects : All sedentary 40–79 year old patients visiting their general practitioner during the study 's recruitment period . Intervention : General practitioners were prompted by the patient to give oral and written advice on physical activity during usual consultations . Exercise specialists continued support by telephone and post . Control patients received usual care . Main outcome measures : Change in physical activity , quality of life ( as measured by the “ short form 36 ” ( SF-36 ) question naire ) , cardiovascular risk ( Framingham and D'Agostino equations ) , and blood pressure over a 12 month period . Results : 74 % ( 117/159 ) of general practitioners and 66 % ( 878/1322 ) of screened eligible patients participated in the study . The follow up rate was 85 % ( 750/878 ) . Mean total energy expenditure increased by 9.4 kcal/kg/week ( P=0.001 ) and leisure exercise by 2.7 kcal/kg/week ( P=0.02 ) or 34 minutes/week more in the intervention group than in the control group ( P=0.04 ) . The proportion of the intervention group undertaking 2.5 hours/week of leisure exercise increased by 9.72 % ( P=0.003 ) more than in the control group ( number needed to treat=10.3 ) . SF-36 measures of self rated “ general health , ” “ role physical , ” “ vitality , ” and “ bodily pain ” improved significantly more in the intervention group ( P<0.05 ) . A trend towards decreasing blood pressure became apparent but no significant difference in four year risk of coronary heart disease . Conclusion : Counselling patients in general practice on exercise is effective in increasing physical activity and improving quality of life over 12 months . What is already known on this topic Counselling patients in general practice on exercise has result ed in gains in physical fitness and activity , but no health benefits have been found What this study adds Counselling patients in general practice on exercise is effective in increasing physical activity and improving quality of life over 12 months without evidence of adverse effects The intervention may reduce blood pressure by an average of 1–2 mm Hg over 12 months No changes in the risk of coronary heart disease were observed The intervention is sustainable in usual general practice Prompting practice staff to deliver the intervention may have increased its Abstract Objectives : To establish the effect of an educational intervention for general practitioners on the health behaviours and wellbeing of elderly patients . Design : R and omised controlled trial with 1 year follow up . Setting : Metropolitan general practice s in Melbourne , Australia . Subjects : 42 general practitioners and 267 of their patients aged over 65 years . Intervention : Educational and clinical practice audit programme for general practitioners on health promotion for elderly people . Main outcome measures : Patients ' physical activity , functional status , self rated health , immunisation status , social contacts , psychological wellbeing , drug usage , and rate of influenza vaccination . Primary efficacy variables were changes in outcome measures over 1 year period . Results : Patients in the intervention group had increased ( a ) walking by an average of 88 minutes per fortnight , ( b ) frequency of pleasurable activities , and ( c ) self rated health compared with the control group . No change was seen in drug usage , rate of influenza vaccination , functional status , or psychological wellbeing as a result of the intervention . Extrapolations of the known effect of these changes in behaviour suggest mortality could be reduced by 22 % if activity was sustained for 5 years . Conclusions : Education of the general practitioners had a positive effect on health outcomes of their elderly patients . General practitioners may have considerable public health impact in promotion of health for elderly patients . Key messages Few educational interventions for doctors have shown benefit to the health of patients Elderly people were identified in the UK health initiatives as in need of additional attention , and levels of health protective behaviours were low in community surveys A multifaceted educational intervention for general practitioners was effective in improving walking behaviour , self rated health status , and the frequency of social contacts in elderly patients General practitioners are effective in improving health and health behaviours in their elderly Objective To assess the effectiveness of a primary care based programme of exercise on prescription among relatively inactive women over a two year period . Design R and omised controlled trial . Setting 17 primary care practice s in Wellington , New Zeal and Participants 1089 women aged 40 - 74 not undertaking 30 minutes of moderate intensity physical activity on at least five days of the week Intervention Brief physical activity intervention led by nurse with six month follow-up visit and monthly telephone support over nine months . Main outcome measure Physical activity assessed at baseline and 12 and 24 months . Secondary outcomes were quality of life ( SF-36 ) , weight , waist circumference , blood pressure , concentrations of fasting serum lipids , glycated haemoglobin ( HbA1c ) , glucose , insulin , and physical fitness . Results Mean age was 58.9 ( SD 7 ) years . Trial retention rates were 93 % and 89 % at 12 and 24 months , respectively . At baseline , 10 % of intervention participants and 11 % of control participants were achieving 150 minutes of at least moderate intensity physical activity a week . At 12 months rates increased to 43 % and 30 % and at 24 months to 39.3 % and 32.8 % ( P<0.001 ) , respectively . SF-36 physical functioning ( P=0.03 ) and mental health ( P<0.05 ) scores improved more in intervention compared with control participants , but role physical scores were significantly lower ( P<0.01 ) . There were no significant differences in clinical outcomes . More falls ( P<0.001 ) and injuries ( P=0.03 ) were recorded in the intervention group . Conclusions This programme of exercise on prescription increased physical activity and quality of life over two years , although falls and injuries also increased . This finding supports the use of exercise on prescription programmes as part of population strategies to reduce physical inactivity . Trial registration Australian New Zeal and Clinical Trials Registry ( ANZCTR ) ANZCTRN012605000490673 OBJECTIVE This study tested the effectiveness of brief primary care provider interventions delivered in a college student health center to a sample of college students who screened positive for high-risk drinking . METHOD Between November 2005 and August 2006 , 8,753 students who presented as new patients to the health service at a large public university were screened for high-risk drinking , and 2,484 students ( 28 % ) screened positive on the 5/4 gender-specific high-risk drinking question ( i.e. , five or more drinks per occasion for men and four or more for women ) . Students who screened positive for high-risk drinking and consented to participate ( N= 363 ; 52 % female ) were r and omly assigned either to a control group ( n = 182 ) or to an experimental group ( n = 181 ) . Participants in the experimental group received two brief intervention sessions that were founded in motivational interviewing techniques and delivered by four specially trained providers within the student health center . Data on alcohol use and related harms were obtained from a Web-based Healthy Lifestyle Question naire , 30-day Timeline Followback alcohol-use diaries , the Rutgers Alcohol Problem Index ( RAPI ) , and eight items from the Drinker Inventory of Consequences-2L . RESULTS Repeated measures analysis showed that , compared with the control group ( C ) , the intervention group ( I ) had significant reductions in typical estimated blood alcohol concentration ( BAC ) ( C = .071 vs I = .057 at 3 months ; C = .073 vs I = .057 at 6 months ) , peak BAC ( C = . 142 vs I = .112 at 3 months ; C = .145 vs I = .108 at 6 months ) , peak number of drinks per sitting ( C = 8.03 vs I = 6.87 at 3 months ; C = 7.98 vs I = 6.52 at 6 months ) , average number of drinks per week ( C = 9.47 vs I = 7.33 at 3 months ; C = 8.90 vs I = 6.16 at 6 months ) , number of drunk episodes in a typical week ( C = 1.24 vs I = 0.85 at 3 months ; C = 1.10 vs I = 0.71 at 6 months ) , number of times taken foolish risks ( C = 2.24 vs I = 1.12 at 3 months ) , and RAPI sum scores ( C = 6.55 vs I = 4.96 at 6 months ; C = 6.17 vs I = 4.58 at 9 months ) . CONCLUSIONS Brief interventions delivered by primary care providers in a student health center to high-risk-drinking students may result in significantly decreased alcohol consumption , high-risk drinking , and alcohol-related harms OBJECTIVE To investigate the long-term effectiveness of a general practice monitoring system with respiratory expert recommendations for general practitioners ' management of patients with chronic obstructive pulmonary disease ( COPD ) , compared with usual care . DESIGN , SETTING S AND PARTICIPANTS A multicentre r and omised controlled trial of patients with COPD , clustered by general practice s ; 200 participants were recruited to maintain at least 75 participants per group for analysis . The trial took place from July 2005 to February 2008 in the south-western region of the Netherl and s. INTERVENTION Ongoing half-yearly monitoring of COPD patients with respiratory expert recommendations for the GP was compared with usual care . MAIN OUTCOME MEASURES Primary outcome - Chronic Respiratory Question naire ( CRQ ) score ; secondary outcomes - CRQ domain scores , generic health-related quality of life ( Short-Form 12 and EuroQol-5D ) , breathlessness ( Modified Medical Research Council score ) , exacerbations , and decline in forced expiratory volume in 1 second . A detailed process evaluation was performed along with the trial . RESULTS Data from 170 participants were analysed . Based on repeated measurement analyses , the additional gain in CRQ score during follow-up was 0.004 points for monitoring compared with usual care ( 95 % CI , - 0.172 to 0.180 ) . Also , no important differences between monitoring and the usual care group were found for secondary outcomes . Half the monitoring visits result ed in disease management recommendations by a respiratory expert , and 46 % of these recommendations were implemented by the GPs . Patient adherence to lifestyle recommendations was low . CONCLUSION An expert-supported monitoring system for patients with COPD was not clinical ly effective . As patients had a pre-existing entry in the monitoring system , the population may be well regulated , with reduced room for improvement . TRIAL REGISTRATION www . clinical trials.gov NCT00542061 PACE ( Physician-based Assessment and Counseling for Exercise ) is an individualized theory-based minimal intervention strategy aim ed at the enhancement of regular physical activity . The aim of this study was to evaluate the effectiveness of a PACE intervention applied by general practitioners ( GPs ) on potential determinants of physical activity . A r and omized controlled trial was conducted in 29 general practice s with the following inclusion criteria for patients : aged between 18 and 70 years , diagnosed with hypertension , hypercholesterolemia and /or non-insulin-dependent diabetes mellitus , and not in maintenance stage for regular physical activity . The intervention consisted of two visits with the GP and two telephone booster calls by a physical activity counselor . Determinants of physical activity were assessed with question naires at baseline , and at 8-week ( short ) , 6-month ( medium ) and 1-year ( long ) follow-up . A significant positive effect was observed on self-efficacy , and on the use of cognitive and behavioral processes of change , at both short- and medium-term follow-up . The intervention respondents also perceived fewer barriers for regular physical activity at short-term and used behavioral processes of change more at long-term follow-up . No intervention effect was observed for perceived benefits of physical activity . In conclusion , this GP-based PACE intervention result ed in positive changes in potential determinants of physical activity BACKGROUND The study examined the effectiveness of primary -care counseling using a 2-pronged intervention to increase physical activity ( PA ) in a southeastern US city . METHODS Two hundred thirty-seven patients were r and omly assigned to 1 of 3 groups ( experimental [ counseling and educational map ] , control group # 1 [ counseling only ] , or control # 2 [ st and ard care ] ) to identify PA differences . The experimental group received physician counseling and an educational map highlighting accessible recreational facilities within a 2-mile radius of the health center . RESULTS Patients in the experimental group increased their weekly PA in comparison with patients in the controls . Significant differences were observed for patients between groups for PA ( F = 7.648 , df 3,423 , P = .000 ) , PA x visits interaction ( F = 5.500 , df 3,423 , P = .001 ) , and the PA x group interaction ( F = 3.068 , df 6,848 , P = .006 ) . CONCLUSIONS This approach can perhaps increase the PA levels of underserved adults Background : There is insufficient and conflicting evidence about whether more intensive behavioural support is more effective than basic behavioural support for smoking cessation and whether primary care nurses can deliver effective behavioural support . Methods : A r and omised controlled trial was performed in 26 UK general practice s. 925 smokers of ⩾10 cigarettes per day were r and omly allocated to basic or weekly support . All participants were seen before quitting , telephoned around quit day , and seen 1 and 4 weeks after the initial appointment ( basic support ) . Participants receiving weekly support had an additional telephone call at 10 days and 3 weeks after the initial appointment and an additional visit at 2 weeks to motivate adherence to nicotine replacement and renew quit attempts . 15 mg/16 h nicotine patches were given to all participants . The outcome was assessed by intention to treat analyses of the percentage confirmed sustained abstinence at 4 , 12 , 26 and 52 weeks after quit day . Results : Of the 469 and 456 participants in the basic and weekly arms , the numbers ( % ) who quit and the percentage difference were 105 ( 22.4 % ) vs 102 ( 22.4 % ) , 0.1 % ( 95 % CI −5.3 % to 5.5 % ) at 4 weeks , 66 ( 14.1 % ) vs 52 ( 11.4 % ) , −2.6 % ( 95 % CI −6.9 % to 1.7 % ) at 12 weeks , 50 ( 10.7 % ) vs 40 ( 8.8 % ) , −1.9 % ( 95 % CI −5.7 % to 2.0 % ) at 26 weeks and 36 ( 7.7 % ) vs 30 ( 6.6 % ) , −1.1 % ( 95 % CI −4.4 % to 2.3 % ) at 52 weeks . Conclusions : The absolute quit rates achieved are those expected from nicotine replacement alone , implying that neither basic nor weekly support were effective . Primary care smoking cessation treatment should provide pharmacotherapy with sufficient support only to ensure it is used appropriately , and those in need of support should be referred to specialists OBJECTIVES To investigate the effectiveness of a non-structured 15-min educational intervention by general practitioners ( GPs ) on modifications of daily diet among healthy adults . DESIGN Two arms r and omized trial lasting 12 months . SETTING Italian general practitioner wards . Subjects A total of 3,186 men and women aged 18 - 65 years recruited in the medical ward by their GPs . INTERVENTIONS An educational intervention and a brochure on the basics of a healthy diet based on the Italian Guidelines for a Correct Nutrition , 1998 . The main study goal was to attain an intake of fruits and vegetables > 5 servings per day . Follow-up visit every 6 months . Main outcome measures Weight , blood pressure , and a 40-items Food Frequency Question naire . RESULTS The intervention group showed a slightly reduced net intake of meat and a slightly increased net intake of fruits and vegetables , fish products , and olive oil . Body mass index ( BMI ) changed only in the treatment arm [ -0.41 95 % confidence interval ( 95 % CI ) -0.11 to -0.53 ] . The net change at 1 year in the intervention arm was + 1.31 ( CI 0.90 - 4.39 ) for fruits and vegetables , and -0.22 ( -0.11 to -0.69 ) for meat ( portions per week ) . We also computed a ' healthy diet score ' reflecting compliance with recommended dietary habits . In the intervention group , the mean score at recruitment was significantly lower than the mean score at the end of follow-up ( Crude score change = 0.29 ; CI 0.19 - 0.48 ) . No differences were observed in the control group ( Crude score change = -0.04 ; CI -0.22 - 0.02 ) . The difference in score from baseline to the final visit , comparing the intervention vs the control group , was statistically significant ( P < 0.001 ) ( MANOVA adjusted by sex , BMI , education , and time ) . CONCLUSIONS A brief educational intervention by GPs can induce multiple diet changes that may lower BMI and potentially reduce chronic disease risk in generally healthy adults Lifestyle programmes delivered by academic nurse-counsellors in a primary care setting lowered blood pressure ( BP ) among at-risk patients . We examined whether the programmes could be successfully implemented by nurses employed in Australian general practice s. In a r and omised controlled trial , 212 of 591 eligible 20–75-year olds with hypertension , Type II diabetes or coronary disease from seven practice s volunteered . Patients were r and omised to : a ‘ Low ’ group with one face-to-face individual counselling session , then monthly telephone contacts for 1 year ( n=69 ) ; a ‘ High ’ group with individual face-to-face counselling up to 1 h monthly for 1 year ( n=74 ) or a control group receiving usual care only ( n=69 ) , and were evaluated at baseline and 12 and 18 months later ; 164 individuals completed the study . Patients ' usual doctors continued to prescribe in all groups . Changes in 24 h ambulatory BP did not differ significantly between groups at 12 months ( Low , −2±2/1±1 mmHg ; High , + 4±2/1± 1 mmHg ; usual care , + 1±2/1±1 mmHg ) or 18 months ( −2±2/2±1 mmHg ; −4±2/3±2 mmHg ; −1±2/2± 1 mmHg , respectively ) . Antihypertensive drugs prescribed decreased by 12 months in 33 % of the High , 5 % of the Low and 13 % of the control groups ( P=0.008 ) and by 36 , 7 and 16 % at 18 months ( P=0.018 ) . After 18 months , targets for BP control were not met in about 60 % of patients and almost 50 % had clinic BP above 140/90 mmHg . Year-long interaction with nurse-counsellors may influence longer-term antihypertensive drug prescription , possibly by improving compliance . Suboptimal BP control suggests that continuing physician education on BP targets is needed BACKGROUND : The objective of this study was to determine the effects of a brief primary care provider-delivered counseling intervention on the reduction of alcohol consumption by high-risk drinkers . The intervention was implemented as part of routine primary care medical practice . METHODS : We performed a controlled clinical trial with 6- and 12-month follow-up . Three primary care practice s affiliated with an academic medical center were r and omly assigned to special intervention ( SI ) or usual care ( UC ) . A total of 9,772 primary care patients were screened for high-risk drinking . A fourth site was added later . From the group that was screened , 530 high-risk drinkers entered into the study , with 447 providing follow-up at 12 months . The intervention consisted of brief ( 5–10 minute ) patient-centered counseling plus an office system that cued providers to intervene and provided patient educational material s. RESULTS : At 12-month follow-up , after controlling for baseline differences in alcohol consumption , SI participants had significantly larger changes ( P=.03 ) in weekly alcohol intake compared to UC ( SI=−5.7 drinks per week ; UC=−3.1 drinks per week ) , and of those who changed to safe drinking at 6 months more SI participants maintained that change at 12 months than UC . CONCLUSIONS : Project Health provides evidence that screening and very brief ( 5–10 minute ) advice and counseling delivered by a patient ’s personal physician or nurse practitioner as a routine part of a primary care visit can reduce alcohol consumption by high-risk drinkers BACKGROUND Patient non-compliance with prescribed treatment is an important factor in the lack of success in cardiovascular prevention . Another important cause is non-adherence of caregivers to the guidelines . It is not known how doctors and nurses differ in the application of guidelines . Patient compliance to treatment may vary according to the type of caregiver . OBJECTIVE To compare adherence to cardiovascular prevention delivered by practice nurses and by general practitioners . SETTING Six primary health care centres in the Netherl and s ( 25 general practitioners , six practice nurses ) . METHODS 701 high risk patients were included in a r and omised trial . Half of the patients received nurse-delivered care and half received care by general practitioners . For 91 % of the patients treatment concerned secondary prevention . The Dutch guideline on cardiovascular prevention was used as protocol . A structured self-administered question naire was sent by post to patients . Data were extracted from the practice data base and the question naire . RESULTS Intervention was received by 77 % of respondents who visited the practice nurse compared to 57 % from the general practitioner group ( OR = 2.56 , p < 0.01 ) . More lifestyle intervention was given by the practice nurse ; 46 % of patients received at least one lifestyle intervention ( weight , diet , exercise , and smoking ) compared to 13 % in general practitioner group ( OR = 3.24 , p < 0.001 ) . In addition , after one year more patients from the practice nurse group used cardiovascular drugs ( OR = 1.9 , p = 0.03 ) . Nurses inquired more frequently about patient compliance to medical treatment ( OR = 2.1 , p < 0.01 ) . Regarding patient compliance , no statistical difference between study groups in this trial was found . CONCLUSION Practice nurses adhered better to the Dutch guideline on cardiovascular prevention than general practitioners did . Lifestyle intervention advice was more frequently given by practice nurses . Improvement of cardiovascular prevention is still necessary . Both caregivers should inquire about patient adherence on a regular basis Objective To assess whether lifestyle counselling is effective in non-pharmacological treatment of hypertension in primary health care . Design Open r and omized controlled trial . Setting Ten municipal primary health care centres in eastern Finl and . Patients Seven hundred and fifteen subjects aged 25–74 years with systolic blood pressure 140–179 mmHg and /or diastolic blood pressure 90–109 mmHg or antihypertensive drug treatment . Interventions Systematic health counselling given by local public health nurses for 2 years . Main outcome measures Blood pressure , lipids and lifestyle data were collected annually . Results Among participants with no antihypertensive drug treatment , the net reductions after 1 year both in systolic blood pressure [ −2.6 mmHg ; 95 % confidence interval ( CI ) , −4.7 to −0.5 mmHg ] and in diastolic blood pressure ( −2.7 mmHg ; 95 % CI , −4.0 to −1.4 mmHg ) were significant in favour of the intervention group . This difference in blood pressure change was maintained during the second year . In participants with antihypertensive drug treatment , no significant difference in blood pressure reduction was seen between the groups during the study . Conclusions A relatively modest , but systematic counselling in primary health care can , at least among untreated hypertensive subjects , produce reductions in blood pressure levels that are modest for the individual , but very important from the public health point of view AIMS To determine the effectiveness of Motivational Enhancement Therapy ( MET ) for hazardous drinkers in Primary Care Unit ( PCU ) setting s in rural Thail and . METHODS A r and omized controlled trial was conducted in eight PCUs in Ubonratchatanee and Chachoengsao provinces in Thail and . Hazardous drinkers were identified using the World Health Organization-recommended Alcohol Use Disorder Identification Test . Of 117 eligible participants ( 91 % male ) , 59 were r and omized to the intervention group to receive MET in three individual appointments with a trained nurse and 58 to an assessment -only control group . Outcome evaluations were carried out after 6 weeks , 3 months and 6 months . RESULTS Follow-up data were available on 84 , 94 and 91 % of subjects , respectively , at the three intervals . Self-reported drinks per drinking day , frequency of hazardous drinking assessed either on a daily or weekly basis , and of binge drinking sessions were reduced in the intervention group more than in the control group ( P < 0.05 ) after both 3 and 6 months . The groups did not generally differ at 6 weeks . However , although self-reported consumption in both groups fell from baseline to 6-month follow-up , serum gamma-glutamyl transferase increased in both groups , which raises doubts about the validity of this marker in this sample and /or the validity of the self-reported data in this study . CONCLUSION MET delivered by nurses in PCUs in Thail and appears to be an effective intervention for male hazardous drinkers . Uncertainties about the validity of self-reported data jeopardize the safety of this conclusion The associations between sociodemographic variables , psychological factors , and changes in dietary fat consumption over 4 months were assessed in a r and omized controlled trial of behavioral counseling versus st and ard advice . Patients were 141 men and 150 women , with an average age of 52.1 years and total cholesterol level of 7.27 mmol/l ( 278 mg/dl ) . Smokers , younger patients , and those with greater body mass index had higher fat intake at baseline . Behavioral counseling led to greater reductions in fat intake than did st and ard advice . Self-efficacy and ratings of benefits of low-fat diets were related to fat consumption at baseline , and changes in these measures were correlated with changes in fat intake . Family support , baseline anticipated regret , and ( for the behavioral counseling group only ) baseline behavioral intentions predicted reductions in fat intake . The results indicated that psychosocial variables associated cross-sectionally with fat consumption do not necessarily predict change and that factors involved in the process of change and the prediction of change need to be differentiated OBJECTIVE Smokers who are not ready to quit are a very difficult group to treat . Physicians , nurses , and nurse practitioners are in a unique position to encourage patients to quit smoking . However , the best approach to do so is not clear . METHODS A two-group r and omized controlled trial with 218 pack-a-day precontemplative and contemplative smokers recruited from the community . The laboratory-based study was design ed to simulate outpatient visits to general practitioners . Participants were r and omized to a 15-min intervention to compare the effectiveness of brief motivational or prescriptive counseling by a health professional . Thirteen outcome variables included intentions to quit and verbal reports at 1 and 6 months with biological verification . A composite outcome measure was constructed to provide greater power to detect study differences . RESULTS Approximately 33 % of the sample reported at least one 24-h quit period during the 6 months they were followed after the trial . Results suggest that while neither treatment was superior , there were subgroup differences . Participants in the motivational condition were also more likely to respond to follow-up calls . CONCLUSIONS AND PRACTICE IMPLICATION S Motivational interviewing and prescriptive advice were equally effective for precontemplative and contemplative smokers . Practitioners should use the method that appeals to them Background : Preventive guidelines on cardiovascular risk management recommend lifestyle changes . Support for lifestyle changes may be a useful task for practice nurses , but the effect of such interventions in primary prevention is not clear . We examined the effect of involving patients in nurse-led cardiovascular risk management on lifestyle adherence and cardiovascular risk . Methods : We performed a cluster r and omized controlled trial in 25 practice s that included 615 patients . The intervention consisted of nurse-led cardiovascular risk management , including risk assessment , risk communication , a decision aid and adapted motivational interviewing . The control group received a minimal nurse-led intervention . The self-reported outcome measures at one year were smoking , alcohol use , diet and physical activity . Nurses assessed 10-year cardiovascular mortality risk after one year . Results : There were no significant differences between the intervention groups . The effect of the intervention on the consumption of vegetables and physical activity was small , and some differences were only significant for subgroups . The effects of the intervention on the intake of fat , fruit and alcohol and smoking were not significant . We found no effect between the groups for cardiovascular 10-year risk . Interpretation : Nurse-led risk communication , use of a decision aid and adapted motivational interviewing did not lead to relevant differences between the groups in terms of lifestyle changes or cardiovascular risk , despite significant within-group differences BACKGROUND Physical activity is a major modifiable risk factor for cardiovascular disease , but it is unclear what combination of feasible approaches , using existing re sources in primary care , work best to initiate increased physical activity . AIM To assess three approaches to initiate increased physical activity . DESIGN OF STUDY R and omised controlled ( 2 X 2 X 2 ) factorial trial . SETTING Four general practice s. METHOD One hundred and fifty-one sedentary patients with computer documented risk factors for cardiovascular disease were r and omised to eight groups defined by three factors : prescription by general practitioners ( GPs ) for brisk exercise not requiring a leisure facility ( for example , walking ) 30 minutes per day , 5 days per week ; counselling by practice nurses , based on psychological theory to modify intentions and perceived control of behaviour , and using behavioural implementation techniques ( for example , contracting , ' rehearsal ' ) ; use of the Health Education Authority booklet ' Getting active , feeling fit ' . RESULTS Single interventions had modest effects . There was a trend from the least intensive interventions ( control + /- booklet ) to the more intensive interventions ( prescription and counselling combined + /- booklet ) for both increased physical activity and fitness ( test for trend , P = 0.02 and P = 0.05 , respectively ) . Only with the most intense intervention ( prescription and counselling combined ) were there significant increases in both physical activity and fitness from baseline ( Godin score = 14.4 , 95 % confidence interval [ CI ] = 7.8 to 21 , which was equivalent to three 15-minute sessions of brisk exercise and a 6-minute walking distance = 28.5 m , respectively , 95 % CI = 11.1 to 45.8 ) . Counselling only made a difference among those individuals with lower intention at baseline . CONCLUSION Feasible interventions using available staff , which combine exercise prescription and counselling explicitly based on psychological theory , can probably initiate important increases in physical activity Purpose sTo test the effectiveness of motivational interviewing in a population of hazardous drinkers utilizing community health care centers in rural southeastern Idaho . Data sources This study targeted rural people at risk for alcohol dependence utilizing low-income community health care centers in rural southeastern Idaho . The Alcohol Use Disorders Identification Test ( AUDIT ) was used to screen interested clients ' alcohol use . Clients achieving an AUDIT score indicating hazardous alcohol use were recruited into the study and r and omized into a control or treatment group . Twenty-six hazardous drinkers attending five low-income community health centers participated in the study . The experimental group participated in one motivational interviewing session with the investigator , a family nurse practitioner ( NP ) . The comparison group received no treatment . Alcohol use was tracked for 6 weeks after successful recruitment into the program . Conclusions Participants in the study significantly decreased their average number of drinks per day . At time 1 ( pretreatment ) , the control group drank 4.37 drinks per day and the treatment group drank 4.65 drinks per day . At time 2 ( posttest ) , the control group drank 3.77 drinks per day and the treatment group drank 1.95 drinks per day . The effects of the motivational interviewing treatment on hazardous drinking also were measured by serum gamma-glutamyltransferase ( GGT ) , a liver function test . There was also a significant decrease in the GGT from pretest to posttest in the treatment group . Implication s for practice The results of this investigation found that motivational interviewing shows promise as an effective intervention for hazardous drinkers attending low-income community clinics . Although other possible explanations could be postulated for the positive changes in sample participants , the data indicate that the motivational interviewing approach was responsible for a significant portion of the positive changes within the current sample . The information collected from the study adds to the literature on hazardous drinking , research , and treatment of this significant problem . Negotiating change in behavior is part of the practice of NPs . People struggling with alcohol use are more likely to encounter NPs , family doctors , or social workers than counselors specializing in alcohol treatment . Motivational interviewing is specifically design ed for preparing people for change . Because most people resist being told what to do , that is , “ you have to stop drinking , ” use of motivational interviewing principles can decrease resistance and optimize change . Additionally , identifying and intervening with hazardous drinking in a primary care setting can reduce healthcare costs and reduce the stigma of specialist care . Adding this valuable communication skill to the competencies of NPs is important to both clients and NPs BACKGROUND Lifestyle interventions reduce cardiovascular risk and risk of diabetes mellitus , but reports on long-term effects on quality of life ( QOL ) and health care utilization are rare . We investigated the impact of a primary health care-based lifestyle intervention program on QOL and cost-effectiveness over 3 years . METHODS A total of 151 men and women , aged 18 to 65 years , at moderate to high risk for cardiovascular disease , were r and omly assigned to either lifestyle intervention with st and ard care or st and ard care alone . Intervention consisted of supervised exercise sessions and diet counseling for 3 months , followed by regular group meetings over a 3-year period . Change in QOL was measured with EuroQol ( 5-dimensional EuroQol-5D [ EQ-5D ] and EuroQol-VAS [ EQ-VAS ] ) , the 36-Item Short-Form Health Survey ( SF-36 ) , and the 6-dimensional Short-Form 6D ( SF-6D ) . The health economic evaluation was performed from a societal view and a treatment perspective . In a cost-utility analysis , the costs , gained quality -adjusted life-years ( QALYs ) , and savings in health care were considered . Cost-effectiveness was also described using the net monetary benefit method . RESULTS Significant differences between the groups over the 3-year period were shown in the EQ-VAS ( P = .002 ) , SF-6D ( P = .01 ) , and SF-36 ( P = .04 ) physical component summary but not in the EQ-5D ( P = .24 ) or SF-36 ( P = .37 ) mental component summary . The net savings were $ 47 per participant . Costs per gained QALY , savings not counted , were $ 1668 to $ 4813 . Probabilities of cost-effectiveness were 89 % to 100 % when the amount of $ 50,000 was used as stakeholder 's threshold of willingness to pay for a gained QALY . CONCLUSION Lifestyle intervention in primary care improves QOL and is highly cost-effective in relation to st and ard care . Trial Registration clinical trials.gov Identifier : NCT00486941 BACKGROUND The long-term effects of disease management programmes for coronary heart disease on health status are unknown . In a r and omized trial of nurse-led secondary prevention clinics , we found significantly improved health status at 1 year . Participants were followed-up again at 4 years to determine if improvements had been sustained . OBJECTIVE Our aim was to evaluate the effects on health of nurse-led clinics for the secondary prevention of coronary heart disease in primary care . METHODS A total of 1343 patients with coronary heart disease were r and omized to nurse-led secondary prevention clinics or usual care , with follow-up at 1 and 4 years by review of medical case notes and national data sets , and postal question naires . The study involved a stratified , r and om sample of 19 general practice s in north-east Scotl and . Health status was measured by the SF-36 question naire , chest pain by the angina TyPE specification and anxiety and depression by the hospital anxiety and depression scale . RESULTS At 1 year , there were significant improvements in five of eight SF-36 domains ( all functioning scales , pain and general health ) in patients r and omized to clinics . Role limitations attributed to physical problems improved the most [ adjusted difference 8.52 , 95 % confidence interval ( CI ) 4.16 - 12.9 ] . At 4 years , the intervention group scored higher than control in all domains , but differences were no longer significant . At 1 year , fewer patients in the intervention group reported worsening chest pain ( odds ratio 0.59 , 95 % C1 0.37 - 0.94 ) . At 4 years , there were no significant differences between the proportion of intervention or control group patients who reported chest pain in the last week or who reported worsening chest pain . No significant effects were observed on anxiety or depression at 1 or 4 years . CONCLUSION We have demonstrated previously a significantly greater survival in attendees at nurse-led secondary prevention clinics . Despite this , improvements in health status achieved in the first year of the study were reduced at 4 years . The case for nurse-led clinics remains strong , but further research is required on ways to optimize current health status Physician-delivered , stop-smoking interventions significantly improve quit rates among smoking patients [ 1 - 6 ] . Unfortunately , only about one half of physicians in non research setting s consistently counsel smokers [ 7 - 11 ] , and fewer than one half of all smokers report that a physician has ever advised them to quit [ 12 - 14 ] . Given the pressures of routine medical practice , it is not surprising that physicians do not take 3 to 5 minutes to counsel every smoking patient they see . Tobacco counseling competes with other pressing clinical tasks ; physicians are often too busy to routinely and repeatedly counsel all patients who smoke [ 11 , 15 - 17 ] . Physicians will deliver a cessation protocol as part of a study [ 5 , 6 , 18 ] , but barriers such as a lack of time , training , and confidence make counseling in non research setting s less likely [ 1 , 4 , 19 , 20 ] . New approaches [ 21 - 23 ] , such as involving other office staff in counseling [ 17 , 24 , 25 ] , are needed if tobacco counseling is to become a consistent and sustainable part of medical care delivery [ 26 ] . Because physicians see roughly 70 % , or 38 million , of the 53 million smokers in the United States each year [ 15 ] , even a modestly effective physician-driven intervention would have considerable impact on the nation 's health . This study tested the feasibility and effectiveness of a team counseling approach design ed to minimize the burden on physicians by using non-physician clinic staff to provide the more time-consuming parts of cessation counseling . Key features of the team approach were a brief ( 30-second ) physician-delivered cessation message , referral to an on-site nurse or other staff for additional cessation support , and the use of videos to deliver much of the intervention in an efficient and st and ardized manner . A previous report of process and short-term outcome measures showed that this organized team approach proved practical and sustainable [ 27 ] . The participating physicians and other providers delivered brief advice to 86 % of identified smokers during the 1-year intake period , and most patients ( 87 % ) saw the counselor for material s and additional counseling . Nurse-Assisted counseling led to significantly improved quit rates at 3 months compared with brief physician advice alone . We present the effects of the intervention on long-term abstinence at 1 year . Methods Setting We conducted our study in two large primary care facilities of Kaiser Permanente Northwest Region , a group- practice health maintenance organization ( HMO ) in Portl and , Oregon . Receptionists asked patients between 18 and 70 years of age to complete a health habit survey while waiting for their visit . The patients were seeing 1 of 60 primary care physicians ( n = 42 ) , physician assistants ( n = 7 ) , or nurse practitioners ( n = 11 ) in outpatient internal medicine and family practice offices . Intervention Regular clinic nurses and clinical assistants collected the surveys as patients were taken to examination rooms and attached a notice to the medical charts of smokers ( n = 3161 ) to alert providers to deliver a brief stop-smoking advice message . Providers were oriented to their role in a 1-hour training session . They were encouraged to use their own words but to not go beyond the following basic 30-second message : The best thing you can do for your health is to stop smoking and I want to advise you to stop as soon as possible . I know it can be hard and many try several times before they finally make it . You may or may not want to stop now , but I want you to talk briefly with our health counselor , who has some tips to make stopping easier when you decide the time is right . The 2707 ( 86 % ) smokers who received the provider advice message were considered participants in the study , regardless of whether they were willing to see the counselor or had any interest in quitting smoking . By the end of follow-up , 16 patients died , leaving a total sample of 2691 . At the conclusion of the physician consultation , patients were seen by an on-site project nurse or health counselor who described what would be offered and obtained verbal consent to proceed . Patients who would not see the health counselor were mailed material s appropriate to their treatment assignment . Two r and om digits contained in the patient 's health record number were used to assign patients to one of the following four interventions : advice , self-quit , group-referral , or combination treatment . Physicians remained blind to treatment assignment . Advice participants received the 30-second provider advice message and a brief pamphlet , Why Do You Smoke ? , from the health counselor . This clear and systematic advice would probably be more effective than no treatment or usual care , which were not included for logistic and ethical reasons . The self-quit condition included cessation advice , a carbon monoxide assessment , and a 10-minute How to Quit Smoking video design ed specifically for this population . The video focused on the need to make a personal decision to quit , the steps to successful quitting , the frequent need for repeated efforts , and the importance of setting a specific quit date and using substitutes to smoking . The counselor provided a stop-smoking kit including smoking substitutes such as gum , toothpicks , and cinnamon sticks . A choice of one of three stop-smoking manuals was offered . Most participants chose the National Cancer Institute 's manual , Quit for Good ( 54 % ) , although others chose Calling it Quits ( 17 % ) or a two-part workbook produced by the American Lung Association titled , Freedom from Smoking in 20 Days and A Lifetime of Freedom from Cigarettes , respectively ( 29 % ) . Patients were encouraged to set a specific quit date or some other specific plan of action and the counselor arranged to call the patient , usually within 2 to 4 weeks , to check on progress toward cessation . Patients were also mailed a set of stop-smoking tip sheets and a series of six professionally design ed bimonthly newsletters devoted to smoking cessation . Group-referral participants also received advice , the carbon monoxide assessment , and a video . In this case , however , the video encouraged patients to join the HMO 's intensive stop-smoking group program known as Freedom from Cigarettes . This program entails nine group meetings over 2 months . In a recent study , this program achieved roughly a 35 % biochemically verified 1-year quit rate [ 28 ] . Patients were provided a brochure , a schedule of group sessions , and a time-limited coupon to waive the program fee . Efforts were made to schedule the patient for an upcoming group . Reminder postcards were sent 1 week before the scheduled meeting , and patients were called several days after the meeting to check on progress and , if necessary , to reschedule . Combination participants also received advice , the carbon monoxide assessment , and a third video , which described both the self-directed and the professionally led group approaches to smoking cessation . Self-directed cessation techniques , as well as the pros and cons of joining a professionally run program , were presented . Participants were asked to choose an approach that made sense for them . The self-help manual , stop-smoking kit , group material s , and fee-waiver coupon were all provided . Participants were encouraged to either set a quit date or sign up for a specific group session , and a telephone call was arranged to check on progress . Tip sheets and the bimonthly newsletters were mailed to all combination participants . Follow-up and Analyses Participants were surveyed by mail 3 and 12 months after their initial visits . Nonresponders were interviewed by telephone by an assessor who was blind to treatment assignment . Participants reporting abstinence from tobacco for at least 7 days before the 12-month assessment were asked to schedule appointments at a convenient clinic location or at their homes to provide saliva sample s for biochemical confirmation . The primary end point was a two-point prevalence measure , which was defined as consecutive abstinence at both the 3- and 12-month assessment s. Nonrespondents and those lost to follow-up were considered to be smokers . Results As shown in Table 1 , participants in the four treatment groups were similar in terms of baseline age , sex , race , education , occupation , cigarettes smoked per day , stage of change , confidence in ability to quit , perceived degree of overweight , and subjective health status [ 27 ] . Table 1 . Baseline Characteristics by Treatment Group * Self-reported smoking status was obtained on a high percentage of participants at both the 3-month ( 88 % ) and 12-month ( 86 % ) follow-up assessment s. Response rates did not differ significantly across treatment groups . The proportion of participants who reported one or more serious attempts to quit in the year following their clinic visit was significantly higher ( P < 0.004 ) among self-quit participants ( 53 % ) relative to advice participants ( 46 % ) . Group-referral ( 48 % ) and combination participants ( 50 % ) did not differ from advice participants in terms of quit attempts . All three nurse-assisted interventions self-quit , group referral , and combination result ed in higher 3-month point prevalence quit rates than did the advice treatment ( Table 2 ) . At the 12-month follow-up , a larger percentage of participants reported abstinence , although differences between treatment arms were reduced . The 12-month point prevalence definition of abstinence , however , includes both long-term ex-smokers and those who quit as little as 1 week before the 1-year follow-up . With the more conservative primary end point , consecutive abstinence at both the 3-month and 12-month assessment s , the three nurse-assisted interventions were superior to the advice intervention . Because quit rates for the three nurse-assisted interventions were similar for all analyses ( P > 0.2 ) , they were collapsed and compared to the advice intervention . Quit rates in the nurse-assisted groups were significantly higher than advice for the 3-month ( 6 BACKGROUND Most studies that have analysed the effect of secondary prevention of coronary heart disease come from hospitals . Those that are community-based have been conducted mainly by nurses and follow-up was generally too short to show impact on cardiovascular events . METHODS This is a multi-centre r and omised controlled clinical trial in which patients in the intervention group received periodic postal reminders to see their general practitioner every three months during a 3-year follow-up . General practitioners reinforced healthy lifestyle recommendations to patients and review ed drug therapies at these quarterly intervals . Patients in the control group received usual care . RESULTS A total of 983 patients aged 30 - 79 were included . During the 3-year follow-up , 67 patients died and 156 experienced a non-fatal cardiovascular event . The event rates and all-cause mortality were similar in the intervention and control groups ( 24.0 % and 23.5 % , and 8.1 % and 9.9 % , respectively ) . Improvement in quality of life was similar in both groups . Blood pressure and high-density lipoprotein cholesterol were more frequently within recommended levels in the intervention group than in controls : odds ratio 1.63 , 95 % confidence interval 1.05 - 2.51 , and odds ratio 2.61 , 95 % confidence interval 1.32 - 5.18 , respectively . CONCLUSIONS Intensive secondary prevention conducted by general practitioners may improve long-term blood pressure control and increase high-density lipoprotein cholesterol in patients with stable coronary disease Objective . To examine whether training GPs in motivational interviewing ( MI ) can improve type 2 diabetic patients ’ ( 1 ) underst and ing of diabetes , ( 2 ) beliefs regarding prevention and treatment , and ( 3 ) motivation for behaviour change . Methods . A r and omized controlled trial including 65 GPs and 265 type 2 diabetic patients . The GPs were r and omized in two groups , one with and one without MI training . Both groups received training in target-driven intensive treatment of type 2 diabetic patients . The intervention was a 1½-day residential course in MI with ½-day follow-up twice during the first year . The patient data stemmed from previously vali date d question naires . Main outcome measures . The Health Care Climates Question naire assesses the patient – doctor relationship and type of counselling . The Treatment Self-Regulation Question naire assesses the degree to which behaviour tends to be self-determined . The Diabetes Illness Representation Question naire assesses beliefs and underst and ing of type 2 diabetes . The Summary of Diabetes Self Care Activities assesses the extent of various self-care activities related to type 2 diabetes . Results . The response rate to our question naires was 87 % . Patients in the intervention group were significantly more autonomous and motivated in their inclination to change behaviour after one year compared with the patients from the control group . Patients in the intervention group were also significantly more conscious of the importance of controlling their diabetes , and had a significantly better underst and ing of the possibility of preventing complications . Conclusion . MI improved type 2 patients ’ underst and ing of diabetes , their beliefs regarding treatment aspects , their contemplation on and motivation for behaviour change . Whether our results can be sustained long term and are clinical ly relevant in terms of changes in risk profile advocates further research AIMS Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies . By conducting a pragmatic controlled trial ( PCT ) , we aim ed at evaluating the effectiveness of the WHO recommendations for screening and brief intervention ( SBI ) in general practice . METHODS A r and omized PCT ( brief counselling intervention vs no intervention ) involving 39 Danish general practitioners ( GPs ) . Systematic screening of 6897 adults led to inclusion of 906 risky drinkers , and research follow-up on 537 of these after 12 - 14 months . Outcome measures focused on patients ' acceptance of screening and intervention and their self-reported alcohol consumption . RESULTS Patient acceptance of screening and intervention -10.3 % ( N = 794 ) of the target population ( N = 7 , 691 ) explicitly refused screening . All intervention group subjects ( N = 442 ) were exposed to an instant brief counselling session while only 17.9 % of them ( 79/442 ) attended a follow-up consultation that was offered by their GP . Consumption Changes At one-year follow-up , average weekly consumption had increased by 0.7 drinks in both comparison groups . As secondary findings , we observed an indiscriminate absolute risk reduction ( ARR = 0.08 ( 95 % CI : -0.02 ; 0.18 ) ) in male binge drinking , but adverse intervention effects for women on the secondary outcomes ( binge drinking ARR = -0.30 ( 95 % CI : -0.47 ; -0.09 ) ) . CONCLUSIONS The results of brief interventions in everyday general practice performed on the basis of systematic question naire screening may fall short of theoretical expectations . When applied to non-selected groups in everyday general practice SBI may have little effect and engender diverse outcome . Women may be more susceptible to defensive reactions than men OBJECTIVES The purpose of this study was to determine whether written advice from general practitioners increases physical activity among sedentary people more than verbal advice alone . METHODS Sedentary patients ( n = 456 ) received verbal advice on increasing physical activity and were then r and omized to an exercise prescription ( green prescription ) group or a verbal advice group . RESULTS The number of people engaging in any recreational physical activity at 6 weeks increased substantially , but significantly more so in the green prescription group . Also , more participants in the green prescription group increased their activity over the period . CONCLUSIONS A written goal -oriented exercise prescription , in addition to verbal advice , is a useful tool for general practitioners in motivating their parents to increase physical activity The HEART project was conducted in general practice to determine whether lifestyle strategies , aim ed at increasing physical activity and dietary modification , can be substituted for drug therapy in patients who have been well controlled on antihypertensive medication . In addition to blood pressure ( BP ) and risk factor outcomes , lifestyle behaviours , quality of life of patients , and the acceptability of the approach to both general practitioners ( GPs ) and patients involved in the trial were assessed . Patients ( n = 45 ) with a history of hypertension and who had been well controlled for at least the past 6 months ( BP < 160/95 mmHg ) were r and omised to a continued medication ( C ) group ( n = 24 ) or a withdrawal ( W ) group ( n = 21 ) . Subjects had received antihypertensive therapy for an average of 7.8 years ( range 1 - 28 years ) . Drug therapy in the W group was recommenced if BP exceeded 160/95 mmHg on two consecutive visits . Both groups were counselled regarding lifestyle behaviour change by their GP throughout the study and were provided with specifically developed self-help material s. Subjects were review ed at least monthly over a 9-month period . Following r and omisation , there were no significant differences between the two groups for BP , heart rate , age , duration of therapy , total cholesterol or body mass index . All but three subjects ( one from the W and two from the C group ) completed 9 months of monitoring following r and omisation and there were no cardiovascular events ; 71 % of subjects remained off drug therapy and were well controlled at the 9-month follow-up ( 15/21 ) with mean BP of 141/85 mmHg ( W ) and 139/86 mmHg ( C ) . Systolic BP tended to increase during the study period in both W and C groups , however , no significant differences were observed in mean systolic or diastolic BP either between the two groups or within each group in comparison to baseline values . Resting heart rate , body mass index and cholesterol levels remained unchanged in both W and C groups after 9 months follow-up . There were no changes attributable to the lifestyle intervention in the subjects continuing drug therapy in BP or lifestyle variables over the study period . However , the group stopping therapy had a 6 % reduction in body mass index after 9 months . These data suggest that a proportion of motivated patients willing to trial a lifestyle approach can cease drug therapy and be adequately maintained by the prescription of lifestyle advice via their GP for at least a 9-month period . Cessation of drug therapy may be an important motivating factor to achieve weight loss in this group OBJECTIVES This study assessed stages of change in fat intake , physical activity , and cigarette smoking during a r and omized controlled trial of behavioral counseling . METHODS Twenty general practice s ( primary health care centers ) were r and omized to lifestyle counseling by behavioral methods or to usual health promotion . A total of 883 patients were selected for the presence of 1 or more of the following risk factors : cigarette smoking , high cholesterol , or a combination of a high body mass index and low physical activity . Stage of change ( precontemplation , contemplation , preparation , and action/maintenance ) was assessed at baseline and after 4 and 12 months . RESULTS The odds of moving to action/maintenance for behavioral intervention vs control patients at 4 months were 2.15 ( 95 % confidence interval [ CI ] = 1.30 , 3.56 ) for fat reduction , 1.89 ( 95 % CI = 1.07 , 3.36 ) for increased physical activity , and 1.77 ( 95 % CI = 0.76 , 4.14 ) for smoking cessation . The likelihood of achieving action/maintenance was related to baseline stage for all 3 behaviors . CONCLUSIONS Brief behavioral counseling based on advice matched to stage of readiness for change may be valuable in encouraging healthy lifestyles among patients in primary care at raised risk of cardiovascular disease Abstract Objective : To measure the effect of behaviourally oriented counselling in general practice on healthy behaviour and biological risk factors in patients at increased risk of coronary heart disease . Design : Cluster r and omised controlled trial . Participants : 883 men and women selected for the presence of one or more modifiable risk factors : regular cigarette smoking , high serum cholesterol concentration ( 6.5 - 9.0 mmol/l ) , and high body mass index ( 25 - 35 ) combined with low physical activity . Intervention : Brief behavioural counselling , on the basis of the stage of change model , carried out by practice nurses to reduce smoking and dietary fat intake and to increase regular physical activity . Main outcome measures : Question naire measures of diet , exercise , and smoking habits , and blood pressure , serum total cholesterol concentration , weight , body mass index , and smoking cessation ( with biochemical validation ) at 4 and 12 months . Results : Favourable differences were recorded in the intervention group for dietary fat intake , regular exercise , and cigarettes smoked per day at 4 and 12 months . Systolic blood pressure was reduced to a greater extent in the intervention group at 4 but not at 12 months No differences were found between groups in changes in total serum cholesterol concentration , weight , body mass index , diastolic pressure , or smoking cessation . Conclusions : Brief behavioural counselling by practice nurses led to improvements in healthy behaviour . More extended counselling to help patients sustain and build on behaviour changes may be required before differences in biological risk factors emerge OBJECTIVES This study evaluated the effectiveness of a low-intensity dietary intervention in primary care practice in lowering dietary fat intake and raising dietary fiber intake . METHODS A r and omized controlled trial of 28 physician practice s in six primary care clinics enrolled , by telephone , adult patients who had appointments for nonurgent nonacute visits . Of 3490 eligible patients contacted , 2111 completed baseline interview ; 86.1 % also completed a 12-month follow-up . Physicians gave intervention participants a self-help booklet and a brief motivational message . Changes in fat and fiber from baseline to 12-month follow-up were evaluated . RESULTS Intervention and control groups both reported a decrease in fat intake and an increase in fiber intake . The differential change and 95 % confidence interval ( CI ) for the percentage of energy obtained from fat was -1.2 ( CI = -0.71 , -1.7 ) ( P = .0015 ) , for grams fiber/1000 kcal 0.32 ( CI = -0.066 , 0.71 ) ( P = .086 ) , for fat score -0.044 ( CI = -0.016 , -0.072 ) ( P = .010 ) , and for fiber score 0.036 ( CI = 0.011 , 0.061 ) ( P = .014 ) , with greater reductions in fat and greater increase in fiber in the intervention group . CONCLUSIONS This low-intensity intervention was effective in dietary behavior change Abstract Objectives : To evaluate the effects of nurse led clinics in primary care on secondary prevention , total mortality , and coronary event rates after four years . Design : Follow up of a r and omised controlled trial by postal question naires and review of case notes and national data sets . Setting : Stratified , r and om sample of 19 general practice s in north east Scotl and . Participants : 1343 patients ( 673 intervention and 670 control ) under 80 years with a working diagnosis of coronary heart disease but without terminal illness or dementia and not housebound . Intervention : Nurse led secondary prevention clinics promoted medical and lifestyle components of secondary prevention and offered regular follow up for one year . Main outcome measures : Components of secondary prevention ( aspirin , blood pressure management , lipid management , healthy diet , exercise , non-smoking ) , total mortality , and coronary events ( non-fatal myocardial infa rct ions and coronary deaths ) . Results : Mean follow up was at 4.7 years . Significant improvements were shown in the intervention group in all components of secondary prevention except smoking at one year , and these were sustained after four years except for exercise . The control group , most of whom attended clinics after the initial year , caught up before final follow up , and differences between groups were no longer significant . At 4.7 years , 100 patients in the intervention group and 128 in the control group had died : cumulative death rates were 14.5 % and 18.9 % , respectively ( P=0.038 ) . 100 coronary events occurred in the intervention group and 125 in the control group : cumulative event rates were 14.2 % and 18.2 % , respectively ( P=0.052 ) . Adjusting for age , sex , general practice , and baseline secondary prevention , proportional hazard ratios were 0.75 for all deaths ( 95 % confidence intervals 0.58 to 0.98 ; P=0.036 ) and 0.76 for coronary events ( 0.58 to 1.00 ; P=0.049 ) Conclusions : Nurse led secondary prevention improved medical and lifestyle components of secondary prevention and this seemed to lead to significantly fewer total deaths and probably fewer coronary events . Secondary prevention clinics should be started sooner rather than later . What is already known on this topic Several effective interventions exist for the secondary prevention of coronary heart disease , but implementing them in practice has proved difficult Secondary prevention programmes for coronary heart disease have improved short term outcomes such as processes of care and quality of life What this study adds Short term improvements in uptake of secondary prevention produced by nurse led clinics are maintained in the longer term Improved medical and lifestyle components of secondary prevention produced by nurse led clinics seem to lead to fewer total deaths and coronary BACKGROUND Today , heavy drinking is a common health hazard among women . The evidence in favor of providing some kind of brief intervention to reduce drinking is quite convincing . However , we do not know if intervention works in a natural environment of routine health care . The purpose of this study was to evaluate the effectiveness of long-lasting , brief alcohol intervention counseling for women in a routine general practice setting . METHODS In five primary care outpatient clinics in a Finnish town , 118 female early-phase heavy drinkers who consulted their general practitioners for various reasons were given brief alcohol intervention counseling . Intervention groups A ( n = 40 ) and B ( n = 38 ) were offered seven and three brief intervention sessions , respectively , over a 3-yr period . The control group C ( n = 40 ) was advised to reduce drinking at baseline . Main outcome measures were self-reported weekly alcohol consumption , carbohydrate-deficient transferrin , mean corpuscular volume ( MCV ) , aspartate aminotransferase , alanine aminotransferase , and gamma-glutamyltransferase . RESULTS Depending on the outcome measure and the study group , clinical ly meaningful reduction of drinking was found in 27 % to 75 % of the heavy drinkers . Within all the groups , MCV significantly decreased . However , there were no statistically significant differences between study groups A , B , and C in the mean changes between the beginning and endpoint in the main outcome measures . CONCLUSIONS The present study indicated that minimal advice , as offered to group C , was associated with reduced drinking as much as the brief intervention , as offered to groups A and B , given over a 3-yr period . Furthermore , in the routine setting of the general practice office , the effectiveness of the brief intervention may not be as good as in special research conditions . The factors possibly reducing the effectiveness in a routine setting are unknown . Thus , different methods of implementing brief intervention need to be evaluated to find better ways to support general practice personnel in their efforts to help heavy-drinking female patients to reduce their drinking BACKGROUND Brief advice to stop smoking from general practitioners ( GPs ) has been repeatedly shown to increase smoking cessation by a small , but measurable amount . Some studies have suggested that adding more intensive interventions to brief advice may increase its effectiveness , but it is unclear whether this is true in general practice . AIMS To determine whether brief advice from a doctor together with counselling and follow-up from a trained practice nurse is more effective than brief advice alone in helping people to stop smoking . METHODS The design was a r and omized controlled trial . Four hundred and ninety-seven general practice patients aged older than 18 years and smoking at least one cigarette per day in six general practice s in Oxfordshire , Berkshire , and Buckinghamshire were r and omized to one of two interventions : brief verbal or written advice from a GP plus extended counselling and follow-up from a trained practice nurse ; brief advice from a GP alone . The primary outcome was sustained abstinence from smoking at three and 12 months . A secondary outcome was forward movement in the stages of change cycle . RESULTS The proportion showing sustained abstinence was 3.6 % in the extended counselling group , and 4.4 % in the brief advice group ( difference = -0.8 % ; 95 % confidence interval = -4.3 % to 2.6 % ) . Seventy-four ( 30 % ) of those r and omized to extended counselling actually took up this offer . No significant progression in stages of change was detected between the two groups . CONCLUSIONS In unselected general practice patients who smoke , brief advice from a GP combined with intensive intervention and follow-up by a practice nurse is no more effective than brief advice alone BACKGROUND In an effort to find more practical smoking intervention models for primary -care setting s , three physician- and -nurse team approaches to patient counseling were compared with brief physician advice alone . METHODS Subjects were 3,161 adult smokers surveyed while waiting to see 1 of 40 primary -care physicians . Physicians delivered a brief stop-smoking prompt to 2,707 ( 86 % ) of these smokers and referred them to an on-site smoking counselor ( e.g. , nurse ) who r and omly provided a two-page pamphlet ( advice-only control ) or one of three brief nurse-assisted interventions : ( a ) self-quit training , ( b ) recruitment to a group program , or ( c ) a combination intervention . Smokers usually ( 87 % ) agreed to see the counselor . RESULTS After 3 months , subjects in the three nurse-assisted conditions were more likely to report a serious quit attempt ( 50 % vs 39 % , P less than 0.001 ) than were physician-advice-only subjects . Quit rates at 3 months were also higher ( P less than 0.001 ) in the nurse-assisted self-quit ( 12.9 % ) , recruitment ( 14.1 % ) , and combination ( 13.0 % ) conditions , compared with those for brief physician advice only ( 7.6 % ) . CONCLUSION If long-term efficacy is confirmed , these nurse-assisted counseling approaches will serve as practical smoking intervention models for most medical-care delivery setting Abstract Objectives To assess whether blood pressure control in primary care could be improved with the use of patient held targets and self monitoring in a practice setting , and to assess the impact of these on health behaviours , anxiety , prescribed antihypertensive drugs , patients ' preferences , and costs . Design R and omised controlled trial . Setting Eight general practice s in south Birmingham . Participants 441 people receiving treatment in primary care for hypertension but not controlled below the target of < 140/85 mm Hg . Interventions Patients in the intervention group received treatment targets along with facilities to measure their own blood pressure at their general practice ; they were also asked to visit their general practitioner or practice nurse if their blood pressure was repeatedly above the target level . Patients in the control group received usual care ( blood pressure monitoring by their practice ) . Main outcome measures Primary outcome : change in systolic blood pressure at six months and one year in both intervention and control groups . Secondary outcomes : change in health behaviours , anxiety , prescribed antihypertensive drugs , patients ' preferences of method of blood pressure monitoring , and costs . Results 400 ( 91 % ) patients attended follow up at one year . Systolic blood pressure in the intervention group had significantly reduced after six months ( mean difference 4.3 mm Hg ( 95 % confidence interval 0.8 mm Hg to 7.9 mm Hg ) ) but not after one year ( mean difference 2.7 mm Hg ( – 1.2 mm Hg to 6.6 mm Hg ) ) . No overall difference was found in diastolic blood pressure , anxiety , health behaviours , or number of prescribed drugs . Patients who self monitored lost more weight than controls ( as evidence d by a drop in body mass index ) , rated self monitoring above monitoring by a doctor or nurse , and consulted less often . Overall , self monitoring did not cost significantly more than usual care ( £ 251 ( $ 437 ; 364 euros ) ( 95 % confidence interval £ 233 to £ 275 ) versus £ 240 ( £ 217 to £ 263 ) . Conclusions Practice based self monitoring result ed in small but significant improvements of blood pressure at six months , which were not sustained after a year . Self monitoring was well received by patients , anxiety did not increase , and there was no appreciable additional cost . Practice based self monitoring is feasible and results in blood pressure control that is similar to that in usual care BACKGROUND There is a need for primary care providers to have brief effective methods to intervene with high-risk drinkers during a regular outpatient visit . OBJECTIVE To determine whether brief physician- and nurse practitioner-delivered counseling intervention is efficacious as part of routine primary care in reducing alcohol consumption by high-risk drinkers . METHODS Academic medical center-affiliated primary care practice sites were r and omized to special intervention or to usual care . From a screened population of 9772 patients seeking routine medical care with their primary care providers , 530 high-risk drinkers were entered into the study . Special intervention included training providers in a brief ( 5- to 10-minute ) patient-centered counseling intervention , and an office support system that screened patients , cued providers to intervene , and made patient education material s available . The primary outcome measures were change in alcohol use from baseline to 6 months as measured by weekly alcohol consumption and frequency of binge drinking episodes . RESULTS Participants in the special intervention and usual care groups were similar on important background variables and potential confounders except that special intervention participants had significantly higher baseline levels of alcohol usage ( P = .01 ) . At 6-month follow-up , in the 91 % of the cohort who provided follow-up information , alcohol consumption was significantly reduced when adjusted for age , sex , and baseline alcohol usage ( special intervention , -5.8 drinks per week ; usual care , -3.4 drinks per week ; P = .001 ) . CONCLUSIONS This study provides evidence that screening and very brief ( 5- to 10-minute ) advice and counseling delivered by a physician or nurse practitioner as part of routine primary care significantly reduces alcohol consumption by high-risk drinkers OBJECTIVE To study the effect of a community-based walking intervention on blood pressure among older people . METHOD The study design was a r and omized controlled trial conducted in a rural area of Taiwan between October 2002 and June 2003 . A total of 202 participants aged 60 years and over with mild to moderate hypertension was recruited . Participants r and omized to the intervention group ( n=102 ) received a six-month community-based walking intervention based on self-efficacy theory . A public health nurse provided both face-to-face and telephone support design ed to assist participants to increase their walking . Control group participants ( n=100 ) received usual primary health care . Primary outcome was change in systolic blood pressure and secondary outcomes were exercise self-efficacy , self-reported walking and diastolic blood pressure . RESULTS At six-month follow-up the mean change in systolic blood pressure was a decrease of 15.4 mmHg and 8.4 mmHg in the intervention and control group , respectively . The difference in mean change between the two groups was -7.0 mmHg ( 95 % CI , -11.5 to -2.5 mmHg , p=0.002 ) . Improvement in exercise self-efficacy scores was greater among intervention group participants ( mean difference 1.23 , 95 % CI , 0.5 to 2.0 , p=0.001 ) . Intervention group participants were more likely to report walking more ( p<0.0005 ) but no differences were observed in diastolic blood pressure ( p=0.19 ) . CONCLUSIONS Among hypertensive older people , a six-month community-based walking intervention was effective in increasing their exercise self-efficacy and reducing systolic blood pressure Aims To compare health effects and risk reduction in two different strategies of nutritional counselling in primary health care for patients at high risk of ischaemic heart disease . Methods In a cluster-r and omized trial 60 general practitioners ( GPs ) in the Copenhagen County were r and omized to give nutritional counselling or to refer patients to a dietician . Patients were included after opportunistically screening ( n = 503 patients ) , and received nutritional counselling by GP or dietician over 12 months . Health effects were measured by changes in weight , waist circumference and blood lipids . Risk of cardiovascular disease was calculated by The Copenhagen Risk Score . Data on use of medicine and primary health care was obtained from central registers . Results Altogether 339 ( 67 % ) patients completed the intervention . Weight loss was larger in the dietician group ( mean 4.5 kg vs. 2.4 kg ) , and increase of HDL-cholesterol was larger in the GP group ( mean 0.13mmol/l vs. 0.03mmol/l ) . The reduction of the cardiovascular risk score was significantly larger in the GP group ( P = 0.0005 ) . Other health outcomes were not significantly different . Conclusions GPs were aware of substantial risk factors of cardiovascular disease and addressed these when counselling . The guidance from a GP was of significant importance for risk reduction in relation to IHD . However , a long-term lifestyle intervention by GP was difficult to implement . In the case of obesity it was effective to refer to long-term nutritional counselling by a dietician BACKGROUND Binge drinking is a common pattern of alcohol use in the US . However , no studies have evaluated the effectiveness of brief interventions targeting only binge drinkers . METHODS R and omized controlled clinical trial with a 12-month follow-up period conducted from March 1 , 2003 to March 1 , 2006 in Spain . Of a screened population of 15,325 patients seeking routine medical care from their primary care providers , patients who met inclusion criteria were r and omized into an experimental group ( n=371 ) or a control group ( n=381 ) . The primary outcome measures were the frequency of binge drinking episodes and weekly alcohol intake . RESULTS There were no significant differences at baseline between groups in alcohol use and demographic variables . At the end of the 12-month follow-up period , there were significant reductions in binge-drinking status ( 52.2 % vs 67.2 % , P < .001 ) , number of episodes of binge drinking ( 1.14 vs 1.56 , P < .001 ) , number of drinks weekly ( 19.2 vs 22.4 , P < .001 ) , and frequency of excessive alcohol intake in 7 days ( 47.9 % vs 66.6 % , P > .001 ) . CONCLUSIONS This study provided evidence that screening and brief counseling delivered by a primary care physician as part of regular health care significantly reduced binge drinking episodes in binge drinkers |
326 | 29,320,366 | Specific immunotherapy demonstrated remarkable improvement in survival of patients with glioma and could be a considerable choice of treatment in the future . | Abstract Although different immunotherapeutic approaches have been developed for the treatment of glioma , there is a discrepancy between clinical trials limiting their approval as common treatment .
So , the current systematic review and meta- analysis were conducted to assess survival and clinical response of specific immunotherapy in patients with glioma . | We investigated the putative benefits of simultaneous teleradiotherapy and anti-epidermal growth factor receptor ( EGFR ) 125I monoclonal antibody ( MAb ) 425 radioimmunotherapy , when applied after neurosurgery in high- grade gliomas , over teleradiotherapy alone . In comparison to previous studies which have reported good results with this type of radioimmunotherapy , we advanced the adjuvant radioimmunotherapy step , that is , gave it during , not after , teleradiotherapy . The r and omized prospect i ve study examined two groups : simultaneous postoperative teleradiotherapy and radioimmunotherapy ( TRT + RIT ; eight patients ) versus teleradiotherapy alone ( TRT ; 10 patients ) . Patients who after primary operation of grade III ( 6 cases ) or IV glioma ( 12 cases ) , showed no or less than 2 mL of remnant tumor on post-operative magnetic resonance ( MR ) study and were not treated postoperatively by chemotherapy were enrolled and r and omized . Anti-EGFR 125IMAb 425 RIT was started during week 4 of radiotherapy , not later than 8 weeks after neurosurgery , and was repeated three times at 1-week intervals . Total activity given was 5026 + 739 MBq/patient . The tolerance of TRT was good . No immediate side effects of concomitant anti-EGRF 125I RIT were observed . Observation showed a median total survival ( as evaluated from the primary neurosurgical treatment ) of 14 months ( range 3.5 - 28 months ) . There was no improvement in disease-free or total survival in the group of patients treated by TRT + RIT after neurosurgery . In addition , an immunohistochemical analysis of EGFR expression in gliomas was performed in a group of 100 cases and was distinctly positive in 50 % grade IV gliomas and 68 % grade III gliomas . We conclude that simultaneous radiotherapy and radioimmunotherapy with anti-EGFR 125I-MAb 425 is not beneficial over radiotherapy alone in adjuvant treatment of high- grade gliomas after neurosurgery . We also recommend individual confirmation of EGFR expression in further anti-EGFR radioimmunotherapy trials UNLABELLED The median survival for adults with recurrent primary malignant gliomas is 56 weeks following surgery , radiation , and chemotherapy . Generally , reoperation can extend the median survival an additional 26 - 32 weeks . We have developed an aggressive treatment program that utilizes low doses of interleukin-2 ( IL-2 ) combined with ex vivo activated killer cells ( LAK ) infused via an indwelling catheter placed into the surgical resection cavity . Autologous leukocytes were collected during a st and ard 3 - 4 h , outpatient leukapheresis procedure , then activated ex vivo for 4 - 5 days with high doses of IL-2 . The treatment protocol consisted of two 2-week cycles of therapy over a 6-week period . Patients with stable disease or objective response on follow-up MRI scans were retreated at 3-month intervals . Acute and cumulative IL-2-related toxicities were observed , but limited , and included fever , headache and transient neurologic irritation . Corticosteroid levels and usage were strictly controlled during immunotherapy , although higher doses were used intermittently to mitigate toxicity . Biologic changes included lymphocytic infiltration , regional eosinophilia , tumor necrosis , and the localized production of IL-2 , IFN-gamma and IL-12 , demonstrated by in situ hybridization and immunohistochemistry . SUMMARY IL-2 plus autogeneic LAK cells can be safely administered intracavitary to treat high grade primary brain tumors with limited toxicity within the central nervous system . Six out of 28 patients had long-term survival of greater than 2 years post-reoperation plus immunotherapy with 2 patients alive over 8 years . The presence of a marked regional eosinophilia appeared to correlate with increased survival and may be predictive of a biologic and therapeutic response . Regional adoptive immune therapy was well tolerated and should be considered an option for patients with high- grade tumors refractive to st and ard therapeutic approaches OBJECT This single-institution Phase II study tests the efficacy of adjuvant radioimmunotherapy with (125)I-labeled anti-epidermal growth factor receptor 425 murine monoclonal antibody ( (125)I-mAb 425 ) in patients with newly diagnosed glioblastoma multiforme ( GBM ) . METHODS A total of 192 patients with GBM were treated with (125)I-mAb 425 over a course of 3 weekly intravenous injections of 1.8 GBq following surgery and radiation therapy . The primary end point was overall survival , and the secondary end point was toxicity . Additional subgroup analyses were performed comparing treatment with (125)I-mAb 425 ( RIT , 132 patients ) , (125)I-mAb 425 and temozolomide ( TMZ+RIT , 60 patients ) , and a historical control group ( CTL , 81 patients ) . RESULTS The median age was 53 years ( range 19 - 78 years ) , and the median Karnofsky Performance Scale score was 80 ( range 60 - 100 ) . The percentage of patients who underwent debulking surgery was 77.6 % and that of those receiving temozolomide was 31.3 % . The overall median survival was 15.7 months ( 95 % CI 13.6 - 17.8 months ) . The 1- and 2-year survivals were 62.5 and 25.5 % , respectively . For subgroups RIT and TMZ+RIT , the median survivals were 14.5 and 20.2 months , respectively . No Grade 3 or 4 toxicity was seen with the administration of (125)I-mAb 425 . The CTL patients lacked Karnofsky Performance Scale scores , had poorer survival , were older , and were less likely to receive radiation therapy . On multivariate analysis , the hazard ratios for RIT versus CTL , TMZ+RIT versus CTL , and TMZ+RIT versus RIT were 0.49 ( p < 0.001 ) , 0.30 ( p < 0.001 ) , and 0.62 ( p = 0.008 ) , respectively . CONCLUSIONS In this large Phase II study of 192 patients with GBM treated with anti-epidermal growth factor receptor (125)I-mAb 425 radioimmunotherapy , survival was 15.7 months , and treatment was safe and well tolerated Purpose Adoptive cell immunotherapy involves an ex vivo expansion of autologous cytokine-induced killer ( CIK ) cells before their reinfusion into the host . We evaluated the efficacy and safety of CIK cell immunotherapy with radiotherapy-temozolomide ( TMZ ) for the treatment of newly diagnosed glioblastomas . Experimental design In this multi-center , open-label , phase 3 study , we r and omly assigned patients with newly diagnosed glioblastoma to receive CIK cell immunotherapy combined with st and ard TMZ chemoradiotherapy ( CIK immunotherapy group ) or st and ard TMZ chemoradiotherapy alone ( control group ) . The efficacy endpoints were analyzed in the intention-to-treat set and in the per protocol set . Results Between December 2008 and October 2012 , a total of 180 patients were r and omly assigned to the CIK immunotherapy ( n = 91 ) or control group ( n = 89 . In the intention-to-treat analysis set , median PFS was 8.1 months ( 95 % confidence interval ( CI ) , 5.8 to 8.5 months ) in the CIK immunotherapy group , as compared to 5.4 months ( 95 % CI , 3.3 to 7.9 months ) in the control group ( one-sided log-rank , p = 0.0401 ) . Overall survival did not differ significantly between two groups . Grade 3 or higher adverse events , health-related quality of life and performance status between two groups did not show a significant difference . Conclusions The addition of CIK cells immunotherapy to st and ard chemoradiotherapy with TMZ improved PFS . However , the CIK immunotherapy group did not show evidence of a beneficial effect on overall survival Previous clinical trials of dendritic cell (DC)-based immunotherapy in patients with glioblastoma multiforme ( GBM ) have reported induction of systemic immune responses and prolonged survival . From 2003 to 2005 , we performed a clinical trial in which patients with malignant glioma underwent surgery for maximal cytoreduction followed by a 6-month 10-injection course of autologous DC-tumor vaccine therapy , each injection containing 1 - 6 × 10(7 ) DC . Of the 17 treated patients ( 16 with World Health Organization grade IV and one with grade III glioma ) , eight ( 47.1 % ) had an initial transient elevation in aspartate aminotransferase (AST)/alanine aminotransferase ( ALT ) . Vaccination caused some tumor shrinkage and increased concentration of tumor-infiltrating CD8(+ ) lymphocytes . Median survival and 5-year survival were 525 days and 18.8 % , respectively , for 16 patients with grade IV glioma ( 381 days and 12.5 % for eight newly diagnosed ; 966 days and 25 % for eight relapsed patients ) compared to 380 days and 0 % for 63 historical control patients . We concluded that autologous DC-tumor immunotherapy benefits patients with malignant glioma but may cause transient but reversible elevation of serum AST/ALT levels PURPOSE To investigate the safety and the immunologic and clinical responses of dendritic cell therapy for patients with recurrent malignant glioma . EXPERIMENTAL DESIGN Twenty-four patients with recurrent malignant glioma ( 6 grade 3 and 18 grade 4 patients ) were evaluated in a phase I/II clinical study of dendritic cell therapy . All patients were resistant to the st and ard maximum therapy . The patient 's peripheral blood dendritic cells were generated with granulocyte macrophage colony-stimulating factor , plus interleukin 4 with or without OK-432 , and pulsed with an autologous tumor lysate . Dendritic cells were injected intradermally , or both intratumorally and intradermally every 3 weeks . RESULTS The protocol s were well tolerated with only local redness and swelling at the injection site in several cases . Clinical responses were as follows : 1 patient with partial response , 3 patients with minor response , 10 patients with stable disease , and 10 patients with progressive disease . The patients whose dendritic cells were matured with OK-432 had longer survival times than the dendritic cells from patients without OK-432 maturation . The patients with both intratumoral and intradermal administrations had a longer survival time than the patients with intradermal administration only . Increased ELISPOT and delayed-type hypersensitivity responses after vaccination could provide good laboratory markers to predict the clinical outcome of patients receiving dendritic cell vaccination . The overall survival of patients with grade 4 glioma was 480 days , which was significantly better than that in the control group . CONCLUSIONS This study showed the safety and clinical response of autologous tumor lysate-pulsed dendritic cell therapy for patients with malignant glioma . Dendritic cell therapy is recommended for further clinical studies in malignant glioma patients Background The prognosis of patients bearing high grade glioma remains dismal . Epidermal Growth Factor Receptor ( EGFR ) is well vali date d as a primary contributor of glioma initiation and progression . Nimotuzumab is a humanized monoclonal antibody that recognizes the EGFR extracellular domain and reaches Central Nervous System tumors , in non clinical and clinical setting . While it has similar activity when compared to other anti-EGFR antibodies , it does not induce skin toxicity or hypomagnesemia . Methods A r and omized , double blind , multicentric clinical trial was conducted in high grade glioma patients ( 41 anaplastic astrocytoma and 29 glioblastoma multiforme ) that received radiotherapy plus nimotuzumab or placebo . Treatment and placebo groups were well-balanced for the most important prognostic variables . Patients received 6 weekly doses of 200 mg nimotuzumab or placebo together with irradiation as induction therapy . Maintenance treatment was given for 1 year with subsequent doses administered every 3 weeks . The objectives of this study were to assess the comparative overall survival , progression free survival , response rate , immunogenicity and safety . Results The median cumulative dose was 3200 mg of nimotuzumab given over a median number of 16 doses . The combination of nimotuzumab and RT was well-tolerated . The most prevalent related adverse reactions included nausea , fever , tremors , anorexia and hepatic test alteration . No anti-idiotypic response was detected , confirming the antibody low immunogenicity . The mean and median survival time for subjects treated with nimotuzumab was 31.06 and 17.76 vs. 21.07 and 12.63 months for the control group . Conclusions In this r and omized trial , nimotuzumab showed an excellent safety profile and significant survival benefit in combination with irradiation . Trial registration Cuban National Register for clinical trials ( No. 1745 ) ( http://registroclinico.sld.cu/ensayos ) The primary goal of this Phase I study was to assess the safety and bioactivity of tumor lysate-pulsed dendritic cell ( DC ) vaccination to treat patients with glioblastoma multiforme and anaplastic astrocytoma . Adverse events , survival , and cytotoxicity against autologous tumor and tumor-associated antigens were measured . Fourteen patients were thrice vaccinated 2 weeks apart with autologous DCs pulsed with tumor lysate . Peripheral blood mononuclear cells were differentiated into phenotypically and functionally confirmed DCs . Vaccination with tumor lysate-pulsed DCs was safe , and no evidence of autoimmune disease was noted . Ten patients were tested for the development of cytotoxicity through a quantitative PCR-based assay . Six of 10 patients demonstrated robust systemic cytotoxicity as demonstrated by IFN-γ expression by peripheral blood mononuclear cells in response to tumor lysate after vaccination . Using HLA-restricted tetramer staining , we identified a significant expansion in CD8 + antigen-specific T-cell clones against one or more of tumor-associated antigens MAGE-1 , gp100 , and HER-2 after DC vaccination in four of nine patients . A significant CD8 + T-cell infiltrate was noted intratumorally in three of six patients who underwent reoperation . The median survival for patients with recurrent glioblastoma multiforme in this study ( n = 8) was 133 weeks . This Phase I study demonstrated the feasibility , safety , and bioactivity of an autologous tumor lysate-pulsed DC vaccine for patients with malignant glioma . We demonstrate for the first time the ability of an active immunotherapy strategy to generate antigen-specific cytotoxicity in brain tumor patients Clinical and immunological analysis of the efficiency of combined immunotherapy with the use dendritic cells for the treatment of malignant glioma of the brain was carried out . Dendritic cells generated in the presence of granulocyte-macrophage CSF and IFN-α retain their functional characteristics in patients with gliomas , which suggests the possibility of their use for the treatment of malignant tumors ( glioma ) of the brain . Combined therapy using interferon-induced dendritic cells was associated with generation of antigen-specific immune response during vaccinations . The results indicate satisfactory tolerance of combined immunotherapy using dendritic cells and the absence of toxic side effects at the stage of adoptive immunotherapy and at the stage of vaccinations with dendritic cells . Clinical trials showed that vaccinations with dendritic cells included into combined immunotherapy improved the quality of life and survival of patients with malignant gliomas BACKGROUND Concurrent treatment with temozolomide and radiotherapy followed by maintenance temozolomide is the st and ard of care for patients with newly diagnosed glioblastoma . Bevacizumab , a humanized monoclonal antibody against vascular endothelial growth factor A , is currently approved for recurrent glioblastoma . Whether the addition of bevacizumab would improve survival among patients with newly diagnosed glioblastoma is not known . METHODS In this r and omized , double-blind , placebo-controlled trial , we treated adults who had central ly confirmed glioblastoma with radiotherapy ( 60 Gy ) and daily temozolomide . Treatment with bevacizumab or placebo began during week 4 of radiotherapy and was continued for up to 12 cycles of maintenance chemotherapy . At disease progression , the assigned treatment was revealed , and bevacizumab therapy could be initiated or continued . The trial was design ed to detect a 25 % reduction in the risk of death and a 30 % reduction in the risk of progression or death , the two co primary end points , with the addition of bevacizumab . RESULTS A total of 978 patients were registered , and 637 underwent r and omization . There was no significant difference in the duration of overall survival between the bevacizumab group and the placebo group ( median , 15.7 and 16.1 months , respectively ; hazard ratio for death in the bevacizumab group , 1.13 ) . Progression-free survival was longer in the bevacizumab group ( 10.7 months vs. 7.3 months ; hazard ratio for progression or death , 0.79 ) . There were modest increases in rates of hypertension , thromboembolic events , intestinal perforation , and neutropenia in the bevacizumab group . Over time , an increased symptom burden , a worse quality of life , and a decline in neurocognitive function were more frequent in the bevacizumab group . CONCLUSIONS First-line use of bevacizumab did not improve overall survival in patients with newly diagnosed glioblastoma . Progression-free survival was prolonged but did not reach the prespecified improvement target . ( Funded by the National Cancer Institute ; Clinical Trials.gov number , NCT00884741 . ) Purpose Dendritic cell ( DC ) vaccines have recently emerged as an innovative therapeutic option for glioblastoma patients . To identify novel surrogates of anti-tumor immune responsiveness , we studied the dynamic expression of activation and inhibitory markers on peripheral blood lymphocyte ( PBL ) subsets in glioblastoma patients treated with DC vaccination at UCLA . Experimental Design Pre-treatment and post-treatment PBL from 24 patients enrolled in two Phase I clinical trials of dendritic cell immunotherapy were stained and analyzed using flow cytometry . A univariate Cox proportional hazards model was utilized to investigate the association between continuous immune monitoring variables and survival . Finally , the immune monitoring variables were dichotomized and a recursive partitioning survival tree was built to obtain cut-off values predictive of survival . Results The change in regulatory T cell ( CD3+CD4+CD25+CD127low ) frequency in PBL was significantly associated with survival ( p = 0.0228 ; hazard ratio = 3.623 ) after DC vaccination . Furthermore , the dynamic expression of the negative co-stimulatory molecule , CTLA-4 , was also significantly associated with survival on CD3+CD4 + T cells ( p = 0.0191 ; hazard ratio = 2.840 ) and CD3+CD8 + T cells ( p = 0.0273 ; hazard ratio = 2.690 ) , while that of activation markers ( CD25 , CD69 ) was not . Finally , a recursive partitioning tree algorithm was utilized to dichotomize the post/pre fold change immune monitoring variables . The result ant cut-off values from these immune monitoring variables could effectively segregate these patients into groups with significantly different overall survival curves . Conclusions Our results suggest that monitoring the change in regulatory T cell frequencies and dynamic expression of the negative co-stimulatory molecules on peripheral blood T cells , before and after DC vaccination , may predict survival . The cut-off point generated from these data can be utilized in future prospect i ve immunotherapy trials to further evaluate its predictive validity Establishment of a detection platform for glioblastoma-dendritic cell ( DC ) vaccine preparation and to determine the efficacy of the vaccine in a clinical trial . Autologous glioblastoma-DC vaccine was prepared from a glioblast specimen procured from surgical resection . The specimen was used to enrich the vaccine with peripherally blood-derived DCs after heat-shock induced , glioblastoma apoptosis . The control group received conventional treatment of surgery and radio-chemotherapy post-operation . The therapeutic group received a combination of glioblastoma-DC vaccine and conventional therapy . A comparison of the functional immune parameters , including tumor control , rate live time , Karnofsky scores , and complications occurring in each group were observed and recorded . The proportions of peripheral CD3 + , CD3+CD4 + , CD4+/CD8 + , and NK cells were significantly higher after DC vaccination than the control group ( P < 0.05 ) . Serum levels of IL-2 , IL-12 , and IFN-γwere significantly higher after DC vaccination than in the control group ( P < 0.05 ) . Nine months after vaccination , tumor control rate is significantly improved in the DC group compared with the control group ( P < 0.05 ) ; survival rate was significantly higher in DC group than in control group ( P < 0.05 ) and the time to relapse was significantly longer in DC group than that in control group ( P < 0.05 ) . Karnofsky scores were better in DC vaccination group 6 and 9 months post-treatment compared with the control group ( P < 0.05 ) . The combination of glioma DC vaccine and radiotherapy/chemotherapy post-operatively enhances the immune function of patients , increases the tumor control rate , prolongs the survival time and relapse duration , improves the quality of life , and therefore provides a more effective intervention of treating glioblastoma Background The growth and recurrence of several cancers appear to be driven by a population of cancer stem cells ( CSCs ) . Glioblastoma , the most common primary brain tumor , is invariably fatal , with a median survival of approximately 1 year . Although experimental data have suggested the importance of CSCs , few data exist regarding the potential relevance and importance of these cells in a clinical setting . Methods We here present the first seven patients treated with a dendritic cell (DC)-based vaccine targeting CSCs in a solid tumor . Brain tumor biopsies were dissociated into single-cell suspensions , and autologous CSCs were exp and ed in vitro as tumorspheres . From these , CSC-mRNA was amplified and transfected into monocyte-derived autologous DCs . The DCs were aliquoted to 9–18 vaccines containing 107 cells each . These vaccines were injected intradermally at specified intervals after the patients had received a st and ard 6-week course of post-operative radio-chemotherapy . The study was registered with the Clinical Trials.gov identifier NCT00846456 . Results Autologous CSC cultures were established from ten out of eleven tumors . High- quality RNA was isolated , and mRNA was amplified in all cases . Seven patients were able to be weaned from corticosteroids to receive DC immunotherapy . An immune response induced by vaccination was identified in all seven patients . No patients developed adverse autoimmune events or other side effects . Compared to matched controls , progression-free survival was 2.9 times longer in vaccinated patients ( median 694 vs. 236 days , p = 0.0018 , log-rank test ) . Conclusion These findings suggest that vaccination against glioblastoma stem cells is safe , well-tolerated , and may prolong progression-free survival In this Phase I trial , patients ' peripheral blood dendritic cells were pulsed with peptides eluted from the surface of autologous glioma cells . Three biweekly intradermal vaccinations of peptide-pulsed dendritic cells were administered to seven patients with glioblastoma multiforme and two patients with anaplastic astrocytoma . Dendritic cell vaccination elicited systemic cytotoxicity in four of seven tested patients . Robust intratumoral cytotoxic and memory T-cell infiltration was detected in two of four patients who underwent reoperation after vaccination . This Phase I study demonstrated the feasibility , safety , and bioactivity of an autologous peptide-pulsed dendritic cell vaccine for patients with malignant glioma The results are reported of a r and omized prospect i ve clinical trial carried out to assess the value of specific active immunotherapy using irradiated autologous tumour cells in patients with glioblastoma multiforme treated by radical surgery and post-operative irradiation . The results in 62 patients show no statistically significant difference in survival between the group receiving adjuvant autologous tumour cells and those treated with surgery and radiotherapy alone . All 27 patients receiving tumour cells were dead at 30 months , whereas 7 of the 35 controls were alive at this time . The results were considered sufficiently discouraging to ab and on the trial at this stage on the grounds that there was sufficient evidence in this study that the administration of irradiated autologous cells was of no benefit to patients with high grade astrocytomata Although outcome following bevacizumab among recurrent grade IV malignant glioma patients is documented as poor by several analyses , outcome for recurrent grade III patients following bevacizumab therapy has not been specifically evaluated . We performed a pooled analysis of 96 recurrent grade III malignant glioma patients enrolled on three consecutive phase II bevacizumab salvage trials to evaluate overall outcome following bevacizumab trial discontinuation . Outcome on the three bevacizumab trials , which included similar eligibility , treatment and assessment criteria , was comparable . Forty-nine patients who progressed on bevacizumab trial therapy and remained alive for at least 30 days elected to receive additional therapy . These patients achieved a median PFS-6 and OS of 30.6 % ( 95 % CI : 18.4 , 43.6 ) and 10.3 months ( 95 % CI : 5.2 , 11.7 ) , respectively . Among patients who continued bevacizumab therapy ( n = 23 ) after study progression , PFS-6 and median OS were 39.1 % ( 95 % CI : 19.9 , 58.0 ) and 9.2 months ( 95 % CI : 5.2 , 13.6 ) , respectively , compared to 23.1 % ( 95 % CI : 9.4 , 40.3 ; P = 0.51 ) and 10.3 months ( 95 % CI : 2.5 , 14.4 ; P = 0.91 ) for patients who initiated non-bevacizumab containing therapy ( n = 26 ) . Outcome after discontinuation of bevacizumab therapy for recurrent grade III malignant glioma patients is associated with improved outcome compared to historical data for recurrent grade IV malignant glioma patients . Salvage therapies following bevacizumab failure have modest activity for grade III malignant glioma patients that is independent of further bevacizumab continuation Abstract Object Treatment for glioblastoma multiforme has failed to show any progress for decades . While specific immunization with tumor cells modified with Newcastle-Disease-Virus ( NDV ) has been reported successful in some extracerebral tumors , its effect on glioblastoma is unknown . We report on 11 patients , in whom this approach was analyzed . Methods A vaccine was produced from autologous tumor cell cultures of 11 patients with glioblastoma . After completed surgery and radiotherapy an intracutaneous vaccination was performed 4 times with a 2 week interval and finally after 3 months . Local reactions , general side effects and survival were monitored closely . Results The local reaction of the skin after injection of vaccine increased from 1.67 to 4.05 cm2 in 8 weeks . The skin reaction after parallel injection of inactivated , untreated tumor cells increased from 0.11 to 1.09 cm2 . The median survival was 46 weeks ( mean 60 weeks ) . No side effects were noted . Conclusion Active specific immunization with NDV-modified glioblastoma cells produced a noticeable peripheral immune response . In this preliminary series survival of patients was not significantly longer after active specific immunization than after combined treatment of surgery , radiotherapy and chemotherapy . As there were no side effects , however , active specific immunization may be nobreak considered an alternative in the management of glioblastoma PURPOSE A r and omised , open label phase III trial was conducted to evaluate efficacy of nimotuzumab , a monoclonal antibody against epidermal growth factor receptor ( EGF-R ) added to st and ard therapy for newly diagnosed glioblastoma . PATIENTS AND METHODS 149 glioblastoma patients stratified as with or without residual tumour were r and omly assigned to receive either intravenous nimotuzumab 400 mg weekly added to st and ard radiochemotherapy followed by 400 mg biweekly after twelve weeks or st and ard radiochemotherapy . Progression status after 52 weeks ( 12moPFS ) and progression-free survival ( PFS ) based on Macdonald criteria were co- primary and overall survival ( OS ) , toxicity and quality of life secondary end-points . RESULTS 142 patients were evaluated for efficacy ( per protocol cohort ) . 12 moPFS was 25.6 % in the experimental arm and 20.3 % in the control group . In residual tumour patients ( n=81 ) median PFS was 5.6 versus 4.0 months , ( hazard ratio ( HR ) , 0.87 ; 95 % confidence interval ( CI ) , 0.55 - 1.37 ) , for patients without residual tumour ( n=61 ) it was 10.6 versus 9.9 months , ( HR , 1.01 ; 95 % CI , 0.57 - 1.77 ) . Median OS in patients with residual tumour was 19.5 versus 16.7 months , ( HR , 0.90 ; 95 % CI , 0.52 - 1.57 ; P=0.7061 ) , for patients without 23.3 versus 21.0 months ( HR , 0.77 ; 95 % CI , 0.41 - 1.44 ; P=0.4068 ) . A small cohort of MGMT non-methylated patients with residual tumour showed PFS of 6.2 versus 4.0 months ( HR , 0.77 ; 95 % CI , 0.35 - 1.67 ; P=0.4997 ) and OS of 19.0 versus 13.8 months ( HR , 0.66 ; 95 % CI , 0.27 - 1.64 ; P=0.3648 ) . EGF-R amplification did not correlate with clinical efficacy of nimotuzumab . Nimotuzumab was well tolerated . CONCLUSION This study , albeit negative , contains hypothesis generating signals supporting evaluation of correlative , efficacy-predicting tumour parameters for nimotuzumab in the treatment of glioblastoma This study was performed to obtain safety and survival data for patients with histologically confirmed recurrent glioblastoma multiforme ( GBM ) who received intralesional lymphokine-activated killer ( LAK ) cells following surgery . LAK cells were generated by incubating peripheral blood mononuclear cells with interleukin-2 for 3 to 5 days in vitro . Forty patients with pathologic confirmation of GBM at surgery had placement of autologous LAK cells into the tumor cavity . The 23 men and 17 women had a median age of 48 years ( range 21–76 ) . The median interval from the original diagnosis of glioma to LAK treatment was 10.9 months . Patients received an average of 2.0 ± 1.0 × 109 LAK cells , with viability of 91 ± 6.8 % . Treatment was well tolerated ; there was one death within 60 days . At a median follow-up of 2.3 years , median survival post-LAK was 9.0 months ; 1-year survival was 34 % . Gender , age , location of tumor , LAK cell lytic activity , number of cells implanted , and inclusion of interleukin-2 at cell instillation were not correlated with outcome . Median survival from the date of original diagnosis for 31 patients who had GBM at initial diagnosis was 17.5 months versus 13.6 months for a control group of 41 contemporary GBM patients ( p2 = 0.012 ) . This treatment is safe and feasible . The median survival rates are higher than reported in most published series of patients who underwent reoperation for recurrent GBM . A r and omized trial would be needed to establish therapeutic benefit PURPOSE Immunologic targeting of tumor-specific gene mutations may allow precise eradication of neoplastic cells without toxicity . Epidermal growth factor receptor variant III ( EGFRvIII ) is a constitutively activated and immunogenic mutation not expressed in normal tissues but widely expressed in glioblastoma multiforme ( GBM ) and other neoplasms . PATIENTS AND METHODS A phase II , multicenter trial was undertaken to assess the immunogenicity of an EGFRvIII-targeted peptide vaccine and to estimate the progression-free survival ( PFS ) and overall survival ( OS ) of vaccinated patients with newly diagnosed EGFRvIII-expressing GBM with minimal residual disease . Intradermal vaccinations were given until toxicity or tumor progression was observed . Sample size was calculated to differentiate between PFS rates of 20 % and 40 % 6 months after vaccination . RESULTS There were no symptomatic autoimmune reactions . The 6-month PFS rate after vaccination was 67 % ( 95 % CI , 40 % to 83 % ) and after diagnosis was 94 % ( 95 % CI , 67 % to 99 % ; n = 18 ) . The median OS was 26.0 months ( 95 % CI , 21.0 to 47.7 months ) . After adjustment for age and Karnofsky performance status , the OS of vaccinated patients was greater than that observed in a control group matched for eligibility criteria , prognostic factors , and temozolomide treatment ( hazard ratio , 5.3 ; P = .0013 ; n = 17 ) . The development of specific antibody ( P = .025 ) or delayed-type hypersensitivity ( P = .03 ) responses to EGFRvIII had a significant effect on OS . At recurrence , 82 % ( 95 % CI , 48 % to 97 % ) of patients had lost EGFRvIII expression ( P < .001 ) . CONCLUSION EGFRvIII-targeted vaccination in patients with GBM warrants investigation in a phase III , r and omized trial BACKGROUND This study sought to evaluate effectiveness of autologous dendritic cell vaccine ( immunotherapy ) for glioblastoma multiforme ( GBM ) . METHODS Patients 14 to 70 years of age with newly diagnosed GBM and Karnofsky Performance Scale ( KPS ) score > 70 who were receiving initial treatment were enrolled and were r and omized into 2 groups during the 5-year study period . Eighteen patients underwent conventional treatment ( surgery , radiotherapy , and chemotherapy ) and received adjuvant autologous dendritic cell vaccine , and 16 patients ( control group ) underwent conventional treatment only . Administration of the vaccine was begun within 1 to 2 months postoperatively , with 10 inoculations given over 6 months . Outcome measures were overall survival ( OS ) ; progression-free survival ( PFS ) ; 1- , 2- , and 3-year survival rates , and quality of life ( QoL ) . RESULTS Follow-up time ranged from 14 to 56 months ( median , 33 months ) . The 1- , 2- , and 3-year survival rates were 88.9 % , 44.4 % , and 16.7 % for the vaccine group , respectively , and 75.0 % , 18.8 % , and 0 % , respectively , for the control group , ( P = 0.299 , 0.0035 , 0.0014 , respectively ) . The median OS for the vaccine group was 31.9 months and for the control group was 15.0 months ( P < 0.002 ) . The median progression-free survival ( PFS ) for the vaccine group was 8.5 months , and 8.0 months for the control group ( P = 0.075 ) . The surviving fraction was significantly higher in the vaccine group based on Kaplan-Meier analysis . CONCLUSIONS Adjuvant immunotherapy with whole-cell lysate dendritic cell vaccine may improve short-term survival . It seems to be safe , and its long-term effectiveness is worthy of further investigation |
327 | 10,711,565 | Factors shown to increase perineal integrity include avoiding episiotomy , spontaneous or vacuum-assisted rather than forceps birth , and in nulliparas , perineal massage during the weeks before childbirth .
Second-stage position has little effect . | OBJECTIVE To review systematic ally techniques proposed to prevent perineal trauma during childbirth and meta-analyze the evidence of their efficacy from r and omized controlled trials . | The maternal half-sitting and supine position during the second stage of fullterm labor was compared in 100 women who , after identical opening phases in supine position , r and omly delivered in half-sitting ( 50 degrees , n = 50 ) or supine position ( n = 50 ) . The whole duration of the second stage of labor or the time spent in active pushing did not differ between the groups . Vacuum extraction was needed twice ( 4 % ) in the group delivering in half-sitting and six times ( 12 % ) in the group delivering in supine position . Vaginal tear occurred in one mother in both groups . Early decelerations in fetal cardiotocography were seen 22 times in half-sitting and 14 times in supine group ( p less than 0.05 ) . However , late decelerations were seen in only one mother with half-sitting , as compared to five mothers with supine position . Four infants of mothers giving birth in supine position had 1 minute APGAR scores 7 or less , whereas all infants of mothers delivering in half-sitting position had APGAR scores higher than 7 . Subjectively the mothers liked more the half-sitting position . We conclude that a women can deliver in half-sitting position without maternal or fetal risks Two hundred ninety-four women were r and omly allocated to a group in which the use of a birthing stool ( experimental group ) or a conventional semirecumbent position ( control group ) was encouraged . The birthing stool was 32 cm high and allowed the parturient to sit upright and to squat . The husb and could sit close behind his wife and support her back . No differences were observed between the two groups regarding mode of delivery , length of the second stage of labor , oxytocin augmentation , perineal trauma , labial lacerations , or vulvar edema . Infant outcome measured by Apgar scores at 1 and 5 minutes postpartum and numbers of neonatal intensive care unit transfers was the same in both groups . Mean estimated blood loss and the number of mothers with a postpartum hemorrhage 600 ml or more were greater in the experimental group than in the control group . Women in the experimental group reported less pain during the second stage of labor , and they and their spouses were more satisfied with the birth position than were parents in the control group . Midwives were less satisfied with their working posture in the experimental group OBJECTIVE : To compare the outcomes of the current practice of liberally or routinely employing episiotomy to prevent perineal tears and pelvic floor relaxation ( control group ) to a policy of restricting episiotomy use to specific fetal and maternal indications ( experimental group ) . DESIGN : A r and omized controlled trial ( RCT ) . SETTING : Three university hospitals in Montreal . SUBJECTS : Seven hundred three low-risk women enrolled at 30 to 34 weeks of gestation were r and omized late in labor to the design ated trial arm , by parity , and followed up to 3 months postpartum . MAIN OUTCOME MEASURES : Antepartum and postpartum information on perineal trauma and pain , pelvic floor symptoms ( urinary incontinence ) , and sexual activity was collected through the use of st and ard question naires ; pelvic floor function was measured by electromyographic ( EMG ) perineometry . RESULTS : Restricting episiotomy use in primiparous women was associated with similar sutured perineal trauma to the liberal or routine approach . Multiparous women in the restricted episiotomy group more often gave birth with an intact perineum ( 31 % compared with 19 % , odds ratio ( OR ) = 1.85 , 95 % confidence interval ( CI ) = 1.09 to 3.16 ) . All but one 3rd/4th-degree perineal tear was associated with median episiotomy ( 46 of 47 in primiparous women and 6 of 6 among multiparous women ) . No difference between trial groups was found in postpartum perineal pain , antepartum and 3-month postpartum EMG perineometry , and urinary and pelvic floor symptoms . CONCLUSIONS : We found no evidence that liberal or routine use of episiotomy prevents perineal trauma or pelvic floor relaxation . Virtually all severe perineal trauma was associated with median episiotomy . Restriction of episiotomy use among multiparous women result ed in significantly more intact perineums and less perineal suturing Women throughout the ages have preferred to be delivered with their trunks vertical and most delivery positions illustrated in historical texts show birth in an upright posture with abducted thighs . A consumer attitude study in our hospital showed that patients have considerable interest in alternative birth positions . Squatting has been advocated to prevent caval compression , increase the diameter of the pelvic outlet and , perhaps with least justification , to enlist the force of gravity and thereby facilitate maternal expulsive effort . Despite the extensive literature advocating squatting birth , the suggested advantages of this method have not been examined in any formal , let alone unbiased study . We therefore conducted a r and omised trial to examine the effect of squatting on the duration of second stage of labour , the duration of pushing , and several other variables One hundred eighteen nulliparous patients delivered under conduction anesthesia who met the st and ard criteria for low forceps delivery were r and omly assigned to one of three groups to be delivered by low Tucker-McLane forceps , Silastic vacuum extraction system , or Mityvac vacuum extractor . Significant maternal soft tissue trauma was identified in 48.9 % of the forceps group , 36.1 % of the Silastic group , and 21.6 % of the Mityvac group . Superficial fetal scalp changes were found in 71 % of the forceps group , 44 % of the Silastic group , and 46 % of the Mityvac group . Of these , cephalhematomatas were noted in 2.2 % of the forceps group , 13.9 % of the Silastic group , and 16.2 % of the Mityvac group . All three instruments were considered effective outlet delivery Episiotomy is a widely-done intervention in childbirth , regardless of poor scientific evidence of its benefits . This r and omised controlled trial compares selective with routine use of a mediolateral episiotomy for women having first and second deliveries in 8 public maternity units in Argentina . 2606 women participated ; 1555 were nulliparous ( 778 in the selective group and 777 in the routine group ) and 1051 primiparous ( 520 in the selective group and 531 in the routine group ) . The two interventions compared were selective ( limited to specified maternal or fetal indications ) , and routine episiotomy ( following the hospital 's previous policy ) . Episiotomy was done in 30.1 % of deliveries in the selective , and 82.6 % in the routine group . The main outcome measure was severe perineal trauma . Severe perineal trauma was uncommon in both groups but was slightly less frequent in the selective group ( 1.2 % vs 1.5 % ) . Anterior perineal trauma was more common in the selective group but posterior perineal surgical repair , perineal pain , healing complications , and dehiscence were all less frequent in the selective group . Routine episiotomy should be ab and oned and episiotomy rates above 30 % can not be justified One hundred and eighty one primigravid women delivering vaginally in July and August 1982 in the Rotunda Hospital , Dublin , were r and omly allocated to one of two groups . Patients in one group were to undergo episiotomy . Those in the other group were not to undergo episiotomy unless it was considered to be essential . The outcome was compared with that of the clinical practice over the previous six months at the hospital . Of the 92 patients allocated not to undergo episiotomy , seven ( 8 % ) had one done for medical reasons compared with 507 ( 89 % ) in the previous six months . First degree tears occurred in 23 ( 25 % ) and second degree tears in 43 ( 47 % ) . Nineteen ( 21 % ) , however , retained an intact perineum compared with only 35 ( 6 % ) of the women who had delivered in the preceding six months . Assessment s of perineal pain , bruising , swelling , and healing and records of ingestion of analgesics were made for the first four days after delivery , and again at a check up six weeks after delivery , in patients who had had spontaneous vertex deliveries . Forty patients who underwent episiotomy and 37 who sustained a second degree tear formed two comparable groups . There was no difference in outcome between them . Data were also evaluated for 19 women who retained an intact perineum , 22 who sustained a first degree tear , and 11 who underwent episiotomy and epidural anaesthesia ; all 52 of these women had spontaneous vertex deliveries . Despite severe soft tissue injury in two patients those who fared best were those who retained an intact perineum . First degree tears were associated with symptoms similar to those associated with second degree tears . Those who fared worst were women who underwent episiotomy after epidural anaesthesia . The value of routine episiotomy in primigravid patients is question ed , but the final decision can be made only by the accoucheur at the time of imminent delivery The association between episiotomy and severe ( third- and fourth-degree ) perineal lacerations was studied in 24,114 women . The overall rates of severe lacerations were 8.3 and 1.5 % for primiparous and multiparous women , respectively . Women who had midline episiotomies were nearly 50 times more likely and women who had mediolateral episiotomies were over eight times more likely to suffer a severe laceration than were women who did not undergo an episiotomy . Severe lacerations were also more common after use of forceps , in occiput transverse and posterior presentations , among women with smaller pelvic outlet measurements or lower prepregnant weight , and with larger fetuses . The same factors that caused a woman to have an increased risk of laceration also made performance of an episiotomy more likely . After statistical adjustment for these risk factors , mediolateral episiotomy was associated with a 2.5-fold reduction in the risk of severe lacerations among primiparous women , and a statistically nonsignificant 2.4-fold increase among multiparous women , compared with no episiotomy . Midline episiotomy was associated with statistically significant 4.2- and 12.8-fold increases in the risk of lacerations among primiparous and multiparous women , respectively . We conclude that the risks and benefits of midline episiotomy should be evaluated in a r and omized clinical trial that compares policies of “ usual ” versus conservative use of episiotomy Abstract . The incidence and magnitude of retinal hemorrhages ( RH ) in a group of 23 preterm infants ( 29–35 weeks ) born spontaneously in vertex presentation have been compared with those of 23 others ( 28‐35 weeks ) born by gentle extraction with small forceps . Distribution to the groups was r and om . The overall frequency of RH in both groups together was low , 6 % , with no statistically significant difference between the groups . No fundi with severe ( grade III ) hemorrhages were seen . Both the incidence and magnitude of RH were less in the preterm neonates when compared with previously reported figures in term infants born spontaneously or with forceps extraction . The study provides further evidence in support of the hypothesis that fetal head compression with venous congestion is the main cause of RH in the newborn Although the performance of perineal massage by a woman or her partner during the last weeks of pregnancy may help to prevent perineal trauma at delivery , the technique has never been evaluated rigorously . This study examined the feasibility of a r and omized , controlled trial , and more specifically assessed the participation rate , the acceptability of the intervention , and whether or not an attending physician could remain blind to participants ' groups . The pilot study was a single-blinded , r and omized , controlled trial . Nulliparous women , 32 to 34 weeks pregnant , were recruited from June 8 to July 31 , 1992 , at the offices of family physicians and obstetricians who practice at the Hôpital du Saint-Sacrement in Quebec City . Women assigned to the intervention group practice d daily 10-minute perineal massage and completed a diary , and those in the control group had st and ard care . Women and attending physicians completed a question naire about the aspect of blindness . Among the 174 women who delivered during the study period , 104 ( 59.8 % ) were approached by a midwife and 46 ( 26.4 % ) were r and omized . Twenty ( 91.0 % ) of the 22 women in the massage group returned their perineal massage diaries . Based on the postpartum question naire , 20 women practice d the technique at least four times a week for three weeks or longer . No woman in the control group practice d massage . The attending physician was aware of the woman 's group in only three instances ( 6.7 % ) . Based on the results of this pilot study , a r and omized , controlled trial to evaluate the efficacy of perineal massage in preventing perineal trauma at birth appears feasible Objective To compare the effect of two methods of perineal management used during spontaneous vaginal delivery on the prevalence of perineal pain reported at 10 days after birth OBJECTIVE Our purpose was to compare consequences for women of receiving versus not receiving median episiotomy early and 3 months post partum on the outcomes perineal pain , urinary and pelvic floor functioning by electromyography , and sexual functioning and to analyze the relationship between episiotomy and third- and fourth-degree tears . STUDY DESIGN A secondary cohort analysis was performed of participants within a r and omized clinical trial , analyzed by type of perineal trauma and pain , pelvic floor , and sexual consequences of such trauma , while controlling for trial arm . The study was conducted in three university or community hospitals ; 356 primiparous and 341 multiparous women were studied . RESULTS Early and 3-month-postpartum perineal pain was least for women who gave birth with an intact perineum . Spontaneous perineal tears were less painful than episiotomy . Sexual functioning was best for women with an intact perineum or perineal tears . Postpartum urinary and pelvic floor symptoms were similar in all perineal groups . At 3 months post partum those delivered with an intact perineum had the strongest pelvic floor musculature , those with episiotomy the weakest . Among primiparous women third- and fourth-degree tears were associated with median episiotomy ( 46/47 ) . After forceps births were removed and 21 other variables potentially associated within such tears were controlled for , episiotomy was strongly associated with third- and fourth-degree tears ( odds ratio + 22.08 , 95 % confidence interval 2.84 to 171.53 ) . Physicians using episiotomy at high rates also used other procedures , including cesarean section , more frequently . CONCLUSION Perineal and pelvic floor morbidity was greatest among women receiving median episiotomy versus those remaining intact or sustaining spontaneous perineal tears . Median episiotomy was causally related to third- and fourth-degree tears . Those using episiotomy at the highest rates were more likely use other interventions as well . Episiotomy use should be restricted to specified fetal-maternal indications A new obstetric chair has been design ed to overcome some of the problems of those currently available commercially . The chair has been used to assess the effects of the sitting position in the second stage of labour on the outcome of delivery in 304 women r and omly allocated to be delivered either in the chair or in the conventional dorsal position . Delivery in the chair conferred no benefits to mother or baby and result ed in greatcr mean blood loss and a higher rate of postpartum haemorrhage Summary . A total of 304 women , for whom operative delivery was considered necessary in the second stage of labour , were r and omly assigned to delivery by vacuum extraction or forceps . Of those allocated to forceps a higher proportion of babies were actually delivered with the allocated instrument ; however , the caesarean section rate was also higher in this group . Maternal trauma , use of analgesia and blood loss at delivery were significantly less in the group allocated to vacuum extraction . Vacuum extraction did , however , appear to predispose to an increase in mild neonatal jaundice . More serious neonatal morbidity was rare in both groups and the trial was of insufficient size to rule out a clinical ly important differential effect of the two instruments on these measures of outcome . Another trial is now needed to address this still open question more rigorously In a prospect i ve r and omized study , women who practice d perineal massage during the last 6 weeks of pregnancy ( n = 10 ) were compared with a control group ( n = 10 ) . The experimental group was comprised of healthy parous and nulliparous women . Control subjects were matched for parity , fetal weight , gestational age , and maternal age . Chisquare analysis for independence was significant ( ξ2 = 9.89 p < .01 ) . This study supported the hypothesis that women who practice perineal massage at least four times per week will have a lower incidence of episiotomy and lacerations than those who do not It is routine to require women to ' take a deep breath in , hold it and push ' in the second stage of labour , but there is no scientific evidence to support this practice . In a r and omized controlled trial of spontaneous ( n = 15 ) versus directed ( n = 17 ) pushing in the second stage , no adverse effects of spontaneous pushing on the woman or baby were found . There was a negative correlation between the length of the second stage and the venous cord blood pH at delivery in the directed pushing group , suggesting that a long second stage was disadvantageous to the fetus when the woman was using a directed pushing technique . No such association was found in the spontaneous pushing group , despite the fact that the women in this group had a significantly longer mean second stage Background . Pushing in the second stage of labor can be forced or follow the spontaneous urge to bear down . Recent studies have shown that spontaneous pushing results in a longer second stage , fewer CTG changes , higher arterial pH and less damage to the birth canal . Method . R and omized trial of spontaneous vs. forced pushing in 350 primiparous women . Results . There was no difference between the r and omized groups in duration of second stage of labor , umbilical arterial pH or damage to the birth canal . Of the women allotted to spontaneous pushing , 65.6 % used the closed glottis technique for more than half the expulsive phase . When dividing the women into two groups according to the actual pushing technique used most , open or closed glottis , it turned out that women who used the open glottis technique had a shorter second stage of labor and gave birth to infants with lower birth weight Objective To study the effects of antenatal perineal massage on subsequent perineal outcomes at delivery A controlled clinical trial involving 151 primigravidae and 18 midwives assessed the acceptability and outcome of second‐stage labour in upright positions . Women who had no specific antenatal preparation and preferences regarding labour positions were managed either conventionally ( semi‐recumbent and lateral ) , or encouraged to adopt upright positions ( squatting , kneeling , sitting or st and ing ) according to individual preference . Of the women allocated to the upright position 74 % completed the second stage upright , with kneeling being the most favoured position , but squatting was , despite all assistance , too difficult to maintain . Adoption of upright positions result ed in a higher rate of intact perineums . There was a clinical ly apparent reduction of forceps deliveries in the upright group which influenced midwives ' attitudes . Moving the parturient from recumbent to upright positions was often perceived to be beneficial when there was slow progress . Estimated blood loss was similar in the two groups , as was the condition of the newborn ( Apgar score and umbilical artery pH ) . Alternative positions in the second stage of labour , in particular kneeling , are achievable even without specific birth aids and antenatal preparation . They appear safe , acceptable to most parturients and their midwives , and arc easily integrated into modern labour ward practice ; they may have clinical advantages which need further investigation The study was conducted on 200 normal pregnant women who were r and omly classified into 2 groups of 100 cases each . The control group comprised mothers in supine position throughout labour and delivery ( 46 primigravidae and 54 multigravidae ) . The squatting group consisted of cases who were kept ambulatory during the 1st stage and were asked to squat on ordinary delivery cots during the 2nd stage of labour . Third stage of labour was conducted in supine position . The squatting group comprised 42 primigravidae and 58 multigravidae . There was a mean difference ( shortening ) of 3 hours in primigravidae and 2 hours in multigravidae in the duration of 1st stage of labour between the squatting and control groups . In the duration of 2nd stage of labour the mean differences in primigravidae and multigravidae of the squatting and control groups were 20 and 13.5 minutes respectively . In the squatting group there were 79 normal vaginal delivery , 16 forceps delivery and 5 caesarean sections whereas in the control group there were 80 , 18 and 2 cases respectively . Although foetal complications were comparable in both the groups , the incidence of maternal injuries was observed in 14 cases in control group and 38 cases in squatting group . It was concluded that without proper birthing chairs which can give good perineal support , the usual supine position is preferable A new obstetric aid , the ' Birth Cushion ' allows the parturient to sink into a supported squatting posture for the second stage of labour and delivery ; it fits onto conventional delivery beds . A prospect i ve , controlled trial of 427 primiparae compared the outcome of labour in women r and omly allocated to squatting ( 218 ) or conventional semirecumbent ( 209 ) management . The squatting group had significantly fewer forceps deliveries ( 9 % vs 16 % ) and significantly shorter second stages ( median length of pushing 31 vs 45 min ) than the semirecumbent group . There were fewer perineal tears , but more labial tears , in the squatting group . Apgar scores , blood loss , and post-partum vulvar oedema were similar in both groups . 82 % of the women in the squatting group maintained upright positions for most of the second stage , and reported great satisfaction with the supported squatting position . The traditional birth posture of squatting can be easily adapted for modern labour management and has advantages for women in their first labour One thous and women were allocated at r and om to one of two perineal management policies , both intended to minimise trauma during spontaneous vaginal delivery . In one the aim was to restrict episiotomy to fetal indications ; in the other the operation was to be used more liberally to prevent perineal tears . The result ant episiotomy rates were 10 % and 51 % respectively . An intact perineum was more common among those allocated to the restrictive policy . This group experienced more perineal and labial tears , however , and included four of the five cases of severe trauma . There were no significant differences between the two groups either in neonatal state or in maternal pain and urinary symptoms 10 days and three months post partum . Women allocated to the restrictive policy were more likely to have resumed sexual intercourse within a month after delivery . These findings provide little support either for liberal use of episiotomy or for cl aims that reduced use of the operation decreases postpartum morbidity This study examines the use of episiotomy and the frequency of perineal lacerations in a primary care maternity center staffed by certified nurse midwives ( Booth Maternity Center ) and a tertiary care teaching hospital where deliveries were performed by physicians ( Thomas Jefferson University Hospital ) . The study sample ( 1262 women ) was a stratified r and om selection of singleton live births in 1977 and 1978 at Booth Maternity Center and Thomas Jefferson University Hospital , with the demographic characteristics of women at Booth Maternity Center used as the sampling frame . Data were abstract ed from medical records . Clinical and demographic factors that might be associated with the likelihood of having an episiotomy or experiencing a perineal laceration were examined using logistic regression . After controlling for other significant factors , women at Thomas Jefferson University Hospital were twice as likely to have an episiotomy as women at Booth Maternity Center . Use of an episiotomy was associated with a decrease in perineal lacerations of first- or second-degree , but a fourfold increase in the incidence of third-degree lacerations Objective — To determine whether nulliparae whose second stage of labour is conducted in an obstetric birth chair have a lower incidence of instrumental delivery than those using a conventional delivery bed OBJECTIVE The aim of the study was to evaluate the effectiveness of perineal massage during pregnancy for the prevention of perineal trauma at birth . STUDY DESIGN Pregnant women with ( n = 493 ) and without ( n = 1034 ) a previous vaginal birth from 5 hospitals in the province of Québec , Canada , participated in this single-blind , r and omized , controlled trial . All participants received oral and written information on the prevention of perineal trauma . Women in the experimental groups were requested to perform a 10-minute perineal massage daily from the 34th or 35th week of pregnancy until delivery . RESULTS Among participants without a previous vaginal birth , 24.3 % ( 100/411 ) from the perineal massage group and 15.1 % ( 63/417 ) from the control group were delivered vaginally with an intact perineum , for a 9.2 % absolute difference ( 95 % confidence interval 3.8%-14.6 % ) . The incidence of delivery with an intact perineum increased with compliance with regular practice of perineal massage ( chi2 for trend 13.2 , P = 0.0003 ) . Among women with a previous vaginal birth , 34.9 % ( 82/235 ) and 32.4 % ( 78/241 ) in the massage and control groups , respectively , were delivered with an intact perineum , for an absolute difference of 2.5 % ( 95 % confidence interval -6.0 % to 11.0 % ) . There were no differences between the groups in the frequency of sutured vulvar and vaginal tears , women 's sense of control , and satisfaction with the delivery experience . CONCLUSION Perineal massage is an effective approach to increasing the chance of delivery with an intact perineum for women with a first vaginal delivery but not for women with a previous vaginal birth A r and omised study of 189 deliveries was conducted to compare performance in the conventional dorsal position with that in a birth chair . There was no significant difference in the length of the second stage of labour , the time spent bearing down , or the need for operative delivery . Overall blood-loss was greater among patients delivered in the chair but more of this group had either an intact perineum or only superficial damage . The condition of the neonates in the two delivery groups was similar A r and omised prospect i ve study of 407 primiparous patients compared the consequences of midline and mediolateral episiotomies . The patients ' estimates of the pain from their episiotomies were similar . Anal sphincter injury was significantly more common after a midline procedure but no rectovaginal fistulae occurred . Scarring was less noticeable after the midline incision and intercourse began earlier Summary . In a trial conducted at the North Staffordshire and Billinge Maternity Hospitals ( NSMH and BMH ) a total of 264 women who required an assisted delivery in the second stage of labour were r and omly assigned to be delivered either by Kobayashi silicone cup ventouse or by forceps . A larger proportion ( 90 % ) of those assigned to the forceps group were actually delivered by the allocated instrument compared to those in the silicone cup group ( 73 % ) . However , there was a significantly higher rate of maternal morbidity in terms of perineal trauma and discomfort in the forceps group . No differences in neonatal morbidity were detected OBJECTIVE Our purpose was to determine the efficacy of the obstetric forceps versus the M-cup , a new vacuum extractor cup , and maternal-neonatal complication rates . STUDY DESIGN Over a 10-month period operative vaginal deliveries were r and omized between the obstetric forceps and the M-cup vacuum extractor cup . Maternal demographics , indication for intervention , analgesia , position , station , degree of asynclitism , fetal caput-molding , and time from application to delivery were prospect ively recorded . Episiotomy and extensions , lacerations , and the reason for ab and onment of the r and omized instrument were noted in both groups . Fetal weight , Apgar scores , cord arterial gases , hyperbilirubinemia , phototherapy , and any evidence of fetal trauma were documented at delivery or in the nursery . RESULTS Six hundred thirty-seven women were r and omized , 315 in the forceps group and 322 in the M-cup group . There were no differences in maternal demographic variables . The station , position , degree of asynclitism , or requirement for rotation was not different between the groups . The corrected efficacy rates were forceps 92 % and M-cup 94 % ( p = 0.217 ) . The M-cup deliveries were accomplished more rapidly than forceps deliveries ( p < 0.001 ) and were associated with a lower rate of episiotomy ( p < 0.001 ) , third-degree ( p < 0.001 ) and fourth-degree ( p = 0.002 ) lacerations , but blood loss as clinical ly estimated ( p = 0.232 ) or as measured by hemoglobin levels ( p = 0.166 ) was not significantly different . Forceps deliveries were associated with fewer clinical ly diagnosed cephalhematomas ( p = 0.015 ) than M-cup deliveries were , but there were no differences in the number of neonates diagnosed with hyperbilirubinemia ( p = 0.377 ) or in the number of infants treated with phototherapy ( p = 0.660 ) . CONCLUSIONS The M-cup vacuum extractor cup appears to be as efficient ( and faster ) than the obstetric forceps but is associated with significantly more fetal cephalhematomas , whereas maternal injuries are more common with the forceps OBJECTIVE To compare assisted vaginal delivery by forceps with delivery by vacuum extractor , where a new vacuum extractor policy was employed which dictated the cup to be used in specific situations . DESIGN Multicentre r and omised controlled trial . SETTING Four district general hospitals in the West Midl and s. SUBJECTS Six hundred-seven women requiring assisted vaginal delivery , of whom 296 were allocated to vacuum extractor delivery and 311 to forceps . MAIN OUTCOME MEASURES Delivery success rate , maternal perineal and vaginal injuries , maternal anaesthetic requirements , neonatal scalp and facial injuries . RESULTS Of the vacuum extractor group , 85 % were delivered by the allocated instrument compared to 90 % in the forceps group ( odds ratio ( OR ) 0.64 ; 95 % confidence intervals ( CI ) 0.4 - 1.04 ) . However , more women in the vacuum extractor group were delivered vaginally ( 98 % ) than in the forceps group ( 96 % ) . There were significantly fewer women with anal sphincter damage or upper vaginal extensions in the vacuum extractor group ( 11 % vs 17 % , OR 0.6 ; 95 % CI , 0.38 - 0.97 ) . There were significantly fewer women in the vacuum extractor group requiring epidural or spinal anaesthetics ( 25.4 % vs 32.7 % , OR 0.69 ; 95 % CI 0.49 - 0.99 ) or general anaesthetics ( 1 % vs 4 % , OR 0.17 ; 95 % CI 0.04 - 0.76 ) . Although there were significantly more babies in the vacuum extractor group with cephalhaematomata ( 9 % vs 3 % , OR 3.3 ; 95 % CI 1.4 - 7.4 ) there were fewer babies in the vacuum extractor group with other facial injuries . There were three babies in the forceps group with unexplained neonatal convulsions . CONCLUSIONS Assisted vaginal delivery using the new vacuum extractor policy is associated with significantly less maternal trauma than with forceps . Further studies are required to assess neonatal morbidity adequately Summary : A prospect i ve study of 56 primigravidas was performed to assess the advantages , disadvantages and acceptability of the upright posture during the second stage of labour . Twenty‐seven patients laboured in the second stage in a birthing chair , in an upright position . Twenty‐one patients laboured in bed in the recumbent position and acted as controls . No difference could be found in the length of second stage , ease or type of delivery between the 2 groups . No differences were detected in the condition of the neonates between the 2 groups . This birthing chair was found to be an acceptable mode of delivery to most of those patients using it This prospect i ve study compared 29 nulliparous women who practice d perineal massage in the last 6 weeks of pregnancy with a control group of 26 . Episiotomy and /or second degree ( or greater ) perineal laceration occurred in 48 % of experimental subjects and 77 % of controls . Chi square analysis showed a significant difference between the groups ( p < 0.05 ) . Perineal massage may be one technique that will decrease the need for episiotomy . Suggestions for further research are discussed |
328 | 27,818,486 | In addition to the patients with comorbidities , it is unlikely that AMI patients suffering from cardiac instability , who are obliged to have bed rest , will perform conventional exercise training .
Nevertheless , even low-intensity resistance muscle training could be a burden for patients with cardiovascular instability .
Functional electrical stimulation or neuromuscular electrical stimulation ( NMES ) of muscles is expected to be an alternative mode of rehabilitation for AMI patients who are intolerant to conventional exercise training .
A meta- analysis of r and omized , controlled trials in CHF patients comparing NMES with conventional exercise training showed that conventional cycle training produced superior improvements in exercise capacity to that of NMES .
Also , compared with NMES therapy , conventional exercise training is more simple and practical in that no special apparatus is needed .
Therefore , the introduction of NMES is expected to raise the implementation rate of CR in patients who are intolerant of exercise training . | C ardiac rehabilitation ( CR ) , consisting of patient education and conventional exercise therapy such as aerobic or resistance muscle training , has been demonstrated to improve exercise capacity , quality of life , and longterm prognosis in patients with acute myocardial infa rct ion ( AMI ) , which is the reason why the introduction of CR after AMI is strongly recommended by clinical practice guidelines .
A systematic review of the existing literature on the participation and adherence to CR following AMI revealed that patients with comorbidities , such as chronic obstructive pulmonary disease ( COPD ) or depression , had a low participation rate , even if they underwent successful coronary revascularization .
The NMES of leg muscles is a modality that induces muscular contraction of the quadriceps and the gastrocnemius by the percutaneous stimulation of peripheral nerves through self-adhesive surface electrodes ( Figure ) .
NMES is a passive muscle training to maintain muscle mass and strength and prevent muscular atrophy .
Additionally , long-term NMES therapy of lower limb muscles was recently reported to improve vascular endothelial function , exercise capacity , and quality of life , and relieve emotional stress in chronic heart failure ( CHF ) patients with preserved left ventricular ejection fraction ( LVEF ) as well as those with reduced LVEF .
Could this NMES be a substitute for conventional exercise training ? | AIMS Patients with chronic heart failure ( CHF ) exhibit detrimental changes in skeletal muscle that contribute to their impaired physical performance . This study investigates the possibility of counteracting these changes by chronic low-frequency electrical stimulation ( CLFS ) of left and right thigh muscles . METHODS AND RESULTS ( mean+/-SD ) 32 CHF patients ( 53+/-10 years ) with an LVEF of 22+/-5 % , NYHA II-IV , undergoing optimized drug therapy , were r and omized in a CLFS group ( CLFSG ) or a control group ( controls ) . The groups differed in terms of the intensity of stimulation , which elicited strong muscle contractions only in the CLFSG , whereas the controls received current input up to the sensory threshold without muscle contractions . Functional capacity was assessed by peak VO(2 ) , work capacity , and a 6-min-walk ( 6-MW ) . Muscle biopsies were analyzed for myosin heavy chain ( MHC ) isoforms , citrate synthase ( CS ) and glyceraldehydephosphate dehydrogenase ( GAPDH ) activities . Peak VO(2)(mlmin(-1)kg -1 ) increased from 9.6+/-3.5 to 11.6+/-2.8 ( P<0.001 ) in the CLFSG , and decreased from 10.6+/-2.8 to 9.4+/-3.2 ( P<0.05 ) in the controls . The increase in the CLFSG was paralleled by increases in maximal workload ( P<0.05 ) and oxygen uptake at the anaerobic threshold ( P<0.01 ) . The corresponding values of the controls were unchanged , as also the 6-MW values , the MHC isoform distribution , and both CS and GAPDH activities . In the CLFSG , the 6-MW values increased ( P<0.001 ) , CS activity was elevated ( P<0.05 ) , GAPDH activity decreased ( P<0.01 ) , and the MHC isoforms were shifted in the slow direction with increases in MHCI at the expense of MHCIId/x ( P<0.01 ) . CONCLUSIONS Our results suggest that CLFS is a suitable treatment to counteract detrimental changes in skeletal muscle and to increase exercise capacity in patients with severe CHF OBJECTIVE Inflammation has been found to play a role in the etiology of cardiovascular disease as well as provoke endothelial dysfunction . Inflammatory cytokines associated with endothelial function are interleukin-6 ( IL-6 ) and tumor necrosis factor-alpha ( TNF-alpha ) . IL-6 is exercise intensity dependent and has been shown to inhibit TNF-alpha expression directly . The aim of this study was to investigate the interaction of IL-6 and TNF-alpha on endothelial function in response to acute exercise in overweight men exhibiting different physical activity profiles . METHODS AND PROCEDURES Using a r and omized mixed factorial design , 16 overweight men ( 8 active , maximal exercise capacity ( VO(2)peak ) = 34.2 + /- 1.7 , BMI = 27.4 + /- 0.7 and 8 inactive , VO(2)peak = 30.9 + /- 1.2 , BMI = 29.3 + /- 1.0 ) performed three different intensity acute exercise treatments . Brachial artery flow-mediated dilation ( FMD ) and subsequent blood sample s were taken pre-exercise and 1 h following the cessation of exercise . RESULTS Independent of exercise intensity , the active group displayed a 24 % increase ( P = 0.034 ) in FMD following acute exercise compared to a 32 % decrease ( P = 0.010 ) in the inactive group . Elevated ( P < 0.001 ) concentrations of IL-6 following moderate ( 50 % VO(2 ) ) and high ( 75 % VO(2 ) ) intensity acute exercise were observed in both groups ; however , concentrations of TNF-alpha were unchanged in response to acute exercise ( P = 0.584 ) . DISCUSSION The FMD response to acute exercise is enhanced in active men who are overweight , whereas inactive men who are overweight exhibit an attenuated response . The interaction of IL-6 and TNF-alpha did not provide insight into the physiological mechanisms associated with the disparity of FMD observed between groups |
329 | 19,104,375 | The rate of congenital malformations did not differ between pregnancies treated with insulin and those treated with oral agents .
: No substantial maternal or neonatal outcome differences were found with the use of glyburide or metformin compared with use of insulin in women with GDM | OBJECTIVE : Little is known about the comparative risks and benefits of medical treatments for gestational diabetes mellitus ( GDM ) .
We conducted a systematic review of r and omized controlled trials and observational studies of maternal and neonatal outcomes in women with GDM treated with oral diabetes agents compared with all types of insulin . | OBJECTIVE We sought to investigate the association between glyburide dose , degree of severity in gestational diabetes mellitus ( GDM ) , level of glycemic control , and pregnancy outcome in insulin- and glyburide-treated patients . STUDY DESIGN In a secondary analysis of our previous r and omized study , 404 women were analyzed . The association among glyburide dose , severity of GDM , and selected maternal and neonatal factors was evaluated . Severity levels of GDM were stratified by fasting plasma glucose ( FPG ) from the oral glucose tolerance test ( OGTT ) . Infants with birth weight at or above the 90th percentile were considered large-for-gestational age ( LGA ) . Macrosomia was defined as birth weight > or = 4000 g. Well-controlled was defined as mean blood glucose < or = 95 mg/dL. The association between glyburide- and insulin-treated patients by severity of GDM and neonatal outcome was evaluated . RESULTS The dose received for the glyburide-treated patients was 2.5 mg-32 % ; 5 mg-23 % ; 10 mg-17 % ; 15 mg-8 % ; and 20 mg-20 % . Patients were grouped into low ( < or = 10 mg ) and high ( > 10 mg ) daily dose of glyburide . A comparison between severity of the disease ( fasting plasma glucose categories ) and highest dose of glyburide revealed a significant difference between the low-95 FPG and the other severity categories ( P = .02 ) . Of patients in the well-controlled glycemic group , only 6 % required the high dose of glyburide ( > 10 mg ) . In patients with poor glycemic control ( mean blood glucose > 95 mg/dL ) , 38 % received the high dose of glyburide ( P = .0001 ) . Comparison between the high glyburide ( > 10 mg ) and the low glyburide dosages ( < or = 10 mg ) revealed that the rate of macrosomia was 16 % vs 5 % and LGA 22 % vs 8 % , ( P = .01 ) , respectively . No significant difference was found in composite outcome , metabolic complications , and Ponderal Index between the 2 dose groups . Stratification by disease severity revealed a significantly lower rate of LGA for both the glyburide- and insulin-treated subjects . No significant difference was found between metabolic , respiratory , and neonatal intensive care unit ( NICU ) for patients within each fasting plasma glucose severity category . CONCLUSION Glyburide and insulin are equally efficient for treatment of GDM in all levels of disease severity . Achieving the established level of glycemic control , not the mode of pharmacologic therapy , is the key to improving the outcome in GDM Objective To compare the use of glyburide and insulin in the treatment of gestational diabetes . Design R and omized controlled trial . Setting Maternal health clinics in San Antonio , Texas . Patients Women with mild gestational diabetes ( n = 404 ) at 11 - 33 weeks gestation . Only women with a singleton pregnancy were eligible . Intervention Glyburide ( starting dose 2.5 mg , increased as necessary to achieve target glycaemic control to a maximum of 20 mg ) or insulin ( 0.7 U per kg body weight , three times daily , increased as necessary ) . If blood glucose goals were not met after 2 weeks of treatment with the maximal dose of glyburide , treatment was switched to insulin . Main outcome measures Primary outcome was achievement of a desirable level of glycaemic control ( strict target ranges were set for mean , fasting , prepr and ial and postpr and ial blood glucose , measured by frequent home monitoring ) . Neonatal outcomes were also assessed . Main results Eighty-two percent of women in the glyburide group and 88 % of women in the insulin group achieved the target blood glucose values ( difference = -6 % , 95 % confidence interval ( CI ) -13 % to + 1 % , P = 0.07 ) . Considerably less women in the glyburide group had blood glucose values below 40 mg ( 2.2 mmol/l ) per decilitre ( 2 % vs. 20 % , difference -18 % , 95 % CI -24 % to -13 % , P < 0.0001 ) . In the glyburide group , 4 % of women were switched to insulin as the maximal dose failed to produce target blood glucose values . There were no significant differences in neonatal outcomes , including cord serum insulin . Conclusion Treatment of women with gestational diabetes , after the first trimester of pregnancy , with glyburide rather than insulin can achieve similar glycaemic control , with less hypoglycaemia OBJECTIVE We sought to determine whether pregnancy outcome differs between obese and morbidly obese GDM patients and to assess pregnancy outcome in association with mode of treatment and level of glycemic control . METHODS A cohort study of 4,830 patients with gestational diabetes ( GDM ) , treated in the same center using the same diabetic protocol , was performed . Obesity was defined as prepregnancy BMI > 30 and < 35 kg/m(2 ) ; morbid obesity was defined as prepregnancy BMI > or=35 kg/m(2 ) . Well-controlled GDM was defined as mean blood glucose < 105 mg/dl . Pregnancy outcome measures included the rates of large for gestational age ( LGA ) and macrosomic babies , metabolic complications , the need for NICU admission and /or respiratory support , rate of shoulder dystocia , and the rate of cesarean section . RESULTS Among the GDM patients , the rates of obesity and morbid obesity were 15.7 % ( 760 out of 4830 , BMI : 32.4+/-1.6 kg/m(2 ) ) and 11.6 % ( 559 out of 4830 , BMI : 42.6+/-2.2 kg/m(2 ) ) , respectively . No differences were found with regard to maternal age , ethnicity , gestational age at delivery or oral glucose tolerance test ( OGTT ) results . Moreover , similar rates of cesarean section , fetal macrosomia , shoulder dystocia , composite outcome , and metabolic complications were noted . Insulin treatment was initiated for 62 % of the obese and 73 % of the morbidly obese GDM patients ( P<0.002 ) . Similar rates of obese and morbidly obese patients achieved desired levels of glycemic control ( 63 % versus 61 % , respectively ) . In both obese and morbidly obese patients who achieved a desired level of glycemic control ( < 105 mg/dl ) , no difference was found in pregnancy outcome except that both neonatal metabolic complications and composite outcomes were more prevalent in diet-treated subjects in comparison to insulin-treated GDM patients . CONCLUSION In obese women with GDM , pregnancy outcome is compromised regardless of the level of obesity or treatment modality OBJECTIVES Equivalent efficacy of glyburide and insulin for treatment of gestational diabetes ( GDM ) was demonstrated in a recent r and omized trial . We describe our experience with glyburide in practice , and suggest factors that predict failure of glyburide treatment . METHODS Women with GDM treated with glyburide were studied . They were divided into two groups : those who achieved adequate glycemic control with glyburide , and those who did not . The groups were compared in terms of baseline characteristics , including diabetes risk factors and glucose testing values . Receiver operating characteristics ( ROC ) curves were generated to identify thresholds for fasting plasma glucose and body mass index ( BMI ) that would predict glyburide failure . RESULTS Seventy-five women were analyzed : 63 ( 84 % ) were successfully treated with glyburide , and 12 ( 16 % ) were not . Baseline characteristics were similar between the groups , except that failures had higher 3-h glucose tolerance test ( GTT ) values at all time points . ROC curves for fasting plasma glucose , pre-pregnancy BMI and BMI at diagnosis revealed no cut-off points for predicting failure of glyburide therapy . However , when fasting plasma glucose value on the GTT was > or = 110 mg/dl , 24 % of women failed to respond to glyburide , compared to 12 % at < 110 mg/dl ( p = 0.15 ) . CONCLUSIONS In treatment of GDM , glyburide is successful in achieving good glycemic control in most women . Women with high fasting plasma glucose levels , however , may not respond adequately to glyburide therapy |
330 | 26,222,246 | Lidocaine 2 % gel , misoprostol , and most NSAIDs did not help reduce pain .
Some lidocaine formulations , tramadol , and naproxen had some effect on reducing IUC insertion-related pain in specific groups . | BACKGROUND Fear of pain during insertion of intrauterine contraception ( IUC ) is a barrier to use of this method .
IUC includes copper-containing intrauterine devices and levonorgestrel-releasing intrauterine systems .
Interventions for pain control during IUC insertion include non-steroidal anti-inflammatory drugs ( NSAIDs ) , local cervical anesthetics , and cervical ripening agents such as misoprostol . | BACKGROUND Misoprostol is an agent that may ripen the cervix in nonpregnant women . Here , we investigate whether vaginal misoprostol administered prior to intrauterine device ( IUD ) insertion reduces the number of failed insertions , insertion-related complications and pain during insertion . METHODS We conducted a double-blinded , multicenter r and omized controlled trial among patients requesting an IUD . Nulli- and multi-parous women were included , and both copper-containing and levonorgestrel-releasing IUDs were used . Participants were allocated to either 400 μg misoprostol or placebo ( administered 3h prior to IUD insertion ) . The primary outcome measure was failed insertion . Secondary outcome measures were insertion-related complications , pain , difficulty of insertion and side-effects . RESULTS Two hundred and seventy participants were r and omized . After drop out for various reasons ( mainly no show ) , 199 participants had an IUD inserted ; 102 received misoprostol and 97 received placebo . Only three insertions failed ; two in the misoprostol group and one in the placebo group [ P = 0.59 , relative risk ( RR ) 1.9 , 95 % confidence interval ( CI ) 0.2 - 20.6 ] . The overall incidence of insertion-related complications was 21.8 % in the misoprostol versus 19.1 % in the placebo group ( mainly vasovagal-like reactions ) and did not differ between groups ( P = 0.65 , RR 1.1 , 95 % CI 0.7 - 2.0 ) . No difference in pain scores between groups was found . Side-effects were more common in the misoprostol group ( P = 0.05 , RR 1.3 , 95 % CI 1.0 - 1.7 ) . CONCLUSION The study showed no benefit for use of misoprostol prior to IUD insertion . However , there is a tendency of possible harm regarding side-effects . Therefore , we would not recommend st and ard pretreatment with misoprostol . The trial was registered in the European Clinical Trials Data base EudraCT 2006 - 006897 - 60 In a double-blind , r and omized , placebo-controlled study conducted at a contraception clinic , 55 women ( three nulliparous ) were given either ibuprofen 600 mg or placebo 1 - 4 hours prior to insertion of IUD , 4 - 6 hours after insertion of IUD and the following morning . Pain was assessed by ten point Numerical Rating Scales during insertion , in the first 4 - 6 hours and in the following three days . No benefit of ibuprofen was demonstrated at insertion or at any other time during the first three days . The patients were further r and omized to type of IUD : TCu-380A and Nova T ( R. ) . No difference in pain scores was evaluated between these OBJECTIVES : To estimate the effects of self-administered misoprostol compared with placebo before intrauterine device ( IUD ) insertion in nulliparous women . METHOD : Nulliparous women requesting either the copper T380A or levonorgestrel IUD were r and omized to self-administer either 400 & mgr;g of misoprostol or placebo ( vaginally or buccally ) 3–4 hours before the IUD insertion appointment . The primary outcome was health care provider – perceived ease of insertion recorded on a visual analog scale ( anchors : 0 extremely easy , 100 impossible ) . Patients completed question naires addressing pain using a vali date d visual analog scale ( anchors : 0 none , 100 worst imaginable ) before insertion , immediately postinsertion , and before clinic discharge . RESULTS : Of the 108 women enrolled in the study , 54 received misoprostol and 54 received placebo . There was no significant difference in perceived ease of insertion between the two groups ( 25.0 mm [ st and ard error 3.5 ] compared with 27.4 mm [ st and ard error 3.5 ] , P=.64 ) . Patients who received misoprostol before IUD insertion had significantly higher pain scores before placement ( 17.1 mm [ st and ard error 3.5 ] compared with 4.7 mm [ st and ard error 2.0 ] , P=.003 ) . Groups did not differ in perception of pain during IUD insertion ( 58.4 mm [ st and ard error 3.3 ] compared with 56.9 mm [ st and ard error 3.0 ] , P=.74 ) . There were two expulsions in the misoprostol group and none in the placebo group . Failed insertions , need for adjuvant pain medication , and need for cervical dilation or ultrasonographic guidance did not differ between the two groups . CONCLUSION : Self-administered misoprostol before IUD insertion does not ease IUD insertion or reduce patient-perceived pain in nulliparous women . These data do not support the routine use of misoprostol before IUD insertion in nulliparous women . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT00886834 . LEVEL OF EVIDENCE : Abstract Objective To investigate whether sublingual misoprostol administered one hour before intrauterine device ( IUD ) insertion reduces failed insertions , insertion-related complications and pain in parous women delivered only by elective caesarean section ( CS ) . Methods Single-blind r and omised controlled trial conducted in Ismailia , Egypt , between July 2010 and December 2011 . Women who had never delivered otherwise than by elective CS and desirous of using an IUD were r and omly allocated to receive sublingually 400 μg misoprostol and 100 mg diclofenac ( misoprostol group ) or 100 mg diclofenac alone ( control group ) one hour before IUD insertion . Outcome measures were failed insertion , ease of insertion judged by the investigators , insertion-related complications , and patients ’ satisfaction . Results In all , 255 women ( 130 and 125 in the study and control groups , respectively ) had an IUD inserted . Seven insertions failed : five in the control group , and two in the study group . Ease of insertion and patients ’ satisfaction were comparable in both groups . Abdominal pain and nausea were the commonest side effects reported in the misoprostol group . Conclusion Sublingual administration of misoprostol one hour before IUD insertion in parous women with no previous vaginal delivery does not facilitate the procedure and may cause undesirable side effects . This approach is not recommended as a st and ard treatment OBJECTIVE Anticipated pain with intrauterine device ( IUD ) insertion may be a barrier to widespread use . Our objective was to evaluate the efficacy of intracervical 2 % lidocaine gel for pain relief with IUD insertion . STUDY DESIGN We performed a double-blind , r and omized controlled trial of women undergoing IUD insertion . Participants were r and omly assigned to 2 % lidocaine or placebo gel . Study gel ( 3 mL ) was placed 3 minutes prior to IUD insertion . Pain scores were measured at various time points using a 10-point visual analog scale . RESULTS Of the 200 participants r and omized , 199 completed the study . Pain scores among lidocaine and placebo arms were similar at tenaculum placement ( lidocaine and placebo : median , 4 ; range , 0 - 10 ; P = .15 ) and with insertion ( lidocaine : median , 5 ; range , 1 - 10 ; placebo : median , 6 ; range , 0 - 10 ; P = .16 ) . These results did not differ by parity . CONCLUSION Topical or intracervical 2 % lidocaine gel prior to IUD insertion does not decrease pain scores STUDY QUESTION Is the pain associated with levonorgestrel-releasing intrauterine system ( LNG-IUS ) insertion reduced by intracervical anesthesia in women without previous vaginal birth ? SUMMARY ANSWER Intracervical anesthesia was not associated with reduced pain in women without previous vaginal birth . WHAT IS KNOWN ALREADY The pain associated with the insertion of intrauterine contraceptives ( IUCs ) is a limiting factor for the use of these contraceptives by some women . No prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of IUCs . However , previous studies included women with previous vaginal delivery , and injectable intracervical anesthesia was not evaluated in any of these studies . STUDY DESIGN , SIZE , DURATION This was a r and omized , open , parallel-group clinical trial that evaluated 100 women without previous vaginal delivery who wished to use the LNG-IUS for the first time . These women were evaluated immediately after LNG-IUS insertion and then 2 h and 6 h later . PARTICIPANTS / MATERIAL S , SETTING , METHODS The 100 women were r and omized into two groups : ( i ) use of a non-steroidal anti-inflammatory drug ( NSAID ) ( ibuprofen , 400 mg ) 1 h prior to LNG-IUS insertion ; or ( ii ) 2 % lidocaine intracervical injection 5 min prior to LNG-IUS insertion . The women were evaluated immediately after LNG-IUS insertion and then 2 h and 6 h after insertion . Two pain scales were used ( the visual analogue scale and the facial pain scale ) in addition to assessing the ease of insertion ( as rated by the provider ) and the level of discomfort during the procedure ( as rated by the patient ) . Multivariate logistic regression was performed to analyze the predictors associated with moderate/severe pain . MAIN RESULTS AND THE ROLE OF CHANCE The pain and discomfort associated with LNG-IUS insertion , and the ease of insertion of the LNG-IUS did not differ between the groups . Nulliparity was more associated with moderate/severe pain [ adjusted odds ratio ( OR ) : 3.1 ( 95 % confidence interval ( CI ) : 1.3 - 7.80 ] . Injectable intracervical anesthesia use reduced the risk of moderate/severe pain by 40 % [ adjusted OR : 0.6 ( 95 % CI : 0.2 - 1.4 ) ] . The difference between the mean pain score in the intracervical anesthesia group and the NSAID group was < 10 % ; thus , the effect size of the intervention was not significant . LIMITATIONS , REASONS FOR CAUTION Intracervical anesthesia was compared with an oral medication in this study . Intracervical injection of a saline solution or even a dry needling as the placebo for a double-blind study could be a more adequate control ; however , this approach was not a protocol approved by the institutional review board . Considering that the majority of the insertions were easy ( > 80 % in both groups ) , the results may not be extrapolated to difficult insertions with moderate/severe pain where local anesthesia may have a role . WIDER IMPLICATION S OF THE FINDINGS The findings can be generalized to most insertions in nulliparous women or in those without a previous vaginal delivery . There is currently no evidence to recommend the routine use of prophylactic intracervical anesthesia prior to LNG-IUS insertion ; there is no evidence that this treatment reduces insertion-related pain . STUDY FUNDING /COMPETING INTERESTS RAF and CSV give occasional lectures for Bayer Healthcare . This study received funding from the National Institute of Hormones and Women 's Health , National Council for Scientific and Technological Development ( CNPq ) . TRIAL REGISTRATION NUMBER NCT02155166 Background Bladder distension is thought to cause the uterine axis to become more aligned with the cervical canal . Among women undergoing assisted conception it has been demonstrated that having a full bladder facilitates the passage of an intrauterine catheter for embryo transfer . Objective To determine if insertion of intrauterine contraceptive devices is easier in women who have a full bladder at the time of insertion . Methods 200 women requesting intrauterine contraception with a pre-filled bladder were r and omised to delayed emptying ( after insertion ; n=100 ) or immediate emptying ( before insertion ; n=100 ) . Comparisons were made between doctors ’ reported ease of insertion and women 's pain scores . Results There was no significant difference with reported ease of insertion between the groups . Doctors reported that insertions were either ‘ very easy ’ or ‘ quite easy ’ in 82 % and 83 % of women in the immediate and delayed emptying groups , respectively ( 95 % CIs for difference −10 % to + 11 % ) . There was no significant difference in reported pain scores , with mean pain scores ( out of 10 ) of 3.8 and 4.4 in the delayed and immediate emptying groups , respectively . Conclusions Bladder filling does not have a significant effect on ease of insertion of an intrauterine method of contraception . Insertion is mostly associated with low levels of discomfort , even in the presence of a full bladder STUDY QUESTION How effective is the vaginal administration of misoprostol in dilating the cervix prior to inserting an intrauterine device ( IUD ) in nulligravidas ? SUMMARY ANSWER The use of misoprostol at a dose of 400 µg administered vaginally 4 h prior to IUD insertion increased the ease of insertion and reduced the incidence of pain during the procedure , although the frequency of cramps increased following misoprostol use . WHAT IS KNOWN AND WHAT THIS PAPER ADDS Misoprostol has been widely used in Obstetrics and Gynecology ; however , its usefulness and efficacy in facilitating IUD insertion in nulligravidas have yet to be established . The present study shows that the benefits of misoprostol use prior to IUD insertion include facilitating insertion and reducing pain during the procedure ; therefore , weighing up the benefits encountered against the only negative side effect ( cramps prior to insertion ) , these results suggest that misoprostol use should become st and ard practice to facilitate IUD insertion in nulligravidas . STUDY DESIGN , SIZE DURATION A r and omized , double-blind clinical trial was conducted . PARTICIPANTS / MATERIAL S , SETTING METHODS Nulligravid women of reproductive age were su bmi tted to IUD insertion between July 2009 and November 2011 at the Instituto de Medicina Integral Prof. Fern and o Figueira in Recife , Pernambuco , Brazil . A total of 179 women were r and omly allocated to two groups : 86 to receive 400 µg of misoprostol vaginally 4 h prior to IUD insertion and 93 to receive placebo . Risk ratios ( RRs ) were calculated as measures of relative risk , together with their 95 % confidence intervals ( 95 % CI ) . The number needed to treat ( NNT ) and the number needed to harm ( NNH ) were also calculated . MAIN RESULTS AND THE ROLE OF CHANCE Significant differences were found between the groups for all the immediate end points studied , with less difficulty in inserting the IUD [ RR = 0.49 ( 23/86 versus 51/93 ) ; 95 % CI : 0.33 - 0.72 ; P = 0.00005 ] , a lower risk of dilatation < 4 mm [ RR = 0.48 ( 24/86 versus 54/93 ) ; 95 % CI : 0.33 - 0.70 ; P = 0.0001 ] , a reduction in moderate-to-severe pain at IUD insertion [ RR = 0.56 ( 32/86 versus 62/93 ] ; 95 % CI : 0.41 - 0.76 ; P = 0.00008 ) , as well as a lesser likelihood of experiencing a disagreeable or very disagreeable sensation [ RR = 0.49(29/86 versus 64/93 ) ; 95 % CI : 0.35 - 0.68 ; P = 0.000004 ] in the group that was given misoprostol compared with the group that received placebo . There was no significant difference between the groups in relation to complications during IUD insertion . There were no cases of uterine perforation in either group . The frequency of cramps was 40 % higher in the misoprostol group . LIMITATIONS , REASONS FOR CAUTION The present study showed a positive balance between the benefits and risks of the use of misoprostol ; however , it is not feasible to conclude that its use is imperative prior to IUD insertion in nulligravidas and IUD insertion should not be canceled when the medication is unavailable . WINDER IMPLICATION S OF THE FINDINGS In view of its effect in promoting cervical dilatation , misoprostol may be used prior to IUD insertion both in nulligravidas and in any women with cervical stenosis irrespective of parity . STUDY FUNDING This study was funded by the Instituto de Medicina Integral Prof Fern and o Figueira . COMPETING INTERESTS None BACKGROUND This study was conducted to examine the effects of prophylactic misoprostol prior to intrauterine device ( IUD ) placement in nulliparous women . STUDY DESIGN Nulliparous , reproductive-aged women desiring an IUD for contraception were r and omized to receive 400 mcg of buccal misoprostol or placebo 90 min prior to IUD insertion . Subjects completed a series of 100-mm visual analogue scales ( VAS , anchors : 0=none , 100 mm = worst imaginable ) to measure their perceived pain at several times points ( anticipated pain , leg positioning , speculum placement , tenaculum placement , IUD insertion , equipment removal and 5 min postinsertion ) . Secondary outcomes included provider " ease of placement " ( 100-mm VAS , anchors : 0=easy , 100 mm = extremely difficult ) , side effects and retention of the IUD after 1 month ( self-report or clinic visit ) . The study had 80 % power ( α=0.05 , one-sided ) to detect a reduction with treatment of 20 mm in VAS scores with a combined sample size of 34 . RESULTS A total of 40 subjects were r and omized to receive either misoprostol or placebo , and 35 completed the study . Five subjects withdrew ( four prior to receiving study medication and one declined IUD ) . Baseline characteristics were similar between groups . There were no significant differences in patient-reported pain with IUD placement [ misoprostol 65 mm ( SD 21 ) , placebo 55 mm ( SD 21 ) , p=.83 ] or at any other time point . Moreover , the misoprostol group reported significantly more preinsertion nausea ( 29 % vs. 5 % , p=.05 ) and cramping ( 47 % vs. 16 % , p=.04 ) than the placebo group . While provider-reported ease of insertion was not significantly different between groups , three placebo patients required additional dilation vs. none in the misoprostol group . All 35 subjects underwent follow-up at least 1 month postinsertion , and no expulsions were reported . CONCLUSION Prophylactic misoprostol prior to IUD placement in nulliparous women did not reduce patient perceived pain , but it did appear to increase preinsertion side effects BACKGROUND Misoprostol has been studied intensively to produce cervical dilatation . To date , no studies have evaluated the effectiveness , safety or acceptability of this treatment for repeat intrauterine device insertions . STUDY DESIGN This study was a r and omized , double-blind , placebo-controlled trial on the consecutive use of the levonorgestrel-releasing intrauterine system ( LNG-IUS ) . Women who had used their first LNG-IUS for 4 years and 3 to 9 months and opted for an immediate replacement with a second LNG-IUS received a single sublingual dose of 400 mcg misoprostol or placebo 3 h prior to the LNG-IUS insertion . RESULTS The proportion of easy insertions as judged by the investigator was 93 % ( 40/43 ) in subjects r and omized to misoprostol and 91 % ( 42/46 ) in the placebo group ( p=1.0 for the difference of proportions ) . No or mild pain at insertion was reported by 37 % and 35 % of subjects in the misoprostol and placebo groups , respectively . However , adverse events related to the study drug were more common in the misoprostol group . CONCLUSION Sublingual misoprostol did not have a significant effect on the ease of insertion in subjects having a repeat insertion of the LNG-IUS OBJECTIVE To examine the effects of preprocedure misoprostol on intrauterine device ( IUD ) placement in nulliparous women . STUDY DESIGN In this r and omized controlled double-blind trial at the University of New Mexico reproductive health clinic , nulliparous women requesting an IUD were r and omized to 400 mcg of buccal misoprostol or placebo 2 - 8 hours before insertion . Primary outcomes included pain on a 10-cm visual analog scale and women 's perception of the value of delaying insertion for an effective medication . Provider ease of insertion and need for adjunctive insertion measures were also assessed , on a visual analog scale . Participants indicated maximum pain after IUD insertion , pain level they would tolerate to avoid delay in IUD insertion , and preference for IUD insertion without delay if an effective medication was available . RESULTS Of 85 women enrolled , 3 were ineligible ; 42 were r and omized to misoprostol and 40 to placebo . There were no differences between groups in worst insertion pain , ( 5.8 ± 2.0 vs 5.9 ± 2.0 , P = .94 ) , provider ease of insertion ( 2.2 ± 2.2 vs 2.5 ± 2.2 ; P = .54 ) or adjunctive measures ( 14 % vs 25 % ; P = .27 ) . The groups were willing to tolerate the same mean pain ( 4.9 ± 2.5 vs 5.7 ± 2.4 , P = .18 ) to avoid waiting for medication . The majority of women ( 85 % ) preferred to wait for an effective medication . CONCLUSION Misoprostol for nulliparous women did not decrease pain or improve the ease of insertion of an IUD . Most women were willing to wait for a medication that decreases pain , indicating a need to pursue alternatives for pain control with IUD insertion Objective Fear of pain during intrauterine device ( IUD ) insertion can be a barrier to widespread use of this safe and highly effective contraceptive method . Our objective was to determine the effectiveness of topical 10 % lidocaine spray for pain control during IUD insertion . Methods A total of 200 subjects with the request for IUD insertion were included in the study . The patients were r and omly divided into two groups : lidocaine spray ( n=100 ) and placebo ( n=100 ) . The pain experienced during the procedure was measured immediately after insertion by a st and ard Visual Analogue Scale ( VAS ) administered by a separate research er with maintenance of allocation concealment . Results The mean pain score during the procedure was 1.01±1.20 in the lidocaine spray group and 3.23±1.60 in the placebo spray group ( p<0.001 ) . Lidocaine spray treatment significantly lowered the overall procedural pain score compared with placebo . Conclusions Significant pain reduction during IUD insertion can be achieved by using 10 % lidocaine spray alone . Lidocaine spray can be accepted as a non-invasive , easy to apply and more comfortable local anaesthetic method for IUD insertion . Trial registration number NCT02020551 BACKGROUND This study was conducted to investigate the effects of a 1 % lidocaine paracervical block on perceived patient pain during intrauterine device ( IUD ) insertion . STUDY DESIGN We r and omized 50 women undergoing IUD insertion to receive either a 10-mL 1 % lidocaine paracervical block or no local anesthetic before IUD insertion . Women marked their pain on a 100-mm visual analogue scale ( VAS ) ( 0 mm = no pain , 100 mm = worst pain possible ) at various points of the procedure ( speculum insertion , tenaculum placement , paracervical block administration , IUD insertion and 5 min postprocedure ) . RESULTS Twenty-six women received the paracervical block before IUD insertion , and 24 received no local anesthesia . Groups were similar in age , parity , ethnicity , education and complications . Women who received the paracervical block reported a median VAS score of 24.0 mm with IUD insertion , and women who did not receive local anesthetic reported a median VAS score of 62.0 mm with IUD insertion ; p=.09 . CONCLUSION Compared with no anesthetic , a 1 % lidocaine paracervical block did not result in a statistically significant decrease in perceived pain with IUD insertion BACKGROUND Providers often underestimate patient pain . This study investigated if providers accurately assess pain during intrauterine device ( IUD ) insertion . STUDY DESIGN This is a secondary analysis of a r and omized trial . Participants rated pain on a 100-mm visual analogue scale ( VAS ) . Providers marked a similar VAS for maximum level and timing of participant pain . RESULTS The mean patient maximum pain was 64.8 mm ( SD , 27 ) compared to 35.3 mm ( SD , 26 ) rated by the provider ( p<.001 ) . Patient and provider agreement on most painful time point of procedure was weak ( kappa statistic , 0.16 ) . CONCLUSIONS Providers underestimate pain during IUD insertion . IMPLICATION S To our knowledge , this is the first paper to compare provider and patient perceptions of pain during IUD insertion . Underst and ing this relationship will help guide further research about IUD insertion pain and techniques and could improve patient counseling OBJECTIVE Concern about pain during placement of an intrauterine device ( IUD ) represents a barrier to use , especially among nulliparous women . We hypothesized that nitroglycerin gel applied vaginally 30 min prior to IUD placement would reduce insertion-related pain . STUDY DESIGN We design ed a r and omized , double-blinded , placebo-controlled pilot study to evaluate the efficacy and tolerability of 0.5-mg nitroglycerin gel ( 1 mL ) or identical placebo gel applied vaginally in nulliparous women 30 min prior to IUD placement . The study was limited to women who opted for the levonorgestrel-releasing intrauterine system . Subjects completed a series of 100-mm visual analogue scales at several time points . The primary outcome was subject-reported pain with passage of the IUD through the cervix . Secondary outcomes included subject-reported pain at other time points , provider-reported ease of insertion , side effects , adverse events and need for additional dilation . RESULTS A total of 24 women were r and omized . Baseline characteristics were similar between groups . The mean pain score with IUD deployment was 55.0 mm [ st and ard deviation ( SD ) = 29.7 mm ] in the placebo group and 57.4 mm ( SD 22.1 mm ) in the nitroglycerin group ( p=.82 ) . There was no difference in ease of insertion reported by providers . Two subjects required dilation , one in each group . CONCLUSION Vaginal administration of 0.5-mg nitroglycerin gel 30 min prior to IUD placement does not appear to decrease patient-reported procedural pain among nulliparous women or ease of insertion for providers INTRODUCTION Intrauterine device ( IUD ) is the most common reliable , effective and reversible contraceptive method used worldwide and in areas with high growth rate is of particular importance . IUD insertion is associated with high anxiety in most people that causes pain and discomfort . The aim of this study was to determine the effects of aromatherapy on anxiety and pain caused by IUD insertion . METHODS This study was conducted on 106 women in a health care center located in Ardebil , Iran . Participants were divided into two groups by r and omized blocks of 4 and 6 . In the experimental group lavender scent was inhaled and in the control group the placebo was inhaled 30 minutes before IUD insertion . The anxiety of the participants was measured by Spielberger question naire , and the pain of IUD insertion was measured immediately after the insertion using visual analog scale ( range 0 - 10 ) . RESULTS The mean score ( st and ard deviation ) of anxiety before intervention was 43.2 ( 9.2 ) in the experimental group that decreased after intervention to 39.0 ( 10.5 ) ( p < 0.001 ) , while this score was 42.2 ( 9.0 ) and 41.5 ( 8.4 ) before and after the intervention in the control group ( p = 0.21 ) . Mean differences of anxiety in both groups was statistically significant ( p < 0.001 ) . The pain score after intervention did not show significant difference between two groups ( p = 0.51 ) . CONCLUSION Aromatherapy with lavender inhalation was effective in decreasing anxiety in IUD procedure , and this method can be used in health care centers as complementary treatments CONTEXT Insertion pain or fear of it may make women hesitate to use the intrauterine device ( IUD ) ; a long-term , reversible , highly-effective contraception method . Further study has been recommended on the effects of lidocaine ( xylocaine ) gel on IUD insertion pain in the recent Cochran review . AIMS To determine the effect of lidocaine gel on pain from TCu-380AIUD insertion . MATERIAL S AND METHODS At a health center in Tabriz , Iran , 96 women were allocated into 3 groups using block r and omization with 6 and 9 block sizes considering allocation concealment . In 1 st group , lidocaine 2 % gel and in the 2 nd , lubricant gel was placed in the cervical canal 1 minute before an IUD insertion , and the 3 rd group got no intervention . Immediately after IUD insertion , pain during the insertion was measured using 0 - 10 cm visual analogue scale . STATISTICAL ANALYSIS USED Kruskal-Wallis and linear regression in SPSS-13 were used to identify effect of lidocaine gel on the pain . RESULTS Overall , the mean pain score was 3.5 ± 1.8 . In univariate analysis , there was no significant difference in pain scores between the 3 groups . Also , results of linear regression model by controlling effect of the possible confounding showed no significant effect of lidocaine gel on the insertion pain . The mean pain score in the lidocaine group was 0.39 less than the no intervention group , but it was not significant ( CI 95 % of the difference : -1.3 , 0.57 ) . CONCLUSIONS Use of 2 % lidocaine gel into the cervical canal has no effect on reducing overall pain during IUD insertion BACKGROUND Pain during intrauterine device ( IUD ) insertion can be a barrier to initiation . Clinical trials have found misoprostol and nonsteroidal drugs to be ineffective ( Am J Obstet Gynecol 2006;195:1272 - 1277 , Hum Reprod 2011;26:323 - 329 , Hum Reprod 2007;22:2647 - 2652 ) . One study suggested that 2 % lidocaine gel decreased pain ; however , study design problems limit its validity ( Brit J Fam Plann 1996;22:177 - 180 ) . We tested whether intracervical 2 % lidocaine gel decreased insertion pain compared to placebo . STUDY DESIGN We planned a r and omized , double-blinded clinical trial of 200 women . We placed 2 % lidocaine gel or placebo in the cervix prior to uterine sounding . Participants rated pain by marking a 100-mm visual analogue scale at four time points . RESULTS We r and omized 200 participants and placed 197 IUDs . Pain was greatest at uterine sounding and similar between groups : placebo group mean 51.6 mm ( SD 25 ) , lidocaine group mean 55.5 mm ( SD 30 , p=.33 ) . Stratified analyses accounting for parity showed no treatment effect . Multivariable analyses identified longer time since last pregnancy , lower parity and higher anticipated pain as predictors of pain during sounding , and dysmenorrhea and the levonorgestrel IUD as additional predictors during IUD insertion . CONCLUSIONS Intracervical 2 % lidocaine gel does not decrease IUD insertion pain . Underst and ing predictors of increased pain may help providers with preprocedure counseling OBJECTIVE : To assess the relationship of preinsertion vaginal ultrasound assessment and menstrual and gynecologic history as predictors of difficult or painful intrauterine device insertion in nulligravid women . METHODS : Nulligravid women seeking contraception were invited to participate in this nonr and omized study and given the choice between the levonorgestrel-releasing intrauterine system or a copper-releasing intrauterine device . All 165 enrolled women were interviewed and a pelvic examination , including vaginal ultrasonography , was performed before insertion . Insertion difficulties and pain intensity were recorded and assessed against uterine measurements and background characteristics . RESULTS : Most insertions were assessed as easy ( n=144 [ 89.4 % ] ) and only two ( 1.2 % ) failed . Most women had uterine measurements smaller than the studied devices . Odds for difficulties at insertion decreased with every increasing millimeter in total uterine length ( odds ratio [ OR ] 0.86 , 95 % confidence interval [ CI ] 0.78–0.96 , P=.006 ) and cervical length ( OR 0.85 , 95 % CI 0.74–0.97 , P=.02 ) and similarly with every decreasing degree of ( straighter ) flexion angle ( OR 0.96 , 95 % CI 0.94–0.99 , P=.005 ) . No absolute threshold measurements could be determined . Still , the majority of insertions in small and flexed uteri were uneventful . Severe insertion pain was common ( n=94 [ 58.4 % ] ) . Severe dysmenorrhea was the only predictor of insertion pain ( OR 8.16 95 % CI 2.56–26.02 , P<.001 ) . CONCLUSION : Ultrasonographic evaluation does not give additional information compared with clinical pelvic examination and sound measure . Although smaller uterine length measurements and steeper flexion angle more often predicted difficulties , the majority of insertions were uneventful in women with small measures . Dysmenorrhea was the only predictor of pain . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT01685164 . LEVEL OF EVIDENCE : BACKGROUND The copper intrauterine device ( IUD ) is a highly effective and safe contraceptive method , also in nulliparous women . However , insertion of an IUD through a narrow cervix may be technically difficult . Misoprostol has been shown to be effective for cervical priming in non-pregnant women prior to hysteroscopy . METHODS Eighty nulliparous women requesting an IUD were r and omly allocated to receive sublingually 400 microg misoprostol and 100 mg diclofenac ( misoprostol group ) or 100 mg diclofenac alone ( control group ) 1 h prior to IUD insertion . Cervical dilatation was measured prior to insertion using Hegar pins . Ease of insertion was judged by the investigator . Pain , bleeding and side effects were recorded at insertion and until follow-up performed one month later . RESULTS Following treatment with misoprostol , insertion was significantly easier than in the control group [ P = 0.039 , difference 19.36 % , confidence interval ( CI ) -0.013 , 39.99 ] . Pain estimated on a visual analogue scale ( 1 - 10 ) showed no evidence of a difference between the groups . The overall distribution of side effects did not differ . However , shivering was more common in the misoprostol group ( P = 0.0084 , difference 23.27 % , CI 6.64 , 39.90 ) . CONCLUSIONS Misoprostol facilitates insertion of an IUD , and reduces the number of difficult and failed attempts of insertions in women with a narrow cervical canal . The optimal regimen of misoprostol remains to be defined OBJECTIVE To investigate the pharmacokinetics , safety , and analgesic efficacy of a novel topical formulation of lidocaine at insertion of an intrauterine device ( IUD ) . DESIGN R and omized controlled trial ; phase-I and phase-II studies . SETTING University and public hospitals . PATIENT(S ) Women aged ≥18 years who wanted to receive an IUD . Four women were parous in phase I ; all in phase II were nulliparous . INTERVENTION(S ) A single , 8.5-mL dose of lidocaine formulation ( SHACT ) was administered ( to the portio , cervix , and uterus ) with a specially design ed applicator . MAIN OUTCOME MEASURE(S ) The phase-I study ( single-arm ) was design ed for pharmacokinetic assessment ; the phase-II study ( r and omized ) was intended for investigation of efficacy and safety . RESULT ( S ) From the phase-I study ( 15 participants ) , mean pharmacokinetic values were : maximum plasma concentration : 351 ± 205 ng/mL ; time taken to reach maximum concentration : 68 ± 41 minutes ; and area under the concentration-time curve from 0 to 180 minutes : 717 ± 421 ng*h/mL. Pain relief was observed with lidocaine vs. placebo in the phase-II study ( 218 women , r and omized ) . Mean visual analog scale score for maximum pain during the first 10 minutes after IUD insertion was 36 % lower with lidocaine than with placebo ( 28.3 ± 24.6 vs. 44.2 ± 26.0 ) . Pain intensity was also significantly lower in the lidocaine group at 30 minutes . On average , 3 of 4 patients will have less pain with lidocaine than with placebo . Adverse events were similar in the placebo and lidocaine groups . No serious adverse events were reported . CONCLUSION ( S ) Lidocaine provides pain relief lasting for 30 - 60 minutes for women undergoing IUD insertion , without any safety concerns . Further studies of this lidocaine formulation , for IUD insertion and other clinical applications , are planned . CLINICAL TRIAL REGISTRATION NUMBER 2011 - 005660 - 18 and 2011 - 006220 - 20 ( EudraCT ) BACKGROUND The LNG-IUS has increasingly been used for contraception , treatment of menorrhagia and endometrial protection during hormone replacement therapy since mid-1990s . Thus , many women use the LNG-IUS consecutively . However , published data on the bleeding pattern regarding consecutive use of the LNG-IUS is scarce . METHODS We performed a prospect i ve 15-month multicentre study on the bleeding profile , removal and insertion procedures and safety of the second LNG-IUS in fertile-aged women who had used their first LNG-IUS between 4 years 3 months and 4 years 9 months and who opted for the insertion of a second IUS immediately after removal of the first IUS . Bleeding data were reported descriptively starting from the last 90 days of the first IUS use and continuing for up to 1 year . RESULTS Of the 234 subjects screened , 204 ( 87 % ) entered the trial . The median number of bleeding/spotting days during the last 90 days of the first LNG-IUS was 7 ( 25 and 75 % percentiles 0 and 15 ) . Due to bleeding associated with the insertion procedure , this increased to 8 days ( 4 and 18 ) during the first 90-day reference period , thereafter decreasing to 4 ( 0 and 10 ) days during the second to fourth reference periods . Only one expulsion and no pregnancies , pelvic inflammatory diseases or perforations occurred . A total of 12 subjects ( 5.9 % ) prematurely discontinued the study : five due to an adverse event and seven due to other reasons ( inclusive of loss to follow-up ) . CONCLUSIONS This study confirms the favourable bleeding profile and safety of consecutive use of the LNG-IUS BACKGROUND Concern about pain during placement of an intrauterine device ( IUD ) represents a barrier to use , especially among nulliparous women . We hypothesized that nitroprusside gel applied intracervically prior to IUD placement would reduce insertion-related pain . STUDY DESIGN We performed a r and omized , double-blinded , placebo-controlled pilot study to evaluate the efficacy and tolerability of 10-mg nitroprusside gel ( 1 mL ) or identical placebo gel applied intracervically in nulliparous women immediately prior to IUD placement . Subjects completed a series of 100-mm visual analogue scales at several time points . The primary outcome was subject-reported pain with IUD insertion . Secondary outcomes included provider-reported ease of insertion , subject-reported pain at other time points , side effects , adverse events and need for additional dilation . RESULTS A total of 24 women were r and omized . Baseline characteristics were similar between groups . The mean pain score with IUD deployment was 73 mm ( SD 17 mm ) in the placebo group and 59 mm ( SD 26 mm ) in the nitroprusside group ( p=.15 ) . There was no difference in ease of insertion reported by providers . Two subjects required dilation , one in each group . There were two vasovagal reactions in the nitroprusside group and none in the placebo group . CONCLUSIONS Intracervical administration of 10-mg nitroprusside gel immediately prior to IUD insertion does not appear to provide a clinical ly relevant improvement in patient-reported pain with IUD insertion among nulliparous women OBJECTIVE To determine the effectiveness of 6 mL of 2 % lidocaine cervical gel for pain during intrauterine device ( IUD ) insertion . STUDY DESIGN This is a r and omized double-blind placebo controlled trial of 6 mL of 2 % lidocaine gel for IUD insertion pain among first-time IUD users . No other analgesia other than the study intervention was provided . The study was conducted at a university-based obstetrics and gynecology clinic . The primary outcome , pain during IUD insertion on a 0 to 100-mm visual analog scale , was analyzed using the t test . RESULTS Seventy-three women received placebo gel , and 72 women received 2 % lidocaine gel . The groups had similar sociodemographic and clinical characteristics . Baseline pain scores with speculum insertion were no different between the two groups . The lidocaine group reported a mean pain score with tenaculum placement of 37.5 ( median : 39 ) compared to the placebo group of 41.6 ( median : 37 ) ( p=.4 ) . Similarly , pain with IUD insertion was no different with a mean pain score of 35.2 ( median : 34 ) in the lidocaine group and 36.7 ( median 36 ) in the placebo group ( p=.8 ) . CONCLUSIONS Two percent lidocaine gel placed on the anterior lip of the cervix and at the internal os did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel . IMPLICATION S Among first-time IUD users , including both nulliparous and multiparous women , 6 mL of 2 % lidocaine gel placed on the anterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared to placebo gel OBJECTIVE To evaluate if ibuprofen 800 mg reduces pain with intrauterine device ( IUD ) insertion among U.S. women . STUDY DESIGN We conducted a r and omized , double-blind , placebo-controlled trial of women undergoing IUD insertion approximately 2 - 6weeks following first-trimester uterine aspiration . Subjects were r and omized to receive ibuprofen 800 mg or placebo 30 - 45min prior to IUD insertion . A 100-mm visual analog scale ( VAS ) was administered to measure pain after speculum insertion ( baseline ) and immediately following IUD insertion . RESULTS A total of 202 women were enrolled , with 101 r and omized to each group ( ibuprofen or placebo ) . Sociodemographic characteristics and baseline VAS scores were similar between groups . The median pain score with IUD insertion was 41.5 mm in the placebo group and 38.0 mm in the ibuprofen group ( p=.50 ) . Mean and median pain scores did not differ between placebo and ibuprofen when nulliparous and parous women were analyzed independently . Overall , median pain scores were 17.5 mm higher in nulliparous women than parous women ( p=.004 ) . Median pain scores did not differ by age , IUD-type , history of dysmenorrhea or time since aspiration . CONCLUSIONS Administration of ibuprofen 800 mg prior to IUD insertion does not reduce pain associated with the procedure for U.S. women . Overall , nulliparous women report more pain with IUD insertion than multiparous women BACKGROUND Potential pain with IUD insertion is a concern for women . Studies have found that systemic and local cervical therapies do not reduce pain scores . Since intrauterine infusion of lidocaine may reduce pain with endometrial aspiration , in this pilot study , we tested whether such infusion through an inexpensive endometrial aspirator could reduce IUD insertion pain scores with IUD insertion . STUDY DESIGN In this r and omized , double-blinded , placebo control pilot study of 40 women undergoing IUD insertion , pain scores of women receiving 1.2 mL 2 % lidocaine versus normal saline ( 1:1 ) infused 3 min prior to IUD insertion were measured using a 0 - 9-point scale . RESULTS Pain at tenaculum placement was similar between groups . There was no difference in mean pain scores during IUD insertion of women infused with lidocaine ( 2.95 ) versus normal saline ( 3.75 ) , p=.37 . Considerable variation in pain scores was noted ; 46 % of subjects had pain scores ≤2 while 33 % had pain scores ≥5 . CONCLUSION Use of 2 % lidocaine administered through an endometrial aspirator did not significantly reduce IUD insertion pain scores in this pilot study Objective To determine whether nitric oxide donors can induce cervical ripening before surgical termination of pregnancy in the first trimester BACKGROUND Despite the high efficacy of the levonorgestrel-releasing intrauterine system ( LNG-IUS ) in preventing pregnancy , uptake of the intrauterine devices remains low in the United States . Decreasing pain at the time of intrauterine device insertion may be one way to increase interest in this method of contraception . STUDY DESIGN We conducted a double-blind , placebo-controlled trial , r and omizing women to 800 mg ibuprofen or placebo 45 min prior to LNG-IUS insertion to determine effect of ibuprofen on the pain of LNG-IUS insertion . RESULTS Eighty-one women completed the study : 44 received ibuprofen , and 37 received placebo . Women in the ibuprofen and placebo groups had similar mean scores for anticipated pain ( 4.07 and 3.91 , respectively ; p=.79 ) , pain with tenaculum placement ( 3.86 and 3.81 , respectively ; p=.90 ) and pain with insertion ( 3.69 and 3.34 , respectively ; p=.91 ) . CONCLUSION Administration of ibuprofen prophylaxis for LNG-IUS insertion does not decrease pain at the time of insertion BACKGROUND Intrauterine devices ( IUDs ) provide highly effective , reversible , long-term contraception that is appropriate for many women after first-trimester uterine aspiration . However , the effects of immediate versus delayed IUD insertion after uterine aspiration on rates of complications and IUD use are uncertain . METHODS We performed a r and omized noninferiority trial involving women undergoing uterine aspiration for induced or spontaneous abortion at 5 to 12 weeks of gestation who desired an IUD . Subjects were r and omly assigned ( in a 5:6 ratio ) to IUD insertion immediately after the procedure or 2 to 6 weeks afterward ( delayed insertion ) . The primary outcome was the rate of IUD expulsion 6 months after IUD insertion ; an expulsion rate 8 percentage points higher in the immediate-insertion group was defined as inferior . RESULTS Among 575 women who underwent r and omization , an IUD was inserted in 100 % ( 258 of 258 ) of the women in the immediate-insertion group and in 71.3 % ( 226 of 317 ) of those in the delayed-insertion group ( difference , 28.7 percentage points ; 95 % confidence interval [ CI ] , 23.7 to 33.7 ) . The 6-month expulsion risk was 5.0 % ( 13 of 258 women ) after immediate insertion and 2.7 % ( 6 of 226 ) after delayed insertion ( difference , 2.3 percentage points ; 95 % CI , -1.0 to 5.8 ) , which was consistent with the predefined criterion for noninferiority . Six-month rates of IUD use were higher in the immediate-insertion group ( 92.3 % , vs. 76.6 % after delayed insertion ; P<0.001 ) . Adverse events were rare and did not differ significantly between groups . No pregnancies occurred in the immediate-insertion group ; five occurred in the delayed-insertion group ( P=0.07 ) , all in women who never received an IUD . CONCLUSIONS The 6-month rate of expulsion of an IUD after immediate insertion was higher than but not inferior to that after delayed insertion . Immediate insertion result ed in higher rates of IUD use at 6 months , without an increased risk of complications . ( Funded by the Susan Thompson Buffett Foundation ; Clinical Trials.gov number , NCT00562276 . ) OBJECTIVE To compare the analgesic efficacy of oral tramadol and naproxen sodium on pain during insertion of an intrauterine device ( IUD ) . DESIGN R and omized , double-blinded , clinical trial ( Canadian Task Force classification I ) . SETTING University-affiliated hospital . Single-center . PATIENTS One hundred three patients scheduled for insertion of an IUD . INTERVENTIONS Patients were r and omly assigned to receive oral tramadol 50 mg capsules ( n = 35 ) or naproxen sodium 550 mg tablets ( n = 34 ) or placebo ( n = 34 ) 1 hour before insertion of the IUD . After insertion of the IUD , pain intensity was evaluated using a visual analog scale ( VAS , 0 - 10 ) . Adverse effects , patient satisfaction with the medication , and preference for using it during future insertions were also recorded . MEASUREMENTS AND MAIN RESULTS The VAS scores were significantly different during IUD insertion among the 3 groups ( p = .001 ) . Pain scores in the tramadol group were significantly lower than in the naproxen group ( p = .003 ) , and the scores in the naproxen group was significantly lower than in the control group ( p = .001 ) . Patient satisfaction with the medication and preference for its future use were significantly lower in the control group than in the other 2 groups ( p = .001 ) . CONCLUSION Prophylactic analgesia using 50 mg tramadol and 550 mg naproxen , delivered orally , can be used to relieve pain during IUD insertion . However , tramadol capsules were found to be more effective than naproxen tablets BACKGROUND Barriers to intrauterine device ( IUD ) use in nulliparous women include fear of pain with insertion and provider perception of difficulty with insertion . The goal of this study was to evaluate whether misoprostol prior to IUD insertion in nulliparous women eased insertion and decreased pain . STUDY DESIGN This was a double-blinded , r and omized , controlled trial . Nulliparous women requesting an IUD were r and omized to buccal placement of 400-mcg misoprostol or placebo . Provider ease of insertion and patient-reported pain were measured using a 100-mm visual analogue scale . RESULTS Seventy-three subjects completed the study . Baseline characteristics were similar between groups . Provider perception of ease of insertion was not different between study and control groups ( 28.97 mm , 22.33 mm , p=.18 ) . Pain immediately prior to IUD insertion ( 10.84 vs. 2.11 ; p=.003 ) and after IUD insertion ( 46.50 vs. 35.14 ; p=.040 ) was higher for those in the study group compared to the control group . CONCLUSION This study demonstrates that it is not helpful to provide misoprostol for cervical ripening prior to insertion of IUDs as it does not improve ease of insertion for provider or decrease reported pain for the woman , and it may increase women 's pain experience with insertion . IMPLICATION STATEMENT Our study demonstrates that providers do not perceive nulliparous IUD insertion as difficult ; women do experience pain with insertion but find the experience acceptable . The addition of misoprostol for cervical ripening prior to insertion does not ease insertion for providers and increases the pain level experienced by women Abstract The purpose of this prospect i ve cohort study was to compare pain during IUD insertion between women with a history of vaginal delivery and women without a history of vaginal delivery . First-time IUD users chose either the CuT380A or the levonorgestrel IUS . We enrolled 49 women with previous vaginal delivery and 49 women with no history of vaginal delivery ( either only caesarean deliveries or nulliparous ) . The mean pain score on a 0–100 mm visual analog scale during insertion in the vaginal delivery group was 34.7 ( SD 31.6 ) compared with 51.2 ( SD 29.2 ) in the group without previous vaginal delivery ( p = 0.009 ) . In multivariable analysis controlling for age , breast-feeding , expected pain , baseline anxiety , insertion timing ( 6–12 weeks postpartum , 2–4 weeks post-abortion or interval ) , and insertion difficulty , history of vaginal delivery was associated with a 15.5 point reduction in pain ( 95 % CI , –27.4 , –3.7 ) . Other significant predictors of pain were ‘ expected pain ’ and ‘ insertion difficulty ’ |
331 | 24,075,281 | In conclusion , despite ongoing refinements in chemotherapy regimens , anthracyclines still pose a significant risk of cardiotoxicity , especially in those requiring a high cumulative dose or chest radiotherapy | The management of individual patients requiring anthracyclines remains challenging because uncertainty persists on predictors of cardiotoxicity .
We aim ed to perform a systematic review and meta- analysis on incidence and predictors of anthracycline chemotherapy in patients with cancer . | BACKGROUND Cardiomyopathy following anthracycline chemotherapy may have ominous clinical implication s in cancer patients treated with this effective yet potentially toxic therapy . Early detection at sub clinical stage is pivotal to minimize the risk of overt cardiotoxicity . Liposomal anthracyclines have the potential for more selective uptake by cancer cells and reduced cardiac toxicity . OBJECTIVE We design ed a single-center r and omized clinical trial , the Liposomal doxorubicin-Investigational chemotherapy-Tissue Doppler imaging Evaluation ( LITE ) pilot study to compare the safety of liposomal doxorubicin vs st and ard epirubicin in terms of clinical and sub clinical cardiotoxicity . METHODS Whereas diagnostic and prognostic instruments effective at early recognition of cardiomyopathy are lacking , promising data have been reported for tissue Doppler imaging ( TDI ) echocardiography . The study will enroll 80 patients with breast cancer and indication to anthracycline chemotherapy , r and omizing them in a 1:1 ratio to liposomal doxorubicin or st and ard epirubicin . The primary end-point will be the comparison of changes from baseline to 12-month follow-up of left ventricular TDI systolic function parameters , and the co- primary end-point will be based instead on changes in TDI diastolic function parameters . Among secondary end-points , we will adjudicate changes in st and ard 2-dimensional echocardiography parameters , including ejection fraction , peak values of biochemical markers of cardiac damage and heart failure , ie cardiac troponin T and BNP , overall survival , functional class , freedom from cancer recurrence , and adverse effects of chemotherapy . CONCLUSIONS Results of the LITE pilot study should provide important clinical and mechanistic insights on the promising role of liposomal anthracyclines in patients with breast cancer and indication to anthracycline chemotherapy ( Clinical Trials.gov identifier NCT00531973 ) Background — An increase in troponin I soon after high-dose chemotherapy ( HDC ) is a strong predictor of poor cardiological outcome in cancer patients . This finding has important clinical implication s and provides a rationale for the development of prophylactic strategies for preventing cardiotoxicity . Angiotensin-converting enzyme inhibitors slow the progression of left ventricular dysfunction in different clinical setting s , but their role in the prevention of cardiotoxicity has never been investigated . Methods and Results — Of the 473 cancer patients evaluated , 114 ( 72 women ; mean age , 45±12 years ) who showed a troponin I increase soon after HDC were r and omized to receive ( angiotensin-converting enzyme inhibitor group ; 20 mg/d ; n=56 ) or not to receive ( control subjects ; n=58 ) enalapril . Treatment was started 1 month after HDC and continued for 1 year . Cardiological evaluation was performed at baseline and at 1 , 3 , 6 , and 12 months after HDC . The primary end point was an absolute decrease > 10 percent units in left ventricular ejection fraction , with a decline below the normal limit value . A significant reduction in left ventricular ejection fraction and an increase in end-diastolic and end-systolic volumes were observed only in untreated patients . According to the Kaplan-Meier analysis , the incidence of the primary end point was significantly higher in control subjects than in the angiotensin-converting enzyme inhibitor group ( 43 % versus 0 % ; P<0.001 ) . Conclusions — In high-risk , HDC-treated patients , defined by an increased troponin I value , early treatment with enalapril seems to prevent the development of late cardiotoxicity Anthracyclines are established cardiotoxic agents ; however , the exact extent and time course of such cardiotoxicity has not been appraised in detail . We aim ed to exploit serial measurements of st and ard and tissue Doppler imaging ( TDI ) echocardiographic parameters collected in a prospect i ve clinical trial to clarify the outlook of cardiac function during and long after anthracycline chemotherapy . Women enrolled in a r and omized trial focusing on liposomal doxorubicin-based chemotherapy for breast cancer and providing ≥4 separate echocardiographic assessment s were included . Repeat-measure nonparametric analyses were used to appraise changes over time in the st and ard and tissue Doppler imaging echocardiographic parameters . A total of 39 patients with serial imaging evaluations were enrolled . Significant temporal changes were found for the left ventricular ejection fraction and diastolic parameters , despite different temporal trends . Specifically , the left ventricular ejection fraction exhibited a V-shaped trend , decreasing initially from 63 % to 61 % but then recovering to 64 % ( p < 0.001 ) , with a similar trend in the TDI E/Em ratio ( p = 0.011 ) . In contrast , persistent impairments typical of an L-shaped trend were found for the E wave ( p = 0.006 ) , TDI lateral Em wave ( p = 0.001 ) , and TDI septal Em wave ( p = 0.001 ) . In conclusion , sub clinical temporal changes in the st and ard and TDI echocardiographic parameters after anthracycline chemotherapy showed a distinctive pattern of transient impairment followed by full recovery of the left ventricular ejection fraction versus a persistent impairment of the diastolic parameters , which must be taken into account in the everyday treatment of such patients Doxorubicin is a highly effective and widely used cytotoxic agent with application that is limited by cardiotoxicity related to the cumulative dose of the drug . A large‐scale study that retrospectively evaluated the cardiotoxicity of doxorubicin reported that an estimated 7 % of patients developed doxorubicin‐related congestive heart failure ( CHF ) after a cumulative dose of 550 mg/m2 . To assess whether this estimate is reflective of the incidence in the broader clinical oncology setting , the authors evaluated data from three prospect i ve studies to determine both the incidence of doxorubicin‐related CHF and the accumulated dose of doxorubicin at which CHF occurs OBJECTIVE --To assess the cardiac status of long-term survivors of pediatric malignancies who received chemotherapy , including anthracyclines . DESIGN AND METHOD - Patients were evaluated by echocardiogram from 4 to 20 years ( median , 7 years ) after completion of anthracyclines , with prospect i ve and retrospective analysis . PATIENTS --The consecutive sample of 201 patients had received a total anthracycline dose of 200 to 1275 mg/m2 ( median , 450 mg/m2 ) , and 51 patients had mediastinal radiotherapy . MAIN OUTCOME MEASURES --The overall incidence and severity of abnormal systolic cardiac function were determined for the entire cohort . Risk factors of total anthracycline dose , mediastinal radiotherapy , age during treatment , and length of follow-up were examined . RESULTS --Twenty-three percent ( 47/201 ) of the cohort had abnormal cardiac function on noninvasive testing at long-term follow-up . Correlation between total cumulative dose , length of follow-up , and mediastinal irradiation with incidence of abnormalities was significant . Fifty-six patients were followed up for 10 years or more ( median , 12 years ) , with a median anthracycline dose of 495 mg/m2 . Thirty-eight percent ( 21/56 ) of these patients , compared with 18 % ( 26/145 ) of patients evaluated after less than 10 years , had abnormal findings . Sixty-three percent of patients followed up for 10 years or more after receiving 500 mg/m2 or more of anthracyclines had abnormal findings . Nine of 201 patients had late symptoms , including cardiac failure and dysrhythmia , and three patients died suddenly . Microscopic examination of the myocardium on biopsy and autopsy revealed fibrosis . CONCLUSION --The 23 % incidence of late cardiac abnormalities warrants continued evaluation of patients after anthracyclines to guide patient care and the design of future chemotherapeutic protocol OBJECTIVES This study sought to evaluate the efficacy of enalapril and carvedilol to prevent chemotherapy-induced left ventricular systolic dysfunction ( LVSD ) in patients with hematological malignancies . BACKGROUND Current chemotherapy may induce LVSD . Angiotensin-converting enzyme inhibitors and beta-blockers prevent LVSD in animal models of anthracycline-induced cardiomyopathy . METHODS In this r and omized , controlled study , 90 patients with recently diagnosed acute leukemia ( n = 36 ) or patients with malignant hemopathies undergoing autologous hematopoietic stem cell transplantation ( HSCT ) ( n = 54 ) and without LVSD were r and omly assigned to a group receiving enalapril and carvedilol ( n = 45 ) or to a control group ( n = 45 ) . Echocardiographic and cardiac magnetic resonance ( CMR ) imaging studies were performed before and at 6 months after r and omization . The primary efficacy endpoint was the absolute change from baseline in LV ejection fraction ( LVEF ) . RESULTS The mean age of patients was 50 ± 13 years old , and 43 % were women . At 6 months , LVEF did not change in the intervention group but significantly decreased in controls , result ing in a -3.1 % absolute difference by echocardiography ( p = 0.035 ) and -3.4 % ( p = 0.09 ) in the 59 patients who underwent CMR . The corresponding absolute difference ( 95 % confidence interval [ CI ] ) in LVEF was -6.38 % ( 95 % CI : -11.9 to -0.9 ) in patients with acute leukemia and -1.0 % ( 95 % CI : -4.5 to 2.5 ) in patients undergoing autologous HSCT ( p = 0.08 for interaction between treatment effect and disease category ) . Compared to controls , patients in the intervention group had a lower incidence of the combined event of death or heart failure ( 6.7 % vs. 22 % , p = 0.036 ) and of death , heart failure , or a final LVEF < 45 % ( 6.7 % vs. 24.4 % , p = 0.02 ) . CONCLUSIONS Combined treatment with enalapril and carvedilol may prevent LVSD in patients with malignant hemopathies treated with intensive chemotherapy . The clinical relevance of this strategy should be confirmed in larger studies . ( Prevention of Left Ventricular Dysfunction During Chemotherapy [ OVERCOME ] ; NCT01110824 ) |
332 | 21,412,904 | Oral mefenamic acid 500 mg was effective at treating moderate to severe acute postoperative pain , based on limited data . | BACKGROUND Mefenamic acid is a non-steroidal anti-inflammatory drug ( NSAID ) .
It is most often used for treating pain of dysmenorrhoea in the short term ( seven days or less ) , as well as mild to moderate pain including headache , dental pain , postoperative and postpartum pain .
It is widely available in many countries worldwide .
OBJECTIVES To assess the efficacy of single dose oral mefenamic acid in acute postoperative pain , and any associated adverse events . | Abstract Variability in patients ' response to interventions in pain and other clinical setting s is large . Many explanations such as trial methods , environment or culture have been proposed , but this paper sets out to show that the main cause of the variability may be r and om chance , and that if trials are small their estimate of magnitude of effect may be incorrect , simply because of the r and om play of chance . This is highly relevant to the questions of ‘ How large do trials have to be for statistical accuracy ? ’ and ‘ How large do trials have to be for their results to be clinical ly valid ? ’ The true underlying control event rate ( CER ) and experimental event rate ( EER ) were determined from single‐dose acute pain analgesic trials in over 5000 patients . Trial group size required to obtain statistically significant and clinical ly relevant ( 0.95 probability of number‐needed‐to‐treat within ±0.5 of its true value ) results were computed using these values . Ten thous and trials using these CER and EER values were simulated using varying group sizes to investigate the variation due to r and om chance alone . Most common analgesics have EERs in the range 0.4–0.6 and CER of about 0.19 . With such efficacy , to have a 90 % chance of obtaining a statistically significant result in the correct direction requires group sizes in the range 30–60 . For clinical relevance nearly 500 patients are required in each group . Only with an extremely effective drug ( EER>0.8 ) will we be reasonably sure of obtaining a clinical ly relevant NNT with commonly used group sizes of around 40 patients per treatment arm . The simulated trials showed substantial variation in CER and EER , with the probability of obtaining the correct values improving as group size increased . We contend that much of the variability in control and experimental event rates is due to r and om chance alone . Single small trials are unlikely to be correct . If we want to be sure of getting correct ( clinical ly relevant ) results in clinical trials we must study more patients . Credible estimates of clinical efficacy are only likely to come from large trials or from pooling multiple trials of conventional ( small ) size OBJECTIVES There has been growing awareness that alleviation of wound pain and associated symptoms after obstructive sleep apnea ( OSA ) surgeries may improve the quality of care . We performed a hospital-based study to compare the effectiveness and safety of two different regimens in the treatment of postoperative pain . STUDY DESIGN A prospect i ve , r and omized , and parallel-group study . METHODS Ninety OSA patients were enrolled for surgical treatments in this study . Forty-five patients ( group 1 ) were r and omized to receive intravenous ketorolac and another 45 patients ( group 2 ) were given the conventional regimen of oral mefenamic acid and intramuscular meperidine after OSA surgeries for 3 days at hospital . Postoperative discomfort was measured by a self- assessment question naire on the 1st and 3rd days after surgery . Any adverse effect of pain treatment was carefully monitored . Patients ' satisfaction with postoperative pain treatment was evaluated 1 month postoperatively . RESULTS On the 1st postoperative day , group 1 patients had a significantly lower mean score in six out of eight pain-related symptoms than group 2 patients had ( P<.05 ) . At the 3rd postoperative day , significant differences remained for two symptoms . Group 1 patients were generally more satisfied with their pain treatment than were group 2 patients ( P=.01 ) . Increased risk of postoperative bleeding for group 1 was not observed in this study . CONCLUSIONS A short-term administration of intravenous ketorolac is noninferior to the conventional regimen and represents a safe and effective treatment for wound pain , particularly in the 1st day , after OSA surgeries in selected patients Abstract A previously established relationship for deriving dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics has been tested using an independent data set . Individual patient information from 18 RCTs of parallel‐group design in acute postoperative pain ( after abdominal , gynaecological and oral surgery ) was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with > 50%maxTOTPAR for the different treatments . The relationship between the measures was investigated in 85 treatments with over 3400 patients . In 80 of 85 treatments ( 94 % ) agreement between calculated and actual number of patients with > 50%maxTOTPAR was within four patients per treatment and in 72 ( 85 % ) was within three ( average of 40 patients per treatment , range 21–58 patients ) . Summing the positive and negative differences between actual and calculated numbers of patients with > 50%maxTOTPAR gave an average difference of 0.30 patients per treatment arm . Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events , such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data in acute pain studies enables data published as means to be used for quantitative systematic review s which require data in dichotomous form A double-blind r and omized single dose study of the analgesic effects of 650 mg aspirin , 250 mg mefenamic acid , the combination of 650 mg aspirin and 250 mg mefenamic acid and placebo on 120 patients with pain following oral surgery was conducted . Patients evaluated their pain intensity and extent of pain relief at 1 , 2 , 3 and 4 h after drug administration . For most parameters , including the sum of the pain intensity differences and the sum of the hourly pain relief scores , each of the drugs was more effective than placebo . Aspirin – mefenamic acid in combination was more effective than both drugs alone , and aspirin and mefenamic acid alone were equally effective for most of the analgesic variables Single doses of piroxicam ( 20 mg ) and mefenamic acid ( 500 mg ) were compared , double-blind , for analgesic effectiveness in the treatment of oral surgical pain in out- patients . Excluding placebo responders and patients with mild or no baseline pain , 118 cases ( 57 piroxicam , 61 mefenamic acid ) were analyzed for efficacy . The treatments were statistically equivalent and highly effective ; over 75 % of patients in both groups reported a reduction of 2 points or more in pain severity . The percentage of patients reporting complete relief of severe pain was slightly higher for piroxicam , the onset of analgesic activity was equivalent , and side effects were infrequent ( 5 % ) and mild with both medications . Piroxicam was clearly efficacious in relieving post-exodontic pain . If these findings are confirmed in other painful conditions and safety on extended use is established , piroxicam should prove quite useful as a general analgesic for the treatment of a wide variety of painful conditions & NA ; Reports of RCTs of analgesics frequently describe results of studies in the form of mean derived indices , rather than using discontinuous events — such as number or proportion of patients with 50 % pain relief . Because mean data inadequately describe information with a non‐normal distribution , combining mean data in systematic review s may compromise the results . Showing that dichotomous data can reliably be derived from mean data , at least in acute pain models , indicates that more meaningful overviews or meta‐ analysis may be possible . This study investigated the relationship between continuous and dichotomous analgesic measures in a set of individual patient data , and then used that relationship to derive dichotomous from continuous information in r and omised controlled trials ( RCTs ) of analgesics . Individual patient information from 13 RCTs of parallel‐group and crossover design in acute postoperative pain was used to calculate the percentage of the maximum possible pain relief score ( % maxTOTPAR ) and the proportion of patients with greater than 50 % pain relief ( > 50%maxTOTPAR ) for the different treatments . The relationship between the measures was investigated in 45 actual treatments and 10 000 treatments simulated using the underlying actual distribution ; 1283 patients had 45 separate treatments . Mean % maxTOTPAR correlated with the proportion of patients with > 50%maxTOTPAR ( r2 = 0.90 ) . The relationship calculated from all the 45 treatments predicted to within three patients the number of patients with more than 50 % pain relief in 42 of 45 treatments , and 98.8 % of 10 000 simulated treatments . For seven effective treatments , actual numbers‐needed‐to‐treat ( NNT ) to achieve > 50%maxTOTPAR compared with placebo were very similar to those derived from calculated data The efficacy of mefenamic acid , aspirin , and a placebo for control of postendodontic pain was compared in a double-blind , r and omized study of 150 patients . Medication was begun immediately prior to the endodontic therapy and continued for a total of eight doses . The results were analyzed in terms of the patients ' assessment s of postendodontic pain , the need for additional analgesic medication , and the patients ' and investigator 's evaluations of drug efficacy . The results indicate that mefenamic acid was well tolerated . Mefenamic acid was equal to , or exceeded , aspirin in ability to control postendodontic pain in every comparison made . The converse was never true . Mefenamic acid was statistically superior to placebo in every comparison made . Aspirin was not consistently superior to the placebo . Under the conditions of this trial , it can be stated that , for control of pain following simple endodontic therapy , mefenamic acid rather than aspirin is the drug of choice & NA ; A data base of r and omised clinical trials ( RCTs ) in pain research published from 1950 to 1990 was created following an extensive literature search . By applying a refined MEDLINE search strategy from 1966 to 1990 and by h and ‐ search ing more than 1 000 000 pages of a total of 40 biomedical journals published during the period 1950–1990 , more than 8000 RCTs were identified . The RCTs were published in more than 800 journals and over 85 % appeared between 1976 and 1990 . If the trend of the last 15 years persists , a total of more than 15 000 RCTs will be published in pain relief by the year 2000 . A detailed description of methods to ensure efficient use of re sources during the identification , retrieval and management of the information in pain relief and other fields is given . Emphasis is made on the importance of refining MEDLINE search strategies , on the use of volunteers to h and ‐ search journals and on careful monitoring of each of the steps of the process . The potential uses of the data base to guide clinical and research decisions are discussed Abstract One way to ensure adequate sensitivity for analgesic trials is to test the intervention on patients who have established pain of moderate to severe intensity . The usual criterion is at least moderate pain on a categorical pain intensity scale . When visual analogue scales ( VAS ) are the only pain measure in trials we need to know what point on a VAS represents moderate pain , so that these trials can be included in meta‐ analysis when baseline pain of at least moderate intensity is an inclusion criterion . To investigate this we used individual patient data from 1080 patients from r and omised controlled trials of various analgesics . Baseline pain was measured using a 4‐point categorical pain intensity scale and a pain intensity VAS under identical conditions . The distribution of the VAS scores was examined for 736 patients reporting moderate pain and for 344 reporting severe pain . The VAS scores corresponding to moderate or severe pain were also examined by gender . Baseline VAS scores recorded by patients reporting moderate pain were significantly different from those of patients reporting severe pain . Of the patients reporting moderate pain 85 % scored over 30 mm on the corresponding VAS , with a mean score of 49 mm . For those reporting severe pain 85 % scored over 54 mm with a mean score of 75 mm . There was no difference between the corresponding VAS scores of men and women . Our results indicate that if a patient records a baseline VAS score in excess of 30 mm they would probably have recorded at least moderate pain on a 4‐point categorical scale The analgesic effectiveness of aqueous and alcoholic formulations of lignocaine ( 5 % ) spray was compared with that of mefenamic acid ( 500 mg ) or placebo in a double-blind study in 103 primiparous patients complaining of moderate or severe perineal pain associated with episiotomy . The results , assessed after a single dose , showed that the aqueous lignocaine formulation provided a level of pain relief superior to that obtained with the alcoholic formulation or placebo , and similar to that obtained with mefenamic acid The efficacy of mefenamic acid , aspirin , and placebo in the control of postsurgical pain was compared in a double-blind , r and omized study of forty-seven patients . Medication was begun as soon as the anesthetic began to wear off and was continued as needed to a maximum of eight doses over a 48-hour period . The results were analyzed in terms of the patient 's assessment of postsurgical pain , and the patient 's and the investigator 's evaluation of drug efficacy . In the population studied , mefenamic acid was well tolerated . Mefenamic acid was clearly superior to placebo and equalled or exceeded the ability of aspirin to control postsurgical pain in the parameters measured |
333 | 23,821,307 | We found limited evidence of weight gain when using POCs .
Weight change for the POC group generally did not differ significantly from that of the comparison group using another contraceptive .
Appropriate counseling about typical weight gain may help reduce discontinuation of contraceptives due to perceptions of weight gain | BACKGROUND Progestin-only contraceptives ( POCs ) are appropriate for many women who can not or should not take estrogen .
Many POCs are long-acting , cost-effective methods of preventing pregnancy .
However , concern about weight gain can deter the initiation of contraceptives and cause early discontinuation among users .
OBJECTIVES The primary objective was to evaluate the association between progestin-only contraceptive use and changes in body weight . | OBJECTIVE To determine if increasing the hormone dose or eliminating the hormone-free interval improves key pharmacokinetic ( PK ) alterations caused by obesity during oral contraceptive ( OC ) use . STUDY DESIGN Obese [ body mass index ( BMI ) ≥30 kg/m(2 ) ] , ovulatory , otherwise healthy , women received an OC containing 20 mcg ethinyl estradiol (EE)/100 mcg levonorgestrel ( LNG ) dosed cyclically ( 21 days active pills with 7-day placebo week ) for two cycles and then were r and omized for two additional cycles to the following : continuous cycling ( CC , a dose neutral arm using the same OC with no hormone-free interval ) or increased dose ( ID , a dose escalation arm using an OC containing 30 mcg EE/150 mcg LNG cyclically ) . During Cycles 2 , 3 and 4 , outpatient visits were performed to assess maximum serum concentration ( Cmax ) , area under the curve ( AUC0-∞ ) and time to steady state as well as pharmacodynamics . These key PK parameters were calculated and compared within groups between baseline and treatment cycles . RESULTS A total of 31 women enrolled and completed the study ( CC group , n=16 ; ID group , n=15 ) . Demographics were similar between groups [ mean BMI : CC , 38 kg/m(2 ) ( S.D. 5.1 ) ; ID , 41 kg/m(2 ) ( S.D. 7.6 ) ] . At baseline , the key LNG PK parameters were no different between groups ; average time to reach steady state was 12 days in both groups ; Cmax were CC : 3.82±1.28 ng/mL and ID : 3.13±0.87 ng/mL ; and AUC0-∞ were CC : 267±115 h ng/mL and ID : 199±75 h ng/mL. Following r and omization , the CC group maintained steady-state serum levels whereas the ID group had a significantly higher Cmax ( p<.001 ) but again required 12 days to achieve steady state . However , AUC was not significantly different between CC ( 412±255 h ng/mL ) and ID ( 283±130 h ng/mL ) . Forty-five percent ( 14/31 ) of the study population had evidence of an active follicle-like structure prior to r and omization and afterwards this decreased to 9 % ( 3/31 ) . CONCLUSION Both increasing the OC dose and continuous dosing appear to counteract the impact of obesity on key OC PK parameters . IMPLICATION S Obesity adversely affects the pharmacokinetics of very low dose OC pills . Although the impact of these changes on OC efficacy is still under debate , PK parameters can be normalized in obese users by continuous dosing or increasing to a low-dose pill Abstract Objectives To compare variations in bone mineral density ( BMD ) and body composition ( BC ) in depot-medroxyprogesterone acetate ( DMPA ) users and nonusers after providing counselling on healthy lifestyle habits . Methods An exploratory study in which women aged 18 to 40 years participated : 29 new DMPA users and 25 new non-hormonal contraceptive users . All participants were advised on healthy lifestyle habits : sun exposure , walking and calcium intake . BMD and BC were assessed at baseline and 12 months later . Statistical analysis included the Mann-Whitney test or Student 's t-test followed by multiple linear regression analysis . Results Compared to the controls , DMPA users had lower BMD at vertebrae L1 and L4 after 12 months of use . They also had a mean increase of 2 kg in total fat mass and an increase of 2.2 % in body fat compared to the non-hormonal contraceptive users . BMD loss at L1 was less pronounced in DMPA users with a calcium intake ≥ 1 g/day compared to DMPA users with a lower calcium intake . Conclusions DMPA use was apparently associated with lower BMD and an increase in fat mass at 12 months of use . Calcium intake ≥ 1 g/day attenuates BMD loss in DMPA users . Counselling on healthy lifestyle habits failed to achieve its aims . Chinese Abstract 摘 要 目的 比较健康生活习惯指导对长效醋酸甲羟孕酮应用者和不用者骨密度和体成分影响的差异 。 方法 一项针对年龄在18岁至40岁妇女的探索性研究：29名用长效醋酸甲羟孕酮，25名用非激素类避孕。建议所有的参与者都养成健康的生活习惯：晒太阳，散步和摄入钙。在开始和12个月后评估骨密度和体成分。统计分析包括Mann-Whitney检验或多元线性回归分析后行t-检验 。 结果 与对照组相比，用长效醋酸甲羟孕酮12个月后，脊椎L1和L4的骨密度较低。与非激素避孕药使用者比，他们的平均总脂肪增加了2kg，并且体内的脂肪增加2.2%；每天摄入1g钙的长效醋酸甲羟孕酮组与较低钙摄入的长效醋酸甲羟孕酮组比，两组L1的骨密度丢失不太明显 。 结论 醋酸甲羟孕酮的使用与骨密度降低明显相关，并且用药12个月后脂肪含量增加。使用醋酸甲羟孕酮时，每天摄入1克钙会抑制骨质丢失。健康生活习惯的建议未能实现其目标 BACKGROUND Studies showed that hormonal fluctuations that occur over the human menstrual cycle affect energy intake and expenditure . However , little is known about the possible effects on body weight regulation that may arise when these cyclic changes are suppressed with hormonal contraceptives . OBJECTIVE The aim of this study was to examine how a progestational contraceptive drug ( depot medroxyprogesterone acetate ) affects food intake , resting energy expenditure ( REE ) , and body weight in young women . DESIGN Twenty normal-weight women were tested in a single-blind , placebo-controlled experiment . Body weight , REE , and 3-d food intake ( food provided ) were measured in the follicular and luteal phases of 2 menstrual cycles before a single injection of depot medroxyprogesterone or saline solution was administered . Measurements were also taken 4 times after injection : in the luteal and follicular phases of 2 cycles in the placebo group and 2 wk apart ( to mimic timing of the menstrual phases ) in the drug group . RESULTS Before injection , the phase of the menstrual cycle affected both energy intake and REE . The study participants consumed more energy ( 4.3 % ; P = 0.02 ) and expended more energy at rest ( 4.3 % ; P = 0.0002 ) in the luteal phase than in the follicular phase . Comparison of pre- and postinjection means showed that treatment with the contraceptive drug had no significant effects on energy intake , REE , or body weight . CONCLUSIONS This study showed that , although phases of the menstrual cycle affected energy intake and REE , depot medroxyprogesterone acetate did not alter energy intake or expenditure or cause weight gain in young women BACKGROUND Concerns about weight gain may influence contraceptive use . We compared the change in body weight over the first 12 months of use between women using the etonogestrel ( ENG ) implant , the levonorgestrel intrauterine system ( LNG-IUS ) or depot medroxyprogesterone acetate ( DMPA ) with women using the copper intrauterine device ( IUD ) . STUDY DESIGN This was a sub study of the Contraceptive CHOICE Project , a prospect i ve cohort study of 9256 women provided no-cost contraception . Women who had been using the ENG implant , LNG-IUS , DMPA or copper IUD continuously for at least 11 months were eligible for participation . We obtained body weight at enrollment and at 12 months and compared the weight change for each progestin-only method to the copper IUD . RESULTS We enrolled a total of 427 women : 130 ENG implant users , 130 LNG-IUS users , 67 DMPA users and 100 copper IUD users . The mean weight change ( in kilograms ) over 12 months was 2.1 for ENG implant users [ st and ard deviation (SD)=6.7 ] ; 1.0 for LNG-IUS users ( SD=5.3 ) ; 2.2 for DMPA users ( SD=4.9 ) and 0.2 for copper IUD users ( SD=5.1 ) . The range of weight change was broad across all contraceptive methods . In the unadjusted linear regression model , ENG implant and DMPA use were associated with weight gain compared to the copper IUD . However , in the adjusted model , no difference in weight gain with the ENG implant , LNG-IUS or DMPA was observed . Only Black race was associated with significant weight gain ( 1.3 kg , 95 % confidence interval=0.2 - 2.4 ) when compared to other racial groups . CONCLUSIONS Weight change was variable among women using progestin-only contraceptives . Black race was a significant predictor of weight gain among contraceptive users INTRODUCTION The study was conducted to assess the impact of depot medroxyprogesterone acetate subcutaneous injection 104 mg/0.65 mL ( DMPA-SC 104 ) on body weight . METHODS Changes in weight from pretreatment were analyzed using data from two 1-year , noncomparative trials of DMPA-SC 104 ( North/South American , N=722 ; European/Asian , N=1065 ) and a 3-year , r and omized study ( SC/IM ) comparing DMPA-SC 104 ( N=266 ) with the DMPA intramuscular injection 150 mg/mL ( DMPA-IM 150 ) . For each study , additional analyses were conducted for changes in body weight by age ( < 25 , 25 to 35 and > 35 years ) and body mass index ( BMI ) ( < or=25 , > 25 to < or=30 and > 30 kg/m2 ) subgroups . RESULTS In both 1-year trials , the mean ( + /-SD ) weight gain at month 12 was < 2 kg [ 1.7 kg ( + /-4.5 SD ) in the Americas trial and 1.4 kg ( + /-3.6 SD ) in the Europe/Asia trial ] . In the SC/IM trial , mean weight changes were similar between DMPA-SC 104 and DMPA-IM 150 groups , with mean ( + /-SD ) gains at month 36 of 4.5+/-8.5 and 5.8+/-8.7 kg , respectively . Similar differences in weight gain were observed by age or baseline BMI in all studies . CONCLUSION DMPA-SC 104 was associated with modest weight gain in most women STUDY OBJECTIVE Since bone loss has been observed among adolescents on depot medroxyprogesterone acetate ( DMPA ) , a clinical population that commonly experiences weight gain , we were interested in examining the direct relationship between body weight and bone mineral density ( BMD ) in adolescents on DMPA as compared to those on oral contraceptive pills ( OC ) or on no hormonal contraception ( control ) . DESIGN Prospect i ve , Longitudinal study . SETTING Four urban adolescent health clinics in a large metropolitan area . PARTICIPANTS Postmenarcheal girls , age 12 - 18 years , selecting DMPA , OC or no hormonal contraception . INTERVENTIONS At baseline , 6 , 12 , 18 , and 24 months , all study participants underwent measurement of weight and BMD of the hip and spine . MAIN OUTCOME MEASURES The correlation between weight and BMD , and the correlation between change in weight and change in BMD were assessed at each time point . RESULTS Body weight was significantly ( P < 0.05 ) positively correlated with femoral neck BMD and spine BMD at each time point regardless of contraceptive method . Change in body weight at 12 and 24 months was highly correlated with change in femoral neck BMD ( P < 0.0001 ) for all treatment groups . No statistically significant correlation between change in weight and change in spine BMD was seen in the DMPA , OC , or control subjects at 12 or 24 months . CONCLUSION Weight gain on DMPA may mitigate loss of BMD among adolescent users OBJECTIVE To examine weight changes in a large cohort of obese and nonobese adolescent girls initiating depot medroxyprogesterone acetate ( DMPA ) , an oral contraceptive ( OC ) , or no hormonal contraceptive method ( control ) . DESIGN , SETTING , AND PARTICIPANTS Prospect i ve study of 450 adolescent girls , aged 12 to 18 years , who attended 4 urban health clinics and selected DMPA , OC , or control . Data collection occurred at baseline and at 6 , 12 , and 18 months ; consisted of structured interview and measurement of height and weight ; and occurred from April 19 , 2000 , through September 26 , 2003 . MAIN OUTCOME MEASURE Weight was examined as mean change over 18 months and actual weight at each study visit . On the basis of preliminary analyses , we stratified the sample according to baseline obesity status ( nonobese , body mass index [ calculated as weight in kilograms divided by the square of height in meters ] < 30 ; obese , body mass index > or = 30 ) . RESULTS Adolescent girls who were obese at initiation of DMPA gained significantly more weight than did obese girls starting OC or control ( P<.001 for both ) . At 18 months , mean weight gain was 9.4 , 0.2 , and 3.1 kg for obese girls receiving DMPA , receiving OC , and control , respectively . Weight gain in obese girls receiving DMPA was also greater than weight gain in all nonobese categories ( 4.0 kg , DMPA ; 2.8 kg , OC ; 3.5 kg , control ; P<.001 ) . A significant interaction ( P = .006 ) between length of time receiving DMPA and weight gain was evident for obese subjects . CONCLUSIONS Over 18 months , DMPA use was associated with increasing rates of weight gain in obese subjects . The potential contribution to severe obesity in this population is concerning BACKGROUND A formulation of depot medroxyprogesterone acetate ( DMPA ) has been developed that allows subcutaneous injection ( 104 mg/0.65 mL ; DMPA-SC ) and achieves highly effective contraception with a similar tolerability profile to intramuscular DMPA ( 150 mg/mL ; DMPA-IM ) . STUDY DESIGN This r and omized , evaluator-blinded study was design ed to compare efficacy , safety , and user satisfaction in women receiving DMPA-SC ( n=266 ) or DMPA-IM ( n=268 ) for 2 years with an option to continue for a third year . The primary objectives were to evaluate bone mineral density ( BMD ) changes and contraceptive efficacy after 2 years . RESULTS A total of 225 women completed the first 2 years of this study ( DMPA-SC , n=116 ; DMPA-IM , n=109 ) . After 2 years of DMPA use , BMD loss was marginally smaller in the DMPA-SC group than in the DMPA-IM group at both the total hip ( -3.3 % and -3.6 % , respectively ) and lumbar spine ( -4.3 % and -5.0 % , respectively ) . In those women who received DMPA during the third year , there were no statistically significant differences in BMD loss between DMPA-SC and DMPA-IM groups at the end of Year 3 . Recovery of BMD was observed in the small sub population of women who had discontinued DMPA-SC or DMPA-IM after the second year . The 2-year treatment-failure cumulative pregnancy rate was 0 % in the DMPA-SC group and 0.8 % ( 95 % confidence interval , 0.00 - 2.37 % ) in the DMPA-IM group ( life-table method ) . Adverse events were similar in the two groups except that injection site reactions were more common in the DMPA-SC group . CONCLUSION DMPA-SC is an effective and well-tolerated contraceptive option , providing comparable efficacy and BMD safety to DMPA-IM Little information is available from outside clinic setting s about the acceptability of depot medroxyprogesterone acetate ( DMPA , Depo-Provera ) as an injectable contraceptive . In this national , population -based study , New Zeal and women aged 25 to 54 years were selected at r and om from voter rolls . The 1864 subjects were interviewed by telephone after an initial approach by letter . More than 1 in 8 women ( 13.7 % ) had used DMPA at some time . The proportion was higher among Maori women and among those of lower income and education , but DMPA had been used by a substantial proportion of all socioeconomic groups . A quarter of all users reported receiving only a single injection of DMPA , and only 53 % had used this method for a total of 12 months or more . Only 5 ( 1.6 % ) of discontinuations were attributed to contraceptive failure ; this corresponds to a contraceptive failure rate of 0.9 per 100 woman-years . Side effects were given as the most common reasons for stopping , with menstrual disturbances and weight gain being cited most often . Other reasons for stopping included no further need for contraception or doubts about the appropriateness of DMPA . In this developed country population , DMPA is widely used for short periods but its acceptability is limited by the occurrence of side effects To compare the contraceptive efficacy , tolerability , and bleeding patterns , 200 healthy female volunteers received , in an open , comparative , r and omized , multicenter study in China , either a single-rod ( Implanon ) or a six-capsule ( Norplant ) contraceptive implant for 2 years with an optional extension of up to 4 years . Women were exposed to Implanon for 341.6 woman-years and Norplant for 329.1 woman-years . There were no pregnancies during the study . Per 90-day reference period , the median number of bleeding/spotting days with Implanon decreased from 33.5 in the first period to 19.0 - 21.5 days in the last year . Similarly , with Norplant , the median number of bleeding/spotting days decreased from 34.5 to 18.0 - 23.0 days , respectively . The number of bleeding/spotting episodes during year 1 was 2.0 per 90-day reference period with Implanon and 3.0 per period with Norplant ( p < 0.05 for periods 1 - 4 ) . For the remaining 90-day periods , there was no statistical difference between the two groups . In general , there was less frequent bleeding with Implanon compared with Norplant , whereas the incidences of amenorrhea and infrequent bleeding were higher with Implanon than with Norplant . The mean overall incidence of prolonged bleeding fell markedly during the study , from 66.0 % in reference period 1 to 27.3 % in period 16 with Implanon and from 69.0 % to 21.7 % with Norplant , respectively . The most common adverse events were related to disturbed bleeding patterns , which were also the major reasons for discontinuation ( Implanon n = 8 ; Norplant n = 14 ) . Normal menses returned in almost all subjects within 3 months after removal of the implants . Implanon was inserted in a mean time of 0.61 min and Norplant in 3.90 min ( p < 0.001 ) . Similarly , the mean time required to remove the implant was significantly shorter for Implanon than for Norplant ( 2.18 min vs 11.25 min , p < 0.001 ) . The maximum time required for removal of the implant was 10 min for the Implanon group and 60 min for the Norplant group . In both groups , blood pressure and hemoglobin were not affected , whereas body weight tended to increase . It can be concluded that both contraceptive systems demonstrated excellent contraceptive efficacy and were well tolerated . Compared with Norplant , there was less frequent bleeding with Implanon , whereas the incidence of infrequent bleeding and amenorrhea was higher . Implanon was significantly quicker to insert and to remove than was the multiple capsule system STUDY QUESTION Does intensive counselling before insertion and throughout the first year of use have any influence on discontinuation rates due to unpredictable menstrual bleeding in users of three long-acting reversible contraceptives ( LARCs ) ? SUMMARY ANSWER Intensive counselling had a similar effect to routine counselling in terms of discontinuation rates due to unpredictable menstrual bleeding in new users of the contraceptives . WHAT IS KNOWN ALREADY Contraceptive efficacy and satisfaction rates are very high with LARCs , including the etonogestrel (ENG)-releasing implant , the levonorgestrel-releasing intrauterine system ( LNG-IUS ) and the TCu380A intrauterine device ( IUD ) . However , unpredictable menstrual bleeding constitutes the principal reason for premature discontinuation , particularly in the cases of the ENG-implant and the LNG-IUS . STUDY DESIGN , SIZE , DURATION A r and omized clinical trial was conducted between 2011 and 2013 , and involved 297 women : 98 ENG-implant users , 99 LNG-IUS users and 100 TCu380A IUD users . PARTICIPANTS , SETTING , METHODS Women accepting each contraceptive method were r and omized into two groups after the women chose their contraceptive method . Group I received routine counselling at the clinic , including information on safety , efficacy and side effects , as well as what to expect regarding bleeding disturbances . Group II received ' intensive counselling ' . In addition to the information provided to those in Group I , these women also received leaflets on their chosen method and were seen by the same three professionals , the most experienced at the clinic , throughout the year of follow-up . These three professionals went over all the information provided at each consultation . Women in both groups were instructed to return to the clinic after 45 ( ±7 ) days and at 6 and 12 ( ±1 ) months after insertion . They were instructed to record all bleeding episodes on a menstrual calendar specifically provided for this purpose . Additionally , satisfaction with the method was evaluated by a question naire completed by the women after 12 months of use of the contraceptive method . MAIN RESULTS AND THE ROLE OF CHANCE There were no significant differences between the intensive and routine counselling groups on the discontinuation rates due to unpredictable menstrual bleeding of the three contraceptives under evaluation . The 1-year cumulative discontinuation rates due to menstrual bleeding irregularities were 2.1 , 2.7 and 4.0 % and the continuation rates were 82.6 , 81.0 and 73.2 % , for the ENG-implant , the LNG-IUS or the TCu380A IUD users , respectively . The main reasons for discontinuation of the methods were weight gain in users of the ENG-implant and expulsion of the TCu380A . LIMITATIONS , REASONS FOR CAUTION The main limitations are that we can not assure generalization of the results to another setting s and that the routine counselling provided by our counsellors may already be appropriate for the women attending the clinic and so consequently intensive counselling including written leaflets was unable to influence the premature discontinuation rate due to unpredictable menstrual bleeding . Additionally , counselling could discourage some women from using the LARC methods offered in the study and consequently those women may have decided on other contraceptives . WIDER IMPLICATION S OF THE FINDINGS Routine counselling may be sufficient for many women to help reduce premature discontinuation rates and improve continuation rates and user satisfaction among new users of LARC methods . TRIAL REGISTRATION NUMBER The trial was registered at clinical trials.gov ( NCT01392157 ) . STUDY FUNDING /COMPETING INTEREST(S ) The study was partially funded by the Fundação de Apoio a Pesquisa do Estado de São Paulo ( FAPESP ) grant # 2012/01379 - 0 , the Brazilian National Research Council ( CNPq ) grant # 573747/2008 - 3 and by Merck ( MSD ) , Brazil under an unrestricted grant . The LNG-IUS were donated by the International Contraceptive Access Foundation ( ICA ) and the copper IUD by Injeflex , São Paulo , Brazil . L.B. has occasionally served on the Board of MSD , Bayer and Vifor DMPA-SC 104 mg/0.65 mL is a new , low-dose subcutaneous ( SC ) formulation of Depo-Provera contraceptive injection ( 150 mg/mL medroxyprogesterone acetate injectable suspension ) that provides efficacy , safety and immediacy of onset equivalent to Depo-Provera intramuscular ( IM ) injection . Two large , open-label , Phase 3 studies assessed the 1-year contraceptive efficacy , safety and patient satisfaction with DMPA-SC administered every 3 months ( 12 - 13 weeks ) . Zero pregnancies were reported in both studies , which included a total of 16,023 woman-cycles of exposure to DMPA-SC and substantial numbers of overweight or obese women . DMPA-SC was well-tolerated and adverse events were similar to those reported previously with Depo-Provera IM . Thus , DMPA-SC offers women a new , highly effective and convenient long-acting contraceptive option BACKGROUND There is little information about body weight and body composition ( BC ) among users of the levonorgestrel-releasing intrauterine system ( LNG-IUS ) . The aim of this study was to evaluate body weight and BC in LNG-IUS users compared to users of the TCu380A intrauterine device ( IUD ) . STUDY DESIGN A prospect i ve study was done with 76 new users of both contraceptive methods . Women were paired by age ( ±2 years ) and body mass index ( BMI , kg/m² , ±2 ) . Body weight and BC ( % lean mass and % fat mass ) were evaluated by a trained professional at baseline and at 1 year of contraceptive use . The BC measurements were obtained using Lunar DXA equipment . Weight and BC were evaluated in each woman at baseline and at 12 months and analyzed as the mean change within each woman . Then , the changes in weight and BC for each woman were calculated and then compared between LNG-IUS and TCu380A IUD users ( paired data for each woman ) . The central -to-peripheral fat ratio was calculated by dividing trunk fat by the upper and lower limb fat . RESULTS There were no significant differences at time of IUD insertion between LNG-IUS and TCu380A IUD users regarding age ( mean±SD ) ( 34.4±7.5 vs. 33.9±8.0 years ) , BMI ( 25.3±4.1 vs. 25.9±4.1 ) and number of pregnancies ( 1.9±0.2 vs. 1.7±0.2 ) , respectively . Mean body weight gain of 2.9 kg was observed among LNG-IUS users at 12 months ( p=.0012 ) , whereas the body weight of TCu380A IUD users only increased by 1.4 kg ( p=.067 ) . There was no significant difference in body weight change between the two groups of users at 12 months . The variation in the central -to-peripheral fat ratio was the same between the two groups ( -1.6 % vs. -0.2 % ; p=.364 ) . LNG-IUS users showed a 2.5 % gain in fat mass ( p=.0009 ) and a 1.4 % loss of lean mass , whereas TCu380A IUD users showed a loss of 1.3 % of fat mass ( p=.159 ) and gain of 1.0 % of lean mass ( p=.120 ) . TCu380A IUD users gained more lean mass than LNG-IUS users ( p=.0270 ) , although there was no significant difference between the two groups after 12 months of use . CONCLUSIONS Although an increase in mean fat mass among LNG-IUS users at 12 months of use was observed , it should be noted that an increase of body weight was also observed in both groups after 1 year of insertion of the device . However , a study with a larger number of women and long-term evaluation is necessary to evaluate these body changes In a r and omized three-year clinical trial at seven clinics , the performance of levonorgestrel rod ( LNG ROD ) implants used by 600 women was compared with that of soft tubing NORPLANT implants used by 598 women . No pregnancies occurred in either group of women and , accordingly , body weight did not affect the efficacy of either type of implant . There were neither statistically significant nor important differences in termination rates for any reason over the three years . Complaint and illness rates during use of either of the two implant types were statistically indistinguishable and were attributable to the same set of conditions . Seventy-one per 100 of the women using each implant regimen continued to the three-year point , for an average annual continuation rate of 89 per 100 . Removals of LNG ROD implants were accomplished in about half the time required for removal of Norplant capsule implants ( p < 0.001 ) OBJECTIVE To compare longitudinal changes in bone mineral density ( BMD ) among first-time depot medroxyprogesterone acetate ( DMPA ) users to women using no hormonal contraception , and evaluate user characteristics associated with that BMD change . DESIGN Prospect i ve longitudinal study . SETTING Healthy volunteers in an academic research environment . PATIENT(S ) Women , aged 18 to 35 , choosing DMPA for contraception ( n = 178 ) and women using no hormonal contraception ( n = 145 ) . MAIN OUTCOME MEASURE(S ) Hip and spine BMD measured , at three-month intervals for 24 months , by dual energy x-ray absorptiometry . RESULT ( S ) Mean hip BMD declined 2.8 % ( SE = 0.034 ) 12 months following DMPA initiation and 5.8 % ( SE = 0.096 ) after 24 months . Mean spine ( L1-L3 ) BMD declined 3.5 % ( SE = 0.022 ) and 5.7 % ( SE = 0.034 ) , respectively , after one and two years of DMPA use . Mean hip and spine BMD of control participants changed less than 0.9 % over the same period . Among DMPA users , body mass index ( BMI ) change was inversely associated with BMD change at the hip , but not at the spine . Calcium intake , physical activity , and smoking did not influence BMD change in either group . CONCLUSION ( S ) Hip and spine BMD declined after one DMPA injection and this decline continued with each subsequent injection for 24 months . With the exception of increasing BMI among DMPA users , no user characteristics offered protection against DMPA-related BMD loss Two-hundred- and -forty healthy women , ages 18 to 40 years , were r and omized in a ratio of 2:5 to use NORPLANT implants or NORPLANT-2 implants . Through three years of use , no pregnancies were recorded among women using NORPLANT implants and two pregnancies were noted among women using NORPLANT-2 implants result ing in a cumulative net pregnancy rate of 1.3 + /- 0.9 per 100 acceptors ( mean + /- SE ) by the end of year three . This difference was not statistically significant . During the fourth year , no pregnancies were observed in the NORPLANT group , but 4 pregnancies occurred in the NORPLANT-2 group . The most common reason for terminating the study was bleeding disturbances . During the first year there were significantly more terminations due to bleeding problems in the NORPLANT group than in the NORPLANT-2 group . However , during the second year of use the proportion of women discontinuing for bleeding problems dropped considerably among NORPLANT users and during the third year very few women in either group discontinued because of bleeding problems . The continuation rates after one year were for NORPLANT users 59.4 % and for NORPLANT-2 users 77.2 % . Corresponding figures after three years of use were 46.1 % and 51.7 % , respectively . The second most common reason for discontinuation was depression and other mood changes . In both groups we noted a slight increase in weight during the study and a slight decrease in blood pressure and hemoglobin levels with time . In conclusion , both NORPLANT and NORPLANT-2 implants are very effective methods for contraception . The efficacy of NORPLANT-2 implants , however , was not acceptable during the fourth year of use in this study . The latter system could , however , become a suitable three-year contraceptive method , possibly with less bleeding disturbances than NORPLANT in the first year Final results are presented from a two-year WHO multinational comparative trial of three regimens : depot-medroxyprogesterone acetate ( DMPA ) given at 90-day intervals , norethisterone enanthate ( NET-EN ) given at 60-day intervals for the entire study period ( NET-EN ( 60-day ) ) , and NET-EN given at 60-day intervals for six months and thereafter at 84-day intervals ( NET-EN ( 84-day ) ) . 1587 DMPA subjects were observed for 20,550 woman-months , 789 NET-EN ( 60-day ) subjects were observed for 10,361 woman-months , and 796 NET-EN ( 84-day ) subjects were observed for 10,331 woman-months . This clinical trial represents the largest clinical trial undertaken on injectable contraceptives . After two years , the pregnancy rate with NET-EN ( 84-day ) was 1.4 ( + /- 0.6 S.E. ) per 100 women , as compared with the two-year rates of 0.4 ( + /- 0.3 S.E. ) per 100 women observed with DMPA and 0.4 ( + /- 0.2 S.E. ) with NET-EN ( 60-day ) . Both discontinuation rates for amenorrhea and the prevalence of amenorrhea lasting more than 90 days were significantly higher with DMPA than with either NET-EN regimen . Terminations for bleeding problems were similar with the three treatments , despite a better cyclic pattern for the first six months with the NET-EN regimens . The three treatments were comparable with respect to discontinuation rates for other medical or personal reasons , and for all reasons combined . For family planning programs , NET-EN ( 60-day ) has the advantage of low pregnancy rates compared to NET-EN ( 84-day ) , and a schedule of administration that does not change . Both NET-EN regimens produce less amenorrhea than DMPA . However , the NET-EN ( 60-day ) regimen has the logistic and economic disadvantage of requiring more frequent injections . All three injectable regimens compare favourably with oral contraceptives in terms of pregnancy and total continuation rates observed in clinical trial setting OBJECTIVE : To compare longitudinal changes in weight , body fat , and ratio of central to peripheral fat mass among first-time depot-medroxyprogesterone acetate ( DMPA ) users to women using no hormonal contraception , and to evaluate user characteristics associated with that change . DESIGN : Prospect i ve longitudinal study .SUBJECTS : Healthy women , aged 18–35 y , using DMPA for contraception ( n=178 ) and women using no hormonal contraception ( n=145 ) . MEASUREMENTS : Weight , body fat , and the central distribution of fat , measured at 3-month intervals for 30 months , by electronic scale and dual-energy X-ray absorptiometry ( DEXA ) . The ratio of central to peripheral distribution of body fat was computed by dividing the body fat in the conventional DEXA trunk region of interest ( ROI ) by the ROI 's that encompass the arms , hips and legs . RESULTS : Women using DMPA had a significantly greater increase in all measures of fatness than women using no hormonal method of contraception ( P<0.03 ) . The observed weight of DMPA users increased from a mean of 69.4 kg ( s.d.=16.9 ) at baseline to 75.5 kg ( s.d.=25.0 ) at 30 months ; an increase of 6.1 kg ( 8.8.% ) . Fat mass increased from a mean of 25.3 kg ( s.d.=12.6 kg ) at baseline to 31.4 kg ( s.d.=17.8 ) ; an increase of 6.1 kg ( 23.6 % ) in DMPA users . The ratio of central to peripheral fat mass in DMPA users changed from 0.95 ( s.d.=0.155 ) at baseline to 1.01(s.d.=0.198 ) at 30 months . In contrast , weight , fat mass and the ratio of central to peripheral fat mass of control participants remained virtually unchanged over the same time period . Women with higher baseline physical activity levels had a smaller increase in body fat ( P=0.003 ) and the fat ratio ( P=0.03 ) , but not weight ( P=0.48 ) . No other user characteristics including , smoking , past oral contraceptive use or previous pregnancies predicted change in level of fatness . CONCLUSIONS : This study has demonstrated a change in body composition toward greater fatness and toward a central redistribution of fat among DMPA users as compared to controls and provides important information to be used when counseling women regarding contraceptive methods . Given the potential long-term implication of these changes , further study is recommended to determine whether the gains in fatness are reversed following DMPA discontinuation and to examine the role of progestins in the development and maintenance of obesity A new contraceptive ( LNG rod implants , Jadelle , Leiras Oy 's registered trademark for rod implants ) was prospect ively evaluated in r and omized 5 year comparison with Norplant ( Population Council 's registered trademark for contraceptive implants releasing levonorgestrel ) capsule implants . The study involved 1198 women at seven centres . No pregnancies occurred in the first 4 years . At 5 years , the cumulative pregnancy rate was 1 per 100 users or less for each regimen . Annual discontinuation rates averaged 11 - 12 per 100 users ( P > 0.05 ) , corresponding to 5 year continuation rates of 55.1 for rods and 53.0 per 100 for capsules . Mean annual discontinuation rates for menstrual disturbances were 3.5 and 4.2 per 100 for rod and capsule implants respectively ( P > 0.05 ) , and mean annual removal rates for medical problems were 3.5 and 3.0 per 100 ( P > 0.05 ) respectively . Apart from menstrual problems , headache , weight gain and acne were the principal medical reasons for removal . In proportional hazard analyses , family formation variables , age , parity and desire/non desire for another child , recorded at admission , significantly affected discontinuation rates for major decrement categories and for all reasons combined . Mean rod removal time was half that of Norplant ( P < 0.01 ) ; complications of rod removal were at a lower rate . With these contraceptives indistinguishable in performance except for ease and speed of removal , LNG rod implants appear to be preferable to Norplant for use through 5 years by virtue of relative ease of removal BACKGROUND Obese women have higher rates of pregnancy complications , making the prevention of unintended pregnancies in this group of particular importance . STUDY DESIGN We performed a secondary analysis of data from Active Mothers Postpartum ( AMP ) , a r and omized controlled trial aim ed at postpartum weight reduction . We assessed contraceptive use among 361 overweight/obese women 12 months postpartum . Logistic regression was used to model the effect of body mass index ( BMI ) categories on effective contraceptive use ( intrauterine , hormonal or sterilization methods ) while adjusting for potential confounders including age , race , parity , breastfeeding , education and chronic illness . RESULTS Effective contraceptive use was reported by 45 % of women . In the multivariable model , women with a BMI > or=35 kg/m(2 ) were less likely to use effective contraception than women with a BMI < 30 kg/m(2 ) ( OR 0.5 , 95 % CI 0.3 - 0.8 ) . There was a trend towards less use of effective contraception among women with a BMI 30 - 34.9 kg/m(2 ) as compared to women with a BMI < 30 kg/m(2 ) . CONCLUSION At 12 months postpartum , obese women were less likely to use effective contraceptive methods than overweight women . Although certain contraceptive methods may be preferred over others in this population , providers should reinforce the importance of effective contraception to avoid unintended pregnancies in obese women BACKGROUND There are an increase in bone loss during the first 6 months postpartum and a complete recovery postweaning . A few studies of steroid contraceptive use during this period provide some evidence towards protection of bone loss with progestin-only contraceptive methods . OBJECTIVE The study was conducted to evaluate forearm bone mineral density ( BMD ) of breastfeeding postpartum women using nonhormonal and progestin-only contraceptive methods . STUDY DESIGN A prospect i ve cohort study of postpartum women had an analysis performed at 6 months postpartum correlating BMD with contraceptive use . Forearm BMD was measured 7 - 10 days , 3 months and 6 months postpartum . Eighty-two women were analyzed , comparing nonhormonal ( 54 ) and progestin-only ( 28 ) contraceptive methods . Information about breastfeeding duration , amenorrhea and body mass index was collected . RESULTS Baseline characteristics of the study population showed no statistical differences between the groups . The median duration of breastfeeding for both groups was 183 days . A significant BMD decrease was observed for the nonhormonal group ( p<.001 ) ; however , no statistical difference was detected for the progestin-only group . Body mass index , BMD at 7 - 10 days postpartum and total duration of breastfeeding were positively correlated with BMD at 6 months . CONCLUSIONS Our findings suggest a preventive effect towards postpartum bone loss with progestin-only contraception in breastfeeding women OBJECTIVE The purpose of this study was to determine changes in bodyweight and composition that result from hormonal contraception . STUDY DESIGN Dual-energy x-ray absorptiometry was performed at baseline and every 6 months for 3 years for 703 women ( African American , 200 ; white , 247 ; Hispanic , 256 ) who were beginning the use of oral contraception ( OC ; n = 245 ) , depot medroxyprogesterone acetate ( DMPA ; n = 240 ) , or nonhormonal contraception ( NH ; n = 218 ) . DMPA discontinuers were observed for up to 2 years to examine the reversibility of the observed changes . RESULTS Over 36 months , DMPA users increased their weight ( + 5.1 kg ) , body fat ( + 4.1 kg ) , percent body fat ( + 3.4 % ) , and central -to-peripheral fat ratio ( + 0.1 ) more than OC and NH users ( P < .01 ) . OC use did not cause weight gain . After DMPA discontinuation , NH users lost 0.42 kg in 6 months ; OC users gained 0.43 kg in 6 months . CONCLUSION Bodyweight and fat significantly increase with the use of DMPA . After discontinuation of DMPA , some decrease in bodyweight and fat occurs when NH is used OBJECTIVE To evaluate whether initiation of a contraceptive implant , a method of long-acting reversible contraception , reduces condom use , as measured by a biomarker of recent semen exposure [ prostate-specific antigen ( PSA ) ] . STUDY DESIGN We conducted a r and omized controlled clinical trial in which 414 Jamaican women at high risk for sexually transmitted infections ( STIs ) attending family planning clinics received the contraceptive implant at baseline ( " immediate " insertion arm , N=208 ) or at the end ( " delayed " insertion arm , N=206 ) of a 3-month study period . Participants were tested for PSA at baseline and two follow-up study visits and were asked about their sexual activity and condom use . RESULTS At baseline , 24.9 % of women tested positive for PSA . At both follow-up visits , the prevalence of PSA detection did not significantly differ between the immediate versus delayed insertion arm [ 1-month : 26.1 % vs. 20.2 % , prevalence ratio (PR)=1.3 , 95 % confidence interval (CI)=0.9 - 1.9 ; 3-month : 25.6 % vs. 23.1 % , PR= 1.1 , 95 % CI=0.8 - 1.6 ] . The change in PSA positivity over the three study visits was not significantly larger in the immediate arm compared to the delayed arm ( 1-sided p-value of .15 ) . CONCLUSIONS Contraceptive implants can be successfully introduced into a population at high risk of unintended pregnancy and STIs without a biologically detectable difference in unprotected sex in the short term . This information strengthens the evidence to support promotion of implants in such population s and can help refine counseling for promoting and maintaining use of condoms among women who choose to use implants . IMPLICATION S Sex unprotected by a condom was not higher over 3 months in women receiving a contraceptive implant , compared with those not receiving the implant Abstract The present paper reports the bleeding patterns and side effects experienced by women using norethisterone oenanthate ( NET-OEN ) and depot-medroxyprogesterone acetate ( DMPA ) in a WHO-sponsored comparative trial . Only a small minority of women had consistently normal cycles : the vast majority experienced some menstrual abnormality , with 47 % of NET-OEN and 70.6 % of DMPA users not having any normal cycles . Amenorrhoea was significantly more frequent with DMPA than with NET-OEN and its incidence increased with time . At the end of one year 35 % of DMPA and 8.6 % of NET-OEN users had total amenorrhoea . There were only minor differences between the two drugs with respect to the frequency or duration of bleeding episodes , but DMPA caused significantly more spotting than NET-OEN . With both treatments there were large individual variations and the bleeding pattern was totally unpredictable . Headache , the most important nonmenstrual side effect , was reported by 6.9 % of the NET-OEN and 10.7 % of the DMPA users . In the case of DMPA its incidence increased with time . Other complaints such as abdominal discomfort and nervousness were reported with similar frequency on both drugs . There was , with both treatments , a slight increase in body weight and a decrease in blood pressure BACKGROUND Weight gain is a frequent reason for discontinuing the contraceptive with depot-medroxyprogesterone acetate ( DMPA ) . STUDY DESIGN This 3-year retrospective cohort study assessed body mass index ( BMI ; kg/m(2 ) ) variations in 379 current or past DMPA users compared to TCu380A intrauterine device ( IUD ) users matched for age and BMI , categorized into G1 ( normal weight ) , G2 ( overweight ) or G3 ( obese ) according to baseline BMI . Variations in weight and BMI were evaluated using analysis of variance . RESULTS BMI increased progressively in all groups but significantly more in G1 and G2 DMPA users compared to nonusers and according to duration of use . In the G3 subgroup , weight trends were similar in the DMPA and IUD users . CONCLUSIONS Normal and overweight women increased BMI with DMPA use ; however , obese women did not increase weight . Weight increase in DMPA users could be associated with metabolic alterations related to duration of use in normal and overweight women and to alterations already present in obese women . Prospect i ve studies are required to determine triggering factors . DMPA use < or=3 years was not associated with weight increase in women with BMI ( kg/m(2 ) ) > or=30 PURPOSE To determine weight variation in women with different Body Mass Index ( BMI ) in use of trimestral injections of depot-medroxyprogesterone acetate ( DMPA ) , and compare it to women users of a non-hormonal method . METHODS Retrospective study with the chart review of 226 DMPA users and 603 controls , users of DIU TCu380A . Women were distributed in categories , according to their initial BMI , as having normal weight ( < 25 kg/m(2 ) ) , overweight ( 25 to 29,9 kg/m(2 ) ) and being obese ( > or=30 kg/m(2 ) ) , and were followed-up for six years , with yearly measurements of weight and BMI . The statistic test ANOVA was used to measure the weight variation among the groups in each BMI category every year . RESULTS The average age at the onset of the method employed was higher in the study group than in the controls , in all the BMI categories : 31.6+/-SD 7.1 X 27.4+/-SD 5.5 in the normal weight category ( p<0.0001 ) ; 37.3+/-SD 6.8 X 29.2+/-SD 6.0 in the overweight category ( p<0.0001 ) ; and 35.3+/-SD 6.4 X 29.7+/-SD 5.8 among obese women ( p<0.0001 ) . DMPA users showed weight increase as compared to the controls in the overweight category ( p=0.0082 ) ; and the weight increase along the observation period was also higher among the DMPA users than among the controls , for the normal weight ( p<0.0001 ) and overweight ( p=0.0008 ) categories . In the obese group , there was no BMI variation between the groups , nor along the period during which they were using the method . CONCLUSIONS There was no change in weight gain among DMPA users from the obese category . Prospect i ve studies should be done with metabolic tests to establish the determining factors of weight gain in normal and overweight women The present work was a r and omized comparative study of two injectable progestogen-only contraceptives . The first group ( 200 subjects ) received 150 mg of depotmedroxyprogesterone acetate ( Depoprovera ) every 84 + /- 7 days and the second ( 200 subjects ) received 200 mg of norethisterone enanthate ( Noristerat ) every 56 + /- 7 days . Acceptors of injectable contraceptives in Assiut , Egypt , were mainly women looking for fertility termination . Menstrual disruption was the main side effect among both treatment groups . Amenorrhoea was the commonest menstrual complaint and was the main reason for discontinuation in both groups . Only one pregnancy occurred during NET-EN use ; two more pregnancies occurred , one in each of the two groups but there were indications that conception preceded the first injection . Menstrual irregularities were generally more frequent with DMPA users . However , DMPA had better one-year continuation rates than NET-EN ( 68.8 + /- 3.5 and 57.1 + /- 3.6 per 100 women , respectively ) STUDY OBJECTIVE To examine the relationship between dietary intake and weight gain among adolescent females initiating depot medroxyprogesterone acetate ( DMPA ) . DESIGN Prospect i ve observational study . SETTING Two urban Adolescent Medicine clinics . PARTICIPANTS 45 postmenarchal females , age 12 to 21 , enrolled after self- selecting to initiate DMPA . INTERVENTION Participants received 150 mg DMPA intramuscularly every 12 weeks . Height , weight , and 24-hour dietary recall were collected at baseline , 3 , 6 , and 12 months . MAIN OUTCOME MEASURE Body mass index ( BMI ) over time calculated as weight (kg)/height ( m(2 ) ) . Associations between dietary variables and BMI were evaluated with repeated measures analysis of variance modeling . RESULTS Mean chronological and gynecologic ages were 16.2 ± 1.5 and 4.2 ± 1.8 years , respectively . Mean BMI increased from 23.7 ± 5.3 to 25.3 ± 5.7 over 12 months . Average dietary intake included : 1781.4 ± 554.1 total kilocalories , 228.5 g ± 69.8 carbohydrates , 71.0 g ± 27.3 fat , and 61.0 g ± 20.2 protein . These diet measures were not associated with BMI over time . Dietary fiber , magnesium , and linoleic acid were inversely associated with increased BMI over time ( P < .05 ) CONCLUSION : We found no evidence that general measures of diet ( energy , carbohydrates , fat , and protein ) , as assessed by 24-hour recall , were predictive of weight gain on DMPA . Several nutrients abundant in foods that benefit overall health were inversely associated with increased BMI over time , suggesting that diet quality , rather than quantity , is a more important predictor of DMPA-associated weight gain OBJECTIVES Weight gain is a concern with the contraceptive depot-medroxyprogesterone acetate ( DMPA ) ; however , this issue remains controversial . The objective of this study was to compare body weight ( BW ) and body composition ( BC ) in DMPA and copper intrauterine device ( IUD ) users at baseline and after one year of use . STUDY DESIGN We enrolled new DMPA users and age and weight matched new IUD users into this prospect i ve study . Weight and height were measured , BC ( fat and lean mass ) was evaluated using dual-energy X-ray absorptiometry , and physical activity was assessed at baseline and at 12 months . Student 's paired t test and the Wilcoxon paired test for matched sample s were used . RESULTS Ninety-seven women were enrolled for the study ; 26 matched pairs continued using the initial method for at least one year , and completed the baseline and 12 month assessment s. An increase of 1.9 kg occurred in BW ( p=.02 ) in DMPA users at 12 months of use , result ing from an increase in fat mass of 1.6 kg ( p=.03 ) . Weight remained stable in IUD users ; however , there was an increase in lean mass at 12 months of use ( p=.001 ) . The number of women practicing physical activity increased in this group . There was a significant difference between the groups regarding the variation in the percentage of central fat ( p=.04 ) . CONCLUSION Weight gain in the DMPA group after the first year of use result ed from an increase in fat mass . Weight remained stable in the IUD group ; however , an increase in lean mass and a reduction in localized abdominal fat mass occurred , possibly because more users were practicing physical activity . IMPLICATION S STATEMENT There was a greater increase in body weight in DMPA users compared to TCu380A IUD users in the first year of use of the contraceptive method . Furthermore , the weight increase in users of DMPA occurred principally as the result of an increase in fat mass . Physical activity probably could increase the lean mass in the users of TCu380A IUD |
334 | 26,183,031 | RESULTS Intervention delivery in combination of setting s seemed to have higher improvements in breastfeeding rates .
Greatest improvements in early initiation of breastfeeding , exclusive breastfeeding and continued breastfeeding rates , were seen when counselling or education were provided concurrently in home and community , health systems and community , health systems and home setting s , respectively .
Baby friendly hospital support at health system was the most effective intervention to improve rates of any breastfeeding . | AIM To provide comprehensive evidence of the effect of interventions on early initiation , exclusive , continued and any breastfeeding rates when delivered in five setting s : ( i ) Health systems and services ( ii ) Home and family environment ( iii ) Community environment ( iv ) Work environment ( v ) Policy environment or a combination of any of above . | OBJECTIVE To pilot , among women with gestational diabetes mellitus ( GDM ) , the feasibility of a prenatal/postpartum intervention to modify diet and physical activity similar to the Diabetes Prevention Program . The intervention was delivered by telephone , and support for breastfeeding was addressed . RESEARCH DESIGN AND METHODS The goal was to help women return to their prepregnancy weight , if it was normal , or achieve a 5 % reduction from prepregnancy weight if overweight . Eligible participants were identified shortly after a GDM diagnosis ; 83.8 % consented to be r and omly assigned to intervention or usual medical care ( 96 and 101 women , respectively ) . The retention was 85.2 % at 12 months postpartum . RESULTS The proportion of women who reached the postpartum weight goal was higher , although not statistically significant , in the intervention condition than among usual care ( 37.5 vs. 21.4 % , absolute difference 16.1 % , P = 0.07 ) . The intervention was more effective among women who did not exceed the recommended gestational weight gain ( difference in the proportion of women meeting the weight goals : 22.5 % , P = 0.04 ) . The intervention condition decreased dietary fat intake more than the usual care ( condition difference in the mean change in percent of calories from fat : −3.6 % , P = 0.002 ) and increased breastfeeding , although not significantly ( condition difference in proportion : 15.0 % , P = 0.09 ) . No differences in postpartum physical activity were observed between conditions . CONCLUSIONS This study suggests that a lifestyle intervention that starts during pregnancy and continues postpartum is feasible and may prevent pregnancy weight retention and help overweight women lose weight . Strategies to help postpartum women overcome barriers to increasing physical activity are needed Breastfeeding rates among low-income women in the east-south- central United States are among the lowest in the country . This study examined the effect of a peer counseling program on breastfeeding initiation and duration in a low-income rural population in West Tennessee . A postpartum survey and chart review were conducted with WIC clients at nine health departments . Response rate was 99 % ( 291/293 ) . Breastfeeding initiation and duration at 6 weeks were increased in the peer counselor group ( n= 156 ) compared with women in the no-peer counselor group ( n= 135 ) ( 53 % vs. 33%,p<0.001 , and 26 % vs. 13%,p=0.006 , respectively ) . Multivariate analysis revealed that women in the peer counselor group were significantly more likely to initiate breastfeeding ( OR=2.43 , 95 % CI=1.23 - 4.67 ) and to be breastfeeding at 6 weeks ( OR=2.78 , 95 % CI=2.08 - 9.5 1 ) , than those in the no-peer counselor group We evaluated the single and combined effects of introducing a motivational video and peer counseling into four matched WIC clinics on breastfeeding initiation and continuation at 7 - 10 days among African-American WIC participants . Of the 242 women with complete data , 48 % initiated breastfeeding , but only 31 % were still breastfeeding at 7 - 10 days . Initiation was associated with cesarean delivery , infant feeding instruction , no artificial milk discharge pack , attending the peer counselor only-intervention site , and intention to breastfeed . Continuation was influenced by infant feeding instruction , no artificial milk discharge pack , and intention to breastfeed . Overall , trends toward a positive impact of the breastfeeding promotion activities were evident but weak , and largely gone by 7 - 10 days postpartum Abstract Objectives : To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives . Design : R and omised controlled trial with six month follow up . Setting : Recruitment in a university teaching hospital and care provided in women 's homes . Participants : 623 postnatal women allocated at r and om to intervention ( 311 ) or control ( 312 ) group . Intervention : Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker . Main outcome measure : General health status as measured by the SF-36 and risk of postnatal depression . Breast feeding rates , satisfaction with care , use of services , and personal costs . Results : At six weeks there was no significant improvement in health status among the women in the intervention group . At six weeks the mean total NHS costs were £ 635 for the intervention group and £ 456 for the control group ( P=0.001 ) . At six months figures were £ 815 and £ 639 ( P=0.001 ) . There were no differences between the groups in use of social services or personal costs . The women in the intervention group were very satisfied with the support worker visits . Conclusions : There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36 . There were no savings to the NHS over six months after the introduction of the community postnatal support worker service Background Exclusive Breastfeeding ( EBF ) refers to the practice of feeding breast milk only , ( including expressed breast milk ) to infants ; and excluding water , other liquids , breast milk substitutes , and solid foods . Inadequately breastfed infants are likely to be undernourished and have childhood infections . EBF knowledge and infant feeding practice s have not been studied sufficiently in Sokoto State , Nigeria . We describe the results of a r and omized community trial to promote Exclusive Breastfeeding ( EBF ) in two local government areas Kware and Bodinga selected as intervention and control groups respectively . Methods During advocacy meetings with community leaders , a Committee was formed . Members of the Committee were consulted for informed consent and selection of ten female volunteers who would educate mothers about breastfeeding during home visits . Participants comprised mothers of infants who were breastfeeding at the time of the study . A total of 179 mothers were recruited through systematic r and om sampling from each community . Volunteers conducted in-person interviews using a structured question naire and counseled mothers in the intervention group only . Results At baseline , intervention and control groups differed significantly regarding maternal occupation ( P=0.07 ) , and age of the index child ( P=0.07 ) . 42 % of infants in the intervention group were up to 6 months old and about 30 % of them were exclusively breastfed . Intention to EBF was significantly associated with maternal age ( P=0.01 ) , education ( P=0.00 ) and women who were exclusively breastfeeding ( P=0.00 ) . After counseling , all infants up to 6 months of age were exclusively breastfed . The proportion of mothers with intention to EBF increased significantly with maternal age ( P=0.00 ) , occupation ( P=0.00 ) and women who were exclusively breastfeeding ( P=0.01 ) . Post-intervention surveys showed that source of information and late initiation of breastfeeding was not significantly associated with intention to EBF . Mothers who reported practicing EBF for 6 months , were older ( P=0.00 ) multi-parous ( P=0.05 ) and more educated ( P=0.00 ) compared to those who did not practice EBF . Among them , significantly increased proportion of women agreed that EBF should be continued during the night ( P=0.03 ) , infant should be fed on dem and ( P=0.05 ) , sick child could be given medication ( P=0.02 ) , EBF offered protection against childhood diarrhea ( P=0.01 ) , and helped mothers with birth spacing ( P=0.00 ) . Conclusion This study shows that there is a need for reaching women with reliable information about infant nutrition in Sokoto State . The results show decreased EBF practice among working mothers , young women , mothers with poor education and fewer than five children . Counseling is a useful strategy for promoting the duration of EBF for six months and for developing support systems for nursing mothers . Working mothers may need additional re sources in this setting to enable them to practice EBF A r and omized controlled trial is used to determine whether assigning mixed feeders to a breastfeeding clinic within 1 week postpartum will increase exclusive breastfeeding at 1 month among Hispanic immigrants . Subjects are eligible for the Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) , and 85 % are monolingual Hispanic . Mothers ( n = 522 ) of infants at low risk for hyperbilirubinemia are approached at bedside 20 to 48 hours after delivery and r and omly assigned to treatment or control groups . Intent-to-treat analysis of feeding behavior at 4 weeks postpartum indicates that the intervention group is more likely to be exclusively breastfeeding ( 16.4 % vs 10 % in the control group , P = .03 ; adjusted odds ratio 1.87 ; 95 % confidence interval , 1.07 - 3.26 ) ; that the incidence of formula supplementation does not differ between groups ; and that the intervention group is less likely to supplement with water and tea ( P < .002 ) . J Hum Lact . 25(3):287 - 296 OBJECTIVE To determine whether peer counselors impacted breastfeeding duration among premature infants in an urban population . DESIGN This was a r and omized controlled clinical trial . SETTING The trial was conducted in the Newborn Intensive Care Unit at Boston Medical Center , an inner-city teaching hospital with approximately 2000 births per year . PARTICIPANTS One hundred eight mother-infant pairs were enrolled between 2001 and 2004 . Pairs were eligible if the mother intended and was eligible to breastfeed per the 1997 guidelines from the American Academy of Pediatrics and if the infant was 26 to 37 weeks ' gestational age and otherwise healthy . INTERVENTION Subjects were r and omized to either a peer counselor who saw the mother weekly for 6 weeks or to st and ard of care . MAIN OUTCOME MEASURE The main outcome measure was any breast-milk feeding at 12 weeks postpartum . RESULTS Intervention and control groups were similar on all measured sociodemographic factors . The average gestational age of infants was 32 weeks ( range , 26.3 - 37 weeks ) with a mean birth weight of 1875 g ( range , 682 - 3005 g ) . At 12 weeks postpartum , women with a peer counselor had odds of providing any amount of breast milk 181 % greater than women without a peer counselor ( odds ratio , 2.81 [ 95 % confidence interval , 1.11 - 7.14 ] ; P = .01 ) . CONCLUSIONS Peer counselors increased breastfeeding duration among premature infants born in an inner-city hospital and admitted to the neonatal intensive care unit . Peer counseling programs can help to increase breastfeeding in this vulnerable population OBJECTIVE Recent studies have raised the issue of lower breastfeeding rates for mothers enrolled in the Special Supplemental Nutrition Program for Women , Infants and Children ( WIC ) . We wanted to explore this association of WIC and lower breastfeeding in Nurse Family Partnership Program ( NFP ) , a national representative group of mother-baby pairs on which extensive background data are available . Our aim was to compare breastfeeding rates at 6 and 12 months in NFP high-risk mothers who were enrolled in WIC to those who were not enrolled in WIC . METHODS We conducted a retrospective secondary analysis in mothers and infants from this cohort for 2000 - 2005 ( n = 3,570 ) . RESULTS We found that at 6 months of age , 87.8 % of mothers who were not breastfeeding were enrolled in WIC as compared to 82.6 % of mothers who were breastfeeding ( p < 0.001 ) . However , in the multivariate analysis , WIC was no longer a significant predictor of breastfeeding . CONCLUSIONS Prospect i ve evaluation of this issue is warranted particularly with the implementation of changes in the WIC Food Package and Breastfeeding Promotion In northern Nigeria , interventions are urgently needed to narrow the large gap between international breastfeeding recommendations and actual breastfeeding practice s. Studies of integrated microcredit and community health interventions documented success in modifying health behaviors but typically had uncontrolled design s. We conducted a cluster-r and omized controlled trial in Bauchi State , Nigeria , with the aim of increasing early breastfeeding initiation and exclusive breastfeeding among female microcredit clients . The intervention had 3 components . Trained credit officers led monthly breastfeeding learning sessions during regularly scheduled microcredit meetings for 10 mo . Text and voice messages were sent out weekly to a cell phone provided to small groups of microcredit clients ( 5 - 7 women ) . The small groups prepared songs or dramas about the messages and presented them at the monthly microcredit meetings . The control arm continued with the regular microcredit program . R and omization occurred at the level of the monthly meeting groups . Pregnant clients were recruited at baseline and interviewed again when their infants were aged ≥6 mo . Logistic regression models accounting for clustering were used to estimate the odds of performing recommended behaviors . Among the clients who completed the final survey ( n = 390 ) , the odds of exclusive breastfeeding to 6 mo ( OR : 2.4 ; 95 % CI : 1.4 , 4.0 ) and timely breastfeeding initiation ( OR : 2.6 ; 95 % CI : 1.6 , 4.1 ) were increased in the intervention vs. control arm . Delayed introduction of water explained most of the increase in exclusive breastfeeding among clients receiving the intervention . In conclusion , a breastfeeding promotion intervention integrated into microcredit increased the likelihood that women adopted recommended breastfeeding practice s. This intervention could be scaled up in Nigeria , where local organizations provide microcredit to > 500,000 clients . Furthermore , the intervention could be adopted more widely given that > 150 million women , many of childbearing age , are involved in microfinance globally The importance of exclusive breast-feeding in the first 6 mo of life is widely recognized , but most mothers still do not reach this goal . Several studies have shown that face-to-face lactation counseling is effective in increasing not only exclusive breast-feeding rates but also the total duration of breast-feeding . However , it is unclear whether counseling could increase breast milk intake . The purpose of this study was to evaluate the effect of lactation counseling on breast milk intake , assessed through the deuterium dilution method . This was a blind , r and omized intervention trial of lactation counseling in a sample of 188 babies born in Pelotas , selected with the same criteria used for the WHO Multicentre Growth Reference Study ( MGRS ) . The main outcomes were breast-feeding pattern and duration for all infants as well as breast milk intake for a sub sample of 68 infants at the age of 4 mo . Mothers in the control group were almost twice as likely to stop breast-feeding by 4 mo as those in the intervention group ( prevalence ratio 1.85 ; P = 0.04 ) . Cox regression confirmed that the velocity of weaning was twice as high in the control group . Breast milk and total water intakes did not differ between the groups . The deuterium dilution technique proved to be a practical means of assessing breast milk intake . Lactation counseling reduced early weaning , but breast milk intake at 4 mo was not affected BACKGROUND Strong associations between delayed initiation of breastfeeding and increased neonatal mortality ( 2 - 28 d ) were recently reported in rural Ghana . Investigation into the biological plausibility of this relation and potential causal pathways is needed . OBJECTIVE The objective was to assess the effect of early infant feeding practice s ( delayed initiation , prelacteal feeding , established neonatal breastfeeding ) on infection-specific neonatal mortality in breastfed neonates aged 2 - 28 d. DESIGN This prospect i ve observational cohort study was based on 10 942 breastfed singleton neonates born between 1 July 2003 and 30 June 2004 , who survived to day 2 , and whose mothers were visited in the neonatal period . Verbal autopsies were used to ascertain the cause of death . RESULTS One hundred forty neonates died from day 2 to day 28 ; 93 died of infection and 47 of noninfectious causes . The risk of death as a result of infection increased with increasing delay in initiation of breastfeeding from 1 h to day 7 ; overall late initiation ( after day 1 ) was associated with a 2.6-fold risk [ adjusted odds ratio ( adj OR ) : 2.61 ; 95 % CI : 1.68 , 4.04 ] . Partial breastfeeding was associated with a 5.7-fold adjusted risk of death as a result of infectious disease ( adj OR : 5.73 ; 95 % CI : 2.75 , 11.91 ) . No obvious associations were observed between these feeding practice s and noninfection-specific mortality . Prelacteal feeding was not associated with infection ( adj OR : 1.11 ; 95 % CI : 0.66 , 1.86 ) or noninfection-specific ( adj OR : 1.33 ; 95 % CI : 0.55 , 3.22 ) mortality . CONCLUSIONS This study provides the first epidemiologic evidence of a causal association between early breastfeeding and reduced infection-specific neonatal mortality in young human infants Exclusive breast-feeding ( EBF ) rates remain low despite numerous health benefits associated with this behavior . We conducted a r and omized trial on the effect of lactation counseling on EBF , which controlled for the Hawthorne effect while also varying the timing of the intervention . Pregnant women attending prenatal clinics in Tema were r and omly assigned to 1 of 2 intervention groups ( IG ) or to a control group ( C ) , as follows : 1 ) EBF support given pre- , peri- , and postnatally ( IG1 ; n = 43 ) ; 2 ) EBF support given only peri- and postnatally ( IG2 ; n = 44 ) ; or 3 ) nonbreast-feeding health educational support ( C ; n = 49 ) that had an equal amount of contact with lactation counselors . Two educational sessions were provided prenatally , and 9 home follow-up visits were provided in the 6-mo postpartum period . Infant feeding data were collected monthly at the participant 's home . The 3 groups did not differ in sociodemographic characteristics . At 6 mo postpartum , 90.0 % in IG1 and 74.4 % in IG2 had exclusively breast-fed during the previous month . By contrast , only 47.7 % in C were doing so ( P = 0.008 ) . Similarly , the percentage of EBF during the 6 mo was significantly higher ( P = 0.02 ) among IG1 and IG2 ( 39.5 % ) than among C ( 19.6 % ) . The 100 % increase in EBF rates can be attributed to the lactation counseling provided . Additional prenatal EBF support may not be needed within a context of strong routine prenatal EBF education OBJECTIVE Breast-feeding counselling has been identified as the intervention with the greatest potential for reducing child deaths , but there is little experience in delivering breast-feeding counselling at scale within routine health systems . The study aim was to compare rates of exclusive breast-feeding associated with a breast-feeding counselling intervention in which community health agents ( CHA ) received 20 h of training directed at counselling and practical skills with rates pre-intervention when CHA received 4 h of didactic teaching . DESIGN Cross-sectional surveys of breast-feeding practice s were conducted pre- and post-intervention in r and om sample s of 1266 and 1245 infants aged 0 - 5.9 months , respectively . SETTING Recife , Brazil , with a population of 2 million . SUBJECTS CHA ( n 1449 ) of Brazil 's Family Health Programme were trained to provide breast-feeding counselling at home visits . RESULTS Rates of exclusive breast-feeding improved when CHA were trained to provide breast-feeding counselling and were significantly higher by 10 - 13 percentage points at age 3 - 5.9 months when compared with pre-intervention rates ( P < 0.05 ) . Post-intervention point prevalence of exclusive breast-feeding for infants aged < 4 months was 63 % and for those aged < 6 months was 50 % . CONCLUSIONS Multifunctional CHA were able to deliver breast-feeding counselling at scale within a routine health service and this was associated with a significant increase in rates of exclusive breast-feeding . The study reinforces the need to focus training on counselling and practical skills ; a key component was an interactive style that utilized the knowledge and experience of CHA . The findings are relevant to the call by international organizations to scale up breast-feeding counselling BACKGROUND Obese women often have difficulties breastfeeding . OBJECTIVE We evaluated whether telephone-based support could increase the duration of breastfeeding in obese women and , thereby , reduce offspring growth . DESIGN We recruited 226 dyads of obese mothers and their singleton , healthy , term infants . The women were r and omly assigned to 6 mo of breastfeeding support or st and ard care controls . At 6 mo , there were 207 dyads in the study ; 105 dyads received support , and 102 dyads were control subjects . One International Board Certified Lactation Consultant carried out the intervention , which was based on structured interviews and consisted of encouraging telephone calls . RESULTS The support group breastfed exclusively for a median of 120 d ( 25th-75th percentiles : 14 - 142 d ) compared with 41 d ( 3 - 133 d ) for control subjects ( P = 0.003 ) . Any breastfeeding was maintained for a median of 184 d ( 92 - 185 d ) for the support group compared with 108 d ( 16 - 185 d ) for control subjects ( P = 0.002 ) . Support increased the adjusted ORs for exclusive breastfeeding at 3 mo and the ratios for partial breastfeeding at 6 mo to 2.45 ( 95 % CI : 1.36 , 4.41 ; P = 0.003 ) and 2.25 ( 95 % CI : 1.24 , 4.08 ; P = 0.008 , respectively ) . Although the duration of exclusive breastfeeding was inversely associated with infant weight ( β = -4.39 g/d ; 95 % CI : -0.66 , -8.11 g/d ; P = 0.021 ) and infant length at 6 mo ( β = -0 . 012 cm/d ; 95 % CI : -0.004 , -0.02 cm/d ; P = 0.004 ) , the breastfeeding support did not achieve a significant effect on infant growth at 6 mo ( n = 192 ) . CONCLUSIONS Telephone-based advisory support was very effective in prolonging breastfeeding in obese mothers who often terminate the breastfeeding of their infants prematurely . A longer duration of breastfeeding may decrease risk of noncommunicable diseases in these infants . This trial was registered at clinical trials.gov as NCT01235663 The effects of implementation WHO/UNICEF Breastfeeding Hospital Initiative ( BFHI ) and community postnatal support on breastfeeding rates were examined during and after the breastfeeding promotion campaign in one county of Croatia . Comparison with a control group indicated increase of breastfeeding prevalence in a period of BFHI implementation ( 1994 - 1998 ) - 68 % vs. 87 % at infant age 1 mo . , 30 % vs. 54 % at 3 mo . , 11.5 % vs. 28 % at 6 mo . , and 2 % vs. 3.5 % at infant age 11 - 12 mo . ( chi-square test , p < 0.05 ) . More considerable increase has been noticed in period 1999 - 2000 which is characterized by breastfeeding support groups activity : 68 % vs. 87 % at infant age 1 mo . , 30 % vs. 66 % at 3 mo . , 11.5 % vs. 49 % at 6 mo . , and 2 % vs. 23 % at infant age 11 - 12 mo . ( chi-square test , p < 0.05 ) . Our conclusion is that activities aim ing to promote breastfeeding in maternity hospitals have had limited success . They have result ed in satisfactory increase of breastfeeding prevalence in early infant 's period , but for far-reaching effect postnatal support is also required CONTEXT Promotion of breastfeeding in Brazilian maternity hospitals . OBJECTIVE To quantify changes in the breastfeeding duration among mothers served by hospitals exposed to the Wellstart-SLC course , comparing them with changes among mothers attended by institutions not exposed to this course . DESIGN R and omized Institutional Trial . SETTING The effects of training on breastfeeding duration was assessed in eight Brazilian hospitals assigned at r and om to either an exposed group ( staff attending the Wellstart-SLC course ) or a control group . SAMPLE For each of the eight study hospitals , two cohorts of about 50 children were visited at home at one and six months after birth . The first cohort ( n = 494 ) was composed of babies born in the month prior to exposure to the Wellstart-SLC course , and the second cohort ( n = 476 ) was composed of babies born six months subsequent to this exposure . MAIN MEASUREMENTS Kaplan-Meier curves were plotted to describe the weaning process and log-rank tests were used to assess statistical differences among survival curves . Hazard ratio ( HR ) estimates were calculated by fitting Cox proportional hazard regression models to the data . RESULTS The increases in estimated , adjusted rates for children born in hospitals with trained personnel were 29 % ( HR = 0.71 ) and 20 % ( HR = 0.80 ) for exclusive and full breastfeeding , respectively . No changes were identified for total breastfeeding . CONCLUSION This r and omized trial supports a growing body of evidence that training hospital health professionals in breastfeeding promotion and protection results in an increase in breastfeeding duration AIMS To assess the association between attendance at antenatal education sessions and breastfeeding during the first year of life . BACKGROUND Although there is evidence that antenatal education encourages breastfeeding , the size and duration of its effect remain unclear . DESIGN A prospect i ve cohort study . METHODS The study was conducted in Bizkaia ( North of Spain ) between May 2005-June 2007 with a consecutive sample of 614 primiparas . Women were classified into three groups according to whether they had received antenatal education and , if so , how many classes ( 0 , 1 - 4 , or 5 or more ) . Telephone interviews at 1·5 , 3 , 6 and 12 months were used to estimate the risk of cessation of any breastfeeding and to compare the groups with Cox proportional hazards regression models adjusted for potential confounders . FINDINGS Initially , 90 % of women breastfed their infants , with no differences between the groups . During the first month , the risk of cessation of any breastfeeding was three times as high among non-attendees and twice as high among women who attended 1 - 4 classes compared with those who attended 5 or more classes . The risk was , however , similar in the three groups from the end of first month onwards . CONCLUSION The results suggest that though antenatal education may be associated with higher rates of breastfeeding in our setting this is only the case for the first month after the birth . Further research is necessary to optimize this beneficial effect to achieve long-term continuation of breastfeeding To assess the feasibility of a pediatric primary care based intervention to promote healthful behaviors among 0–6 month old infants and their mothers . We enrolled two intervention practice s ( 60 mother-infant pairs ) and one usual care control practice ( 24 pairs ) in a non-r and omized controlled trial . We completed visits and interviews with 80 ( 95 % ) pairs at birth and 6 months . The intervention included ( 1 ) brief focused negotiation by pediatricians , ( 2 ) motivational counseling by a health educator , and ( 3 ) group parenting workshops . We evaluated the intervention effects on infant feeding , sleep duration , TV viewing , and mothers ’ responsiveness to satiety cues . Maternal behavioral targets included postpartum diet , physical activity , TV and sleep . At 6 months , fewer intervention than control infants had been introduced to solid foods ( 57 % vs. 82 % ; P = 0.04 ) , and intervention infants viewed less TV ( mean 1.2 vs. 1.5 h/d ; P = 0.07 ) . Compared to control infants , intervention infants had larger increases in their nocturnal sleep duration from baseline to follow up ( mean increase 1.9 vs. 1.3 h/d ; P = 0.05 ) ; larger reductions in settling time ( mean reduction −0.70 vs. −0.10 h/d ; P = 0.02 ) ; and larger reductions in hours/day of nighttime wakefulness ( mean reduction −2.9 vs. −1.5 h/d ; P = 0.08 ) . There were no differences in breastfeeding , response to satiety cues , or maternal health behaviors . A program of brief focused negotiation by pediatricians , individual coaching by health educators using motivational interviewing , and group parenting workshops tended to improve infant feeding , sleep and media exposure , but had less impact on mothers ’ own health-related behaviors OBJECTIVE Maternal obesity is associated with poor breastfeeding outcomes , yet no intervention has been developed to improve them . To ascertain whether increased breastfeeding support or provision of a breast pump is a feasible , effective intervention to improve breastfeeding , we enrolled obese women who intended to breastfeed in two r and omized trials . METHODS In Bassett Improving Breastfeeding Study ( BIBS ) 1 , 40 women received targeted breastfeeding support in the hospital and via telephone or usual care . Information regarding breastfeeding was collected via telephone for 7 days after delivery and at 30 and 90 days postpartum . In BIBS 2 , 34 obese mothers received a manual or electric breast pump to use for 10 - 14 days or no pump ; data collection was similar . RESULTS In both experiments , r and omization failed to distribute women of differing postpartum body mass index adequately among the treatment groups . When analyses were adjusted for this , there was no difference in BIBS 1 between targeted and usual care groups and in BIBS 2 among the treatment groups in the proportion of women still breastfeeding at the times studied . CONCLUSIONS In future studies of obese women , stratified r and omization may be necessary . Further development of interventions to help obese women achieve optimal breastfeeding outcomes is required OBJECTIVE to investigate the relationship between adherence to six of the Baby Friendly Hospital Initiative ( BFHI ) Ten steps to successful breast feeding and the duration of breast feeding in first-time mothers . DESIGN a prospect i ve study to assess the duration of breast feeding up to 6 months postpartum . Survival analysis techniques ( Kaplan-Meier curves and Cox proportional hazard models ) were used to interpret the data . PARTICIPANTS 317 women who had given birth to their first baby ( at term ) in a large teaching maternity hospital in Adelaide , South Australia , during the period March to November 2003 . FINDINGS ignoring all other factors , we found that women whose babies received a bottle feed , used a pacifier or dummy , or who used a nipple shield during their postnatal stay , were at significantly greater risk of weaning ( p0.05 ) . After adjusting for socio-demographic variables , self-efficacy , intended duration of breast feeding , and method of delivery , the results unexpectedly showed that the only significant predictor of early weaning was breast feeding on dem and . However , a composite variable indicating use of one or more of nipple shields , a dummy or bottle feeds while in hospital result ed in a significantly greater risk of weaning ( p=0.05 ) . IMPLICATION S FOR PRACTICE socio-demographic and cultural factors may be more important determinants of the duration of breast feeding than some of the very specific hospital practice s targeted in the Ten steps to successful breast feeding . From a public health perspective , we may influence the duration of breast feeding through better post-discharge support services , or through interventions that improve attitudes to breast feeding in specific socio-cultural and economic groups OBJECTIVE To determine the effects of a prenatal breastfeeding workshop on maternal breastfeeding self-efficacy and breastfeeding duration . DESIGN R and omized controlled trial . SETTING Large tertiary hospital in Ontario , Canada . PARTICIPANTS 110 primiparous women expecting a single child , an uncomplicated birth , and planning to breastfeed . INTERVENTION 2.5-hour prenatal breastfeeding workshop based on adult learning principles and self-efficacy theory . MAIN OUTCOME MEASURE Maternal breastfeeding self-efficacy and the numbers of days and amount of breastfeeding were measured at four and eight weeks postpartum . RESULTS / DATA ANALYSIS : Over time , maternal breastfeeding self-efficacy scores increased in both groups . Women who attended the workshop had higher self-efficacy scores and a higher proportion were exclusively breastfeeding compared to women who did not attend the workshop . There was little difference in the average number of days of breastfeeding , but the intervention group had less weaning . CONCLUSIONS The workshop increased maternal breastfeeding self-efficacy and exclusive breastfeeding Objective . To investigate whether supporting fathers to recognize the relevance of their role in the success of breastfeeding and teaching them how to prevent and to manage the most common lactation problems would result in more women breastfeeding . Methods . A controlled trial , in which the participating fathers were allocated in 2-month blocks to a child care training session , was conducted of 280 mothers considering breastfeeding and their 280 partners at a university obstetric department in Naples , Italy . Support and advice about breastfeeding was provided to all of the mothers . Among the fathers of the intervention group , the training session included the management of breastfeeding ; among those of the control group , it did not . Primary outcome was the prevalence of full breastfeeding at 6 months . Secondary outcomes were the proportion of women who perceived their milk to be insufficient , who stopped breastfeeding because of problems , and who reported to have received help in breastfeeding management by their partners . Results The prevalence of full breastfeeding at 6 months was 25 % ( 35 of 140 ) in the intervention group and 15 % ( 21 of 140 ) in the control group and that of any breastfeeding at 12 months was 19 % ( 27 ) and 11 % ( 16 ) , respectively . Perceived milk insufficiency was significantly more frequent among the mothers of the control group ( 38 [ 27 % ] of 140 vs 12 [ 8.6 % ] of 140 ) , as well as breastfeeding interruption because of problems with lactation ( 25 [ 18 % ] of 140 vs 6 [ 4 % ] of 140 ) . Moreover , significantly more women in the intervention group reported receiving support and relevant help with infant feeding management from their partners ( 128 [ 91 % ] of 140 vs 48 [ 34 % ] of 140 ) . Among the women who had reported difficulties with lactation in the intervention and control groups ( 96 [ 69 % ] and 89 [ 64 % ] , respectively ) , the prevalence of full breastfeeding at 6 months was 24 % and 4.5 % , respectively . Conclusions Teaching fathers how to prevent and to manage the most common lactation difficulties is associated with higher rates of full breastfeeding at 6 months OBJECTIVE To determine if supplementary structured breastfeeding counseling ( SSBC ) for both parents compared with conventional hospital breastfeeding support ( CHBS ) improves the duration of breastfeeding in very low-birth-weight infants up to 1 year old . DESIGN R and omized trial with longitudinal follow-up of infants at term , and ages 1 , 3 , 6 , and 12 months ( infant ages corrected for prematurity ) . SETTING A tertiary-level neonatal intensive care unit ( NICU ) and geographically defined region in central -west Ontario , Canada . PARTICIPANTS Parents of infants with a birth weight less than 1500 g , who planned to breastfeed . INTERVENTIONS The SSBC consisted of viewing a video on breastfeeding for preterm infants ; individual counseling by the research lactation consultant ; weekly personal contact in the hospital ; and frequent postdischarge contact through the infants ' first year or until breastfeeding was discontinued . The CHBS group had st and ard breastfeeding support from regular staff members confined to the period of hospitalization in the NICU . MAIN OUTCOME MEASURE Duration of breastfeeding . RESULTS At study entry , there were no statistically significant differences in major demographic characteristics between groups . The mean duration of breastfeeding was 26.1 weeks ( SD = 20.8 ; median , 17.4 ) in the SSBC group and 24.0 weeks ( SD = 20.5 ; median , 17.4 ) in the CHBS group ( not statistically significant ) . CONCLUSIONS Long-term breastfeeding counseling of parents of very low-birth-weight infants in this study did not demonstrate a significant difference in duration of breastfeeding . These results may be explained by the high motivation to breastfeed in both groups , a relatively advantaged population , and the availability of community breastfeeding re sources , which may have diminished any significant differences that could have result ed from a breastfeeding intervention . The results of this study , compared with previous studies of very low-birth-weight infants , indicate a new trend to longer duration of breastfeeding in preterm infants Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Background . Despite growing evidence of the benefits of prolonged breastfeeding for mother and infant health , the rate of breastfeeding at infant age of 6 months remains below the Healthy People 2010 goal . The greatest decrease in the breastfeeding rate occurs during the first 4 postpartum weeks . Mothers who discontinue breastfeeding early are more likely to report lack of confidence in their ability to breastfeed , problems with the infant latching or suckling , and lack of individualized encouragement from their clinicians in the early postdischarge period . Observational studies suggest that primary care physicians can increase breastfeeding rates through specific advice and practice s during routine preventive visits . However , robust scientific evidence based on r and omized , controlled trials is currently lacking . Objective . The purpose of this study was to determine whether attending an early , routine , preventive , outpatient visit delivered in a primary care physician ’s office would improve breastfeeding outcomes . Design . The study was a prospect i ve , r and omized , parallel-group , open trial . Setting . Participants were recruited at a level 3 maternity facility , with an average of 2000 births per year , in France . Participants . A total of 231 mothers who had delivered a healthy singleton infant ( gestational age : ≥37 completed weeks ) and were breastfeeding on the day of discharge were recruited and r and omized ( 116 were assigned to the intervention group and 115 to the control group ) between October 1 , 2001 , and May 31 , 2002 ; 226 mother-infant pairs ( 112 in the intervention group and 114 in the control group ) contributed data on outcomes . Intervention . Support for breastfeeding in the control group included the usual verbal encouragement provided by the maternity ward staff members , a general health assessment and an evaluation for evidence of successful breastfeeding behavior by the pediatrician working in the obstetrics department on the day of discharge , provision of the telephone number of a peer support group , m and atory routine , preventive , outpatient visits at 1 , 2 , 3 , 4 , 5 , and 6 months of infant age , and 10 weeks of paid maternity leave ( extended to 18 weeks after the birth of the third child ) . In addition to the usual predischarge and postdischarge support , the mothers in the intervention group were invited to attend an individual , routine , preventive , outpatient visit in the office of 1 of the 17 participating primary care physicians ( pediatricians or family physicians ) within 2 weeks after the birth . The participating physicians received a 5-hour training program on breastfeeding , delivered in 2 parts in 1 month , before the beginning of the study . Outcome Measures . The primary outcome was the prevalence of exclusive breastfeeding reported at 4 weeks ( defined as giving maternal milk as the only food source , with no other foods or liquids , other than vitamins or medications , being given ) . The secondary outcomes included any breastfeeding reported at 4 weeks , breastfeeding duration , breastfeeding difficulties , and satisfaction with breastfeeding experiences . Classification into breastfeeding categories reported at 4 weeks was based on 24-hour dietary recall . Results . Ninety-two mothers ( 79.3 % ) assigned to the intervention group and 8 mothers ( 7.0 % ) assigned to the control group reported that they had attended the routine , preventive , outpatient visit in the office of 1 of the 17 primary care physicians participating in the study . Mothers in the intervention group were more likely to report exclusive breastfeeding at 4 weeks ( 83.9 % vs 71.9 % ; hazard ratio : 1.17 ; 95 % confidence interval [ CI ] : 1.01–1.34 ) and longer breastfeeding duration ( median : 18 weeks vs 13 weeks ; hazard ratio : 1.40 ; 95 % CI : 1.03–1.92 ) . They were less likely to report any breastfeeding difficulties ( 55.3 % vs 72.8 % ; hazard ratio : 0.76 ; 95 % CI : 0.62–0.93 ) . There was no significant difference between the 2 groups with respect to the rate of any breastfeeding at 4 weeks ( 89.3 % vs 81.6 % ; hazard ratio : 1.09 ; 95 % CI : 0.98–1.22 ) and the rate of mothers fairly or very satisfied with their breastfeeding experiences ( 91.1 % vs 87.7 % ; hazard ratio : 1.04 ; 95 % CI : 0.95–1.14 ) . Conclusions . Although we can not exclude the possibility that findings might differ in other health care systems , this study provides preliminary evidence of the efficacy of breastfeeding support through an early , routine , preventive visit in the offices of trained primary care physicians . Our findings also suggest that a short training program for practicing physicians might contribute to improving breastfeeding outcomes . Multifaceted interventions aim ing to support breastfeeding should involve primary care physicians Since very few tools used in health education are carefully evaluated , the aim of this study was to examine the effect that a breastfeeding information booklet had on breastfeeding behaviour . Feedback about breastfeeding information needs from a preliminary study of 58 Perth mothers at 3 months postpartum provided the basis for the development of an information booklet . The sample consisted of 150 mothers of full-term infants who were breastfeeding for the first time . Upon discharge from hospital , a r and om sample of 75 mothers were sent the booklet . These mothers and a control group ( n = 75 ) were surveyed for 52 weeks to compare breastfeeding duration . Although the breastfeeding information booklet was found to be useful by 97 % of the experimental group , there was no significant difference noted for breastfeeding duration between groups . Study findings have implication s for clinical practice in highlighting the importance of breastfeeding information in increasing mothers ' confidence , providing suggestions for breastfeeding practice , and helping mothers not to feel alone in their concerns . Further research should include investigations into the association between mothers reaching their intended goal for breastfeeding duration and being satisfied with the breastfeeding experience . Success with breastfeeding tends to be measured by duration alone , but no research to date has specifically examined the criteria mothers use to determine if their breastfeeding experience was successful OBJECTIVE to assess the ability of a Breast-Feeding Self-Efficacy Scale ( BSES ) score measured at 1 week postpartum to predict the duration of breast-feeding in first-time mothers , and to develop a minimal set of potential confounders , including the BSES and demographic variables , for comparing the apparent effect of other influences on the duration of breast-feeding . DESIGN a prospect i ve cohort study , with primary outcome the duration of breast feeding up to 6 months postpartum . PARTICIPANTS 317 women who had given birth to their first baby ( at term ) in a large teaching maternity hospital in Adelaide , South Australia , during the period March to November , 2003 . FINDINGS the BSES at 1 week postpartum was a strong predictor of the duration of breast-feeding in these first-time mothers . Its ability to predict the duration of breast-feeding was largely independent of the other factors ( intended duration of breast-feeding , mother 's level of education , country of birth , housing situation , smoking status and method of delivery ) , which were also found to be significant predictors of breast-feeding duration . IMPLICATION S FOR PRACTICE the BSES ( including a new short form version ) has been confirmed by our study as an important instrument for identifying women at risk of early cessation of breast-feeding . Together with other demographic variables , it should be useful for targeting limited re sources to those most in need Objectives : We report on a nonr and omized intervention cohort study to increase exclusive breast-feeding rates for 6 months after delivery in HIV-positive and HIV-negative women in KwaZulu-Natal , South Africa . Methods : Lay counselors visited women to support exclusive breast-feeding : four times antenatally , four times in the first 2 weeks postpartum and then fortnightly to 6 months . Daily feeding practice s were collected at weekly intervals by separate field workers . Cumulative exclusive breast-feeding rates from birth were assessed by Kaplan – Meier analysis and association with maternal and infant variables was quantified in a Cox regression analysis . Findings : One thous and , two hundred and nineteen infants of HIV-negative and 1217 infants of HIV-positive women were followed postnatally . Median duration of exclusive breast-feeding was 177 ( R = 1–180 ; interquartile range : 150–180 ) and 175 days ( R = 1–180 ; interquartile range : 137–180 ) in HIV-negative and HIV-positive women , respectively . Using 24-h recall , exclusive breast-feeding rates at 3 and 5 months were 83.1 and 76.5 % , respectively , in HIV-negative women and 72.5 and 66.7 % , respectively , in HIV-positive women . Using the most stringent cumulative data , 45 % of HIV-negative and 40 % of HIV-positive women adhered to exclusive breast-feeding for 6 months . Counseling visits were strongly associated with adherence to cumulative exclusive breast-feeding at 4 months , those who had received the scheduled number of visits were more than twice as likely to still be exclusively breast-feeding than those who had not ( HIV-negative women : adjusted odds ratio : 2.07 , 95 % confidence interval : 1.56–2.74 , P < 0.0001 ; HIV-positive women : adjusted odds ratio : 2.86 , 95 % CI 2.13–3.83 , P < 0.0001 ) . Conclusion : It is feasible to promote and sustain exclusive breast-feeding for 6 months in both HIV-positive and HIV-negative women , with home support from well trained lay counselors BACKGROUND Exclusive breastfeeding rates in Malaysia remains low despite the implementation of the Baby Friendly Hospital Initiative ( BFHI ) policy in government hospitals . It has been suggested that any form of postnatal lactation support will lead to an increase in exclusive breastfeeding rates . OBJECTIVE To study the effectiveness of telephone lactation counselling on breastfeeding practice s. DESIGN Single blinded , r and omised controlled trial ( RCT ) . SETTING Maternity wards in a public hospital in Kuala Lumpur , Malaysia . PARTICIPANTS 357 mothers , each of whom had delivered a full term , healthy infant via spontaneous vaginal delivery . METHODS Mothers were followed up for 6 months . The intervention group ( n=179 ) received lactation counselling via telephone twice monthly by certified lactation counsellors in addition to receiving the current conventional care of postnatal breastfeeding support . The control group ( n=178 ) received the current conventional care of postnatal breastfeeding support . Definitions of breastfeeding practice s were according to World Health Organization ( WHO ) definitions . Participants answered a self-administered question naire during recruitment and were later followed up at one , four and 6-month intervals during the postpartum period via a telephone-based question naire . RESULTS At 1 month , a higher percentage of mothers in the intervention group practice d exclusive breastfeeding , compared to the control group ( 84.3 % vs. 74.7 % , OR 1.825 95 % , p=0.042 , CI=1.054 , 3.157 ) . At 4 and 6 months postpartum , similar percentages of mothers from the two groups practice d exclusive breastfeeding ( 41.98 % vs. 38.99 % ; 12.50 % vs. 12.02 % , no significant differences , both p>0.05 ) . Slightly higher numbers of mothers in the control group had completely stopped breastfeeding at the 1 , 4 and 6 month marks , compared to the intervention group ( 7.4 % vs. 5.4 % ; 12.6 % vs. 9.9 % ; 13.9 % vs. 9.4 % ; all p>0.05 ) . The reason cited by most mothers who had completely stopped breastfeeding during the early postpartum period was a low breast milk supply , while returning to work was the main reason for stopping breastfeeding later in the postpartum period . CONCLUSIONS Telephone lactation counselling provided by certified lactation counsellors from the nursing profession was effective in increasing the rate of exclusive breastfeeding for the first postpartum month but not during the 4 and 6month postpartum intervals A comparative study has been made on two groups of 102 mothers each who delivered children in the postnatal ward of obstetrics and gynaecology department of Calcutta National Medical College before and after the introduction of BFHI ( Baby Friendly Hospital Initiative ) . The study revealed that only 14.3 % of the babies who were delivered normally were given their first breast feed in time , the ideal time of half an hour , while not a single baby delivered by caesarean section were given their breast feed within the stipulated time period of 4 - 6 hours . However , there has been a significant overall reduction in the time gap between the birth and the first breast feed in all types of delivery . BFHI has also made significant reduction of prelacteal feeds and in-between feeds in the newborns especially those delivered normally . The fact that babies of first order and those delivered by caesarean section are lagging behind as far as exclusive breast feeding is concerned has been highlighted in the study The vast majority of breastfeeding mothers in Western countries have routine access to multimedia and Internet re sources at home . The aim of this study was to assess the effectiveness of a CD-ROM-based intervention in increasing the rates of breastfeeding . We conducted a pre- and post-intervention study involving four control and four intervention maternity units in France . All breastfeeding mothers in intervention units were given a CD-ROM-based program addressing various breastfeeding topics . The primary outcome was any breastfeeding at 4 weeks assessed by follow-up telephone interview . The secondary outcomes included breastfeeding duration , breastfeeding difficulties after discharge and satisfaction with the breastfeeding experience . The rates of any breastfeeding at 4 weeks varied from 88.6 % ( 209/236 ) to 87.9 % ( 211/240 ) and from 86.0 % ( 222/258 ) to 88.0 % ( 228/259 ) for mothers enrolled in intervention and control maternity units , respectively ( P for interaction=0.54 ) . The hazard of breastfeeding discontinuation for mothers enrolled in intervention units did not vary significantly across study periods after adjusting for education level , epidural anaesthesia , breastfeeding assessment score and return to work ( P for interaction=0.18 ) . The rates of breastfeeding at 4 weeks remained unchanged when restricting the analysis to the mothers who actually received ( 87.8 % [ 173/197 ] ) or used [ 88.2 % ( 105/119 ) ] the CD-ROM during the post-intervention period . No significant differences were found in secondary outcomes between the two study groups . A CD-ROM-based intervention for breastfeeding mothers provides no additional benefit to usual post-natal care . Further study is needed to assess the effectiveness of multimedia packages as part of more intensive multifaceted interventions OBJECTIVE To determine changes in the breastfeeding practice s of mothers after receiving counseling on ' Ten Steps to Successful Breastfeeding ' as defined by the Baby Friendly Hospital Initiative comparing baby friendly hospitals ( BFHs ) and non-baby-friendly hospitals in Sindh , Pakistan . METHODS The observational study was conducted from June 2007 to June 2009 in r and omly selected baby-friendly and non-baby-friendly hospitals of Sindh , Pakistan . Non-probability purposive sampling was employed . The maternity staff was trained on ' Ten Steps to Successful Breastfeeding.'The changes in breastfeeding practice s were analysed by SPSS version 15 . RESULTS A total of 236 women were included in the study . Of them , 196 ( 83.05 % ) were from baby-friendly hospitals and 40 ( 16.94 % ) from non-baby-friendly hospitals . Besides , 174 ( 88.7 % ) mothers in baby-friendly hospitals and 5 ( 12.5 % ) in non-baby-friendly hospitals during antenatal care received counseling by healthcare providers . There was an increase in breastfeeding practice up to 194 ( 98.97 % ) in the first category compared to 12 ( 30 % ) in the other category . CONCLUSION Counseling under the Baby Friendly Hospital Initiative improved breastfeeding practice s up to 98.97 % in baby-friendly compared to non-baby-friendly hospitals BACKGROUND The purpose of this demonstration project was to test the effectiveness of a volunteer peer counseling program for promoting breastfeeding in a community . METHODS The two-year project was conducted in Iowa from September 1994 to September 1996 . Both intervention and control groups were rural low-income pregnant and postpartum women who qualified for the Women , Infants and Children 's ( WIC ) nutritional program . The intervention was initiated in two counties with 143 clients , of whom 72 completed the project . The control group was drawn from six counties that had received no significant breastfeeding promotion programs during the previous three years . The intervention was the assignment of trained volunteers with previous successful personal experience with breastfeeding as peer counselors to low-income pregnant women . Both before and after the baby was born , the volunteers taught a series of in-home , one-to-one lessons about healthy diet and breastfeeding , and maintained informal contact to answer questions or help with concerns . RESULTS Women in the intervention group improved dietary intake when compared with the control group . Knowledge of breastfeeding and good nutrition improved slightly . Eighty-two percent of intervention compared with 31 percent of control group women initiated breastfeeding . Mean duration of breastfeeding for intervention and control group women was 5.7 and 2.5 weeks , respectively . At 4 weeks , 56 percent of intervention and 10 percent of control group women were still breastfeeding . CONCLUSION A volunteer peer counseling program that provides low-income women with role models , accurate information , support , and encouragement can increase the duration of breastfeeding , and thus contribute to healthier infants OBJECTIVE to assess the effectiveness of a peer support worker ( PSW ) service on breast-feeding continuation . DESIGN cluster r and omised controlled trial ( IS RCT N16126175 ) . SETTING Primary Care Trust , UK serving a multi-ethnic , socio-economically disadvantaged population . PARTICIPANTS 2,724 women giving birth following antenatal care from 66 clinics : 33 clinics ( 1,267 women ) r and omised to the PSW service and 33 clinics ( 1,457 women ) to usual care . 848 women consented to additional follow-up by question naire at 6 months . INTERVENTION PSW service provided in the antenatal and postnatal period . MEASUREMENTS any and exclusive breast feeding at 10 - 14 days obtained from routine computerised records and at 6 weeks and 6 months from a question naire . FINDINGS follow-up : 94 % at 10 - 14 days , 67.5 % at 6 months . There was no difference in any breast feeding at 10 - 14 days between intervention and usual care , odds ratio ( OR ) 1.07 ( 95 % CI 0.87 - 1.31 , p=0.54 ) . Proportion of women reporting any breast feeding in the intervention group at 6 weeks was 62.7 % and 64.5 % in the usual care group OR 0.93 ( 95 % CI 0.64 - 1.35 ) ; and at 6 months was 34.3 % and 38.9 % , respectively , OR 1.06 ( 95 % CI 0.71 - 1.58 ) . KEY CONCLUSIONS universal antenatal peer support and postnatal peer support for women who initiated breast feeding did not improve breast-feeding rates up to 6 months in this UK population . IMPLICATION S FOR PRACTICE with high levels of professional support part of usual maternity care it may not be possible for low intensity peer support to produce additional benefit . More intensive or targeted programmes might be effective , but should have concurrent high quality evaluation This prospect i ve intervention study was undertaken to assess the impact of repeated breast-feeding counselling on the rate of exclusive breast-feeding up to five months . The study was carried out in two breast-feeding counselling sub-centres , established at the community level in the vicinity of two maternity facilities and one main centre established in an urban children hospital . Eighty-four pregnant mothers who attended the maternity facilities for delivery of babies were r and omly selected and repeatedly counselled regarding breast-feeding -- once just before delivery and subsequently at the completion of 1 , 2 , 3 , 4 , 5 , 6 , 9 , and 12 month(s ) of age of the child . These child-mother pairs comprised the intervention group . Another group of 90 child-mother pairs was selected from the maternity facilities . Mothers in this group ( comparison group ) received a single session of breast-feeding counselling just before delivery of babies . Fifty-nine and 55 child-mother pairs in the intervention and the comparison groups respectively completed the one-year follow-up . In the intervention group , 54.2 % and in the comparison group 36.4 % of the babies were exclusively breastfed up to five months of age . Forty-two ( 88 % ) children in the intervention group and 29 ( 53 % ) in the comparison group were given complementary foods at the optimum time , e.g. after completion of five months , and 81 % of the children in the intervention group and 100 % of the children in the comparison group were given complementary foods in the first year of life . It was observed that repeated organized breast-feeding counselling significantly improved the prevalence of exclusive breast-feeding to 54 % which is much above the existing national prevalence ( 12.7 % ) in Bangladesh Objectives . In Switzerl and , the Baby-Friendly Hospital Initiative ( BFHI ) proposed by the United Nations Children 's Fund ( UNICEF ) was introduced in 1993 to promote breastfeeding nationwide . This study reports results of a national study of the prevalence and duration of breastfeeding in 2003 throughout Switzerl and and analyzes the influence of compliance with UNICEF guidelines of the hospital where delivery took place on breastfeeding duration . Methods . Between April and September 2003 , a r and om sample of mothers who had given birth in the past 9 months in Switzerl and received a question naire on breastfeeding and complementary feeding . Seventy-four percent of the contacted mothers ( n = 3032 ) participated ; they completed a 24-hour dietary recall question naire and reported the age at first introduction of various foods and drinks . After excluding question naires with missing information relevant for the analyses , we analyzed data for 2861 infants 0 to 11 months of age , born in 145 different health facilities . Because it was known whether each child was born in a design ated baby-friendly hospital ( 45 hospitals ) or in a health facility in the process of being evaluated for BFHI inclusion ( 31 facilities ) , we were able to assess a possible influence of the BFHI on breastfeeding success . For this purpose , we merged individual data with hospital data on compliance with the UNICEF guidelines , from a data source collected on an annual basis for quality monitoring of design ated baby-friendly hospitals and health facilities in the evaluation process . Information on actual compliance with the guidelines allowed us to investigate the relationship between breastfeeding outcomes and compliance with UNICEF guidelines . We were also able to compare the breastfeeding results with those for non – baby-friendly health facilities . The comparison was based on median duration s of exclusive , full , and any breastfeeding calculated for each group . To allow for other known influencing factors , we calculated adjusted hazard ratios by using Cox regression ; we also conducted logistic regression analyses with the 24-hour dietary recall data , to calculate adjusted odds ratios for validation of results from the retrospectively collected data . Results . In 2003 , the median duration of any breastfeeding was 31 weeks at the national level , compared with 22 weeks in 1994 , and the median duration of full breastfeeding was 17 weeks , compared with 15 weeks in 1994 . The proportion of exclusively breastfed infants 0 to 5 months of age was 42 % for infants born in baby-friendly hospitals , compared with 34 % for infants born elsewhere . Breastfeeding duration for infants born in baby-friendly hospitals , compared with infants born in other hospitals , was longer if the hospital showed good compliance with the UNICEF guidelines ( 35 weeks vs 29 weeks for any breastfeeding , 20 weeks vs 17 weeks for full breastfeeding , and 12 weeks vs 6 weeks for exclusive breastfeeding ) . To control for differences in the study population between the different types of health facilities , hazard and odds ratios were calculated as described above , taking into account socioeconomic and medical factors . Although the analysis of the retrospective data showed clearly that the duration of exclusive and full breastfeeding was significantly longer if delivery occurred in a baby-friendly hospital with high compliance with the UNICEF guidelines , whereas this effect was less prominent in other baby-friendly health facilities , this difference was less obvious in the 24-hour recall data . Only for the duration of any breastfeeding could a positive effect be seen if delivery occurred in a baby-friendly hospital with high compliance with the UNICEF guidelines . Known factors involved in the evaluation of baby-friendly hospitals showed the expected influence , on the individual level , on duration of exclusive , full , and any breastfeeding . If a child had been exclusively breastfed in the hospital , the median duration of exclusive , full , and any breastfeeding was considerably longer than the mean for the entire population or for those who had received water-based liquids or supplements in the hospital . A positive effect on breastfeeding duration could be shown for full rooming in , first suckling within 1 hour , breastfeeding on dem and , and also the much-debated practice of pacifier use . After controlling for medical problems before , during , and after delivery , type of delivery , well-being of the mother , maternal smoking , maternal BMI , nationality , education , work , and income , all of the factors were still significantly associated with the duration of full , exclusive , or any breastfeeding . Conclusions . Our results support the hypothesis that the general increase in breastfeeding in Switzerl and since 1994 can be interpreted in part as a consequence of an increasing number of baby-friendly health facilities , whose clients breastfeed longer . Nevertheless , several alternative explanations for the longer breastfeeding duration for deliveries that occurred in baby-friendly hospitals can be discussed . In Switzerl and , baby-friendly hospitals actively use their certification by UNICEF as a promotional asset . It is thus possible that differences in breastfeeding duration are attributable to the fact that mothers who intend to breastfeed longer would choose to give birth in a baby-friendly hospital and these mothers would be more willing to comply with the recommendations of the UNICEF guidelines . Even if this were the case , however , this selection bias would not explain the differences in breastfeeding duration between design ated baby-friendly health facilities with higher compliance with the UNICEF guidelines and those with lower compliance . Especially this last point strongly supports a beneficial effect of the BFHI , because mothers do not know how well hospitals comply with the UNICEF program . The fact that breastfeeding rates have generally improved even in non – baby-friendly health facilities may be indirectly influenced by the BFHI ; its publicity and training programs for health professionals have raised public awareness of the benefits of breastfeeding , and the number of professional lactation counselors has increased continuously . Breastfeeding prevalence and duration in Switzerl and have improved in the past 10 years . Children born in a baby-friendly health facility are more likely to be breastfed for a longer time , particularly if the hospital shows high compliance with UNICEF guidelines . Therefore , the BFHI should be continued but should be extended to include monitoring for compliance , to promote the full effect of the BFHI BACKGROUND Breastfeeding can ameliorate some of the complex health issues faced by low-income families . Women who breastfeed and their infants have lower health care costs compared with those who formula feed . Increasing the duration of breastfeeding is recognized as a national priority , particularly for low-income women . This community-based r and omized clinical trial involving low-income mothers compared usual care with an intervention comprising hospital and home visits , and telephone support by a community health nurse/peer counselor team for 6 months after delivery . METHODS Forty-one women were recruited after delivery of a full-term singleton infant and r and omly assigned to intervention or usual care groups . RESULTS Women receiving the community health intervention breastfed longer than the women receiving usual care . The infants in the intervention group had fewer sick visits and reported use of fewer medications than infants in the usual care group . The intervention cost ( $ 301/mother ) was partially offset by cost savings on formula and health care . CONCLUSIONS Community health nurse and peer counselor support can increase breastfeeding duration in low-income women , and has the potential to reduce total costs including the cost of support BACKGROUND The aim of the study was to determine whether peer counselling in the antenatal and post-natal period would increase the prevalence and duration of breastfeeding among low-income women in Glasgow . METHODS The study was design ed as a quasi-experimental evaluation of a community-based breastfeeding promotion programme . The intervention comprised peer counselling of pregnant women , support of breastfeeding mothers and local awareness-raising activities . The study subjects were all women attending the antenatal booking clinic resident in either the intervention or control area . Data were collected by means of four self-completion question naires , two administered antenatally and two post-natally . The proportions intending to breastfeed or breastfeeding in the intervention and control groups were compared at each assessment and over time . RESULTS Of the 995 women enrolled in the study , data were available for analysis on 919 ( 92 per cent ) to 6 weeks postnatally . At booking , 18 per cent of the intervention group and 21 per cent of the control group stated an intention to breastfeed . At delivery , the proportions initiating breastfeeding were 23 per cent of the intervention subjects and 20 per cent of the controls , and by 6 weeks post-natally , the proportion providing any breast milk had declined to 10 per cent of the intervention group and 8 per cent of the control group . Using multivariate analysis to adjust for factors ( such as socio-economic status ) known to influence breastfeeding , the breastfeeding prevalence was significantly higher in the intervention group relative to the controls at delivery [ odds ratio ( OR ) 2.0 ; 95 per cent confidence interval ( CI ) 1.2 - 3.1 , p = 0.006 ] . By 6 weeks post-natally the difference between the two groups was not statistically significant ( OR 1.8 ; 95 per cent CI 1.0 - 3.4 , p=0.07 ) . CONCLUSIONS As the impact of the intervention was not sustained even for the modest duration of 6 weeks postnatally , it would be premature to justify widespread use of peer support programmes to increase the prevalence of breastfeeding in socially disadvantaged communities Abstract Objective To investigate whether offering volunteer support from counsellors in breast feeding would result in more women breast feeding . Design R and omised controlled trial . Setting 32 general practice s in London and south Essex . Participants 720 women considering breast feeding . Main outcome measures Primary outcome was prevalence of any breast feeding at six weeks . Secondary outcomes were the proportion of women giving any breast feeds , or bottle feeds at four months , duration of any breast feeding , time to introduction of bottle feeds , and satisfaction with breast feeding . Results Offering support in breast feeding did not significantly increase the prevalence of any breast feeding to six weeks ( 65 % ( 218/336 ) in the intervention group and 63 % ( 213/336 ) in the control group ; relative risk 1.02 , 95 % confidence interval 0.84 to 1.24 ) . Survival analysis up to four months confirmed that neither duration of breast feeding nor time to introduction of formula feeds differed significantly between control and intervention groups . Not all women in the intervention group contacted counsellors postnatally , but 73 % ( 123/179 ) of those who did rated them as very helpful . More women in the intervention group than in the control group said that their most helpful advice came from counsellors rather than from other sources . Conclusions Women valued the support of a counsellor in breast feeding , but the intervention did not significantly increase breastfeeding rates , perhaps because some women did not ask for help This quasi-experimental study was conducted in Shiraz , the Islamic Republic of Iran , on 120 pairs of mothers and infants in a maternity hospital that had a rooming-in programme . All 59 mothers in the study group received breastfeeding education , face-to-face , after delivery and during follow-up for 4 months in the mother and child health ( MCH ) centre or in their homes ; the remaining 61 mothers comprised the control group . Exclusive breastfeeding rates were significantly higher in the study group ( 54 % ) than in the control group ( 6.5 % ) , but 5 % and 18 % of infants , respectively , in the study and control groups had stopped breastfeeding by the age of 4 months . The mean number of days of diarrhoea experienced by infants in the study group were significantly lower ( P < or = 0.004 ) than in the control group . At the end of 4 months , the mean weight and length of the infants were significantly higher ( both P < 0.05 ) in the study group than in the control group . The findings indicate that rooming-in is very important for promoting exclusive breastfeeding and that there is a need for continuous breastfeeding education of mothers OBJECTIVES To determine whether the outcomes of routine home visiting by public health nurses ( PHN ) after early obstetrical discharge differ from those of a screening telephone call design ed to identify mothers who need further intervention . METHODS Primiparas delivering a singleton infant and eligible for postpartum follow-up were r and omized to a home visit or screening telephone call . Data were collected by telephone from 733 participants located at two tertiary care centres in Ontario . Outcomes included maternal confidence at two weeks , health problems of the infants between discharge and four weeks postpartum , breastfeeding rates at six months and costs of the two models . RESULTS Differences between the sample s at the two sites necessitated stratified analyses . No differences were detected between the groups in maternal confidence ( p = 0.96 ) , health problems of infants ( p = 0.87 ) , or rates of breastfeeding at six months ( p = 0.22 ) . However , at both sites the cost of routine home visits was found to be higher than that of screening by telephone . CONCLUSION Although universal access to postpartum support is important , the results suggest that a routine home visit is not always necessary to identify the women who need it . These results can be generalized only to low-risk women and infants OBJECTIVE To determine the impact of facility-based semi-intensive and home-based intensive counselling in improving exclusive breast-feeding ( EBF ) in a low-re source urban setting in Kenya . DESIGN A cluster r and omized controlled trial in which nine villages were assigned on a 1:1:1 ratio , by computer , to two intervention groups and a control group . The home-based intensive counselling group ( HBICG ) received seven counselling sessions at home by trained peers , one prenatally and six postnatally . The facility-based semi-intensive counselling group ( FBSICG ) received only one counselling session prenatally . The control group ( CG ) received no counselling from the research team . Information on infant feeding practice s was collected monthly for 6 months after delivery . The data -gathering team was blinded to the intervention allocation . The outcome was EBF prevalence at 6 months . SETTING Kibera slum , Nairobi . SUBJECTS A total of 360 HIV-negative women , 34 - 36 weeks pregnant , were selected from an antenatal clinic in Kibera ; 120 per study group . RESULTS Of the 360 women enrolled , 265 completed the study and were included in the analysis ( CG n 89 ; FBSICG n 87 ; HBICG n 89 ) . Analysis was by intention to treat . The prevalence of EBF at 6 months was 23.6 % in HBICG , 9.2 % in FBSICG and 5.6 % in CG . HBICG mothers had four times increased likelihood to practise EBF compared with those in the CG ( adjusted relative risk = 4.01 ; 95 % CI 2.30 , 7.01 ; P=0.001 ) . There was no significant difference between EBF rates in FBSICG and CG . CONCLUSIONS EBF can be promoted in low socio-economic conditions using home-based intensive counselling . One session of facility-based counselling is not sufficient to sustain EBF We investigated the effectiveness of a program of intensive postpartum support for low-income , breast-feeding women and identified potential predictors of prolonged breast-feeding in this population . Ninety-seven low-income women were r and omized to receive intensive postpartum education and support for breast-feeding or to receive only the routine assistance provided by the obstetrical nurses . Both groups were telephoned 6 weeks post partum to determine the method of infant feeding then , and those still breast-feeding were contacted monthly until complete weaning had occurred . No significant difference in breast-feeding duration between the two groups was noted . There was no association between duration of nursing and race , marital status , or the need to return to work or school . Earlier age at introduction of supplement , younger maternal age , and participation in prenatal classes predicted breast-feeding duration by logistic regression Despite substantial evidence of maternal and infant benefits of breastfeeding , adolescent mothers initiate breastfeeding less often and maintain breastfeeding for shorter duration s when compared to their adult counterparts . A r and omized controlled trial drawing on the theory of planned behavior and developmental theory was conducted to determine if an education and counseling intervention provided by a lactation consultant — peer counselor team increased breastfeeding initiation and duration up to 6 months postpartum among adolescent mothers . Study participants ( N = 289 ) enrolled from multiple prenatal clinic and school setting s , were 15 to 18 years old , and predominately African American , single , and primiparous . The intervention , which started in the second trimester of pregnancy and extended through 4 weeks postpartum , positively influenced breastfeeding duration ( p < .001 ) within the experimental group , but not breastfeeding initiation or exclusive breastfeeding rates . This education/support intervention was partially effective in enhancing breastfeeding outcomes . Implication s for research and practice are described OBJECTIVE To assess the efficacy of peer counseling to promote exclusive breastfeeding ( EBF ) among low-income inner-city women in Hartford , Conn. DESIGN Participants recruited prenatally were r and omly assigned to either receive support for EBF from a peer counselor plus conventional breastfeeding support ( peer counseling group [ PC ] ) or only conventional breastfeeding support ( control group [ CG ] ) and followed through 3 months post partum . SETTING Low-income predominantly Latina community . PARTICIPANTS Expectant mothers , less than 32 weeks gestation and considering breastfeeding ( N = 162 ) . Intervention Exclusive breastfeeding peer counseling support offering 3 prenatal home visits , daily perinatal visits , 9 postpartum home visits , and telephone counseling as needed . MAIN OUTCOME MEASURES Exclusive breastfeeding rates at hospital discharge , 1 , 2 , and 3 months post partum ( n = 135 ) . RESULTS At hospital discharge , 24 % in the CG compared with 9 % in the PC had not initiated breastfeeding , with 56 % and 41 % , respectively , nonexclusively breastfeeding . At 3 months , 97 % in the CG and 73 % in the PC had not exclusively breastfed ( relative risk [ RR ] = 1.33 ; 95 % CI , 1.14 - 1.56 ) during the previous 24 hours . The likelihood of nonexclusive breastfeeding throughout the first 3 months was significantly higher for the CG than the PC ( 99 % vs 79 % ; RR = 1.24 ; 95 % CI , 1.09 - 1.41 ) . Mothers in the CG were less likely than their PC counterparts to remain amenorrheic at 3 months ( 33 % vs 52 % ; RR = 0.64 ; 95 % CI , 0.43 - 0.95 ) . The likelihood of having 1 or more diarrheal episode in infants was cut in half in the PC ( 18 % vs 38 % ; RR = 2.15 ; 95 % CI , 1.16 - 3.97 ) . CONCLUSION Well-structured , intensive breastfeeding support provided by hospital and community-based peer counselors is effective in improving exclusive breastfeeding rates among low-income , inner-city women in the United States Objective To evaluate the affect of an antenatal educational breastfeeding intervention on women 's breastfeeding duration Object To evaluate the effects of psychosocial support during labour , delivery and the immediate postpartum period provided by a female companion ( doula ) OBJECTIVE To examine associations between doula care , early breastfeeding outcomes , and breastfeeding duration . DESIGN Prospect i ve cohort . SETTING Regional hospital in northern California . PARTICIPANTS Low-income , full gestation primiparae receiving doula care ( n=44 ) or st and ard care ( n=97 ) . MEASURES Birth outcomes and newborn feeding data obtained from the hospital record . Follow-up interviews conducted at day 3 to record the timing of onset of lactogenesis and breastfeeding behavior and at 6 weeks to obtain current breastfeeding status . RESULTS Adjusting for baseline differences , women receiving doula care were significantly more likely to have a short stage II labor , a noninstrumental vaginal delivery , and to experience onset of lactogenesis within 72 hours postpartum ( timely onset of lactogenesis ) . Overall , 68 % of women receiving doula care and 54 % of women receiving st and ard care were breastfeeding at 6 weeks . In the subset with a prenatal stressor ( n=63 ) , the doula care group was more than twice as likely to be breastfeeding at 6 weeks ( 89 % vs. st and ard care , 40 % ) . Breastfeeding at 6 weeks was also significantly associated with timely onset of lactogenesis and maternal report that the infant " sucked well " at day 3 . CONCLUSIONS Doula care was associated with improved childbirth outcomes and timely onset of lactogenesis . Both directly and as mediated by timely onset of lactogenesis , doula care was also associated with higher breastfeeding prevalence at 6 weeks AIMS The objectives of this study were to design a structured prenatal education programme on breastfeeding and to evaluate the effectiveness of the programme . Indicators of effectiveness were selected based on Kirkpatrick 's Training Evaluation Model , including satisfaction with the programme , breastfeeding knowledge , breastfeeding attitude , breastfeeding satisfaction , breastfeeding problems and rate of exclusive breastfeeding . METHODS This study applied a quasi-experimental design . The experimental group included 46 women who received a 90-minute group educational programme on breastfeeding during their 20th-36th week of pregnancy . Each experimental subject was matched by a control subject according to age , educational level , work status and pregnancy gestational age . Control subjects did not receive any intervention . Data were collected through self-administered question naires at preintervention , postintervention , three days postpartum and one month postpartum . RESULTS Satisfaction with the programme was high . The experimental group had higher scores in breastfeeding knowledge and breastfeeding attitude at three days postpartum . The experimental group showed higher breastfeeding satisfaction at three days and one month postpartum . There were no significant differences in experiencing breastfeeding problems . The rate of exclusive breastfeeding was higher for the experimental group at three days and one month postpartum , but the differences were not statistically significant . CONCLUSION This study demonstrated the effectiveness of a prenatal education programme on maternal knowledge , attitude and satisfaction toward breastfeeding . RELEVANCE TO CLINICAL PRACTICE Other hospitals could apply this model to plan and evaluate their prenatal education programme on breastfeeding BACKGROUND Breastfeeding peer counseling has improved breastfeeding rates in developing countries ; however , its impact in this country has not been adequately evaluated . OBJECTIVE To evaluate the effectiveness of an existing , breastfeeding peer counseling program within the United States . DESIGN R and omized , prospect i ve , controlled trial in which participants were recruited prenatally and r and omly assigned to receive either routine breastfeeding education or routine breastfeeding education plus peer counseling . SETTING An urban hospital serving a large population of low-income Latinas . PARTICIPANTS Pregnant women ( < or = 26 weeks ' gestation ) were recruited from the hospital 's prenatal clinic . Inclusion criteria specified that participants be low income , be considering breastfeeding , have delivered a healthy , full-term singleton , and have access to a telephone . Intervention Breastfeeding peer counseling services included 1 prenatal home visit , daily perinatal visits , 3 postpartum home visits , and telephone contact as needed . MAIN OUTCOME MEASURES Breastfeeding rates at birth and 1 , 3 , and 6 months postpartum . RESULTS The proportion not initiating breastfeeding was significantly lower in the intervention group than among controls ( 8/90 [ 9 % ] vs 17/75 [ 23 % ] ; relative risk , 0.39 ; 95 % confidence interval , 0.18 - 0.86 ) . The probability of stopping breastfeeding also tended to be lower in the intervention group at both 1 month ( 36 % vs 49 % ; relative risk , 0.72 ; 95 % confidence interval , 0.50 - 1.05 ) and 3 months ( 56 % vs 71 % ; relative risk , 0.78 ; 95 % confidence interval , 0.61 - 1.00 ) . CONCLUSION These findings demonstrate that , in the United States , peer counselors can significantly improve breastfeeding initiation rates and have an impact on breastfeeding rates at 1 and 3 months post partum BACKGROUND The World Health Organization ( WHO ) developed the Baby-Friendly Hospital Initiative to improve hospital maternity care practice s that support breastfeeding . In Hong Kong , although no hospitals have yet received the Baby-Friendly status , efforts have been made to improve breastfeeding support . The aim of this study was to examine the impact of Baby-Friendly hospital practice s on breastfeeding duration . METHODS A sample of 1,242 breastfeeding mother-infant pairs was recruited from four public hospitals in Hong Kong and followed up prospect ively for up to 12 months . The primary outcome variable was defined as breastfeeding for 8 weeks or less . Predictor variables included six Baby-Friendly practice s : breastfeeding initiation within 1 hour of birth , exclusive breastfeeding while in hospital , rooming-in , breastfeeding on dem and , no pacifiers or artificial nipples , and information on breastfeeding support groups provided on discharge . RESULTS Only 46.6 percent of women breastfed for more than 8 weeks , and only 4.8 percent of mothers experienced all six Baby-Friendly practice s. After controlling for all other Baby-Friendly practice s and possible confounding variables , exclusive breastfeeding while in hospital was protective against early breastfeeding cessation ( OR : 0.61 ; 95 % CI : 0.42 - 0.88 ) . Compared with mothers who experienced all six Baby-Friendly practice s , those who experienced one or fewer Baby-Friendly practice s were almost three times more likely to discontinue breastfeeding ( OR : 3.13 ; 95 % CI : 1.41 - 6.95 ) . CONCLUSIONS Greater exposure to Baby-Friendly practice s would substantially increase new mothers ' chances of breastfeeding beyond 8 weeks postpartum . To further improve maternity care practice s in hospitals , institutional and administrative support are required to ensure all mothers receive adequate breastfeeding support in accordance with WHO guidelines This research examined the effect of peer support on breastfeeding duration and exclusivity ( breastfeeding without supplements ) in a population of low-income women during the first 3 months postpartum . Participants in the peer counselor group ( n = 18 ) exhibited higher rates of exclusive breastfeeding across time than those without a counselor ( n = 18 ) , and more exclusive breastfeeding was associated with long duration overall . Mother 's career plans had the greatest effect on duration of breastfeeding . Women who intended to return to work , attend school , or both breastfed 6 to 9 weeks less than participants who intended to stay home . Attendance at a breastfeeding class and knowing someone who had breastfed was significantly correlated with a longer duration of breastfeeding . Nutritionists from the Women , Infants and Children ( WIC ) Program were the primary source of breastfeeding information . Two main factors discouraged women from breastfeeding : returning to work , school , or both and the perception of a diminished milk supply . Greater emphasis should be placed on prenatal breastfeeding education for low-income women , and their mothers and gr and mothers should be included . Peer support is one important component of social support in the area of breastfeeding that community health nurses ( CHNs ) can utilize . CHNs are in a unique position to assist working mothers , provide support , and develop educational programs to enhance breastfeeding success in this population OBJECTIVE Harmful effects of short postpartum hospital stays include dehydration and malnutrition of breastfed infants . These may be prevented by adequate breastfeeding frequency ; however , rigorous research to determine the relative effectiveness of various follow-up strategies in supporting breastfeeding frequency is absent . This study addressed the question , " Is there a difference in breastfeeding frequency or infant weight gain for singleton infants discharged within 36 hours ' postpartum who received either community nurse ( home visit ) or hospital nurse ( clinic ) follow-up ? " METHODS A r and omized , controlled trial was conducted at a university teaching hospital ( 3700 births/y ) and affiliated community health centers . A consecutive sample of 586 healthy mother-infant pairs were recruited from January 1997 to September 1998 before discharge ; 513 ( 87.5 % ) contributed data on 1 or more outcomes . Forty-eight-hour postpartum telephone contact and day 3 nurse contact in the home ( experimental ) or at the hospital ( control ) were provided . The main outcomes measured were breastfeeding frequency and infant weight gain assessed at 2 weeks ' postpartum by maternal diary and weight at home by research assistants , masked to group allocation . RESULTS No clinical ly important or statistically significant group differences were found in daily breastfeeding frequency ( mean difference experimental minus control = 0.1 feeds [ 95 % confidence interval : -0.1 - 0.3 ] ) or daily rate of infant weight gain ( -1.1 g [ -2.5 - 0.3 ] ) based on intention-to-treat analyses . CONCLUSIONS Follow-up by nurses after short postpartum hospital stays , in either the home or a hospital-based clinic , of healthy infants discharged at < 36 hours seems associated with satisfactory infant breastfeeding outcomes BACKGROUND Recently enacted federal legislation m and ates insurance coverage of at least 48 hours of postpartum hospitalization , but most mothers and newborns in the United States will continue to go home before the third postpartum day . National guidelines recommend a follow-up visit on the third or fourth postpartum day , but scant evidence exists about whether home or clinic visits are more effective . METHODS We enrolled 1163 medically and socially low-risk mother-newborn pairs with uncomplicated delivery and r and omly assigned them to receive home visits by nurses or pediatric clinic visits by nurse practitioners or physicians on the third or fourth postpartum day . In contrast with the 20-minute pediatric clinic visits , the home visits were longer ( median : 70 minutes ) , included preventive counseling about the home environment , and included a physical examination of the mother . Clinical utilization and costs were studied using computerized data bases . Breastfeeding continuation , maternal depressive symptoms , and maternal satisfaction were assessed by means of telephone interviews at 2 weeks ' postpartum . RESULTS Comparing the 580 pairs in the home visit group and the 583 pairs in the pediatric clinic visit group , no significant differences occurred in clinical outcomes as measured by maternal or newborn rehospitalization within 10 days postpartum , maternal or newborn urgent clinic visits within 10 days postpartum , or breastfeeding discontinuation or maternal depressive symptoms at the 2-week interview . The same was true for a combined clinical outcome measure indicating whether a mother-newborn pair had any of the above outcomes . In contrast , higher proportions of mothers in the home visit group rated as excellent or very good the preventive advice delivered ( 80 % vs 44 % ) , the provider 's skills and abilities ( 87 % vs 63 % ) , the newborn 's posthospital care ( 87 % vs 59 % ) , and their own posthospital care ( 75 % vs 47 % ) . On average , a home visit cost $ 255 and a pediatric clinic visit cost $ 120 . CONCLUSIONS For low-risk mothers and newborns in this integrated health maintenance organization , home visits compared with pediatric clinic visits on the third or fourth postpartum hospital day were more costly , but were associated with equivalent clinical outcomes and markedly higher maternal satisfaction . This study had limited power to identify group differences in rehospitalization , and may not be generalizable to higher-risk population s without comparable access to integrated hospital and outpatient care Infant mortality and morbidity risk is linked to formula usage . The proportion of Filipino infant formula users rose 6 % between 2003 and 2008 . It is hypothesized this rise result ed from aggressive formula industry marketing . We conducted a household survey between April and December 2006 and focus groups in April-May 2007 in The Philippines to examine the association between mothers ' exposure to advertising and other information sources and formula feeding decisions . Sixteen barangays ( communities ) were r and omly selected from three purposively selected disadvantaged rural , urban and mixed municipalities . A total of 345 households had children under 24-months age : 114 , 142 and 89 households from the rural , urban and mixed municipalities , respectively . In addition 38 respondents participated in 3 focus groups of 10 - 15 participants each , from three selected barangays . After adjusting for education and economic indicators logistic regression analysis showed that , children were more likely to be given formula if their mother recalled advertising messages , or a doctor , or mother or relative recommended it . Those using formula were 6.4 ( 1.8 - 23.1 ) times more likely to stop breastfeeding before 12 months . The focus groups described how television advertisements , doctors and medical representatives enticed them to use formula . We conclude that two factors were strongly associated with the decision to formula feed : self-reported advertising exposure , and physicians ' recommendations OBJECTIVE The purpose of this study was to compare breastfeeding duration in mothers after delivery who were assigned r and omly to a behavioral educational intervention vs enhanced usual care . STUDY DESIGN We conducted a r and omized trial . Self-identified black and Latina mothers early after delivery were assigned r and omly to receive a behavioral educational intervention or enhanced usual care . The 2-step intervention aim ed to prepare and educate mothers about postpartum symptoms and experiences ( including tips on breastfeeding and breast/nipple pain ) and to bolster social support and self-management skills . Enhanced usual care participants received a list of community re sources and received a 2-week control call . Intention-to-treat analyses examined breastfeeding duration ( measured in weeks ) for up to 6 months of observation . This study was registered with clinical trial.gov ( NCT01312883 ) . RESULTS Five hundred forty mothers were assigned r and omly to the intervention ( n = 270 ) vs control subjects ( n = 270 ) . Mean age was 28 years ( range , 18 - 46 years ) ; 62 % of the women were Latina , and 38 % were black . Baseline sociodemographic , clinical , psychosocial , and breastfeeding characteristics were similar among intervention vs control subjects . Mothers in the intervention arm breastfed for a longer duration than did the control subjects ( median , 12.0 vs 6.5 weeks , respectively ; P = .02 ) Mothers in the intervention arm were less likely to quit breastfeeding over the first 6 months after delivery ( hazard ratio , 0.79 ; 95 % confidence interval , 0.65 - 0.97 ) . CONCLUSION A behavioral educational intervention increased breastfeeding duration among low-income , self-identified black and Latina mothers during the 6-month postpartum period BACKGROUND Training programs are commonly viewed as an effective way to improve breastfeeding-related practice s of health professionals . The objective of this study was to determine whether a 3-day training program for maternity ward professionals was followed by an increase in duration of any breastfeeding . METHODS A before- and -after study was conducted involving two retrospective r and om sample s of 308 mothers who had delivered a healthy singleton infant of 37 weeks ' or more gestation and 2,500 g or more birthweight in a level 3 maternity ward in a university hospital in France . Data were gathered from medical records and postal question naire . RESULTS Study participants included 169 mothers ( 54.9 % ) in the pre-intervention sample and 178 ( 57.8 % ) in the post-intervention sample . The prevalence of any breastfeeding at birth was 77.5 percent ( 70.5%-83.6 % ) in the pre-intervention sample and 82.6 percent ( 76.2%-87.8 % ) in the post-intervention sample ( p=0.24 ) ; the median duration of any breastfeeding was 13 weeks and 16 weeks , respectively(chi2 log-rank test=5.8 , p=0.02 ) . The decreased risk of weaning in the post-intervention sample persisted after adjustment for baseline characteristics ( adjusted hazard ratio=0.70 [ 0.54 - 0.91 ] ) . It was paralleled by significant improvement in maternity ward practice s that are known to affect the duration of breastfeeding . CONCLUSION An intensive 3-day training program for maternity ward professionals can be followed by a significant but moderate increase in the duration of any breastfeeding . Multifaceted interventions involving prenatal components and community support should be planned in Western countries with low to intermediate prevalence of breastfeeding Abstract . A prospect i ve study of the course of breast feeding was carried out in 75 r and omly selected women . Weekly interviews were performed from the day after delivery until the termination of breast feeding , but in no case for longer than 6 months . In each case a detailed analysis was made of the factors leading to transient lactation crises or to complete cessation of breast feeding . A second group of 71 mothers , also r and omly selected , was interviewed in retrospect only , 6 months after delivery , and served as controls . Twenty‐four weeks after delivery 47 % of the mothers in the weekly interview group were still breast feeding . The corresponding figure in the control group was 38 % . In both groups only few mothers terminated lactation for medical reasons , while about one fourth stopped for some other reason and about one half because of a combination of factors . Brief case reports are presented to illustrate how varying the factors were that threatened breast feeding Exclusive breastfeeding has generally been considered incompatible with working separated from the infant . This prospect i ve , controlled intervention trial shows that breastfeeding support , including anticipatory counseling and monthly clinical follow-up of the mother and infant , can significantly increase the percentage of infants exclusively fed with breastmilk at the end of 6 months of life . Over 80 per cent of women from control and intervention groups expressed a desire to breastfeed for more than 6 months and more than 50 per cent thought it was best for the infant to be exclusively breastfed for 6 months . Only 6 per cent of women in the control group were able to complete 6 months of exclusive breastmilk feeding compared to 53 per cent of those in the intervention group . The most important difference between the strategies used by both groups of mothers for maintaining exclusive breastmilk feeding after returning to work was that only 23 per cent of the control group practice d milk expression compared to 66 per cent in the intervention group . All women from the supported group stated that they would advise a friend to combine exclusive breastfeeding and work and that they would like to do so again with another child AIMS To evaluate the effectiveness of home-based peer counselling to increase breastfeeding rates for unfavourably low birthweight babies . METHODS R and omized clinical trial carried out in maternity hospitals and households in Fortaleza , one of the regions in Brazil with very low income ; 1003 mothers and their newborns were selected in eight maternity hospitals . Newborns needed were healthy and weighed less than 3000 g. INTERVENTION Breastfeeding counselling , conducted by lay counsellors from the community , during home visits carried out on days 5 , 15 , 30 , 60 , 90 and 120 after birth . MAIN OUTCOME MEASURE Feeding methods in the fourth month of life . RESULTS The intervention increased exclusive breastfeeding ( 24.7 % vs 19.4 % ; p=0.044 ) , delayed the introduction of formula and increased the time infants substituted breastfeeding to bottle milk ( bottle milk 33.4 % in the control group and 20.1 % in the intervention group ; p=0.00002 ) . When comparing the frequency of artificial breastfeeding versus all other forms of breastfeeding ( exclusive+predominant+partial ) , the intervention increased breastfeeding rates in 39 % ( RR=0.61 ; CI 95 % : 0.50 - 0.75 ) ; 15 % of children were free from artificial feeding ( absolute risk reduction ) . The number of families to be visited to avoid one child receiving artificial feeding ( NNT ) was 7 ( CI 95 % : 5 - 13 ) . CONCLUSIONS Breastfeeding counselling , promoted by lay counsellors , can impact favourably on exclusive breastfeeding rates and contribute to delaying the utilization of milk formula and weaning . The intervention has great application potential because most cities in the northeast of Brazil count on community health workers that could do the counselling As an intervention against diarrhoea , promotion of breastfeeding has been suggested by the World Health Organization ( WHO ) . In the present study from Guinea Bissau we tested the possibilities of promoting breastfeeding at a local health centre . A total of 1250 children were allocated r and omly into two groups . Mothers in the intervention group were given health education according to WHO 's recommendations ; about exclusive breastfeeding for at least the first 4 mo , prolonged breastfeeding and family planning methods . At 4 mo of age introduction of weaning food was delayed in the intervention group ( risk rate 1.18 ( 95 % CI 1.03‐1.38 ) and more mothers had an IUD inserted ( risk rate 2.45 ( 1.27‐4.70 ) . The median length of breastfeeding was 23 mo in both groups . There was no difference in the number of children weaned early . Although exclusive breastfeeding was promoted by the intervention , early weaning of children in special risk groups was not avoided . An evaluation of the impact of the WHO recommendations in different setting s is warranted . □ Breastfeeding promotion , intervention study , Guinea Bissau , epidemiology , WHO This study examined the effect of support from trained peer counselors on breastfeeding initiation , duration , and exclusivity among low-income urban women . Training of counselors , under the supervision of a registered nurse certified in lactation , adapted education techniques from Paulo Freire to provide information about lactation management and other health care issues . The study compared infant feeding practice s of women who planned to breastfeed and received support from counselors ( counselor group , N=59 ) to women who requested counselors but , owing to inadequate numbers of trained counselors , did not have a counselor ( No-counselor group , N=43 ) . Women in the counselor group had significantly greater ( p<.05 ) breastfeeding initiation ( 93 percent vs. 70 percent ) , exclusivity ( 77 percent vs. 40 percent ) , and duration ( mean of 15 weeks vs. mean of 8 weeks ) than women in the no-counselor group . The findings suggest that peer counselors , well-trained , and with on-going supervision , can have a positive effect on breastfeeding practice s among low-income urban women who intend to breastfeed BACKGROUND Despite high levels of breastfeeding initiation in Australia , only 46 percent of women are still breastfeeding ( exclusively or partially ) 6 months later , with marked differences between social groups . This study aim ed to determine the influence of mid-pregnancy breastfeeding education on the proportions of women breastfeeding at hospital discharge , and on the duration of breastfeeding . METHODS A r and omized controlled trial to compare two strategies for increasing the initiation and duration of breastfeeding was conducted , in which 981 primiparas who attended a public , tertiary women 's hospital in Melbourne , Australia , were r and omized to one of two interventions or to st and ard care ( 327 in each group ) . The interventions were a 1.5-hour class on practical aspects of breastfeeding using a previously tested tool ( Practical Skills ) , and two 1-hour classes exploring family and community attitudes toward , and experiences of , breastfeeding ( Attitudes ) . Both interventions took place in interactive small groups when women were in mid-pregnancy . Breastfeeding initiation was ascertained by interview 2 to 4 days after birth , and breastfeeding duration was assessed by telephone interview 6 months after birth . RESULTS Neither intervention increased breastfeeding initiation or duration compared with st and ard care . Rates at initiation were 97 percent ( 296/306 ) for the Practical Skills intervention , 95 percent ( 291/308 ) for the Attitudes intervention , and 96 percent ( 297/310 ) for st and ard care . Rates at 6 months were , respectively , 55 percent ( 162/297 ) , 50 percent ( 146/293 ) , and 54 percent ( 162/299 ) . CONCLUSIONS In setting s where breastfeeding initiation is already high , neither study intervention could be recommended as an effective strategy to increase breastfeeding initiation or duration OBJECTIVE To determine the effects of a partner-supported , incentive-based educational program on rates and duration of breast-feeding among low-income women . DESIGN Women who expressed a willingness to participate in the breast-feeding educational program were r and omly assigned to one of two groups : an intervention group and a control group who received usual breast-feeding education . SETTING Clinics of the Special Supplemental Food Program for Women , Infants , and Children in Flagstaff , Ariz. SUBJECTS Sixty-eight primiparous pregnant women with expected due date s between May 1992 and December 1992 were willing to participate in the study . Of these , 34 were r and omly assigned to the intervention group and 34 to the control group . Approximately 81 % of the women completed the study : 29 in the control group and 26 in the intervention group . INTERVENTION The intervention consisted of special incentives ( prizes ) for women and their partners to participate in a breast-feeding class for expectant couples and an educational series on childbirth . Women were also encouraged to use a breast-feeding support program in which peers serve as role models . MAIN OUTCOME MEASURES The primary outcome measure was infant feeding method . Data were collected from mothers in both groups at the time of discharge from the hospital and at 2 weeks , 6 weeks , and 3 months postpartum . STATISTICAL ANALYSES PERFORMED Binomial proportional analyses of the feeding data were performed . RESULTS Women in the intervention group reported a higher percentage of breast-feeding at all measurement times . APPLICATIONS These findings suggest that incentives , such as donated prizes , can be used to attract primiparous women from lower socioeconomic groups , along with their partners , to participate in educational interventions design ed to promote breast-feeding . Participation by couples in breast-feeding promotion activities can dramatically increase the rate and duration of breast-feeding BACKGROUND In the Netherl and s , the initiation rate of breast-feeding ( BF ) was 80 % in 2002 , but only 35 % of the mothers continued to breast-feed for 3 months . This study examined the effectiveness of a breast-feeding promotion program to increase the continuation of breast-feeding . METHODS A cluster-r and omized intervention trial was used . Ten child health care centers in three regions of the home health care were r and omly allocated to the program or usual care . Elements in the program were health counseling , measures to enhance cooperation , early signaling of breast-feeding problems and continuity of care , and lactation consultancy . Pregnant mothers who applied for home health care in the intervention or usual care regions were enrolled and were followed up from pregnancy until 6 months postpartum ( n = 683 ) . The primary outcome measure was the continuation of breast-feeding until at least 3 months . RESULTS The 3-month breast-feeding rate was 32 % in the intervention and 38 % in the control groups ( OR = 0.79 , 95 % CI = 0.58 - 1.08 ) . CONCLUSION The program was not effective . We discuss possible explanations from the design and execution of the trial and give some points for improvement of our program , such as the categories of caregivers involved and the number and duration of contacts after parturition Many factors are associated with low breast-feeding rates among black low-income women . This study examines whether , despite such factors , health professionals ' prenatal education of black poor women is associated with increased breast-feeding rates . Black women born in the United States who attended a midwives prenatal clinic ( N = 159 ) were r and omly assigned to two types of prenatal education or were followed up in a control group . All women were interviewed on entry into the study and after delivery of their infants . Women assigned to group classes attended at least one session discussing myths , problems , and benefits of breast-feeding . Women assigned to individual prenatal counseling spoke with a pediatrician or nurse practitioner , who discussed breast-feeding topics similar to those covered in the classes . Women in the control group received no additional prenatal education . The three study groups had significantly different percentages of women who breast-fed ( controls 22 % , classes 46 % , individual sessions 53 % ) . Higher percentages of women in the study groups carried out their prenatal plans to breast-feed ( controls 50 % , classes 86 % , individual sessions 62 % ) or breast-fed despite prenatal plans to bottle-feed ( controls 10 % , classes 26 % , individual sessions 48 % ) . After multivariable analysis controlling for age , prenatal plans to breast-feed , prior breast-feeding experience , perceived support for breast-feeding , education , gravidity , and employment plans , women in intervention groups had a higher likelihood of breast-feeding than control subjects . These findings suggest that an increase in relatively simple , not-too-time-consuming educational efforts in institutions and offices serving black low-income women might yield significant narrowing of the gap in breast-feeding rates between white affluent women and black low-income women BACKGROUND Exclusive breastfeeding is recommended until age 6 months . We assessed the feasibility , effectiveness , and safety of an educational intervention to promote exclusive breastfeeding for this length of time in India . METHODS We developed the intervention through formative research , pair-matched eight communities on their baseline characteristics , and r and omised one of each pair to receive the intervention and the other to no specific intervention . We trained health and nutrition workers in the intervention communities to counsel mothers for exclusive breastfeeding at multiple opportunities . We enrolled 1115 infants born in the 9 months after training-552 in the intervention and 473 in the control communities . Feeding at age 3 months , and anthropometry and of diarrhoea prevalence at age 3 months and 6 months were assessed . All analyses were by intention to treat . FINDINGS We assessed 483 and 412 individuals at 3 months in the intervention and control groups , respectively , and 468 and 412 at 6 months . At 3 months , exclusive breastfeeding rates were 79 % ( 381 ) in the intervention and 48 % ( 197 ) in the control communities ( odds ratio 4.02 , 95 % CI 3.01 - 5.38 , p<0.0001 ) . The 7-day diarrhoea prevalence was lower in the intervention than in the control communities at 3 months ( 0.64 , 0.44 - 0.95 , p=0.028 ) and 6 months ( 0.85 , 0.72 - 0.99 , p=0.04 ) . The mean weights and lengths , and the proportion with weight-for-height or height-for-age Z scores of 2 or less , at age 3 months and 6 months did not differ much between groups . Intervention effect on exclusive breastfeeding , diarrhoeal morbidity , and anthropometry at age 6 months in the low-birthweight subgroup was similar to that for all births . INTERPRETATION Promotion of exclusive breastfeeding until age 6 months in a developing country through existing primary health-care services is feasible , reduces the risk of diarrhoea , and does not lead to growth faltering This study assesses the impact of an intervention known as the Ten Steps to Healthy Feeding : A Nutritional Guide for Children under Two on nutritional conditions and infant health in low-income families . Two hundred newborns were r and omized to the intervention group and three hundred to the control group . Parents of the intervention group received nutritional orientation during the child 's first year of life . Both groups received visits at 6 and 12 months and routine follow-up by their pediatricians . The results ( n = 397 ) showed that the intervention was associated with a higher proportion of exclusive breastfeeding at 4 months ( RR = 1.58 ; 95%CI : 1.21 - 2.06 ) and 6 months ( RR = 2.34 ; 95%CI : 1.37 - 3.99 ) and breastfeeding at 12 months ( RR = 1.26 ; 95%CI : 1.02 - 1.55 ) and a lower proportion of children with diarrhea ( RR = 0.68 ; 95%CI : 0.51 - 0.90 ) , respiratory problems ( RR = 0.63 ; 95%CI : 0.46 - 0.85 ) , use of medication ( RR = 0.56 ; 95%CI : 0.34 - 0.91 ) , and dental caries ( RR = 0.56 ; 95%CI : 0.32 - 0.96 ) in the 12 - 16 month bracket . The intervention had no effect on the occurrence of anemia , hospitalization , or nutritional status . The results suggest that the nutritional orientation program led to positive changes in infant feeding practice s and health conditions , but that it was insufficient to prevent iron deficiency anemia A r and omized controlled trial was conducted to evaluate two interventions for prolonging the duration of breast-feeding in a multiethnic sample of 343 low-income urban women . One intervention compared research breast-feeding bedside counseling by a trained counselor , who also made eight telephone calls during the first 3 months of the infant 's life , with the routine breast-feeding counseling provided in the hospital by nurses . The other intervention compared commercial discharge packs provided by formula companies with research discharge packs design ed to be consistent with the WHO Code of Marketing of Breastmilk Substitutes . When infants were 4 months old , a telephone interviewer unaware of treatment status contacted 95 % ( 324/343 ) of the women to determine the infants ' feeding and health histories . Compared with routine counseling , research counseling delayed the first introduction of solid foods to the infant 's diet ( P = .03 , one-tailed ) but did not exert a statistically significant effect on breast-feeding by 4 months ' postpartum . Women who received the research discharge pack , compared with those who received the commercial pack , were more likely to prolong exclusive breast-feeding ( P = .004 , one-tailed ) , to be partially breast-feeding at 4 months postpartum ( P = .04 , one-tailed ) , and to delay the daily use of solid foods in the infant 's diet ( P = .017 , one-tailed ) . Among the women who received research counseling , the research discharge pack was associated with lower rates of rehospitalization of infants than was the commercial pack ( 1 % v 14 % ; P = .014 , two-tailed ) . We conclude that in high-risk maternity population s , commercial discharge material s for breast-feeding women should be replaced by material s consistent with the WHO Code BACKGROUND Exclusive breastfeeding is recommended worldwide but not commonly practised . We undertook a r and omised controlled study of the efficacy of home-based peer counselling to increase the proportion of exclusive breastfeeding among mothers and infants residing in periurban Mexico City . METHODS Two intervention groups with different counselling frequencies , six visits ( 44 ) and three visits ( 52 ) , were compared with a control group ( 34 ) that had no intervention . From March , 1995 , to September , 1996 , 170 pregnant women were identified by census and invited to participate in the study . Home visits were made during pregnancy and early post partum by peer counsellors recruited from the same community and trained by La Leche League . Data were collected by independent interview . Exclusive breastfeeding was defined by WHO criteria . FINDINGS 130 women participated in the study . Only 12 women refused participation . Study groups did not differ in baseline factors . At 3 months post partum , exclusive breastfeeding was practised by 67 % of six-visit , 50 % of three-visit , and 12 % of control mothers ( intervention groups vs controls , p<0.001 ; six-visit vs three-visit , p=0.02 ) . Duration of breastfeeding was significantly ( p=0.02 ) longer in intervention groups than in controls , and fewer intervention than control infants had an episode of diarrhoea ( 12 % vs 26 % , p=0.03 ) . INTERPRETATION This is the first reported community-based r and omised trial of breastfeeding promotion . Early and repeated contact with peer counsellors was associated with a significant increase in breastfeeding exclusivity and duration . The two-fold decrease in diarrhoea demonstrates the importance of breastfeeding promotion to infant health Objective To compare a shortened hospital stay with midwife visits at home to usual hospital care after delivery BACKGROUND Most mothers stop breast-feeding before the recommended 6 months post partum . A systematic review showed that breast-feeding support programs by health care professionals did not substantially improve breast-feeding outcomes beyond 2 months post partum . We conducted a r and omized controlled trial to evaluate the effect of peer ( mother-to-mother ) support on breast-feeding duration among first-time breast-feeding mothers . METHODS We recruited 256 breast-feeding mothers from 2 semi-urban community hospitals near Toronto and r and omly assigned them to a control group ( conventional care ) or a peer support group ( conventional care plus telephone-based support , initiated within 48 hours after hospital discharge , from a woman experienced with breast-feeding who attended a 2.5-hour orientation session ) . Follow-up of breast-feeding duration , maternal satisfaction with infant feeding method and perceptions of peer support received was conducted at 4 , 8 and 12 weeks post partum . RESULTS Significantly more mothers in the peer support group than in the control group continued to breast-feed at 3 months post partum ( 81.1 % v. 66.9 % , p = 0.01 ) and did so exclusively ( 56.8 % v. 40.3 % , p = 0.01 ) . Breast-feeding rates at 4 , 8 and 12 weeks post partum were 92.4 % , 84.8 % and 81.1 % respectively among the mothers in the peer support group , as compared with 83.9 % , 75.0 % and 66.9 % among those in the control group ( p < or = 0.05 for all time periods ) . The corresponding relative risks were 1.10 ( 95 % confidence interval [ CI ] 1.01 - 2.72 ) at 4 weeks , 1.13 ( 95 % CI 1.00 - 1.28 ) at 8 weeks and 1.21 ( 95 % CI 1.04 - 1.41 ) at 12 weeks post partum . In addition , when asked for an overall rating of their feeding experience , significantly fewer mothers in the peer support group than in the control group were dissatisfied ( 1.5 % v. 10.5 % ) ( p = 0.02 ) . Of the 130 mothers who evaluated the peer support intervention , 81.6 % were satisfied with their peer volunteer experience and 100 % felt that all new breast-feeding mothers should be offered this peer support intervention . INTERPRETATION The telephone-based peer support intervention was effective in maintaining breast-feeding to 3 months post partum and improving satisfaction with the infant feeding experience . The high satisfaction with and acceptance of the intervention indicates that breast-feeding peer support programs , in conjunction with professional health services , are effective Background Maternal malnutrition and poor gestational weight gain are the most important causes of low birth weight and high rates of newborn mortality . Objective To assess the effects of nutrition counseling in the third trimester of pregnancy on maternal weight gain , birth weight of newborn , and breastfeeding practice s. Methods This was a longitudinal experimental study with nutrition intervention for a period of 3 months . One hundred fifteen women ( 57 in the intervention group and 58 in the comparison group ) who were visiting the Maternal and Child Health Training Institute at 6 months of pregnancy were r and omly selected . The intervention group was given nutrition education twice in the first month and once a month for the next 2 months before delivery ; the comparison group received routine hospital advice on food intake , immunization , personal hygiene , and breastfeeding . The women were weighed monthly up to delivery , the newborn infants ' birth weights were measured within 24 hours after delivery , and breastfeeding practice s were observed 1 month after delivery . Results Women in the intervention group gained 1.73 kg more weight during the third trimester than women in the comparison group ( 5.61 vs. 3.88 kg , p < 0.001 ) . The mean birthweight of babies of women in the intervention group was 0.44 kg greater than that of babies of women in the comparison group ( 2.86 vs. 2.42 kg , p < 0.001 ) . In the intervention group , 10.5 % of babies were born with low birthweight , compared with 48.3 % of the babies of women in the comparison group ( p < 0.001 ) . In the intervention group , 75.4 % of mothers initiated breastfeeding within 1 hour after birth , compared with 34.5 % of mothers in the comparison group ( p < 0.001 ) . Conclusions Nutrition education only during the third trimester improved weight gain during pregnancy , reduced 78 % of low birth weight , and improved breast-feeding practice This pilot study aim ed to test the effectiveness of a structured telephonic counselling ( STC ) on exclusive breastfeeding ( EB ) on healthy babies . The study was carried out on 114 primiparous women from February to March 2009 . After r and omization , women were divided into two groups : 55 receiving STC and 59 receiving conventional counselling . At 1 , 3 and 5 months after delivery , a nurse specialist evaluated the EB rates , the influence of mother 's educational level and employment status on EB . Breastfeeding rates in STC were higher compared to conventional counselling ( P < 0.01 ) ; resuming work was not an EB discouraging variable as 74.5 % women in the STC resumed work vs. 54.2 % of the conventional counselling . Breastfeeding promotion should start during pregnancy , advising women about benefits for the child in receiving human milk . STC should be used to improve EB in primiparous women BACKGROUND The advantages of breastfeeding have been well established for both mothers and their infants . Existing research reports equivocal effects of early discharge and postpartum home care on breastfeeding success . The purpose of this study was to compare the effects of breastfeeding support offered in hospital and home setting s on breastfeeding outcomes and maternal satisfaction for mothers of term and near-term newborns who experienced st and ard or early discharge . METHODS In a r and omized controlled trial with prognostic stratification for gestational age , 101 term and 37 near-term ( 35 - 37 weeks ' gestational age ) mother-newborn pairs were r and omized to either a st and ard care group ( st and ard care and st and ard length of hospitalization ) or an experimental group ( st and ard hospital care with early discharge and home support from nurses who were certified lactation consultants ) . Data collection occurred before r and omization , at discharge from hospital , and from 5 to 12 days postpartum . Primary outcomes included breastfeeding rates and maternal satisfaction . RESULTS More mothers of term newborns in the experimental group were breastfeeding exclusively at follow-up ( p = 0.02 ) compared with the control group . No significant breastfeeding differences occurred among mothers with near-term newborns in the experimental and st and ard care groups . CONCLUSIONS In-home lactation support appears to facilitate positive breastfeeding outcomes for mothers of term newborns . This may also be a beneficial model of postpartum care for mothers of near-term newborns ; however , further research is required . The findings suggest implication s for health caregivers and policy makers with respect to postpartum lactation and health care services Objective . To determine whether an individualized , prenatal and postnatal , lactation consultant intervention result ed in increased cumulative intensity of breastfeeding up to 52 weeks . Design . The r and omized , nonblinded , controlled trial recruited women from prenatal care . Baseline prenatal interviews covered demographic data and breastfeeding experience , intention , and knowledge . Interviews at 1 , 2 , 3 , 4 , 6 , 8 , 10 , and 12 months after birth collected data on weekly feeding patterns , infant illness , and infant health care use . Setting . Two community health centers serving low-income , primarily Hispanic and /or black women . Participants . The analytic sample included 304 women ( intervention : n = 145 ; control : n = 159 ) with ≥1 postnatal interview . Intervention . Study lactation consultants attempted 2 prenatal meetings , a postpartum hospital visit , and /or home visits and telephone calls . Control subjects received the st and ard of care . Outcome Measures . Cumulative breastfeeding intensity at 13 and 52 weeks , based on self-reports of weekly feeding , on a 7-level scale . Results . The intervention group was more likely to breastfeed through week 20 ( 53.0 % vs 39.3 % ) . Exclusive breastfeeding rates were low and did not differ according to group . In multivariate analyses , control subjects had lower breastfeeding intensity at 13 weeks ( odds ratio [ OR ] : 1.90 ; 95 % confidence interval [ CI ] : 1.13–3.20 ) and 52 weeks ( OR : 2.50 ; 95 % CI : 1.48–4.21 ) . US-born control subjects had lowest breastfeeding intensity at 13 weeks ( OR : 5.22 ; 95 % CI : 2.43–11.22 ) and 52 weeks ( OR : 5.25 ; 95 % CI : 2.44–11.29 ) . There were no significant differences in breastfeeding intensity among the US-born intervention , foreign-born intervention , and foreign-born control groups . Conclusions . This “ best- practice s ” intervention was effective in increasing breastfeeding duration and intensity . Breastfeeding promotion should focus on US-born women and exclusive breastfeeding Abstract Problem : Breastfeeding rates and related hospital practice s need improvement in Italy and elsewhere . Training of staff is necessary , but its effectiveness needs assessment . Context : Eight hospitals in different regions of Italy . Design : Controlled , non-r and omised study . Data collected in three phases . Training after the first phase in group 1 hospitals and after the second phase in group 2 . Strategies for change : Training of trainers and subsequent training of health workers with a slightly adapted version of the 18 hour Unicef course on breastfeeding management and promotion . Key measures for improvement : Hospital practice s , knowledge of 571 health workers , and breastfeeding rates at discharge , three , and six months in 2669 mother and baby pairs . Effects of change : After training hospitals improved their compliance with the “ ten steps to successful breast feeding , ” from an average of 2.4 steps at phase one to 7.7 at phase three . Knowledge scores of health professionals increased from 0.41 to 0.72 in group 1 ( training after phase one ) and from 0.53 to 0.75 in group 2 ( after phase two ) . The rate of exclusive breast feeding at discharge increased significantly after training : 41 % to 77 % in group 1 and 23 % to 73 % in group 2 , as did the rates of full ( exclusive plus predominant ) breast feeding at three months ( 37 % to 50 % in group 1 v 40 % to 59 % in group 2 ) and any breast feeding at six months ( 43 % to 62 % in group 1 v 41 % to 64 % in group 2 ) . Lessons learnt : Training for at least three days with a course including practical sessions and counselling skills is effective in changing hospital practice s , knowledge of health workers , and breastfeeding rates OBJECTIVE Recognizing that an expectant father may influence a mother 's decision to breast- or formula-feed , we tested the effectiveness of a simple , educational intervention that was design ed to encourage fathers to advocate for breastfeeding and to assist his partner if she chooses to breastfeed . STUDY DESIGN We conducted a r and omized controlled trial in which expectant fathers ( n = 59 ) were assigned r and omly to attend either a 2-hour intervention class on infant care and breastfeeding promotion ( intervention ) or a class on infant care only ( control group ) . The classes , which were led by a peer-educator , were interactive and informal and utilized different media to create an accessible environment for participants . Couples were recruited during the second trimester from a university obstetrics practice . RESULTS Overall , breastfeeding was initiated by 74 % of women whose partners attended the intervention class , as compared with 41 % of women whose partners attended the control class ( P = .02 ) . CONCLUSION Expectant fathers can be influential advocates for breastfeeding , playing a critical role in encouraging a woman to breastfeed her newborn infant OBJECTIVES Assess the effectiveness of home visits for advising mothers about breast feeding and weaning on early childhood caries ( ECC ) at the age of 12 months . METHODS A r and omized field trial was conducted in mothers who gave birth within the public health system in the Brazilian city of Sao Leopoldo ( intervention group = 200 ; controls = 300 ) . The intervention group received the advice 10 days after the child 's birth , monthly up to 6 months , at 8 , 10 and 12 months , based on the ' Ten Steps for Healthy Feeding ' , a Brazilian national health policy for primary care , based on WHO guidelines . Both groups had research assessment at 6 and 12 months , with dental caries investigated in this last assessment ; 122 children were lost in the 1-year follow-up ; 378 were assessed for caries : two predentulous children were excluded from the analysis . Mann-Whitney U was used to test if the average number of decayed surfaces ( DS ; white spots and cavities ) differed between the intervention and control groups , and logistic regression to estimate the effects of the intervention on the odds of ECC . Chi-square test was used to test for differences between the intervention and control groups in the distribution of feeding behaviours tackled by the dietary intervention . RESULTS 10.2 % of the children in the intervention group and 18.3 % of the controls had caries . The odds of caries was 48 % lower for the intervention group , adjusted for number of teeth ( OR = 0.52 , 95 % CI = 0.27 - 0.97 ) . Mean DS were lower for the intervention group ( 0.37 ) when compared with the control group ( 0.63 ) , ( Mann-Whitney U , P = 0.03 ) . The intervention group had significantly longer duration of exclusive breast feeding ( P = 0.000 ) , later introduction of sugar ( P = 0.005 ) , and smaller probability of ever having eaten biscuits ( P = 0.000 ) , honey ( P = 0.003 ) , soft drinks ( P = 0.02 ) , fromage-frais ( P = 0.001 ) , chocolate and sweets ( P = 0.001 ) . CONCLUSIONS ECC is a public health problem in that population . The home visits for dietary advice appear to help reducing dental caries in infants . Greater efforts are needed to tackle cariogenic dietary behaviours even further , as a relevant proportion of children of the intervention group were shown to present with dental caries . Further studies should examine the effect of the intervention in the longer term OBJECTIVE To evaluate the effectiveness of a breastfeeding promotion program in the Women , Infant and Children ( WIC ) Supplemental Nutrition Program participants . STUDY DESIGN This r and omized clinical trial included 52 women in the intervention group who received one-to-one pre- and postnatal breastfeeding education and support from a lactation consultant . Women ( n = 52 ) r and omized to controls received st and ard breastfeeding services . Data regarding their infants ' feeding ( classified as exclusive , partial , and bottle ) during the first 7 days , 1 , 2 , and 3 months of age were compared . Additionally , the mothers were surveyed to assess their knowledge , attitude , and beliefs regarding breastfeeding . RESULTS Among the 104 enrolled women , 91 ( 87.5 % ) were Hispanic . Almost all the pregnant women had planned to breastfeed their infants . Although the majority of women reported breastfeeding their infants , 45.6 % in the intervention group and 28.9 % of controls practice d exclusive breastfeeding during the first 7 days . By 3 months , the rate of exclusive breastfeeding in the intervention and control groups had dropped to 13.9 % and 10.5 % , respectively . Parity , mode of delivery , previous experience with breastfeeding , rooming in , and return to work did not significantly affect the exclusive breastfeeding rate . Maternal knowledge , attitude , and beliefs regarding breastfeeding were comparable between the study groups at the baseline stage as well as 3 months postpartum . CONCLUSIONS Participation in the proposed breastfeeding promotion program by the low-income mothers was associated with an insignificant increase in the exclusive breastfeeding rate during the first 3 postpartum months BACKGROUND Exclusive breastfeeding ( EBF ) is reported to be a life-saving intervention in low-income setting s. The effect of breastfeeding counselling by peer counsellors was assessed in Africa . METHODS 24 communities in Burkina Faso , 24 in Ug and a , and 34 in South Africa were assigned in a 1:1 ratio , by use of a computer-generated r and omisation sequence , to the control or intervention clusters . In the intervention group , we scheduled one antenatal breastfeeding peer counselling visit and four post-delivery visits by trained peers . The data gathering team were masked to the intervention allocation . The primary outcomes were prevalance of EBF and diarrhoea reported by mothers for infants aged 12 weeks and 24 weeks . Country-specific prevalence ratios were adjusted for cluster effects and sites . Analysis was by intention to treat . This study is registered with Clinical Trials.gov , number NCT00397150 . FINDINGS 2579 mother-infant pairs were assigned to the intervention or control clusters in Burkina Faso ( n=392 and n=402 , respectively ) , Ug and a ( n=396 and n=369 , respectively ) , and South Africa ( n=535 and 485 , respectively ) . The EBF prevalences based on 24-h recall at 12 weeks in the intervention and control clusters were 310 ( 79 % ) of 392 and 139 ( 35 % ) of 402 , respectively , in Burkina Faso ( prevalence ratio 2·29 , 95 % CI 1·33 - 3·92 ) ; 323 ( 82 % ) of 396 and 161 ( 44 % ) of 369 , respectively , in Ug and a ( 1·89 , 1·70 - 2·11 ) ; and 56 ( 10 % ) of 535 and 30 ( 6 % ) of 485 , respectively , in South Africa ( 1·72 , 1·12 - 2·63 ) . The EBF prevalences based on 7-day recall in the intervention and control clusters were 300 ( 77 % ) and 94 ( 23 % ) , respectively , in Burkina Faso ( 3·27 , 2·13 - 5·03 ) ; 305 ( 77 % ) and 125 ( 34 % ) , respectively , in Ug and a ( 2·30 , 2·00 - 2·65 ) ; and 41 ( 8 % ) and 19 ( 4 % ) , respectively , in South Africa ( 1·98 , 1·30 - 3·02 ) . At 24 weeks , the prevalences based on 24-h recall were 286 ( 73 % ) in the intervention cluster and 88 ( 22 % ) in the control cluster in Burkina Faso ( 3·33 , 1·74 - 6·38 ) ; 232 ( 59 % ) and 57 ( 15 % ) , respectively , in Ug and a ( 3·83 , 2·97 - 4·95 ) ; and 12 ( 2 % ) and two ( < 1 % ) , respectively , in South Africa ( 5·70 , 1·33 - 24·26 ) . The prevalences based on 7-day recall were 279 ( 71 % ) in the intervention cluster and 38 ( 9 % ) in the control cluster in Burkina Faso ( 7·53 , 4·42 - 12·82 ) ; 203 ( 51 % ) and 41 ( 11 % ) , respectively , in Ug and a ( 4·66 , 3·35 - 6·49 ) ; and ten ( 2 % ) and one ( < 1 % ) , respectively , in South Africa ( 9·83 , 1·40 - 69·14 ) . Diarrhoea prevalence at age 12 weeks in the intervention and control clusters was 20 ( 5 % ) and 36 ( 9 % ) , respectively , in Burkina Faso ( 0·57 , 0·27 - 1·22 ) ; 39 ( 10 % ) and 32 ( 9 % ) , respectively , in Ug and a ( 1·13 , 0·81 - 1·59 ) ; and 45 ( 8 % ) and 33 ( 7 % ) , respectively , in South Africa ( 1·16 , 0·78 - 1·75 ) . The prevalence at age 24 weeks in the intervention and control clusters was 26 ( 7 % ) and 32 ( 8 % ) , respectively , in Burkina Faso ( 0·83 , 0·45 - 1·54 ) ; 52 ( 13 % ) and 59 ( 16 % ) , respectively , in Ug and a ( 0·82 , 0·58 - 1·15 ) ; and 54 ( 10 % ) and 33 ( 7 % ) , respectively , in South Africa ( 1·31 , 0·89 - 1·93 ) . INTERPRETATION Low-intensity individual breastfeeding peer counselling is achievable and , although it does not affect the diarrhoea prevalence , can be used to effectively increase EBF prevalence in many sub-Saharan African setting s. FUNDING European Union Sixth Framework International Cooperation-Developing Countries , Research Council of Norway , Swedish International Development Cooperation Agency , Norwegian Programme for Development , Research and Education , South African National Research Foundation , and Rockefeller Brothers Foundation OBJECTIVES This quasi-experimental study examined the effects of a new breastfeeding empowerment programme provided to post-partum mothers within 3 days of entering post-partum care centres on their breastfeeding empowerment , problems and practice rate . METHOD The study employed a non-equivalent control group non-synchronized design . Participants who conformed with the selection criteria were selected from two post-partum care centres affiliated with hospitals in a city in South Korea . Each of the two study groups included 30 participants . The breastfeeding empowerment programme comprised four 60-minute sessions , and was applied for 4 weeks to mothers in the experimental group . RESULTS The breastfeeding empowerment scores were higher in the experimental group than in the control group ( p=0.007 ) , and there were fewer breastfeeding problems in the former group ( p=0.012 ) and the breastfeeding rates were higher in the former group ( p=0.017 , 0.002 and 0.002 at 4 , 8 and 12 weeks post-partum , respectively ) . CONCLUSIONS These results indicate that the provision of breastfeeding empowerment programmes to help mothers to identify and solve problems by themselves can improve breastfeeding empowerment , problem and practice rates , and hence should be considered useful as a post-partum nursing intervention in clinical setting s. The effectiveness of the various components of the breastfeeding empowerment programme developed in this study should be verified in field trials BACKGROUND WHO and UNICEF launched the Integrated Management of Childhood Illness ( IMCI ) strategy in the mid-1990s to reduce deaths from diarrhoea , pneumonia , malaria , measles , and malnutrition in children younger than 5 years . We assessed the effect of IMCI on health and nutrition of children younger than 5 years in Bangladesh . METHODS In this cluster r and omised trial , 20 first-level government health facilities in the Matlab subdistrict of Bangladesh and their catchment areas ( total population about 350 000 ) were paired and r and omly assigned to either IMCI ( intervention ; ten clusters ) or usual services ( comparison ; ten clusters ) . All three components of IMCI-health-worker training , health-systems improvements , and family and community activities-were implemented beginning in February , 2002 . Assessment included household and health facility surveys tracking intermediate outputs and outcomes , and nutrition and mortality changes in intervention and comparison areas . Primary endpoint was mortality in children aged between 7 days and 59 months . Analysis was by intention to treat . This study is registered , number IS RCT N52793850 . FINDINGS The yearly rate of mortality reduction in children younger than 5 years ( excluding deaths in first week of life ) was similar in IMCI and comparison areas ( 8.6%vs 7.8 % ) . In the last 2 years of the study , the mortality rate was 13.4 % lower in IMCI than in comparison areas ( 95 % CI -14.2 to 34.3 ) , corresponding to 4.2 fewer deaths per 1000 livebirths ( 95 % CI -4.1 to 12.4 ; p=0.30 ) . Implementation of IMCI led to improved health-worker skills , health-system support , and family and community practice s , translating into increased care-seeking for illnesses . In IMCI areas , more children younger than 6 months were exclusively breastfed ( 76%vs 65 % , difference of differences 10.1 % , 95 % CI 2.65 - 17.62 ) , and prevalence of stunting in children aged 24 - 59 months decreased more rapidly ( difference of differences -7.33 , 95 % CI -13.83 to -0.83 ) than in comparison areas . INTERPRETATION IMCI was associated with positive changes in all input , output , and outcome indicators , including increased exclusive breastfeeding and decreased stunting . However , IMCI implementation had no effect on mortality within the timeframe of the assessment . FUNDING Bill & Melinda Gates Foundation , WHO 's Department of Child and Adolescent Health and Development , and US Agency for International Development In a r and omised controlled trial a lactation nurse assisted mothers during the early weeks after parturition both in hospital and at home . All mothers who started breast feeding were entered into the trial . The lactation nurse significantly extended duration in the study group compared with controls , particularly during the first four weeks and among women of lower social class BACKGROUND Peer support may improve breastfeeding rates but the evidence is inconclusive . Previous studies and review s recommend trials in different healthcare setting s. AIM To test if a specified programme of peer support affects the initiation and /or the duration of breastfeeding . DESIGN OF STUDY A two-group r and omised controlled trial of peer support for breastfeeding with evaluation of breastfeeding initiation and duration on an intention-to-treat basis . SETTING General practice in Ayrshire , Scotl and . METHOD Following informed consent , 225 women at 28 weeks gestation were allocated to control or peer support group by post-recruitment concealed allocation . All peer support and control group mothers received normal professional breastfeeding support . Additionally , those in the peer support group still breastfeeding on return home from hospital had peer support until 16 weeks . RESULTS Thirty-five of the 112 ( 31 % ) women in the peer support group were breastfeeding at 6 weeks compared to 33/113 ( 29 % ) in the control group , a difference of 2 % ( 95 % confidence interval = -10 % to 14 % ) . The median breastfeeding duration for all women in the peer support group was 2 days compared to 1 day for the control group and the Kaplan-Meier survival plot shows the peer support group overall breastfeeding slightly longer than the control group , with no statistically significant difference by logrank test ( P = 0.5 ) . The median breastfeeding duration among primagravidae in the peer support group was 7 days , compared to 3 days for the control group . Among women who started to breastfeed the medians were 72 days in the peer support group and 56 days in the control group . These differences were not statistically significant . CONCLUSIONS Peer support did not increase breastfeeding in this population by a statistically significant amount OBJECTIVES To determine the predictors of pacifier use during the first year of life and to assess the influence of pacifier use on the duration of breastfeeding . METHODOLOGY A prospect i ve cohort study was conducted . Three hundred and fifty mother-infant pairs were followed to 1 year of age to determine the impact of the use of a pacifier on the duration of breastfeeding . RESULTS A cohort of 441 mothers were enrolled and 79 % participated . Ninety four per cent were followed up to 1 year . Daily pacifier use was associated with early cessation of breastfeeding ( risk ratio ( RR ) 1.71 ; 95 % confidence interval ( 95%CI ) 1.29 , 2.28 ) and a reduced duration of full breastfeeding ( adjusted ( adj . ) RR 1.35 ; 95%CI 1.05 , 1.74 ) . Finger sucking was not associated with a reduced duration of breastfeeding ( RR 1.05 ; 95%CI 0.81 , 1.37 ) . Pacifier use less than daily was not associated with a change in duration of breastfeeding ( RR 1.02 ; 95%CI 0.75 , 1.39 ) . Most mothers commenced the use of a pacifier within the first month . Multiple logistic regression analysis found that the use of a pacifier was associated with male gender ( adj . RR 1.97 ; 95%CI 1.23 , 3.13 ) , maternal smoking in pregnancy ( adj . RR 2.23 ; 95%CI 1.01 , 4.95 ) , and low maternal confidence with breastfeeding ( adj . RR 2.70 ; 95%CI 1.48 , 4.93 ) . CONCLUSIONS Daily pacifier use is associated with a reduced duration of breastfeeding . Less frequent pacifier use does not reduce the duration of breastfeeding Research ers attempted to increase the initiation of breastfeeding and its duration to 6 months among a group of low-income , Hispanic women through an intervention program which included prenatal education and home based postpartum support . All participants were telephoned after delivery to determine infant feeding method . Duration of breastfeeding was determined by counting the number of days from initiation to the last day the baby was put to the breast . The Bayesian approach was used for the statistical analyses . In the intervention group , the propensity to initiate breastfeeding exceeded that of the control group . Results indicate the intervention group had twice ( 2.31 ) the odds of starting breastfeeding , twice ( 1.84 - 3.15 ) the odds of continuing to breastfeed for 6 months , and only half ( .50-.54 ) the tendency to quit at any one time than did the control group OBJECTIVE To compare the frequency of breast-feeding before and after the " Best Start " breast-feeding educational program was implemented . DESIGN Preintervention-postintervention trial . SETTING A women 's health center and children 's hospital serving a low-income population . PATIENTS Ninety mother-infant pairs of whom the infants were born between January 2 and February 28 , 1993 , compared with 90 mother-infant pairs of whom the infants were born between January 2 and February 28 , 1994 . INTERVENTION Best Start , a breast-feeding education program , was presented to health professionals and clerical staff of the Women 's Health Center . At the first prenatal visit , a woman is asked , " What do you know about breast-feeding ? " instead of " Are you going to breast-feed or bottle-feed this baby ? " The program elicits and acknowledges the mother 's concerns and then educates her about the benefits of breast-feeding . This is repeated at each prenatal visit . OUTCOME MEASURES Sociodemographic data and breast-feeding rates of preintervention groups were compared with those of postintervention groups . Both hospital and out-patient records were review ed . RESULTS In 1993 , 13 ( 15 % ) of 86 mothers breast-fed at hospital discharge compared with 25 ( 31 % ) of 81 in 1994 ( P < .03 ) . At the 2-week clinic visit , 11 ( 13 % ) of 86 were still breast-feeding in 1993 compared with 17 ( 21 % ) of 81 in 1994 ( P > .20 ) . The impact on mothers aged 19 years or less was particularly marked , with a tripling of the breast-feeding rate at hospital discharge from 11 % ( 2/18 ) in 1993 to 37 % ( 10/27 ) in 1994 . CONCLUSION This simple , low-cost educational intervention with a change in the manner of presentation significantly improved the breast-feeding rates of this low-income population CONTEXT Current evidence that breastfeeding is beneficial for infant and child health is based exclusively on observational studies . Potential sources of bias in such studies have led to doubts about the magnitude of these health benefits in industrialized countries . OBJECTIVE To assess the effects of breastfeeding promotion on breastfeeding duration and exclusivity and gastrointestinal and respiratory infection and atopic eczema among infants . DESIGN The Promotion of Breastfeeding Intervention Trial ( PROBIT ) , a cluster-r and omized trial conducted June 1996-December 1997 with a 1-year follow-up . SETTING Thirty-one maternity hospitals and polyclinics in the Republic of Belarus . PARTICIPANTS A total of 17 046 mother-infant pairs consisting of full-term singleton infants weighing at least 2500 g and their healthy mothers who intended to breastfeed , 16491 ( 96.7 % ) of which completed the entire 12 months of follow-up . INTERVENTIONS Sites were r and omly assigned to receive an experimental intervention ( n = 16 ) modeled on the Baby-Friendly Hospital Initiative of the World Health Organization and United Nations Children 's Fund , which emphasizes health care worker assistance with initiating and maintaining breastfeeding and lactation and postnatal breastfeeding support , or a control intervention ( n = 15 ) of continuing usual infant feeding practice s and policies . MAIN OUTCOME MEASURES Duration of any breastfeeding , prevalence of predominant and exclusive breastfeeding at 3 and 6 months of life and occurrence of 1 or more episodes of gastrointestinal tract infection , 2 or more episodes of respiratory tract infection , and atopic eczema during the first 12 months of life , compared between the intervention and control groups . RESULTS Infants from the intervention sites were significantly more likely than control infants to be breastfed to any degree at 12 months ( 19.7 % vs 11.4 % ; adjusted odds ratio [ OR ] , 0.47 ; 95 % confidence interval [ CI ] , 0.32 - 0.69 ) , were more likely to be exclusively breastfed at 3 months ( 43.3 % vs 6.4 % ; P<.001 ) and at 6 months ( 7.9 % vs 0.6 % ; P = .01 ) , and had a significant reduction in the risk of 1 or more gastrointestinal tract infections ( 9.1 % vs 13.2 % ; adjusted OR , 0.60 ; 95 % CI , 0.40 - 0.91 ) and of atopic eczema ( 3.3 % vs 6.3 % ; adjusted OR , 0.54 ; 95 % CI , 0.31 - 0.95 ) , but no significant reduction in respiratory tract infection ( intervention group , 39.2 % ; control group , 39.4 % ; adjusted OR , 0.87 ; 95 % CI , 0.59 - 1.28 ) . CONCLUSIONS Our experimental intervention increased the duration and degree ( exclusivity ) of breastfeeding and decreased the risk of gastrointestinal tract infection and atopic eczema in the first year of life . These results provide a solid scientific underpinning for future interventions to promote breastfeeding OBJECTIVE : To address the impact of simple antenatal educational interventions on breastfeeding practice . METHODS : A r and omized controlled trial was carried out in a tertiary referral center from May 2002 to December 2004 . A r and om sample of eligible low-risk antenatal patients was recruited from clinics in the National University Hospital , Singapore . Group A received breastfeeding educational material and individual coaching from a lactation counselor . Group B received breastfeeding educational material with no counseling . Group C received routine antenatal care only . RESULTS : A total of 401 women were recruited . Mothers receiving individual counseling and educational material practice d exclusive and predominant breastfeeding more often than mothers receiving routine care alone at 3 months ( odds ratio [ OR ] 2.6 , 95 % confidence interval [ CI ] 1.2–5.4 ) and 6 months ( OR 2.4 , 95 % CI 1.0–5.7 ) postpartum . More mothers practice d exclusive and predominant breastfeeding at 6 months among women receiving individual counseling compared with women exposed to educational material alone ( OR 2.5 , 95 % CI 1.0–6.3 ) . CONCLUSION : Where breastfeeding practice s are suboptimal , simple one-encounter antenatal education and counseling significantly improve breastfeeding practice up to 3 months after delivery . Provision of printed or audiovisual educational material is not enough . Health care workers should make every effort to have one face-to-face encounter to discuss breastfeeding with expectant mothers before they deliver . CLINICAL TRIAL REGISTRATION : Clinical Trials.gov , www . clinical trials.gov , NCT002770192 LEVEL OF EVIDENCE : OBJECTIVE To evaluate the efficacy of an intervention program to increase breast-feeding in a low-income , inner-city population . DESIGN A r and omized , nonblinded clinical control trial . Patients were followed up through pregnancy , delivery , and the first year of the infant 's life or until the time of weaning from the breast , whichever came first . SETTING The ambulatory care center for prenatal and pediatric care and the inpatient maternity unit of a primary care center that serves a low-income , inner-city population . PATIENTS There were a total of 108 patients : 51 were r and omized to the intervention group that received prenatal and postnatal lactation instruction from a lactation consultant , and 57 were r and omized to the control group that received the st and ard of care at the institution . Patients in the control group were not seen by the lactation consultant . The two groups were similar demographically . INTERVENTION This program consisted of individual prenatal lactation consultation , daily rounds by the lactation consultant on the postpartum unit , and outpatient follow-up at 48 hours after discharge , at the time that the infant was 1 week of age , and at all future health supervision visits for infants up to 1 year of age . MAIN OUTCOME MEASURES The incidence and duration of breast-feeding . RESULTS There was a markedly higher incidence of breast-feeding in the intervention group , as compared with that of the control group ( 61 % vs 32 % , respectively ; P = .002 ) . The duration of breast-feeding was also significantly longer in the intervention group ( P = .005 ) . CONCLUSIONS This lactation program increased the incidence and duration of breast-feeding in our low-income cohort . We suggest that similar efforts that are applied to analogous population s may increase the incidence and duration of breast-feeding in low-income population s in the United States OBJECTIVES To pilot test a newly developed breastfeeding self-efficacy intervention . DESIGN Pilot r and omized controlled trial ( RCT ) . SETTING An acute care hospital located in Northwestern Ontario that is the sole provider of maternity care for the city and referral center for the region . PARTICIPANTS One-hundred- and -fifty primiparous women intending to breastfeed their healthy , term , singleton infant . INTERVENTION A st and ardized , individualized nursing intervention protocol was design ed and administered to increase mothers ' breastfeeding self-efficacy . Participants were r and omly allocated to the intervention group or control group using sealed , opaque envelopes . Participants in the intervention group received three individualized , self-efficacy enhancing sessions with the research er : two in-hospital and one by telephone . Participants in the control group received st and ard in-hospital and community care . MAIN OUTCOME MEASURES Feasibility , compliance , and the acceptability of the breastfeeding self-efficacy intervention . Other outcomes assessed were breastfeeding self-efficacy , duration , and exclusivity . RESULTS Findings suggest that the intervention was feasible ; there was a high degree of protocol compliance , and the majority of mothers reported that the intervention was beneficial . Mothers in the intervention group had higher rates of breastfeeding self-efficacy , duration , and exclusivity at 4 and 8 weeks postpartum . However , the differences between groups were not statistically significant . CONCLUSION The pilot RCT provided valuable information in examining the feasibility of the trial design and intervention BACKGROUND Although there are many benefits to breastfeeding , its prevalence and duration in many countries is still lower than the international recommendation for 6-month exclusive breastfeeding . The objective of the present study was to investigate whether a knowledge sharing practice s with empowerment strategies ( KSPES ) program on antenatal education and postnatal support strategies improves the rates of 6-month exclusive breastfeeding during the first six months postpartum compared with a st and ard knowledge of breastfeeding techniques . MATERIAL AND METHOD A r and omized controlled trial was conducted . Pregnant women of more than 32 weeks ' gestation were r and omly assigned to receive a routine st and ard knowledge of breastfeeding techniques alone ( control group ) or with KSPES on antenatal education and postnatal support strategies ( study group ) . The primary outcome was the rate of exclusive breastfeeding at 6-month postpartum . The secondary outcomes were rates at 7 days , 14 days , 1 , 2 , 3 , 4 , and 5 months postpartum . RESULTS Rates of exclusive breastfeeding in the study group were significantly higher when compared with those in the control group at 14 days ( 82.5 % vs. 52.6 % , p = 0.005 ) , 1 month ( 77.5 % vs. 52.6 % , p = 0.021 ) , 2 months ( 62.5 % vs. 368 % , p = 0.023 ) , 4 months ( 35.0 % vs. 7.9 % , p = 0.008 ) , 5 months ( 25.0 % vs. 2.6 % , p = 0.012 ) , and 6 months postpartum ( 20.0 % vs. 0 % , p = 0.005 ) . CONCLUSION KSPES on antenatal education and postnatal support strategies significantly improve rates of exclusive breastfeeding at 6-month postpartum . These strategies also significantly improve rates of exclusive breastfeeding at 14 days , 1 , 2 , 4 , 5 , and 6 months postpartum OBJECTIVE Breastfeeding initiation rates were compared at Boston Medical Center before ( 1995 ) , during ( 1998 ) , and after ( 1999 ) Baby-Friendly policies were in place . Boston Medical Center , an inner-city teaching hospital that provides care primarily to poor , minority , and immigrant families , achieved Baby-Friendly status in 1999 . METHODS Two hundred complete medical records , r and omly selected by a computer , were review ed from each of 3 years : 1995 , 1998 , and 1999 . Infants were excluded for medical records missing feeding data , human immunodeficiency virus-positive parent , neonatal intensive care unit admission , maternal substance abuse , adoption , incarceration , or hepatitis C-positive mother . All infant feedings during the hospital postpartum stay were tallied , and each infant was categorized into 1 of 4 groups : exclusive breast milk , mostly breast milk , mostly formula , and exclusive formula . RESULTS Maternal and infant demographics for all 3 years were comparable . The breastfeeding initiation rate increased from 58 % ( 1995 ) to 77.5 % ( 1998 ) to 86.5 % ( 1999 ) . Infants exclusively breastfed increased from 5.5 % ( 1995 ) to 28.5 % ( 1998 ) to 33.5 % ( 1999 ) . Initiation rates increased among US-born black mothers in this population from 34 % ( 1995 ) to 64 % ( 1998 ) to 74 % ( 1999 ) . CONCLUSIONS Full implementation of the Ten Steps to Successful Breastfeeding leading to Baby-Friendly design ation is an effective strategy to increase breastfeeding initiation rates in the US hospital setting OBJECTIVES to determine whether a specific ' h and s-off ' breastfeeding technique , based on the physiology of suckling and clinical experience , if taught to mothers in the immediate postnatal period , improves their chances of breastfeeding successfully and reduces the incidence of problems . To investigate the factors associated with breastfeeding at two and six weeks postpartum using logistic regression analysis . DESIGN a non-r and omised prospect i ve cohort phased intervention study . SETTING subjects recruited from one postnatal ward in St. Michael 's Hospital , Bristol from October 1996 to November 1998 . PARTICIPANTS 1400 South Bristol mothers who were breastfeeding on discharge from hospital . Three hundred and ninety-five of these mothers were scored for efficiency of using the breastfeeding technique . INTERVENTION a ' h and s-off ' breastfeeding technique was taught to midwives in hospital who subsequently taught mothers in their care . MEASUREMENTS frequencies of exclusive and ' any breastfeeding ' at two and six weeks from question naires sent to mothers at home , and incidence of breastfeeding problems . FINDINGS significant increases were observed in the proportion of mothers exclusively breastfeeding at two weeks ( P < 0.001 ) and six weeks ( P=0.02 ) and in ' any breastfeeding ' rates ( P=0.005 ) at two weeks after the technique intervention . The incidence of mothers feeling that they did ' not have enough milk ' ( perceived milk insufficiency ) decreased significantly after the breastfeeding technique had been taught ( P=0.02 ) . Logistic regression analysis produced a model which showed that mothers with high scores for the ' h and s-off ' technique were significantly more likely to be breastfeeding at six weeks compared with those who did not use all the elements of the technique ( OR 2.4 ; CI 1.3 , 4.3 ) . Factors associated with continuing to breastfeed at two and six weeks postpartum were also investigated using logistic regression . At two weeks , the significant factors associated with breastfeeding included mothers feeling that they had a ' plentiful milk supply ' ( OR 3.3 ; CI 2.1 , 5.3 ) , not using a dummy ( OR 2.6 ; CI 1.6 , 4.0 ) , not giving the baby any other fluid in hospital ( OR 2.4 ; CI 1.5 , 3.8 ) and receiving enough support for breastfeeding from hospital staff ( OR 2.1 ; CI 1.3 , 3.5 ) . By six weeks , in addition to these factors , the encouragement from a supportive partner , other family members and health professionals in enabling women to continue to breastfeed was found to show the largest associations with the maintenance of breastfeeding [ ( OR 37.2 ; CI 17.3 , 80.2 ) for all three encouraging ( 327/817 ; 40 % of breastfeeders ) compared with no encouragement ( 67/817 ; 8 % of breastfeeders ) ] . CONCLUSIONS in the immediate postnatal period , if mothers are taught good breastfeeding technique by midwives in a ' h and s-off ' style , which enables mothers to position and attach their babies for themselves , and which is based on a physiological approach , breastfeeding rates are increased and the incidence of perceived milk insufficiency decreases . Successful breastfeeding in the early weeks was associated both with practice s and support in hospital and with factors at home including not using dummies and having a supportive partner , family and health professionals who are encouraging breastfeeding . IMPLICATION S FOR PRACTICE teaching mothers how to breastfeed in a ' h and s-off ' way is important in empowering mothers to ' do it for themselves ' and in improving breastfeeding rates . Widespread adoption of consistent good practice is achievable following a brief workshop teaching session . Using the ' breastfeeding score checklist ' may help midwives to assess a breastfeed more accurately and determine which aspects need improving . Health professionals should aim to educate all key family members , whenever an opportunity arises both during pregnancy and postnatally , in the benefits of breast milk for babies in the first few months of life and how to encourage and support a mother in the early weeks of breastfeeding AIM Exclusive breastfeeding increases survival and optimizes growth of low-birthweight ( LBW ) infants . If supported , mothers can overcome the unique difficulties associated with breastfeeding from birth to 6 mo . We tested the efficacy of postnatal peer counselling among first-time mothers that aim ed to increase exclusive breastfeeding of term LBW infants . METHODS In a Manila hospital , 204 mothers were r and omized into three groups . Two intervention groups receiving home-based counselling visits , one by counsellors trained in breastfeeding counselling ( n=68 ) , the other by counsellors trained in general childcare ( n=67 ) , were compared with a control group of mothers ( n=69 ) who did not receive counselling . RESULTS Eighty-eight per cent of the participating pairs completed the trial . At 6 mo , 44 % of the breastfeeding counselled mothers , 7 % childcare-counselled mothers and none of the mothers in the control group were exclusively breastfeeding . More mothers in the breastfeeding counselled group than in the other groups were still breastfeeding at 6 mo . Twenty-four infants who were exclusively breastfed for 6 mo did not have any diarrhoea . All groups had improved mean weight-for-age Z-scores at 6 mo . CONCLUSION This study has provided fundamental evidence of successful intervention to achieve 6 mo of exclusive breastfeeding among term LBW infants . By improving health outcomes , enhanced breastfeeding offers a distinct possibility of disrupting the intergenerational cycle of undernourished women giving birth to LBW infants Purpose To investigate whether implementation of a formal breastfeeding education program including a breastfeeding protocol , a re source guide , and educational presentations would have an impact on knowledge , comfort level , and attitudes toward breastfeeding among healthcare providers , and on amount of exclusive breastfeeding at our hospital . Design and Methods Quasi-experimental study that included a survey to obtain a preintervention baseline measurement and a postintervention measurement 6 months after the implementation of the formal breastfeeding education program . The sample was obstetricians , pediatricians , and nurses who interact with breastfeeding mothers at our hospital . Additionally , we surveyed breastfeeding mothers who gave birth at our hospital to determine the impact on the nurse observation of breastfeeding , exclusivity of breastfeeding , and nighttime feedings . Results Healthcare providers showed increased levels of knowledge and comfort dealing with breastfeeding issues after the education program . Knowledge scores were significantly improved ( pre- vs. postimplementation scores were 20.2 vs. 22.2 , p < .05 ) . Comfort level scores were also significantly improved ( pre- vs. postimplementation scores were 20.7 vs. 29.4 , p < .05 ) . There was no statistically significant change in attitude toward breastfeeding ( preimplementation score = 43.8 , postimplementation score = 43.4 , p = .075 ) . For the mothers , the preintervention group reported exclusive breastfeeding 55 % of the time versus 63 % ( p = .046 ) in the postintervention group . There was an increase in nurse observation of breastfeeding after the intervention : 84 % versus 92 % ( p = .046 ) , and breastfeeding patients reported an increase in nighttime breastfeeding after the intervention ( 55 % vs. 71 % , p = 0.001 ) , with a result ing decrease in formula supplementation in the nursery at night ( 28 % vs. 21 % , p = .006 ) . Clinical Implication sThis study shows how an educational program and adherence to protocol s can increase exclusive breastfeeding as well as improve healthcare provider knowledge , comfort level , and attitudes about breastfeeding . Our interventions also result ed in an increase in nurse observation of breastfeeding , nighttime breastfeeding , and a decrease in the use of formula supplementation at night . This study suggests that positive changes can be made with an educational program and protocol OBJECTIVE To assess whether an antenatal teaching session on position and attachment of the baby on the breast had an effect on postnatal nipple pain , nipple trauma and breast feeding duration . The study was planned as a pilot study to allow an adequate sample size to be calculated for a larger study . DESIGN An observer blind experimental design was used . Women were r and omly assigned to either the experimental group teaching session or the control group . SETTING One public hospital in Western Australia . PARTICIPANTS 70 primiparae who intended to breast feed their baby were recruited from the antenatal clinic of the study hospital at 36 weeks ' gestation . INTERVENTION Antenatal group sessions on position and attachment of the baby on the breast were conducted by a lactation consultant . MEASUREMENTS AND FINDINGS During the first four postnatal days , position and attachment was measured by LATCH ( Latch on , Audible swallow , Type of nipple , Comfort and Help ) ( Jensen et al 1994 ) , nipple pain was measured by the Visual Analogue Scale ( VAS ) and nipple trauma was measured by the Nipple Trauma Index ( NTI ) . The analysis of variance ( ANOVA ) results indicated that the women in the experimental group were better able to attach the baby on the breast and had significantly less nipple pain and trauma than the control group . At six weeks postnatally , 31 of the 35 women in the experimental group were breast feeding compared to 10 of the 35 in the control group . CONCLUSIONS AND IMPLICATION S These initial findings suggest that midwives can make the best use of decreasing re sources by using practical ' h and s on ' antenatal group teaching as an effective strategy to increase breast feeding rates This r and omized clinical trial compared frequencies of exclusive breastfeeding and lactationrelated problems during the first 30 days among 74 mothers who received a 30-minute counseling session on breastfeeding technique in the maternity ward , and 137 controls . The frequency of exclusive breastfeeding among mothers who had received intervention was similar to controls by 7 days ( 79.7 % vs 82.5 % , respectively ) and 30 days ( 60.8 % vs 53.3 % ) . There was no difference between groups in the frequency of sore nipples at 7 and 30 days , in breast engorgement and mastitis , and in the quality of breastfeeding technique at 30 days . Therefore , a single intervention at maternity was not sufficient to improve breastfeeding technique , increase exclusive breastfeeding rates , and reduce the incidence of breastfeeding problems during the first month The effectiveness of a breastfeeding education intervention consisting of a 11/2-hour m and ated session for all nursing staff , with an optional self-paced tutorial , was evaluated in a small rural Canadian hospital . The intervention was design ed to increase exclusive breastfeeding rates , create positive beliefs and attitudes among staff members , and increase compliance with the World Health Organization/UNICEF Baby-Friendly Hospital Initiative ( BFHI ) . Staff surveys and chart audits were conducted at both the intervention and control site hospitals prior to the intervention and 7 months after the intervention . Over a 7-month period , the intervention hospital experienced an increase in BFHI compliance ( 24.4 vs. 31.9 , P<.01 ) , breastfeeding beliefs ( 55.0 vs. 58.8 , P<.05 ) , and exclusive breastfeeding rates ( 31 % vs. 54 % of breastfed babies , P<.05 ) but no change in breastfeeding attitudes ( 44.0 vs. 44.9 , P=.80 ) . The control site experienced no change in BFHI compliance , beliefs , or attitudes but a significant decrease in exclusive breastfeeding rates ( 43 % vs. 0 % , P<.05 ) Atrialwas conducted with 51women r and omly assigned either to a conventional nursing care group or to an individualized professional support group ; to examine the effect of professional support on breastfeeding status at 4 weeks postpartum . All participants identified themselves as having no prior support . At 4 weeks postpartum , 17 out of 25 ( 68 % ) and 26 out of 26 ( 100 % ) women in the control and intervention groups , respectively , continued to breastfeed ( P=.005 ) . Results indicate that postpartum care augmented with individualized professional support commenced in the hospital and continued in the community significantly increases the duration of breastfeeding among women who identify themselves as being without support for the first month postpartum BACKGROUND Promotion of breastfeeding is an important child-survival intervention , yet little is known about which promotional strategies are the most effective . We aim ed to compare the effects on rates of breastfeeding of two systems for promotion of breastfeeding in Brazil -- a hospital-based system and the same system combined with a programme of home visits . METHODS In February , 2001 , maternity staff from two hospitals in Pernambuco , Brazil , were trained according to the Baby-Friendly Hospital Initiative ( BFHI ) . In a r and omised trial between March and August , 2001 , 350 mothers giving birth at these hospitals were assigned ten postnatal home visits to promote and support breastfeeding ( n=175 ) or no home visits ( n=175 ) . Breastfeeding practice s were studied on days 1 , 10 , 30 , 60 , 90 , 120 , 150 , and 180 by research ers unaware of group allocation . The primary outcome measure was the rate of exclusive breastfeeding from birth to 6 months . Analyses were by intention to treat . FINDINGS The hospital-training intervention achieved a high rate ( 70 % ) of exclusive breastfeeding in the hospitals , but this rate was not sustained at home and at 10 days of age only 30 % of infants were exclusively breastfed The patterns of exclusive breastfeeding in the two trial groups for days 10 - 180 differed significantly ( p<0.0001 ) , with a mean aggregated prevalence of 45 % among the group assigned home visits compared with 13 % for the group assigned none . INTERPRETATION The BFHI achieves high rates of exclusive breastfeeding in hospital ; however , in Brazil at least , the rates fall rapidly thereafter . Reliance on the BFHI as a strategy for breastfeeding promotion should be reassessed . A combination of promotional systems ( hospital-based and in the community ) is needed BACKGROUND Although lactation experts suggest that a correct positioning and attachment technique reduces breastfeeding problems and enhances long-term breastfeeding , evidence from r and omized trials is lacking . The objective of this study was to evaluate the effect of postpartum positioning and attachment education on breastfeeding outcomes in first-time mothers . METHOD A r and omized trial was performed in a public hospital in Adelaide , South Australia , where 160 first-time mothers were r and omly allocated to receive either structured one-to-one education ( experimental group ) or usual postpartum care ( control group ) within 24 hours of birth . The primary outcome was breastfeeding at 6 weeks and 3 and 6 months postpartum ; other outcomes were nipple pain and trauma in hospital and at 6 weeks and 3 and 6 months , and satisfaction with breastfeeding . RESULTS No significant differences occurred in breastfeeding rates between the groups at each endpoint , although a trend in the direction of lower rates was seen at each endpoint in the experimental group . This group reported less nipple pain on days 2 ( p = 0.004 ) and 3 ( p = 0.04 ) , but this was not sustained on follow-up . No differences were observed in nipple trauma in hospital or in self-reported nipple pain and /or trauma at the three endpoints . Experimental group women were less satisfied with breastfeeding at 3 and 6 months postpartum when using a one-item measure ; however , a multiple-item measure showed no significant differences at the three endpoints . CONCLUSIONS The intervention did not increase breastfeeding duration at any assessment time or demonstrate any differences between the groups on secondary outcomes . The trend toward lower breastfeeding rates in the experimental group suggests a need for a larger trial to evaluate whether or nor postpartum positioning and attachment education may negatively affect breastfeeding OBJECTIVE The purpose of this study was to assess whether providing a breastfeeding support team results in higher breastfeeding rates at 6 , 12 , and 24 weeks postpartum among urban low-income mothers . METHODS DESIGN A r and omized controlled trial with mother-infant dyads recruited from 2 urban hospitals . PARTICIPANTS Breastfeeding mothers of full-term infants who were eligible for Special Supplemental Nutrition Program for Women , Infants , and Children ( n=328 ) were r and omized to intervention ( n=168 ) or usual-care group ( n=160 ) . INTERVENTION The 24-week intervention included hospital visits by a breastfeeding support team , home visits , telephone support , and 24-hour pager access . The usual-care group received st and ard care . OUTCOME MEASURE Breastfeeding status was assessed by self-report at 6 , 12 , and 24 weeks postpartum . RESULTS There were no differences in the sociodemographic characteristics between the groups : 87 % were African American , 80 % single , and 51 % primiparous . Compared with the usual-care group , more women reported breastfeeding in the intervention at 6 weeks postpartum , 66.7 % vs 56.9 % ( odds ratio , 1.71 ; 95 % confidence interval , 1.07 - 2.76 ) . The difference in rates at 12 weeks postpartum , 49.4 % vs 40.6 % , and 24 weeks postpartum , 29.2 % vs 28.1 % , were not statistically significant . CONCLUSIONS The intervention group was more likely to be breastfeeding at 6 weeks postpartum compared with the usual-care group , a time that coincided with the most intensive part of the intervention OBJECTIVE Early postpartum home visiting is universal in many Western countries . Studies from developing countries on the effects of home visits are rare . In Syria , where the postpartum period is rather ignored , this study aim ed to assess whether a community-based intervention of postnatal home visits has an effect on maternal postpartum morbidities ; infant morbidity ; uptake of postpartum care ; use of contraceptive methods ; and on selected neonatal health practice s. DESIGN A r and omized controlled trial was carried out in Damascus . Three groups of new mothers were r and omly allocated to receive either 4 postnatal home visits ( A ) , one visit ( B ) , or no visit ( C ) . SAMPLE A total of 876 women were allocated and followed up . INTERVENTION Registered midwives with special training made a one or a series of home visits providing information , educating , and supporting women . RESULTS A significantly higher proportion of mothers in Groups A and B reported exclusively breastfeeding their infants ( 28.5 % and 30 % , respectively ) as compared with Group C ( 20 % ) , who received no visits . There were no reported differences between groups in other outcomes . CONCLUSIONS While postpartum home visits significantly increased exclusive breastfeeding , other outcomes did not change . Further studies framed in a nonbiomedical context are needed . Other innovative approaches to improve postnatal care in Syria are needed INTRODUCTION Women 's traditional way of breastfeeding has altered in Jordan with rates declining in recent years . OBJECTIVE The objectives of this study were to test whether the introduction of an educational program supporting breastfeeding would increase the proportion of women who breastfed fully to six months , improve the women 's level of breastfeeding knowledge , and decrease the proportion of infants admitted to hospitals due to gastrointestinal illnesses . METHODS A r and omized controlled trial was conducted in 90 primiparous women who had given birth to a healthy , full term , singleton baby at two hospitals in the southern region of Jordan . Women were r and omly allocated to either the intervention group ( n=45 ) , in which they were offered a one-to-one postnatal educational session and follow-up phone calls at two months and four months postpartum , or the control group ( n=45 ) , in which they received routine postnatal care . The primary outcomes were the proportion of women fully breastfeeding their babies at six months and the women 's level of breastfeeding knowledge at six months postpartum . RESULTS The postnatal education and support program significantly improved breastfeeding knowledge measured by differences between mean pre- and post-test scores . This was statistically significant for the intervention group ( p<0.001 ) but was not significant for the control ( p=0.23 ) . The proportion of women fully breastfeeding their babies at 6 months was not found to be statistically significantly different between the intervention group ( 39 % ) and the control group ( 27 % ) , percentage difference=12 % ( 95 % confidence interval [ -9 % to 30 % ] , Chi squared : χ(2)=3.54 , p>0.05 ) . CONCLUSIONS Although the postnatal education and support program improved breastfeeding knowledge among women in the study , this increase in knowledge did not translate to an increase in the duration of full breastfeeding to six months The Baby-Friendly Hospital Initiative ( BFHI ) is based on the Ten Steps to Successful Breast-Feeding , a program which summarize the practice s that maternity wards need to adopt to support breastfeeding.1 There are more than 16 000 Baby-Friendly Hospitals throughout the world , and of these , more than 200 are located in Brazil . Despite the abundance of studies evaluating each of the 10 steps or a combination of them , information on the impact of BFHI on the duration of breastfeeding is limited . Recently , a large r and omized controlled trial including 31 hospitals in Belarus showed that an intervention based on BFHI principles increased breastfeeding rates , especially exclusive breastfeeding.2 The present study reproduced these results using a less complex study design Following a prospect i ve survey that showed a very low rate of breast-feeding ( 10 % ) in 1977 - 79 among Chinese women in Montreal , a culturally targeted program , which included individual prenatal counselling and a community-wide promotion and education campaign , was developed to improve the rates . The study group consisted of all Chinese women delivering in 1980 and 1981 who had taken their infants to one pediatrician for continuing care . The rates of breast-feeding in the 88 women who had received prenatal counselling and the 93 women who had not were compared . Although the rates were substantially increased for both groups over the 1977 - 79 rate ( 54 % and 34 % in 1980 and 65 % and 55 % in 1981 respectively ) , the 2-year rate was significantly higher for the counselled group compared with the uncounselled group in the later study ( 59 % v. 43 % ) . The greatest effect of counselling was seen in young , primiparous women of higher socioeconomic status who spoke French or English in addition to Chinese . However , 33 % of the counselled women who had started breast-feeding had stopped by 1 month , compared with only 15 % of the uncounselled women . Thus , although the rates of breast-feeding in ethnic groups can be increased with the use of a language - and culture-specific approach , more support and encouragement must be given to women who start breast-feeding so that they will continue longer OBJECTIVE To determine whether postnatal ' h and s off ' care by midwives on positioning and attachment of the newborn baby improves breast-feeding duration . DESIGN Mothers were r and omised at the first postnatal feed to receive either care by a midwife trained in the experimental protocol or by a control midwife undertaking routine care . SETTING Eight wards in four English Midl and s hospitals . PARTICIPANTS 370 primiparous mothers with term babies who intended to breast feed , and could sit out of bed to do so . INTERVENTIONS Experimental protocol of verbal-only advice on positioning and attachment , delivered at the first postnatal ward feed compared with routine care by a qualified midwife . MAIN OUTCOME MEASURES Duration of breast feeding up to 17 weeks as assessed by diaries and interviews with mothers and protocol adherence from self-completed checklist by the midwife . The mothers ' self-reported experience of care and support before , during and after delivery were assessed at 6 weeks , and feeding outcomes and employment status at 17 weeks . FINDINGS Experimental group mothers more often held the baby across their lap and received ' h and s off advice ' , but fewer babies in the experimental than control groups attached and fed : 59 % ( 106/180 ) vs. 67 % ( 118/175 ) , p=0.1 . No significant differences were found in the numbers of mothers breast feeding at 6 or 17 weeks in the experimental and control groups ( stopped exclusive breast feeding : 76 % ( 130/172 ) vs. 77 % ( 126/163 ) at 6 weeks ; 96 % ( 167/174 ) vs. 96 % ( 161/168 ) at 17 weeks ; odds ratio 1.02 , 95 % CI 0.77 to 1.22 ; p=0.8 ; stopped any breast feeding : 35 % ( 61/172 ) vs. 32 % ( 53/167 ) at 6 weeks ; 63 % ( 109/173 ) vs. 60 % ( 101/167 ) at 17 weeks ; odds ratio 1.10 , 0.84 to 1.45 ; p=0.5 ) . There were no significant differences in the incidence of problems with breast feeding and care experienced by mothers before or during hospitalisation ( other than at the first postnatal ward feed ) , nor after discharge home . CONCLUSIONS No significant beneficial effect was found on breast-feeding duration of the verbal- only advice on positioning and attachment , perhaps because aspects of the intervention are already within routine UK practice . Other care practice s at subsequent feeds may negate benefits of care at earlier feeds . ' H and s off ' care at the first feed may be less important to subsequent feeding than achieving a first feed under supervision in the postnatal ward . IMPLICATION S FOR PRACTICE Midwives can be trained in a 4-hr workshop to achieve improved knowledge of ' h and s off ' positioning and attachment care , and these can be translated into clinical practice . Future studies should differentiate the elements of the care that are effective in achieving postnatal feeds , and apply this advice consistently at successive feeds OBJECTIVE To evaluate the relative effects introducing motivational videotapes and /or peer counseling in Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) clinics serving African-American women have on breast-feeding duration . DESIGN Experimental intervention study . Pregnant women were enrolled at or before 24 weeks gestation and were followed up until postpartum week 16 . Women were interviewed at enrollment , 7 to 10 days , 8 weeks , and 16 weeks postpartum . SUNJECTS/ SETTING : One hundred fifteen African-American WIC participants who initiated breast-feeding and who had been enrolled in 1 of 4 clinics . INTERVENTION Two-by-two factorial design , in which 4 clinics were r and omly assigned to receive either no intervention , a motivational video package intervention , a peer-counseling intervention , or both interventions . MAIN OUTCOME MEASURES Breast-feeding duration in weeks and relative risk ratios for breast-feeding cessation before 16 weeks postpartum . STATISTICAL ANALYSIS PERFORMED Contingency table analysis , including chi2 tests and log-rank tests ; multivariate analysis using Cox proportional hazards regression analysis . RESULTS A higher proportion of women were breast-feeding at 8 and 16 weeks postpartum in the intervention clinics than in the control clinic . The proportion of women reporting breast-feeding declined at 8 and 16 weeks postpartum , but the rate of decline was slower in the 3 intervention clinics than in the control clinic . Being younger than 19 years of age or older than 25 years of age , having a male infant , and returning to work or school all negatively affected breastfeeding duration , whereas previous breast-feeding experience positively influenced breast-feeding duration . APPLICATIONS/ CONCLUSIONS WIC-based peer counselor support and motivational videos can positively affect the duration of breast-feeding among African-American women . WIC nutritionists and other health professionals in contact with this population should exp and their efforts toward promoting increased duration of breast-feeding The rate of breastfeeding among immigrant Vietnamese women in Western countries is low compared to those in Vietnam . To counteract this trend , a language and culture specific education program was developed . An experimental design was used to test the effectiveness of this program . The sample consisted of 182 prenatal Vietnamese women . Data collection included question naires and interviews . Results suggested that the education program had significant effects on knowledge , attitudes , planned and actual behaviour towards breastfeeding . However , the effect did not sustain until 6 months postpartum . Implication s for nursing practice and further research are discussed Hospital interventions in support of breastfeeding have been highly successful in areas where the indigenous population has a well established environment of breastfeeding . However , programmes design ed to improve breastfeeding patterns in urban population s have met with mixed success . This paper presents a prospect i ve intervention study with a control group in which a health system-based breastfeeding promotion programme was initiated to support optimal breastfeeding for both child health and child spacing . Following collection of control data , a four-step intervention programme ( Breastfeeding Promotion Program ) was instituted . This paper reports the process of the development of the intervention programme as well as the comparison of the control and study population s. Major findings include significant increases in duration of full breastfeeding from 31.6 per cent at 6 months in the control group to 66.8 per cent in the intervention group . The duration of lactational amenorrhea was similarly increased : 22 per cent of the control mothers and 56 per cent of the intervention group women were in amenorrhoea at 180 days . The cost-effectiveness of the hospital changes is illustrated OBJECTIVE To assess the effectiveness of a home-based early intervention on infant feeding practice s and " tummy time " for infants in the first year of life . DESIGN R and omized controlled trial with follow-up measures scheduled at 6 and 12 months . SETTING Socially and economically disadvantaged areas of Sydney , Australia . PARTICIPANTS We recruited 667 first-time mothers and their infants in 2007 and 2008 . INTERVENTIONS The intervention consisted of 5 or 6 home visits from a specially trained research nurse delivering a staged home-based intervention in the antenatal period and at 1 , 3 , 5 , 9 , and 12 months . MAIN OUTCOME MEASURE Changes in infant feeding practice s and " tummy time . " RESULTS The intervention group had a significantly higher median duration of breastfeeding at 12 months than the control group ( 17 weeks [ 95 % confidence interval , 13.9 - 20.4 weeks ] vs 13 weeks [ 95 % confidence interval , 10.1 - 15.0 weeks ] ; P = .03 ) . Compared with the control group , the hazard ratio for stopping breastfeeding in the intervention group was 0.82 ( 95 % confidence interval , 0.68 - 0.99 ) . The intervention also result ed in a significantly later introduction of solid foods ( P < .001 for trend ) , reducing the proportion of mothers who introduced solids before 6 months by 12 % ( 95 % confidence interval , 4%-20 % ) from 74 % to 62 % . The intervention also decreased the age at which infants started tummy time ( P = .03 for trend ) and increased the daily practice of tummy time by 7 % from 76 % to 83 % ( P = .05 ) . CONCLUSION The home-based early intervention delivered by trained community nurses significantly improved some infant feeding practice s and result ed in earlier daily practice of tummy time . TRIAL REGISTRATION anzctr.org.au Identifier : ACTRN012607000168459 OBJECTIVE To evaluate the effectiveness of proactive telephone breastfeeding support in low-income , primiparous , primarily Latina women on 1 ) duration and exclusivity of breastfeeding , 2 ) satisfaction with feeding , 3 ) rationale for discontinuing breastfeeding and 4 ) health care utilization . METHODS R and omized controlled trial comparing usual care to 2 weeks of daily telephone calls by nurses by using culturally informed scripted protocol s ; and qualitative study of focused interviews on a sample of women in the intervention group ( n = 40 ) . RESULTS Breastfeeding duration and exclusivity rates , feeding method satisfaction , and reasons for stopping breastfeeding did not differ significantly between intervention ( n = 161 ) and control ( n = 180 ) groups , with 74 % of both breastfeeding at 1 month and 28 % and 37 % , respectively , at 6 months . Insufficient milk supply was the main reason for stopping in both groups . Intervention infants were less likely to have a sick visit by 1 month ( 25 % ) than controls ( 35 % , P = .05 ) . Qualitative interviews revealed that the intervention was informative and helpful , with breastfeeding reported as healthier but harder ; formula was a good alternative . Intervention mothers reporting < or = 2 supplemental formula feedings on day 4 were more likely than mothers reporting > or =3 supplemental feedings to breastfeed at 1 month ( odds ratio 7.7 ; 95 % confidence interval 2.4 - 24.3 ) . CONCLUSIONS Two weeks of daily telephone support did not increase breastfeeding duration but was associated with a decrease in sick visits in the first month . Early supplementation and the perception of formula as a good alternative to dealing with the breastfeeding difficulties appeared to be factors in failure of the intervention Purpose To examine the impact of various breastfeeding outcomes of three cohorts receiving different methods of prenatal breastfeeding education . Methods Retrospective cohort design with patients attending a breastfeeding education class at an Army medical center . Controls were matched for sponsor rank , marital status , and smoking status . One hundred ninety-four mothers who expressed intent to breastfeed received breastfeeding education as follows : ( a ) a class that used video demonstration and group teaching by a lactation consultant , ( b ) a new mothers ' support group with one-on-one teaching prenatally and weekly meetings postpartum , taught by a lactation consultant and a pediatrician , and ( c ) a control group educated at prenatal visits only . Descriptive statistics , chi-square , ANOVA , unpaired t test , and logistic regression were used to analyze the data . Results Women who attended prenatal breastfeeding classes had significantly increased breastfeeding at 6 months when compared to controls ( p = .01 ) . There was no significant difference in rates between types of classes offered ( p = .45 ) . Clinical Implication sPrenatal breastfeeding education can influence the amount of time women breastfeed . All providers of prenatal care should consider offering such classes in order to improve breastfeeding rates BACKGROUND Teenage pregnancies are associated with negative socioeconomic effects . Our aim was to ascertain whether a postnatal home-visiting service for teenage mothers younger than age 18 years could reduce the frequency of adverse neonatal outcomes and improve knowledge of contraception , breastfeeding , and infant vaccination schedules in this parent group . METHODS We enrolled 139 adolescents , attending a teenage pregnancy clinic , in a r and omised controlled trial . After completing an antenatal question naire design ed to assess their knowledge of contraception , infant vaccination , and breastfeeding , we assigned participants to either receive five structured postnatal home visits by nurse-midwives ( n=65 ) or not ( n=71 ) . Assessment interviews were done 6 months postpartum . Our primary endpoint was unadjusted difference in knowledge between groups , and incidence of predefined adverse neonatal outcomes . Analysis was by intention to treat . FINDINGS Three women withdrew before r and omisation because of late fetal loss , 11 mothers withdrew because of adverse neonatal outcomes ( adverse neonatal outcome was a primary endpoint , but result ed in withdrawal from the study for knowledge outcomes ) , and one left voluntarily . Follow-up data were , therefore , available for 124 teenagers . Postnatal home visits were associated with a reduction in adverse neonatal outcomes ( intervention : 2 ; control : 9 ; relative risk 0.24 , 95 % CI 0.05 - 1.08 ) , and a significant increase in contraception knowledge ( mean difference 0.92 , 95 % CI 0.32 - 1.52 ) . However , there was no significant increase in knowledge with respect to breastfeeding or infant vaccination schedules associated with the home visits . INTERPRETATION Postnatal home-visiting services by nurse-midwives reduce adverse neonatal events and improve contraception outcomes , but do not affect breastfeeding or infant vaccination knowledge or compliance A r and omized controlled trial study design was used to investigate the effectiveness of a Healthy Families America model prenatal intervention for increasing breastfeeding rates among Latina immigrants residing in an impoverished New York City community . Exposure to the intervention did not affect mother report of any breastfeeding ( ABF ) during the first week postpartum , but it did affect mother report of exclusive breastfeeding ( EBF ) . Thirty-two percent ( 44/137 ) of mothers exposed to the intervention reported EBF during the first week postpartum compared to 20 % ( 20/101 ) of mothers not exposed to the intervention ( odds ratio 1.92 ; 95 % confidence interval 1.05 - 3.52 ) . This positive effect of the intervention on EBF remained statistically significant after controlling for the negative effect of household income on EBF ( adjusted odds ratio , 1.89 ; 95 % confidence interval , 1.02 - 3.50 ) . Additional research is needed on the effectiveness of breastfeeding promotion programs targeting low-income Latinas . J Hum Lact . 25(4):404 - 411 |
335 | 26,330,299 | Conclusions The literature review showed that simple phone and letter reminders for scheduling or prompting of the date and time of an appointment to more complex web-based multidisciplinary programs with patient self-management can have a positive impact on clinical and behavioral outcomes for diabetes patients .
Multifaceted interventions aim ed at appointment management and preparation during various phases of the medical outpatient care process improves diabetes disease management | Background Successful diabetes disease management involves routine medical care with individualized patient goals , self-management education and on-going support to reduce complications .
Without interventions that facilitate patient scheduling , improve attendance to provider appointments and provide patient information to provider and care team , preventive services can not begin .
This review examines interventions based upon three focus areas : 1 ) scheduling the patient with their provider ; 2 ) getting the patient to their appointment , and ; 3 ) having patient information integral to their diabetes care available to the provider .
This study identifies interventions that improve appointment management and preparation as well as patient clinical and behavioral outcomes . | OBJECTIVE To assess the effects of web-based care management on glucose and blood pressure control over 12 months in patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS For this study , 104 patients with diabetes and HbA(1c ) ( A1C ) > or = 9.0 % who received their care at a Department of Veterans Affairs medical center were recruited . All participants completed a diabetes education class and were r and omized to continue with their usual care ( n = 52 ) or receive web-based care management ( n = 52 ) . The web-based group received a notebook computer , glucose and blood pressure monitoring devices , and access to a care management website . The website provided educational modules , accepted uploads from monitoring devices , and had an internal messaging system for patients to communicate with the care manager . RESULTS Participants receiving web-based care management had lower A1C over 12 months ( P < 0.05 ) when compared with education and usual care . Persistent website users had greater improvement in A1C when compared with intermittent users ( -1.9 vs. -1.2 % ; P = 0.051 ) or education and usual care ( -1.4 % ; P < 0.05 ) . A larger number of website data uploads was associated with a larger decline in A1C ( highest tertile -2.1 % , lowest tertile -1.0 % ; P < 0.02 ) . Hypertensive participants in the web-based group had a greater reduction in systolic blood pressure ( P < 0.01 ) . HDL cholesterol rose and triglycerides fell in the web-based group ( P < 0.05 ) . CONCLUSIONS Web-based care management may be a useful adjunct in the care of patients with poorly controlled diabetes Abstract OBJECTIVE : There is a well-documented gap between diabetes care guidelines and the services received by patients in almost all health care setting s. This project reports initial results from a computer-assisted , patient-centered intervention to improve the level of recommended services received by patients from a wide variety of primary care providers . DESIGN AND SETTING S : Eight hundred eighty-six patients with type 2 diabetes under the care of 52 primary care physicians participated in the Diabetes Priority Program . Physicians were stratified and r and omized to intervention or control conditions and evaluated on 2 primary outcomes : number of recommended laboratory screenings and recommended patient-centered care activities completed . Secondary outcomes were evaluated using the Problem Areas in Diabetes scale and the Patient Health Question naire (PHQ)-9 depression scale , and the RE- AIM framework was used to evaluate potential for dissemination . RESULTS : The program was well-implemented and significantly improved both number of recommended laboratory assays ( 3.4 vs 3.1 ; P<.001 ) and patient-centered aspects of diabetes care patients received ( 3.6 vs 3.2 ; P<.001 ) compared to those in r and omized control practice s. Activities that were increased most were foot exams ( follow-up rates of 80 % vs 52 % ; P<.003 ) and nutrition counseling ( 76 % vs 52 % ; P<.001 ) . CONCLUSIONS : Patients are very willing to participate in a brief computer-assisted intervention that is effective in enhancing quality of diabetes care . Staff in primary care offices can consistently deliver an intervention of this nature , but most physicians were unwilling to participate in this translation research study BACKGROUND Telemonitoring interventions featuring transmission of home glucose records to healthcare providers have result ed in improved glycemic control in patients with diabetes . No research has addressed the intensity or duration of telemonitoring required to sustain such improvements . PURPOSE The DiaTel study ( 10 January 2005 to 1 November 2007 ) compared active care management ( ACM ) with home telemonitoring ( n=73 ) to monthly care coordination ( CC ) telephone calls ( n=77 ) among veterans with diabetes and suboptimal glycemic control . The purpose of the DiaTel Extension was to assess whether initial improvements could be sustained with interventions of the same or lower intensity among participants who re-enrolled in a 6-month extension of DiaTel . METHODS DiaTel participants receiving ACM were re-assigned r and omly to monthly CC calls with continued telemonitoring but no active medication management ( ACM-to-CCHT , n=23 ) or monthly CC telephone calls ( ACM-to-CC , n=21 ) . DiaTel participants receiving CC were re-assigned r and omly to continued CC ( CC-to-CC , n=28 ) or usual care ( UC , ie , CC-to-UC , n=29 ) . Hemaglobin A1c ( HbA1c ) was assessed at 3 and 6 months following re-r and omization . RESULTS Marked HbA1c improvements observed in DiaTel ACM participants were sustained 6 months after re-r and omization in both ACM-to-CCHT and ACM-to-CC groups . Lesser HbA1c improvements observed in DiaTel CC participants were sustained in both CC-to-CC and CC-to-UC groups . No benefit was apparent for continued transmission of glucose data among DiaTel ACM participants or continued monthly telephone calls among DiaTel CC participants 6 months after re-r and omization . CONCLUSION Significant improvements in HbA1c achieved using home telemonitoring and active medication management for 6 months were sustained 6 months later with interventions of decreased intensity in VA Health System-qualified veterans . CLINICAL TRIAL REG . NO : NCT00245882 , http://www . clinical trials.gov The purpose of this study was to investigate the effectiveness of a Web-based intervention on self-reported blood sugars for older adults with diabetes . Participants who were r and omized in the first phase to the intervention group ( n = 15 ) aged 60 and older with diabetes accessed a study Web site that provided them access to an on-line library , advice and counseling from a nurse via e-mail , a personal electronic log of self-management activities , and weekly on-line problem-solving group discussion s. Longitudinal mixed-effects modeling was used to investigate the effects of the Web-based intervention on blood sugar levels over a 6-month period . Participants who had fewer than six self-reported medical comorbidities ( n = 8) at baseline were more likely to experience a linear decline on blood sugar levels than participants reporting more than six comorbidities . A significant interaction appeared among the time of day blood sugar readings were reported , baseline A1c , and the number of comorbidities . Participants who had more than six comorbidities ( n = 7 ) experienced increased blood sugar levels over the study period , specifically with AM fasting and before bedtime reporting times . Participants with fewer than six comorbidities experienced a decline in blood sugar levels during the same testing times . Findings show that a Web-based intervention was not effective in improving blood sugar readings among adults with six or more comorbidities at baseline . Future research needs to further investigate the role comorbidities may play with the outcomes of Web-based interventions OBJECTIVE Web-based diabetes management can be used to provide frequent interactions between patients and providers and thus result in improved glycemic control . METHODS In a single-center , prospect i ve feasibility study , 16 poorly controlled patients with either type 1 or 2 diabetes mellitus were enrolled to assess the impact of using MyCareTeam , a web-based diabetes management application , for diabetes management . Patients were asked to transfer their blood glucose data electronically , maintain exercise logs , and communicate with their provider via MyCareTeam . The provider gave clinical interventions to optimize blood glucose control and provided feedback via MyCareTeam . Diabetes , nutrition , and exercise information was also available via MyCareTeam . RESULTS A significant reduction of over 2.22 % points in hemoglobin A1C was seen for the total patient population . Differences between moderate/heavy users ( n = 8) versus light/never users ( n = 8) of MyCareTeam were evaluated for intergroup differences based upon utilization . Moderate/heavy users had a significant 6-month A1C reduction of 3.15 percentage points compared with a reduction of 1.28 percentage points in light/never users . Other secondary end points were improved as well , including systolic blood pressure , diastolic blood pressure , total cholesterol , high-density lipoprotein , low-density lipoprotein , and triglycerides . However , as expected , body mass index levels increased because of aggressive diabetes management with insulin therapy . CONCLUSIONS These results demonstrate a significant treatment effect from the MyCareTeam application . A larger r and omized control trial is under way at the Boston Veterans Administration Healthcare System . If these results are confirmed as expected , then web-based diabetes management may prove to be the link to achieving target American Diabetes Association glycemic goals in patients with poorly controlled diabetes PURPOSE Dyslipidemia treatment dramatically decreases coronary heart disease risk in diabetes , yet only a minority of these patients are screened or achieve optimal low-density lipoprotein ( LDL ) cholesterol levels . Our aim was to increase the percentage of diabetic patients in whom lipid management was achieved through electronic and direct educational detailing . METHODS The study cohort comprised 884 diabetic patients at 12 primary care practice s. Practice sites were r and omized to one of three intervention groups : electronic educational detailing , direct ( face-to-face ) educational detailing , or control . Direct and electronic detailing were performed over a 12-month period . All sites were notified of our goal to enhance lipid testing among diabetic patients . Chart abstract ion was performed 15 months after the start of the intervention . For the entire population ( n=884 ) , the proportion of patients with lipid testing was calculated , and changes from pre- to postintervention were compared across groups . We compared pre- and postintervention LDL-cholesterol changes between groups using least square means to account for site variation . RESULTS Favorable provider actions increased significantly with the intervention ( + 22 % compared with + 6 % in controls , P=.01 ) . By logistic regression , electronic detailing increased the likelihood of lipid testing ( odds ratio 3.0 , confidence interval 1.6 - 5.7 ) , as did direct detailing ( odds ratio 1.8 , confidence interval 0.9 - 3.7 ) in patients with no preintervention LDL test ( n=432 ) . Lipid testing tended to increase to a greater extent at intervention sites ( + 23 % for the combination of electronic and direct detailing vs + 11 % for controls , P=.06 ) . CONCLUSIONS Brief educational detailing either through direct or electronic communication favorably impacts provider behavior regarding dyslipidemia care for diabetic patients OBJECTIVE We hypothesized that people with type 2 diabetes in an online diabetes self-management program , compared with usual-care control subjects , would 1 ) demonstrate reduced A1C at 6 and 18 months , 2 ) have fewer symptoms , 3 ) demonstrate increased exercise , and 4 ) have improved self-efficacy and patient activation . In addition , participants r and omized to listserve reinforcement would have better 18-month outcomes than participants receiving no reinforcement . RESEARCH DESIGN AND METHODS A total of 761 participants were r and omized to 1 ) the program , 2 ) the program with e-mail reinforcement , or 3 ) were usual-care control subjects ( no treatment ) . This sample included 110 American Indians/Alaska Natives ( AI/ANs ) . Analyses of covariance models were used at the 6- and 18-month follow-up to compare groups . RESULTS At 6 months , A1C , patient activation , and self-efficacy were improved for program participants compared with usual care control subjects ( P < 0.05 ) . There were no changes in other health or behavioral indicators . The AI/AN program participants demonstrated improvements in health distress and activity limitation compared with usual-care control subjects . The subgroup with initial A1C > 7 % demonstrated stronger improvement in A1C ( P = 0.01 ) . At 18 months , self-efficacy and patient activation were improved for program participants . A1C was not measured . Reinforcement showed no improvement . CONCLUSIONS An online diabetes self-management program is acceptable for people with type 2 diabetes . Although the results were mixed they suggest 1 ) that the program may have beneficial effects in reducing A1C , 2 ) AI/AN population s can be engaged in and benefit from online interventions , and 3 ) our follow-up reinforcement appeared to have no value An intervention package was examined to determine its effectiveness in increasing office visits and in reducing the incidence of nonelective hospitalizations ( those for urgent or emergent reasons ) . The intervention included mailings of information , appointment reminders , and intense follow-up by telephone of visit failures for rescheduling . Eight hundred fifty-four patients receiving drug therapy for diabetes mellitus were stratified by risk of nonelective hospitalization and r and omly assigned to the control group or the intervention group . After two years , the intervention group averaged 9.1 per cent more kept scheduled visits per month than the control group ( 0.371 vs. 0.340 , p=0.02 ) . However , the mean incidence of nonelective hospitalizations per month was not significantly different between intervention and control groups ( 0.040 vs. 0.041 , p=0.9 ) , nor was there a difference in nonelective hospital days per month ( 0.443 vs. 0.425 , p=0.7 ) . The authors conclude that while mailings and telephone calls can increase office visits , the intervention is not sufficient to reduce morbidity necessitating nonelective hospitalizations of diabetic patients OBJECTIVE —To test Web-based care management of glycemic control using a shared electronic medical record with patients who have type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a trial of 83 adults with type 2 diabetes r and omized to receive usual care plus Web-based care management or usual care alone between August 2002 and May 2004 . All patients had GHb ≥7.0 % , had Web access from home , and could use a computer with English language –based programs . Intervention patients received 12 months of Web-based care management . The Web-based program included patient access to electronic medical records , secure e-mail with providers , feedback on blood glucose readings , an educational Web site , and an interactive online diary for entering information about exercise , diet , and medication . The primary outcome was change in GHb . RESULTS —GHb levels declined by 0.7 % ( 95 % CI 0.2−1.3 ) on average among intervention patients compared with usual-care patients . Systolic blood pressure , diastolic blood pressure , total cholesterol levels , and use of in-person health care services did not differ between the two groups . CONCLUSIONS —Care management delivered through secure patient Web communications improved glycemic control in type 2 diabetes OBJECTIVE To assess the effect of an Internet-based glucose monitoring system ( IBGMS ) on A1C levels in patients with type 2 diabetes treated with insulin . RESEARCH DESIGN AND METHODS This trial involved 50 patients r and omly assigned to receive either conventional treatment alone or with additional follow-up through an IBGMS for 6 months . Patients r and omized to the intervention group uploaded blood glucose readings every 2 weeks to a secure Web site for review and receipt of feedback from their endocrinologist . A1C and laboratory test results were collected at 0 , 3 , and 6 months . RESULTS The baseline parameters were not significantly different . Over a 6-month follow-up , A1C dropped from 8.8 to 7.6 % ( P < 0.001 ) in the intervention group compared with 8.5 to 8.4 % ( P = 0.51 ) in the control group . CONCLUSIONS The use of IBGMS significantly improved A1C levels in patients with type 2 diabetes treated with insulin BACKGROUND Optimal care for patients with diabetes is difficult to achieve in clinical practice . OBJECTIVE To evaluate the impact of a registry and decision support system on processes of care , and physiologic control . PARTICIPANTS R and omized trial with clustering at the practice level , involving 7,412 adults with diabetes in 64 primary care practice s in the Northeast . INTERVENTIONS Provider decision support ( reminders for overdue diabetes tests , alerts regarding abnormal results , and quarterly population reports with peer comparisons ) and patient decision support ( reminders and alerts ) . MEASUREMENTS AND MAIN RESULTS Process and physiologic outcomes were evaluated in all subjects . Functional status was evaluated in a r and om patient sample via question naire . We used multiple logistic regression to quantify the effect , adjusting for clustering and potential confounders . Intervention subjects were significantly more likely to receive guideline -appropriate testing for cholesterol ( OR = 1.39 ; [ 95%CI 1.07 , 1.80 ] P = 0.012 ) , creatinine ( OR = 1.40 ; [ 95%CI 1.06 , 1.84 ] P = 0.018 ) , and proteinuria ( OR = 1.74 ; [ 95%CI 1.13 , 1.69 ] P = 0.012 ) , but not A1C ( OR = 1.17 ; [ 95 % CI 0.80 , 1.72 ] P = 0.43 ) . Rates of control of A1C and LDL cholesterol were similar in the two groups . There were no differences in blood pressure , body mass index , or functional status . CONCLUSIONS A chronic disease registry and decision support system based on easily obtainable laboratory data was feasible and acceptable to patients and providers . This system improved the process of laboratory monitoring in primary care , but not physiologic control We conducted a r and omized controlled trial for 12 weeks in patients with type 2 diabetes living in a rural part of Korea . The intervention group ( n = 35 ) was managed by a diabetes centre which provided specialized management mediated by a primary health-care nurse who used a PDA-type blood glucometer with a bar code detector to measure the capillary glucose levels . The control group ( n = 36 ) received usual care . Compared with baseline , HbA1c was significantly reduced at three-month follow-up in the intervention group ( 8.0 % vs. 7.5 % ; P < 0.01 ) , but not in the control group . Total cholesterol was significantly reduced in the intervention group ( 10.7 mmol/L vs. 10.4 mmol/L ; P = 0.043 ) . Fasting plasma glucose and triglyceride levels were lower at follow-up in both groups , but the difference was not significant . The new system could be implemented widely and would contribute to improving the quality of diabetes care , even in isolated rural areas Many patients with diabetes do not receive recommended st and ards of care . Diabetes patients were seen by a pharmacist in a diabetes assessment service ( DAS ) 1 week prior to a physician appointment to complete diabetes st and ards . Completion rates of American Diabetes Association ( ADA ) st and ards were compared between patients of 5 physicians offered the DAS intervention and a concurrent cohort of r and omly selected patients of nonparticipating physicians . A total of 94 patients were seen by DAS ; 210 patients comprised the controls . DAS patients had a significantly higher proportion of each st and ard completed ( glycosylated hemoglobin , lipids , foot exam , eye referral , pneumococcal and influenza vaccination , and urine microalbumin ) compared with the control group ( P < .001 ) . An average of 3.3 ± 1.8 diabetes st and ards per patient were completed . A planned visit with a pharmacist prior to a physician appointment , with the goal of completing ADA st and ards of care , was feasible and effective in this university-based family medicine center Background Most studies of diabetes self-management that show improved clinical outcome performance involve multiple , time-intensive educational sessions in a group format . Most provider performance feedback interventions do not improve intermediate outcomes , yet lack targeted , patient-level feedback . Methods 5,457 low-income adults with diabetes at eight federally-qualified community health centers participated in this nested r and omized trial . Half of the patients received report card mailings quarterly ; patients at 4 of 8 clinics received report cards at every clinic visit ; and providers at 4 of 8 clinics received quarterly performance feedback with targeted patient-level data . Expert-recommended glycemic , lipid , and blood pressure outcomes were assessed . Assessment of report card utility and patient and provider satisfaction was conducted through mailed patient surveys and mid- and post-intervention provider interviews . Results Many providers and the majority of patients perceived the patient report card as being an effective tool . However , patient report card mailings did not improve process outcomes , nor did point-of-care distribution improve intermediate outcomes . Clinics with patient-level provider performance feedback achieved a greater absolute increase in the percentage of patients at target for glycemic control compared to control clinics ( 6.4 % vs 3.8 % respectively , Generalized estimating equations St and ard Error 0.014 , p < 0.001 , CI -0.131 - -0.077 ) . Provider reaction to performance feedback was mixed , with some citing frustration with the lack of both time and ancillary re sources . Conclusions Patient performance report cards were generally well received by patients and providers , but were not associated with improved outcomes . Targeted , patient-level feedback to providers improved glycemic performance . Provider frustration highlights the need to supplement provider outreach efforts . Trial Registration Clinical Trials.gov : AIM To investigate the effectiveness of a nurse short message service ( SMS ) by cellular phone and wire Internet on plasma glucose levels in people with diabetes for six months . BACKGROUND Blood glucose management system using telemedicine approaches may maintain the appropriate blood glucose levels in type-2 diabetic patients . DESIGN A control group pre-test-post-test design was used to assess the effectiveness of nurse 's education . METHODS Twenty-five patients were r and omly assigned to an intervention group and 26 to a control group . The intervention was applied for six months . The goal of the intervention was to keep blood glucose concentrations close to the normal range . Participants were requested to input their blood glucose level , diet and exercise diary everyday in the website by cellular phone or wire Internet . The research er sends optimal recommendations to each patient using SMS by cellular phone and wire Internet weekly . RESULTS Glycosylated hemoglobin ( HbA(1)c ) decreased 1.15 % points at three months and 1.05 % points at six months compared with baseline in the intervention group . Patients in the intervention group had a decrease of two hours post meal glucose ( 2HPMG ) of 85.1 mg/dl at three months and 63.1 mg/dl at six months compared with baseline . CONCLUSION This web-based intervention using SMS of cellular phone improved HbA(1)c and 2HPMG for six months in type-2 diabetic patients . RELEVANCE TO CLINICAL PRACTICE An SMS of cellular phone intervention by a nurse can reduce HbA(1)c and 2HPMG for six months in type-2 diabetic patients OBJECTIVE To test effects of a web-based decision support tool , the diabetes Disease Management Application ( DMA ) , developed to improve evidence -based management of type 2 diabetes . RESEARCH DESIGN AND METHODS We conducted a group r and omized controlled trial of 12 intervention and 14 control staff providers and 307 intervention and 291 control patients with type 2 diabetes in a hospital-based internal medicine clinic . Providers were r and omly assigned from May 1998 through April 1999 to have access to the DMA ( intervention ) or not to have access ( control ) . The DMA displays interactive patient-specific clinical data , treatment advice , and links to other web-based care re sources . We compared patients in the intervention and control groups for changes in processes and outcomes of care from the year preceding the study through the year of the study by intention-to-treat analysis . RESULTS The DMA was used for 42 % of scheduled patient visits . The number of HbA(1c ) tests obtained per year increased significantly in the intervention group ( + 0.3 tests/year ) compared with the control group ( -0.04 tests/year , P = 0.008 ) , as did the number of LDL cholesterol tests ( intervention , + 0.2 tests/year ; control , + 0.01 tests/year ; P = 0.02 ) and the proportions of patients undergoing at least one foot examination per year ( intervention , + 9.8 % ; control , -0.7 % ; P = 0.003 ) . Levels of HbA(1c ) decreased by 0.2 in the intervention group and increased by 0.1 in the control group ( P = 0.09 ) ; proportions of patients with LDL cholesterol levels < 130 mg/dl increased by 20.3 % in the intervention group and 10.5 % in the control group ( P = 0.5 ) . CONCLUSIONS Web-based patient-specific decision support has the potential to improve evidence -based parameters of diabetes care BACKGROUND Nurse 's education using telemedicine results in a decrease in blood glucose levels in patients with type 2 diabetes . OBJECTIVE To investigate the effectiveness of an educational intervention that used both the cellular phone and the Internet to provide a short-messaging service ( SMS ) relating to plasma glucose levels . METHODS Twenty-five patients were r and omly assigned to an intervention group and 26 to a control group . The intervention was applied for 12 weeks . The goal of the intervention was to keep blood glucose concentrations close to the normal range . Patients in the intervention group were asked to access a website by using a cellular phone or to wiring the Internet and input their blood glucose levels every day . Participants were sent the optimal recommendations by both cellular phone and the Internet weekly . RESULTS Patients in the intervention group had a mean decrease in glycosylated haemoglobin ( HbA(1)c ) levels of 1.15 % and those in the control group had a mean increase of HbA(1)c levels of 0.07 % ( p=0.005 ) . There was a significant mean change in the 2hrs post-meal glucose ( 2HPMG ) level for the intervention group ( p<0.05 ) , with a mean change of -4.7mmol/l . The mean change in the control group was not significant . CONCLUSION This educational intervention using the Internet and an SMS by cellular phone improved levels of HbA(1)c and 2HPMG OBJECTIVE --To evaluate the effectiveness and acceptability of central ly organised prompting for coordinating community care of non-insulin dependent diabetic patients . DESIGN --R and omised single centre trial . Patients allocated to prompted care in the community or to continued attendance at hospital diabetic clinic ( controls ) . Median follow up two years . SETTING --Two hospital outpatient clinics , 38 general practice s , and 11 optometrists in the catchment area of a district general hospital in Islington . PATIENTS --181 patients attending hospital outpatient clinics . NULL HYPOTHESIS -- There is no difference in process of medical care measures and medical outcome between prompted community care and hospital clinic care . RESULTS --14 hospital patients failed to receive a single review in the clinic as compared with three patients in the prompted group ( chi 2 = 6.1 , df = 1 ; p = 0.013 ) . Follow up for retinal screening was better in prompted patients than in controls ; two prompted patients defaulted as against 12 controls ( chi 2 = 6.9 , df = 1 ; p = 0.008 ) . Three measures per patient yearly were more frequent in prompted patients : tests for albuminuria ( median 3.0 v 2.3 ; p = 0.03 ) , plasma glucose estimations ( 3.1 v 2.5 ; p = 0.003 ) , and glycated haemoglobin estimations ( 2.4 v 0.9 ; p < 0.001 ) . Continuity of care was better in the prompted group ( 3.2 v 2.2 review s by each doctor seen ; p < 0.001 ) . The study ended with no significant differences between the groups in last recorded r and om plasma glucose concentration , glycated haemoglobin value , numbers admitted to hospital for a diabetes related reason , and number of deaths . Question naires revealed a high level of patient , general practitioner , and optometrist satisfaction . CONCLUSIONS --Six monthly prompting of non-insulin treated diabetic patients for care by inner city general practitioners and by optometrists is effective and acceptable OBJECTIVE To evaluate an online disease management system supporting patients with uncontrolled type 2 diabetes . MATERIAL S AND METHODS Engaging and Motivating Patients Online With Enhanced Re sources for Diabetes was a 12-month parallel r and omized controlled trial of 415 patients with type 2 diabetes with baseline glycosylated hemoglobin ( A1C ) values ≥7.5 % from primary care sites sharing an electronic health record . The intervention included : ( 1 ) wirelessly uploaded home glucometer readings with graphical feedback ; ( 2 ) comprehensive patient-specific diabetes summary status report ; ( 3 ) nutrition and exercise logs ; ( 4 ) insulin record ; ( 5 ) online messaging with the patient 's health team ; ( 6 ) nurse care manager and dietitian providing advice and medication management ; and ( 7 ) personalized text and video educational ' nuggets ' dispensed electronically by the care team . A1C was the primary outcome variable . RESULTS Compared with usual care ( UC , n=189 ) , patients in the intervention ( INT , n=193 ) group had significantly reduced A1C at 6 months ( -1.32 % INT vs -0.66 % UC ; p<0.001 ) . At 12 months , the differences were not significant ( -1.14 % INT vs -0.95 % UC ; p=0.133 ) . In post hoc analysis , significantly more INT patients had improved diabetes control ( > 0.5 % reduction in A1C ) than UC patients at 12 months ( 69.9 ( 95 % CI 63.2 to 76.5 ) vs 55.4 ( 95 % CI 48.4 to 62.5 ) ; p=0.006 ) . CONCLUSIONS A nurse-led , multidisciplinary health team can manage a population of diabetic patients in an online disease management program . INT patients achieved greater decreases in A1C at 6 months than UC patients , but the differences were not sustained at 12 months . More INT than UC patients achieved improvement in A1C ( > 0.5 % decrease ) . Trial registered in clinical trials.gov : # NCT00542204 OBJECTIVE To evaluate the impact of primary care group visits ( chronic care clinics ) on the process and outcome of care for diabetic patients . RESEARCH DESIGN AND METHODS We evaluated the intervention in primary care practice s r and omized to intervention and control groups in a large-staff model health maintenance organization ( HMO ) . Patients included diabetic patients > or = 30 years of age in each participating primary care practice , selected at r and om from an automated diabetes registry . Primary care practice s were r and omized within clinics to either a chronic care clinic ( intervention ) group or a usual care ( control ) group . The intervention group conducted periodic one-half day chronic care clinics for groups of approximately 8 diabetic patients in their respective doctor 's practice . Chronic care clinics consisted of st and ardized assessment s ; visits with the primary care physician , nurse , and clinical pharmacist ; and a group education/peer support meeting . We collected self-report question naires from patients and data from administrative systems . The question naires were mailed , and telephoned interviews were conducted for nonrespondents , at baseline and at 12 and 24 months ; we queried the process of care received , the satisfaction with care , and the health status of each patient . Serum cholesterol and HbA1c levels and health care use and cost data was collected from HMO administrative systems . RESULTS In an intention-to-treat analysis at 24 months , the intervention group had received significantly more recommended preventive procedures and helpful patient education . Of five primary health status indicators examined , two ( SF-36 general health and bed disability days ) were significantly better in the intervention group . Compared with control patients , intervention patients had slightly more primary care visits , but significantly fewer specialty and emergency room visits . Among intervention participants , we found consistently positive associations between the number of chronic care clinics attended and a number of outcomes , including patient satisfaction and HbA1c levels . CONCLUSIONS Periodic primary care sessions organized to meet the complex needs of diabetic patients imrproved the process of diabetes care and were associated with better outcomes OBJECTIVE The Internet is used worldwide as a communication tool . To improve the quality of diabetes control , we investigated the effectiveness of an Internet-based blood glucose monitoring system ( IBGMS ) on controlling the changes in HbA(1c ) levels . RESEARCH DESIGN AND METHODS We conducted a r and omized clinical trial involving 110 patients who visited the outpatient clinic at the Kangnam St. Mary 's Hospital for 3 months . The study subjects were treated with IBGMS for 12 weeks , and the control group received the usual outpatient management over the same period . HbA(1c ) and other laboratory tests were performed twice , once at the beginning of the study and again at the end of the study . RESULTS The test results from the beginning of the study established that there were no significant differences between the two groups with respect to age , sex , diabetes duration , BMI , blood pressure , HbA(1c ) , and other laboratory data . On follow-up examination 12 weeks later , HbA(1c ) levels were significantly decreased from 7.59 to 6.94 % within the intervention group ( P < 0.001 ) . At the end of the study , HbA(1c ) levels in the intervention group were significantly lower than in the control group after adjusting the baseline HbA(1c ) ( 6.94 vs. 7.62 % ; P < 0.001 , respectively ) . Among patients with baseline HbA(1c ) < 7.0 % , the patients in the intervention group had lower HbA(1c ) than those in the control group ( 6.38 vs. 6.99 % ; P < 0.05 ) . Among the patients with a baseline HbA(1c ) > or = 7.0 % , the difference between the two groups appeared more obvious : HbA(1c ) levels at the end of the study were 8.12 % . CONCLUSIONS This new IBGMS result ed in a significant reduction of HbA(1c ) during the study period . We propose that this IBGMS be used as a method for improving diabetes control This article describes the design and implementation of an online diabetes self-management intervention for a sample of inner-city African Americans with diabetes . Study participants were r and omly assigned to the treatment ( 26 ) and control ( 21 ) conditions . The results indicate that treatment group participants were more likely to achieve positive outcomes in terms of lowered hemoglobin A1c and body mass index measurements than were control group members . These findings support the development of telehealth interventions to promote effective chronic disease management in medically underserved communities OBJECTIVE Investigate the effectiveness of an educational intervention that used both the cellular phone with a short messaging service ( SMS ) and the Internet on the glycemic control of the patients with type 2 diabetes mellitus . METHODS Twenty-five patients were r and omly assigned to an intervention group and twenty-six to a control group . The intervention was applied for 12 months . The goal of the intervention was to keep blood glucose concentrations close to the normal range ( HbA(1)c<7 % ) . Patients in the intervention group were asked to access a website by using a cellular phone or to wiring the Internet and input their blood glucose levels weekly . Participants were sent the optimal recommendations by both cellular phone and the Internet weekly . RESULTS Participants in the intervention group had lower HbA(1)c over 12 months when compared with the control group . At 12 months the change from baseline in HbA(1)c was -1.32 in the intervention group versus + 0.81 in the control group . Two hours post-meal glucose ( 2HPMG ) had a significantly greater decline in the intervention group after 12 months when compared with the control group ( -100.0 versus + 18.1mg/dl ) . CONCLUSION This educational intervention using the Internet and a SMS by cellular phone rapidly improved and stably maintained the glycemic control of the patients with type 2 diabetes mellitus OBJECTIVE To evaluate the effectiveness of a cluster visit model led by a diabetes nurse educator for delivering outpatient care management to adult patients with poorly controlled diabetes . RESEARCH DESIGN AND METHODS This study involved a r and omized controlled trial among patients of Kaiser Permanente 's Pleasanton , CA , center who were aged 16 - 75 years and had either poor glycemic control ( HbA1c > 8.5 % ) or no HbA1c test performed during the previous year . Intervention subjects received multidisciplinary outpatient diabetes care management delivered by a diabetes nurse educator , a psychologist , a nutritionist , and a pharmacist in cluster visit setting s of 10 - 18 patients /month for 6 months . Outcomes included change ( from baseline ) in HbA1c levels ; self-reported changes in self-care practice s , self-efficacy , and satisfaction ; and utilization of inpatient and outpatient health care . RESULTS After the intervention , HbA1c levels declined by 1.3 % in the intervention subjects versus 0.2 % in the control subjects ( P < 0.0001 ) . Several self-care practice s and several measures of self-efficacy improved significantly in the intervention group . Satisfaction with the program was high . Both hospital ( P = 0.04 ) and outpatient ( P < 0.01 ) utilization were significantly lower for intervention subjects after the program . CONCLUSIONS A 6-month cluster visit group model of care for adults with diabetes improved glycemic control , self-efficacy , and patient satisfaction and result ed in a reduction in health care utilization after the program BACKGROUND A prerequisite to translating research findings into practice is information on consistency of implementation , maintenance of results , and generalization of effects . This follow-up report is one of the few experimental studies to provide such information on Internet-based health education . METHODS We present follow-up data 10 months following r and omization on the " Diabetes Network ( D-Net ) " Internet-based self-management project , a r and omized trial evaluating the incremental effects of adding ( 1 ) tailored self-management training or ( 2 ) peer support components to a basic Internet-based , information-focused comparison intervention . Participants were 320 adult type 2 diabetes patients from participating primary care offices , mean age 59 ( SD = 9.2 ) , who were relatively novice Internet users . RESULTS All intervention components were consistently implemented by staff , but participant website usage decreased over time . All conditions were significantly improved from baseline on behavioral , psychosocial , and some biological outcomes ; and there were few differences between conditions . Results were robust across on-line coaches , patient characteristics , and participating clinics . CONCLUSIONS The basic D-Net intervention was implemented well and improvements were observed across a variety of patients , interventionists , and clinics . There were , however , difficulties in maintaining usage over time and additions of tailored self-management and peer support components generally did not significantly improve results OBJECTIVE —To investigate the long-term effectiveness of the Internet-based glucose monitoring system ( IBGMS ) on glucose control in patients with type 2 diabetes . RESEARCH DESIGN AND METHODS —We conducted a prospect i ve , r and omized , controlled trial in 80 patients with type 2 diabetes for 30 months . The intervention group was treated with the IBGMS , while the control group made conventional office visits only . HbA1c ( A1C ) was performed at 3-month intervals . For measuring of the stability of glucose control , the SD value of A1C levels for each subject was used as the A1C fluctuation index ( HFI ) . RESULTS —The mean A1C and HFI were significantly lower in the intervention group ( n = 40 ) than in the control group ( n = 40 ) . ( A1C [ mean ± SD ] 6.9 ± 0.9 vs. 7.5 ± 1.0 % , P = 0.009 ; HFI 0.47 ± 0.23 vs. 0.78 ± 0.51 , P = 0.001 ; intervention versus control groups , respectively ) . Patients in the intervention group with a basal A1C ≥7 % ( n = 27 ) had markedly lower A1C levels than corresponding patients in the control group during the first 3 months and maintained more stable levels throughout the study ( P = 0.022 ) . Control patients with a basal A1C < 7 % ( n = 15 ) showed the characteristic bimodal distribution of A1C levels , whereas the A1C levels in the intervention group remained stable throughout the study with low HFI . CONCLUSIONS —Long-term use of the IBGMS has proven to be superior to conventional diabetes care systems based on office visits for controlling blood glucose and achieving glucose stability This study aim ed to test the effects of providing Web-based diabetes education to individuals with type 2 diabetes on the A1c level and health check attendance . The study participants comprised 122 individuals with type 2 diabetes , who had access to the Internet , had completed their basic diabetes education , and had similar basic situational factors . Using a r and omization method , these participants were chosen from the patients being monitored by the diabetes nurses . The experimental group ( n = 61 ) was monitored via the Web . From measurements recorded in the sixth month of monitoring , we found that A1c levels of the individuals with diabetes who were monitored through the Web decreased ( t = 6.63 ; P < .05 ) , and the rate of attending health check visits increased ( z = 5.97 ; P < .05 ) , while no difference was detected in the control group ( t = −0.63 ; P = .534 ; z = −0.80 ; P = .426 ) . To maintain glycemic control , Web use could be adopted as a complementary tool for monitoring individuals with diabetes AIM To investigate whether a comprehensive strategy involving both patients and professionals , with the introduction of a diabetes passport as a key component , improves diabetes care . METHODS The first 150 consecutive patients who visited their internist for a diabetes check up at the internal medicine outpatient departments at each of nine Dutch general hospitals were included in this 1 year clustered , r and omised , controlled trial . Health care professionals attended an educational meeting about the use and dissemination of the diabetes passport which is a patient held record . They also received aggregated feedback on baseline data and personal feedback . Educational meetings were also organised for patients . Patient files were used in conjunction with question naires to determine adherence rates . Data were analysed using multilevel regression analysis . RESULTS Small but significant changes were found in mean HbA1c levels . In the intervention group , positive health changes for patients were found ( -0.3 % ) when compared to those in the control group ( + 0.2 % ) . Diastolic blood pressure improved slightly , but no changes were found in systolic blood pressure or cholesterol . Improvements were found with regard to levels of examination of patients ' feet and in patient education . CONCLUSIONS Efforts to improve professional practice involving both professionals and patients led to small improvements in HbA1c and diastolic blood pressure levels . Further study is needed to establish whether a better structured health care delivery , operating in a more supportive environment can enhance these effects OBJECTIVE We evaluated the impact of automated telephone disease management ( ATDM ) calls with telephone nurse follow-up as a strategy for improving outcomes such as mental health , self-efficacy , satisfaction with care , and health-related quality of life ( HRQL ) among low-income patients with diabetes mellitus . RESEARCH DESIGN This was a r and omized , controlled trial . SUBJECTS Two hundred forty-eight primarily English- and Spanish-speaking adults with diabetes enrolled at the time of visits to a county health care system . INTERVENTION In addition to usual care , intervention patients received biweekly ATDM calls with telephone follow-up by a diabetes nurse educator . Patients used the ATDM calls to report information about their health and self-care and to access self-care education . The nurse used patients ' ATDM reports to allocate her time according to their needs . MEASURES Patient-centered outcomes were measured at 12 months via telephone interview . RESULTS Compared with patients receiving usual care , intervention patients at follow-up reported fewer symptoms of depression ( P = 0.023 ) , greater self-efficacy to conduct self-care activities ( P = 0.006 ) , and fewer days in bed because of illness ( P = 0.026 ) . Among English-speaking patients , those receiving the intervention reported greater satisfaction with their health care overall and with the technical quality of the services they received , their choice of providers and continuity of care , their communication with providers , and the quality of their health outcomes ( all P < 0.042 ) . Intervention and control patients had roughly equivalent scores for established measures of anxiety , diabetes-specific HRQL , and general HRQL . CONCLUSIONS This intervention had several positive effects on patient-centered outcomes of care but no measurable effects on anxiety or HRQL OBJECTIVE To evaluate the effectiveness of using personalized follow-up , as compared to reminder letters , in increasing return rates at urban eye disease screening clinics for African Americans with diabetes , and to identify factors predictive of the patient 's likelihood of returning for annual follow-up exams . RESEARCH DESIGN AND METHODS All patients attending free community-based retinopathy screening clinics who were advised to return in one year for another diabetes eye evaluation ( DEE ) were r and omized to st and ard or personalized follow-up interventions . Patients in the st and ard follow-up group received reminder letters a month before it was time to return for their next annual DEE . Patients in the intensive personalized intervention also received the letters , but those patients who did not call for an appointment within 10 days received a phone call from project staff , encouraging them to return for a DEE . RESULTS One hundred thirty-two African Americans with diabetes were r and omized to one of the 2 treatments . The return rate for the intensive , personalized follow-up group was 66 % , significantly ( P=.001 ) higher than the 35 % return rate for the st and ard follow-up group . CONCLUSION This study demonstrated the efficacy of personal contact by telephone in improving return rates for annual DEEs in this population of patients . This finding is consistent with one of the key design principles of the project , which was to establish credible personal relationships with community leaders and patients as a means to maximize the utilization of the eye screening clinics Background : Diabetes mellitus is a complex disease with serious complications . Electronic decision support , providing information that is shared and discussed by both patient and physician , encourages timely interventions and may improve the management of this chronic disease . However , it has rarely been tested in community-based primary care . Methods : In this pragmatic r and omized trial , we r and omly assigned adult primary care patients with type 2 diabetes to receive the intervention or usual care . The intervention involved shared access by the primary care provider and the patient to a Web-based , colour-coded diabetes tracker , which provided sequential monitoring values for 13 diabetes risk factors , their respective targets and brief , prioritized messages of advice . The primary outcome measure was a process composite score . Secondary outcomes included clinical composite scores , quality of life , continuity of care and usability . The outcome assessors were blinded to each patient ’s intervention status . Results : We recruited sequentially 46 primary care providers and then 511 of their patients ( mean age 60.7 [ st and ard deviation 12.5 ] years ) . Mean follow-up was 5.9 months . The process composite score was significantly better for patients in the intervention group than for control patients ( difference 1.27 , 95 % confidence interval [ CI ] 0.79–1.75 , p < 0.001 ) ; 61.7 % ( 156/253 ) of patients in the intervention group , compared with 42.6 % ( 110/258 ) of control patients , showed improvement ( difference 19.1 % , p < 0.001 ) . The clinical composite score also had significantly more variables with improvement for the intervention group ( 0.59 , 95 % CI 0.09–1.10 , p = 0.02 ) , including significantly greater declines in blood pressure ( −3.95 mm Hg systolic and −2.38 mm Hg diastolic ) and glycated hemoglobin ( −0.2 % ) . Patients in the intervention group reported greater satisfaction with their diabetes care . Interpretation : A shared electronic decision-support system to support the primary care of diabetes improved the process of care and some clinical markers of the quality of diabetes care . ( Clinical Trials.gov trial register no. NCT00813085 . OBJECTIVE To assess the outcome of diabetes care in a practice -based research network after the introduction of an audit-enhanced monitoring system ( AEMS ) . STUDY DESIGN An AEMS was introduced into family practice s participating in the academic research network of Nijmegen University , Nijmegen , the Netherl and s. One and 7 years later , a cross-sectional analysis was performed on the outcome of care in all type 2 diabetes patients under treatment by their family physicians . POPULATION Approximately 42,000 patients in 1993 and approximately 46,000 patients in 1999 at 10 family practice s participating in the university 's academic research network . OUTCOMES MEASURED Targets of care were HbA1c < 8.5 % and blood pressure < 150/85 mm Hg . Targets for lipids depended on age , cardiovascular morbidity , and smoking status . RESULTS In 1993 , 540 type 2 diabetes patients were included ; in 1999 , 851 such patients were included , representing a prevalence of 1.3 % and 2.0 % , respectively . Glycemic control improved statistically significantly by the percentage of patients with HbA1c < 8.5 % ( 87 % vs 59 % , P = .0001 ) and the mean HbA1c ( 7.1 % vs 8.2 % , P = .0001 ) from the first to the second cohort . Mean blood pressure and the percentage of patients above the target blood pressure did not change . The mean cholesterol ( 207 mg/dL vs 238 mg/dL [ 5.4 mmol/L vs 6.2 mmol/L ] , P = .0001 ) and the percentage of patients who met their target lipid levels ( 72 % vs 52 % , P = .001 ) also improved between 1993 and 1999 . In addition , an increased percentage of patients attended an annual review in the past year ( 73 % vs 84 % ) . CONCLUSIONS Outcomes of diabetes care in a family practice research setting using an AEMS were comparable with those reported under r and omized controlled trial conditions A total of 175 patients with Types 1 and 2 diabetes in primary care and university hospital outpatient departments were r and omized into a study group ( n = 101 ) or usual care ( n = 74 ) . The study group used an e-health application with a diabetes management system and a home care link . Usual care did not involve e-health , i.e. the patients made regular general practitioner visits about every three months . After 12 months HbA1c decreased significantly in both groups of patients . The differences were small , but HbA1c was significantly lower in the study group than the controls . Diastolic blood pressure , fasting plasma glucose , serum total cholesterol , serum LDL-cholesterol and serum triglycerides were significantly lower in the study than in the control group . This was achieved with fewer visits by study patients to doctors and nurses . Use of e-health in diabetes care for 12 months was able to provide equivalent diabetic control to usual care , and improved cardiovascular risk factors BACKGROUND The emergence of the World Wide Web in the last decade has made it feasible for the Internet to be a vehicle for chronic disease management . METHODS A r and omized controlled trial ( n = 62 ) testing the effects of a 6-month web-based intervention plus usual care , compared with usual care alone , among adults 60 years of age and older with diabetes . The outcomes were hemoglobin A1c ( HbA1c ) , blood pressure , weight , cholesterol , and high-density lipoprotein ( HDL ) levels . RESULTS A multivariate analysis of covariance controlling for all baseline outcome variables , age , gender , and number of years with diabetes showed significant ( P = 0.001 ) reductions in HbA1c , weight , and cholesterol level and significant improvement in HDL levels in the intervention versus the control group . CONCLUSIONS Findings show a web-based intervention was effective in improving HbA1c , weight , cholesterol , and HDL levels at a 6-month follow-up . Future research is needed to investigate the long-term effectiveness of web-based interventions BACKGROUND Disease registries , audit and feedback , and clinical reminders have been reported to improve care processes . OBJECTIVE To assess the effects of a registry-generated audit , feedback , and patient reminder intervention on diabetes care . DESIGN R and omized controlled trial conducted in a resident continuity clinic during the 2003–2004 academic year . PARTICIPANTS Seventy-eight categorical Internal Medicine residents caring for 483 diabetic patients participated . Residents r and omized to the intervention ( n = 39 ) received instruction on diabetes registry use ; quarterly performance audit , feedback , and written reports identifying patients needing care ; and had letters sent quarterly to patients needing hemoglobin A1c or cholesterol testing . Residents r and omized to the control group ( n = 39 ) received usual clinic education . MEASUREMENTS Hemoglobin A1c and lipid monitoring , and the achievement of intermediate clinical outcomes ( hemoglobin A1c < 7.0 % , LDL cholesterol < 100 mg/dL , and blood pressure < 130/85 mmHg ) were assessed . RESULTS Patients cared for by residents in the intervention group had higher adherence to guideline recommendations for hemoglobin A1c testing ( 61.5 % vs 48.1 % , p = .01 ) and LDL testing ( 75.8 % vs 64.1 % , p = .02 ) . Intermediate clinical outcomes were not different between groups . CONCLUSIONS Use of a registry-generated audit , feedback , and patient reminder intervention in a resident continuity clinic modestly improved diabetes care processes , but did not influence intermediate clinical outcomes PURPOSE The present study evaluated whether an intervention using the SMS by personal cellular phone and internet would improve the levels of plasma glucose of obese type 2 diabetes at 3 , 6 , 9 , and 12 months . METHODS This is a quasi-experimental design with pre- and follow-up tests . Participants were recruited from the endocrinology outpatient department of tertiary care hospital located in an urban city of South Korea . Eighteen patients were r and omly assigned to an intervention group and 16 to a control group . The goal of the intervention was to decrease body weight and keep blood glucose concentrations close to the normal range . Patients were requested to record their blood glucose level in a weekly diary on the website by personal cellular phones or computer internet . The research er sent optimal recommendations to each patient , by both the cellular phone and the Internet weekly . The intervention was applied for 1 year . RESULTS Glycosylated hemoglobin ( HbA(1)c ) decreased 1.22 percentage points at 3 months , 1.09 percentage points at 6 months , 1.47 percentage points at 9 months , and 1.49 percentage points at 12 months compared with baseline in the intervention group ( all time points , p<0.05 ) . The percentage change in the control group was , however , not significant . Patients in the intervention group had a decrease of 2-h post-pr and ial test ( 2HPPT ) of 120.1mg/dl at 3 months , 58.9 mg/dl at 6 months , 62.0mg/dl at 9 months , and 102.9 mg/dl at 12 months compared with baseline ( all time points , p<0.05 ) . The mean change in the control group was , however , not significant . CONCLUSION This web-based intervention using SMS of personal cellular phone and Internet improved HbA(1)c and 2HPPT at 3 , 6 , 9 , and 12 months in patients with obese type 2 diabetes OBJECTIVE To determine whether a system of telemedicine support can improve glycemic control in type 1 diabetes . RESEARCH DESIGN AND METHODS A 9-month r and omized trial compared glucose self-monitoring real-time result transmission and feedback of results for the previous 24 h in the control group with real-time graphical phone-based feedback for the previous 2 weeks together with nurse-initiated support using a web-based graphical analysis of glucose self-monitoring results in the intervention group . All patients aged 18 - 30 years with HbA(1c ) ( A1C ) levels of 8 - 11 % were eligible for inclusion . RESULTS A total of 93 patients ( 55 men ) with mean diabetes duration ( means + /- SD ) 12.1 + /- 6.7 years were recruited from a young adult clinic . In total , the intervention and control groups transmitted 29,765 and 21,400 results , respectively . The corresponding median blood glucose levels were 8.9 mmol/l ( interquartile range 5.4 - 13.5 ) and 10.3 mmol/l ( 6.5 - 14.4 ) ( P < 0.0001 ) . There was a reduction in A1C in the intervention group after 9 months from 9.2 + /- 1.1 to 8.6 + /- 1.4 % ( difference 0.6 % [ 95 % CI 0.3 - 1.0 ] ) and a reduction in A1C in the control group from 9.3 + /- 1.5 to 8.9 + /- 1.4 % ( difference 0.4 % [ 0.03 - 0.7 ] ) . This difference in change in A1C between groups was not statistically significant ( 0.2 % [ -0.2 to 0.7 , P = 0.3 ) . CONCLUSIONS Real-time telemedicine transmission and feedback of information about blood glucose results with nurse support is feasible and acceptable to patients , but to significantly improve glycemic control , access to real-time decision support for medication dosing and changes in diet and exercise may be required A mobile phone with a glucometer integrated into the battery pack ( the ‘ Diabetes Phone ’ ) was launched in Korea in 2003 . We compared its effect on management of type 2 diabetes to the Internet-based glucose monitoring system ( IBGMS ) , which had been studied previously . We conducted a r and omized trial involving 69 patients for three months . Participants were assigned to an Internet group or a phone group . The phone group communicated with medical staff through the mobile phone only . Their glucose-monitoring data were automatically transferred to individual , web-based charts and they received medical recommendations by short message service . The Internet group used the IBGMS . There were no significant differences between the groups at baseline . After three months ' intervention , HbA1c levels of both groups had decreased significantly , from 7.6 % to 6.9 % for the Internet group and from 8.3 % to 7.1 % for the phone group ( P < 0.01 ) . Levels of patient satisfaction and adherence to medical advice were similar . Mobile , bidirectional communication between doctors and patients using the diabetes phone was as effective for glucose control as the previously-studied Internet-based monitoring system and it was good for patient satisfaction and adherence AIMS The rapidly increasing prevalence of chronic diseases is an important challenge to healthcare systems worldwide . To improve the quality and efficiency of chronic disease care , we investigated the effectiveness and applicability of the Ubiquitous Chronic Disease Care ( UCDC ) system using cellular phones and the internet for overweight patients with both Type 2 diabetes and hypertension . METHODS We conducted a r and omized , controlled clinical trial over 3 months that included 123 patients at a university hospital and a community public health centre . RESULTS After 12 weeks , there were significant improvements in HbA(1c ) in the intervention group ( 7.6 + /- 0.9 % to 7.1 + /- 0.8 % , P < 0.001 ) compared with the control group ( 7.4 + /- 0.9 % to 7.6 + /- 1.0 % , P = 0.03 ) . Furthermore , we observed a significant reduction in systolic and diastolic blood pressure , as well as improvements in total cholesterol , low-density lipoprotein-cholesterol and triglyceride levels in the intervention group . Furthermore , there was a significant increase in adiponectin levels in the intervention group compared with the control group , although high-sensitivity C-reactive protein and interleukin-6 levels did not change in either group . CONCLUSIONS The novel UCDC system presented in this paper improved multiple metabolic parameters simultaneously in overweight patients with both Type 2 diabetes and hypertension BACKGROUND : Although mailed reminders have been used for prevention among general population s , few studies have evaluated their effectiveness among chronically ill population s. OBJECTIVE : We evaluated the effectiveness of mailed reminders for improving diabetes management . The reminder included a letter from the individual ’s primary care physician ( PCP ) , a self-care h and book , a preventive care checklist , and specific recommendations regarding receipt of routine monitoring and screening . METHODS : Of 195 PCPs practicing with a large group practice , 111 agreed to have their adult patients with diabetes r and omized to receive the reminder ( n=1,641 ) or usual care ( n=1,668 ) . Using data from automated data bases , we fit generalized estimating equations to evaluate the effect of reminder receipt on fasting lipid profile and glycated hemoglobin testing , dilated retinal exam receipt , and visit frequency during the 6 and 12 months following r and omization , and glycated hemoglobin and cholesterol levels in the year following r and omization . RESULTS : Reminder and usual care recipients did not differ in sociodemographic , clinical , or prior testing characteristics . In the 6 months following r and omization , reminder recipients were more likely to receive a retinal exam ( odds ratio [ OR ] , 1.29 ; 95 % confidence interval [ 95 % CI ] , 1.12 to 1.49 ) and diabetes visit ( OR , 1.28 ; 95 % CI , 1.12 to 1.47 ) . In the 12 months following r and omization , reminder recipients were more likely to receive a glycated hemoglobin test ( OR , 1.21 ; 95 % CI , 1.03 to 1.43 ) , retinal exam ( OR , 1.23 ; 95 % CI , 1.07 to 1.41 ) , and diabetes visit ( OR , 1.25 ; 95 % CI , 1.09 to 1.29 ) . In the follow-up year , reminder recipients also tended to have a glycated hemoglobin test that did not reflect poor control ( < 9.5 % ) . CONCLUSIONS : We found small but significant improvements in the management of patients with diabetes receiving a computerized mailed reminder BACKGROUND Group medical clinics ( GMCs ) are widely used in the management of diabetes and hypertension , but data on their effectiveness are limited . OBJECTIVE To test the effectiveness of GMCs in the management of comorbid diabetes and hypertension . DESIGN R and omized , controlled trial . ( Clinical Trials.gov registration number : NCT00286741 ) SETTING 2 Veterans Affairs Medical Centers in North Carolina and Virginia . PATIENTS 239 patients with poorly controlled diabetes ( hemoglobin A(1c ) [ HbA(1c ) ] level > or = 7.5 % ) and hypertension ( systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg ) . INTERVENTION Patients were r and omly assigned within each center to either attend a GMC or receive usual care . Clinics comprised 7 to 8 patients and a care team that consisted of a primary care general internist , a pharmacist , and a nurse or other certified diabetes educator . Each session included structured group interactions moderated by the educator . The pharmacist and physician adjusted medication to manage each patient 's HbA(1c ) level and blood pressure . MEASUREMENTS Hemoglobin A(1c ) level and systolic blood pressure , measured by blinded research personnel at baseline , study midpoint ( median , 6.8 months ) , and study completion ( median follow-up , 12.8 months ) . Linear mixed models , adjusted for clustering within GMCs , were used to compare HbA(1c ) levels and systolic blood pressure between the intervention and control groups . RESULTS Mean baseline systolic blood pressure and HbA(1c ) level were 152.9 mm Hg ( SD , 14.2 ) and 9.2 % ( SD , 1.4 ) , respectively . At the end of the study , mean systolic blood pressure improved by 13.7 mm Hg in the GMC group and 6.4 mm Hg in the usual care group ( P = 0.011 by linear mixed model ) , whereas mean HbA(1c ) level improved by 0.8 % in the GMC group and 0.5 % in the usual care group ( P = 0.159 ) . LIMITATION Measurements of effectiveness may have been limited by concomitant improvements in the usual care group that were due to co-intervention . CONCLUSION Group medical clinics are a potent strategy for improving blood pressure but not HbA(1c ) level in diabetic patients . PRIMARY FUNDING SOURCE U.S. Department of Veterans Affairs Health Services Research and Development Service ABSTRACT BACKGROUND The impact of open access ( OA ) scheduling on chronic disease care and outcomes has not been studied . OBJECTIVE To assess the effect of OA implementation at 1 year on : ( 1 ) diabetes care processes ( testing for A1c , LDL , and urine microalbumin ) , ( 2 ) intermediate outcomes of diabetes care ( SBP , A1c , and LDL level ) , and ( 3 ) health-care utilization ( ED visits , hospitalization , and outpatient visits ) . METHODS We used a retrospective cohort study design to compare process and outcomes for 4,060 continuously enrolled adult patients with diabetes from six OA clinics and six control clinics . Using a generalized linear model framework , data were modeled with linear regression for continuous , logistic regression for dichotomous , and Poisson regression for utilization outcomes . RESULTS Patients in the OA clinics were older , with a higher percentage being African American ( 51 % vs 34 % ) and on insulin . In multivariate analyses , for A1c testing , the odds ratio for African-American patients in OA clinics was 0.47 ( CI : 0.29 - 0.77 ) , compared to non-African Americans [ OR 0.27 ( CI : 0.21 - 0.36 ) ] . For urine microablumin , the odds ratio for non-African Americans in OA clinics was 0.37 ( CI : 0.17 - 0.81 ) . At 1 year , in adjusted analyses , patients in OA clinics had significantly higher SBP ( mean 6.4 mmHg , 95 % CI 5.4 – 7.5 ) . There were no differences by clinic type in any of the three health-care utilization outcomes . CONCLUSION OA scheduling was associated with worse processes of care and SBP at 1 year . OA clinic scheduling should be examined more critically in larger systems of care , multiple health-care setting s , and /or in a r and omized controlled trial Brief , cost-effective interventions to promote diabetes self-management are needed . This study evaluated the effects of a brief , regular , proactive , telephone “ coaching ” intervention delivered by paraprofessionals on diabetes adherence , glycemic control , diabetes-related medical symptoms , and depressive symptoms . Therapeutic mechanisms underlying the intervention ’s effect on the primary outcomes were also examined . Adults diagnosed with type 2 diabetes ( N = 62 ) were r and omly assigned to receive the “ coaching ” intervention and treatment as usual , or only treatment as usual . The intervention increased frequency of exercise and feet inspection , improved diet , reduced diabetes medical symptoms , and lowered depressive symptoms . Self-efficacy , reinforcement , and awareness of self-care goals mediated the treatment effect on depression , exercise , and feet inspection , respectively . A brief telephone intervention delivered by paraprofessionals had positive effects on type 2 diabetes patients AIM Conventional follow-up of type 1 diabetic patients treated with continuous subcutaneous insulin infusion ( CSII ) was compared with intensive coaching using the Web and the cellular phone network for retrospective data transmission and short message service ( SMS ) . METHODS Thirty poorly controlled patients ( HbA1c 7.5 - 10 % ) were enrolled in a bicenter , open-label , r and omized , 12-month , two-period , crossover study . After a 1-month run-in period , 15 patients were r and omly assigned to receive weekly medical support through SMS based upon weekly review of glucose values , while 15 patients continued to download self-monitored blood glucose ( SMBG ) values on a weekly basis without receiving SMS . After 6 months , patients crossed over to the alternate sequence for 6 additional months . Visits at the clinic were maintained every 3 months . RESULTS Patients with long-st and ing inadequately controlled diabetes ( 24 + /- 13 years ) were included . A non-significant trend to reduction in HbA(1c ) ( -0.25+/-0.94 % , P<0.10 ) and mean glucose values ( -9.2+/-25 mg/dl , P=0.06 ) during the 6-month SMS sequence was observed as compared with the no-SMS period . No safety issue ( hypoglycemia , glucose variability ) was reported . Adherence to SMBG was not affected by the trial . Quality of life analysis suggests a significant improvement in DQOL global score , as well as the DQOL satisfaction with life subscale , during the SMS sequence . CONCLUSIONS Long-term telemedical follow-up of insulin pump-treated patients using a cellular phone- , SMS- and Web-based platform is feasible , safe , does not alter quality of life and associated with a trend toward improved metabolic control Background : Electronic health records ( EHRs ) have been implemented throughout the United States with varying degrees of success . Past EHR implementation experiences can inform health systems planning to initiate new or exp and existing EHR systems . Key “ critical success factors , ” e.g. , use of disease registries , workflow integration , and real-time clinical guideline support , have been identified but not fully tested in practice . Methods : A pre/postintervention cohort analysis was conducted on 495 adult patients selected r and omly from a diabetes registry and followed for 6 years . Two intervention phases were evaluated : a “ low-dose ” period targeting primary care provider ( PCP ) and patient education followed by a “ high-dose ” EHR diabetes management implementation period , including a diabetes disease registry and office workflow changes , e.g. , diabetes patient pre identification to facilitate real-time diabetes preventive care , disease management , and patient education . Results : Across baseline , “ low-dose , ” and “ high-dose ” postintervention periods , a significantly greater proportion of patients ( a ) achieved American Diabetes Association ( ADA ) guidelines for control of blood pressure ( 26.9 to 33.1 to 43.9 % ) , glycosylated hemoglobin ( 48.5 to 57.5 to 66.8 % ) , and low-density lipoprotein cholesterol ( 33.1 to 44.4 to 56.6 % ) and ( b ) received recommended preventive eye ( 26.2 to 36.4 to 58 % ) , foot ( 23.4 to 40.3 to 66.9 % ) , and renal ( 38.5 to 53.9 to 71 % ) examinations or screens . Conclusions : Implementation of a fully functional , specialized EHR combined with tailored office workflow process changes was associated with increased adherence to ADA guidelines , including risk factor control , by PCPs and their patients with diabetes . Incorporation of previously identified “ critical success factors ” potentially contributed to the success of the program , as did use of a two-phase approach AIMS Care management may improve the quality of diabetes care by enhancing contact between high-risk patients and their providers . This prospect i ve , longitudinal , r and omized trial sought to investigate whether telephone or online care management improves diabetes-related outcomes over time compared with usual care supplemented with Internet access and training . SUBJECTS AND METHODS One hundred fifty-one adult subjects with type 2 diabetes mellitus and an elevated hemoglobin A1c ( A1c ) level ( ≥8.5 % ) were r and omly assigned to online care management ( n=51 ) , telephone-based care management ( n=51 ) , or Web training ( n=49 ) groups . Online and telephone participants interacted with a care manager through a diabetes education and care management Web site and by telephone , respectively . The Web training group was provided with online diabetes self-management re sources but no care management support . The primary outcome measure was A1c measured every 3 months for a year . RESULTS A1c declined significantly and substantially in all groups over 12 months . A1c declined linearly at a rate of 0.32 % ( P<0.0001 ) per quarter for the online group , 0.36 % ( P<0.0001 ) for the telephone group , and 0.41 % for the Web training group ( P<0.0001 ) . The rate of change over time did not differ significantly among groups . The groups converged at 12 months with average absolute A1c difference of -1.5 % . The number of interactions with care providers was not significantly associated with the change in A1c . Blood pressure , weight , lipid levels , and diabetes distress did not differ among groups over time . CONCLUSIONS Online , telephone-based care management , and Web training for diabetes patients with elevated A1c were each associated with a substantial improvement in A1c over a 1-year period . Internet access and training alone may be as effective as care management in patients with poorly controlled diabetes BACKGROUND Web-based personal health records ( PHRs ) have been advocated as a means to improve type 2 diabetes mellitus ( DM ) care . However , few Web-based systems are linked directly to the electronic medical record ( EMR ) used by physicians . METHODS We r and omized 11 primary care practice s. Intervention practice s received access to a DM-specific PHR that imported clinical and medications data , provided patient-tailored decision support , and enabled the patient to author a " Diabetes Care Plan " for electronic su bmi ssion to their physician prior to upcoming appointments . Active control practice s received a PHR to up date and su bmi t family history and health maintenance information . All patients attending these practice s were encouraged to sign up for online access . RESULTS We enrolled 244 patients with DM ( 37 % of the eligible population with registered online access , 4 % of the overall population of patients with DM ) . Study participants were younger ( mean age , 56.1 years vs 60.3 years ; P < .001 ) and lived in higher-income neighborhoods ( median income , $ 53,784 vs $ 49,713 ; P < .001 ) but had similar baseline glycemic control compared with non participants . More patients in the intervention arm had their DM treatment regimens adjusted ( 53 % vs 15 % ; P < .001 ) compared with active controls . However , there were no significant differences in risk factor control between study arms after 1 year ( P = .53 ) . CONCLUSIONS Previsit use of online PHR linked to the EMR increased rates of DM-related medication adjustment . Low rates of online patient account registration and good baseline control among participants limited the intervention 's impact on overall risk factor control . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00251875 AIMS The aim of the study was to develop and test the feasibility of a three months web-based intervention , delivered by a smartphone to support self-management in patients with type 2 diabetes . METHODS The intervention included use of a smartphone enabling access to daily web-based diaries and individualized written situational feedback . The participants registered their eating behavior , medication taking , physical activities and emotions three times daily using the mobile device . They also registered their fasting blood glucose level in the morning diary . A therapist had immediate access to su bmi tted diaries and used the situational information to formulate a personalized feedback based on Acceptance Commitment Therapy . The purpose of the diaries and the situational feedback was to stimulate self-management . RESULTS Eleven of the fifteen participants included in the study completed the intervention , which was evaluated as supportive and meaningful . Most of the participants reported positive life style changes . The response rate to the daily registration entries was good and few technical problems were encountered . CONCLUSIONS The described intervention is feasible and should be tested out in a large-scale study . The developed smartphone application seems a promising tool for supporting patients with type 2 diabetes to make important life style changes Objective : The epidemic proportions and management complexity of diabetes have prompted efforts to improve clinic throughput and efficiency . One method of system re design based on the chronic care model is the Shared Medical Appointment ( SMA ) in which groups of patients ( 8–20 ) are seen by a multi-disciplinary team in a 1–2 h appointment . Evaluation of the impact of SMAs on quality of care has been limited . The purpose of this quality improvement project was to improve intermediate outcome measures for diabetes ( A1c , SBP , LDL-cholesterol ) focusing on those patients at highest cardiovascular risk . Setting : Primary care clinic at a tertiary care academic medical center . Subjects : Patients with diabetes with one or more of the following : A1c > 9 % , SBP blood pressure > 160 mm Hg and LDL-c > 130 mg/dl were targeted for potential participation ; other patients were referred by their primary care providers . Patients participated in at least one SMA from 4/05 to 9/05 . Study design : Quasi-experimental with concurrent , but non-r and omised controls ( patients who participated in SMAs from 5/06 through 8/06 ; a retrospective period of observation prior to their SMA participation was used ) . Intervention : SMA system re design Analytical methods : Paired and independent t tests , χ2 tests and Fisher Exact tests . Results : Each group had up to 8 patients . Patients participated in 1–7 visits . At the initial visit , 83.3 % had A1c levels > 9 % , 30.6 % had LDL-cholesterol levels > 130 mg/dl , and 34.1 % had SBP ⩾160 mm Hg . Levels of A1c , LDL-c and SBP all fell significantly postintervention with a mean ( 95 % CI ) decrease of A1c 1.4 ( 0.8 , 2.1 ) ( p<0.001 ) , LDL-c 14.8 ( 2.3 , 27.4 ) ( p = 0.022 ) and SBP 16.0 ( 9.7 , 22.3 ) ( p<0.001 ) . There were no significant differences at baseline between control and intervention groups in terms of age , baseline intermediate outcomes , or medication use . The reductions in A1c in % and SBP were greater in the intervention group relative to the control group : 1.44 vs –0.30 ( p = 0.002 ) for A1c and 14.83 vs 2.54 mm Hg ( p = 0.04 ) for SBP . LDL-c reduction was also greater in the intervention group , 16.0 vs 5.37 mg/dl , but the difference was not statistically significant ( p = 0.29 ) . Conclusions : We were able to initiate a programme of group visits in which participants achieved benefits in terms of cardiovascular risk reduction . Some barriers needed to be addressed , and the operations of SMAs evolved over time . Shared medical appointments for diabetes constitute a practical system re design that may help to improve quality of care BACKGROUND Guidelines for type 2 diabetes care in general practice are well known and accepted , but the implementation falls short . OBJECTIVE To implement these guidelines by introducing a diabetes support service ( DSS ) to support the care delivered by the GP . METHODS A controlled , non-r and omised study with delayed intervention in the control group ; 78 GPs ( n=51 for the intervention and n=21 for the control group ) in the south of the Netherl and s and 613 of their type 2 diabetic patients participated . Data were collected on the frequency , content and results of the check-ups ( fasting blood glucose , HbA1c , cholesterol , cholesterol/HDL ratio , triglycerides , creatinine , blood pressure , fundus photography , foot examination , body mass index and smoking status ) for 3 years . The year before signing up with the DSS was taken for the pre- measurements and after 2 years of DSS the post- measurements took place . The effect of the DSS was analysed in a mixed model with repeated measurement covariance structure . RESULTS At baseline the intervention and control group did not differ in control frequency and outcome ( HbA1c ) . After the intervention the percentage of patients that attended four or more quarterly check-ups ( with at least testing of fasting blood glucose or HbA1c ) increased from 59 to 78 % . In contrast , the frequency of check-ups in the control group remained constant . This effect was significant . The HbA1c remained the same in the intervention group while there was a significant deterioration in the HbA1c in the control group . CONCLUSION Simple logistic support by the DSS proved to have the capacity to implement type 2 diabetes guidelines in general practice Background : Logistic support to general practitioners improves the care processes for patients with diabetes but is not sufficient to meet all criteria . Aim : To introduce patient-oriented interventions by a practice nurse in general practice s which already use logistic support to improve the care processes for patients with diabetes . Design of study : A controlled before – after study with delayed intervention in the control group . Setting : 51 practice s ( n = 23 for the intervention and n = 28 for the control group ) in the south of The Netherl and s and 900 of their patients with type 2 diabetes . Methods : Data were collected on the results of the checkups ( fasting blood glucose , glycosylated haemoglobin ( HbA1C ) , cholesterol , cholesterol/high-density lipoprotein ratio , triglycerides , creatinine , blood pressure , fundus photo , foot exam and body mass index ) , smoking status , physical activity and medication use . The effect of the patient-oriented intervention was analysed in a mixed model with repeated measurement covariance structure . Results : The HbA1C improved in the intervention group ( from 7.3 to 7.1 ) , while that of the control group deteriorated ( from 7.2 to 7.3 ) . The percentage of patients with an HbA1C ⩾8.5 was halved after the intervention ( from 13 to 6 ) . Patients in the intervention group started to exercise more besides their daily activities compared with the control group . The need for medication increased more in the control group than in the intervention group ( more changes to insulin and more defined daily dose ( DDD ) oral medication ) . Conclusion : Patient-oriented interventions in addition to logistic support have a positive effect on diabetic patient outcomes Given that 14 million Americans have diabetes [ 1 ] , the common complications of this disorder , such as foot ulcers and lower extremity amputations , are of major concern to the medical community . Approximately 20 % of all diabetic patients hospitalized in the United States are admitted because of foot complications [ 2 , 3 ] . Furthermore , about 50 % of all nontraumatic amputations in the United States are done in patients with diabetes [ 1 , 4 ] . This proportion equates to about 55 000 amputations a year [ 1 ] or 59.7 amputations for every 10 000 persons with diabetes [ 5 ] . Patients who undergo an amputation are at greater risk for a second similar procedure on either the same or the other leg [ 6 , 7 ] . Yet , it has been estimated that about one half of the amputations in patients with diabetes , or about one fourth of the total amputations done in the United States , are preventable [ 1 , 4 ] . Recently , the focus has been on preventive strategies that minimize foot damage in diabetic patients and thereby reduce the rates of ulcers and amputations . These preventive strategies are based on two observations : first , that simple efforts on the part of the health care provider or patient can reduce the likelihood of subsequent amputation due to diabetes-associated foot disease [ 8 ] ; and second , that many of these simple procedures are not being systematic ally applied by health care providers or patients [ 9 ] . For example , studies indicate that physicians infrequently examine the feet of patients with diabetes [ 9 , 10 ] . Also , most patients with diabetes do not engage in simple foot-care assessment s to identify lesions requiring early treatment [ 11 ] . Preventive strategies are not systematic ally applied for several reasons : First , patients may not be aware of foot-care procedures or how to do them , or they may not believe that such procedures can make a difference ; second , podiatry and orthopedics services that could assist in foot salvage in diabetic patients may not be available ; and , finally , the health care system may make it difficult for patients or health care providers to examine the feet of patients with diabetes [ 10 ] . Several uncontrolled studies found that implementation of improved foot-care programs can significantly reduce lower extremity complications in patients with diabetes ; these studies showed a 44 % to 85 % reduction in the rate of lower extremity amputations [ 4 , 12 - 14 ] . A recent casecontrol study also supports the implementation of preventive strategies , such as foot care , use of protective footwear , and aggressive treatment of foot infection by patients or health care providers , to decrease the risk for lower extremity amputation [ 15 ] . The intervention in our study was design ed to reduce the prevalence of risk factors for lower extremity amputations in patients with noninsulin-dependent diabetes and involved the three major elements of a prevention program : the patient , health care providers , and the health care system . Specifically , we did a r and omized , controlled trial to determine whether a comprehensive foot-care intervention could improve patients ' knowledge and performance of appropriate foot care ; increase the number of referrals to specialty clinics such as the podiatry clinic ; increase the frequency of foot examinations by health care providers and the documentation of risk factors in the medical record ; and improve short-term patient outcomes such as skin and nail conditions known to be risk factors for ulcers and amputations . Methods Setting Our study , the design of which is summarized in Figure 1 , was done from April 1989 to March 1991 in the academic general medicine practice of the Regenstrief Health Center in Indianapolis , Indiana [ 16 ] . The practice is subdivided into four primary care teams ( labeled A , B , C , and D ) , each with its own nursing and clerical staff . Each team sees patients for eight half-day sessions per week , with each session staffed by one or two faculty internists and two to four housestaff . Teams A and C were r and omly assigned to the intervention group ; teams B and D were assigned to the control group . Previous studies in which this method of r and omization was used have shown no baseline interteam differences in patient characteristics and physician practice behavior and no effect of the team on the study outcome [ 16 - 19 ] . Figure 1 . Summary of the study design . Patient Identification and Recruitment The computerized Regenstrief Medical Record System [ 20 ] was used to identify approximately 3000 patients with noninsulin-dependent diabetes , as well as the date and time of their next appointment . Only patients with noninsulin-dependent diabetes who were seen at least two times in the preceding year by the same provider were included in the study . Additional criteria for inclusion were as follows : an age greater than 40 years ; a diagnosis of diabetes after 30 years of age ; a diagnosis of diabetes based on National Diabetes Data Group criteria [ 21 ] or the presence of disease requiring medication for the control of hyperglycemia ; an intention to obtain care at the general medicine practice for the next 2 years ; and a body weight that was either ideal or heavier than ideal . Exclusion criteria included pregnancy ; major psychiatric illness , including dementia ; terminal illness likely to cause death within 1 year ; renal failure ( serum creatinine > 440 mol/L ) ; previous bilateral amputations above or below the knee ; or an inability to provide any self-care . Patients of investigators involved in the protocol were also excluded from the study . Of the 728 eligible patients , 244 refused to participate , 89 enrolled in the study but failed to keep their appointments for assessment , and 395 were assessed by trained nurse-clinicians . Of the 395 patients assessed , 352 ( 89 % ) completed the study ; 43 patients ( 11 % ) did not complete the study for the following reasons : death ( 11 patients ) ; change of residence ( 15 patients ) ; illness ( 6 patients ) ; transportation problems ( 3 patients ) ; and miscellaneous reasons ( 8 patients ) . Patient Assessment Sample s for determining fasting plasma glucose , cholesterol , triglyceride , high-density lipoprotein , hemoglobin A1C , and C-peptide levels were obtained from enrolled patients and immediately transported to a certified laboratory for analysis . Patients gave a history and had a physical examination at study entry and approximately 1 year later ( mean , 11.8 1.5 months ) . These examinations focused on risk factors for amputation and were administered by two trained nurse-clinicians who were blinded to the patients ' experimental conditions . Foot-related data derived from the history and physical examination included the patient 's self-reported foot-care behaviors ; the quality of the patient 's examination of his or her feet ; the severity of any foot lesions ; and the presence of musculoskeletal abnormalities , dermatologic conditions , peripheral vascular disease , and peripheral neuropathy ( the neuropathy assessment included quantitative measures of pressure and temperature sensation ) . Patients were question ed about their regular foot-care routine and were asked to show how they examined their feet . During this self-examination , nurse-clinicians observed whether patients ' scrutinized the toenails , the soles of the feet , and the area between toes . Musculoskeletal and dermatologic abnormalities were assessed using st and ard definitions of findings such as callus , hammer toe , and Charcot foot [ 3 , 22 ] . The nurse-clinicians palpated the dorsalis pedis , posterior tibial , and femoral pulses bilaterally in their assessment for peripheral vascular disease . If a pulse was absent at any one of the six sites palpated , the assessment was considered abnormal . Foot lesions were rated for severity using the Seattle Wound Classification System [ 23 ] , which ranges from a grade of 1.1 ( absence of lesions ) to a grade of 10 ( entire foot or leg is gangrenous ) . In our study , a foot lesion was defined as any wound , with or without functional interruption of the protective cutaneous barrier , ranging from a superficial scratch to an ulcer involving the epidermis . A serious foot lesion was defined by a severity grade of at least 1.3 , which indicates a minor , nonulcerated lesion with clinical evidence of healing sufficient to close previous interruption of the cutaneous barrier [ 23 ] or a blister . Pressure and temperature sensations were measured using the 5.07-log ( 0.1 mg)-force Semmes-Weinstein monofilament and the thermal sensitivity testing apparatus , according to st and ard techniques [ 24 - 26 ] . Thermal sensitivity was considered abnormal if the patient had a value greater than 2 st and ard deviations from the mean value for a group of healthy persons without diabetes ( warm > 2.04 C ; cool > 1.58 C ) . Practice Patterns of Health Care Providers Immediately after each scheduled visit , study patients had a structured interview [ 10 ] with a research assistant , who asked about foot self-examination and foot-care education given by health care providers ( the primary care physician or nursing personnel ) . In addition , a chart audit was conducted by a nurse-clinician who was blinded to the patients ' experimental condition . Information abstract ed from the medical record included the physician 's documentation of the findings from the history and physical examination ; any referral to podiatry , orthopedics , or vascular surgery clinics ; and diagnostic-test ordering related to the evaluation and treatment of diabetes-associated foot problems . Intervention The intervention cohort was exposed to several risk-reduction strategies . The nurse-clinicians conducted the patient education session with one to four patients , covering appropriate foot-care behaviors and footwear , using a commercially available slide and audiotape presentation [ 27 ] and pamphlets [ 28 ] . Behavioral contracts regarding desired foot-care behaviors were negotiated with each patient . Follow-up was done by telephone 2 weeks after the education sessions to remind patients This study applied a 6-month educational intervention that used the technology of the short message service ( via cellular phones ) and the Internet for obese patients with type 2 diabetes . Eighteen patients were r and omly assigned to an intervention group and 16 were assigned to a control group ( N = 34 ) . Patients in the intervention group were asked to access a web site by using personal cellular phones or computer Internet services to input their blood glucose levels daily . Participants were then sent optimal recommendations via cellular phone and the Internet weekly . After 6 months , the intervention group had a statistically significant decrease in glycosylated hemoglobin , fasting plasma glucose , 2-hour postmeal glucose , and total cholesterol , as compared with the control group OBJECTIVE To evaluate a system for improving diabetes care in remote Indigenous communities . DESIGN R and omised , unblinded cluster trial over one year ( 1 March to 29 February 2000 ) . PARTICIPANTS AND SETTING Primary healthcare staff in 21 primary healthcare centres in the Torres Strait and Northern Peninsula Area ( NPA ) Health Service District , north Queensl and , and 678 people with diabetes , mostly Torres Strait Isl and ers . INTERVENTION Diabetes recall system established at eight of the 21 sites , as well as staff training in basic diabetes care , regular phone calls from the project officer , a two-monthly newsletter and a mid-project workshop . MAIN OUTCOME MEASURES Regular checks of weight , blood pressure , eye and foot care , serum lipid levels and glucose monitoring and control , urinary albumin to creatinine ratio and serum creatinine levels , and administration of recommended vaccines ; hospitalisation in the previous 12 months . RESULTS There was improvement in most measures at most sites , except for blood pressure monitoring and control , and vaccination status . Intervention sites showed greater improvement in most indicators than control sites ( combined relative risk [ RR ] , 1.21 ; 95 % CI , 1.03 - 1.43 ) . The intervention group showed a 32 % reduction in hospital admissions for diabetes-related conditions over the study period ( P=0.012 ) . At follow-up , patients in intervention sites were 40 % less likely to be hospitalised for a diabetes-related condition than those in control sites ( RR , 0.60 ; 95 % CI , 0.41 - 0.86 ; P=0.007 ) . CONCLUSION A simple recall system , managed by local healthcare workers and supported by a diabetes outreach service , achieved significant improvements in diabetes care and reduced hospitalisations in a high-risk population BACKGROUND To determine whether a Web-based diabetes case management program based in an electronic medical record can improve glycemic control ( primary outcome ) and diabetes-specific self-efficacy ( secondary outcome ) in adults with type 1 diabetes , a pilot r and omized controlled trial was conducted . METHODS A 12-month r and omized trial tested a Web-based case management program in a diabetes specialty clinic . Patients 21 - 49 years old with type 1 diabetes receiving multiple daily injections with insulin glargine and rapid-acting analogs who had a recent A1C > 7.0 % were eligible for inclusion . Participants were r and omized to receive either ( 1 ) usual care plus the nurse-practitioner-aided Web-based case management program ( intervention ) or ( 2 ) usual clinic care alone ( control ) . We compared patients in the two study arms for changes in A1C and self-efficacy measured with the Diabetes Empowerment Scale . RESULTS A total of 77 patients were recruited from the diabetes clinic and enrolled in the trial . The mean baseline A1C among study participants was 8.0 % . We observed a nonsignificant decrease in average A1C ( -0.48 ; 95 % confidence interval -1.22 to 0.27 ; P = 0.160 ) in the intervention group compared to the usual care group . The intervention group had a significant increase in diabetes-related self-efficacy compared to usual care ( group difference of 0.30 ; 95 % confidence interval 0.01 to 0.59 ; P = 0.04 ) . CONCLUSIONS Use of a Web-based case management program was associated with a beneficial treatment effect on self-efficacy , but change in glycemic control did not reach statistical significance in this trial of patients with moderately poorly controlled type 1 diabetes . Larger studies may be necessary to further clarify the intervention 's impact on health outcomes OBJECTIVES To evaluate the use of automated systems to prompt patients with diabetes mellitus to obtain overdue laboratory tests for its effectiveness in promoting test compliance and to compare letters , telephone messages , and combinations . STUDY DESIGN R and omized controlled trial . METHODS All subjects ( N = 13,057 ) were adult members of Southern California Kaiser Permanente with diabetes and with no record of glycosylated hemoglobin , low-density lipoprotein cholesterol , and urinary microalbumin tests in more than 1 year . The effectiveness of automated telephone calls and letters was compared versus a no-contact control group using the following 5 intervention groups : letter , call , letter that is followed by a call 4 weeks later , call that is followed by a letter 4 weeks later , and letter-call-letter combination . Messages were in English and in Spanish . Adherence to all testing was compared at 8 weeks and 12 weeks after initial contact using chi(2 ) test and logistic regression analysis . RESULTS The proportions of each study group compliant with all tests were 18 % to 19 % among controls , 21 % for a letter or a call , 25 % for a letter-call or call-letter , and 26 % for a letter-call-letter ; letter-call and call-letter were significantly different versus controls ( P < .001 ) , and letter-call-letter was not significantly different versus letter-call . Older age was associated with compliance ( P < .001 ) . CONCLUSIONS The pairing of automated letters and telephone calls in any order was more effective than any single intervention in promoting compliance with diabetes monitoring tests . The relative cost of the letter-call and call-letter approaches to outreach should be considered to determine which is preferred in any given situation |
336 | 29,253,218 | Conclusions We identified key predictors for recovery in a community setting s from five countries . | Background Psychological therapies are increasingly delivered in community care setting s. In existing literature , patient , disorder and service variables are known to have a significant impact on the recovery outcomes for patients undergoing psychological treatment in secondary care . | OBJECTIVE A culturally focused psychiatric ( CFP ) consultation service was implemented to increase engagement in mental health care and reduce depressive symptoms among adult Latino primary care patients . The aim of this study was to assess preliminary efficacy of the CFP consultation service to reduce depressive symptoms . METHODS In a r and omized controlled study , primary care clinics were r and omly selected to provide either the two-session CFP intervention or enhanced usual care . For CFP intervention participants , study clinicians ( psychologists or psychiatrists ) provided a psychiatric assessment , psychoeducation , cognitive-behavioral tools , and tailored treatment recommendations ; primary care providers were provided a consultation summary . Depressive symptoms ( as measured by the Quick Inventory of Depressive Symptomatology-Self Rated [ QIDS-SR ] ) were assessed at baseline and six-month follow-up . Multiple regression analysis was conducted to evaluate whether CFP intervention participants showed greater improvement in depressive symptoms at follow-up , with control for baseline depression , clinic site , and significant covariates . RESULTS Participants ( N=118 ) were primarily Spanish-monolingual speakers ( 64 % ) . Although depressive symptoms remained in the moderate range for both groups from baseline to six months , symptom reduction was greater among CFP intervention participants ( mean±SD change in QIDS-SR score=3.46±5.48 ) than those in usual care ( change=.09±4.43 ) . The final multiple regression model indicated that participation in the CFP intervention predicted lower depressive symptoms at follow-up ( unst and ardized beta=-3.09 , p=.008 ) , independent of baseline depressive symptoms , clinic site , age , gender , and employment status . CONCLUSIONS Results suggest that Latinos experiencing depressive symptoms may benefit from a short-term CFP consultation . Findings also support the integration of psychiatric interventions for Latinos in the primary care setting OBJECTIVE This study examined the utilization of mental health treatments over a three-year period among patients with schizotypal , borderline , avoidant , or obsessive-compulsive personality disorders compared with patients with major depressive disorder and no personality disorder . METHODS A prospect i ve , longitudinal study design was used to measure treatment use for 633 individuals aged 18 to 45 years during a three-year period . RESULTS Patients with borderline personality disorder were significantly more likely than those with major depressive disorder to use most types of treatment . Furthermore , all patients continued using high-intensity , low- duration treatments throughout the study period , whereas individual psychotherapy attendance declined significantly after one year . CONCLUSIONS Although our data showed that patients with borderline personality disorder used more mental health services than those with major depressive disorder , many questions remain about the adequacy of the treatment received by all patients with personality disorders The present study investigated the effects of personality disorders ( PDs ) and specific PD-related beliefs on the results of (cognitive-)behavioral therapy for anxiety disorders in a sample of 398 out patients . The authors used a prospect i ve design in which relationships between PD variables before treatment and outcome measures at posttest and follow-up were evaluated with multilevel analyses . People with PDs and PD-related beliefs reported higher symptom levels at outcome . However , these effects were not as strong as might be expected on the basis of prevailing clinical thought in this area . Dropout rates were not influenced by the presence of 1 or more PDs or PD-related beliefs . Results indicate that treatment of anxiety disorders in patients with concomitant one or more PDs is appropriate BACKGROUND Mental health problems such as depression and anxiety are common in Multiple Sclerosis ( MS ) and are often under treated . AIMS This paper reports on the clinical effectiveness of a cognitive behaviour therapy service for common mental disorders in people with MS and compares it to previous r and omised controlled trials ( RCTs ) of cognitive behaviour therapy ( CBT ) in this population . METHODS 49 patients were deemed appropriate for CBT and 29 accepted treatment . Assessment s were completed at baseline and end of treatment and included the Hospital Anxiety & Depression Scale . Results in the form of a st and ardized effect of treatment were compared with five previous RCTs . RESULTS The results from this clinical service indicated statistically significant outcomes with reductions in depression and anxiety . The uncontrolled effect size was large but inferior to those found in published RCTs . CONCLUSIONS Cognitive behaviour therapy is effective for people with MS in routine clinical practice . Possible limits on effectiveness include more liberal patient selection , lack of specificity in rating scales and heterogeneity of target problems . Given the high rates of distress in this population , routine psychological interventions within neurology services are justifiable . Future research should aim to maximise CBT in such setting Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more The outcome of a r and omized controlled trial of cognitive behavior therapy in addition to treatment as usual ( CBT plus TAU ) compared with TAU alone ( TAU ) in one hundred and six participants meeting diagnostic criteria for borderline personality disorder is described . We anticipated that CBT plus TAU would decrease the number of participants with in-patient psychiatric hospitalizations or accident and emergency room contact or suicidal acts over twelve months treatment and twelve months follow-up , compared with TAU . We also anticipated that CBT plus TAU would lead to improvement in a range of secondary outcomes of mental health and social functioning compared to TAU . Of the 106 participants r and omized , follow-up data on 102 ( 96 % ) was obtained at two years . Those r and omized to CBT were offered an average of 27 sessions over 12 months and attended on average 16 ( range 0 to 35 ) . We found that the global odds ratio of a participant in the CBT plus TAU group compared with the TAU alone group having any of the outcomes of a suicidal act , in-patient hospitalization , or accident and emergency contact in the 24 months following r and omization was 0.86 ( 95 % confidence interval [ CI ] 0.45 to 1.66 , p = 0.66 ) . The corresponding global odds ratio , excluding accident and emergency room contact , was 0.75 ( 95 % CI 0.37 to 1.54 , p = 0.44 ) . In terms of the number of suicidal acts , there was a significant reduction over the two years in favor of CBT plus TAU over TAU , with a mean difference of -0.91 ( 95 % CI -1.67 to -0.15 , p = 0.020 ) . Across both treatment arms there was gradual and sustained improvement in both primary and secondary outcomes , with evidence of benefit for the addition of CBT on the positive symptom distress index at one year , and on state anxiety , dysfunctional beliefs and the quantity of suicidal acts at two year follow-up . CBT can deliver clinical ly important changes in relatively few clinical sessions in real clinical setting Background Variability in patient-reported outcomes of psychological treatments has been partly attributed to therapists – a phenomenon commonly known as therapist effects . Meta-analytic review s reveal wide variation in therapist-attributable variability in psychotherapy outcomes , with most studies reporting therapist effects in the region of 5 % to 10 % and some finding minimal to no therapist effects . However , all except one study to date have been conducted in high-intensity or mixed intervention groups ; therefore , there is scarcity of evidence on therapist effects in brief low-intensity psychological interventions . Objective To examine therapist effects in low-intensity interventions for depression and anxiety in a naturalistic setting . Data and Analysis Session-by-session data on patient-reported outcome measures were available for a cohort of 1,376 primary care psychotherapy patients treated by 38 therapists . Outcome measures included PHQ-9 ( sensitive to depression ) and GAD-7 ( sensitive to general anxiety disorder ) measures . Three-level hierarchical linear modelling was employed to estimate therapist-attributable proportion of variance in clinical outcomes . Therapist effects were evaluated using the intra-cluster correlation coefficient ( ICC ) and Bayesian empirical predictions of therapist r and om effects . Three sensitivity analyses were conducted : 1 ) using both treatment completers and non-completers ; 2 ) a sub- sample of cases with baseline scores above the conventional clinical thresholds for PHQ-9 and GAD-7 ; and 3 ) a two-level model ( using patient-level pre- and post-treatment scores nested within therapists ) . Results The ICC estimates for all outcome measures were very small , ranging between 0 % and 1.3 % , although most were statistically significant . The Bayesian empirical predictions showed that therapist r and om effects were not statistically significantly different from each other . Between patient variability explained most of the variance in outcomes . Conclusion Consistent with the only other study to date in low intensity interventions , evidence was found to suggest minimal to no therapist effects in patient-reported outcomes . This draws attention to the more prominent source of variability which is found at the between-patient level PURPOSE For depressed older primary care patients , this study aim ed to examine ( a ) characteristics associated with depression treatment preferences ; ( b ) predictors of receiving preferred treatment ; and ( c ) whether receiving preferred treatment predicted satisfaction and depression outcomes . DESIGN AND METHODS Data are from 1,602 depressed older primary care patients who participated in a multisite , r and omized clinical trial comparing usual care to collaborative care , which offered medication and counseling for up to 12 months . Baseline assessment included demographics , depression , health information , prior depression treatment , potential barriers , and treatment preferences ( medication , counseling ) . At 12 months , services received , satisfaction , and depression outcomes were assessed . RESULTS More patients preferred counseling ( 57 % ) than medication ( 43 % ) . Previous experience with a treatment type was the strongest predictor of preference . In addition , medication preference was predicted by male gender and diagnosis of major depression ( vs dysthymia ) . The collaborative care model greatly improved access to preferred treatment , especially for counseling ( 74 % vs 33 % in usual care ) . Receipt of preferred treatment did not predict satisfaction or depression outcomes ; these outcomes were most strongly impacted by treatment condition . IMPLICATION S Many depressed older primary care patients desire counseling , which is infrequently available in usual primary care . Discussion of treatment preferences should include an assessment of prior treatment experiences . A collaborative care model that increases collaboration between primary care and mental health professionals can increase access to preferred treatment . If preferred treatment is not available , collaborative care still results in good satisfaction and depression outcomes Purpose There is substantial evidence to suggest that Black and minority ethnic ( BME ) patients are disproportionately detained under the Mental Health Act ( MHA ) . We examined ethnic differences in patients assessed for detention and explored the effect of ethnicity after controlling for confounders . Methods A prospect i ve study of all MHA assessment s conducted in 1 year ( April 2009–March 2010 ) within Birmingham and Solihull Mental Health Foundation Trust , UK . Proportion of assessment s and detentions within denominator population of service users and regional population s were calculated . Multiple regression analysis was conducted to determine which variables were associated with the outcome of MHA assessment and the role of ethnicity . Results Of the 1115 assessment s , 709 led to detentions ( 63.58 % ) . BME ethnic groups were statistically more likely to be assessed and detained under the MHA as compared to Whites , both in the service user and the ethnic population estimates in Birmingham , UK . MHA detention was predicted by having a serious mental illness , the presence of risk , older age and living alone . Ethnicity was not associated with detention under the MHA with age , diagnosis , risk and level of social support accounted for . Conclusion The BME ‘ disproportionality ’ in detention rates seems to be due to higher rates of mental illness , greater risk and poorer levels of social support rather than ethnicity per se UNLABELLED The UK 's Improving Access to Psychological Therapies ( IAPT ) initiative provides evidence -based psychological interventions for mild to moderate common mental health problems in a primary care setting . Predictors of treatment response are unclear . This study examined the impact of personality disorder status on outcome in a large IAPT service . We hypothesised that the presence of probable personality disorder would adversely affect treatment response . METHOD We used a prospect i ve cohort design to study a consecutive sample of individuals ( n = 1249 ) . RESULTS Higher scores on a screening measure for personality disorder were associated with poorer outcome on measures of depression , anxiety and social functioning , and reduced recovery rates at the end of treatment . These associations were not confounded by demographic status , initial symptom severity nor number of treatment sessions . The presence of personality difficulties independently predicted reduced absolute change on all outcome measures . CONCLUSIONS The presence of co-morbid personality difficulties adversely affects treatment outcome among individuals attending for treatment in an IAPT service . There is a need to routinely assess for the presence of personality difficulties on all individuals referred to IAPT services . This information will provide important prognostic data and could lead to the provision of more effective , personalised treatment in IAPT OBJECTIVES To evaluate clinical effectiveness at 4 weeks of antidepressant therapy for mothers with postnatal depression ( PND ) compared with general supportive care ; to compare outcome at 18 weeks of those r and omised to antidepressant therapy with those r and omised to listening visits as the first intervention ( both groups were to be allowed to receive the alternative intervention after 4 weeks if the woman or her doctor so decided ) ; and to assess acceptability of antidepressants and listening visits to users and health professionals . DESIGN A pragmatic two-arm individually r and omised controlled trial . SETTING Participants were recruited from 77 general practice s : 21 in Bristol , 21 in south London and 35 in Manchester . PARTICIPANTS A total of 254 women who fulfilled International Classification of Diseases version 10 criteria for major depression in the first 6 postnatal months were recruited and r and omised . INTERVENTIONS Women were r and omised to receive either an antidepressant , usually a selective serotonin reuptake inhibitor prescribed by their general practitioner ( GP ) , or non-directive counselling ( listening visits ) from a specially trained research health visitor ( HV ) . The trial was design ed to compare antidepressants with general supportive care for the first 4 weeks , after which women allocated to listening visits commenced their sessions . It allowed for women to receive the alternative intervention if they had not responded to their allocated intervention or wished to change to , or add in , the alternative intervention at any time after 4 weeks . MAIN OUTCOME MEASURES The duration of the trial was 18 weeks . Primary outcome , measured at 4 weeks and 18 weeks post r and omisation , was the proportion of women improved on the Edinburgh Postnatal Depression Scale ( EPDS ) , that is scoring < 13 . Secondary outcomes were the EPDS measured as a continuous variable at 4 and 18 weeks , and scores on various other question naires . RESULTS At 4 weeks , women were more than twice as likely to have improved if they had been r and omised to antidepressants compared with listening visits , which started after the 4-week follow-up , i.e. after 4 weeks of general supportive care [ primary intention-to-treat ( ITT ) , 45 % versus 20 % ; odds ratio ( OR ) 3.4 , 95 % confidence interval ( CI ) 1.8 to 6.5 , p < 0.001 ] . Explanatory analyses emphasised these findings . At 18 weeks , ITT analysis revealed that the proportion of women improving was 11 % greater in the antidepressant group , but logistic regression analysis showed no clear benefit for one group over the other [ 62 % versus 51 % , OR 1.5 ( 95 % CI 0.8 to 2.6 ) , p = 0.19 ] . Overall , there was a difference between the groups in favour of the antidepressant group of about 25 percentage points at 4 weeks , which reduced at 18 weeks . No statistical support existed for a benefit of antidepressants at 18 weeks , but 95 % CIs could not rule out a clinical ly important benefit . It was difficult for GPs not to prescribe antidepressants to women r and omised to listening visits after the initial 4 weeks , so many women received both interventions in both groups by 18 weeks and consequently power was reduced . Qualitative interviews with women revealed a preference for listening visits but an acceptance that antidepressants might be necessary . They wished to be reassured that their GP and HV were offering continuity of care focusing on their particular set of circumstances . Interviews with GPs and HVs revealed lack of collaboration in managing care for women with PND ; neither professional group was willing to assume responsibility . CONCLUSIONS At 4 weeks , antidepressants were significantly superior to general supportive care . Trial design meant that by 18 weeks many of the women initially r and omised to listening visits were also receiving antidepressants , and more vice versa . The lack of evidence for differences at 18 weeks is likely to reflect a combination of reduced power and the considerable degree of switching across the two interventions . Qualitative study revealed that women found both antidepressants and listening visits effective depending on their circumstances and preferences . The trial indicates that early treatment with antidepressants leads to clinical benefit for women with PND Cognitive-behavioral therapy ( CBT ) is an evidence -based treatment for anxiety ; however , a growing body of research suggests that CBT effect sizes are smaller in Veteran sample s. The aim of this study was to perform secondary data analyses of a r and omized controlled trial of CBT for late-life generalized anxiety disorder compared with treatment as usual ( TAU ) in a Veteran ( n = 101 ) and community-based ( n = 122 ) sample . Veterans had lower income and less education than community participants , greater severity on baseline measures of anxiety and depression , poorer physical health , and higher rates of psychiatric comorbidity . Treatment effects were statistically significant in the community sample ( all ps < 0.01 ) , but not in Veterans ( all ps > 0.05 ) . Further analyses in Veterans revealed that poorer perceived social support significantly predicted poorer outcomes ( all ps < 0.05 ) . Our results underscore the complexity of treating Veterans with anxiety , and suggest that additional work is needed to improve the efficacy of CBT for Veterans , with particular attention to social support We report an extensive study which compares cognitive therapy , antidepressant drugs and a combination of these two , in depressed patients seen either in general practice or an out-patient department . One-hundred and forty patients were screened for primary major depression and 64 patients completed the trial . All were rated on seven measures of mood , including independent observer-rated and self-rated depression and scales of anxiety and irritability . Patients were r and omly assigned to cognitive therapy , antidepressants or a combination of the two . The antidepressant drug group did less well in both hospital and general practice and combination treatment was superior to drug treatment in both hospital and general practice . In general practice , cognitive therapy was superior to drug treatment . The presence of endogenous features did not affect response to treatment . The results are discussed in terms of Beck 's cognitive theory of depression and factors of presumed causal importance of depression in general practice CONTEXT Impoverished minority women experience a higher burden from depression than do white women because they are less likely to receive appropriate care . Little is known about the effectiveness of guideline -based care for depression with impoverished minority women , most of whom do not seek care . OBJECTIVE To determine the impact of an intervention to deliver guideline -based care for depression compared with referral to community care with low-income and minority women . DESIGN , SETTING , AND PARTICIPANTS A r and omized controlled trial conducted in the Washington , DC , suburban area from March 1997 through May 2002 of 267 women with current major depression , who attended county-run Women , Infants , and Children food subsidy programs and Title X family planning clinics . Outcomes Hamilton Depression Rating Scale measured monthly from baseline through 6 months ; instrumental role functioning ( Social Adjustment Scale ) and social functioning ( Short Form 36-Item Health Survey ) measured at baseline and 3 and 6 months . INTERVENTIONS Participants were r and omly assigned to an antidepressant medication intervention ( trial of paroxetine switched to buproprion , if lack of response ) ( n = 88 ) , a psychotherapy intervention ( 8 weeks of manual-guided cognitive behavior therapy ) ( n = 90 ) , or referral to community mental health services ( n = 89 ) . RESULTS Both the medication intervention ( P<.001 ) and the psychotherapy intervention ( P = .006 ) reduced depressive symptoms more than the community referral did . The medication intervention also result ed in improved instrumental role ( P = .006 ) and social ( P = .001 ) functioning . The psychotherapy intervention result ed in improved social functioning ( P = .02 ) . Women r and omly assigned to receive medications were twice as likely ( odds ratio , 2.04 ; 95 % confidence interval , 0.98 - 4.27 ; P = .057 ) to achieve a Hamilton Depression Rating Scale score of 7 or less by month 6 as were those referred to community care . CONCLUSIONS Guideline -concordant care for major depression is effective for these ethnically diverse and impoverished patients . More women engaged in a sufficient duration of treatment with medications compared with psychotherapy , and outcome gains were more extensive and robust for medications OBJECTIVE To investigate predictors and moderators of treatment outcome by comparing immediate face-to-face cognitive behavioral therapy ( FtF-CBT ) to a Stepped Care treatment model comprising three steps : Psychoeducation , Internet-delivered CBT , and FtF-CBT for panic disorder ( PD ) and social anxiety disorder ( SAD ) . METHOD Patients ( N = 173 ) were recruited from nine public mental health out-patient clinics and r and omized to immediate FtF-CBT or Stepped Care treatment . Characteristics related to social functioning , impairment from the anxiety disorder , and comorbidity was investigated as predictors and moderators by treatment format and diagnosis in multiple regression analyses . RESULTS Lower social functioning , higher impairment from the anxiety disorder , and a comorbid cluster C personality disorder were associated with significantly less improvement , particularly among patients with PD . Furthermore , having a comorbid anxiety disorder was associated with a better treatment outcome among patients with PD but not patients with SAD . Patients with a comorbid depression had similar outcomes from the different treatments , but patients without comorbid depression had better outcomes from immediate FtF-CBT compared to guided self-help . CONCLUSIONS In general , the same patient characteristics appear to be associated with the treatment outcome for CBT provided in low- and high-intensity formats when treated in public mental health care clinics . The findings suggest that patients with lower social functioning and higher impairment from their anxiety disorder benefit less from these treatments and may require more adapted and extensive treatment . CLINICAL TRIALS.GOV : Identifier : NCT00619138 |
337 | 26,572,815 | In general , exercise produces an improvement in depression in older adults with more evidence in the short-term ( 3 months ) and strength training at high intensity . | BACKGROUND The literature supports the benefits of exercise in people with depressive disorders , but there is controversy over these benefits in depressed elderly .
OBJECTIVE To determine the effect of different types of exercise on depression in older adults using a systematic review of clinical trials . | Background Depression is a disabling , prevalent condition . Physical activity programs may assist depression management in older people , ameliorate co-morbid conditions and reduce the need for antidepressants . The UPLIFT pilot study assessed the feasibility of older depressed people attending a community-based progressive resistance training ( PRT ) program . The study also aim ed to determine whether PRT improves depressive status in older depressed patients . Methods A r and omised controlled trial was conducted . People aged ≥ 65 years with depressive symptoms were recruited via general practice s. Following baseline assessment , subjects were r and omly allocated to attend a local PRT program three times per week for 10 weeks or a brief advice control group . Follow-up assessment of depressive status , physical and psychological health , functional and quality of life status occurred post intervention and at six months . Results Three hundred and forty six people responded to the study invitation , of whom 22 % had depressive symptoms ( Geriatric Depression Scale , GDS-30 score ≥ 11 ) . Thirty two people entered the trial . There were no significant group differences on the GDS at follow-up . At six months there was a trend for the PRT intervention group to have lower GDS scores than the comparison group , but this finding did not reach significance ( p = 0.08 ) . More of the PRT group ( 57 % ) had a reduction in depressive symptoms post program , compared to 44 % of the control group . It was not possible to discern which specific components of the program influenced its impact , but in post hoc analyses , improvement in depressive status appeared to be associated with the number of exercise sessions completed ( r = -0.8 , p < 0.01 ) . Conclusion The UPLIFT pilot study confirmed that older people with depression can be successfully recruited to a community based PRT program . The program can be offered by existing community-based facilities , enabling its ongoing implementation for the potential benefit of other older people BACKGROUND Although exercise has been shown to relieve depression , little is known about its mechanism or dose-response characteristics . We hypothesized that high intensity progressive resistance training ( PRT ) would be more effective than either low intensity PRT or st and ard care by a general practitioner ( GP ) in depressed elderly persons , and that high intensity PRT would provide superior benefits in quality of life , sleep quality , and self-efficacy . METHODS Sixty community-dwelling adults > 60 years with major or minor depression were r and omized to supervised high intensity PRT ( 80 % maximum load ) or low intensity PRT ( 20 % maximum load ) 3 days per week for 8 weeks , or GP care . RESULTS A 50 % reduction in the Hamilton Rating Scale of Depression score was achieved in 61 % of the high intensity , 29 % of the low intensity , and 21 % of the GP care group ( p = .03 ) . Strength gain was directly associated with reduction in depressive symptoms ( r = 0.40 , p = .004 ) , as was baseline social support network type ( F = 3.52 , p = .015 ) , whereas personality type , self-efficacy , and locus of control were unrelated to the antidepressant effect . Vitality quality -of-life scale improved more in the high intensity group than in the others ( p = .04 ) . Sleep quality improved significantly in all participants ( p < .0001 ) , with the greatest relative change in high intensity PRT ( p = .05 ) . CONCLUSIONS High intensity PRT is more effective than is low intensity PRT or GP care for the treatment of older depressed patients We examined the effects of two physical activity modes on depressive symptoms over a 5-year period among older adults and change in physical self-esteem as a mediator of changes in depressive symptoms . Formerly sedentary , older adults ( N = 174 ) were r and omly assigned into 6-month conditions of either walking or low-intensity resistance/flexibility training . Depressive symptoms and physical self-esteem were measured before and after the 6-month intervention , and 12 and 60 months after intervention initiation . Depressive symptoms scores were decreased immediately after the intervention , followed by a sustained reduction for 12 and 60 months after intervention initiation ; there was no differential pattern of change between the physical activity modes . Change in physical self-esteem predicted change in depressive symptoms . This study supports the effectiveness of an exercise intervention for the sustained reduction of depressive symptoms among sedentary older adults and physical self-esteem as a potential mediator of this effect BACKGROUND Previous observational and interventional studies have suggested that regular physical exercise may be associated with reduced symptoms of depression . However , the extent to which exercise training may reduce depressive symptoms in older patients with major depressive disorder ( MDD ) has not been systematic ally evaluated . OBJECTIVE To assess the effectiveness of an aerobic exercise program compared with st and ard medication ( ie , antidepressants ) for treatment of MDD in older patients , we conducted a 16-week r and omized controlled trial . METHODS One hundred fifty-six men and women with MDD ( age , > or = 50 years ) were assigned r and omly to a program of aerobic exercise , antidepressants ( sertraline hydrochloride ) , or combined exercise and medication . Subjects underwent comprehensive evaluations of depression , including the presence and severity of MDD using Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition criteria and Hamilton Rating Scale for Depression ( HAM-D ) and Beck Depression Inventory ( BDI ) scores before and after treatment . Secondary outcome measures included aerobic capacity , life satisfaction , self-esteem , anxiety , and dysfunctional cognitions . RESULTS After 16 weeks of treatment , the groups did not differ statistically on HAM-D or BDI scores ( P = .67 ) ; adjustment for baseline levels of depression yielded an essentially identical result . Growth curve models revealed that all groups exhibited statistically and clinical ly significant reductions on HAM-D and BDI scores . However , patients receiving medication alone exhibited the fastest initial response ; among patients receiving combination therapy , those with less severe depressive symptoms initially showed a more rapid response than those with initially more severe depressive symptoms . CONCLUSIONS An exercise training program may be considered an alternative to antidepressants for treatment of depression in older persons . Although antidepressants may facilitate a more rapid initial therapeutic response than exercise , after 16 weeks of treatment exercise was equally effective in reducing depression among patients with MDD Abstract : A r and omised controlled trial was conducted to determine whether a 12–month program of group exercise had beneficial effects on physiological and cognitive functioning and mood in 187 older community – dwelling women . The exercisers ( n= 94 ) and controls ( n= 93 ) were well matched in terms of the test measures and a number of health and life – style assessment s. The mean number of classes attended by the 71 exercise subjects who completed the program was 59.0 ( range 26 to 82 ) . At the end of the trial , the exercisers showed significant improvements in reaction time , strength , memory span and measures of wellbeing when compared with the controls . There was also an indication that anxiety had been reduced in the exercisers . Within the exercise group , improvements in memory span were associated with concomitant improvements in both reaction time and muscle strength . Also , within this group , initial mood measures were significantly inversely associated with improvements at retest , which suggests that the program may have normalised mood states in subjects who had high initial depression , anxiety and stress levels , rather than inducing improvements in all subjects . These findings suggest that group exercise has beneficial effects on physiological and cognitive functioning and wellbeing in older people Objective : To examine a 1-year follow-up of a 4-month , controlled clinical trial of exercise and antidepressant medication in patients with major depressive disorder ( MDD ) . Methods : In the original study , 202 sedentary adults with MDD were r and omized to : a ) supervised exercise ; b ) home-based exercise ; c ) sertraline ; or d ) placebo pill . We examined two outcomes measured at 1-year follow-up ( i.e. , 16 months post r and omization ) : 1 ) continuous Hamilton Depression Rating Scale score ; and 2 ) MDD status ( depressed ; partial remission ; full remission ) in 172 available participants ( 85 % of the original cohort ) . Regression analyses were performed to examine the effects of treatment group assignment , as well as follow-up antidepressant medication use and self-reported exercise ( Godin Leisure-Time Exercise Question naire ) , on the two outcomes . Results : In the original study , patients receiving exercise achieved similar benefits compared with those receiving sertraline . At the time of the 1-year follow-up , rates of MDD remission increased from 46 % at post treatment to 66 % for participants available for follow-up . Neither initial treatment group assignment nor antidepressant medication use during the follow-up period were significant predictors of MDD remission at 1 year . However , regular exercise during the follow-up period predicted both Hamilton Depression Rating Scale scores and MDD diagnosis at 1 year . This relationship was curvilinear , with the association concentrated between 0 minute and 180 minutes of weekly exercise . Conclusion : The effects of aerobic exercise on MDD remission seem to be similar to sertraline after 4 months of treatment ; exercise during the follow-up period seems to extend the short-term benefits of exercise and may augment the benefits of antidepressant use . Trial Registration : clinical trials.gov Identifier : NCT00331305 . MDD = major depressive disorder ; HAM-D = Hamilton Depression Rating Scale ; SCID = Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition Axis I Disorders ; PSSS = Perceived Social Support Scale BACKGROUND Laughter Yoga founded by M. Kataria is a combination of unconditioned laughter and yogic breathing . Its effect on mental and physical aspects of healthy individuals was shown to be beneficial . OBJECTIVE The objective of this study was to compare the effectiveness of Kataria 's Laughter Yoga and group exercise therapy in decreasing depression and increasing life satisfaction in older adult women of a cultural community of Tehran , Iran . METHODS Seventy depressed old women who were members of a cultural community of Tehran were chosen by Geriatric depression scale ( score>10 ) . After completion of Life Satisfaction Scale pre-test and demographic question naire , subjects were r and omized into three groups of laughter therapy , exercise therapy , and control . Subsequently , depression post-test and life satisfaction post-test were done for all three groups . The data were analyzed using analysis of covariance and Bonferroni 's correction . RESULTS Sixty subjects completed the study . The analysis revealed a significant difference in decrease in depression scores of both Laughter Yoga and exercise therapy group in comparison to control group ( p<0.001 and p<0.01 , respectively ) . There was no significant difference between Laughter Yoga and exercise therapy groups . The increase in life satisfaction of Laughter Yoga group showed a significant difference in comparison with control group ( p<0.001 ) . No significant difference was found between exercise therapy and either control or Laughter Yoga group . CONCLUSION Our findings showed that Laughter Yoga is at least as effective as group exercise program in improvement of depression and life satisfaction of elderly depressed women OBJECTIVES This report released findings of a r and omized controlled trial conducted in Hong Kong to further our underst and ing of the psychosocial effects of qigong on elderly persons with depression . DESIGN Eighty-two participants with a diagnosis of depression or obvious features of depression were recruited and r and omly assigned into the intervention and comparison group . The intervention group was given a 16-week period of Qigong practice while the comparison group participated in a newspaper reading group with same duration and frequency . RESULTS After eight weeks of qigong practice , the intervention group participants outstripped themselves in improvement in mood , self-efficacy and personal well being , and physical and social domains of self-concept when compared with comparison subjects . After 16 weeks of practice , the improvement generalized to the daily task domain of the self-concept . CONCLUSIONS This report shows that regular qigong practice could relieve depression , improve self-efficacy and personal well being among elderly persons with chronic physical illness and depression PURPOSE We wanted to assess the effectiveness of a home-based physical activity program , the Depression in Late Life Intervention Trial of Exercise ( DeLLITE ) , in improving function , quality of life , and mood in older people with depressive symptoms . METHODS We undertook a r and omized controlled trial involving 193 people aged 75 years and older with depressive symptoms at enrollment who were recruited from primary health care practice s in Auckl and , New Zeal and . Participants received either an individualized physical activity program or social visits to control for the contact time of the activity intervention delivered over 6 months . Primary outcome measures were function , a short physical performance battery comprising balance and mobility , and the Nottingham Extended Activities of Daily Living scale . Secondary outcome measures were quality of life , the Medical Outcomes Study 36-item short form , mood , Geriatric Depression Scale ( GDS-15 ) , physical activity , Auckl and Heart Study Physical Activity Question naire , and self-report of falls . Repeated measures analyses tested the differential impact on outcomes over 12 months ’ follow-up . RESULTS The mean age of the participants was 81 years , and 59 % were women . All participants scored in the at – risk category on the depression screen , 53 % had a Diagnostic and Statistical Manual of Mental Disorders or International Classification of Diseases , Tenth Revision diagnosis of major depression or scored more than 4 on the GDS-15 at baseline , indicating moderate or severe depression . Almost all participants , 187 ( 97 % ) , completed the trial . Overall there were no differences in the impact of the 2 interventions on outcomes . Mood and mental health related quality of life improved for both groups . CONCLUSION The DeLLITE activity program improved mood and quality of life for older people with depressive symptoms as much as the effect of social visits . Future social and activity interventions should be tested against a true usual care control CONTEXT Older adults with social isolation , medical comorbidity , and physical impairment are more likely to be depressed but may be less able to seek appropriate care for depression compared with older adults without these characteristics . OBJECTIVE To determine the effectiveness of a home-based program of detecting and managing minor depression or dysthymia among older adults . DESIGN AND SETTING R and omized controlled trial with recruitment through community senior service agencies in metropolitan Seattle , Wash , from January 2000 to May 2003 . PATIENTS One hundred thirty-eight patients aged 60 years or older with minor depression ( 51.4 % ) or dysthymia ( 48.6 % ) . Patients had a mean of 4.6 ( SD , 2.1 ) chronic medical conditions ; 42 % of the sample belonged to a racial/ethnic minority , 72 % lived alone , 58 % had an annual income of less than 10 000 dollars , and 69 % received a form of home assistance . INTERVENTIONS Patients were r and omly assigned to the Program to Encourage Active , Rewarding Lives for Seniors ( PEARLS ) intervention ( n = 72 ) or usual care ( n = 66 ) . The PEARLS intervention consisted of problem-solving treatment , social and physical activation , and potential recommendations to patients ' physicians regarding antidepressant medications . MAIN OUTCOME MEASURES Assessment s of depression and quality of life at 12 months compared with baseline . RESULTS At 12 months , compared with the usual care group , patients receiving the PEARLS intervention were more likely to have at least a 50 % reduction in depressive symptoms ( 43 % vs 15 % ; odds ratio [ OR ] , 5.21 ; 95 % confidence interval [ CI ] , 2.01 - 13.49 ) , to achieve complete remission from depression ( 36 % vs 12 % ; OR , 4.96 ; 95 % CI , 1.79 - 13.72 ) , and to have greater health-related quality -of-life improvements in functional well-being ( P = .001 ) and emotional well-being ( P = .048 ) . CONCLUSIONS The PEARLS program , a community-integrated , home-based treatment for depression , significantly reduced depressive symptoms and improved health status in chronically medically ill older adults with minor depression and dysthymia The present study has been carried out to investigate the effects of group-based Turkish folkloric dances on physical performance , balance , depression and quality of life ( QoL ) in 40 healthy adult elderly females over the age of 65 years . Subjects were r and omly allocated into Group 1 ( folkloric dance-based exercise ) and Group 2 ( control ) . A 8-week dance-based exercise program was performed . Outcome measures included a 20-m walk test , a 6-min walk test , stair climbing and chair rise time , Berg balance scale ( BBS ) , the Medical Outcomes Study ( MOS ) 36-item short form health survey ( SF-36 ) , and geriatric depression scale ( GDS ) question naires . In Group 1 statistically significant improvements were found in most of the physical performance tests , BBS and some SF-36 subscales after the exercise ( p<0.05 ) . In the Group 2 there was no clinical ly significant change in the variables . Comparing the groups , significant improvements in favor of Group 1 have emerged in most of the functional performance tests , in some of the SF-36 subscales and BBS score ( p<0.05 ) . We achieved improvements in physical performance , balance and QoL in elderly females . Application of folkloric dance specific to countries as an exercise program for elderly people may be helpful This study examines and compares the effect of aerobic and resistance exercise on emotional and physical function among older persons with initially high or low depressive symptomatology . Data are from the Fitness , Arthritis and Seniors Trial , a trial among 439 persons 60 years or older with knee osteoarthritis r and omized to health education ( control ) , resistance exercise , or aerobic exercise groups . Depressive symptoms ( assessed by the Center for Epidemiologic Studies --Depression scale ) and physical function ( disability , walking speed , and pain ) were assessed at baseline and after 3 , 9 , and 18 months . Compared with results for the control group , aerobic exercise significantly lowered depressive symptoms over time . No such effect was observed for resistance exercise . The reduction in depressive symptoms with aerobic exercise was found both among the 98 participants with initially high depressive symptomatology and among the 340 participants with initially low depressive symptomatology and was the strongest for the most compliant persons . Aerobic and resistance exercise significantly reduced disability and pain and increased walking speed both , and to an equal extent , in persons with high depressive symptomatology and persons with low depressive symptomatology BACKGROUND Depression in elderly people may be contributed to by the multiple losses of aging . Exercise has the potential to positively impact many of these losses simultaneously . We tested the hypothesis that progressive resistance training ( PRT ) would reduce depression while improving physiologic capacity , quality of life , morale , function and self-efficacy without adverse events in an older , significantly depressed population . METHODS We conducted a 10-week r and omized controlled trial of volunteers aged 60 and above with major or minor depression or dysthymia . Subjects were r and omized for 10 weeks to either a supervised PRT program three times a week or an attention-control group . RESULTS A total of 32 subjects aged 60 - 84 , mean age 71.3 + /- 1.2 yr , were r and omized and completed the study . No significant adverse events occurred . Median compliance was 95 % . PRT significantly reduced all depression measures ( Beck Depression Inventory in exercisers 21.3 + /- 1.8 to 9.8 + /- 2.4 versus controls 18.4 + /- 1.7 to 13.8 + /- 2 , p = .002 ; Hamilton Rating Scale of Depression in exercisers 12.3 + /- 0.9 to 5.3 + /- 1.3 versus controls 11.4 + /- 1.0 to 8.9 + /- 1.3 , p = .008 ) . Quality of life subscales of bodily pain ( p = .001 ) , vitality ( p = .002 ) , social functioning ( p = .008 ) , and role emotional ( p = .02 ) were all significantly improved by exercise compared to controls . Strength increased a mean of 33 % + /- 4 % in exercisers and decreased 2 % + /- 2 % in controls ( p < .0001 ) . In a multiple stepwise regression model , intensity of training was a significant independent predictor of decrease in depression scores ( r2 = .617 , p = .0002 ) . CONCLUSIONS PRT is an effective antidepressant in depressed elders , while also improving strength , morale , and quality of life Objective : To determine the effect of a general group-based exercise programme on cognitive performance and mood among seniors without dementia living in retirement villages . Design : R and omised controlled trial . Setting : Four intermediate care and four self-care retirement village sites in Sydney , Australia . Participants : 154 seniors ( 19 men , 135 women ; age range 62 to 95 years ) , who were residents of intermediate care and self-care retirement facilities . Intervention : Participants were r and omised to one of three experimental groups : ( 1 ) a general group-based exercise ( GE ) programme composed of resistance training and balance training exercises ; ( 2 ) a flexibility exercise and relaxation technique ( FR ) programme ; or ( 3 ) no-exercise control ( NEC ) . The intervention groups ( GE and FR ) participated in 1-hour exercise classes twice a week for a total period of 6 months . Main outcome measures : Using st and ard neuropsychological tests , we assessed cognitive performance at baseline and at 6-month re-test in three domains : ( 1 ) fluid intelligence ; ( 2 ) visual , verbal and working memory ; and ( 3 ) executive functioning . We also assessed mood using the Geriatric Depression Scale ( GDS ) and the Positive and Negative Affect Schedule ( PANAS ) . Results : The GE programme significantly improved cognitive performance of fluid intelligence compared with FR or NEC . There were also significant improvements in the positive PANAS scale within both the GE and FR groups and an indication that the two exercise programmes reduced depression in those with initially high GDS scores . Conclusions : Our GE programme significantly improved cognitive performance of fluid intelligence in seniors residing in retirement villages compared with our FR programme and the NEC group . Furthermore , both group-based exercise programmes were beneficial for certain aspects of mood within the 6-month intervention period Objective : To evaluate the short-term effects of exercise in patients with major depression . Design : Prospect i ve , r and omised , controlled study . Setting : A university hospital . Patients : A consecutive series of 38 in patients with a major depression episode undergoing st and ard clinical antidepressant drug treatment . Interventions : Patients were r and omly assigned to an exercise ( walking , n = 20 ) or placebo ( low-intensity stretching and relaxation exercises , n = 18 ) group . Training was carried out for 10 days . Main outcome measurements : Severity of depression assessed with the Bech-Rafaelsen Melancholy Scale ( BRMS ) and the Center for Epidemiologic Studies Depression scale ( CES-D ) . Results : After 10 days , reduction of depression scores in the exercise group was significantly larger than in the placebo group ( BRMS : 36 % v 18 % ; CES-D : 41 % v 21 % ; p for both = 0.01 ) ; the proportion of patients with a clinical response ( reduction in the BRMS scores by more than six points ) was also larger for the exercise group ( 65 % v 22 % , p<0.01 ) . Conclusions : Endurance exercise may help to achieve substantial improvement in the mood of selected patients with major depression in a short time BACKGROUND Depression is common in later life . AIMS To determine whether exercise is effective as an adjunct to antidepressant therapy in reducing depressive symptoms in older people . METHOD Patients were r and omised to attend either exercise classes or health education talks for 10 weeks . Assessment s were made " blind " at baseline , and at 10 and 34 weeks . The primary outcome was seen with the 17-item Hamilton Rating Scale for Depression ( HRSD ) . Secondary outcomes were seen with the Geriatric Depression Scale , Clinical Global Impression and Patient Global Impression . RESULTS At 10 weeks a significantly higher proportion of the exercise group ( 55 % v. 33 % ) experienced a greater than 30 % decline in depression according to HRSD ( OR=2.51 , P=0.05 , 95 % CI 1.00 - 6.38 ) . CONCLUSIONS Because exercise was associated with a modest improvement in depressive symptoms at 10 weeks , older people with poorly responsive depressive disorder should be encouraged to attend group exercise activities PURPOSE Although cross-sectional studies have demonstrated an association between higher levels of aerobic fitness and improved neurocognitive function , there have been relatively few interventional studies investigating this relationship , and results have been inconsistent . We assessed the effects of aerobic exercise on neurocognitive function in a r and omized controlled trial of patients with major depressive disorder ( MDD ) . METHODS Two-hundred and two sedentary men ( n = 49 ) and women ( n = 153 ) , aged 40 yr and over and who met diagnostic criteria for MDD , were r and omly assigned to the following : a ) supervised exercise , b ) home-based exercise , c ) sertraline , or d ) placebo pill . Before and after 4 months of treatment , participants completed measures of : Executive Function ( Trail Making Test B-A difference score , Stroop Color-Word , Ruff 2 & 7 Test , Digit Symbol ) , Verbal Memory ( Logical Memory , Verbal Paired Associates ) , and Verbal Fluency/Working Memory ( Animal Naming , Controlled Oral Word Association Test , Digit Span ) . Multivariate analyses of covariance were performed to test the effects of treatment on posttreatment neuropsychological test scores , with baseline neuropsychological test scores , age , education , and change in depression scores entered as covariates . RESULTS The performance of exercise participants was no better than participants receiving placebo across all neuropsychological tests . Exercise participants performed better than participants receiving sertraline on tests of executive function but not on tests of verbal memory or verbal fluency/working memory . CONCLUSIONS We found little evidence to support the benefits of an aerobic exercise intervention on neurocognitive performance in patients with MDD The purpose of this study was to conduct a pilot clinical trial to test the feasibility and efficacy of an exercise program and anti-depressant treatment compared with usual care in improving the emotional and physical functioning of older adults with minor depression . Participants were 37 older adults with minor depression who were r and omized to exercise , sertraline , or usual care ; 32 participants completed the 16-week study . Outcomes included measures of both emotional ( clinician and self-report ) and physical ( observed and self-report ) functioning . There were trends for the superiority of the exercise and sertraline conditions over usual care in improving SF-36 mental health scores and clinician-rated depression scores . Individuals in the exercise condition showed greater improvements in physical functioning than individuals in the usual care condition . Both sertraline and exercise show promise as treatments for late-life minor depression . However , exercise has the added benefit of improving physical functioning as well The 12-month effects of exercise training on psychological outcomes in adults ages 50 - 65 years were evaluated . Ss ( N = 357 ) were r and omly assigned to assessment -only control or to higher intensity group , higher intensity home , or lower intensity home exercise training . Exercisers showed reductions in perceived stress and anxiety in relation to controls ( p < .04 ) . Reductions in stress were particularly notable in smokers . Regardless of program assignment , greater exercise participation was significantly related to less anxiety and fewer depressive symptoms , independent of changes in fitness or body weight ( p < .05 ) . It was concluded that neither a group format nor vigorous activity was essential in attaining psychological benefits from exercise training in healthy adults The effects of yoga and ayurveda on geriatric depression were evaluated in 69 persons older than 60 who were living in a residential home . Participants were stratified by age and gender and r and omly allocated to three groups : Yoga , Ayurveda , or Wait-list Control . The 15-item Geriatric Depression Scale was used to assess depressive symptoms prior to the intervention , and after 3 months and 6 months post-intervention . Participation in one of the three groups lasted 24 weeks . The yoga program ( 7 hours 30 minutes per week ) included physical postures , relaxation techniques , regulated breathing , devotional songs , and lectures . The Ayurveda Group received an herbal preparation twice daily for the whole period . The depression symptom scores of the Yoga Group at both 3 and 6 months decreased significantly , from a group average baseline of 10.6 to 8.1 and 6.7 , respectively ( p < .001 , paired t-test ) . The other groups showed no change . Hence , an integrated approach of yoga including the mental and philosophical aspects in addition to the physical practice s was useful for institutionalized older persons OBJECTIVE Mood disorders are a frequent problem in old age , and their symptoms constitute an important public health issue . These alterations affect the quality of life mainly by restricting social life . The participation in a regular exercise program is an effective way of reducing or preventing the functional decline associated with aging . The aim of the present study was to examine the effects of fitness-endurance activity ( at the intensity of Ventilatory Threshold 1 ( VT-1 ) ) in depression , anxiety and quality of life scores in seniors . METHODS The study involved 46 sedentary seniors aged 60 - 75 ( 66.97 + /- 4.80 ) who were r and omly allocated to two groups : 1 ) Control group , which was neither asked to vary their everyday activities nor to join a regular physical fitness program ; and 2 ) Experimental group , whose members took part in an aerobic fitness program consisting of ergometer cycle sessions 3 times a week on alternate days for six months working at a heart rate corresponding to ventilatory threshold ( VT-1 ) intensity . Subjects were su bmi tted to a basal evaluation using the geriatric depression screening scale -- GDS , STAI trait/state ( anxiety scale ) and SF-36 ( quality of life scale ) . RESULTS Comparing the groups after the study period , we found a significant decrease in depressive and anxiety scores and an improvement in the quality of life in the experimental group , but no significant changes in the control group . CONCLUSION The data suggest that an aerobic exercise program at VT-1 intensity suffices to promote favorable modifications in depressive and anxiety scores to improve the quality of life in seniors BACKGROUND Pharmacological treatment of depression in geriatric patients is often difficult . Although unsupervised exercise has been shown to benefit younger depressed patients , there is no evidence that unsupervised exercise can be used as a maintenance treatment for depression in elderly patients . Our aim was to test the feasibility and efficacy of unsupervised exercise as a long-term treatment for clinical depression in elderly patients . METHODS We studied 32 subjects ( 71.3 + /- 1.2 years of age , mean + /- SE ) in a 20-week , r and omized , controlled trial , with follow-up at 26 months . Subjects were community-dwelling patients with major or minor depression or dysthymia . Exercisers engaged in 10 weeks of supervised weight-lifting exercise followed by 10 weeks of unsupervised exercise . Controls attended lectures for 10 weeks . No contact was made with either group after 20 weeks until final follow-up . Blinded assessment was made with the Beck Depression Inventory ( BDI ) , the Philadelphia Geriatric Morale Scale , and Ewart 's Self Efficacy Scale at 20 weeks and with the BDI and physical activity question naire at 26 months . RESULTS Patients r and omized to the exercise condition completed 18 + /- 2 sessions of unsupervised exercise during Weeks 10 to 20 . The BDI was significantly reduced at both 20 weeks and 26 months of follow-up in exercisers compared with controls ( p < .05-.001 ) . At the 26-month follow-up , 33 % of the exercisers were still regularly weight lifting , versus 0 % of controls ( p < .05 ) . CONCLUSIONS Unsupervised weight-lifting exercise maintains its antidepressant effectiveness at 20 weeks in depressed elderly patients . Long-term changes in exercise behavior are possible in some patients even without supervision PURPOSE The purpose of this study was to determine the effects of a Health Maintenance Program on physical functions and mental health of the elderly in nursing homes . METHOD Sixty elderly(over 65 years old ) in a r and omized control study participated in a 16-week group-based intervention including functional exercises and health education . The participants were divided into 3 groups(Health Maintenance Program Group , Supportive Music Exercise Group , and Control Group ) of 20 elderly each . Data was collected from Dec. 1st , 2005 to Mar. 30th , 2006 . Physical function of lower body strength was assessed using a 30-second chair test , flexibility was assessed using a sit- and -reach test , and static balance was assessed by the ability to balance on one leg with open and closed eyes . Depression was assessed using the Korean Form of the Geriatric Depression Scale and self esteem was assessed using Rosenberg 's Self Esteem Question naire . Data was analyzed by Chi-square test , One-way ANOVA , and Repeated measure two factor analysis . RESULTS A Health Maintenance Program significantly increased muscle strength , flexibility and static balance , but depression and self-esteem scores were not significantly changed . CONCLUSION Findings demonstrated that a Health Maintenance Program was more effective on physical function than mental health of the elderly in nursing homes OBJECTIVES To examine the effects of physical activity counseling on mood among older people unselected for their depressive symptomatology . METHODS Data are from " Screening and Counseling for Physical Activity and Mobility in Older People " project ( SCAMOB ) , conducted in Finl and during 2003 - 2005 . SCAMOB was a 2-year single-blinded r and omized controlled trial among 624 participants 75 years and older r and omized into physical activity counseling group and control group . Depressive symptoms were assessed at baseline and after 24 months using Center for the Epidemiologic Studies Depression Scale . RESULTS Among all the study participants , no effect of intervention was observed . However , among subgroup with minor depressive symptoms at baseline , a significant treatment effect was observed , where depressive symptoms decreased in the intervention group and increased in the control group . CONCLUSIONS These findings suggest that physical activity counseling may reduce depression among those with minor depressive symptoms , which warrants for future studies Thirty community-dwelling , moderately depressed elderly were r and omly assigned to 1 of 3 interventions : experimenter-accompanied exercise in the form of walking , a social contact control condition , and a wait-list control . Exercise and social contact both result ed in significant reductions in both the total and the psychological subscale of the Beck Depression Inventory ( BDI ) . The exercise condition , however , unlike the control conditions , result ed in decreased somatic symptoms of the BDI . These results indicate that , at least in the short term , exercise has a broader effect compared with control conditions in reducing depressive symptoms in the moderately depressed elderly The objective of this study was to determine whether the effects of Tai Chi training on depressive symptoms in Chinese older patients with depression remained statistically significant after social support was controlled . Fourteen community-dwelling older patients from a psychogeriatric outpatient clinic were r and omly assigned to either a 3-month Tai Chi intervention with 36 sessions or a wait-list control . Depression was assessed by the Center for Epidemiological Studies Depression Scale ( CES-D ) , whereas social support was measured by the Lubben Social Network Scale ( LSNS ) . By performing multiple regression analyses , we examined whether the effect of group assignment ( Tai Chi and control groups ) on five measures of depressive symptoms ( i.e. the total scores of the CES-D scale , and scores of all its subscales including symptoms related to somatic , negative affect , interpersonal relation , and well-being ) remained significant after controlling for age , gender , education , and LSNS . Results indicate that the beneficial impact of Tai Chi on five measures of depressive symptoms remained significant when we adjusted for age , gender , and education . On the other h and , the effect of our intervention disappeared when changes of social support were controlled for . Social support might be partly responsible for the effect of Tai Chi on depressive symptoms because practicing Tai Chi is a social activity in nature |
338 | 27,816,862 | Educational ICT was found to be non-inferior to traditional teaching , while offering benefits to teaching and learning efficiency .
Where support is in place , ICT improves the learning environment for staff and students , but human and environmental barriers need to be addressed .
This review illuminates more advantages for ICT in nurse training than previously .
The key advantage of flexibility is supported , though with little evidence for effect on depth of learning | OBJECTIVES To evaluate and summarise the utility and impact of information communication technology ( ICT ) in enhancing student performance and the learning environment in pre- registration nursing . | BACKGROUND In 2006 , a digitalised clinical portfolio was introduced into an undergraduate nursing program . The use of a tablet personal computer ( PC ) with wireless broadb and access could overcome issues around computer access in the clinical setting enhancing authenticity and timeliness of assessment . METHODS In July 2007 , a Hewlett-Packard TC 4400 tablet PC was issued to three participating students . A focus group utilising a semi-structured interview and a survey collected data from the students at the end of the trial to determine the effectiveness of the strategy . RESULTS Participants used tablet PCs to access their portfolios . However , lack of space , busy wards and concerns about the security of the PCs limited their use in the clinical setting . The majority of their journal entries were made at home and within similar time frames to those prior to access to tablet PCs . Participants also used the PCs to provide education to other students and staff but were reluctant to use them in front of patients . CONCLUSION Barriers limiting the use of tablet PCs in the clinical setting may be overcome with greater proficiency in their utility and increased portability of the technology . Tablet PCs offer advantages related to and beyond portfolio use in the clinical setting Background and Aims E-learning is developing fast because of the rapid increased use of smartphones , tablets and portable computers . We might not think of it as e-learning , but today many new e-books are in fact very complex electronic teaching platforms . It is generally accepted that e-learning is as effective as classroom teaching methods , but little is known about its value in relaying contents of different levels of complexity to students . We set out to investigate e-learning effects on simple recall and complex problem-solving compared to classroom teaching . Methods 63 nurses specializing in anesthesiology were evenly r and omized into three groups . They were given internet-based knowledge tests before and after attending a teaching module about respiratory physiology and pulmonology . The three groups was either an e-learning group with eBook teaching material , an e-learning group with case-based teaching or a group with face-to-face case-based classroom teaching . After the module the students were required to answer a post-test . Time spent and the number of logged into the system was also measured . Results For simple recall , all methods were equally effective . For problem-solving , the eCase group achieved a comparable knowledge level to classroom teaching , while textbook learning was inferior to both ( p<0.01 ) . The textbook group also spent the least amount of time on acquiring knowledge ( 33 minutes , p<0.001 ) , while the eCase group spent significantly more time on the subject ( 53 minutes , p<0.001 ) and logged into the system significantly more ( 2.8 vs 1.6 , p<0.001 ) . Conclusions E-learning based cases are an effective tool for teaching complex knowledge and problem-solving ability , but future studies using higher-level e-learning are encouraged . Simple recall skills , however , do not require any particular learning method Objective . To evaluate the effectiveness of a student response system on short- and long-term learning in a required second-year pharmacy course . Method . Student volunteers enrolled in the course Drug Literature Evaluation were blinded and r and omized to 1 of 2 groups . Group 1 attended a lecture in which the instructor used a student response system . Group 2 attended the same lecture by the same instructor an hour later , but no student response system was used . A 16-point unannounced quiz on the lecture material was administered to both groups at the end of class . Approximately 1 month later , both groups were given another unannounced quiz on the same material to test long-term student learning . Results . One hundred seventy-nine ( 92.3 % ) students participated in both quizzes . Students who attended the class in which the student response system was used scored an average 1 point higher on quiz 1 than students who were assigned to the control group ( 10.7 vs. 9.7 ; p = 0.02 ) . No significant difference was seen between the quiz 2 scores of the 2 groups ( 9.5 vs. 9.5 ; p = 0.99 ) . Conclusions . The use of a student response system can positively impact students ' short-term learning ; however , that positive effect did not appear to last over time . Faculty members may want to consider the use of student response systems to enhance student learning in large lecture classes Aim . This pilot study sought to evaluate the effectiveness of academic podcasts in promoting knowledge retention and application in nursing students . Background . Nursing education no longer simply occurs in a fixed location or time . Computer‐enhanced mobile learning technologies , such as academic podcasts , must be grounded in pedagogically sound characteristics to ensure effective implementation and learning in nursing education . Method . A convenience sample of 35 female undergraduate nursing students was r and omized into three groups : a traditional face‐to‐face lecture group , an unsegmented ( non‐stop ) podcast lecture group , and a segmented podcast lecture group . Retention and application of information were measured through a multiple‐choice quiz and a case study based on lecture content . Results . Students in the segmented podcast lecture group demonstrated higher scores on multiple‐choice and case‐ study assessment s than those in the other two groups . Conclusion . Nurse educators should be aware of this finding when seeking to employ podcast lectures in nursing education The purpose of this study was to test whether an interactive , web-based training program is more effective than an existing , flat-text , e-learning program at improving oral health students ' knowledge , motivation , and self-efficacy to address signs of disordered eating behaviors with patients . Eighteen oral health classes of dental and dental hygiene students were r and omized to either the Intervention ( interactive program ; n=259 ) or Alternative ( existing program ; n=58 ) conditions . Hierarchical linear modeling assessed for posttest differences between groups while controlling for baseline measures . Improvement among Intervention participants was superior to those who completed the Alternative program for three of the six outcomes : benefits /barriers , self-efficacy , and skills-based knowledge ( effect sizes ranging from 0.43 to 0.87 ) . This study thus suggests that interactive training programs may be better than flat-text e-learning programs for improving the skills-based knowledge and self-efficacy necessary for behavior change Background : Teaching methods that provide an opportunity for individual engagement and focussed feedback are required to create an active learning environment for case-based teaching in large groups . Aims : A prospect i ve observational controlled study was conducted to evaluate whether the use of an audience response system ( ARS ) would promote an active learning environment during case-based discussion s in large groups , have an impact on student motivation and improve long-term retention . Methods : Group A ( N = 83 ) participated in large group case discussion s where student participation was voluntary , while for group B ( N = 86 ) an ARS was used . Data collection methods included student and teacher surveys , student focus group interviews , independent observations and 1-year post-course testing . Results : Results indicated that the use of an ARS provided an active learning environment during case-based discussion s in large groups by favouring engagement , observation and critical reflection and by increasing student and teacher motivation . Although final exam results were significantly improved in group B , long-term retention was not significantly different between groups . Conclusions : It was concluded that ARS use significantly improved the learning experience associated with case-based discussion s in a large group of undergraduate students With the rapid development of the Internet , online testing is becoming more widely-used in education . The purpose of this study is to explore the learning effectiveness of nursing students using online testing as an assistant tool . The participants were 146 junior college nursing students aged 19 to 20 taking the community health nursing course . With a class as the unit , three classes were r and omized and allocated to one experimental group and two control groups . Two structured question naires were used to obtain the basic data , and the groups ' examination results were also collected . The results of this study showed that before the intervention , there were no significant differences between the experimental and two control groups . After the intervention and adjusting for potential confounders , the score of midterm test in the experimental group was significantly better than those of the control groups . Over half of the students felt that answering 21 to 30 questions in 31 to 60 min for one unit of testing were appropriate . The results of this study showed that online testing is feasible for use as an assistant tool for learning . However , the positive effects of this approach appeared to be short- rather than long-term , and thus more studies are required in future BACKGROUND The aim of nursing education is to prepare students with critical thinking , high interests in profession and high proficiency in patient care . Cooperative learning promotes team work and encourages knowledge building upon discussion . It has been viewed as one of the most powerful learning methods . Technology has been considered an influential tool in teaching and learning . It assists students in gathering more information to solve the problems and master skills better . PURPOSE The purpose of this study was to compare the effect of technology-based cooperative learning with technology-based individual learning in nursing students ' critical thinking in catheterization knowledge gaining , error discovering , skill acquisitions , and overall scores . METHODS This study used a pretest-posttest experimental design . Ninety-eight students were assigned r and omly to one of two groups . Question naires and tests were collected at baseline and after completion of intervention . RESULTS The results of this study showed that there was no significant difference in related catheterization skill performance . However , the remaining variables differed greatly between the two groups . CONCLUSIONS AND APPLICATIONS : This study 's findings guide the research ers and instructors to use technology-based cooperative learning more appropriately . Future research should address the design of the course module and the availability of mobile devices to reach student-centered and learn on the move goals Student performance was compared on written and psychomotor skill tests of freshman dental students receiving conventional lectures versus the same lectures containing interactive components using TurningPoint , a wireless audience response system ( ARS ) . The research design was a controlled crossover study with seventy-seven freshman dental students conducted in a pre clinical operative dentistry course . Two r and omized groups alternated the two study lectures , one with ARS and the other without ARS . Student knowledge retention was measured through written examination using immediate posttest , as well as questions on the unit and final examinations . Psychomotor skill tests were given on both lecture topics . Statistically significant differences indicating superiority of ARS were identified for performance on the immediate posttest and psychomotor skill test only for the lecture " Principles of Dental Bonding . " The other examinations/skill testing showed no significant difference . These results indicate that ARS is a promising teaching tool for dental education BACKGROUND Online learning is growing rapidly worldwide , especially in the health related sectors such as medicine and nursing . Our trial wished to measure the objective ( i.e. final exam results , courseware usage patterns ) and subjective ( satisfaction ) efficiency of online vs. face-to-face learning in a prospect i ve , controlled trial , a first of its kind in Israel . MATERIAL S AND METHODS The trial tested a blended online course , teaching introduction to clinical nephrology . The course was filmed and edited into a learning platform to fit computer based learning . 90 nursing students , from 4 bachelor 's nursing programs in Israel participated in the study . The intervention group included 32 students who studied using the online course , accompanied by 3 frontal meetings dealing with technical and content issues . The reference group included 58 students from 3 nursing programs , study ing in a traditional face-to-face course . RESULTS The final exam results were significantly higher in the intervention group compared with the reference group ( 9.6 ± 2.57 vs. 8.4 ± 2.72 ; p<0.05 ) . Student satisfaction was very high in the intervention group : 97 % thought the course was well organized , 100 % thought the teacher taught clearly and consistently , 90 % thought the teacher encouraged self-thinking,100 % thought the teacher used clarifying examples , 91 % thought the teaching aids helped the learning process and 97 % thought the teaching method contributed to the learning process . The average usage of the online course was 4:10h vs. 14 academic hours ( 10:30 h ) in the traditional course . The daily usage habits of the courseware were also followed , indicating that most learning took place between 12 PM and 1 AM , peaking between 5 PM and 7 PM , and dipping between 3 AM and 10 AM . CONCLUSIONS The online course had higher efficiency compared to the traditional face-to-face course . The subjective feedback of the intervention group proves high satisfaction with online learning |
339 | 24,624,970 | Conclusion Lower health literacy affects key decision-making outcomes , but few existing PtDAs have addressed the needs of lower health literacy users . | Background Effective use of a patient decision aid ( PtDA ) can be affected by the user ’s health literacy and the PtDA ’s characteristics .
Systematic review s of the relevant literature can guide PtDA developers to attend to the health literacy needs of patients .
The review s reported here aim ed to assess:1 .
a ) the effects of health literacy / numeracy on selected decision-making outcomes , and b ) the effects of interventions design ed to mitigate the influence of lower health literacy on decision-making outcomes , and 2 . | Objective To evaluate the effect of a video decision support tool on the preferences for future medical care in older people if they develop advanced dementia , and the stability of those preferences after six weeks . Design R and omised controlled trial conducted between 1 September 2007 and 30 May 2008 . Setting Four primary care clinics ( two geriatric and two adult medicine ) affiliated with three academic medical centres in Boston . Participants Convenience sample of 200 older people ( ≥65 years ) living in the community with previously scheduled appointments at one of the clinics . Mean age was 75 and 58 % were women . Intervention Verbal narrative alone ( n=106 ) or with a video decision support tool ( n=94 ) . Main outcome measures Preferred goal of care : life prolonging care ( cardiopulmonary resuscitation , mechanical ventilation ) , limited care ( admission to hospital , antibiotics , but not cardiopulmonary resuscitation ) , or comfort care ( treatment only to relieve symptoms ) . Preferences after six weeks . The principal category for analysis was the difference in proportions of participants in each group who preferred comfort care . Results Among participants receiving the verbal narrative alone , 68 ( 64 % ) chose comfort care , 20 ( 19 % ) chose limited care , 15 ( 14 % ) chose life prolonging care , and three ( 3 % ) were uncertain . In the video group , 81 ( 86 % ) chose comfort care , eight ( 9 % ) chose limited care , four ( 4 % ) chose life prolonging care , and one ( 1 % ) was uncertain ( χ2=13.0 , df=3 , P=0.003 ) . Among all participants the factors associated with a greater likelihood of opting for comfort care were being a college graduate or higher , good or better health status , greater health literacy , white race , and r and omisation to the video arm . In multivariable analysis , participants in the video group were more likely to prefer comfort care than those in the verbal group ( adjusted odds ratio 3.9 , 95 % confidence interval 1.8 to 8.6 ) . Participants were re-interviewed after six weeks . Among the 94/106 ( 89 % ) participants re-interviewed in the verbal group , 27 ( 29 % ) changed their preferences ( κ=0.35 ) . Among the 84/94 ( 89 % ) participants re-interviewed in the video group , five ( 6 % ) changed their preferences ( κ=0.79 ) ( P<0.001 for difference ) . Conclusion Older people who view a video depiction of a patient with advanced dementia after hearing a verbal description of the condition are more likely to opt for comfort as their goal of care compared with those who solely listen to a verbal description . They also have more stable preferences over time . Trial registration Clinical trials.gov NCT00704886 Background Men considering the prostate specific antigen ( PSA ) test for prostate cancer , an increasingly common male cancer , are encouraged to make informed decisions , as the test is limited in its accuracy and the natural history of the condition is poorly understood . The Web-based PSA decision aid , Prosdex , was developed as part of the UK Prostate Cancer Risk Management Programme in order to help men make such informed decisions . Objectives The aim of this study was to evaluate the effect of the Web-based PSA decision aid , Prosdex , on informed decision making . Methods A Web-based r and omized controlled trial was conducted in South Wales , United Kingdom . Men aged 50 to 75 who had not previously had a PSA test were r and omly allocated to two intervention and two control groups . Participants in the intervention groups either viewed Prosdex or were given a paper version of the text . The main outcome measures were the three components of informed decision making : ( 1 ) knowledge of prostate cancer and PSA , ( 2 ) attitude toward PSA testing , ( 3 ) behavior using a proxy measure , intention to undergo PSA testing . Decisional conflict and anxiety were also measured as was uptake of the PSA test . Outcomes were measured by means of an online question naire for the Prosdex group , the paper version group , and one of two control groups . Six months later , PSA test uptake was ascertained from general practitioners ’ records , and the online question naire was repeated . Results are reported in terms of the Mann-Whitney U-statistic divided by the product of the two sample sizes ( U/mm ) , line of no effect 0.50 . Results Participants were 514 men . Compared with the control group that completed the initial online question naire , men in the Prosdex group had increased knowledge about the PSA test and prostate cancer ( U/mn 0.70 ; 95 % CI 0.62 - 0.76 ) ; less favourable attitudes to PSA testing ( U/mn 0.39 , 95 % CI 0.31 - 0.47 ) ; were less likely to undergo PSA testing ( U/mn 0.40 , 95 % CI 0.32 - 0.48 ) ; and had less decisional conflict ( U/mn 0.32 , 95 % CI 0.25 - 0.40 ) ; while anxiety level did not differ ( U/mn 0.50 , 95 % CI 0.42 - 0.58 ) . For these outcomes there were no significant differences between men in the Prosdex group and the paper version group . However , in the Prosdex group , increased knowledge was associated with a less favourable attitude toward testing ( Spearman rank correlation [ ρ ] = -0.49 , P < .001 ) and lower intention to undergo testing ( ρ = -0.27 , P = .02 ) . After six months , PSA test uptake was lower in the Prosdex group than in the paper version and the question naire control group ( P = .014 ) . Test uptake was also lower in the control group that did not complete a question naire than in the control group that did , suggesting a possible Hawthorne effect of the question naire in favour of PSA testing . Conclusions Exposure to Prosdex was associated with improved knowledge about the PSA test and prostate cancer . Men who had a high level of knowledge had a less favourable attitude toward and were less likely to undergo PSA testing . Prosdex appears to promote informed decision making regarding the PSA test . Trial Registration IS RCT N48473735 ; http://www.controlled-trials.com/IS RCT N48473735 ( Archived by WebCite at http://www.webcitation.org/5r1TLQ5nK Objectives To describe the development , validation and inter-rater reliability of an instrument to measure the quality of patient decision support technologies ( decision aids ) . Design Scale development study , involving construct , item and scale development , validation and reliability testing . Setting There has been increasing use of decision support technologies – adjuncts to the discussion s clinicians have with patients about difficult decisions . A global interest in developing these interventions exists among both for-profit and not-for-profit organisations . It is therefore essential to have internationally accepted st and ards to assess the quality of their development , process , content , potential bias and method of field testing and evaluation . Methods Scale development study , involving construct , item and scale development , validation and reliability testing . Participants Twenty-five research er-members of the International Patient Decision Aid St and ards Collaboration worked together to develop the instrument ( IPDASi ) . In the fourth Stage ( reliability study ) , eight raters assessed thirty r and omly selected decision support technologies . Results IPDASi measures quality in 10 dimensions , using 47 items , and provides an overall quality score ( scaled from 0 to 100 ) for each intervention . Overall IPDASi scores ranged from 33 to 82 across the decision support technologies sample d ( n = 30 ) , enabling discrimination . The inter-rater intraclass correlation for the overall quality score was 0.80 . Correlations of dimension scores with the overall score were all positive ( 0.31 to 0.68 ) . Cronbach 's alpha values for the 8 raters ranged from 0.72 to 0.93 . Cronbach 's alphas based on the dimension means ranged from 0.50 to 0.81 , indicating that the dimensions , although well correlated , measure different aspects of decision support technology quality . A short version ( 19 items ) was also developed that had very similar mean scores to IPDASi and high correlation between short score and overall score 0.87 ( CI 0.79 to 0.92 ) . Conclusions This work demonstrates that IPDASi has the ability to assess the quality of decision support technologies . The existing IPDASi provides an assessment of the quality of a DST 's components and will be used as a tool to provide formative advice to DSTs developers and summative assessment s for those who want to compare their tools against an existing benchmark Background . There is limited evidence about how to ensure that patients are helped to make informed medical care decisions . Objective . To test a decision support intervention for uterine fibroid treatments . Design and Setting . Practical clinical trial to test informed choice assistance in 4 r and omly assigned gynecology clinics compared to 5 others providing a pamphlet . Patients . Three hundred women facing a treatment decision for fibroids over a 13-month period . Intervention . Mailed DVD and brochure about fibroid treatments plus the Ottawa decision guide and an offer of counseling soon after an index visit . Measurements . Mailed survey 6 to 8 weeks later asking about knowledge , preferences , and satisfaction with decision support . Results . In total , 244 surveys were completed for an adjusted response rate of 85.4 % . On a 5-point scale , intervention subjects reported more treatment options being mentioned ( 3.0 v. 2.4 ) , had a higher knowledge score ( 3.3 v. 2.8 ) , and were more likely to report being adequately informed ( 4.4 v. 4.0 ) , and their decision was both more satisfactory ( 4.3 v. 4.0 ) and more consistent with their personal values ( 4.5 v. 4.2 ) . Neither knowledge nor use of the intervention was associated with greater concordance between preferences and decisions . Limitations . Implementation of intervention may not have been well timed to the decision for some patients , limiting their use of the material s and counseling . Conclusion . It is difficult to integrate structured decision support consistently into practice . Decision support for benign uterine conditions showed effects on knowledge and satisfaction but not on concordance The purpose of this study was to develop and test a decision support intervention ( DSI ) to assist women to make and act on informed decisions that are consistent with their values in the area of menopause and hormone replacement therapy ( HRT ) . Mode and intensity of intervention were tested in midlife women ( N = 248 ) , r and omly assigned to one of three intervention formats : written information only , guided discussion , or personalized decision exercise . Data were collected over 12 months . Knowledge , decisional conflict , satisfaction with health care provider , and self-efficacy improved following intervention and were maintained for 12 months for all groups . Women 's adherence to their own plans over 12 months was 59 % ( exercise ) , 76 % ( calcium intake ) , and 89 % ( HRT ) . Carefully written information is effective in promoting knowledge , adherence , and satisfaction among well-educated , interested women . It was concluded that women can underst and complex information , including tradeoffs regarding treatment options . Women will adhere to their own plans , suggesting that consumer rather than provider plans may be the more appropriate gold st and ard for measuring adherence PURPOSE Low health literacy is a significant problem in the United States . At the same time written screening tools such as the American Urological Association symptom score are used more frequently at hospitals and clinics . We previously reported that many patients do not fully underst and this tool and often provide inaccurate information . To combat this problem we developed a novel multimedia version of the American Urological Association symptom score . MATERIAL S AND METHODS In this r and omized , controlled trial we divided 232 patients into a control arm that self-administered the traditional written version of the symptom score and an experimental arm that self-administered the new multimedia version . Patients in each arm were later administered the tool a second time by an interviewer for comparison . Using multivariate analysis we measured disagreement between the self-administered and interviewer administered scores , and compared the 2 arms . RESULTS Patients assigned the written and the multimedia version showed an average error of 3.48 and 1.97 , respectively ( p < 0.001 ) , for a 43 % decrease . Improvement was noted regardless of patient literacy . Errors by patients with low and high literacy decreased from 4.55 to 2.24 and 3.10 to 1.86 ( p = 0.03 and < 0.001 , respectively ) . CONCLUSIONS As a model , the American Urological Association symptom score multimedia version represents an exciting opportunity to improve many other written screening tools since it increased underst and ing and decreased scoring errors across all literacy levels , possibly allowing physicians to treat patients more effectively RATIONALE We developed an evidence -based decision aid for patients with advanced cystic fibrosis considering referral for lung transplantation . OBJECTIVES To prospect ively evaluate whether use of the decision aid increased knowledge about the options , improved realistic expectations , and decreased decisional conflict in adult patients . METHODS We performed a single-blind r and omized controlled trial involving 149 adult patients with cystic fibrosis with an FEV(1 ) < or= 40 % predicted from 14 Canadian and Australian centers . All participants received an education and counseling session from their cystic fibrosis team and were then r and omized to receive the decision aid or usual care . The decision aid is available online at http://decisionaid.ohri.ca/decaids.html . MEASUREMENTS AND MAIN RESULTS The primary end points measured were participants ' knowledge , realistic expectations , and decisional conflict evaluated 3 weeks after r and omization . Patients r and omized to the decision aid had greater knowledge about their options ( P < 0.0001 ) and had more realistic expectations about the benefits and risks of lung transplantation ( P < 0.0001 ) compared with those r and omized to usual care . The total decisional conflict score was significantly lower in the decision aid group 3 weeks postr and omization compared with the usual care group ( 11.6 vs. 20.4 ; P = 0.0007 ) . Decisions were durable ; 88 % of patients in the decision aid group and 75 % in the usual care group maintained the same choice 12 months after r and omization ( P = 0.06 ) . CONCLUSIONS Use of a decision aid for patients with cystic fibrosis considering referral for lung transplantation , in addition to usual education and counseling , improves patient knowledge , realistic expectations , decisional conflict , and patient satisfaction . Clinical trial registered with www . clinical trials.gov ( NCT00345449 ) Abstract BACKGROUND : Little is known about the relative advantages of video versus internet-based decision aids to facilitate shared medical decision making . This study compared internet and video patient education modalities for men considering the prostate specific antigen ( PSA ) test . METHODS : Two hundred and twenty-six men , aged 50 years or older , and scheduled to complete a physical examination at an HMO Health Appraisal Clinic were r and omly assigned to access a website ( N=114 ) or view a 23-minute videotape in the clinic ( N=112 ) prior to deciding whether they wanted to be screened for prostate cancer . RESULTS : There were no between-groups differences in participants ’ ratings of convenience , effort , or satisfaction following exposure to the decision aid . Participants assigned to the video group were more likely to review the material s than individuals assigned to the internet group ( 98.2 % vs 53.5 % ) . Participants in the video group showed significantly greater increases in PSA knowledge and were more likely to decline the PSA test than individuals assigned to the internet group . However , participants in the internet group who review ed the entire online presentation showed similar increases in PSA knowledge as video participants . Only 5 % of all participants visited other websites to inform themselves about the PSA test . CONCLUSIONS : Overall , the video was significantly more effective than the Internet in educating participants about benefits and risks of PSA screening BACKGROUND Low health literacy ( HL ) is an important risk factor for cancer health disparities . OBJECTIVE Describe a continuing medical education ( CME ) program to teach primary care physicians ( PCP ) cancer risk communication and shared decision-making ( SDM ) with low HL patients and baseline skills assessment . DESIGN Cluster r and omized controlled trial in five primary care clinics in New Orleans , LA . PARTICIPANTS Eighteen PCPs and 73 low HL patients overdue for cancer screening . INTERVENTION Primary care physicians completed unannounced st and ardized patient ( SP ) encounters at baseline . Intervention physicians received SP verbal feedback ; academic detailing to review cancer screening guidelines , red flags for identifying low HL , and strategies for effective counseling ; and web-based tutorial of SP comments and checklist items hyperlinked to reference articles/websites . MAIN MEASURES Baseline PCP self-rated proficiency , SP ratings of physician general cancer risk communication and SDM skills , patient perceived involvement in care . RESULTS Baseline assessment s show physicians rated their proficiency in discussing cancer risks and eliciting patient preference for treatment/decision-making as “ very good ” . SPs rated physician exploration of perceived cancer susceptibility , screening barriers/motivators , checking underst and ing , explaining screening options and associated risks/ benefits , and eliciting preferences for screening as “ satisfactory ” . Clinic patients rated their doctor ’s facilitation of involvement in care and information exchange as “ good ” . However , they rated their participation in decision-making as “ poor ” . DISCUSSION The baseline skills assessment suggests a need for physician training in cancer risk communication and shared decision making for patients with low HL . We are determining the effectiveness of teaching methods , required re sources and long-term feasibility for a CME program OBJECTIVES Numeracy , the ability to process basic mathematical concepts , may affect responses to graphical displays of health risk information . Displays of probabilistic risk information using grouped dots are easier to underst and than displays using dispersed dots . However , dispersed dots may better convey the r and omness with which health threats occur , so increasing perceived susceptibility . We hypothesized that low numeracy participants would better underst and risks presented using grouped dot displays , while high numeracy participants would have good underst and ing , regardless of display type . Moreover , we predicted that dispersed dot displays , in contrast to grouped dot displays , would increase risk perceptions and worry only for highly numerate individuals . DESIGN AND METHOD One hundred and forty smokers read vignettes asking them to imagine being at risk of Crohn 's disease , in a 2(display type : dispersed/grouped dots ) x 3(risk magnitude : 3%/6%/50 % ) x 2(numeracy : high/low ) design . They completed measures of risk comprehension , perceived susceptibility and worry . RESULTS More numerate participants had better objective risk comprehension , but this effect was not moderated by display type . There was marginally significant support for the predicted numeracy x display type interaction for worry about Crohn 's disease , but not for perceived susceptibility to the condition . CONCLUSIONS Dispersed dot displays somewhat increase worry in highly numerate individuals , but only numeracy influenced objective risk comprehension . The most effective display type for communicating risk information will depend on the numeracy of the population and the goal ( s ) of the communication Background . This investigation examined factors affecting patient involvement in consultations to decide local treatment for early breast cancer and the effectiveness of two methods of preconsultation education aim ed at increasing patient participation in these discussion Objective To evaluate the effects of a multifaceted empowerment strategy on the actual use of single embryo transfer after in vitro fertilisation . Design R and omised controlled trial . Setting Five in vitro fertilisation clinics in the Netherl and s. Participants 308 couples ( women aged < 40 ) on the waiting list for a first in vitro fertilisation cycle . Interventions The multifaceted strategy aim ed to empower couples in deciding how many embryos should be transferred . The strategy consisted of a decision aid , support of a nurse specialising in in vitro fertilisation , and the offer of reimbursement by way of an extra treatment cycle . The control group received st and ard care for in vitro fertilisation . Main outcome measures Use of single embryo transfer in the first and second treatment cycles as well as decision making variables and costs of the empowerment strategy . Results After the first treatment cycle , single embryo transfer was used by 43 % ( 65/152 ) of couples in the intervention group and 32 % ( 50/156 ) in the control group ( difference 11 % , 95 % confidence interval 0 % to 22 % ; P=0.05 ) . After the second treatment cycle , single embryo transfer was used by 26 % ( 14/154 ) of couples in the intervention group compared with 16 % ( 8/51 ) in the control group ( difference 10 % , −6 % to 26 % ; P=0.20 ) . Compared with couples receiving st and ard care , those receiving the empowerment strategy had significantly higher empowerment and knowledge levels but no differences in anxiety levels . Mean total savings per couple in the intervention group were calculated to be € 169.75 ( £ 146.77 ; $ 219.12 ) . Conclusions A multifaceted empowerment strategy encouraged use of single embryo transfer , increased patients ’ knowledge , reduced costs , and had no effect on levels of anxiety or depression . This strategy could therefore be an important tool to reduce the twin pregnancy rate after in vitro fertilisation . This trial did not , however , demonstrate the anticipated 25 % difference in use of single embryo transfer of the power calculation . Trial registration Clinical Trials.gov NCT00315029 OBJECTIVES To examine the extent to which numeracy predicts consumer-directed health plan ( CDHP ) comprehension and health plan choice . Also , to test whether comprehension can be improved using different presentation approaches . STUDY DESIGN We conducted an experimental laboratory study in which 303 adults viewed information about a hypothetical CDHP and a hypothetical preferred provider organization ( PPO ) presented in several different ways . Participants were r and omized to view plan comparisons in a side-by-side or a common/unique format , and whether or not to view a framework . METHODS Participants completed a survey that included comprehension items , numeracy and literacy assessment s , and sociodemographics . Multivariate regression models were developed to examine the independent effects of numeracy and presentation approach on CDHP comprehension and choice . Interactions between numeracy and presentation approaches were tested . RESULTS Although less numerate consumers understood less about CDHPs , they were substantially more likely to select the CDHP . Providing an overarching framework to highlight the differences between the CDHP and PPO boosted comprehension on items related to the framework message . However , it reduced comprehension on items that were not related to the framework , particularly among the less numerate . Participants reported that the common/unique presentation of comparative information was easier to underst and , yet there was a trend toward less comprehension using that presentation approach . CONCLUSIONS This study highlights the difficulty many consumers have in underst and ing comparative plan information and in making informed healthcare choices . Findings also indicate that some presentation strategies may help the less skilled underst and choices better OBJECTIVE Decision-making at menopause remains a challenge for women and their health care providers as the paradigm for hormone therapy continues to evolve . The role of decision-support for this process remains to be defined . METHODS A r and omized controlled trial of a computer-based hormone therapy ( HT ) decision-aid versus a control intervention consisting of a printed pamphlet among 177 post-menopausal women receiving care in a Veterans Affairs Medical Center . RESULTS Participants found the computer-based decision-aid easy to use and retained risk information incorporated from emerging scientific data . There was no difference between groups with respect to the primary outcomes of knowledge , satisfaction with decision , decisional conflict or HT use . A trend was reported towards decreased decisional conflict in the evidence in decision-making ( p=0.07 ) and factors of uncertainty ( p=0.06 ) domains among the subset of participants who were on HT at baseline and used the computer-based decision-aid . CONCLUSION The computer-based decision-aid was able to effectively incorporate emerging scientific information but was no more effective than a printed pamphlet control with regard to improving decision-process outcomes . PRACTICE IMPLICATION S The incremental benefit of a complex versus simpler decision-aid for post-menopausal women remains to be established prior to widespread dissemination of interactive computer-based HT decision-aids Objective To determine whether a decision aid design ed for adults with low education and literacy can support informed choice and involvement in decisions about screening for bowel cancer . Design R and omised controlled trial . Setting Areas in New South Wales , Australia identified as socioeconomically disadvantaged ( low education attainment , high unemployment , and unskilled occupations ) . Participants 572 adults aged between 55 and 64 with low educational attainment , eligible for bowel cancer screening . Intervention Patient decision aid comprising a paper based interactive booklet ( with and without a question prompt list ) and a DVD , presenting quantitative risk information on the possible outcomes of screening using faecal occult blood testing compared with no testing . The control group received st and ard information developed for the Australian national bowel screening programme . All material s and a faecal occult blood test kit were posted directly to people ’s homes . Main outcome measures Informed choice ( adequate knowledge and consistency between attitudes and screening behaviour ) and preferences for involvement in screening decisions . Results Participants who received the decision aid showed higher levels of knowledge than the controls ; the mean score ( maximum score 12 ) for the decision aid group was 6.50 ( 95 % confidence interval 6.15 to 6.84 ) and for the control group was 4.10 ( 3.85 to 4.36 ; P<0.001 ) . Attitudes towards screening were less positive in the decision aid group , with 51 % of the participants expressing favourable attitudes compared with 65 % of participants in the control group ( 14 % difference , 95 % confidence interval 5 % to 23 % ; P=0.002 ) . The participation rate for screening was reduced in the decision aid group : completion of faecal occult blood testing was 59 % v 75 % in the control group ( 16 % difference , 8 % to 24 % ; P=0.001 ) . The decision aid increased the proportion of participants who made an informed choice , from 12 % in the control group to 34 % in the decision aid group ( 22 % difference , 15 % to 29 % ; P<0.001 ) . More participants in the decision aid group had no decisional conflict about the screening decision compared with the controls ( 51 % v 38 % ; P=0.02 ) . The groups did not differ for general anxiety or worry about bowel cancer . Conclusions Tailored decision support information can be effective in supporting informed choices and greater involvement in decisions about faecal occult blood testing among adults with low levels of education , without increasing anxiety or worry about developing bowel cancer . Using a decision aid to make an informed choice may , however , lead to lower uptake of screening . Trial registration Clinical Trials.gov NCT00765869 and Australian New Zeal and Clinical Trials Registry 12608000011381 PURPOSE Many clinicians lack re sources to engage patients in shared decision making for prostate cancer screening . We sought to evaluate whether previsit educational decision aids facilitate shared decision making . METHODS This r and omized controlled study compared a Web-based and a paper-based decision aid with no previsit education . Men aged 50 to 70 years undergoing a health maintenance examination at a large family practice were enrolled . The primary outcome was patient-reported level of control over the decision to be screened . Secondary outcomes included frequency of screening , patient knowledge , decisional conflict , and time spent discussing screening . RESULTS A total of 497 men participated ( 75 control , 196 brochure , 226 Web site ) . Patients exposed to either aid were no more likely than control patients to report a collaborative decision : 36 % of patients in each group reported equally sharing decision responsibility . Exposure to either decision aid increased patients ’ involvement in decision making compared with the control condition ( Web site , P = .03 ; brochure , P = .03 ) . Only 46 % of control patients reported an active decision-making role , compared with 56 % of Web site and 54 % of brochure patients . Patients exposed to a decision aid answered a greater percentage of knowledge questions correctly ( 54 % control vs 69 % Web site , P < .001 , and vs 69 % brochure , P < .001 ) and were less likely to be screened ( 94 % control vs 86 % Web site , P = .06 , and vs 85 % brochure , P = .04 ) . CONCLUSIONS Patients in the decision aid groups were more informed and more engaged in the screening decision than their control counterparts . Exposure did not promote shared decision-making control , however . Whether shared decision making is the ideal model and how to measure its occurrence are subjects for further research BACKGROUND : Several studies suggest that many parents and research participants have poor underst and ing of the elements of consent , particularly the risks and benefits . However , some data suggest that the format and framing of research risks and benefits may be an important determinant of subject underst and ing . We examined the effect of tabular and graphical presentation of risks and benefits on parents ' underst and ing of a research study . METHODS : Parents of children scheduled to undergo an elective surgical procedure ( n = 408 ) were r and omized to receive information about the risks and benefits of a sham study of postoperative pain control using text , tables , or pictographs and then completed a question naire to examine their gist ( essential ) and verbatim ( actual ) underst and ing of the information . Parent demographics were recorded and their literacy and numeracy skills measured . RESULTS : Parents r and omized to receive information using tables or pictographs had significantly ( P < 0.025 ) greater gist and verbatim underst and ing than did parents who received the information using st and ard text . Tables and pictographs were also superior to text in promoting underst and ing among parents with low numeracy and literacy skills . CONCLUSIONS : Many parents and patients have difficulty in assimilating and interpreting risk/benefit information for both research and treatment . This is due , in part , to the manner in which risks and benefits are communicated and to the literacy and numeracy abilities of the individual . The results of this study suggest a simple and practical method for enhancing underst and ing of risk/benefit statistics for parents with varying numeracy and literacy skills OBJECTIVE Studies have shown that patients with knee pain are not well informed of their potential treatment options and that patient preferences are often discordant with physician practice s. The objective of this pilot study was to test the efficacy of a computer tool to improve informed decision-making for patients with knee pain in an outpatient primary care clinic setting . METHODS Patients with knee pain were r and omized to receive an information pamphlet or to perform a computer task . The latter was design ed to elicit preferences based on patient tradeoffs for route of administration , benefits , and side effects of commonly used treatment options for knee pain . After performing the task , participants were given a printed h and out illustrating their preferences . RESULTS In total , 87 patients were r and omized . Decisional self-efficacy , preparedness to participate in decision-making , and arthritis self-efficacy were greater in participants r and omized to the intervention arm compared to those receiving the information pamphlet ( p < 0.05 for all comparisons ) . CONCLUSION Participants using a tool design ed to increase patient awareness of choice and evaluate the tradeoffs related to available treatment options were more confident in their ability to obtain information about available treatment options , were better prepared to participate in their visit , and had better arthritis related self-efficacy compared to patients receiving an information pamphlet . The results of this pilot study justify future large-scale trials to determine the effectiveness of similar interventions OBJECTIVE To explore how rheumatoid arthritis ( RA ) antirheumatic drug-specific knowledge and numeric literacy , patient trust in physician , and demographic and disease-related factors relate to the confidence of patient decision-making related to disease modifying antirheumatic drugs ( DMARD ) . METHODS Data were analyzed from 628 r and omly selected patients with RA receiving care in community rheumatology practice s , who responded to a multicenter , cross-sectional mail survey . We used multiple regression models to predict patient confidence in DMARD decision-making related to their most recently initiated DMARD . RESULTS Significant positive correlation was found between confidence in DMARD decision and trust in physician , DMARD-specific knowledge , and disease duration , but not risk-related numeric literacy , sex , or education . Negative correlations were found with disease severity and current bother with DMARD side effects . A multiple linear regression model of confidence in DMARD decision had an overall R = 0.788 , R2 = 0.620 ( p < 0.001 ) . The 4 dependent variables contributing significantly to the model were female sex , Medicaid insurance status , satisfaction with RA disease control , and trust in physician , with st and ardized beta = 0.077 , -0.089 , 0.147 , and 0.687 , respectively . CONCLUSION In this sample of community patients with RA , the patient trust in physician had substantially greater effect on confidence in DMARD decision than DMARD-specific knowledge , disease-related factors , or demographic characteristics Background Patients should underst and the risks and benefits of cancer screening in order to make informed screening decisions . Objectives To evaluate the extent of informed decision making in patient-provider discussion s for colorectal ( CRC ) , breast ( BrCa ) , and prostate ( PCa ) cancer screening . Setting National sample of US adults identified by r and om-digit dialing . Design Cross-sectional survey conducted between November 2006 and May 2007 . Participants English-speaking US adults aged 50 y and older who had discussed cancer screening with a health care provider within the previous 2 y. Measurements Cancer screening survey modules that asked about demographic characteristics , cancer knowledge , the importance of various sources of information , and self-reported cancer screening decision-making processes . Results Overall , 1082 participants completed 1 or more of the 3 cancer modules . Although participants generally considered themselves well informed about screening tests , half or more could not correctly answer even 1 open-ended knowledge question for any given module . Participants consistently overestimated risks for being diagnosed with and dying from each cancer and overestimated the positive predictive values of prostate-specific antigen tests and mammography . Providers were the most highly rated information source , usually initiated screening discussion s ( 64%–84 % ) , and often recommended screening ( 73%–90 % ) . However , participants reported that providers elicited their screening preferences in only 31 % ( CRC women ) to 57 % ( PCa ) of discussion s. Although more than 90 % of the discussion s addressed the pros of screening , only 19 % ( BrCa ) to 30 % ( PCa ) addressed the cons of screening . Limitations Recall bias is possible because screening process reports were not independently vali date d. Conclusions Cancer screening decisions reported by patients who discussed screening with their health care providers consistently failed to meet criteria for being informed . Given the high ratings for provider information and frequent recommendations for screening , providers have important opportunities to ensure that informed decision making occurs for cancer screening decisions OBJECTIVE Despite the burden of colorectal cancer and improved health care outcomes with early detection and treatment , screening rates among eligible adults are low . We previously developed through a series of studies an interactive electronic tool , Colorectal Web , to promote colorectal cancer screening . METHOD From May 2002 to December 2003 , we conducted a r and omized controlled trial of Colorectal Web compared to a st and ard Web site on colorectal cancer screening in urban , suburban , and rural communities in Michigan with high colorectal cancer burden . Study participants were age 50 years and older , with no previous colorectal cancer screening . Major outcome was screened for colorectal cancer by 24 weeks post-intervention . RESULTS 174 eligible adults were r and omized and participated . Immediately post-intervention , Colorectal Web participants were significantly more likely to have a preferred colorectal cancer screening method , but this difference did not persist at subsequent follow-up . Eighty-nine participants had been screened for colorectal cancer by 24 weeks post-intervention . The probability of being screened for the Colorectal Web intervention study arm compared to the control is OR=3.23 ( 2.73 - 3.50 95 % Confidence Interval ) . CONCLUSION Colorectal Web is more effective than a st and ard colorectal cancer Web site at prompting previously unscreened individuals to choose a preferred colorectal cancer screening test and to be screened for colorectal cancer Background The rise in Internet use for seeking health information raises questions about the role the Internet may play in how patients make medical decisions . Objective To examine Internet use and perceived importance of different sources of information by patients making 9 specific medical decisions covering prescription medication initiation , cancer screening , and elective surgery . Setting National sample of US adults identified by r and om-digit dialing . Design Cross-sectional survey conducted between November 2006 and May 2007 . Participants The final sample comprised 2575 English-speaking US adults aged 40 y and older who had either undergone 1 of 9 medical procedures or tests or talked with a health care provider about doing so during the previous 2 y. Measurements Participants indicated if they or other family members used the Internet to seek information related to each of the specific medical decisions and rated how important the health care provider , the Internet ( if used ) , family and friends , and the media ( newspapers , magazines , and television ) were in providing information to help make the medical decision . Results Use of the Internet for information related to specific decisions among adults 40 y and older was generally low ( 28 % ) but varied across decisions , from 17 % for breast cancer screening to 48 % for hip/knee replacement . Internet use was higher at younger ages , rising from 14 % among those aged 70 y and older to 38 % for those aged 40 to 49 y. Internet users consistently rated health care providers as the most influential source of information for medical decisions , followed by the Internet , family and friends , and media . Limitations Telephone surveys are limited by coverage and nonresponse . The authors excluded health-related Internet use not associated with the 9 target decisions . Conclusions A minority of patients reported using the Internet to make specific common medical decisions , but use varied widely by type of decision . Perhaps reflecting perceived risk and uncertainty , use was lowest for screening decisions and highest for surgical decisions BACKGROUND We conducted a r and omized controlled trial to evaluate the effects of patient decision support Web sites on decision quality for men considering prostate cancer screening . METHODS Men older than 50 years ( N = 611 ) were r and omly assigned to 1 of 4 Internet conditions : traditional didactic decision aid providing information about prostate-specific antigen ( PSA ) screening options and outcomes ; chronic disease trajectory model for prostate cancer followed by a time-trade-off exercise ; both the didactic decision aid and the chronic disease trajectory model ; or links to public prostate cancer-specific Web sites from credible sources ( control condition ) . Participants completed question naires at baseline and after their physical examination . Primary outcome measures were PSA test choice , prostate cancer treatment preferences , knowledge and concern about prostate cancer , and decisional conflict . RESULTS Participants assigned to view public Web sites were less likely to review information ( 116 participants [ 76.8 % ] review ed ) than those assigned to experimental groups ( 399 [ 86.7 % ] review ed ; P = .004 ) . Greater reductions in PSA screening from pretest to posttest were observed among participants assigned to the traditional decision aid ( -9.1 % ) or chronic disease trajectory model ( -8.7 % ) , compared with participants assigned to the combination ( -5.3 % ) or control ( -3.3 % ) groups ( P = .047 ) . Preferences for watchful waiting increased significantly in all 4 groups ( baseline , 219 [ 35.8 % ] ; follow-up , 303 [ 66.2 % ] ; P < .001 ) . Knowledge scores were lowest for those assigned to public Web sites ( mean [ SD ] score , 7.49 [ 0.19 ] of questions correct ) and highest for the traditional decision aid ( 8.65 [ 0.18 ] of questions correct ; P = .005 ) . CONCLUSION Public Web sites about prostate cancer provide less effective decision support than a specially design ed Internet decision aid Objective Previous studies have not assessed whether evidence -based information about the outcomes of colorectal cancer screening increases informed choice among people from a range of socioeconomic background s nor have they assessed whether this can be administered away from a health-care provider . Methods R and omized controlled trial in six primary care locations . Three hundred and fourteen people aged 50–74 years received a self-administered decision aid ( DA ) booklet about outcomes of biennial faecal occult blood testing ( FOBT ) screening or government consumer guidelines ( G ) . Results Significantly more DA recipients ( 20.9 % ) were ‘ informed ’ compared with G recipients ( 5.8 % ) ( P = 0.0001 , OR 4.32 ; 95 % CI 2.49 to 7.52 ) ; the DA did not affect values clarity ( 61.9 % clear after DA versus 59.1 % after G ) nor screening decisions overall ( 87.3 % would screen after DA versus 90.5 % after G ) . Test uptake at one month was uniformly low ( 5.2 % DA versus 6.6 % G ) ; mostly due to being ‘ too busy ’ . DA recipients were more likely to make decisions ‘ integrating ’ knowledge with values ( 10.4 % DA versus 1.5 % G ) . Decisions not to screen were equally uncommon in both groups but more likely to be uninformed in G ( P = 0.03 ) . More DA recipients from all education levels were ‘ informed ’ ( P = 0.02 ) , particularly in lower education ( 50.0 % DA versus 17.8 % G ) and university-educated groups ( 79.4 % DA versus 32.1 % G ) . Conclusion Detailed absolute risk and benefit information about FOBT screening can be effectively used at home by people to increase informed choice . The DA was effective in people with lower education levels . Trial Registration Unique Protocol ID 211705 Clinical Trials.gov ID NCT 00148226 OBJECTIVE To evaluate the effect of a decision aid ( DA ) on women 's knowledge of the benefits and harms of screening and on their ability to make an informed decision . METHODS An online r and omized controlled trial among 321 women aged 38 - 45 years was conducted . Participants were r and omized to either immediate or delayed access to the online DA which ( i ) explained the benefits and harms , ( ii ) included a values clarification exercise and a worksheet to support decision making . The primary outcome , knowledge of benefits and harms of screening , and secondary outcomes , informed choice ( composite of knowledge , values and intention ) , anxiety and acceptability of the DA were measured using online question naires . RESULTS Women in the intervention group were more knowledgeable ( mean score out of 10 , 7.35 vs 6.27 , p<0.001 ) and were more likely to have made a decision ( 82 % vs 61 % p<0.001 ) . Of those who made a decision , women in the intervention group were less likely to start screening now ( 52 % vs 65 % p=0.05 ) . There was no significant difference in the proportion of women who made an informed choice ( 71 % intervention group vs 64 % control group , p=0.24 ) . The DA was helpful , balanced and clear , and did not make women anxious . CONCLUSIONS The DA increased knowledge and reduced indecision , without increasing feelings of anxiety . PRACTICE IMPLICATION S This decision aid is easy to access online and could be an inexpensive way of supporting women aged 40 who are considering whether to start screening now , or wait until they are 50 . The results of this study demonstrate the potential of DAs to help inform women about both the benefits and risks of screening at this age and to support women and clinicians in this decision making process We investigated whether printed or videotaped information is more effective in enhancing colon cancer knowledge . Subjects ( n = 1100 ) were r and omized into three groups : to receive a booklet , view a videotape , or receive no intervention . Subjects receiving the intervention showed increased knowledge compared with control subjects ( booklet = 23 % and videotape = 26 % vs no intervention = 3 % ) . Findings suggest that personalized educational material s are effective in enhancing colon cancer knowledge Background Although patient participation in the medical encounter confers significant benefits , many patients are reluctant to ask questions of their physicians . Patients ’ literacy level may affect their level of participation and question -asking behaviors . Objective To examine the effect of literacy on the number and types of questions asked by patients during primary care office visits . Design Convenience sample recruited between April and November 2004 . Physician – patient visits were audiotaped , and patient questions from complete encounters ( N = 57 ) were coded using an adaptation of the Roter Interaction Analysis System . Patients Participants were predominantly middle-aged ( mean age = 56.7 years ) , female ( 75.4 % ) , and African American ( 94.7 % ) . Low literacy skills ( ≤6th grade reading level ) were present in 38.6 % . Measurements We hypothesized prospect ively that low-literacy patients would ask fewer total questions and fewer questions about key aspects of their medical care . Results Low-literacy adults asked significantly fewer questions about medical care issues ( median = 4 vs 6 among patients with higher literacy levels , p = .014 ) . They also tended to ask fewer questions overall ( median = 7 vs 10 , p = .070 ) . Low-literacy patients were more likely to ask the physician to repeat something ( p = .013 ) , indicating an initial lack of underst and ing . They were less likely to use medical terminology , refer to medications by name , request additional services , or seek new information . Question -asking behavior was not significantly related to patient gender , age , years of education , or physician – patient gender concordance . Conclusions Literacy level appears to be an important determinant of patients ’ participation in the medical encounter . Low-literacy patients ask fewer questions about their medical care , and this may affect their ability to learn about their medical conditions and treatments BACKGROUND Patient Decision Support ( PDS ) tools assist patients in using medical evidence to make choices consistent that are with their values and in using evidence about consequences of medical alternatives . OBJECTIVE To evaluate a PDS intervention for perimenopausal hormone replacement therapy . We assessed the impact of the PDS on ( 1 ) consistency between the decision to take estrogen replacement therapy ( ERT ) or progesterone/estrogen replacement therapy ( PERT ) and the expected utility of treatment and ( 2 ) likelihood to take ERT and PERT pre- and postintervention . DESIGN Content of the PDS was st and ardized . R and omized trial of three intensities of intervention : ( 1 ) brochure ; ( 2 ) lecture/ discussion ; and ( 3 ) active decision support . SUBJECTS Participants were perimenopausal community volunteers between the ages of 40 and 65 ( n = 248 ) . MEASURES ( 1 ) Consistent with values ( correlation between expected utility ( EU ) and likelihood of taking hormones ) ; and ( 2 ) Likelihood to take hormone replacement therapy . RESULTS ( 1 ) The brochure group was less consistent with the decision analytic model than the lecture/ discussion and active decision support groups . ( 2 ) Influence on decisions : PDS tools increased the number of women certain about whether or not to take hormones . There were no differences among experimental groups . Of 99 women uncertain about ERT pre-PDS , 65 % changed . Twenty-one ( 32 % ) decided against ERT and 44 ( 68 % ) decided for ERT . ( 3 ) More intensive interventions produced modest gains in a normative direction . CONCLUSIONS PDSs using any of 3 formats reduce uncertainty and assist women to make informed decisions . Increased consistency with decision analytic models appears to be driven by better estimates of likelihood of outcomes OBJECTIVE To evaluate an entertainment-based patient decision aid for prostate cancer screening among patients with low or high health literacy . METHODS Male primary care patients from two clinical sites , one characterized as serving patients with low health literacy ( n=149 ) and the second as serving patients with high health literacy ( n=301 ) , were r and omized to receive an entertainment-based decision aid for prostate cancer screening or an audiobooklet-control aid with the same learner content but without the entertainment features . Postintervention and 2-week follow-up assessment s were conducted . RESULTS Patients at the low-literacy site were more engaged with the entertainment-based aid than patients at the high-literacy site . Overall , knowledge improved for all patients . Among patients at the low-literacy site , the entertainment-based aid was associated with lower decisional conflict and greater self-advocacy ( i.e. , mastering and obtaining information about screening ) when compared to patients given the audiobooklet . No differences between the aids were observed for patients at the high-literacy site . CONCLUSION Entertainment education may be an effective strategy for promoting informed decision making about prostate cancer screening among patients with lower health literacy . PRACTICE IMPLICATION S As barriers to implementing computer-based patient decision support programs decrease , alternative models for delivering these programs should be explored Background Racial/ethnic differences in shared decision making about cardiovascular risk-reduction therapy could affect health disparities . Objective To investigate whether patient race/ethnicity is associated with experiences discussing cardiovascular risk-reduction therapy with health care providers . Setting National sample of US adults identified by r and om-digit dialing . Design Cross-sectional survey conducted in November 2006 to May 2007 . Participants Among participants in the National Survey of Medical Decisions ( DECISIONS ) , a nationally representative sample of English-speaking US adults aged 40 and older , the authors analyzed respondents who reported discussing hyperlipidemia or hypertension medications with a health care provider in the previous 2 years . Measurements In multivariate linear and logistic regressions adjusting for age , gender , income , insurance status , perceived health , and current therapy , they assessed the relation between race/ethnicity ( black/Hispanic v. white ) and decision making : knowledge , discussion of pros and cons of therapy , discussion of patient preference , who made the final decision , preferred involvement , and confidence in the decision . Results Of respondents who discussed high cholesterol ( N = 738 ) or hypertension ( N = 745 ) medications , 88 % were white , 9 % black , and 4 % Hispanic . Minorities had lower knowledge scores than whites for hyperlipidemia ( 42 % v. 52 % , difference –10 % [ 95 % confidence interval ( CI ) : 15 , –5 ] , P < 0.001 ) , but not for hypertension . For hyperlipidemia , minorities were more likely than whites to report that the health care provider made the final decision for treatment ( 31.7 % v. 12.3 % whites , difference 19.4 % [ 95 % CI : 6.9 , 33.1 % ] , P < 0.01 ) ; this was not true for hypertension . Limitations Possible limitations include the small percentage of minorities in the sample and potential recall bias . Conclusions Minorities considering hyperlipidemia therapy may be less informed about and less involved in the final decision-making process |
340 | 24,554,274 | Most studies demonstrated a positive association between PA and QoL in the elderly .
PA had a consistent association with the following QoL domains : functional capacity ; general QoL ; autonomy ; past , present and future activities ; death and dying ; intimacy ; mental health ; vitality ; and psychological .
CONCLUSION PA was positively and consistently associated with some QoL domains among older individuals , supporting the notion that promoting PA in the elderly may have an impact beyond physical health . | OBJECTIVE To review information regarding the association of physical activity ( PA ) with quality of life ( QoL ) in the elderly and to identify the study design s and measurement instruments most commonly used in its assessment , in the period 2000 - 2012 . | Background : Dizziness is a very common complaint . The frequency of dizziness increases with age . It affects quality of life negatively for older persons in several ways . Objectives : This study intended to investigate which variables ( physical activity , loneliness , health complaints , need of help for daily living and falls ) differed between those with and without dizziness and also to investigate which factors affected quality of life among older persons with dizziness . Method : An age-stratified , r and omised sample of senior citizens – aged 75 or older – living in the south of Sweden ( n = 4,360 ) answered a question naire concerning demographic data , social network , health complaints and diseases , feelings of loneliness , quality of life ( Short Form 12 ) , frequency of falls and activities . Results : Dizziness was associated with an increased risk of falling . Falls in the last 3 months were reported in 31 % of the subjects with dizziness compared to 15 % among those without ( p < 0.001 ) . Dizziness also correlated with depression , with 42.5 % feeling depressed among the elderly reporting dizziness as compared with 13.2 % . Exercise , both light ( i.e. go for a walk ) or heavy ( i.e. work in the garden ) , correlated with reduced risk of low quality of life among older , dizzy persons , both mental ( light exercise OR 0.58 ; heavy OR 0.48 ) and physical ( light OR 0.62 ; heavy OR 0.21 ) . The proportion of dizzy persons doing light exercise was 75.6 % versus 87.4 % among the not dizzy ( p < 0.001 ) . Exercise reduces the risk of falling and the risk of being depressed , and increases quality of life . Conclusion : Even light exercise seems beneficial both for improving quality of life and to decrease the risk of falling , which in turn will lower the mortality rate . Older persons reporting dizziness should be encouraged and perhaps helped to exercise . If one could increase physical activity among the elderly , it would reduce the number of falls , diminish medical costs , suffering for the individual , and be of paramount medicosocial importance for society Background : Physical activity has been effective in enhancing quality of life ( QOL ) of older adults over relatively short periods of time . However , little is known about the longterm effects of physical activity and even less about the possible mediators of this relationship . Purpose : We examined the mediating effects of psychological variables on the relationship between physical activity and global QOL ( satisfaction with life ) in older adults over a 4-year period . Methods : Participants ( N = 174 , M age = 66.7 years ) completed a battery of psychosocial measures at 1 and 5 years following enrollment in a 6-month r and omized controlled exercise trial . Results : Panel analysis conducted within a covariance modeling framework indicated that physical activity was related to self-efficacy , physical self-esteem , and positive affect at 1 year , and in turn , greater levels of self-efficacy and positive affect were associated with higher levels of QOL . Analyses indicated that changes in physical activity over the 4-year period were related to increases in physical self-esteem and positive affect , but only positive affect directly influenced improvements in QOL . Conclusions : The findings lend support to the position that physical activity effects on QOL are in part mediated by intermediate psychological outcomes and that physical activity can have long-term effects on well-being Background : Physical activity has been positively linked to quality of life ( QOL ) in older adults . Measures of health status and global well-being represent common methods of assessing QOL outcomes , yet little has been done to determine the nature of the relationship of these outcomes with physical activity . Purpose : We examined the roles played by physical activity , health status , and self-efficacy in global QOL ( satisfaction with life ) in a sample of older Black and White women . Method : Participants ( N = 249 , M age = 68.12 years ) completed multiple indicators of physical activity , self-efficacy , health status , and QOL at baseline of a 24-month prospect i ve trial . Structural equation modeling examined the fit of 3 models of the physical activity and QOL relationship . Results : Analyses indicated that relationships between physical activity and QOL , self-efficacy and QOL were all indirect . Specifically , physical activity influenced self-efficacy and QOL through physical and mental health status , which in turn influenced global QOL . Conclusions : Our findings support a social cognitives model of physical activity ’s relationship with QOL . Subsequent tests of hypothesized relationships across time are recommended Background In spite of consistent evidence to suggest that being more physically active is associated with enhanced quality of life ( QOL ) , there have been remarkably few attempts to determine the possible underlying mechanisms in this relationship . Purpose To prospect ively examine the roles played by self-efficacy and physical and mental health status in the physical activity and QOL relationship in older women . Method Older women ( M age = 68.12 years ) completed measures of physical activity , self-efficacy relative to balance , mental and physical health status , and global QOL at baseline ( N = 249 ) and 24-month follow-up ( N = 217 ) . Demographics and general health information were assessed at baseline . A panel analysis within a covariance modeling framework was used to analyze the data . Results Analyses indicated that changes in physical activity over time were associated with residual changes in self-efficacy . Changes in self-efficacy were significantly associated with residual changes in physical and mental health status . Only changes in mental health status were significantly related to residual changes in global QOL . Conclusion Results from this study support the role of self-efficacy in the relationship between physical activity and QOL . Future physical activity promotion programs should include strategies to enhance self-efficacy for physical activity to be most effective for this population Background Although studies suggest that exercise training improves physical performance and health-related quality of life ( HRQOL ) among elderly people , most of these studies have investigated relatively healthy persons . The objective of the present study was to determine the effects of a 12-month multicomponent exercise program on physical performance , daily physical activity , and HRQOL among very elderly people with minor disabilities . Methods The subjects consisted of 65 elders ( median age : 84 years ) who were certified to receive long-term care in the form of support only or Level 1 care ( the lowest level of care required ) ; 31 were allocated to the intervention group and 34 to the control group . The intervention group participated in supervised exercises once a week for 12 months and in home-based exercises . The exercise program consisted of various exercises related to flexibility , muscle strength , balance , and aerobic performance . Results After 12 months of exercise training , the intervention group had significant improvements in lower-limb strength and on the sit- and -reach test ; these effects were not observed in the control group . The control group had significant decreases in grip strength , 6-minute walking distance , walking speed , and stride length ; these decreases were not observed in the intervention group . No clear differences in HRQOL measurements or changes in physical activity were detected between groups . Conclusions The 12-month multicomponent exercise program may effectively improve and maintain the physical performance of very elderly individuals with minor disabilities OBJECTIVES To determine whether elderly people who meet national guidelines have higher physical function ( PF ) scores than those who do not and the effect on functional trajectory when physical activity ( PA ) levels change from above to below this threshold , or vice versa . DESIGN Pooled data . SETTING Two 6-month r and omized controlled trials aim ed at increasing PA in adults . PARTICIPANTS Adults aged 65 to 94 ( N=357 ) . INTERVENTION PA counseling over the telephone and through mailed material s. MEASUREMENTS Self-reported PA dichotomized at 150 minutes/week and PF using the Medical Outcomes Study 36-item Short Form Question naire PF subscale . RESULTS At baseline , individuals reporting 150 minutes or more of moderate PA/week had mean PF scores that were 20.3 points higher than those who did not ( P<.001 ) . Change in PA minutes from above threshold to below threshold or from below threshold to above threshold from baseline to 6 months result ed in an average change in PF of -11.18 ( P<.001 ) and + 5.10 ( P=.05 ) , respectively . CONCLUSION These findings suggest that PA is an important predictor of functional status . Older sedentary adults can improve PF by meeting recommended PA levels . Conversely , dropping below recommended PA levels has a deleterious effect on PF . Given the importance of PF in maintenance of independence and quality of life in older adults , adherence to recommended PA guidelines should be endorsed Purpose This study examined relationships between health-related quality of life ( HRQOL ) and objective assessment s of habitual physical activity in older adults , focusing on interactions between the amount and intensity of activity . Methods Subjects were healthy Japanese aged 65–85 years ( 74 men and 109 women ) . Pedometer/accelerometers measured their step counts and the intensity of physical activity in metabolic equivalents ( METs ) continuously 24 h per day for 1 year . Each individual ’s final HRQOL was assessed using the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) instrument . Results The daily step count and the daily duration of physical activity at an intensity > 3 METs were quite closely correlated ( quadratic r2 = 0.93 , P < 0.05 ) . After controlling for age , sex , and daily step count , the overall SF-36 score and four constituent dimensions ( physical functioning , freedom from pain , vitality , and mental health ) were all significantly higher in individuals spending > 25 % of their total activity at an intensity > 3 METs . However , engagement in activity > 3 METs was not significantly associated with the remaining SF-36 components ( physical limitations , general health , social functioning , and emotional limitations ) . Conclusions Associations between moderate-intensity physical activity and HRQOL in older adults merit further evaluation by prospect i ve studies and /or r and omized controlled trials BACKGROUND Our objective was to assess the effects of targeted exercise programs on health-related quality of life compared with usual care based on the ability to perform activities of daily living ( ADL ) and the Neuropsychiatric Inventory scores in geriatric institutionalized persons . METHODS A r and omized controlled trial of 2 exercise programs vs usual care was conducted in 160 institutionalized persons 65 years or older who were able to underst and basic motor comm and s and to move from one position to another . Interventions were performed over 6 months and were either an adapted tai chi program ( 4 times 30 min/wk ) or a cognition-action program ( 2 times 30 - 45 min/wk ) that focused primarily on an adapted guidance of patient-centered communication skills . The control group received usual care . The study was conducted at 4 setting s. The main outcomes were changes in health-related quality of life based on ADL and Neuropsychiatric Inventory scores after 12 months . RESULTS The control group experienced a decline in ADL over the 12-month period compared with the adapted tai chi and cognition-action groups , but the differences were not significant ( P = .24 and P = .15 , respectively ) . Also , the components of ADL , eg , ability to walk , continence , and nutrition , were maintained better in the intervention groups than in the control group . The total Neuropsychiatric Inventory score also worsened significantly in the control group , while it was unchanged or improved in the intervention groups . The differences between the cognition-action group and the control group were significant ( P > .001 ) . Neuropsychiatric diagnosis subgroups ( such as dementia and psychosis ) did not show a specific response from any intervention . CONCLUSION Adapted exercise programs can slow down the decline in health-related quality of life among heterogeneous , institutionalized elderly persons . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00623532 OBJECTIVE : To test the feasibility of creating a valid and reliable checklist with the following features : appropriate for assessing both r and omised and non-r and omised studies ; provision of both an overall score for study quality and a profile of scores not only for the quality of reporting , internal validity ( bias and confounding ) and power , but also for external validity . DESIGN : A pilot version was first developed , based on epidemiological principles , review s , and existing checklists for r and omised studies . Face and content validity were assessed by three experienced review ers and reliability was determined using two raters assessing 10 r and omised and 10 non-r and omised studies . Using different raters , the checklist was revised and tested for internal consistency ( Kuder-Richardson 20 ) , test-retest and inter-rater reliability ( Spearman correlation coefficient and sign rank test ; kappa statistics ) , criterion validity , and respondent burden . MAIN RESULTS : The performance of the checklist improved considerably after revision of a pilot version . The Quality Index had high internal consistency ( KR-20 : 0.89 ) as did the subscales apart from external validity ( KR-20 : 0.54 ) . Test-retest ( r 0.88 ) and inter-rater ( r 0.75 ) reliability of the Quality Index were good . Reliability of the subscales varied from good ( bias ) to poor ( external validity ) . The Quality Index correlated highly with an existing , established instrument for assessing r and omised studies ( r 0.90 ) . There was little difference between its performance with non-r and omised and with r and omised studies . Raters took about 20 minutes to assess each paper ( range 10 to 45 minutes ) . CONCLUSIONS : This study has shown that it is feasible to develop a checklist that can be used to assess the method ological quality not only of r and omised controlled trials but also non-r and omised studies . It has also shown that it is possible to produce a checklist that provides a profile of the paper , alerting review ers to its particular method ological strengths and weaknesses . Further work is required to improve the checklist and the training of raters in the assessment of external validity OBJECTIVES To examine the hypothesis that changes in self-efficacy and functional performance mediate , in part , the beneficial effect of physical activity on functional limitations over time . DESIGN Prospect i ve , observational study . SETTING Community-based . PARTICIPANTS Two hundred forty-nine community-dwelling older women . MEASUREMENTS Participants completed measures of self-reported physical activity , functional limitations , and self-efficacy . Four measures of physical function performance were also assessed . Measures were completed at baseline and 24 months . Data were analyzed using a panel model within a covariance modeling framework . RESULTS Results indicated that increases in physical activity over time were associated with greater improvements in self-efficacy , which was associated in turn with improved physical function performance , both of which mediated the association between physical activity and functional limitations . Fewer functional limitations at baseline were also associated with higher levels of self-efficacy at 24 months . Age , race , and health status covariates did not significantly change these relationships . CONCLUSION The findings support the mediating roles of self-efficacy and physical function performance in the relationship between longitudinal changes in physical activity and functional limitations in older women BACKGROUND Although inactivity is an important contributor to impaired functioning and disability with age , little is known concerning how improvements in physical functioning and well-being in older adults vary with the type of physical activity undertaken . METHODS One hundred three adults age 65 years and older , recruited via population -based methods , were r and omized to 12 months of community-based , moderate-intensity endurance and strengthening exercises ( Fit & Firm ) or stretching and flexibility exercises ( Stretch & Flex ) . A combination of class- and home-based exercise formats was used . Measured and self-rated physical performance along with perceived functioning and well-being were assessed pre- and postintervention . RESULTS Fit & Firm subjects showed greater 12-month improvements in both measured and self-rated endurance and strength compared to Stretch & Flex subjects . Stretch & Flex subjects reported greater improvements in bodily pain , and Stretch & Flex men evidence d greater improvements in flexibility relative to Fit & Firm subjects . Although overall exercise adherence was high in both exercise conditions ( approximately 80 % ) , subjects in both conditions showed better adherence to the home- versus class-based portions of their exercise prescriptions . CONCLUSIONS Community-based programs focusing on moderate-intensity endurance and strengthening exercises or flexibility exercises can be delivered through a combination of formats that result in improvement in important functional and well-being outcomes . This represents one of the first studies to report significant improvements in an important quality of life outcome -bodily pain-with a regular regimen of stretching and flexibility exercises in a community-based sample of older adults OBJECTIVE Interventions for disease prevention should also be evaluated for quality of life ( QoL ) effects . Few exercise trials have examined QoL in the context of primary disease prevention . Here , we report the QoL outcomes from the Alberta Physical Activity and Breast Cancer Prevention ( ALPHA ) Trial . METHODS The ALPHA trial was a r and omized controlled trial in Calgary and Edmonton , Canada between May 2003 and July 2007 that compared an exercise intervention to a sedentary lifestyle among 320 sedentary , postmenopausal women . The exercise group was asked to perform moderate-to-vigorous intensity aerobic exercise 45 min/day , 5 days/week for 1 year . QoL was assessed by the short form-36 health survey . RESULTS Compared to the control group , the exercise group maintained significantly better physical functioning ( p<0.001 ) , general health ( p<0.001 ) , vitality ( p=0.002 ) , and bodily pain ( p=0.020 ) by 4 - 5 points which exceeds the 3.0 minimally important difference for these scales . Changes in body composition partially mediated the intervention effects . Antidepressant use and the presence of comorbidities moderated some intervention effects . CONCLUSIONS A 1-year moderate-to-vigorous aerobic exercise program prevents declines in the physical aspects of QoL in postmenopausal women . Exercise may have a potentially important advantage for breast cancer prevention compared to other lifestyle or biomedical interventions Objective : To investigate the association between potentially modifiable lifestyle factors and cognitive abilities/depressive symptoms in community-dwelling women aged 70 years and over . Method : Cross-sectional study of community-dwelling women aged 70 years and over ( n = 278 ; mean age = 74.6 years ) . Lifestyle variables assessed included smoking , alcohol consumption , physical activity , nutrition and education . The mental health measures of interest were depression , anxiety , quality of life and cognitive function , as assessed by the Beck Depression Inventory ( BDI ) , Beck Anxiety Inventory ( BAI ) , SF-36 , and the Cambridge Cognitive Examination for Mental Disorders of the Elderly ( CAMCOG ) , respectively . Results : Physically active women were half as likely to be depressed ( BDI score ≥ 10 ) and anxious ( BAI score ≥ 8) when compared to their physically inactive counterparts ( OR = 0.5 , 95 % CI = 0.3–0.8 for both , adjusted for marital status and smoking in the case of depression ) . Having ever smoked more than 20 cigarettes per day was associated with increased risk of depression ( OR = 2.8 , 95 % CI = 1.4–5.5 , adjusted for marital status and physical activity ) . Moderate alcohol use was associated with increased likelihood of having a CAMCOG score within the highest 50 percentile ( OR = 2.0 , 95 % CI = 1.1–3.5 , adjusted for age and education ) , as was more than minimum statutory education ( OR = 2.0 , 95 % CI = 1.1–3.5 , adjusted for age and alcohol consumption ) . There was no obvious association between vitamin B12/folate deficiency or obesity with any of the measures of interest . Conclusions : The results of this study are consistent with the hypothesis that depression is directly associated with heavy smoking and inversely associated with physical activity . They also support the idea that non-harmful alcohol consumption is associated with better cognitive performance . R and omised clinical trials should be now design ed to clarify whether management of lifestyle factors reduces the incidence of mood disorders and cognitive impairment in later life Background : Data regarding the effect of exercise programmes on older adults ’ health-related quality of life ( HRQOL ) and habitual physical activity are inconsistent . Objective : To determine whether a functional tasks exercise programme ( enhances functional capacity ) and a resistance exercise programme ( increases muscle strength ) have a different effect on the HRQOL and physical activity of community-dwelling older women . Methods : Ninety-eight women were r and omised to a functional tasks exercise programme ( function group ) , a resistance exercise programme ( resistance group ) , or normal activity group ( control group ) . Participants attended exercise classes three times a week for 12 weeks . The SF-36 Health Survey question naire and self-reported physical activity were obtained at baseline , directly after completion of the intervention ( 3 months ) , and 6 months later ( 9 months ) . Results : At 3 months , no difference in mean change in HRQOL and physical activity scores was seen between the groups , except for an increased SF-36 physical functioning score for the resistance group compared with the control group ( p = 0.019 ) and the function group ( p = 0.046 ) . Between 3 and 9 months , the self-reported physical functioning score of the function group decreased to below baseline ( p = 0.026 ) , and physical activity ( p = 0.040 ) decreased in the resistance group compared with the function group . Conclusions : Exercise has a limited effect on the HRQOL and self-reported physical activity of community-living older women . Our results suggest that in these subjects HRQOL measures may be affected by ceiling effects and response shift . Studies should include performance-based measures in addition to self-report HRQOL measures , to obtain a better underst and ing of the effect of exercise interventions in older adults Increasing evidence suggests that physical activity can prevent some aspects of mental illness in older people such as depression , dementia and Alzheimer ’s disease . Additionally , limited research has shown that engagement in structured exercise can improve aspects of psychological well-being such as mood and self-perceptions in older adults . However , the relationship between incidental daily activity such as walking or time spent sedentary , with psychological well-being has not been investigated . The Better Ageing Project provided an opportunity to assess well-being and quality of life using st and ardised question naires with 176 adults aged 70 and over . Accelerometry was used to objective ly assess daily energy expended in physical activity at different levels of intensity . In addition , an assessment of the impact of the 12-month Better Ageing structured group exercise programme was assessed through question naires and interviews . Total daily physical activity energy expenditure ( joules/day ) and amount of time spent in activity of at least moderate intensity were weakly related ( r = 0.20–0.28 ) to quality of life , subjective well-being and physical self-perceptions . Time spent sedentary ( min/day ) was weakly and negatively related to several mental health indicators . The quantitative data showed only minor psychological benefits of the exercise intervention . In contrast , interviews with 27 research participants and 4 exercise leaders suggested that important improvements in perceived function and social benefits had been experienced BACKGROUND The association of physical function with progression to dementia has not been well investigated . We aim ed to determine whether physical function is associated with incident dementia and Alzheimer disease ( AD ) . METHODS We performed a prospect i ve cohort study of 2288 persons 65 years and older without dementia . Patients were enrolled from 1994 to 1996 and followed up through October 2003 . Main outcome measures included incident dementia and AD . RESULTS During follow-up 319 participants developed dementia ( 221 had AD ) . The age-specific incidence rate of dementia was 53.1 per 1000 person-years for participants who scored lower on a performance-based physical function test at baseline ( < or = 10 points ) compared with 17.4 per 1000 person-years for those who scored higher ( > 10 points ) . A 1-point lower performance-based physical function score was associated with an increased risk of dementia ( hazard ratio , 1.08 ; 95 % confidence interval , 1.03 - 1.13 ; P < .001 ) , an increased risk of AD ( hazard ratio , 1.06 ; 95 % confidence interval , 1.01 - 1.12 ; P = .01 ) , and an increased rate of decline in the Cognitive Ability Screening Instrument scores ( 0.11 point per year ; 95 % confidence interval , 0.08 - 0.14 ; P < .001 ) after adjusting for age , sex , years of education , baseline cognitive function , APOE epsilon4 allele , family history of AD , depression , coronary heart disease , and cerebrovascular disease . CONCLUSIONS Lower levels of physical performance were associated with an increased risk of dementia and AD . The study suggests that poor physical function may precede the onset of dementia and AD and higher levels of physical function may be associated with a delayed onset Background Little is known about the effects of resistance training on health related quality of life ( HRQL ) in the elderly . Aim The main purpose of the study was to investigate the effects of resistance training on strength , body composition , functional capacity and HRQL in independent living elderly people . We hypothesised that resistance training would improve lean mass , muscle strength , physical function and HRQL . Methods Subjects ( N = 237 , 73.7±5.7yrs , 58.2 % female ) participated in a 12-week resistance exercise program ( 3 times/week ; 3 sets , 6–8 repetitions at 75–80 % of the 1-repetition maximum ) design ed to increase strength and muscle mass of major muscle groups . Body composition , quadriceps- and grip strength , timed up and go test ( TUG ) , six minute walk for distance ( 6MW ) and HRQL were measured at baseline and endpoint . Results Two hundred- and -four participants completed the study . Although the increase in lean mass was small ( + 0.8 kg , P<0.01 ) , quadriceps strength ( + 53.5N ) , grip strength ( + 3.0 lb ) , TUG ( -0.6sec ) , 6MW ( + 33.6 m ) and HRQL ( + 1.2 t-score ) improved significantly ( all P<0.01 ) . Changes in 6MW predicted improvement in HRQL after 12 weeks . Conclusions Our study shows that a 12-week resistance exercise program significantly improves lean mass , muscle strength , physical function and HRQL in elderly individuals , and that improvements in physical function predict improvements in HRQL . Our study indicates that resistance training should be promoted for the elderly as it has the potential to improve physical performance , thereby prolonging healthy , independent aging OBJECTIVE The objective of the study was to explore factors associated with quality of life ( QoL ) of Brazilian community-dwelling older adults . METHODS This was a descriptive exploratory cross-sectional study . Data were collected through a household survey . A r and om sample of 288 older adults from Porto Alegre , Brazil participated in the study . A demographic and health data sheet , the OARS activities of daily living ( ADL ) scale and the WHOQOL-BREF were administered . RESULTS AND DISCUSSION The mean age of participants was 71.2 years ( SD = 7.5 ) and 67.4 % were female . Using multiple linear regression analysis , with overall QoL as the dependent variable , perceived health status , education level , engagement in physical activity , medical conditions , age group and use of primary health care were significant associated factors . With physical QoL as the dependent variable , significant factors included : perceived health status , medical conditions , education , physical activities and dependence in ADL ; with social QoL as the dependent variable , only age group and paid work were significant . In relation to environmental QoL , education and perceived health were significant factors . CONCLUSIONS The results illustrate the complexity of factors influencing QoL. With a better underst and ing of these factors , it is possible to plan appropriate health interventions Background : The population ageing occurring worldwide result ed in multiple research es on sedentary ageing and quality of life . Purpose : To verify the effects of a physical activity programme on the quality of life ( QOL ) of elderly individuals served by a governmental health programme . Design : Descriptive inquiry research . Methods : R and omly distributing 70 elderly individuals in a control group ( n=35 ; mean±SD 69.80±8.05 years ) and an experimental group ( n=35 ; 68.66±5.93 years ) plus QOL evaluation via WHOQOL-Old . Results : The experimental group showed significant best results on the post-test by repeated- measures ANOVA on sensorial functioning ( Δ%=0.022 % , p=0 . 0001 ) , social participation ( Δ%=0.012 % , p=0.013 ) , perceptions of death and dying ( Δ%=0.04 % , p=0.009 ) , intimacy ( Δ%=0.059 % , p=0.05 ) , and total score ( Δ%=0.001 , p=0.000 ) . Conclusions : Sensorial functioning , social participation , perceptions of death and dying , and intimacy play an important role in the positive relationship between physical activity and QOL |
341 | 27,820,534 | Forced air warming was effective in maintaining intraoperative normothermia when compared to passive warming , routine thermal care and no form of warming .
Forced air warming in pregnant women scheduled for caesarean delivery under regional anaesthesia prevented maternal and foetal hypothermia .
In contrast , passive warming with tight elastic b and ages wrapped around the legs ( passive insulation ) in the same patient population had no significant benefits in preventing maternal hypothermia .
However , in arthroscopic knee surgery patients , forced air warming did not result in a decrease in the incidence of postoperative shivering indicating that it was not effective or feasible to extend active warming into recovery in this patient population .
Forced air warming was effective than circulating water mattress in preventing hypothermia in patients who underwent repair of infrarenal aortic aneurysms .
Forced air warming was effective against radiant warming in maintaining intraoperative normothermia in lengthier surgical procedures .Prewarming in different patient population s prevents redistribution hypothermia , especially after one hour of anaesthesia induction .
Intravenous and irrigating fluids warmed ( 38 - 40 ° C ) to a temperature higher than that of room temperature by different fluid warming devices ( both dry and water heated ) proved significantly beneficial to patients in terms of stable haemodynamic variables , and higher core temperature ( core T ) at the end of the surgery ( transurethral prostatectomy and orthopaedic surgery ) .
However , prewarming irrigation fluids in knee arthroscopy patients did not prove beneficial in maintaining normothermia .
Water garment warmer was significantly ( P < 0.05 ) effective than forced air warming in maintaining intraoperative normothermia in orthotopic liver transplantation patients .
Extra warming with forced air compared to routine thermal care was effective in reducing the incidence of surgical wound infections and postoperative cardiac complications , as well as shorten the length of hospital stay .
Passive warming with reflective heating blankets or elastic b and ages wrapped around the legs tightly were found to be ineffective in reducing the incidence or magnitude of hypothermia .
Low-flow anaesthesia with active forced air warming was effective in stabilising patient 's core T during surgical procedures when compared to low-flow anaesthesia alone or low-flow anaesthesia with passive insulation .
Phenylephrine i.v .
infusion result ed in a significantly less reduction in core T after first hour of anaesthesia and patients were warmer until the end of the surgery ( minor oral surgery ) .
Active warming with forced air warming units keeps all patients warmer in the intraoperative and postoperative periods .
Forced air warming compared with alternate forms of warming reduces the incidence of shivering and wound infections , increases thermal comfort and reduces morbid cardiac events . | BACKGROUND Inadvertent hypothermia is common in patient 's undergoing surgical procedures .
Hypothermia within the perioperative environment may have many undesired physiological effects that are associated with significant postoperative morbidity .
Patient 's temperature drops to below 35 ° C during the first hour of anaesthesia because of impaired thermoregulatory mechanism and patient getting cold in the operating theatre .
For this reason , health care professionals working in the perioperative environment need to know what are the most effective strategies for treating or preventing hypothermia to improving patient outcomes following surgical procedures .
However , to date there has been no systematic review of effectiveness with high quality r and omised controlled trials to identify effective strategies for the prevention and /or management of hypothermia in the perioperative environment .
OBJECTIVE The objective of this systematic review was to identify the most effective strategies for the prevention and /or management of hypothermia in the intraoperative and postoperative phases of surgical care . | Background : Hypothermia during and after major abdominal surgery decreases host defenses , increases the incidence of coagulopathy and may alter blood pressure , cardiac contractility and myocardial stability . Methods : We design ed a prospect i ve r and omized study to compare the benefits of a forced air warming system with warm blanket treatments in minimizing the effects of hypothermia on 64 morbidly obese patients undergoing Roux-en-Y gastric bypass . Results : Patients in the forced air warming group ( n = 32 ) had significantly higher perioperative body core temperature , lower central venous pressure and blood pressure readings , lower incidence of shivering , less blood loss intraoperatively and achieved a higher post anesthesia Aldrete Score than those patients in the warmed blanket group ( n = 32 ) . Conclusion : The forced air warming system is safe , cost effective and beneficial in minimizing the undesirable consequences of hypothermia in morbidly obese patients undergoing Roux-en-Y gastric bypass BACKGROUND Mild perioperative hypothermia , which is common during major surgery , may promote surgical-wound infection by triggering thermoregulatory vasoconstriction , which decreases subcutaneous oxygen tension . Reduced levels of oxygen in tissue impair oxidative killing by neutrophils and decrease the strength of the healing wound by reducing the deposition of collagen . Hypothermia also directly impairs immune function . We tested the hypothesis that hypothermia both increases susceptibility to surgical-wound infection and lengthens hospitalization . METHODS Two hundred patients undergoing colorectal surgery were r and omly assigned to routine intraoperative thermal care ( the hypothermia group ) or additional warming ( the normothermia group ) . The patient 's anesthetic care was st and ardized , and they were all given cefam and ole and metronidazole . In a double-blind protocol , their wounds were evaluated daily until discharge from the hospital and in the clinic after two weeks ; wounds containing culture-positive pus were considered infected . The patients ' surgeons remained unaware of the patients ' group assignments . RESULTS The mean ( + /- SD ) final intraoperative core temperature was 34.7 + /- 0.6 degrees C in the hypothermia group and 36.6 + /- 0.5 degrees C in the normothermia group ( P < 0.001 ) Surgical-wound infections were found in 18 of 96 patients assigned to hypothermia ( 19 percent ) but in only 6 of 104 patients assigned to normothermia ( 6 percent , P = 0.009 ) . The sutures were removed one day later in the patients assigned to hypothermia than in those assigned to normothermia ( P = 0.002 ) , and the duration of hospitalization was prolonged by 2.6 days ( approximately 20 percent ) in hypothermia group ( P = 0.01 ) . CONCLUSIONS Hypothermia itself may delay healing and predispose patients to wound infections . Maintaining normothermia intraoperatively is likely to decrease the incidence of infectious complications in patients undergoing colorectal resection and to shorten their hospitalizations Forced-air warming is the most commonly used and effective method of active warming . A new radiant warming device ( Suntouch ™ , Fisher and Paykel ) may provide an alternative when the skin surface available for warming is limited . We conducted a r and omized controlled trial to compare the efficacy of the Suntouch ™ radiant warmer and forced-air warming . With ethics committee approval , 60 surgical patients having procedures anticipated to be more than two hours in duration were recruited . Patients were r and omized to either radiant warming or forced-air warming . All intravenous fluids were warmed but prewarming was not used . The final intraoperative core temperatures ( ° C ) for the radiant warming and forced-air warming groups were 36.0±0.5 and 36.4±0.6 ( P=0.002 ) respectively . No other patient variables were significantly different . The Suntouch ™ is not as effective as the forced air warming for intraoperative warming during long surgical procedures . The device may be useful when forced-air warming is not possible Unintentional hypothermia is common in patients undergoing " routine anesthesia in surgery " . The aims of the study were to estimate the difference of changes of body temperature during abdominal and limb operations and to evaluate the effectiveness of the heated humidifier for reducing intraoperative heat loss . Forty-three patients were r and omly being allocated into 3 groups . Group I consisted of 14 patients undergoing abdominal operation without the use of heated humidifier . Another 22 patients were being assigned as group II to have a heated humidifier on the inspiratory limb of the breathing circuit . The inspired gas was warmed to 39 degrees C and the relative humidity was 90 % . 7 patients undergoing limb operation were attributed to group III without using heated humidifier to humidify and warm up the inspired gas . For body temperature monitoring , the probe was placed on the patient 's nasopharynx and the temperature was measured immediately before induction of anesthesia , post-intubation , and then once again every 15 minutes up to 3 hours after induction . All patients in the 3 groups showed a rapid decrease of body temperature in the first hour and then the hypothermic change was slow down . The lowest level of body temperature was reached at about 2 hours after induction . Patients undergoing abdominal operation decreased body temperature greater than those undergoing limb operation for about 2 degrees C after 3 hours of anesthesia and surgery . Warming and humidifying the inspired gas effectively reduced the heat loss . We concluded that abdominal operation induce hypothermia more than limb operation . The use of heated humidifier was effective in maintaining body temperature Background : This study was design ed to compare the efficacy of two different sites of active forced air warming , upper body or lower body , to maintain normothermia ; and their respective effect on thenar skin temperature in relation to the accelerographic monitoring of neuromuscular blockade during long‐lasting abdominal surgery Perioperative hypothermia is a common problem in anesthesia practice . Regional anesthesia , like general anesthesia , influences the thermoregulatory process . The aim of our study was to compare the efficacy of ondansetron and meperidine in the prevention of shivering during and after spinal anesthesia . Methods : In this double-blind study , 75 patients were r and omized into 3 groups . Group O and Group M were given ondansetron 8 mg and meperidine 0.4 mg/kg intravenously immediately before spinal anesthesia , respectively . Group C received saline at identical times . The core temperatures and the incidence of shivering were recorded . Association between maximum block height and mean rectal temperatures of the patients were also evaluated . Results : The core temperature was preserved in both ondansetron and meperidine groups with respect to the control group . Shivering was observed in 8 % of patients in groups O and M and 36 % in group C. The correlation between maximum block height and mean rectal temperatures was lost in the ondansetron and meperidine groups . Conclusion : Ondansetron and meperidine have similar antishivering effects . In addition , both ondansetron and meperidine altered the correlation between the core temperature and block level during spinal anesthesia We evaluated the efficacy of forced‐air warming to maintain normothermia during liver transplantation . In a prospect i ve , clinical trial 20 patients were r and omly assigned to routine thermal management ( circulating‐water mattress set at 42 ° C , intravenous fluid warming to 37 ° C and passive insulation ) or routine management with additional forced‐air warming of head , chest , and arms . Core temperature was measured in the pulmonary artery . Morphometric and demographic characteristics were similar in each group , as was total administered fluid volume replacement . Core temperatures in each group decreased by about 0.6 ° C during the first 70min of anaesthesia and then by 0.9 ° C within 90 to 120 min in the patients given routine thermal management , but only by 0.4 ° C in those warmed with forced‐air . Subsequently , core temperatures in the control group increased to only 35.7 , SD 0.25 ° C whereas those in the patients given forced‐air warming increased to 36.5 , SD 0.2 ° C . Despite the relatively high ambient temperature , patients warmed only with a circulating‐water mattress and passive insulation became hypothermic during surgery . In contrast , when forced‐air warming was added to this routine thermal management , patients were normothermic at the end of surgery . Forced‐air warming prevented intra‐operative hypothermia during liver transplantation CONTEXT AND OBJECTIVE Inadvertent perioperative hypothermia is common during spinal anesthesia and after midazolam administration . The aim of this study was to evaluate the effects of intraoperative skin-surface warming with and without 45 minutes of preoperative warming in preventing intraoperative and postoperative hypothermia caused by spinal anesthesia in patients with midazolam premedication . DESIGN AND SETTING Prospect i ve and r and omized study at Hospital das Clínicas , Universidade Estadual Paulista , Botucatu . METHODS Thirty patients presenting American Society of Anesthesiologists ( ASA ) physical status I and II who were scheduled for elective lower abdominal surgery were utilized . The patients received midazolam premedication ( 7.5 mg by intramuscular injection ) and st and ard spinal anesthesia . Ten patients ( Gcontrol ) received preoperative and intraoperative passive thermal insulation . Ten patients ( Gpre+intra ) underwent preoperative and intraoperative active warming . Ten patients ( Gintra ) were only warmed intraoperatively . RESULTS After 45 min of preoperative warming , the patients in Gpre+intra had significantly higher core temperatures than did the patients in the unwarmed groups ( Gcontrol and Gintra ) before the anesthesia ( p < 0.05 ) but not at the beginning of surgery ( p > 0.05 ) . The patients who were warmed intraoperatively had significantly higher core temperatures than did the patients in Gcontrol at the end of surgery ( p < 0.05 ) . All the patients were hypothermic at admission to the recovery room ( T CORE < 36 degrees C ) . CONCLUSIONS Forty-five minutes of preoperative warming combined with intraoperative skin-surface warming does not avoid but minimizes hypothermia caused by spinal anesthesia in patients with midazolam premedication UNLABELLED Perioperative hypothermia poses a challenge because of its deleterious effects on patient recovery . The current practice of applying two cotton blankets on patients during surgery is thought to be less ideal than using reflective insulation or forced-air warming . We studied 300 patients who underwent unilateral total knee replacement and were r and omized equally to three groups : ( a ) the two-cotton-blanket group , ( b ) the one-reflective-blanket with one-cotton-blanket group , and ( c ) the forced-air-warming with one-cotton-blanket group . Tympanic temperature readings were taken before surgery in the induction room , on arrival at the recovery room , and at 10-min intervals until discharge from the recovery room . On arrival at the recovery room , the forced-air-warming group had significantly higher temperatures ( adjusted for sex , age , and patient 's induction room temperature ) of 0.577 degrees C + /- 0.079 degrees C ( 95 % confidence interval [ CI ] , 0.427 - 0.726 ; P < 0.001 ) and 0.510 degrees C + /- 0.08 degrees C ( 95 % CI , 0.349 - 0.672 ; P < 0.001 ) more than the reflective-blanket and two-cot-ton-blanket groups , respectively . The forced-air-warming group took a significantly ( P < 0.001 ) shorter time of 18.75 min ( 95 % CI , 13.88 - 23.62 ) to achieve a temperature of 36.5 degrees C in the recovery room as compared with 41.78 min ( 95 % CI , 36.86 - 46.58 ) and 36.43 min ( 95 % CI , 31.23 - 41.62 ) for the reflective-blanket and two-cotton-blanket groups , respectively . The reflective technology was less effective than using two cotton blankets , and the forced-air warming was most efficient in maintaining perioperative normothermia . IMPLICATION S Perioperative hypothermia has deleterious effects on patient recovery . We found in patients having knee surgery that reflective technology was less effective than using two cotton blankets , whereas active surface warming with the forced-air method was most effective in maintaining normothermia UNLABELLED Core hypothermia during the first hour after induction of general anesthesia results largely from an internal core-to-peripheral redistribution of body heat . This redistribution results from both central inhibition of tonic thermoregulatory vasoconstriction in the arteriovenous shunt and anesthetic-induced vasodilation . We therefore tested the hypothesis that acute administration of phenylephrine , a pure alpha-adrenergic agonist , reduces the magnitude of anesthetic-induced core-to-peripheral redistribution of body heat . Patients undergoing minor oral surgery were r and omly assigned to an infusion of 0.5 microgram.kg-1.min-1 phenylephrine i.v . or no treatment ( control ) . The phenylephrine infusion was started immediately before anesthesia was induced with 2.5 mg/kg propofol i.v . Subsequently , anesthesia was maintained with sevoflurane and 60 % nitrous oxide in oxygen . Calf minus toe , skin-temperature gradients < 0 degree C were considered indicative of significant arteriovenous shunt vasodilation . Ambient temperature and end-tidal concentrations of maintenance sevoflurane were comparable in each group . Although there were no significant differences in skin-temperature gradients , core temperatures in the untreated patients decreased significantly more ( 1.2 + /- 0.4 degrees C ) than in those given phenylephrine ( 0.5 + /- 0.2 degree C , P < 0.001 ) . These data suggest that maintaining precapillary vasoconstriction of blood vessels , not in the arteriovenous shunt reduces the magnitude of redistribution hypothermia . IMPLICATION S Core hypothermia immediately after induction of general anesthesia results largely from core-to-peripheral redistribution of body heat . Core temperature reduction during the first hour of anesthesia decreased less in patients given phenylephrine than in untreated controls . These data suggest that maintaining precapillary vasoconstriction possibly reduces the magnitude of redistribution hypothermia STUDY OBJECTIVE To test the hypothesis that only one hour of preinduction skin-surface warming decreases the rate at which core hypothermia develops during the first hour of anesthesia . DESIGN R and omized , prospect i ve study . SETTING Operating theater of a university hospital . PATIENTS 16 ASA status I and II adult patients scheduled for laparoscopic cholecystectomy under general anesthesia . INTERVENTIONS Eight patients were assigned to receive forced-air warming for one hour before induction of anesthesia ( prewarmed group ) ; the other eight patients were covered only with a wool blanket during a similar preinduction period ( control group ) . MEASUREMENTS AND MAIN RESULTS Tympanic membrane ( core ) and mean skin-surface temperatures were measured at 15-minutes intervals , starting one hour before induction of anesthesia . Mean skin temperature increased from 34.0 + /- 0.1 C to 37.0 + /- 0.2 degrees C in the pre-warmed group ( p < 0.05 ) , but remained unchanged at 34.7 + /- 0.3 degrees C in the control group . Core temperature during the preinduction period did not change significantly in either group . Following induction of anesthesia , core temperature decreased at a rate of 1.1 + /- 0.1 degrees C/hr in the control group , but only 0.6 + /- 0.1 degrees C/hr in the pre-warmed group ( p < 0.05 ) . After one hour of anesthesia , six of eight pre-warmed patients had core temperatures of at least 36.5 degrees C , whereas only one of the eight control patients did ( p < 0.05 ) . CONCLUSIONS A single hour of preoperative skin-surface warming reduced the rate at which core hypothermia developed during the first hour of anesthesia . Preoperative skin surface warming is particularly helpful during short procedures because redistribution hypothermia is otherwise difficult to treat Background The purpose of this study was to evaluate the efficacy of an experimental approach to forced air warming using hospital blankets or a Bair Hugger warming unit ( Augustine Medical Inc. , Eden Prairie , MN ) to create a tent of warm air . Methods Adult patients undergoing major surgery were studied . Patients were r and omized to receive forced air warming using either a commercial Bair Hugger blanket ( control group , n = 44 ; set point , 43 ° C ) or st and ard hospital blankets ( experimental group , n = 39 ; set point , 38 ° C ) . Distal esophageal temperatures were monitored . Patients were contacted the following day regarding any problems with the assigned warming technique . Results Surface area covered was 36 ± 12 % ( mean ± SD ) in the experimental group and 40 ± 10 % in the control group . Final temperatures at the end of surgery were similar between groups : experimental , 36.2 ± 0.6 ° C ; control , 36.4 ± 0.7 ° C . A similar number of patients had esophageal temperature less than 36 ° C at the end of surgery in both groups ( experimental , 12 of 39 [ 31 % ] ; control , 12 of 44 [ 27 % ] ) . The majority of patients were satisfied with their anesthetic and warming technique : experimental , 38 of 39 patients ; control , 44 of 44 patients . There were no thermal injuries . Conclusions St and ard hospital blankets heated to 38 ° C forced air were equally as effective as commercial blankets heated with forced air at 43 ° C . However , based on concerns expressed by the manufacturer , this experimental technique should not be used until further safety evaluation has been undertaken A r and omised controlled trial was conducted to compare the efficacy of upper body forced‐air warming ( Bair Hugger ™ , Augustine Medical model 500/OR , Prairie , MN ) with that of an electric heating pad ( Operatherm 202 , KanMed , Bromma , Sweden ) for maintenance of intra‐operative body temperature in 60 patients undergoing laparotomy under general anaesthesia . The nasopharyngeal temperature was recorded throughout the operative period . The mean ( SD ) final temperatures were 36.2 ( 0.4 ) ° C with forced‐air warming and 35.5 ( 1.0 ) ° C with electric heating pad ( p < 0.01 ) . Upper body forced‐air warming is more effective than the heating pad for maintenance of body temperature during laparotomy The hypothesis that forced-air warming preserves core temperature better than circulating-water mattresses was tested in : ( a ) 16 adults undergoing major maxillofacial surgery , including radical node resection and flap reconstruction ; ( b ) 53 adults undergoing hip arthroplasty , having approximately 25 % of their body surface area available for warming ; ( c ) 20 infants undergoing minor maxillofacial surgery ; and ( d ) 10 young children undergoing pelvic or femoral osteotomies . Patients having each type of surgery were r and omly assigned to forced-air warming ( approximately 40 degrees C ) or conductive warming using a full-length circulating-water mattress at 40 degrees C. Forced-air warming was applied to the legs of the adults undergoing maxillofacial surgery and to one arm , the shoulders , and the neck in the adults undergoing hip arthroplasty ; a U-shaped , tubular forced-air cover was positioned around the pediatric patients . Core temperatures increased in all patients given forced-air warming and decreased or remained constant in those without active warming . Furthermore , we needed to decrease the temperature of the warmer from high to medium ( approximately 37 degrees C ) in most patients assigned to forced-air warming to prevent hyperthermia . After 15 h of anesthesia , rectal temperatures in the adults undergoing maxillofacial surgery were 3.4 degrees C higher in the forced-air group ( P < 0.01 ) . After 4 h of anesthesia , esophageal temperatures had increased 0.8 + /- 0.5 degrees C in the patients warmed with forced-air and decreased 0.8 + /- 0.3 degrees C in those warmed by circulating-water mattresses ( P < 0.01 ) . ( ABSTRACT TRUNCATED AT 250 WORDS Twenty patients who received elective abdominal surgery for more than two hours were r and omly assigned into two groups . Group 1 was warmed by using " EXACON " thermal therapy system model TT8200 . Group 2 was warmed by using a thermal blanket of aquamatic K-thermia ( electronic control ) , model PK-600 of American Hamilton medical systems . Other variables were kept constant , and the theater temperature was maintained at 24 degrees C. Core temperature was recorded every five minutes in a two hour period . There were statistically significant differences between these two groups intra-operatively . Decrease of temperature between these two groups had significant changes from 30 minutes to 2 hours ( p less than 0.05 ) . The warming effect of esophageal thermal tube was well controlled by directly warming the central compartment . However , the effect of blanket was unpredictable due to wet dressing and superficial warming of surgical fields . There were no side effects during the study PURPOSE Mild hypothermia has been suggested to be protective against tissue ischemia during aortic operations . However , recent studies have documented detrimental cardiac effects of hypothermia during a variety of operative procedures . The influence of different warming methods and the impact of hypothermia during st and ard aortic procedures was assessed . METHODS One hundred patients who underwent repair of infrarenal aortic aneurysms or aortoiliac occlusive disease were prospect ively r and omized into 2 groups , receiving either a circulating water mattress or a forced air warming blanket . Adjuvant warming methods were st and ardized . The day before surgery , 48-hour Holter monitors were applied and interpreted by a cardiologist blinded to the treatment . R and omization result ed in equivalent groups with regard to patient history , indications for surgery , body mass index , length of surgery , and fluid requirements . RESULTS Core temperatures were significantly warmer during surgery ( 36.3 degrees C + /- 0.7 degrees C vs 35.4 + /- 0.8 degrees C ) and after surgery ( 36.4 degrees C + /- 0.7 degrees C vs 35.6 degrees C + /- 0.9 degrees C ) in patients with forced air warming ( P < .001 ) . The circulating water mattress group had significantly more metabolic acidosis perioperatively ( P = .03 ) . Postoperative length of stay , cardiac complications , and death rates were not significantly different . Subgroup analysis of 83 aneurysm patients comparing normothermia with hypothermia ( temperature less than 36 degrees C ) on arrival to the recovery room identified decreased cardiac output ( P = .02 ) , thrombocytopenia ( P = .02 ) , elevated prothrombin time ( P = .04 ) , and inferior Acute Physiology and Chronic Health Evaluation ( APACHE ) II scores ( P < .001 ) in the hypothermic group . Holter analysis revealed more sinus tachycardia ( ST ) segment changes and ventricular tachycardia in hypothermic aneurysm patients ( P = .05 ) . CONCLUSION Patients treated with forced air blankets had significantly less metabolic acidosis and were kept significantly warmer than those treated with circulating water mattresses . Patients with aneurysms that were kept normothermic had a significantly improved clinical profile , with fewer cardiac events on the Holter recordings . We therefore conclude that ( 1 ) normothermia is protective for infrarenal aortic surgical patients ; and ( 2 ) forced air warming blankets provide improved temperature maintenance compared with circulating water mattresses We have evaluated the efficacy of the delayed forced air warming during abdominal aortic surgery in 18 patients . Patients were allocated r and omly to one of two groups : the control group ( n = 9 ) received no intraoperative warming device ; the Bair-Hugger group ( n = 9 ) had active skin surface warming with an upper body cover . The device was activated when core temperature decreased to less than 36 degrees C. The reduction in core temperature was 0.6 degrees C during the first hour after induction and 0.4 degrees C during the second hour in both groups . In the control group , core temperature continued to decrease until the end of surgery , whereas in the Bair-Hugger group , the reduction in core temperature stopped after 1 h of warming , and then rewarming began . At the end of surgery , core temperature in the Bair-Hugger group was similar to core temperature before induction , and was higher than core temperature in the control group ( P < 0.003 ) OBJECTIVES To investigate the effect using irrigation fluid at body temperature ( isothermic ) on patients ' ( core ) temperature during a transurethral resection of the prostate ( TURP ) and on the amount of peri-operative blood loss , the resection time and the subjective assessment of comfort by the patients . PATIENT AND METHODS In a r and omized study , patients undergoing TURP under spinal anaesthesia were divided into those receiving either isothermic irrigation fluid ( Group 1.28 patients ) or fluid at room temperature ( Group 2.31 patients ) . In Group 1 , a fluid heater maintained the irrigation fluid at body temperature until it reached the bladder . The body temperature of the patients was recorded rectally and orally during and after TURP and the peri-operative blood loss was also measured . The patients were interviewed on the first day after TURP to determine their assessment of comfort during the procedure . RESULTS The decrease in body temperature was 0.74 degree C in Group 1 and 1.71 degrees C in Group 2 , which was significantly different ( P < 0.001 ) . There was no significant difference in blood loss or resection-time . In Group 1 , only four ( 14 % ) of the patients were aware that their body was cooler , compared to 15 ( 50 % ) in Group 2 ( P = 0.038 ) . CONCLUSION Isothermic irrigation during TURP prevents excessive cooling and reduces the level of hypothermia . The reported increased mortality after TURP is probably related to peri-operative cardiac stress , an important factor which could be caused by the rapid decrease in body temperature which accompanies normal irrigation . Because the heating equipment presently available does not interfere with TURP , there are strong arguments for performing every TURP with irrigation fluid at body temperature Background Transurethral resection of the prostate gl and with irrigation fluid at room temperature leads to perioperative hypothermia which could give rise to adverse cardiovascular events in the perioperative period . The use of isothermic irrigation fluid reduces but does not eliminate this risk . Routine use of warm intravenous fluids along with isothermic irrigation had not been documented . This study set out to investigate the effect of the use of warm intravenous fluid together with isothermic irrigation fluid on the body temperature in patients undergoing transurethral resection of the prostate gl and . Methods One hundred and twenty consented patients with obstructing benign prostatic hyperplasia were r and omly assigned to one of 3 groups . Group 1 received irrigation and intravenous fluids at room temperature , group 2 received warmed irrigation fluid at 38 ° C along with intravenous fluid at room temperature while group 3 patients received warmed irrigation fluid and warmed intravenous fluids at 38 ° C . Their perioperative body temperature changes were monitored , analyzed and compared . Results The mean decrease in body temperature at the end of the procedure was significantly greater in group 1 ( 0.98 ± 0.56 ° C ) than in group 2 ( 0.42 ± .21 ° C ) ( p < 0.001 ) . Significantly more patients in group 1 also experienced shivering . However , in group 3 , there was no significant change in the mean body temperature ( p > 0.05 ) and none of them felt cold or shivered . Conclusion It is concluded that the use of isothermic irrigation fluid together with warm intravenous fluids during TURP prevents the occurrence of perioperative hypothermia . Trial registration BACKGROUND Even mild perioperative hypothermia is associated with several severe adverse effects . Resistive heating has possible advantages compared with other active warming systems because it can heat several fields independently . To assess this new warming system , we measured core temperature in patients during surgery who were warmed with circulating water mattresses , forced air covers or resistive heating covers . METHODS Twenty-four patients undergoing laparoscopic cholecystectomy were r and omly assigned to ( i ) circulating water mattress ( 38 degrees C ) , ( ii ) forced air warming ( set to ' medium ' ) or ( iii ) carbon-fibre resistive warming ( 38 degrees C ) . Warming was applied throughout anaesthesia and surgery . The groups were compared using one-way ANOVA and Student-Newman-Keuls tests . RESULTS Confounding factors were similar among the groups . Core temperatures in each group decreased for 20 min , but subsequently increased in the forced air and resistive heating groups . There was no significant difference between the forced air and resistive heating groups at any time . In contrast , core temperature in the circulating water group continued to decrease . Consequently , core temperature in the circulating water group was significantly lower than in the other groups 30 min after anaesthetic induction and at later times . CONCLUSIONS Resistive heating maintains core body temperature as well as forced air heating and both are better than circulating water . Resistive heating offers the advantage of adjustable heating pods OBJECTIVE Perioperative hypothermia might be detrimental to the patient undergoing off-pump coronary artery bypass surgery . We assessed the efficacy of the Allon thermoregulation system ( MTRE Advanced Technologies Ltd , Or-Akiva , Israel ) compared with that of routine thermal care in maintaining normothermia during and after off-pump coronary artery bypass surgery . METHODS Patients undergoing off-pump coronary artery bypass surgery were perioperatively and r and omly warmed with the 2 techniques ( n = 45 per group ) . Core temperature , hemodynamics , and troponin I , interleukin 6 , interleukin 8 , and interleukin 10 blood levels were assessed . RESULTS The mean temperature of the patients in the Allon thermoregulation system group ( AT group ) was significantly ( P < .005 ) higher than that of the patients receiving routine thermal care ( the RTC group ) ; less than 40 % of the latter reached 36 degrees C compared with 100 % of the former . The cardiac index was higher and the systemic vascular resistance was lower ( P < .05 ) by 16 % and 25 % , respectively , in the individuals in the AT group compared with in the individuals in the RTC group during the 4 postoperative hours . End-of-surgery interleukin 6 levels and 24-hour postoperative troponin I levels were significantly ( P < .01 ) lower in the patients in the AT group than in the RTC group . The RTC group 's troponin levels closely correlated with their interleukin 6 levels at the end of the operation ( R = 0.51 , P = .002 ) . CONCLUSIONS Unlike routine thermal care , the Allon thermoregulation system maintains core normothermia in more than 80 % of patients undergoing off-pump coronary artery bypass surgery . Normothermia is associated with better cardiac and vascular conditions , a lower cardiac injury rate , and a lower inflammatory response . The close correlation between the increased interleukin 6 and troponin I levels in the routine thermal care group indicates a potential deleterious effect of lowered temperature on the patient 's outcome We have studied the ability of reflective blankets to reduce net loss of body heat during regional anaesthesia for total hip arthroplasty . Thirty patients were allocated r and omly to either the study group ( insulated with reflective blankets ) or the control group ( no reflective blankets ) . Surgical and operation room draping , theatre temperature and i.v . fluid administration were st and ardized for all patients . Total body heat was deduced from core temperature ( aural canal ) and mean skin temperature ( four measuring sites ) . After 2 h of surgery , loss of body heat was reduced significantly in patients wrapped in reflective blankets ( 26 kJ ) compared with those in the control group ( 95 kJ ) According to a two-phase protocol , 127 patients undergoing arthroscopic knee surgery were r and omly assigned to receive intraoperative warming from a forced-air blanket ( n = 69 ) or conventional warmed cotton blankets ( n = 58 ) . During the initial phase ( Phase I ) , active warming was applied during the intraoperative period only , permitting double-blind assessment of postoperative events . In Phase II , warming was continued into the recovery area , which unblinded the assessment . Active warming raised skin temperature perioperatively , and reduced the decline in core temperature compared to the control group . Postoperatively , core temperature increased toward preoperative values at similar rates in both treatment groups , but was still lower in control patients after an hour in the postanesthesia care unit ( PACU ) . Postoperative shivering occurred in 35 % of all patients and was not prevented by either intraoperative or combined intraoperative and postoperative warming . However , significantly fewer actively warmed patients experienced prolonged postoperative shivering . The addition of postoperative warming appeared to provide little , if any , additional benefit . Despite the decreased duration of postoperative shivering in the actively warmed group , we were unable to demonstrate any reduction in the PACU stay The use of room temperature solutions for body cavity irrigation during surgical procedures can lead to the development of perioperative hypothermia . Hypothermia during this period causes patient discomfort , increases oxygen consumption , interferes with the clotting cascade , and increases the length of hospital stay . Perioperative hypothermia in anesthetized patients also contributes to extended sedation , delayed emergence , and prolonged recovery from neuromuscular blockade . Twenty-four adult American Society of Anesthesiologists ( ASA ) class I and II patients were r and omly assigned to receive warmed arthroscopic irrigation solution or room-temperature irrigation solution in this r and omized , prospect i ve study . Tympanic temperatures were monitored every 15 minutes throughout the surgical and postanesthesia recovery periods . P < .05 was considered significant . Statistical comparison of the mean percent temperature decrease from preoperative baseline between the 2 groups did not support the hypothesis that patients receiving warmed irrigation solution would maintain a higher core body temperature than those receiving room temperature solution Purpose To determine the effect of covering the patient ’s head and face on the prevention of intraoperative hypothermia ( < 35.5 ° C ) . Methods This r and omized , prospect i ve trial included 44 adults undergoing elective abdominal surgery . After the induction of anesthesia with thiopental , in 44 patients their extremities and trunk were covered with towels and sheets . In addition , 22 patients ( covered group ) had their face and head fully covered . Anesthesia was maintained with N2O 50–66 % ( 2–3 L·min−1 ) and isoflurane ( < IMAC ) in oxygen combined with thoracic epidural anesthesia . Core temperature was measured at the tympanic membrane continuously and was recorded at 15 min intervals from the induction of anesthesia . Heat and moisture exchangers were used in their anesthetic circuit . Ambient temperature was maintained near 25 ° C . Results Neither group demonstrated intraoperative hypothermia . However , tympanic membrane temperature at 75 , 90 , 105 min in the covered group were higherthan those of control group ( 36.7 ± 0.4 ° C vs 36.5 ± 0.4 ° C , 36.8 ± 0.5 ° C vs 36.4 ± 0.5 ° C , 36.8 ± 0.5 ° C vs 36.4 ± 0.5 ° C , respectively , P < 0.05 ) . Conclusion Covering the patient ’s head and face maintains intraoperative core temperature . RésuméObjectifDéterminer si le fait de couvrir la tête et le visage des patients contribue à prévenir l’hypothermie peropératoire ( < 35,5 ° C).MéthodeLessai r and omisé et prospect if a porté sur 44 adultes subissant une intervention abdominale élective . Après l’induction de l’anesthésie avec du thiopental , on a couvert les extrémités et le tronc des 44 patients de serviettes et de draps . De plus , pour 22 d’entre eux ( le groupe couvert ) , on a aussi couvert complètement le visage et la tête . On a maintenu l’anesthésie avec du N2O 50–66 % ( 2 - 3 L·min−1 ) et de l’isoflurane ( < ICAM ) mêlé à de l’oxygène , combiné à une anesthésie péridurale thoracique . On a procédé à une mesure continue de la température central e , à la membrane tympanique , et on l’a notée aux 15 min depuis l’induction de l’anesthésie . Les échangeurs de chaleur et d’humidité ont été intégrés au circuit anesthésique . La température ambiante a été maintenue autour de 25 ° C.RésultatsAucun des patients n’a présenté d’hypothermie peropératoire . Cependant , la température prélevée à la membrane tympanique à 75 , 90 et 105 min dans le groupe couvert était plus élevée que dans le groupe témoin ( 36,7 ± 0,4 ° C vs 36,5 ± 0,4 ° C , 36,8 ± 0,5 ° C vs 36,4 ± 0,5 ° C , 36,8 ± 0,5 ° C vs 36,4 ± 0,5 ° C , respectivement , P < 0,05 ) . Conclusion Couvrir la tête et le visage maintient la température central e peropératoire STUDY OBJECTIVE To compare the fluid warming capabilities of the Hotline and Flotem IIe devices in surgical patients , and whether warming intravenous ( i.v . ) fluids with the Hotline device result ed in less hypothermia and less need for other warming methods compared with the Flotem IIe device . STUDY DESIGN Part 1 . Prospect i ve , nonr and omized . Part 2 . Prospect i ve , r and omized . SETTING Teaching hospital , tertiary care center . PATIENTS Part 1 . 24 adult patients undergoing elective surgery . Part 2 . 49 adult patients scheduled for major elective orthopedic or gynecologic surgery of greater than 2 hours ' duration with general anesthesia . INTERVENTIONS Part 1 . Insertion of sterile in-line thermistors along the path of fluids delivered using the Hotline or Flotem device . Part 2 . Patients were r and omly assigned to receive i.v . fluids via the Hotline ( n = 21 ) or Flotem IIe ( n = 18 ) warmers . Intervention for core hypothermia [ lower esophageal temperature ( Teso ) less than 35.5 degrees C ] , was with forced air warming . Intervention for postoperative shivering was with meperidine by a nurse who was blinded to the treatment group . MEASUREMENTS Part 1 . Temperature of infused fluids before and after the warmer ( T in and T out ) and before the fluid entered the patient after insertion of a st and ard 84 cm extension set having a stopcock for injection of medications ( T distal ) . Part 2 . Tympanic ( Ttym ) was recorded before induction of anesthesia ( baseline ) and at 15-minute intervals after induction . Teso was recorded at 15-minute intervals after induction . The maximum intraoperative Ttym decline from baseline ( delta Ttym max ) was calculated . MAIN RESULTS Part 1 . Flow rates were between 1 and 33 ml/min . T out and T distal ( mean + /- SEM ) of fluids infused through the Hotline device were warmer compared with those infused via the Flotem IIe device ( Hotline T out : 35.7 + /- 0.1 degrees C and Hotline T distal : 33.4 + /- 0.2 degrees C vs. Flotem IIe T out : 28.9 + /- 0.2 degrees C and Flotem IIe T distal : 28.3 + /- 0.2 degrees C ; p < 0.001 between warmers ) . Part 2 . Maximal decrease in Ttym from preoperative baseline ( before intervention ) was greater in the Flotem IIe compared with the Hotline group ( delta Ttym max = -1.4 + /- 0.1 vs. -0.9 + /- 0.1 degree C , p = 0.01 ) . Five patients in the Flotem IIe group required forced air warming for treatment of hypothermia versus none in the Hotline group ( p < 0.01 ) . Postoperatively , five patients in the Flotem IIe group required treatment with meperidine for severe shivering versus one patient in the Hotline group ( p < 0.05 ) . CONCLUSIONS The Hotline device delivered fluids to the patient at consistently warmer temperatures compared with the Flotem IIe device during actual clinical conditions . This was associated with maintenance of near normal core temperatures throughout the procedure in the Hotline group , and a decreased need for interventions such as forced-air warming and treatment for severe shivering UNLABELLED The Thermostat device ( Aquarius Medical Corp. , Phoenix , AZ ) is used in a new technique to accelerate recovery from hypothermia by mechanically distending blood vessels in the h and , thereby increasing transfer of exogenous heat to the body core . We evaluated the use of the Thermostat device in patients with mild postoperative hypothermia ( < 36 degrees C ) . We studied adult patients undergoing elective surgery , general anesthesia , and neuromuscular blockade . Patients with an initial postoperative tympanic membrane temperature < 36 degrees C were r and omized into two groups : 1 ) Thermostat , which consisted of a hypothermia warming mitt/seal and thermal exchange chamber for 60 min , and 2 ) conventional treatment , which consisted of warm blankets and /or radiant heat . Of the 191 patients enrolled , 60 ( 31 % ) developed hypothermia and were r and omized to receive the Thermostat ( n = 30 ) or conventional methods ( n = 30 ) . Fourteen patients in the Thermostat group and 17 patients in the conventional group rewarmed to 36 degrees C before discharge from the recovery room ( P is not significant ) . There were no differences in vital signs , rewarming time , time to discharge from the recovery room , or postoperative temperature between groups . We conclude that patients with mild postoperative hypothermia rewarmed in a similar fashion , regardless of whether the Thermostat or conventional methods were used . IMPLICATION S We found that a commercially available negative pressure rewarming device ( Thermostat ; Aquarius Medical Corp. , Phoenix , AZ ) was not effective in accelerating rewarming in postoperative hypothermic surgical patients after general anesthesia Hypothermia occurs commonly during the perioperative period and is preventable with proper warming measures and body temperature monitoring . Using a prospect i ve , r and omized study design , we compared forced-air warming ( Warm Touch , Mallinckrodt Medical , Inc , St Louis , MO ) ( n = 15 ) with routine thermal care ( n = 14 ) during the intraoperative and early postoperative periods . The results show that compared with routine thermal care , forced-air warming result ed in higher core temperatures both intraoperatively and postoperatively . The incidence of shivering was lower and thermal comfort scores were higher in the warming group . A secondary focus in this study was to assess the correlation between body temperatures measured at the urinary bladder , oral cavity , rectum , and tympanic membrane . The results indicated that the sites most highly correlated with tympanic temperature ( listed in order of most to least correlated ) were the bladder , rectum , and oral cavity . Assuming tympanic temperature is most representative of " core " temperature , oral measurements were likely to underestimate core temperature , whereas bladder and rectal temperatures overestimated core temperature . The relationship between body temperatures measured at commonly used monitoring sites must be recognized by nurses to account for the tendency to overestimate or underestimate core temperature . This knowledge can be applied in the management of patients in the operating room or PACU and specifically in the evaluation of PACU patients before discharge Thirty patients with post-operative hypothermia following major surgery ( thoracic , abdominal , orthopaedic ) were allocated r and omly to either active warming with a radiant heater ( 500 W ) or passive rewarming with a reflective blanket . Rectal temperature , mean skin temperature ( at four measuring sites ) , continuous haemoglobin saturation and shivering were measured for 2 h post-operatively . Although post-operative heat supply with a radiant heater result ed in faster rewarming , there were no differences between the two groups with respect to haemoglobin saturation and shivering STUDY OBJECTIVES To evaluate the effects of intraoperative skin-surface warming with and without 1 hour of preoperative warming , in preventing intraoperative hypothermia , and postoperative hypothermia , and shivering , and in offering good conditions to early tracheal extubation . DESIGN Prospect i ve , r and omized , blind study . SETTING Teaching hospital . PATIENTS 30 ASA physical status I and II female patients scheduled for elective abdominal surgery . INTERVENTIONS Patients received st and ard general anesthesia . In 10 patients , no special pre caution s were taken to avoid hypothermia . Ten patients were su bmi tted to preoperative and intraoperative active warming . Ten patients were only warmed intraoperatively . MEASUREMENTS AND MAIN RESULTS Temperatures were recorded at 15-minute intervals . The patients who were warmed preoperatively and intraoperatively had core temperatures significantly more elevated than the other patients during the first two hours of anesthesia . All patients warmed intraoperatively were normothermic only at the end of the surgery . The majority of the patients warmed preoperatively and intraoperatively or intraoperatively only were extubated early , and none had shivering . In contrast , five unwarmed patients shivered . CONCLUSIONS One hour of preoperative warning combined with intraoperative skin-surface warming , not simply intraoperative warming alone , avoided hypothermia caused by general anesthesia during the first two hours of surgery . Both methods prevented postoperative hypothermia and shivering and offered good conditions for early tracheal extubation Background : The infusion of several liters of crystalloid solution at room temperature may significantly contribute to intraoperative hypothermia because warming fluid to core temperature requires body heat . The aim of this study was to evaluate the effect of delivering warmed intravenous ( IV ) fluid to the patient on preventing intraoperative hypothermia OBJECTIVE To assess the relationship between body temperature and cardiac morbidity during the perioperative period . DESIGN R and omized controlled trial comparing routine thermal care ( hypothermic group ) to additional supplemental warming care ( normothermic group ) . SETTING Operating rooms and surgical intensive care unit at an academic medical center . SUBJECTS Three hundred patients undergoing abdominal , thoracic , or vascular surgical procedures who either had documented coronary artery disease or were at high risk for coronary disease . OUTCOME MEASURE The relative risk of a morbid cardiac event ( unstable angina/ischemia , cardiac arrest , or myocardial infa rct ion ) according to thermal treatment . Cardiac outcomes were assessed in a double-blind fashion . RESULTS Mean core temperature after surgery was lower in the hypothermic group ( 35.4+/-0.1 degrees C ) than in the normothermic group ( 36.7+/-0.1 degrees C ) ( P<.001 ) and remained lower during the early postoperative period . Perioperative morbid cardiac events occurred less frequently in the normothermic group than in the hypothermic group ( 1.4 % vs 6.3 % ; P=.02 ) . Hypothermia was an independent predictor of morbid cardiac events by multivariate analysis ( relative risk , 2.2 ; 95 % confidence interval , 1.1 - 4.7 ; P=.04 ) , indicating a 55 % reduction in risk when normothermia was maintained . Postoperative ventricular tachycardia also occurred less frequently in the normothermic group than in the hypothermic group ( 2.4 % vs 7.9 % ; P=.04 ) . CONCLUSION In patients with cardiac risk factors who are undergoing noncardiac surgery , the perioperative maintenance of normothermia is associated with a reduced incidence of morbid cardiac events and ventricular tachycardia BACKGROUND Perioperative hypothermia is physiologically stressful because it elevates blood pressure , heart rate and plasma catecholamine concentration that may increase the risk of cardiac complications , bleeding , wound infection , and post-anaesthesia care unit stay . This study was design ed to evaluate the effects of warming intravenous fluids on perioperative hemodynamic situation , post-operative shivering and recovery in orthopaedic surgery patients . METHODS Perioperative pulse rate , blood pressure , intraoperative esophageal and skin temperature were measured in sixty patients undergoing orthopaedic surgery that were r and omly divided into two groups according to intraoperative IV fluids management . In 30 patients ( hypothermia group ) all IV fluids infused were at room temperature . In the other 30 patients ( normothermia group ) all IV fluids were warmed using a dry IV fluid warmer . RESULTS The core and skin temperatures of the hypothermia and normothermia groups decreased significantly between the induction of anesthesia and the end of surgery , but the drop was greater in the hypothermia group ( P < 0.005 ) . Postoperative mean arterial blood pressure ( non-invasive ) increased significantly more in the hypothermia group versus normothermia group ( p < 0.005 ) . Shivering was observed in 21 of 30 in the hypothermia group and 11 of 30 in the normothermia group ( p < 0.005 ) and recovery time was significantly lower in the normothermia group ( 36 + /- 5 vs. 26 + /- 3 min , p < 0.005 ) . CONCLUSION Intraoperative IV fluid warming reduces perioperative changes to the hemodynamic situation , post-operative shivering , and recovery time OBJECTIVE To determine whether postoperative forced-air warming of cardiac bypass patients in the intensive care unit ( ICU ) results in faster rate of warming and improved outcomes compared with more conventional ICU warming methods . DESIGN Prospect i ve r and omized effectiveness study . SETTING Three hundred fifty-bed university-affiliated hospital . PARTICIPANTS Sixty consenting r and omized patients from a consecutive series of 84 patients undergoing routine adult cardiac surgery . INTERVENTIONS One group of patients received usual patient care , which includes warm blankets and overhead heat lamps . Patients in the other group were placed under forced-air warming devices on arrival in the ICU . Sixty consenting patients ( 30 in each group ) were r and omly assigned to one or the other method of warming . The remaining 24 patients refused r and omization and self-selected a treatment group . MEASUREMENTS AND MAIN RESULTS Results are presented for the r and omized groups . Core temperature , measured by pulmonary artery catheter thermistor , increased in both groups at the rate of 0.25 degree C per hour . No statistically or clinical ly significant differences were found between the group for whom the warming device was used and the st and ard care group in the incidence of postoperative cardiac arrhythmia , duration of time in the ICU , or any other clinical variable . CONCLUSIONS There is no evidence from this study to warrant use of forced-air warming devices for the care of postoperative cardiac surgical patients in the ICU Maintenance of core body temperature in surgical patients presents a challenge to perioperative nurses . Core temperatures less than 36 degrees C are associated with multiple adverse outcomes postoperatively . Internal redistribution of heat from the body core to the colder periphery results in core temperature decreases of 0.5 degrees C to 1.5 degrees C in the first 30 minutes after induction of anesthesia . The purpose of this study was to determine if there was a difference in arrival temperatures to the PACU between surgical patients who had been warmed preoperatively with a forced warm air blanket and those patients warmed with cotton blankets . One hundred patients were r and omly assigned to receive prewarming by using a forced-air warm blanket ( n = 50 ) or a cotton blanket ( n = 50 ) . Temperatures were monitored every 15 minutes throughout the preoperative and postoperative periods . Patients in the forced warm air group had significantly higher temperatures on arrival to the PACU from the OR than did patients in the warm blanket group ( P = .000 ) . Patients in the forced warm air group exhibited a change in temperature of 0.0067 degrees C ( + /-.52 ) compared with a decrease of 0.22 degrees C ( + /-.48 ) for patients in the control group BACKGROUND The aim of this prospect i ve r and omized trial was to evaluate the efficacy of 3 intraoperative warming systems ( Warm-Touch , Thermamed SmartCare OP system , and Allon 2001 ) on maintenance of normothermia and to investigate their effects on perioperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass grafting . METHODS With institutional approval/patient informed consent , 90 patients presenting for elective multiple off-pump coronary artery bypass grafting were r and omly assigned to 1 of the 3 warming systems . Active warming was started after the induction of anesthesia . Perioperative transfusion was based on international guidelines . Body core temperature was recorded every 30 minutes during operation . Perioperative blood loss , autotransfusion , and allogenic transfusions were recorded . Analysis of variance was performed with post hoc Scheffé tests and chi 2 tests . RESULTS Normothermia could be sufficiently maintained during operation by the Allon 2001 only . Final body core temperature was 34.7 degrees C + /- 0.9 degrees C ( Warm-Touch ) , 35.6 degrees C + /- 0.8 degrees C ( Thermamed SmartCare OP ) , and 36.5 degrees C + /- 0.4 degrees C ( Allon 2001 ; P < .001 , Warm-Touch vs Thermamed SmartCare OP , Warm-Touch vs Allon 2001 , and Thermamed SmartCare OP vs Allon 2001 ) . Perioperative blood loss was 2683 + /- 1049 mL ( Warm-Touch ) , 2300 + /- 788 mL ( Thermamed SmartCare OP ) , and 1497 + /- 497 mL ( Allon 2001 ; P = .195 , Warm-Touch vs Thermamed SmartCare OP ; P < .001 , Warm-Touch vs Allon 2001 ; P = .001 , Thermamed SmartCare OP vs Allon 2001 ) . Transfusion requirements were 1097 + /- 874 mL ( Warm-Touch ) , 986 + /- 744 mL ( Thermamed SmartCare OP ) , and 431 + /- 387 mL ( Allon 2001 ; P = .838 , Warm-Touch vs Thermamed SmartCare OP ; P = .003 , Warm-Touch vs Allon 2001 ; P = .013 , Thermamed SmartCare OP vs Allon 2001 ) . Free of allogenic transfusion were 15 ( 51.7 % ; Warm-Touch ) , 18 ( 60 % ; Thermamed SmartCare OP ) , and 24 ( 82.8 % ; Allon 2001 ) patients ( P = .037 ) . CONCLUSIONS The goal of normothermia during off-pump coronary artery bypass grafting was best achieved by the Allon system . With this concept , overall blood loss and transfusion requirements were reduced , hence indicating improved quality of perioperative care STUDY OBJECTIVE To compare the ability of forced-air warming and reflective insulation to maintain intraoperative normothermia . DESIGN Prospect i ve , r and omized clinical trial . SETTING Operating rooms of a general hospital . PATIENTS 20 ASA physical status I and II patients undergoing elective total hip arthroplasty . INTERVENTIONS Patients were r and omly assigned to be warmed intraoperatively using forced-air or reflective insulation . Inspired gases were conditioned using a heat- and -moisture exchanger in both groups , and infused intravenous fluids were warmed to 37 degrees C. MEASUREMENTS AND MAIN RESULTS Distal esophageal ( core ) temperatures decreased approximately 0.5 degrees C in both groups during the first 45 minutes of anesthesia . Subsequently , core temperatures increased slightly in the patients given forced-air warming . In contrast , core temperatures continued to decrease in patients covered with reflective insulation . After 135 minutes of anesthesia , core temperatures were 36.4 + /- 0.6 degrees C ( mean + /- SD ) in the forced-air group but only 35.4 + /- 0.6 degrees C in the insulated group ( p < 0.01 , unpaired t-test ) . These data indicate that forced-air warming is superior to reflective insulation . CONCLUSION Reflective insulation was unable to maintain intraoperative normothermia during total hip arthroplasty . Active warming , such as that provided by forced air , was required to prevent hypothermia PURPOSE : Perioperative hypothermia has been shown to be an important determinant of outcome after open colorectal resections . The degree of hypothermia occurring with laparoscopic-assisted colorectal surgery is , however , unknown , and the effectiveness of st and ard warming measures is untested . This study was design ed to assess hypothermia in open and laparoscopic-assisted colonic resections using a st and ardized warming protocol . METHODS : A prospect i ve , nonr and omized study was performed with temperature measurements recorded every ten minutes . Statistical analysis was based on repeated measures analysis of variance models with significance set at the conventional 95 percent ( two tailed ) . RESULTS : A total of 107 patients were entered into the trial ; 68 had open and 39 had laparoscopic colectomies . The groups were well matched for age , weight , and duration of surgery , with a median operating time of 180 minutes in each group . The average drop in temperature from commencement of surgery to lowest point was 0.68 ° C ( st and ard deviation , 0.08 ) in the open group , compared with 0.53 ° C ( st and ard deviation , 0.06 ) in the laparoscopic group ( P=0.126 ) . CONCLUSIONS : Laparoscopic-assisted colorectal surgery is not associated with a higher incidence of perioperative hypothermia than open colorectal surgery using a st and ard warming regimen for both groups . On the basis of these results , st and ard temperature conservation is adequate , even for long complex laparoscopic procedures Background A new system has been developed that circulates warm water through a whole body garment worn by the patient during surgery . In this study the authors compared two different strategies for the maintenance of intraoperative normothermia . One strategy used a new water garment warming system that permitted active warming of both the upper and lower extremities and the back . The other strategy used a single ( upper body ) forced-air warming system . Methods In this prospect i ve , r and omized study , 53 adult patients were enrolled in one of two intraoperative temperature management groups during open abdominal surgery with general anesthesia . The water-garment group ( n = 25 ) received warming with a body temperature ( rectal ) set point of 36.8 ° C . The forced-air – warmer group ( n = 28 ) received routine warming therapy using upper body forced-air warming system ( set on high ) . The ambient temperature in the operating room was maintained constant at approximately 20 ° C . Rectal , distal esophageal , tympanic , forearm , and fingertip temperatures were recorded perioperatively and during 2 h after surgery . Extubated patients in both groups were assessed postoperatively for shivering , use of additional warming devices , and subjective thermal comfort . Results The mean rectal and esophageal temperatures at incision , 1 h after incision , at skin closure , and immediately postoperatively were significantly higher ( 0.4–0.6 ° C ) in the group that received water-garment warming when compared with the group that received upper body forced-air warming . The calculated 95 % confidence intervals for the above differences in core temperatures were 0.7–0.1 , 0.8–0.2 , 0.8–0.2 , and 0.9–0.1 , retrospectively . In addition , 14 and 7 % of patients in the control upper body forced-air group remained hypothermic ( < 35.5 ° C ) 1 and 2 h after surgery , respectively . No core temperature less than 35.5 ° C was observed perioperatively in any of the patients from the water-garment group . A similar frequency of the thermal stress events ( shivering , use of additional warming devices , subjective thermal discomfort ) was observed after extubation in both groups during the 2 h after surgery . Conclusions The investigated water warming system , by virtue of its ability to deliver heat to a greater percentage of the body , results in better maintenance of intraoperative normothermia that does forced-air warming applied only to the upper extremities , as is common practice Background : The effects of mild hypothermia on blood loss are little known OBJECTIVES After cardiopulmonary bypass , patients often show redistribution hypothermia , also called afterdrop . Forced-air blankets help to reduce afterdrop . This study explores the effect of forced-air blankets on temperature distribution and peripheral perfusion . The blood perfusion data is used to explain the observed temperature effects and the reduction of the afterdrop . METHODS Fifteen patients were enrolled in a r and omised study . In the test group ( n=8 ) , forced-air warmers were used . In the control group ( n=7 ) , only passive insulation was used . Core and skin temperatures and thigh temperatures at 0 , 8 , 18 and 38 mm depth were measured . Laser Doppler flowmetry ( LDF ) was used to record skin perfusion from the big toe . Blood flow through the femoral artery was determined with ultrasound . RESULTS Afterdrop in the test group was smaller than in the control group ( 1.2+/-0.2 degrees C vs 1.8+/-0.7 degrees C : P=0.04 ) whilst no significant difference in mean tissue thigh temperature was found between the groups . Local skin temperature was 2.5 - 3.0 degrees C higher when using forced-air heaters . However , skin perfusion was unaffected . Ultrasound measurements revealed that leg blood flow during the first hours after surgery was reduced to approximately 70 % of pre- and peri-operative values . CONCLUSIONS Forced-air blankets reduce afterdrop . However , they do not lead to clinical relevant changes in deep thigh temperature . LDF measurements show that forced-air heating does not improve toe perfusion . The extra heat especially favours core temperature . This is underlined by the decrease in postoperative leg blood flow , suggesting that the majority of the warmed blood leaving the heart flows to core organs and not to the periphery The importance of maintaining a patient 's core body temperature during anaesthesia to reduce the incidence of postoperative complications has been well documented . The st and ard practice of this institution is the use of a forced air device for intraoperative warming . The purpose of this study was to compare this st and ard with an alternative warming device using a radiant heat source which only heated the face . This prospect i ve , r and omized controlled trial compared the efficacy of two methods of intraoperative warming : the BairHugger ™ ( Augustine Medical , U.S.A. ) forced air device and the SunTouch ™ ( Fisher & Paykel Healthcare , N.Z. ) radiant warmer during laparoscopic cholecystectomy in 42 female patients . Oesophageal core temperatures were recorded automatically on to computer during operations using st and ardised anaesthesia , intravenous infusions and draping . The study failed to show any statistical or clinical difference between the two patient groups in terms of mean core temperature both intraoperatively ( P=0.42 ) and in the recovery period ( P=0.54 ) . Mean start to end core temperature differences were marginly lower in the radiant group ( 0.08 ° C ) but not statistically or clinical ly significantly different . Given some of the drawbacks with forced air systems , such as the expense of the single use blanket , this new radiant warming device offers an alternative method of active warming with advantages in terms of cost and possible application to a wide variety of surgical procedures The efficacy of leg skin warming in preventing hypothermia and shivering was evaluated in two separate prospect i ve , r and omized trials in patients undergoing abdominal surgery . In the first trial , 22 patients were r and omized to receive no hypothermia prevention ( control group ) or active warming with an electric warming blanket ( electric blanket group ) . In the second trial 33 patients were r and omized to receive no hypothermia prevention ( control group ) or forced-air warming ( Bair Hugger ® group ) or forced-air warming with insulation of the air blanket from the environment ( insulated Bair Hugger ® group ) . The core and skin temperatures were measured and changes in body heat content calculated . In the first trial , core temperature was 34.6 ± 0.3 ° C at the end of surgery in the control group vs 36.4 ± 0.1 ° C in the electric warming blanket group ( P < 0.001 ) . Shivering occurred in nine control patients and in one warmed patient ( P < 0.05 ) . In the second trial , core temperature was 35.1 ± 0.2 ° C at the end of surgery in the control group , 36.3 ± 0.1 ° C in the Bair Hugger ® group ( P < 0.01 ) and 37.1 ± 0.1 ° C in the insulated Bair Hugger ® group ( P < 0.01 versus control ; P < 0.05 versus Bair Hugger ® ) . Shivering occurred in one patient of each warmed group and in seven of the control group ( P < 0.05 ) . Skin-surface warming limited to the legs provides sufficient heat ( ranging 34 to 43 watts ) to counterbalance heat losses during abdominal surgery OBJECTIVES Our purpose was to determine the incidence and etiology of hypothermia during laparoscopic surgery and to evaluate the role of irrigation fluid temperature . STUDY DESIGN A prospect i ve r and omized study was performed of 35 women undergoing operative laparoscopy under general anesthesia who received surgical irrigation fluid either at ambient temperature or warmed to 39 degrees C. The core body temperature was determined with use of both an esophageal sensor and a tympanic membrane sensor and was expressed as the change from baseline . Additional data collected included age , height , weight , amount of irrigation fluid and intravenous fluid used , room temperature , length of anesthesia , and amount of carbon dioxide used for pneumoperitoneum . RESULTS Hypothermia occurred in 94 % of all patients , with no difference in incidence between the groups . The minimal core temperature was lower in the ambient temperature group ( -1.7 degrees + /- 0.2 degrees C ) than in the warmed fluid group ( -1.0 degrees + /- 0.2 degrees C ) . Of the variables measured , length of anesthesia and the amount of ambient temperature fluid alone explained the drop in core temperature . CONCLUSION Hypothermia is extremely common in laparoscopic surgery and is related to the length of anesthesia and the use of ambient temperature irrigation fluid . The use of warmed irrigation fluid can decrease , but not eliminate , this drop in core temperature In this trial we compared the hypothermia avoidance abilities of the A rct ic Sun ® Temperature Management System ( a servo-regulated system that circulates temperature-controlled water through unique energy transfer pads adherent to the patient ’s body ) with conventional temperature control methods . Patients undergoing off-pump coronary artery bypass ( OPCAB ) surgery were r and omized to either the A rct ic Sun System alone ( AS group ) or conventional methods ( control group ; increased room temperature , heated IV fluids , convective forced air warming system ) for the prevention of hypothermia ( defined by a temperature < 36 ° C ) . The AS group had nasopharyngeal temperature servo-regulated to a target of 36.8 ° C . Temperature was recorded throughout the operative period and comparisons were made between groups for both the time and area under the curve ( AUC ) for a temperature < 36 ° C ( AUC<36 ° C ) . Twenty-nine patients ( AS group = 14 , control group = 15 ) were studied . The AS group had significantly less hypothermia than the control group , both for duration of time < 36 ° C ( 2.5 [ 0–22 ] min , median [ interquartile range ] AS group versus 118 [ 49–192 ] min , control group ; P = 0.0008 ) as well as for AUC<36 ° C ( 0.3 [ 0–2.2 ] ° C × min , AS group versus 17.1 [ 3.6–173.4 ] ° C × min , control group ; P = 0.002 ) . The A rct ic Sun Temperature Management System significantly reduced intraoperative hypothermia during OPCAB surgery . Importantly , this was achieved in the absence of any other temperature modulating techniques , including the use of IV fluid warming or increases in the ambient operating room temperature BACKGROUND Hypothermia caused by massive transfusion or prolonged exposure during operation is difficult to reverse and is associated with adverse side effects . This prospect i ve , r and omized study evaluated a technique using extracorporeal venovenous recirculation ( EVR ) through a roller pump-driven device with a commercial countercurrent heat exchanger used for treatment of hypothermia ( temperature < 35.5 degrees C ) occurring during elective aortic operation . METHODS Patients undergoing aortic operation had routine prophylaxis against hypothermia including ventilator cascades , warming blankets , and low-velocity fluid warmers . When core temperature was less than 35.5 degrees C , patients were r and omized to continue existing therapy ( control , n = 7 ) or EVR ( n = 8) , performed through two large-bore venous lines . RESULTS There were no differences in age , sex , weight , body surface area , Acute Physiology and Chronic Health Evaluation II score , fluid replacement , length of operation , blood lost or given , induction temperature , red blood cell or platelet structure , hemolysis , length of intensive care unit or hospital stay , complications , or mortality rates . EVR was associated with increased final core temperature ( 35.5 degrees + /- 0.8 degrees [ EVR ] vs 33.8 degrees + /- 0.9 degrees [ control ] ; p < 0.005 ) and body heat content ( -13.9 + /- 62.3 kcal [ EVR ] vs -118.2 + /- 62.2 kcal [ control ] ; p < 0.01 ) , with heat gained being proportional to flow rate . CONCLUSIONS These data show that EVR provides a safe and effective method for the treatment of hypothermia OBJECTIVE Even mild perioperative hypothermia ( 34 degrees -36 degrees C ) can cause numerous adverse outcomes , including morbid cardiac events , coagulopathy with increased blood loss , and a decreased resistance to surgical wound infection . The purpose of this study was to evaluate the effect of fluid warming on preventing hypothermia during off-pump coronary artery bypass ( OPCAB ) surgery . DESIGN A prospect i ve r and omized clinical study . SETTING A tertiary care university hospital . PARTICIPANTS Forty patients undergoing OPCAB procedures . INTERVENTIONS Patients were r and omized into control ( n = 20 ) and Hotline ( n = 20 ) groups . In the Hotline group , all intravenous fluids were warmed to 41 degrees C by using 2 Hotline ( SIMS Inc , Rockl and , MD ) systems . All patients ( control and Hotline groups ) were managed with st and ardized institutional practice by using a combination of increased ambient operating room temperature ( to 25 degrees C ) and the use of a warmed water mattress ( 38 degrees C ) . MEASUREMENTS AND MAIN RESULTS Temperatures were recorded every hour after the induction of anesthesia at the pulmonary artery , nasopharynx , rectum , and bladder . In the Hotline group , temperatures were maintained or increased . In the control group , temperatures gradually decreased . There were no significant differences between the 2 groups in hemodynamic parameters , serum catecholamine concentrations , duration of intensive care unit stay , or duration of ward stay . CONCLUSIONS The results show that the warming of intravenous fluids by using the Hotline system prevents decreases in systemic temperatures during OPCAB surgery Purpose Perioperative hypothermia results largely from core-to-peripheral heat redistribution . Droperidol , which is often used for premedication , promotes vasodilation , and thus may affect redistribution of heat . Accordingly , we tested the hypothesis that preanesthetic droperidol would affect perioperative hypothermia . Methods Twenty-three ASA physical status I patients scheduled for arthroscopic ligament reconstruction were r and omly assigned to two groups to receive no premedication orim droperidol 0.1 mg·kg−1 30 min before anesthesia . Anesthesia was induced and maintained with propofol and fentanyl . We monitored core ( tympanic ) and peripheral ( palm ) temperatures , and skin ( fingertip ) blood flow for two hours after the induction of anesthesia during surgery . Results Before the induction of anesthesia , patients given droperidol were more deeply se date d than those given no premedication . Core temperature , which was similar in both groups before induction , decreased significantly more in the control than in the droperidol patients ( 0.75 ± 0.34 ° C and 0.37 ± 0.20 ° C , respectively , at 75 min after induction ; P < 0.0l ) . Preinduction peripheral temperature and skin blood flow were lower in the control group than in the droperidol group , but the two variables became similar in both groups after induction . Conclusion The results of the present study confirm our hypothesis that premedication with droperidol affects perioperative hypothermia . Droperidol may prevent core-to-peripheral heat redistribution after the induction of anesthesia . RésuméObjectifL’hypothermie périopératoire provient en gr and e partie de la redistribution de la chaleur du centre vers la périphérie . Le dropéridol , souvent utilisé en prémédication , favorise la vasodilatation et peut ainsi agir sur la redistribution de la chaleur . Nous avons donc vérifié si ce dropéridol préanesthésique a un effet sur l’hypothermie périopératoire . MéthodeTrente- trois patients d’état physique ASA I , devant subir une reconstruction ligamentaire arthroscopique , ont été répartis au hasard en deux groupes et ont reçu , ou non , la prémédication i m de 0,1 mg·kg− 1 de dropéridol 30 min avant l’anesthésie induite et maintenue avec du propofol et du fentanyl . Au cours de l’opération , nous avons surveillé les températures central e ( tympan ) et périphérique ( paume ) et le débit sanguin cutané ( bout du doigt ) pendant deux heures après l’induction de l’anesthésie . RésultatsAvant l’induction , les patients qui ont reçu le dropéridol ont expérimenté une sédation plus profonde que ceux de l’autre groupe . La température central e , similaire dans les deux groupes avant l’induction , a chuté de façon significative , et plus dans le groupe témoin comparé au groupe expérimental ( 0,75 ± 0,34 ° C et 0,37 ± 0,20 ° C , respectivement , 75 min après l’induction ; P < 0,01 ) . La température périphérique et le débit sanguin cutané ont été plus bas dans le groupe témoin avant l’induction , mais similaires dans les deux groupes après l’induction . Conclusion Les résultats confirment donc notre hypothèse : la prémédication avec du dropéridol a un effet sur l’hypothermie périopératoire . Le dropéridol peut empêcher la redistribution de la chaleur du centre vers la périphérie après l’induction anesthésique We have measured aural canal ( core ) and skin temperatures , and body heat content in 45 patients undergoing elective hip arthroplasty . They received general anaesthesia which included thiopentone , vecuronium and enflurane and nitrous oxide in oxygen . Patients were allocated r and omly to three groups : group 1 , control ( n = 15 ) , received no intraoperative warming device ; group 2 had passive skin surface warming ( metallized plastic sheet , Thermolite ( n = 15 ) ; and group 3 had active skin surface warming ( forced heated air , Bair-Hugger ) ( n = 15 ) . Duration of surgery , fluid administration and the temperature and relative humidity of the operating theatre were similar for the three groups . Core temperature and mean body heat content decreased significantly during surgery in groups 1 and 2 ( aural canal temperature 1.5 and 1.0 degrees C , and mean body heat content 287 and 189 kJ , respectively ) , while in group 3 these variables remained near preoperative values ( P = 0.001 ) . Mean skin and h and temperatures decreased in the control group , increased in the active warming group and were unchanged in the passive warming group ( P < 0.005 ) , indicating that the forced heated air system was very efficient in providing thermal homeostasis during surgery , while the metallized plastic sheet was able to insulate the skin only from radiant and convective heat losses , without attenuating the reduction in core temperature BACKGROUND To compare passive thermal insulation by reflective blankets with forced-air active warming on the efficacy of normothermia maintenance and time for discharging from the recovery room after combined spinal/epidural anesthesia for total hip arthroplasty . METHODS DESIGN Prospect i ve , r and omized study . SETTING Inpatient anesthesia at three University Departments of orthopedic surgery . PATIENTS 50 ASA physical status I-III patients , who were scheduled for elective total hip arthroplasty . INTERVENTIONS Patients received combined spinal/epidural anesthesia ( CSE ) with intrathecal injection of 15 mg of 0.5 % hyperbaric bupivacaine . All procedures started 8 - 10 a.m. , and operating room temperature was maintained between 21 - 23 degrees C , with relative humidity ranging between 40 - 45 % . As warming therapy patients received either passive thermal insulation of the trunk , the two upper limbs and the unoperated lower limb with reflective blankets ( group passive , n = 25 ) , or forced-air active warming of the two upper limbs ( group active , n = 25 ) . Core temperature was measured before CSE placement ( baseline ) , and then every 30 min until recovery of normothermia . RESULTS Demographic data , duration of surgery , intraoperative blood losses , and crystalloid infusion were similar in the two groups . Arterial blood pressure decreased in both groups compared with baseline values , while no differences in heart rate were observed during the study . Core temperatures in passive group patients decreased more markedly than in actively warmed patients , with a 1 degree C difference between the two groups at the end of surgery ( p < 0.0005 ) . At recovery room entry seven patients in group active ( 24 % ) and 16 patients in group passive ( 64 % ) showed a core temperature < 36 degrees C ( p < 0.01 ) . Achievement of both discharging criteria and normothermia required 32 + /- 18 min in active group and 74 + /- 52 min in passive group ( p < 0.0005 ) . CONCLUSIONS Forced-air cutaneous warming allows the anesthesiologist to maintain normothermia during combined spinal/epidural anesthesia for total hip replacement even if the convective blanket is placed on a relatively small skin surface with reflex vasoconstriction . Maintaining core normothermia decreased the duration of postanesthesia recovery and may , therefore , reduce costs of care We have investigated the influence of active warming before and during operation on blood loss , transfusion requirements , duration of stay in the post-anaesthesia care unit ( PACU ) and perioperative costs in 40 patients undergoing major abdominal surgery . Patients were allocated r and omly to one of two groups : in the study group ( n = 20 ) , patients were actively warmed using forced air for 30 min before induction of general anaesthesia and during anaesthesia . Passive protection against heat loss consisted of circulating water mattresses , blankets and fluid warming devices , and was used both in the active warming group and in the control group ( n = 20 ) . At the end of surgery the change in core temperature was significantly less in the group of actively warmed patients ( 0.5 ( SD 0.8 ) degree C vs 1.5 ( 0.8 ) degree C ; P < or = 0.01 ) . Blood loss and transfusion requirements were less in the actively warmed patients , who had a shorter duration of stay in the PACU ( 94 ( SD 42 ) min vs 217 ( 169 ) min ; P < or = 0.01 ) and a 24 % reduction in total anaesthetic costs Cutaneous warming is reportedly an effective treatment for shivering during epidural and after general anaesthesia . We quantified the efficacy of cutaneous warming as a treatment for shivering . Unwarmed surgical patients ( final intra‐operative core temperatures ∼ 35 ° C ) were r and omly assigned to be covered with a blanket ( n = 9 ) or full‐body forced‐air cover ( n = 9 ) . Shivering was evaluated clinical ly and by oxygen consumption . Forced‐air heating increased mean‐skin temperature ( mean ( SD ) 35.7 ° C ( 0.4 ) vs. 33.2 ° C ( 0.8 ) ; p < 0.0001 ) and lowered core temperature at the shivering threshold ( 35.7 ° C ( 0.2 ) vs. 36.4 ° C(0.2 ) ; p < 0.0001 ) . Active warming improved thermal comfort and significantly reduced oxygen consumption from 9.7 ( 4.4 ) ml.min−1.kg−1 to 5.6 ( 1.9 ) ml.min−1.kg−1(p = 0.038 ) . However , the duration of shivering was similar in the unwarmed ( 37 min ( 11 ) ) and active warming ( 36 min ( 10 ) ) groups . Core temperature contributed about four times as much as skin temperature to control of shivering . Cutaneous warming improved thermal comfort and reduced metabolic stress in postoperative patients , but did not quickly obliterate shivering This study determined the efficiency of a reflective blanket in preventing hypothermia during intra-abdominal gynecological procedures . Forty female patients were studied . A table of r and om numbers was used to assign patients to the reflective blanket group ( experimental ) or the warmed cotton blanket group ( control ) . Esophageal and room temperatures were measured . Data were recorded regarding age , height , weight , body surface area , first-hour intravenous fluid volume , time from induction to skin incision and time from skin incision to peritoneal incision . The study showed no significant differences between groups in regard to esophageal or room temperatures ( ANOVA , p greater than .05 ) . No significant differences between groups in regard to patient characteristics were found ( ANCOVA ) . No correlation was found between esophageal temperature and room temperature in either group . A significant decrease in esophageal temperatures was found in both groups during the first 45 minutes of the study ( p less than .01 ) , after which temperatures stabilized . In conclusion , the reflective blanket was no more efficient than warmed cotton blankets in preventing intraoperative hypothermia . Previous studies showing the greatest decrease in temperature occurred within the first hour of anesthesia and surgery were supported . The reflective blanket may be useful for operating rooms where the storage and heating of cotton blankets is not feasible due to limited space or cost Hypothermia in the immediate postoperative period is associated with postoperative instability , prolonged recovery and increased risk of myocardial ischemia in the subsequent 24 h. This study examined the effect of irrigating-fluid temperature during transurethral resection of the prostate on perioperative temperature regulation . A r and omized prospect i ve study was conducted on twenty-eight consecutive patients undergoing transurethral resections of the prostate . The control group received room-temperature irrigant . The study group received irrigant warmed through the Abbott level-one fluid warmer or in the Ohio Servocare incubator . Fluid temperatures were 17 degrees C for unwarmed fluid , 37 degrees C for level-one fluid , and 35 degrees C for incubator fluid . The incidence of hypothermia ( < or = 36 degrees C ) in the immediate postoperative period was 95 % in the cold-irrigant group and 38 % in the warm-irrigant group ( p = 0.001 ) . The decrease from pre- to postoperative temperature was greater with cold ( 0.95 + /- 0.47 degrees C ) than with warm ( 0.42 + /- 0.64 degrees C ) irrigant ( p = 0.01 ) . The type of anesthesia ( spinal versus general ) and method of fluid warming ( incubator versus level-one ) did not have a significant effect on the perioperative temperature drop . Regression analysis demonstrated that the time of resection , amount of prostate resected , volume of irrigant fluid , and volume of intravenous fluid administered were not independent predictors of intraoperative temperature change STUDY OBJECTIVE To compare the effectiveness of three commonly used intraoperative warming devices . DESIGN A r and omized , prospect i ve clinical trial . SETTING The surgical suite of a university medical center . PATIENTS Twenty adult patients undergoing kidney transplantation for end-stage renal disease . INTERVENTIONS Patients were assigned to one of four warming therapy groups : circulating-water blanket ( 40 degrees C ) , heated humidifier ( 40 degrees C ) , forced-air warmer ( 43 degrees C , blanket covering legs ) , or control ( no extra warming ) . Intravenous fluids were warmed ( 37 degrees C ) , and fresh gas flow was 5 L/min for all groups . No passive heat and moisture exchangers were used . MEASUREMENTS AND MAIN RESULTS The central temperature ( tympanic membrane thermocouple ) decreased approximately 1 degree C during the first hour of anesthesia in all groups . After three hours of anesthesia , the decrease in the tympanic membrane temperature from baseline ( preinduction ) was least in the forced-air warmer group ( -0.5 degrees C + /- 0.4 degrees C ) , intermediate in the circulating-water blanket group ( -1.2 degrees C + /- 0.4 degrees C ) , and greatest in the heated humidifier and control groups ( -2.0 degrees C + /- 0.5 degrees C and -2.0 degrees C + /- 0.7 degrees C , respectively ) . Total cutaneous heat loss measured with distributed thermal flux transducers was approximately 35W ( watts = joules/sec ) less in the forced-air warmer group than in the others . Heat gain across the back from the circulating-water blanket was approximately 7W versus a loss of approximately 3W in patients lying on a st and ard foam mattress . CONCLUSION The forced-air warmer applied to only a limited skin surface area transferred more heat and was clinical ly more effective ( at maintaining central body temperature ) than were the other devices . The characteristic early decrease in central temperature observed in all groups regardless of warming therapy is consistent with the theory of anesthetic-induced heat redistribution within the body Hypothermia is experienced by all patients undergoing major surgical procedures . Hypothermia can lead to postoperative complications affecting oxygenation with neurologic , immunologic , and metabolic consequences . Current methods of heat conservation used in the operating room include blanket warmers , fluid warmers , and anesthesia circuit warmers . These methods are often inadequate at maintaining a patient 's body temperature . The current study used a post-test-only control group design . Subjects in the treatment group had an insulated head cover applied within 1 minute of arrival in the operating room , while those in the control group did not . All subjects had routine heat conservation measures ( blanket warmers , fluid warmers , and anesthesia circuit humidifiers ) . Following induction of anesthesia , subjects ' temperatures were measured using an esophageal stethoscope with thermistor probe at 10 and 70 minutes . Results showed no significant differences between groups at either time point We have evaluated the efficacy of new electric warming blankets , which meet the requirements of the international st and ard for perioperative electrical and thermal safety , in preventing intraoperative hypothermia . We studied 18 patients undergoing abdominal surgery , allocated to one of two groups : in the control group , there was no prevention of intraoperative hypothermia ( n = 8) and in the electric blanket group , two electric blankets covered the legs and upper body ( n = 10 ) . Anaesthesia duration was similar in the two groups ( mean 201 ( SEM 11 ) min ) , as was ambient temperature ( 20.5 ( 0.1 ) degrees C ) . Core temperature decreased during operation by 1.5 ( 0.1 ) degrees C in the control group , but only by 0.3 ( 0.2 ) degree C in the electric blanket group ( P < 0.01 ) . Five patients shivered in the control group compared with one in the electric blanket group ( P < 0.05 ) . We conclude that cutaneous warming with electric blankets was an effective means of preventing intraoperative hypothermia during prolonged abdominal surgery BACKGROUND Prewarming and intraoperative warming with forced air-warming systems prevent perioperative hypothermia and shivering in patients undergoing elective cesarean delivery with epidural anesthesia . We tested the hypothesis that intraoperative lower body forced air-warming prevents hypothermia in patients undergoing elective cesarean delivery with spinal anesthesia . METHODS Thirty healthy patients undergoing cesarean delivery with spinal anesthesia were r and omly assigned to forced air-warming or control groups ( identical cover applied with forced air-warming unit switched off ) . A blinded investigator assessed oral temperature , shivering , and thermal comfort scores at 15-min intervals until discharge from the postanesthetic care unit . Umbilical cord blood gases and Apgar scores were also measured after delivery . RESULTS The maximum core temperature changes were similar in the two groups ( -1.3 degrees C + /- 0.4 degrees C vs -1.3 degrees C + /- 0.3 degrees C for the forced air-warming group and control group , respectively ; P = 0.8 ) . Core hypothermia ( < or = 35.5 degrees C ) occurred in 8 of 15 patients receiving forced air-warming and in 10 of 15 unwarmed patients ( P = 0.5 ) . The incidence and severity of shivering did not significantly differ between groups . Umbilical cord blood gases and Apgar scores were similar in both groups ( P = NS ) . CONCLUSIONS We conclude that intraoperative lower body forced air-warming does not prevent intraoperative hypothermia or shivering in women undergoing elective cesarean delivery with spinal anesthesia STUDY OBJECTIVE To evaluate if active cutaneous warming of the two upper limbs with reflex vasoconstriction is less effective in maintaining intraoperative normothermia than warming the vasodilated unoperated lower limb during combined spinal-epidural anesthesia ( CSE ) . DESIGN Prospect i ve , r and omized study . SETTING Inpatient anesthesia at university departments of orthopedic surgery . PATIENTS 48 ASA physical status I , II , and III patients , who were scheduled for elective total hip arthroplasty . INTERVENTIONS Patients received CSE with intrathecal injection of 15 mg of 0.5 % hyperbaric bupivacaine . All procedures started 8 to 10 AM , and operating room temperature was maintained between 21 degrees and 23 degrees C , with relative humidity ranging between 40 % and 45 % . For warming therapy , patients received active forced-air warming of either the two upper limbs ( Group Upper body , n = 24 ) , or the unoperated lower limb ( Group Lower extremity , n = 24 ) . Core temperature was measured before CSE placement ( baseline ) , and then every 30 minutes until completion of surgery . Time for fulfillment of clinical discharging criteria from the recovery area was evaluated by a blinded observer . MEASUREMENTS AND MAIN RESULTS Demographic data , duration of surgery , intraoperative blood losses , crystalloid infusion , and hemodynamic variables were similar in the two groups . Core temperature slightly decreased in both groups , but at the end of surgery the mean core temperature was 36.2 degrees + /- 0.5 degree C in Group Upper body and 36.3 + /- 0.5 in Group Lower extremity ( NS ) . At recovery room arrival , seven patients in Group Upper body ( 29 % ) and three patients in Group Lower extremity ( 12.5 % ) had a core temperature less than 36 degrees C ( NS ) . Shivering was observed in one patient in Group Upper body and in two patients in Group Lower extremity ( NS ) . Clinical discharging criteria were fulfilled after 37 + /- 16 minutes in Group Upper body and 30 + /- 32 minutes in Group Lower extremity ( NS ) . CONCLUSIONS Forced-air cutaneous warming allows the anesthesiologist to maintain normothermia during CSE for total hip replacement even if the convective blanket is placed on a relatively small skin surface with reflex vasoconstriction . Placing the forced-air warming system on the vasodilated unoperated lower limb may be troublesome to the surgeons and does not offer clinical ly relevant advantages in warming efficiency STUDY OBJECTIVE to compare passive heat retention by low-flow anesthesia , alone and with additional thermal insulation by reflective blankets , with forced-air warming preventing intraoperative hypothermia during combined epidural-general anesthesia . DESIGN R and omized , controlled study . SETTING Inpatient anesthesia at a university department of orthopedic surgery . PATIENTS 30 ASA physical status I and II patients , who were scheduled for elective hip or knee arthroplasty and were free from systemic disease . INTERVENTIONS Patients received epidural block up to T10 by alkalinized lidocaine 2 % , and then were administered st and ard general anesthesia by means of low-flow rebreathing system ( fresh gas flow = 1 L/min ) . All procedures started between 8 and 10 AM , and operating room ( OR ) temperature was maintained between 21 degrees and 23 degrees C , with relative humidity ranging between 40 % and 45 % . For heat retention or warming therapy , patients received either low-flow anesthesia only ( control , n = 10 ) , low-flow anesthesia with additional reflective blankets ( blanket , n = 10 ) , or low-flow anesthesia with active forced-air warming ( forced-air , n = 10 ) . Tympanic temperature was measured at OR arrival ( baseline ) ; immediately following general anesthesia induction ; 30 , 60 , 90 , and 120 minutes from general anesthesia induction ; and at the end of surgery . MEASUREMENTS AND MAIN RESULTS Duration of anesthesia , invasiveness of surgery , and baseline core temperature were similar in the three groups . Core temperature decreased in all the three groups 30 minutes after general anesthesia induction compared with baseline ( p < 0.01 ) ; afterwards , it progressively decreased in the control and blankets groups ( p = 0.004 ) , with a reduction from baseline values measured at the end of surgery of 2.0 degrees C and 1.6 degrees C , respectively . In the forced-air group , after the initial significant decrease ( p = 0.01 vs. baseline ) , core temperature progressively increased to 35.8 + /- 0.6 degrees C , which was similar to preoperative values and significantly higher than either the control or blankets groups ( p = 0.004 ) . CONCLUSIONS During combined epidural-general anesthesia for elective hip and knee arthroplasty , passive heat retention by means of low-flow anesthesia alone and in combination with reflective blankets is ineffective in maintaining intraoperative normothermia and definitely inferior to active forced-air warning Background : In a prospect i ve , r and omized , placebo‐controlled study we investigated the efficacy of 2 different heating methods in 24 patients undergoing abdominal surgery of at least 2 h expected duration Hypothermia during prolonged surgery may be prevented by active and passive warming methods . We have compared r and omly two types of occlusive body wraps in groups of 20 patients . One wrap had additional reflective properties which , by reducing radiative in addition to convective and evaporative heat loss , was expected to improve heat conservation . Patients were studied during hepatopancreatobiliary surgery and both groups were similar in characteristics . Skin and core body temperatures increased and core temperature exceeded 37 degrees C in 40 % of patients in both groups . This continuous increase in temperature was unexpected and the observed heat gain may have been stimulated endogenously by the type of surgery rather than that supplied externally . Overall , mean hourly heat gain was similar in both groups : 71 ( SD 28 ) kJ h-1 in the reflective group and 67 ( 33 ) kJ h-1 in the other group Hypothermia after induction of general anesthesia results largely from core-to-peripheral redistribution of body heat . Both central inhibition of tonic thermoregulatory vasoconstriction in arteriovenous shunts and anesthetic-induced arteriolar and venous dilation contribute to this redistribution . Ketamine , unique among anesthetics , increases peripheral arteriolar resistance ; in contrast , propofol causes profound venodilation that other anesthetics do not . We therefore tested the hypothesis that induction of anesthesia with ketamine causes less core hypothermia than induction with propofol . Twenty patients undergoing elective surgery were r and omly assigned to anesthetic induction with either 1.5 mg/kg ketamine ( n = 10 ) or 2.5 mg/kg propofol ( n = 10 ) . Anesthesia in both groups was subsequently maintained with sevoflurane and 60 % nitrous oxide in oxygen . Forearm minus finger , skin-temperature gradients < 0 ° C were considered indicative of significant arteriovenous shunt vasodilation . Ketamine did not cause vasodilation just after induction , whereas propofol rapidly induced vasodilation . Core temperatures in the patients given ketamine remained significantly greater than those in the patients induced with propofol . These data suggest that maintaining vasoconstriction during induction of anesthesia reduces the magnitude of redistribution hypothermia BACKGROUND Conflicting results have been obtained when using heat and constant negative pressure applied to the arm to induce re-warming in patients with mild hypothermia due to surgery . We hypothesized that pulsating negative pressure would increase skin blood flow and thus heat transfer . The purpose of this study was to compare a new method of applying heat and pulsating negative pressure to the skin with conventional forced-air warming for preventing perioperative hypothermia . METHODS Twenty patients undergoing prolonged laparotomy for gastric surgery were r and omized into two groups . One group ( SM ) received hospital st and ard method : forced-air warming , 43 degrees C ( Bair Hugger ) on the thoracic and upper arm surface . The other group ( NM ) received the new method : warm water and pulsating negative pressure treatment applied in a transparent acrylic cylinder ( 50 x 16 cm ) on one arm . The cylinder was circulated with water at 42.5 degrees C , leaving an air pocket inside the device . Pulsating pressure between 0 and -40 mm Hg was generated in the air pocket inside the cylinder . RESULTS Two groups of 10 patients were studied . Warming was started shortly after induction of general anaesthesia . The two methods performed similarly during the first 60 min , with a mean 0.7 degrees decrease in core temperature . The tympanic temperature curve in NM group then increased and returned to baseline ( 37 degrees C ) by 120 min . The temperature of SM group increased more slowly , reaching 36 degrees C by 120 min ( P < 0.05 ) . CONCLUSION Warm water and pulsating negative pressure was significantly better at treating hypothermia during laparotomy than forced-air warming Background : Perioperative hypothermia is common and likely contributes to morbidity , but the efficacy of prophylactic fluid warming has hardly been analyzed systematic ally . We tested the hypothesis that the use of an infusion/blood warmer , based on the principle of countercurrent heat exchange , reduces incidence and degree of severe hypothermia following aortic surgery BACKGROUND Inspired gases can be warmed and humidified in a variety of ways . The effect of a chemically-reactive heated heat and moisture exchanger/hygroscopic condenser humidifier ( HME/HCH ) on secretions , rate of core body warming , blood loss , and time to extubation was studied in hypothermic post-cardiac surgery patients . METHODS Fifty patients with normal ventricular function , undergoing coronary bypass grafting , were r and omized to receive either a conventional HME ( Gibeck , Humid-Vent 1 [ PN 11112 ] , Hudson RCI , Temecula , California ) or a chemically-heated HME ( Thermax HCH Filter [ PN 9302 ] , Enternet Medical , Las Vegas , Nevada ) following surgery or on arrival in the ICU . Effects on secretions , core temperature , postoperative bleeding , duration of intubation , and added resistance were measured . The Thermax weighs 67 g and adds 79 mL of dead space . The Humid-Vent 1 weighs 9.4 g and adds 10 mL of dead space . RESULTS There was no significant difference between the 2 devices in time to extubation , blood loss , or quality or quantity of secretions . Use of the Thermax device , however , result ed in a more rapid rise in body temperature ( 0.299 degrees C/h with the Thermax vs 0.073 degrees C/h with the Humid-Vent 1 , p = 0.001 ) and more added resistance ( 0.0672 cm H(2)O/L/s with the Thermax vs 0.0123 cm H(2)O/L/s with the Humid-Vent 1 , p = 0.00000172 ) . CONCLUSIONS The Thermax chemically-heated HME results in more rapid warming of mildly hypothermic patients following cardiopulmonary bypass than does a conventional passive HME Background : Intraoperative hypothermia initially results from internal redistribution of heat facilitated by anesthesia-induced vasodilatlon . Preinductlon skin-surface warming minimizes postinduction hypothermia in anesthetized volunteers . However , its efficacy might be reduced in surgical situations , because of multiple sources of heat loss . Methods : Intraoperative core and mean skin temperatures were measured during total hip arthroplasty in 16 patients , r and omly assigned to be covered preoperatlvely with a warming blanket for ≥90 min ( prewarmed group ) or not covered ( unwarmed group ) . Results : During the first hour of anesthesia , core temperature decreased more than twice as much in the unwarmed group ( −0.7 ± 0.1 ° C ; mean ± SE ) than in the prewarmed patients ( −0.3 ± 0.1 ° C ) . At the end of surgery , core temperature was 36.3 ± 0.1 ° C in the prewarmed group and 35.2 ± 0.2 ° C in the unwarmed group . During recovery , seven patients obviously shivered in the unwarmed group and none in the prewarmed group . Conclusions : Preanesthetic skin-surface warming reduces the initial postinductlon hypothermia in surgical patients , preventing intraoperative hypothermia and postoperative shivering even for procedures lasting 3 h or longer Hemodynamic performance and core temperature were recorded during transurethral prostatectomy in 52 patients who were stratified according to cardiac symptom score and then r and omized to undergo st and ard ( 31 ) or isothermic ( 21 ) transurethral prostatectomy . During the st and ard procedure ambient temperature ( 21C ) irrigant was used , while during isothermic prostatectomy warmed irrigant at 38C was used to prevent heat loss from the bladder , and a warming blanket and humidifying filter were used to decrease cutaneous and respiratory heat loss . Core temperature decreased by a mean of 0.8C ( 95 % confidence interval -0.9 to -0.7 ) during st and ard transurethral prostatectomy and by 0.27C ( -0.4 to -0.15 ) during the isothermic procedure . The st and ard prostatectomy group showed a significant hemodynamic response consisting of increased mean arterial pressure ( p < 0.0002 ) , increased index of systemic vascular resistance ( p < 0.0001 ) , bradycardia ( p < 0.02 ) , and decreased Doppler indexes of stroke volume ( p < 0.005 ) and cardiac output ( p < 0.001 ) . The isothermic transurethral prostatectomy group was hemodynamically stable . These differences between the groups suggest that rapid central cooling exerted a significant effect on perioperative hemodynamic performance during transurethral prostatectomy We tested the hypothesis that 15 min of forced-air prewarming , combined with intraoperative warming , prevents hypothermia and shivering in patients undergoing elective cesarean delivery . We simultaneously tested the hypothesis that maintaining maternal normothermia increases newborn temperature , umbilical vein pH , and Apgar scores . Thirty patients undergoing elective cesarean delivery were r and omly assigned to forced-air warming or to passive insulation . Warming started 15 min before the induction of epidural anesthesia . Core temperature was measured at the tympanic membrane , and shivering was grade d by visual inspection . Patients evaluated their thermal sensation with visual analog scales . Rectal temperature and umbilical pH were measured in the infants after birth . Results were compared with unpaired , two-tailed Student ’s t-tests and & khgr;2 tests . Core temperatures after 2 h of anesthesia were greater in the actively warmed ( 37.1 ° C ± 0.4 ° C ) than in the unwarmed ( 36.0 ° C ± 0.5 ° C;P < 0.01 ) patients . Shivering was observed in 2 of 15 warmed and 9 of 15 unwarmed mothers ( P < 0.05 ) . Babies of warmed mothers had significantly greater core temperatures ( 37.1 ° C ± 0.5 ° C vs 36.2 ° C ± 0.6 ° C ) and umbilical vein pH ( 7.32 ± 0.07 vs 7.24 ± 0.07 ) Actively warming patients during surgery is considered the best method of preventing inadvertent hypothermia . In order to investigate the effect of forced air warming on postoperative oxygen consumption , we studied 26 patients undergoing orthopaedic surgery using a prospect i ve , r and omized trial design . We measured oxygen consumption , carbon dioxide production , temperature , thermal comfort and pain scores . Apart from intraoperative temperature , there were no significant differences in these measurements between the two groups . This study demonstrated the gradual heat gain and also the potential for hyperthermia from pre- and intraoperative forced air warming . We conclude that forced air warming is not necessary for moderate duration non-body-cavity surgery if effective preinduction covering of patients and minimal surgical exposure is achieved The investigators examined the effect of infusing continuously warmed ( ie , 37.0 degrees C [ 98.6 degrees F ] ) i.v . fluids in two groups of middle-aged female patients undergoing laparoscopic cholecystectomy procedures . They hypothesized that increasing i.v . fluid temperature during surgery would decrease patients ' risk for hypothermia . One group of patients received prewarmed i.v . fluids that cooled to room temperature during surgery . The second group received i.v . fluids that were warmed continuously by a fluid warmer during the surgical procedures . Analyses of covariance , with the first intraoperative temperature measurement treated as the covariate , revealed nonsignificant results at the P < .05 level . The results suggest that administering continuously warmed i.v . fluids intraoperatively has no significant effect on maintaining patients ' body temperatures during short laparoscopic surgical procedures Background : Intraoperative hypothermia is a common event during open and laparoscopic abdominal surgery . The aim of this study was to compare changes in core temperature between laparoscopic and open gastric bypass ( GBP ) . Methods : 101 patients with a body mass index ( BMI ) of 40 - 60 kg/m2 were r and omly assigned to open ( n=50 ) or laparoscopic ( n=51 ) GBP . Anesthetic technique was similar for both groups . An external warming blanket and passive airway humidification were used intraoperatively . Core temperature was recorded at preanesthesia , at baseline ( after induction ) and at 30-min intervals ; intra-abdominal temperature was additionally measured at 30-min intervals in a subset of 30 laparoscopic GBP patients .The number of patients who developed intraoperative and postoperative hypothermia ( < 36 ° C ) was recorded . Length of operation for both groups and the amount of CO2 gas delivered during laparoscopic operations were also recorded . Results : There was no significant difference between groups with respect to age , gender , mean BMI , and amount of intravenous fluid administered . After induction of anesthesia , core temperature significantly decreased in both groups ; 36 % of patients in the open group and 37 % of patients in the laparoscopic group developed hypothermia . This percentage increased to 46 % in the open group and 41 % in the laparoscopic group during the operation , and then decreased to 6 % in the open group and 8 % in the laparoscopic group in the recovery-room . Core temperature increased during the operative procedure to reach 36.5 ± 0.6 ° Cin the open group and 36.3 ± 0.5 ° Cin the laparoscopic group at 2.5 hours after surgical incision . Intra-abdominal temperature during laparoscopic GBP was significantly lower than core temperature at all measurement points ( p<0.05 ) . Operative time was longer in the laparoscopic group than in the open group ( 232 ± 43 vs 201 ± 38 min , p<0.01 ) . Mean volume of gas delivered during laparoscopic GBP was 650 ± 220 liters . Conclusion : Perioperative hypothermia was a common event during both laparoscopic and open GBP . Despite a longer operative time , laparoscopic GBP did not increase the rate of intraoperative hypothermia when efforts were made to minimize intraoperative heat loss We evaluated whether warming IV fluids result ed in less hypothermia ( core temperature < 35.5[degree sign]C ) compared with room-temperature fluids . Thirty-eight adult out patients undergoing elective gynecological surgery of > 30 min were r and omized to two groups : fluid warming at 42[degree sign]C or control ( room temperature fluids at approximately 21[degree sign]C ) . All patients received general anesthesia with isoflurane , tracheal intubation , st and ard operating room blankets and surgical drapes , and passive humidification of inspired gases . Tympanic membrane ( core ) temperatures were measured at baseline and at 15-min intervals after induction . The incidence of shivering and postoperative requirement for meperidine and /or radiant heat were evaluated . Core temperatures were lower in the control compared with the warm fluid group at the end of surgery ( 35.6 + /- 0.1[degree sign]C vs 36.2 + /- 0.1[degree sign]C ; P < 0.05 ) . More patients had final core temperature < 35.5[degree sign]C in the control compared with the warm fluid group ( 35 % vs 0 % ; P < 0.05 ) . There were no differences in time to discharge from the postanesthesia care unit or the incidence of shivering between the groups . We conclude that fluid warming , in conjunction with st and ard heat conservation measures , was effective in maintaining normothermia during outpatient gynecological surgery ; however , there was no improvement in patient outcome . Implication s : Women who received IV fluid at body temperature had significantly higher core temperatures during and after outpatient gynecological surgery compared with women who received IV fluids at the temperature of the operating room . ( Anesth Analg 1998;87:37 - 41 The decrease of arterial blood pressure and body temperature after epidural or spinal anesthesia is thought to be the result of sympathetic block , which could cause pooling and redistribution of blood into the lower extremities . Studies have demonstrated that leg wrapping with elastic b and ages may reduce the incidence of hypotension after spinal anesthesia . We tried to extend these previous observations to epidural anesthesia by testing the hypothesis that leg wrapping with elastic b and ages should decrease the incidence of hypotension in patients receiving epidural anesthesia . Moreover , we evaluated the effect of this maneuver as regards hypothermia and shivering . Sixty parturients were r and omly allocated to receive either leg wrapping with tight elastic b and ages ( leg-wrapped group ) or not ( control group ) before anesthesia . Sublingual temperature was observed at five periods : baseline , immediately after epidural anesthesia , abdominal skin disinfection , skin incision , and delivery . Hypotension and shivering during the observation periods were also recorded . The incidence of hypotension was significantly less frequent ( P = 0.03 ) in the leg-wrapped group ( 23 % ) compared with the control group ( 50 % ) . Shivering incidences were similar in both groups ( 70 % versus 70 % ) . Sublingual temperature decreased significantly ( P < 0.001 ) throughout the procedure in each group . However , no differences were found between the two groups at each design ated observation , even if compared by the magnitude of temperature decrease . We conclude that although leg wrapping with elastic b and ages prevents maternal hypotension after epidural anesthesia , it does not reduce the incidence or magnitude of hypothermia or prevent shivering STUDY OBJECTIVE To investigate the efficacy of warmed , humidified inspired oxygen ( O(2 ) ) for the treatment of mildly hypothermic postoperative patients . DESIGN Prospect i ve , r and omized , unblinded clinical trial . SETTING Postanesthesia care unit in a tertiary care hospital . PATIENTS AND INTERVENTIONS 30 ASA physical status I , II , and III patients following intraabdominal surgical procedures were r and omly assigned to receive either routine O(2 ) therapy ( control group , n = 15 ) , or warmed ( 42 degrees C ) humidified O(2 ) ( treatment group , n = 15 ) for the initial 90 postoperative minutes . MEASUREMENTS Core ( tympanic ) temperature , dry mouth score and shivering score . MAIN RESULTS Tympanic temperature was similar in both groups on admission ( approximately 35.8 degrees C ) . Rewarming rate in the first postoperative hour was greater in the treatment group ( 0.7 + /- 0.1 degrees C. hr(-1 ) ) compared to the control group ( 0.4 + /- 0.1 degrees C. hr(-1 ) ) ( p = 0.03 ) . Patients receiving the warmed , humidified O(2 ) had a lower incidence of dry mouth compared to the control group ( p = 0.03 ) . The incidence of shivering was low and similar in both groups . CONCLUSIONS Warming and humidifying inspired O(2 ) hastens recovery from hypothermia in postoperative patients Background Unintended hypothermia occurs frequently during surgery and may have adverse effects on the cardiovascular system . Although the mechanisms responsible for the cardiovascular manifestations of hypothermia are unclear , it is possible that they are sympathetically mediated . In this prospect i ve study , relationships between body temperature , the neuroendocrine response , and hemodynamic changes in the perioperative period were examined . Methods Seventy‐four elderly patients , undergoing abdominal , thoracic , or lower extremity vascular surgical procedures , were r and omly assigned to either “ routine care ” ( n = 37 ) or “ forced‐air warming ” ( n = 37 ) groups . Throughout the intraoperative and early postoperative periods , the routine care group received st and ard thermal care , and the forced‐air warming group received forced‐air skin‐surface warming . Core temperature , forearm minus fingertip skin‐surface temperature gradient , and plasma concentrations of epinephrine , norepinephrine , and cortisol were measured throughout the perioperative period , and the two groups were compared . In addition , heart rate and arterial blood pressure were compared between groups . Results The routine care and forced‐air warming groups did not differ with regard to age , sex , type of surgical procedures , anesthetic techniques , or postoperative analgesia . Mean core temperature was lower in the routine care group on admission to the postanesthetic care unit ( routine care , 35.3 plus/minus 0.1 degree Celsius ; forced‐air warming , 36.7 plus/minus 0.1 degree Celsius ; P = 0.0001 ) and remained lower during the early postoperative period . Forearm minus fingertip skin‐surface temperature gradient ( an index of peripheral vasoconstriction ) was greater in the routine care group in the early postoperative period . The mean norepinephrine concentration ( pcg/ml ) was greater in the routine care group immediately after surgery ( 480 plus/minus 70 vs. 330 plus/minus 30 , P = 0.02 ) and at 60 min ( 530 plus/minus 50 vs. 340 plus/minus 30 , P = 0.002 ) and 180 min ( 500 plus/minus 80 vs. 320 plus/minus 30 , P = 0.004 ) postoperatively . Mean epinephrine concentrations were not significantly different between groups . Mean cortisol concentrations were increased in both groups during the early postoperative period ( P < 0.01 ) , but the differences between groups were not significant . Systolic , mean , and diastolic arterial blood pressures were significantly higher in the routine care group . Conclusions Compared with patients in the forced‐air warming group , patients receiving routine thermal care had lower core temperatures , a greater degree of peripheral vasoconstriction , higher norepinephrine concentrations , and higher arterial blood pressures in the early postoperative period . These findings suggest a possible mechanism for hypothermia‐related cardiovascular morbidity in the perioperative period Assessment was made of whether a cold-room environment prior to surgical draping affected patient temperature or the incidence of shivering in the recovery room in patients undergoing major vascular surgery when warming blankets and warmed fluids were used to maintain intraoperative temperature . Forty-two patients scheduled to undergo major vascular surgery were r and omly assigned in equal numbers to a “ cold ” or “ warm ” room . Temperatures in the “ warm ” rooms were 22.2 C or above ( range 22.8–25.6 C ) until draping , and in “ cold ” rooms , 18.9 C or below ( range 13.9–17.8 C ) . Once surgical drapes were placed , the room temperature control was set at its minimum , 17 C. All intravenous fluids and blood were warmed to 37.5 C , and a heating blanket was maintained at 37.8 C before and during the operative procedure . Patient temperatures initially did not differ between groups . Despite significantly greater heat loss prior to draping in the cold-room group ( 0.63 ± 0.14 C ) than in the warm-room group ( 0.32 ± 0.10 C)(p < 0.01 ) , there were no differences in temperature in the recovery room , shivering , myocardial , renal , CNS , pulmonary , or graft morbidity in the two groups . In major intra-abdominal vascular operations the use of warming blankets and the practice of warming all fluids for infusion allow a comfortable room temperature without detriment to patient care OBJECTIVE To compare the effects of two external rewarming methods on body core temperature and the rate of rewarming between two age groups ( less than 65 years , 65 years or more ) of adult , mildly hypothermic patients who have undergone cardiac surgery , during the immediate postoperative period . DESIGN Stratified , r and omized clinical trial . SETTING Five-bed cardiac surgical intensive care unit in a large teaching- research institution . SUBJECTS Thirty-two white patients who had undergone cardiac surgery and who had mildly hypothermic body core temperatures ( 33 degrees to 35 degrees C ) immediately after the surgery . OUTCOME MEASURES Body core temperature was measured with a pulmonary artery catheter thermistor at the time of external rewarming method application and at 60 , 90 , and 150 minutes afterward . Rate of rewarming was measured as body core temperature change in degrees Celsius per hour ( at 36.6 degrees C , minus body core temperature when external rewarming method was applied , divided by total rewarming time ) . Temperatures were recorded six times at intervals of 15 minutes ; then every 30 minutes until a value of 36.6 degrees C was obtained , at which time the blanket was removed ; then hourly for 8 hours . INTERVENTION Either a fluid-filled circulating blanket ( active-conductive external rewarming ) or a reflective blanket ( passive-reflective external rewarming ) was applied immediately after core temperature was measured on admission to the cardiac surgical intensive care unit after surgery . RESULTS External rewarming methods affected body core temperature differently at different times , and there were significant differences in body core temperature across the time periods ( p < 0.05 ) . Both active and passive external rewarming methods showed a sigmoidal rewarming pattern without a downward temperature drift . The fluid-filled circulating blanket produced a quicker and steeper body core temperature change in the early rewarming phase ; the reflective blanket result ed in a more gradual temperature rise . Age did not significantly affect body core temperature , nor did age or external rewarming method significantly influence the rate of rewarming , although total rewarming time was longer for those of more advanced age . Seven subjects with passive rewarming method experienced body core temperature overshoot during the 8-hour period after blanket removal . CONCLUSIONS In this study , conduction and reflection of radiant heat were equally effective in producing an acceptable rate of rewarming but contributed to different internal patterns in core rewarming . The average total rewarming time with the active external rewarming method was 1 hour shorter than with the passive external rewarming method |
342 | 24,501,245 | The balance of evidence suggests that TNF-a antagonists may have a beneficial effect on preventing the progression of sub clinical atherosclerosis and arterial stiffness .
It remains unknown whether this effect is specific to TNF-a antagonists or relates to better control of inflammation irrespective of the disease modification strategy by which this is achieved | OBJECTIVE It remains a matter of debate whether TNF-a antagonists have favourable effects on the cardiovascular ( CV ) system .
This systematic review evaluates the effect of TNF-a blockers on the progression of sub clinical atherosclerosis and arterial stiffness in patients with inflammatory arthritis . | OBJECTIVE Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS . METHODS A r and omized , double-blind , placebo-controlled pilot study was performed in which AS patients were treated with golimumab ( n = 20 ) and placebo ( n = 21 ) for 12 months . Patients from the placebo group who failed to achieve a 20 % response to Assessment of SpondyloArthritis international Society criteria ( ASAS20 ) at 6 months received open-label golimumab . Intima-media thickness ( IMT ) , pulse wave velocity ( PWV ) and augmentation index ( AIx ) were measured at baseline , 6 and 12 months . RESULTS At 6 months , 11/20 ( 55 % ) and 3/21 ( 14 % ) patients from the golimumab and placebo groups achieved an ASAS20 response , respectively ( P = 0.006 ) . There was no significant difference in the change of the vascular parameters between the two groups . In the placebo group , significantly greater progression of the mean IMT [ from 0.51 mm ( S.D. 0.07 ) at baseline to 0.53 mm ( S.D. 0.08 ) at 6 months , P = 0.044 ] and PWV ( from 12.2 m/s ( S.D. 1.6 ) at baseline to 12.6 m/s ( S.D. 1.3 ) , P = 0.028 ] were observed . There was a trend towards progression of the mean IMT in the golimumab group ( P = 0.099 ) but the maximum IMT , PWV and AIx remained unchanged . At 12 months the changes in vascular parameters were similar between the early and delayed ( or no ) golimumab groups . CONCLUSION Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS . Arterial dysfunction may be prevented by golimumab over a period of 6 months , probably because of effective suppression of inflammation . TRIAL REGISTRATION clinical trials.gov ( NCT01212653 Objective . To determine the efficacy of methotrexate ( MTX ) with infliximab ( IFX ) compared with MTX alone in the prevention of atherosclerosis and arterial stiffness in patients with early rheumatoid arthritis ( RA ) . Methods . A r and omized , open-label study in which early RA patients with active disease were treated with MTX alone ( n = 20 ) and MTX plus IFX ( n = 20 ) for 6 months . Patients were assessed every 3 months . Patients from the MTX-alone group who failed to achieve 28-joint Disease Activity Score remission ( DAS28 ≤ 2.6 ) at 6 months were permitted to escape to open-label IFX . Intima-media thickness ( IMT ) , pulse wave velocity ( PWV ) , and augmentation index ( AIx ) were measured at baseline , 6 months , and 12 months . Results . At 6 months , there was a significantly greater reduction in PWV in the MTX-alone group ( 0.18 ± 1.59 m/s ) compared with the MTX plus IFX group ( −0.78 ± 1.13 m/s ; p = 0.044 ) , accompanied by significantly greater reduction in patient ’s global assessment , number of swollen joints , C-reactive protein , and DAS28 in the MTX plus IFX group compared to the MTX-alone group . The changes in IMT and AIx were similar between the 2 groups . At 12 months , there was a trend favoring early combination treatment with regard to the reduction in PWV ( p = 0.06 ) . Conclusion . MTX plus IFX causes a more significant reduction in PWV than MTX alone in patients with early RA after 6-month treatment , and further improvement may be achieved in patients who continued on longterm tumor necrosis factor-α blockers , suggesting that early , effective suppression of inflammation may prevent progression of atherosclerosis by improving vascular function The objective of the study is to evaluate the effect of TNF inhibition on carotid thickness over a 2-year period . 144 women with RA diagnosed according to ACR criteria , without clinical evidence of cardiac and /or vascular disease were enrolled and compared with 78 matched controls . All patients received methotrexate ( 15–20 mg weekly ) for 3 months . Responders ( n = 79 ) continued to be treated with methotrexate , non-responders ( n = 40 ) moved to methotrexate plus a TNF alpha antagonist . Echosonographic studies of carotids were obtained before and after 2-year follow-up . A significant decrease of ca-IMT was observed in anti-TNF-treated patients ( P < 0.001 ) ; on the other h and , no significant variation of ca-IMT was observed after 2 years in MTX-treated patients . Our study indicates that anti-TNF blocking agents , but not methotrexate , are capable of reducing IMT of carotid arteries in female RA patients in a 2-year follow-up Objectives : Vascular endothelial function and common carotid artery intima – medial thickness ( CCA‐IMT ) are well‐established surrogate markers for early atherosclerotic disease , which accounts for 30–40 % of excess mortality in rheumatoid arthritis ( RA ) patients . Our aim was to investigate whether long‐term treatment with anti‐tumour necrosis factor (TNF)α agents can modulate endothelial function and CCA‐IMT . Methods : Twelve patients with RA ( mean age 54.8±15 years ) on anti‐TNFα treatment ( seven adalimumab , five infliximab ) due to uncontrolled disease activity , with mean Disease Activity Score ( DAS28 ) 5.7 ( range 4.6–6.9 ) despite disease‐modifying anti‐rheumatic drugs ( DMARDs ) , were studied prospect ively . Patients were assessed at baseline and after 3 and 18 months for endothelial‐dependent vasodilatation , assessed by flow‐mediated vasodilatation ( FMD ) , endothelial‐independent vasodilatation and CCA‐IMT . RA disease activity and response to therapy were assessed by the DAS28 index . Results : After 18 months of treatment , 67 % of the patients were responders according to European League Against Rheumatism ( EULAR ) response criteria . Anti‐TNFα treatment improved FMD ( from 7±4.3 % to 11.1±3.8 % , p = 0.026 ) whereas CCA‐IMT did not change significantly [ from 0.67 ( 0.4–1 ) to 0.68 ( 0.39–1.2 ) mm ; mean change 0.01 ( −0.06 to 0.08 ) mm ] . Endothelial‐independent vasodilatation remained stable ( 20.4±7.3 % to 22.9±6.5 % , p = 0.4 ) . Conclusions : In this small cohort of patients with RA and no clinical ly overt cardiovascular disease ( CVD ) , after 18 months of treatment with anti‐TNFα agents , endothelial function improved significantly while CCA‐IMT remained stable . Longitudinal studies using more patients are needed to determine the clinical significance of these findings in relation to the risk of atherosclerosis To determine whether treatment with the anti-TNF-alpha blocker adalimumab yields persistent improvement of endothelial function and prevents from morphological progression of sub clinical atherosclerosis in patients with rheumatoid arthritis ( RA ) refractory to conventional therapy , a series of 34 consecutive RA patients , attending hospital outpatient clinics and who were switched from disease modifying antirheumatic drug therapy to anti-TNF-alpha-adalimumab treatment because of severe disease , were assessed by ultrasonography techniques before the onset of adalimumab therapy ( at day 0 ) and then at day 14 and at month 12 . Values of flow-mediated endothelium-dependent vasodilatation at day 14 and at month 12 were significantly higher ( mean ± st and ard deviation ( SD ) : 6.1 ± 3.9 % ; median : 5.7 % at day 14 , and mean ± SD : 7.4 ± 2.8 % ; median : 6.9 % at month 12 ) than those obtained at day 0 ( mean : 4.5 ± 4.0 % ; median : 3.6 % ; P = 0.03 and P < 0.001 , resp . ) . Endothelium-independent vasodilatation results did not significantly change compared with those obtained at day 0 . No significant differences were observed when carotid artery intima-media wall thickness values obtained at month 12 ( mean ± SD : 0.69 ± 0.21 mm ) were compared with those found at day 0 ( 0.65 ± 0.16 mm ) ( P = 0.3 ) . In conclusion , anti-TNF-alpha-adalimumab therapy has beneficial effects on the development of the sub clinical atherosclerosis disease in RA Background — Rheumatoid arthritis ( RA ) is associated with increased cardiovascular risk , which is not explained by traditional cardiovascular risk factors but may be due in part to increased aortic stiffness , an independent predictor of cardiovascular mortality . In the present study , our aim was to establish whether aortic stiffness is increased in RA and to investigate the relationship between inflammation and aortic stiffness . In addition , we tested the hypothesis that aortic stiffness could be reduced with anti – tumor necrosis factor-&agr ; ( TNF-&agr ; ) therapy . Methods and Results — Aortic pulse-wave velocity ( PWV ) , augmentation index , and blood pressure were measured in 77 patients with RA and in 142 healthy individuals . Both acute and chronic inflammatory measures and disease activity were determined . The effect of anti-TNF-&agr ; therapy on PWV and endothelial function was measured in 9 RA patients at 0 , 4 , and 12 weeks . Median ( interquartile range ) aortic PWV was significantly higher in subjects with RA than in control subjects ( 8.35 [ 7.14 to 10.24 ] versus 7.52 [ 6.56 to 9.18 ] m/s , respectively ; P=0.005 ) . In multiple regression analyses , aortic PWV correlated independently with age , mean arterial pressure , and log-transformed C-reactive protein ( R2=0.701 ; P<0.0001 ) . Aortic PWV was reduced significantly by anti-TNF-&agr ; therapy ( 8.82±2.04 versus 7.94±1.86 versus 7.68±1.56 m/s at weeks 0 , 4 , and 12 , respectively ; P<0.001 ) ; concomitantly , endothelial function improved . Conclusions — RA is associated with increased aortic stiffness , which correlates with current but not historical measures of inflammation , suggesting that increased aortic stiffness may be reversible . Indeed , anti-TNF-&agr ; therapy reduced aortic stiffness to a level comparable to that of healthy individuals . Therefore , effective control of inflammation may be of benefit in reducing cardiovascular risk in patients with RA OBJECTIVE To investigate prognostic factors associated with mortality in patients with psoriatic arthritis ( PsA ) . METHODS Patients followed up at the Toronto PsA Clinic between 1978 and 1994 were included . Patients were review ed at initial clinic entry and at 6-month intervals using a st and ard protocol . Data on deaths were collected in a prospect i ve manner , and death certificates were used to identify the primary and antecedent cause(s ) of death . All death information was recorded in the clinic 's computerized data base . Only factors that represented st and ard clinical measures of disease activity and progression were studied . The relationship between potential prognostic factors recorded at the time of the first clinic visit and the mortality rate was determined using the Cox relative risk regression model . RESULTS There were 428 patients ( 234 men and 194 women ) , of whom 68 % were known to be alive on September 1 , 1994 , 20 % were lost to followup but assumed to be alive , and 12 % had died . Multivariate analysis revealed that an erythrocyte sedimentation rate ( ESR ) > 15 mm/hour , medications used prior to initial clinic visit , radiologic damage , and the absence of nail lesions were associated with an increased overall mortality rate . There is some suggestion that prior medication use was least important for deaths associated with the circulatory system , while radiologic damage was particularly important for such deaths . A marked sex-associated effect was noted among deaths caused by injuries/poisoning , since 6 of the deaths occurred in men and only 1 was in a woman . CONCLUSION Patients with PsA are at an increased risk of death compared with the general population . Evidence of previously active and severe disease , as manifested by the prior use of medications and by radiologic changes as well as an elevated ESR at presentation , are prognostic indicators for death . The presence of nail lesions appears to be a protective factor that has the most clinical importance in the context of previously active and severe disease Background Cardiovascular mortality is increased in patients with rheumatoid arthritis ( RA ) . RA is associated with an increased left ventricular mass index ( LVMI ) , a strong marker of cardiovascular mortality , and vessel abnormalities . Experimental studies have suggested that tumour necrosis factor α ( TNFα ) may induce LV hypertrophy . Objective To study the effect of medium-term ( 3- and 6-months ) treatment with the TNFα inhibitor etanercept ( ETN ) and synthetic disease-modifying antirheumatic drugs ( sDMARDs ) on LV morphological features and arterial stiffness in patients with RA . Methods Consecutive female patients with active RA requiring treatment with ETN ( n=28 ) or sDMARDs ( n=20 ) were included . Clinical and biological monitoring , echocardiography and pulse wave velocity ( PWV ) assessment were performed at inclusion and at 3 and 6 months after the start of treatment . Paired t tests and multivariate linear regression analysis were used . Results Mean LVMI tended to be higher at baseline in the ETN group than in the sDMARD group ( 96.5±19.8 vs 84.3±26.8 g/m2 ; p=0.11 for the ETN and sDMARD groups , respectively ) . In patients with ETN treatment , mean LVMI was significantly decreased at 3 and 6 months ( −6.3±7.6 and −14.2±9.3 g/m2 ; p<0.001 ) , with no change from baseline for patients with sDMARD treatment ( −2.2±10.9 and −2.7±10.2 g/m2 , respectively ) . Blood pressure ( BP ) and aortic PWV were not changed by either treatment . Conclusions ETN induced a significant decrease in LVMI with medium-term treatment with no change in BP or PWV . TNFα may be an important factor of LV hypertrophy , which may explain the benefit of TNF inhibitors on cardiovascular morbidity and mortality in RA . These results need to be confirmed by larger studies and with other TNF inhibitors OBJECTIVE To estimate the excess risk of cardiovascular and cerebrovascular diseases among individuals with ankylosing spondylitis ( AS ) in Quebec compared with the general population of Quebec . METHODS A retrospective cohort study was conducted using population -based administrative data from Quebec . The cohort included all adult individuals with at least 1 AS diagnosis on physician billing or hospital discharge records between 1996 and 2006 . A comparison cohort was generated using a 1 % r and om sample of individuals without AS . Cardiovascular and cerebrovascular diseases , and associated hospitalizations , were classified into 1 of 6 subcategories : congestive heart failure , valvular ( aortic or nonaortic ) heart disease , ischemic heart disease , cerebrovascular disease , or " other " cardiovascular disease . The age- and sex-stratified prevalence estimates , and st and ardized prevalence ratios , of cardiovascular or cerebrovascular disease in patients with AS , compared to that in the general population , were calculated . RESULTS The AS cohort included 8,616 individuals diagnosed over the period 1996 - 2006 . The prevalence of cardiovascular and cerebrovascular diseases increased with increasing age for all cardiovascular disease subgroups , and was similar for individuals of both sexes . Age- and sex-stratified prevalence ratios were highest in younger individuals with AS . The age- and sex-st and ardized prevalence ratios comparing the risk among those with AS to the risk in the general population were as follows : for aortic valvular heart disease 1.58 ( 95 % confidence interval [ 95 % CI ] 1.31 - 1.91 ) , for nonaortic valvular heart disease 1.58 ( 95 % CI 1.43 - 1.74 ) , for ischemic heart disease 1.37 ( 95 % CI 1.31 - 1.44 ) , for congestive heart failure 1.34 ( 95 % CI 1.26 - 1.42 ) , for " other " cardiovascular disease 1.36 ( 95 % CI 1.29 - 1.44 ) , for cerebrovascular disease 1.25 ( 95 % CI 1.15 - 1.35 ) , and for any hospitalization for a cardiovascular or cerebrovascular disease 1.31 ( 95 % CI 1.22 - 1.41 ) . CONCLUSION Compared with the general population , patients with AS are at increased risk for many types of cardiovascular and cerebrovascular diseases , and are more likely to be hospitalized for these diseases . The excess risk is greatest in younger patients with AS Premature atherosclerosis is linked to inflammation . Arterial stiffness is a marker of vascular dysfunction . We tested the hypothesis that treatment with infliximab , which is effective in reducing inflammation in rheumatoid arthritis ( RA ) and ankylosing spondylitis ( AS ) , also lowers the augmentation index ( AIx ) in patients with active disease . We also analyzed the subendocardial viability ratio ( SEVR ) , which is a measure of myocardial perfusion relative to cardiac workload . Included in the study were 30 patients ( 17 RA , 13 AS ) . Conventional treatment failed in all patients . The AIx and SEVR were determined by radial applanation tonometry before and after treatment with infliximab , at baseline and at week 7 . After treatment with infliximab , Disease Activity Score for 28 joints ( RA patients ) , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index ( AS patients ) , erythrocyte sedimentation rate ( ESR ) , and C-reactive protein ( CRP ) improved significantly ( p < 0.001 ) . The AIx for all patients increased from 22.0 ± 14.0 % to 24.6 ± 13.0 % ( p = 0.03 ) . The increase in the RA sub-group ( p = 0.01 ) was also significant . The SEVR decreased from 148.6 ± 23.7 % to 141.2 ± 23.7 % ( p = 0.04 ) . Infliximab did not reduce the AIx in patients with RA and AS , although there were clinical improvements and CRP and ESR decreased . Instead , the AIx increased . This could negatively influence cardiac workload OBJECTIVE To establish whether carotid intima-media wall thickness ( IMT ) may be a good predictor for the development of cardiovascular ( CV ) events in patients with rheumatoid arthritis ( RA ) . METHODS A series of 47 RA patients who at the time of recruitment did not have traditional CV risk factors or CV disease were assessed by carotid ultrasonography . Carotid IMT and carotid plaques were measured in the right common carotid artery . Then , a prospect i ve assessment of the CV outcome was performed over a 5-year period . Logistic regression models and receiver operating characteristic curves were performed to evaluate the ability of different variables to predict CV events . RESULTS Carotid IMT was greater in RA patients who over the extended follow-up experienced CV events ( 1.01 + /- 0.16 mm ) compared with the remaining RA patients who did not have CV complications ( 0.74 + /- 0.12 mm ) ( P < 0.001 ) . Also , carotid IMT categorized in quartiles was strongly associated with CV events . In this regard , none of the patients with carotid IMT less than 0.77 mm had CV events . However , 6 of the 10 patients with carotid IMT greater than 0.91 mm experienced CV events ( P value for the trend < 0.001 ) . Carotid IMT yielded a high predictive power for the development of CV events over the 5-year follow-up period . The area under the receiver operating characteristic curve was 0.93 for a model that only included carotid IMT and 0.90 for carotid plaque . CONCLUSIONS The results from the present study support the use of carotid ultrasonography as a predictor of CV events in RA Objective Rheumatoid arthritis ( RA ) is associated with increased coronary artery disease ( CAD ) and sub clinical carotid atheromatosis , reportedly to equal diabetes mellitus ( DM ) . The presence of atheromatic plaques in femoral arteries of RA patients without DM was compared with with DM patients . Methods Femoral plaques were recorded in 30 ( 17 men , age 43.0±12 years , disease duration 9.9±7.1 years ) and 60 older RA patients ( 27 men , age 63.0±7.1 years , disease duration 11.4±7.9 years ) matched 1:1 for age , gender and disease duration with DM types 1 and 2 patients , respectively . All were asymptomatic and free of CAD . Results The number of femoral plaques per patient in either RA subgroup was comparable with DM ( 0.64±0.82 vs 0.77±0.89 in total respective population s , p=0.340 ) ; percentages of patients with femoral plaques were also comparable ( RA vs DM type 1 20 % and 13 % , respectively ; RA vs DM type 2 58 % and 66 % , respectively ) . Hypertension and dyslipidaemia were significantly more frequent in both DM groups than RA groups . Conclusions Sub clinical femoral atheromatosis in RA is analogous to DM , further confirming the territorial unrestricted acceleration of the atheromatic process in these patients . Cardiovascular risk stratification based on both carotid and femoral plaque detection in RA should be addressed prospect ively Objective . To compare the respective effects of tocilizumab ( TCZ ) monotherapy , etanercept ( ETN ) monotherapy , and adalimumab ( ADA ) monotherapy on arterial stiffness in patients with rheumatoid arthritis ( RA ) in an open-label , r and omized controlled trial . Methods . Patients with RA were eligible if they had active disease ( 28-joint Disease Activity Score > 3.2 ) and no prior treatment with methotrexate or biologics . All 64 patients had no history of cardiovascular disease or steroid treatment . Patients were r and omly assigned to receive TCZ alone ( n = 22 ) , ETN alone ( n = 21 ) , or ADA alone ( n = 21 ) . Arterial stiffness was assessed with cardio-ankle vascular index ( CAVI ) and aortic augmentation index normalized to a fixed heart rate of 75 bpm ( AIx@75 ) at baseline and 24 weeks ’ followup . Clinical data were collected at regular visits . Results . The characteristics of each group at baseline were not significantly different . In all groups there was significant attenuation from baseline to 24 weeks in CAVI ( Week 0-Week 24 , TCZ : 0.85 ± 0.15 m/s , p = 0.02 ; ETN : 0.81 ± 0.18 m/s , p = 0.03 ; ADA : 0.90 ± 0.21 m/s , p = 0.02 ) and in AIx@75 . There were no significant differences among the groups in measures of CAVI or AIx@75 . The 3 therapies made no difference to carotid intima-media thickness and carotid artery plaque . Only TCZ increased fasting serum total cholesterol from baseline to 24 weeks . Conclusion . The 3 types of monotherapy limited arterial stiffness in patients with RA to a similar extent BACKGROUND New treatment strategies for early rheumatoid arthritis are evolving rapidly . We aim ed to compare addition of conventional disease-modifying antirheumatic drugs ( sulfasalazine and hydroxychloroquine ) with addition of a tumour necrosis factor antagonist ( infliximab ) to methotrexate in patients with early rheumatoid arthritis . METHODS We undertook a r and omised trial in 15 rheumatology units in Sweden . We enrolled patients with early rheumatoid arthritis ( symptom duration < 1 year ) and administered methotrexate ( up to 20 mg per week ) . After 3 - 4 months , those who had not achieved low disease activity but who could tolerate methotrexate were r and omly allocated by computer addition of either sulfasalazine and hydroxychloroquine or infliximab . Primary outcome was achievement of a good response according to European League Against Rheumatism ( EULAR ) criteria at 12 months . Patients were followed up to 24 months ; here , we present findings at 12 months . Analysis was by intention to treat and we used non-responder imputation . The Swefot ( Swedish Pharmacotherapy ) study is registered in the WHO data base at the Karolinska University Hospital , number CT20080004 . FINDINGS 487 patients were initially enrolled . Of 258 who had not achieved low disease activity with methotrexate , 130 were allocated sulfasalazine and hydroxychloroquine and 128 were assigned infliximab . 32 of 130 ( 25 % ) patients allocated sulfasalazine and hydroxychloroquine achieved the primary outcome compared with 50 of 128 ( 39 % ) assigned infliximab ( risk ratio 1.59 [ 95 % CI 1.10 - 2.30 ] , p=0.0160 ) . Adverse events were balanced fairly well between the two groups and accorded with known adverse events of the drugs used . No deaths occurred in either group . INTERPRETATION In patients with early rheumatoid arthritis in whom methotrexate treatment failed , addition of a tumour necrosis factor antagonist to methotrexate monotherapy is clinical ly superior to addition of conventional disease-modifying antirheumatic drugs . FUNDING Swedish Rheumatism Association , Schering-Plough Background The onset of disease in ankylosing spondylitis ( AS ) is generally earlier than in other joint diseases , exposing patients to a prolonged burden of disease . Whether this is associated with excess mortality is still uncertain . Radiation therapy for AS has previously been shown to increase mortality . The present study investigated st and ardised mortality ratios , causes of death and survival predictors in a large regional cohort of patients with AS . Method A total of 677 patients with AS followed at our hospital since 1977 were matched by gender , age and postal area to three controls from the general population and st and ardised mortality rates ( SMRs ) were calculated . Cause of death was established using patients ' hospital records . In a subset of 360 patients , clinical and demographic data collected during an earlier research visit ( 1998–2000 ) were used in a prospect i ve multivariate analysis of predictors for mortality in AS . Results The crude mortality among patients with AS in this study was 14.5 % ( 98 patients ) ; SMR was only significantly increased among male patients compared with female patients ( 1.63 vs 1.38 , p<0.001 ) . Circulatory disease was the most frequent cause of death ( 40.0 % ) , followed by malignant ( 26.8 % ) and infectious ( 23.2 % ) diseases . Factors independently associated with reduced survival were diagnostic delay ( OR 1.05 ) , increasing levels of C-reactive protein ( OR 2.68 ) , work disability ( OR 3.65 ) and not using any non-steroidal anti-inflammatory drugs ( OR 4.35 ) . Conclusions Mortality is increased in patients with AS and circulatory disease is the most frequent cause of death . Parameters reflecting the duration and intensity of inflammation are associated with reduced survival . These results indicate that , to improve long-term survival in AS , there is a need for early detection and anti-inflammatory treatment as well as a vigilant approach for cardiovascular risk factors OBJECTIVES Increased arterial stiffness , an independent risk factor for premature coronary artery disease , has been reported in patients with RA . The objectives of this study were first to assess , in patients with RA , the relationship between disease activity , inflammation and augmentation index , which is a combined measure of arterial stiffness and pulse wave reflection . The second objective was to establish any effect anti-rheumatic treatment may have on augmentation index . METHODS One hundred and forty-eight RA patients with no previous history of cardiovascular disease ( CVD ) had their augmentation index corrected for a heart rate of 75 beats per minute ( AIx@75 ) , and parameters of RA disease activity and CV risk measured . Forty-seven patients were then treated with either MTX ( n = 21 ) or etanercept ( ETAN ) ( n = 26 ) , and assessment s were repeated at 2 and 4 months . RESULTS Patients with high CRP ( > 10 mg/l ) showed significantly higher mean AIx@75 than those with low CRP ( < or = 10 mg/l ) ( 33 + /- 8 vs 30 + /- 8 % ; P = 0.033 ) . On regression analysis , log(10 ) CRP ( beta = 0.298 ; P = 0.002 ) , gender ( beta = 0.257 ; P = 0.007 ) , BMI ( beta = -0.292 ; P = 0.004 ) , diastolic blood pressure ( beta = 0.260 ; P = 0.009 ) and age ( beta = 0.194 ; P = 0.046 ) were independently associated with AIx@75 . Treatment with ETAN ( 35 + /- 9 , 32.5 + /- 1 and 32.5 + /- 8 % ; P = 0.025 ) but not MTX ( 31 + /- 1 , 31 + /- 1 and 31 + /- 1 % ; P = 0.971 ) attenuated the AIx@75 significantly from baseline to Visits 2 and 3 . CONCLUSIONS Systemic inflammation ( CRP ) is an independent predictor of arterial stiffness and pulse wave reflection in patients with RA . ETAN but not MTX therapy reduces arterial stiffness and pulse wave reflection and may thus improve CV morbidity in RA BACKGROUND Increasing evidence for cardiovascular mortality among patients with psoriasis and psoriatic arthritis ( PsA ) has accumulated , together with evidence for increased prevalence of risk factors for cardiovascular disease ( CVD ) . OBJECTIVES To describe cardiovascular morbidity in PsA , determine its prevalence and identify risk factors for its development . METHODS At the University of Toronto , patients were followed up prospect ively according to a st and ard protocol , including disease-related features and comorbidities . Patients with CVD , including myocardial infa rct ion ( MI ) , angina , hypertension and cerebrovascular accident ( CVA ) , were identified . The prevalence of CVD morbidities in these patients was compared with data from the Canadian Community Health Survey through st and ardised prevalence ratios ( SPRs ) . Cox relative risk regression analysis was used to analyse risk factors . RESULTS At the time of analysis , 648 patients were registered in the data base . After clinic entry , 122 developed hypertension , 38 had an MI and 5 , 21 and 11 had CVA , angina and congestive heart failure ( CHF ) , respectively . 155 patients had at least one of these conditions . The SPRs for MI ( 2.57 ; 95 % CI 1.73 to 3.80 ) , angina ( 1.97 ; 95 % CI 1.24 to 3.12 ) and hypertension ( 1.90 ; 95 % CI 1.59 to 2.27 ) were statistically significant , whereas the SPRs for CHF ( 1.19 ; 95 % CI 0.50 to 2.86 ) and CVA ( 0.91 ; 95 % CI 0.34 to 2.43 ) were not . Factors associated with CVD included diabetes , hyperlipidaemia and high Psoriasis Area and Severity Index scores . CONCLUSION Patients with PsA are at increased risk of cardiovascular morbidities compared with the general population . In addition to known risk factors for CVD , severe psoriasis is an important predictor in patients with BACKGROUND Premature arterial stiffening and atherosclerosis are increased in patients with inflammatory arthropathies such as rheumatoid arthritis ( RA ) , ankylosing spondylitis ( AS ) and psoriatic arthritis ( PsA ) . The proinflammatory protein calprotectin is associated with inflammatory arthropathies , vascular pathology , and acute coronary events . We examined the long-term effects of treatment with tumor necrosis factor (TNF)-α antagonists on aortic stiffness and carotid intima media thickness ( CIMT ) in patients with inflammatory arthropathies , and the relationships to the levels of calprotectin . METHODS Fifty-five patients with RA , AS , or PsA and a clinical indication for anti-TNF-α therapy were included and followed with regular examinations for 1 year . Thirty-six patients starting with anti-TNF-α therapy were compared with a nontreatment group of 19 patients . Examinations included assessment s of aortic stiffness ( aortic pulse wave velocity , aPWV ) , CIMT , and plasma calprotectin . RESULTS After 1 year , aPWV ( mean ( s.d . ) ) was improved in the treatment group , but not in the control group ( -0.54 [ 0.79 ] m/s vs. 0.06 [ 0.61 ] m/s , respectively ; P = 0.004 ) , and CIMT progression ( median ( quartile cut-points , 25th and 75th percentiles ) ) was reduced in the treatment group compared to the control group ( -0.002 [ -0.038 , 0.030 ] mm vs. 0.030 [ 0.011 , 0.043 ] mm , respectively ; P = 0.01 ) . In multivariable analyses , anti-TNF-α therapy over time was associated with improved aPWV ( P = 0.02 ) and reduced CIMT progression ( P = 0.04 ) , and calprotectin was longitudinally associated with aPWV ( P = 0.02 ) . CONCLUSIONS Long-term anti-TNF-α therapy improved aortic stiffness and CIMT progression in patients with inflammatory arthropathies . Calprotectin may be a soluble biomarker reflecting aortic stiffening in these patients OBJECTIVE The role of atherosclerosis in the acute coronary syndromes ( ACS ) that occur in patients with rheumatoid arthritis ( RA ) has not been quantified in detail . We undertook this study to determine the extent to which ACS are associated with carotid atherosclerosis in RA . METHODS We prospect ively ascertained ACS , defined as myocardial infa rct ion , unstable angina , cardiac arrest , or death due to ischemic heart disease , in an RA cohort . We measured carotid atherosclerosis using high-resolution ultrasound . We used Cox proportional hazards models to estimate the association between ACS and atherosclerosis , adjusting for demographic features , cardiovascular ( CV ) risk factors , and RA manifestations . RESULTS We performed carotid ultrasound on 636 patients whom we followed up for 3,402 person-years . During this time , 84 patients experienced 121 new or recurrent ACS events , a rate of 3.5 ACS events per 100 patient-years ( 95 % confidence interval [ 95 % CI ] 3.0 - 4.3 ) . Among the 599 patients without a history of ACS , 66 incident ACS events occurred over 3,085 person-years , an incidence of 2.1 ACS events per 100 person-years ( 95 % CI 1.7 - 2.7 ) . The incidence of new ACS events per 100 patient-years was 1.1 ( 95 % CI 0.6 - 1.7 ) among patients without plaque , 2.5 ( 95 % CI 1.7 - 3.8 ) among patients with unilateral plaque , and 4.3 ( 95 % CI 2.9 - 6.3 ) among patients with bilateral plaque . Covariates associated with incident ACS events independent of atherosclerosis included male sex , diabetes mellitus , and a cumulative glucocorticoid dose of ≥ 20 gm . CONCLUSION Atherosclerosis is strongly associated with ACS in RA . RA patients with carotid plaque , multiple CV risk factors ( particularly diabetes mellitus or hypertension ) , many swollen joints , and a high cumulative dose of glucocorticoids , as well as RA patients who are men , are at high risk of ACS |
343 | 17,909,210 | Methods for Grading the Overall Strength of Evidence for an Intervention Consistent results from many higher- quality studies across a broad range of population s support a high degree of certainty that the results of the studies are true ( the entire body of evidence would be considered good quality ) . | Many nonpharmacologic therapies are available for treatment of low back pain .
Other noninvasive interventions are also available , including psychological therapies , back schools , yoga , and interdisciplinary therapy .
Clinicians managing low back pain vary substantially in the noninvasive therapies they recommend ( 3 ) .
Although earlier review s found little evidence demonstrating efficacy of most noninvasive therapies for low back pain ( 46 ) , many more r and omized trials are now available .
This article summarizes current evidence on noninvasive therapies for low back pain in adults .
According to this system , systematic review s receiving a score of 4 or less ( on a scale of 1 to 7 ) have potential major flaws and are more likely to produce positive conclusions about effectiveness of interventions ( 20 , 21 ) . | Study Design . A prospect i ve , r and omized , single ( investigator ) blind , comparative efficacy trial was conducted . Objective . To compare the efficacy of continuous low-level heat wrap therapy ( 40 C , 8 hours/day ) with that of ibuprofen ( 1200 mg/day ) and acetaminophen ( 4000 mg/day ) in subjects with acute nonspecific low back pain . Summary of Background Data . The efficacy of topical heat methods , as compared with oral analgesic treatment of low back pain , has not been established . Methods . Subjects ( n = 371 ) were r and omly assigned to heat wrap ( n = 113 ) , acetaminophen ( n = 113 ) , or ibuprofen ( n = 106 ) for efficacy evaluation , or to oral placebo ( n = 20 ) or unheated back wrap ( n = 19 ) for blinding . Outcome measures included pain relief , muscle stiffness , lateral trunk flexibility , and disability . Efficacy was measured over two treatment days and two follow-up days . Results . Day 1 pain relief for the heat wrap ( mean , 2 ) was higher than for ibuprofen ( mean , 1.51;P = 0.0007 ) or acetaminophen ( mean , 1.32;P = 0.0001 ) . Extended mean pain relief ( Days 3 to 4 ) for the heat wrap ( mean , 2.61 ) also was higher than for ibuprofen ( mean , 1.68;P = 0.0001 ) or acetaminophen ( mean , 1.95;P = 0.0009 ) . Lateral trunk flexibility was improved with the heat wrap ( mean change , 4.28 cm ) during treatment ( P ≤ 0.009 vs acetaminophen [ mean change , 2.93 cm ] , P ≤ 0.001 vs ibuprofen [ mean change , 2.51 cm ] ) . The results were similar on Day 4 . Day 1 reduction in muscle stiffness with the heat wrap ( mean , 16.3 ) was greater than with acetaminophen ( mean , 10.5;P = 0.001 ) . Disability was reduced with the heat wrap ( mean , 4.9 ) , as compared with ibuprofen ( mean , 2.7;P = 0.01 ) and acetaminophen ( mean , 2.9;P = 0.0007 ) , on Day 4 . None of the adverse events were serious . The highest rate ( 10.4 % ) was reported in the ibuprofen group . Conclusion . Continuous low-level heat wrap therapy was superior to both acetaminophen and ibuprofen for treating low back pain BACKGROUND The effectiveness of massage therapy for low-back pain has not been documented . This r and omized controlled trial compared comprehensive massage therapy ( soft-tissue manipulation , remedial exercise and posture education ) , 2 components of massage therapy and placebo in the treatment of subacute ( between 1 week and 8 months ) low-back pain . METHODS Subjects with subacute low-back pain were r and omly assigned to 1 of 4 groups : comprehensive massage therapy ( n = 25 ) , soft-tissue manipulation only ( n = 25 ) , remedial exercise with posture education only ( n = 22 ) or a placebo of sham laser therapy ( n = 26 ) . Each subject received 6 treatments within approximately 1 month . Outcome measures obtained at baseline , after treatment and at 1-month follow-up consisted of the Rol and Disability Question naire ( RDQ ) , the McGill Pain Question naire ( PPI and PRI ) , the State Anxiety Index and the Modified Schober test ( lumbar range of motion ) . RESULTS Of the 107 subjects who passed screening , 98 ( 92 % ) completed post-treatment tests and 91 ( 85 % ) completed follow-up tests . Statistically significant differences were noted after treatment and at follow-up . The comprehensive massage therapy group had improved function ( mean RDQ score 1.54 v. 2.86 - 6.5 , p < 0.001 ) , less intense pain ( mean PPI score 0.42 v. 1.18 - 1.75 , p < 0.001 ) and a decrease in the quality of pain ( mean PRI score 2.29 v. 4.55 - 7.71 , p = 0.006 ) compared with the other 3 groups . Clinical significance was evident for the comprehensive massage therapy group and the soft-tissue manipulation group on the measure of function . At 1-month follow-up 63 % of subjects in the comprehensive massage therapy group reported no pain as compared with 27 % of the soft-tissue manipulation group , 14 % of the remedial exercise group and 0 % of the sham laser therapy group . INTERPRETATION Patients with subacute low-back pain were shown to benefit from massage therapy , as regulated by the College of Massage Therapists of Ontario and delivered by experienced massage therapists The efficacy of ultrasound therapy in the management of back pain result ing from rupture of the intervertebral disc was evaluated in 3 groups : treatment , placebo , and control . Range of motion of total flexion and extension , total side flexion and total rotation of the lumbar spine , and subjective assessment of pain were used as criteria to determine the efficacy of treatment . Group comparisons showed statistical significance in favor of the treatment group ( p 0.01 ) , leading to the conclusion that ultrasound therapy is significantly effective in the treatment of back pain result ing from prolapse of the lumbar intervertebral disc BACKGROUND CONTEXT Restorative exercise and palliative modalities are frequently used together for the treatment of acute low back pain . However , little is known about the effects of combining these treatments . PURPOSE To evaluate the efficacy of combining continuous low-level heat wrap therapy with directional preference-based exercise on the functional ability of patients with acute low back pain . STUDY DESIGN / SETTING A r and omized controlled trial was conducted at three outpatient medical facilities . PATIENT SAMPLE One hundred individuals ( age 31.2+/-10.6 years ) with low back pain of less than 3 months duration . OUTCOME MEASURES The primary outcome measure was functional ability assessed by the Multidimensional Task Ability Profile question naire . Secondary outcomes were disability assessed by the Rol and -Morris Disability Question naire and pain relief assessed by a 6-point verbal rating scale . METHODS Participants were r and omized to one of four groups : Heat wrap therapy alone ( heat wrap , n=25 ) ; directional preference-based exercise alone ( exercise , n=25 ) ; combination of heat wrap therapy and exercise ( heat+exercise , n=24 ) ; or control ( booklet , n=26 ) . Treatment was administered for five consecutive days and included four visits to the study center over 1 week . RESULTS At 2 days after the conclusion of treatment ( Day 7 ) , functional improvement for heat+exercise was 84 % , 95 % , and 175 % greater than heat wrap , exercise , and booklet , respectively ( p<.05 ) . Seventy-two percent of the subjects in the heat+exercise group demonstrated a return to pre-injury function compared with 20 % , 20 % , and 19 % for heat wrap , exercise , and booklet , respectively ( p<.05 ) . Disability reduction for heat+exercise was 93 % , 139 % , and 400 % greater than heat wrap , exercise , and booklet , respectively ( p<.05 ) . Pain relief for heat+exercise was 70 % and 143 % greater than exercise and booklet , respectively ( p<.05 ) . CONCLUSIONS Combining continuous low-level heat wrap therapy with directional preference-based exercise during the treatment of acute low back pain significantly improves functional outcomes compared with either intervention alone or control . Either intervention alone tends to be more effective than control BACKGROUND Acupuncture is widely used by patients with low back pain , although its effectiveness is unclear . We investigated the efficacy of acupuncture compared with minimal acupuncture and with no acupuncture in patients with chronic low back pain . METHODS Patients were r and omized to treatment with acupuncture , minimal acupuncture ( superficial needling at nonacupuncture points ) , or a waiting list control . Acupuncture and minimal acupuncture were administered by specialized acupuncture physicians in 30 outpatient centers , and consisted of 12 sessions per patient over 8 weeks . Patients completed st and ardized question naires at baseline and at 8 , 26 , and 52 weeks after r and omization . The primary outcome variable was the change in low back pain intensity from baseline to the end of week 8 , as determined on a visual analog scale ( range , 0 - 100 mm ) . RESULTS A total of 298 patients ( 67.8 % female ; mean + /- SD age , 59 + /- 9 years ) were included . Between baseline and week 8 , pain intensity decreased by a mean + /- SD of 28.7 + /- 30.3 mm in the acupuncture group , 23.6 + /- 31.0 mm in the minimal acupuncture group , and 6.9 + /- 22.0 mm in the waiting list group . The difference for the acupuncture vs minimal acupuncture group was 5.1 mm ( 95 % confidence interval , -3.7 to 13.9 mm ; P = .26 ) , and the difference for the acupuncture vs waiting list group was 21.7 mm ( 95 % confidence interval , 13.9 - 30.0 mm ; P<.001 ) . Also , at 26 ( P=.96 ) and 52 ( P=.61 ) weeks , pain did not differ significantly between the acupuncture and the minimal acupuncture groups . CONCLUSION Acupuncture was more effective in improving pain than no acupuncture treatment in patients with chronic low back pain , whereas there were no significant differences between acupuncture and minimal acupuncture In a r and omized controlled trial plus a nonr and omized cohort , the authors investigated the effectiveness and costs of acupuncture in addition to routine care in the treatment of chronic low back pain and assessed whether the effects of acupuncture differed in r and omized and nonr and omized patients . In 2001 , German patients with chronic low back pain were allocated to an acupuncture group or a no-acupuncture control group . Persons who did not consent to r and omization were included in a nonr and omized acupuncture group . All patients were allowed to receive routine medical care in addition to study treatment . Back function ( Hannover Functional Ability Question naire ) , pain , and quality of life were assessed at baseline and after 3 and 6 months , and cost-effectiveness was analyzed . Of 11,630 patients ( mean age=52.9 years ( st and ard deviation , 13.7 ) ; 59 % female ) , 1,549 were r and omized to the acupuncture group and 1,544 to the control group ; 8,537 were included in the nonr and omized acupuncture group . At 3 months , back function improved by 12.1 ( st and ard error ( SE ) , 0.4 ) to 74.5 ( SE , 0.4 ) points in the acupuncture group and by 2.7 ( SE , 0.4 ) to 65.1 ( SE , 0.4 ) points among controls ( difference=9.4 points ( 95 % confidence interval 8.3 , 10.5 ) ; p<0.001 ) . Nonr and omized patients had more severe symptoms at baseline and showed improvements in back function similar to those seen in r and omized patients . The incremental cost-effectiveness ratio was euro10,526 ( euros ) per quality -adjusted life year . Acupuncture plus routine care was associated with marked clinical improvements in these patients and was relatively cost-effective Low back pain is a significant public health problem and one of the most commonly reported reasons for the use of Complementary Alternative Medicine . A r and omized control trial was conducted in subjects with non‐specific chronic low back pain comparing Iyengar yoga therapy to an educational control group . Both programs were 16 weeks long . Subjects were primarily self‐referred and screened by primary care physicians for study of inclusion /exclusion criteria . The primary outcome for the study was functional disability . Secondary outcomes including present pain intensity , pain medication usage , pain‐related attitudes and behaviors , and spinal range of motion were measured before and after the interventions . Subjects had low back pain for 11.2±1.54 years and 48 % used pain medication . Overall , subjects presented with less pain and lower functional disability than subjects in other published intervention studies for chronic low back pain . Of the 60 subjects enrolled , 42 ( 70 % ) completed the study . Multivariate analyses of outcomes in the categories of medical , functional , psychological and behavioral factors indicated that significant differences between groups existed in functional and medical outcomes but not for the psychological or behavioral outcomes . Univariate analyses of medical and functional outcomes revealed significant reductions in pain intensity ( 64 % ) , functional disability ( 77 % ) and pain medication usage ( 88 % ) in the yoga group at the post and 3‐month follow‐up assessment s. These preliminary data indicate that the majority of self‐referred persons with mild chronic low back pain will comply to and report improvement on medical and functional pain‐related outcomes from Iyengar yoga therapy Abstract Objective To determine whether a short course of traditional acupuncture improves longer term outcomes for patients with persistent non-specific low back pain in primary care . Design Pragmatic , open , r and omised controlled trial . Setting Three private acupuncture clinics and 18 general practice s in York , Engl and . Participants 241 adults aged 18 - 65 with non-specific low back pain of 4 - 52 weeks ' duration . Interventions 10 individualised acupuncture treatments from one of six qualified acupuncturists ( 160 patients ) or usual care only ( 81 patients ) . Main outcome measures The primary outcome was SF-36 bodily pain , measured at 12 and 24 months . Other outcomes included reported use of analgesics , scores on the Oswestry pain disability index , safety , and patient satisfaction . Results 39 general practitioners referred 289 patients of whom 241 were r and omised . At 12 months average SF-36 pain scores increased by 33.2 to 64.0 in the acupuncture group and by 27.9 to 58.3 in the control group . Adjusting for baseline score and for any clustering by acupuncturist , the estimated intervention effect was 5.6 points ( 95 % confidence interval −0.2 to 11.4 ) at 12 months ( n = 213 ) and 8.0 points ( 2.8 to 13.2 ) at 24 months ( n = 182 ) . The magnitude of the difference between the groups was about 10%-15 % of the final pain score in the control group . Functional disability was not improved . No serious or life threatening events were reported . Conclusions Weak evidence was found of an effect of acupuncture on persistent non-specific low back pain at 12 months , but stronger evidence of a small benefit at 24 months . Referral to a qualified traditional acupuncturist for a short course of treatment seems safe and acceptable to patients with low back pain . Trial registration IS RCT N80764175 [ controlled-trials.com ] STUDY DESIGN A systematic review of r and omized and nonr and omized controlled trials . SUMMARY OF BACKGROUND DATA Lumbar supports are used in the treatment of low back pain , but also to prevent the onset ( primary prevention ) or recurrences of a low back pain episode ( secondary prevention ) . OBJECTIVES To assess the effects of lumbar sup-ports for prevention and treatment of nonspecific low back pain . METHODS The Medline , Cinahl , and Current Contents data bases ; the Cochrane Controlled Trials Register up to September 1999 ; and the Embase data base up to September 1998 were all search ed . References of identified trials and systematic review s were review ed and the Science Citation Index used to identify additional trials . Method ologic quality assessment and data extraction were performed by two review ers independently . A quantitative analysis was performed in which the strength of evidence was classified as strong , moderate , limited or conflicting , and no evidence . RESULTS Five r and omized and two nonr and omized preventive trials and six r and omized therapeutic trials were included in the review . Only 4 of the 13 studies were of high quality . There was moderate evidence that lumbar supports are not effective for primary prevention . No evidence was found on the effectiveness of lumbar supports for secondary prevention . The systematic review of therapeutic trials showed that there is limited evidence that lumbar supports are more effective than no treatment , whereas it is still unclear whether lumbar supports are more effective than other interventions for treatment of low back pain . CONCLUSIONS There continues to be a need for high quality r and omized trials on the effectiveness of lumbar supports . One of the most essential issues to tackle in these future trials seems to be the realization of adequate compliance Patients with acute or chronic low back pain were treated in a double-blind study that compared transcutaneous electrical nerve stimulation at intense levels and gentle , mechanically administered massage . Transcutaneous electrical nerve stimulation produced significantly greater pain relief , based on two measures of the McGill Pain Question naire , and significant improvement in straight leg raising . There were no significant differences between the two groups in backflexion scores . Pain-relief scores and range-of-motion scores were significantly correlated . The results indicate that pain-relief scores provide valuable information and can easily be obtained from patients for whom pain is a major symptom The effectiveness of spinal manipulation carried out by a non-medical qualified osteopath was compared with that of short-wave diathermy ( SWD ) and a placebo ( detuned SWD ) in 109 patients with low back pain . More than half the subjects in each of the 3 treatment groups benefited immediately from therapy . Significant improvements were observed in the 3 groups at the end of 2 weeks ' treatment , and these were still apparent at 12 weeks . The outcome of treatment was unrelated to the initial severity or duration of pain or to the trend of pain towards deterioration or improvement . It is , therefore , unlikely that the results simply reflect the natural history of low back pain . Benefits obtained with osteopathy and SWD in this study may have been achieved through a placebo effect Study Design . Physicians were surveyed regarding their beliefs about treatment efficacy for patients with low back pain . Objective . To document physician beliefs about the efficacy of specific treatmets and the extent to which these beliefs correspond to current knowledge . Summary of Background Data . Little is known about physician beliefs regarding the efficacy of specific back pain treatments . Methods . A national r and om sample of 2897 physicians were mailed question naires that asked about 1 ) the treatments they would order for hypothetical patients with low back pain and 2 ) the treatments they believed were effective for back pain . Responses were compared with guidelines suggested by the Quebec Task Force on Spinal Disorders . Results . Almost 1200 physicians responded . More than 80 % of these physicians believed physical therapy is effective , but this consensus was lacking for other treatments . Fewer than half of the physicians believed that spinal manipulation is effective for acture or chronic back pain or that epidural steroid injections , traction , and corsets are effective for acute or chronic back painor that epidural steroid injections , traction , and corsets are effective for acute back pain . Bed rest and narcotic analgesics were recommended by substantial minorties of physicians for patients with chronic pain . The Quebec Task Force found little scientific support for the effectiveness of most of the treatments found to be in common use . Conclusions . The lack of consensus among physicians could be attributable to the absence of clear evidence bsed clinical guidelines , ignorance or rejection of existing scientific evidence , excessive commitment to a particular mode of therapy , or a tendency to discount the efficacy of competing treatments BACKGROUND Because the value of popular forms of alternative care for chronic back pain remains uncertain , we compared the effectiveness of acupuncture , therapeutic massage , and self-care education for persistent back pain . METHODS We r and omized 262 patients aged 20 to 70 years who had persistent back pain to receive Traditional Chinese Medical acupuncture ( n = 94 ) , therapeutic massage ( n = 78 ) , or self-care educational material s ( n = 90 ) . Up to 10 massage or acupuncture visits were permitted over 10 weeks . Symptoms ( 0 - 10 scale ) and dysfunction ( 0 - 23 scale ) were assessed by telephone interviewers masked to treatment group . Follow-up was available for 95 % of patients after 4 , 10 , and 52 weeks , and none withdrew for adverse effects . RESULTS Treatment groups were compared after adjustment for prer and omization covariates using an intent-to-treat analysis . At 10 weeks , massage was superior to self-care on the symptom scale ( 3.41 vs 4.71 , respectively ; P = .01 ) and the disability scale ( 5.88 vs 8.92 , respectively ; P<.001 ) . Massage was also superior to acupuncture on the disability scale ( 5.89 vs 8.25 , respectively ; P = .01 ) . After 1 year , massage was not better than self-care but was better than acupuncture ( symptom scale : 3.08 vs 4.74 , respectively ; P = .002 ; dysfunction scale : 6.29 vs 8.21 , respectively ; P = .05 ) . The massage group used the least medications ( P<.05 ) and had the lowest costs of subsequent care . CONCLUSIONS Therapeutic massage was effective for persistent low back pain , apparently providing long-lasting benefits . Traditional Chinese Medical acupuncture was relatively ineffective . Massage might be an effective alternative to conventional medical care for persistent back pain STUDY DESIGN A r and omized trial design ed to compare interferential therapy with motorized lumbar traction and massage management for low back pain in a primary care setting . OBJECTIVE To measure and compare the outcome of interferential therapy and management by motorized lumbar traction and massage . SUMMARY OF BACKGROUND DATA Management of low back pain by interferential therapy and motorized lumbar traction and massage is common in Germany . No reports of previous r and omized trials for the outcome from interferential therapy were found . METHODS Consenting patients were r and omly assigned into one of two groups . A pretreatment interview was performed by the patient using a computer-based question naire . It also incorporated the Oswestry Disability Index and a pain visual analog scale . Management consisted of six sessions over a 2- to 3-week period . Oswestry Disability Indexes and pain visual analog scale scores also were obtained immediately after and at 3 months after treatment . RESULTS A total of 152 patients were recruited . The two treatment groups had similar demographic and clinical baseline characteristics . The mean Oswestry Disability Index before treatment was 30 for both groups ( n = 147 ) . After treatment , this had dropped to 25 , and , at 3 months , were 21 ( interferential therapy ) and 22 ( motorized lumbar traction and massage ) . The mean pain visual analog scale score before treatment was 50 ( interferential therapy ) and 51 ( motorized lumbar traction and massage ) . This had dropped , respectively , to 46 and 44 after treatment and to 42 and 39 at 3 months . CONCLUSIONS This study shows a progressive fall in Oswestry Disability Index and pain visual analog scale scores in patients with low back pain treated with either-interferential therapy or motorized lumbar traction and massage . There was no difference in the improvement between the two groups at the end of treatment . Although there is evidence from several trials that traction alone is ineffective in the management of low back pain , this study could not exclude some effect from the concomitant massage A number of treatments are widely prescribed for chronic back pain , but few have been rigorously evaluated . We examined the effectiveness of transcutaneous electrical nerve stimulation ( TENS ) , a program of stretching exercises , or a combination of both for low back pain . Patients with chronic low back pain ( median duration , 4.1 years ) were r and omly assigned to receive daily treatment with TENS ( n = 36 ) , sham TENS ( n = 36 ) , TENS plus a program of exercises ( n = 37 ) , or sham TENS plus exercises ( n = 36 ) . After one month no clinical ly or statistically significant treatment effect of TENS was found on any of 11 indicators of outcome measuring pain , function , and back flexion ; there was no interactive effect of TENS with exercise . Overall improvement in pain indicators was 47 percent with TENS and 42 percent with sham TENS ( P not significant ) . The 95 percent confidence intervals for group differences excluded a major clinical benefit of TENS for most outcomes . By contrast , after one month patients in the exercise groups had significant improvement in self-rated pain scores , reduction in the frequency of pain , and greater levels of activity as compared with patients in the groups that did not exercise . The mean reported improvement in pain scores was 52 percent in the exercise groups and 37 percent in the nonexercise groups ( P = 0.02 ) . Two months after the active intervention , however , most patients had discontinued the exercises , and the initial improvements were gone . We conclude that for patients with chronic low back pain , treatment with TENS is no more effective than treatment with a placebo , and TENS adds no apparent benefit to that of exercise alone Summary Back schools are high frequency-low cost interventions . Their effectiveness has lately been regarded with skepticism . The variety of back school programs makes an over-all evaluation difficult . The number of evaluative publications has increased dramatically during the last 10 years , including 18 r and omized controlled trials . Results of these studies have been contradictory . The results of two lately published r and omized controlled trials , of 18 r and omized controlled trials , of five systematic review s , two publications conducting metaanalyses , and five task forces presenting guidelines for clinical practice are reported . According to the conclusions of the review s there is limited to strong evidence for the effectiveness of back schools for chronic back pain . The metaanalyses show clear effects for knowledge and behavior change up to 6 months . Three of five task forces recommend back schools for acute pain respectively at worksite . Summarizing the results of the given evidence based recommendations it is concluded that back schools at work sites and back schools with intensive training is effective . There is still need to prove the effectiveness of single elements of the back school programs , of strategies to increase long term effects , the effectiveness for subtypes of patients and the effectiveness of back schools as part of a comprehensive orthopedic pain therapy . ZusammenfassungRückenschulen sind inzwischen weit verbreitete Programme , deren Wirksamkeit in letzter Zeit kritisch diskutiert wurde . Die Heterogenität der Programme i m Hinblick auf Ziele , Inhalte und Vermittlungsformen erschweren allgemeine Aussagen zur Wirksamkeit . Es liegt eine nahezu unüberschaubare Anzahl an Publikationen zur Evaluation von Rückenschulen vor , die unterschiedliche Wirksamkeitskriterien erhoben haben . Die vorliegenden Einzelstudien , darunter 18 mit einem kontrollierten r and omisierten Versuchsplan , kommen zu teilweise widersprechenden Result aten . Um dennoch zu einer allgemeinen Bewertung der Ergebnislage zu kommen , werden 2 jüngere Einzelstudien exemplarisch beschrieben , ebenso wie eine Übersicht über 18 r and omisierte kontrollierte Studien , Schlußfolgerungen von 5 Sammelreferaten , 2 Metaananalysen und 5 Expertenkommissionen , die „ Evidence based-Leitlinien “ zur Beh and lung von Rückenbeschwerden veröffentlichen . Von den Sammelreferaten kommt eines zu keinem Ergebnis , 3 beschreiben eine eingeschränkte Wirksamkeit und eines begründet eine starke Evidenz für die Wirksamkeit von Rückenschulen bei chronischen Beschwerden . Eine Metaanalyse errechnet große Effekte für Verhaltensänderungen und Kenntnisgewinn , die and ere größere Effekte für Rückenschulen als Teil von umfassenden Rehabilitationsprogrammen , 2 der Expertenkommissionen sehen keine Evidenz für die Wirksamkeit von Rückenschulen , 3 sehen die Wirksamkeit bei akuten Beschwerden bzw . am Arbeitsplatz als erwiesen . In der Gesamtbewertung erscheint die Wirksamkeit von Rückenschulprogrammen gesichert , die am Arbeitsplatz durchgeführt werden und die eine intensive Schulung beinhalten . Darüber hinaus muß die Wirkung der Rückenschulen noch deutlicher belegt werden , u. a. die isolierte Wirkung einzelner Bausteine , von Maßnahmen zur Steigerung der Dauerhaftigkeit , der Indikation für bestimmte Patientengruppen und Wirkungen der Rückenschule als Best and teil der Orthopädischen Schmerztherapie PURPOSE The purpose of this r and omized pilot study was to evaluate a possible design for a 6-week modified hatha yoga protocol to study the effects on participants with chronic low back pain . PARTICIPANTS Twenty-two participants ( M = 4 ; F = 17 ) , between the ages of 30 and 65 , with chronic low back pain ( CLBP ) were r and omized to either an immediate yoga based intervention , or to a control group with no treatment during the observation period but received later yoga training . METHODS A specific CLBP yoga protocol design ed and modified for this population by a certified yoga instructor was administered for one hour , twice a week for 6 weeks . Primary functional outcome measures included the forward reach ( FR ) and sit and reach ( SR ) tests . All participants completed Oswestry Disability Index ( ODI ) and Beck Depression Inventory ( BDI ) question naires . Guiding questions were used for qualitative data analysis to ascertain how yoga participants perceived the instructor , group dynamics , and the impact of yoga on their life . ANALYSIS To account for drop outs , the data were divided into better or not categories , and analyzed using chi-square to examine differences between the groups . Qualitative data were analyzed through frequency of positive responses . RESULTS Potentially important trends in the functional measurement scores showed improved balance and flexibility and decreased disability and depression for the yoga group but this pilot was not powered to reach statistical significance . Significant limitations included a high dropout rate in the control group and large baseline differences in the secondary measures . In addition , analysis of the qualitative data revealed the following frequency of responses ( 1 ) group intervention motivated the participants and ( 2 ) yoga fostered relaxation and new awareness/learning . CONCLUSION A modified yoga-based intervention may benefit individuals with CLB , but a larger study is necessary to provide definitive evidence . Also , the impact on depression and disability could be considered as important outcomes for further study . Additional functional outcome measures should be explored . This pilot study supports the need for more research investigating the effect of yoga for this population Conservative therapies for low back pain ( LBP ) entail expense , work loss , and risk of side effects . Because many competing modalities have been advocated , 59 therapeutic trials were examined for adherence to 11 method ological criteria . Common problems included failure to r and omize subjects , use " blind " observers , measure compliance , and adequately describe co- interventions . Applicability of many studies was unclear because of inadequate descriptions of patients , interventions , and relevant outcomes . Flexion exercises , administration of each of three drugs , one traction method , and certain manipulations were each supported by single studies of reasonable validity , but the importance of the results and their applicability to particular types of LBP were unclear . Valid trials supporting use of corsets , bed rest , transcutaneous nerve stimulation , and conventional traction were not found . Better method ological rigor is possible with newer techniques for ensuring blindness to therapy , measuring compliance , and assessing outcomes Study Design . A r and omized clinical trial . Objectives . To assess the efficacy of motorized continuous traction for low back pain . Summary of Background Data . The available studies on the efficacy of lumbar traction do not allow clear conclusions because of severe method ologic flaws . The current trial aim ed to overcome these shortcomings . Methods . Patients with at least 6 weeks of nonspecific low back pain were selected . High‐dose traction was compared with sham ( or low‐dose ) traction . Sham traction was given with a specially developed brace that becomes tighter in the back during traction . This was experienced as if real traction were exerted . The patients and the outcome assessor were unaware of treatment allocation . Outcome measures were : patient 's global perceived effect , severity of main complaints , functional status , pain , range of motion , work absence , and medical treatment . Results for the outcome measures at 12 weeks and 6 months after r and omization are presented . Results . One hundred and fifty‐one patients were r and omly allocated to one of the two treatment methods . Intention‐to‐treat analysis of the 12‐week and 6‐month results showed no statistically significant differences between the groups on all outcome measures ; all 95 % confidence intervals included the value zero . The number of patients lost to follow‐up study was very low . Other analyses showed the same results . Conclusions . Most common flaws of earlier studies on traction therapy could be overcome . This trial did not support the cl aim that traction is efficacious for patients with low back pain AIM Back pain is a highly frequent condition due to many causes , although most of them can not be established with certainty . It is also the current clinical and scientific belief that sacroiliac joint syndrome can be a specific low back pain cause . Nonetheless the existence of clinical tests aim ed at highlighting the responsibility for lumbar pain secondary to sacroiliac dysfunction , it is not easy to diagnose it with either manual or instrumental means . Moreover , uncertainty is diffuse when facing a correct treatment for patients involved . The aim of this study was to verify , in patients with acute or sub-acute low back pain and positive sacroiliac signs , the efficacy of a stabilising therapy ( orthosis and exercises , with previous mesotherapy ) directly targeted to sacroiliac dysfunction versus a symptomatic usual care such as He-Ne laser therapy . METHODS Over a period of 14 months , we recruited 22 patients ( 10 females , mean age 44+/-11 ) with acute and sub-acute low back pain and symptoms and signs suggesting a sacroiliac dysfunction . They were r and omised in a Group laser ( GL ) , 11 patients treated with He-Ne laser therapy targeting the sacroiliac region , and a Group stabilisation ( GS ) , 11 patients treated with mesotherapy , a specific dynamic sacroiliac support ( ILSA ) and specific exercises . Outcome criteria included VAS , and Mens and Laslett sacroiliac tests . RESULTS Out of 449 acute and sub-acute low back pain out- patients , 22 ( 4.9 % ) had symptoms and signs suggesting a sacroiliac dysfunction . A reduction of pain was achieved only in the GS . All pain-provocation and stability tests were negative both after the end of treatment and at the follow-up only in the GS . CONCLUSIONS A targeted approach based on mesotherapy , a specific sacroiliac belt and specific stabilizing exercises proved its efficacy in acute and sub-acute low back pain patients with symptoms and signs suggesting a sacroiliac dysfunction . As soon as it will be possible to identify particular spine syndromes in the universe of non specific low back pain , there will also be the possibility to employ specific therapies Study Design A r and omized prospect i ve trial of manipulation , massage , corset and transcutaneous muscle stimulation ( TMS ) was conducted in patients with subacute low back pain . Objectives The authors determined the relative efficacy of chiropractic treatment to massage , corset , and TMS . Summary of Background Data Although all of these treatments are used for subacute low back pain treatment , there have been few comparative trials using objective outcome criteria . Patients were enrolled for a period of 3 weeks . They were evaluated once a week by question naires , visual analog scale , range of motion , maximum voluntary extension effort , straight leg raising and Biering-Sorensen fatigue test . The dropout rate was highest in the muscle stimulation and corset groups and lowest in the manipulation group . Rates of full compliance did not differ significantly across treatments . A measure of patient confidence was greatest in the manipulation group . Results After 3 weeks , the manipulation group scored the greatest improvements in flexion and pain while the massage group had the best extension effort and fatigue time , and the muscle stimulation group the best extension . Conclusion None of the changes in physical outcome measures ( range of motion , fatigue , strength or pain ) were significantly different between any of the groups The authors carried out a single-blind , r and omized controlled clinical trial of rotational manipulation for low-back pain of recent onset in 81 adults . Control treatments were minimal massage and low-level electrostimulation . Initial status and outcome were measured on scales quantifying symptoms , activities of dally life , mobility , tenderness to palpation , aggravation of pain by coughing or sneezing , limitation of motion on testing , and forward flexion . Both treated and control patients improved rapidly in the 2 - 3-week observation period . On retest there was no statistically significant difference between the improvement scores of the treated or control groups on any of the scales Summary Several new studies have indicated that an active approach to patients with chronic disabling low back pain ( LBP ) seems effective . Some of these studies emphasize the importance of dealing with the patient 's total situation in comprehensive multidisciplinary programs — the bio-psycho-social model . However , these programs are expensive . The aim of this study was to evaluate the rehabilitation outcome from three different active programs in terms of : ( 1 ) return-to-work rate , ( 2 ) days of sick leave , ( 3 ) health-care contacts , ( 4 ) pain and disability scores , and ( 5 ) staying physically active . The subjects included 132 patients r and omized to the study , of whom 123 started one of the treatment programs . They had all had at least 6 months of chronic LBP . The patients were r and omized into one of three programs : group 1 — a full-time , intensive 3-week multidisciplinary program , including active physical and ergonomic training and psychological pain management , followed by 1 day weekly for the subsequent 3 weeks ; group 2 — active physical training , twice a week for 6 weeks , for a total of 24h ; group 3 — psychological pain management combined with active physical training , twice a week for 6 weeks , also for a total of 24h . The results presented here are based on data collected 4 months following treatment , which shows an 86 % response rate . The initial examination and the follow-up evaluation were performed by a blinded observer . The results show that 4 months after treatment , the intensive multidisciplinary program is superior to the less intensive programs in terms of return-to-work rate , health-care contacts , pain and disability scores , and staying physically active . In conclusion , it seems that although the multidisciplinary program is initially expensive compared to the less intensive programs , the savings in sick pay , early retirement pensions , and health care contacts make it economically worthwhile . Long-term follow-up will show whether this effect continues Previous trials to assess the efficacy of lumbar traction for back pain have been method ologically flawed . To avoid these shortcomings , we conducted a r and omised controlled trial in which high-dose traction was compared with sham traction . The sham traction was given with a specially developed brace that tightens in the back during traction . To the patient , the experience is that of traction . The patients and outcome assessor were blinded for the assigned treatment . 151 patients with at least six weeks of non-specific low back pain were r and omised . Intention to treat analysis showed no differences between the groups on all outcome measures ( patients ' global perceived effect , severity of main complaints , functional status and pain ) ; all 95 % confidence intervals included the value zero . The number of withdrawals from treatment , loss to follow-up , and protocol deviations was low . Consequently , the per- protocol analysis showed results similar to the intention to treat analysis . Subgroup analyses did not show any group for which traction might seem promising . Our data do not support the cl aim that traction is effective for patients with low back pain OBJECTIVE --To determine the quality of r and omised controlled trials of exercise therapy for back pain . DESIGN --Computer aided search of published papers and blinded assessment of the methods of studies . SUBJECTS--23 r and omised controlled trials , of which 16 studied exercise therapy given by physiotherapists to individual patients with back pain . Other conservative treatments could be included . MAIN OUTCOME MEASURES --Score for quality of methods ( based on four main categories : study population , interventions , measurement of effect , and data presentation and analysis ) and main conclusion of author(s ) with regard to exercise therapy . RESULTS --Only four studies scored more than 50 points ( maximum 100 ) , indicating that most were of poor quality . Six studies found that exercise was better than reference treatments and 10 reported it to be no better or worse than the reference treatment . Those reporting positive results tended to have higher methods scores ( 4/6 positive v 4/10 negative scored greater than or equal to 42 ) . CONCLUSIONS --No conclusion can be drawn about whether exercise therapy is better than other conservative treatments for back pain or whether a specific type of exercise is more effective . Further trials are needed in which greater attention is paid to methods of study BACKGROUND AND OBJECTIVES The aim of this study was to determine whether low power laser therapy ( Gallium-Arsenide ) is useful or not for the therapy of chronic low back pain ( LBP ) . STUDY DESIGN / MATERIAL S AND METHODS This study included 75 patients ( laser + exercise-25 , laser alone-25 , and exercise alone-25 ) with LBP . Visual analogue scale ( VAS ) , Schober test , flexion and lateral flexion measures , Rol and Disability Question naire ( RDQ ) and Modified Oswestry Disability Question naire ( MODQ ) were used in the clinical and functional evaluations pre and post therapeutically . A physician , who was not aware of the therapy undertaken , evaluated the patients . RESULTS Significant improvements were noted in all groups with respect to all outcome parameters , except lateral flexion ( P < 0.05 ) . CONCLUSIONS Low power laser therapy seemed to be an effective method in reducing pain and functional disability in the therapy of chronic LBP Objective The aim of the study was to compare the therapeutic effect of the superficial and in-depth insertion of acupuncture needles in the treatment of patients with chronic lumbar myofascial pain . Design A prospect i ve r and omized double-blind study of superficial and deep acupuncture was conducted . Setting The study was conducted in the Pain Service Unit of the University of Padova . Patients The study comprised 42 patients with lumbar myofascial pain who were divided into two equal groups ( A and B ) . InterventionIn group A , the needle was introduced in the skin at a depth of 2 mm , whereas in group B the needle was placed deeply into muscular tissue . The treatment was planned for a cycle of eight sessions . Outcome Measures The intensity of pain was evaluated with the McGill Pain Question naire before and after treatment and at the 3-month follow-up examination . Results Although at the end of the treatment there was no evidence of significant statistical differences between the two different groups , pain reduction was greater in the group treated with deep acupuncture . A statistical difference existed between the two groups at the 3-month follow up , with a better result in the deeply stimulated group . Conclusions Clinical results show that deep stimulation has a better analgesic effect when compared with superficial stimulation OBJECTIVE Rehabilitation programs for low back pain ( LBP ) almost always contain massage and exercise therapy in one form or another . AIM This study aim ed to quantify the effectiveness of therapeutic ' Acupuncture ' massage ( APM ; i.e. tonic stimulation of entire meridians ) according to Penzel versus Swedish massage ( SM ) and individual medical exercises ( IE ) versus group exercises ( GE ) in LBP sufferers . PATIENTS AND METHODS 109 patients participating in a complex in-patient rehabilitation program were r and omised to four groups in a 2 x 2 factorial design . Main outcome measures were functional ability/disability ( Functional Question naire Hanover , FFbH ) and pain intensity ( 10 cm visual analogue scale , VAS ) . Pre/post changes were evaluated by means of 2-way analysis of variance ( ANOVA ) . Additionally , lumbar motility was measured by a 2-inclinometer technique . RESULTS Baseline mean FFbH score was 66 ( SD = 18)% , mean pain intensity on VAS was 4.5 ( SD = 2.4 ) cm . Lumbar flexion and extension were 49 ( 13 ) and 13 ( 7 ) . Because of some differences between groups at baseline , group-st and ardized outcomes were used for analysis . APM showed beneficial effects for both disability and pain compared with SM ( group differences : delta FFbH 7.0 % [ 95 % confidence interval ( CI ) 2.5 - 11.6 ] , p = 0.003 ; delta VAS 0.8 cm [ 95 % CI : 2 - 15 ] , p = 0.024 ) . St and ardized response means were SRMFFbH = 0.5 and SRMVAS = 0.8 for APM , as opposed to SRMFFbH = -0.01 and SRMVAS = 0.4 for SM . Neither significant group differences between both exercise groups [ delta FFbH -0.5 % ( 95 % CI -5.2 to 4.2 ) ; delta Vas 0.4 cm ( 95 % CI 0.3 to 1.1 ) ] nor significant interactions between medical exercise and massage were found . CONCLUSIONS Given the fact that even the treatments considered to be the best available achieve at best moderate effects , the observed effect sizes with APM are promising and warrant further investigation in replication studies . In contrast to common view , no superiority of individual versus group exercises could be found in the present study OBJECTIVES To test whether patients with persistent non-specific low back pain , when offered access to traditional acupuncture care alongside conventional primary care , gained more long-term relief from pain than those offered conventional care only , for equal or less cost . Safety and acceptability of acupuncture care to patients , and the heterogeneity of outcomes were also tested . DESIGN A pragmatic , two parallel group , r and omised controlled trial . Patients in the experimental arm were offered the option of referral to the acupuncture service comprising six acupuncturists . The control group received usual care from their general practitioner ( GP ) . Eligible patients were r and omised in a ratio of 2:1 to the offer of acupuncture to allow between-acupuncturist effects to be tested . SETTING Three non-NHS acupuncture clinics , with referrals from 39 GPs working in 16 practice s in York , UK . PARTICIPANTS Patients aged 18 - 65 years with non-specific low back pain of 4 - 52 weeks ' duration , assessed as suitable for primary care management by their general practitioner . INTERVENTIONS The trial protocol allowed up to ten individualised acupuncture treatments per patient . The acupuncturist determined the content and the number of treatments according to patient need . MAIN OUTCOME MEASURES The Short Form 36 ( SF-36 ) Bodily Pain dimension ( range 0 - 100 points ) , assessed at baseline , and 3 , 12 and 24 months . The study was powered to detect a 10-point difference between groups at 12 months post-r and omisation . Cost -- utility analysis was conducted at 24 months using the EuroQoL 5 Dimensions ( EQ-5D ) and a preference-based single index measure derived from the SF-36 ( SF-6D ) . Secondary outcomes included the McGill Present Pain Index ( PPI ) , Oswestry Pain Disability Index ( ODI ) , all other SF-36 dimensions , medication use , pain-free months in the past year , worry about back pain , satisfaction with care received , and safety and acceptability of acupuncture care . RESULTS A total of 159 patients were in the ' acupuncture offer ' arm and 80 in the ' usual care ' arm . All 159 patients r and omised to the offer of acupuncture care chose to receive acupuncture treatment , and received an average of eight acupuncture treatments within the trial . Analysis of covariance , adjusting for baseline score , found an intervention effect of 5.6 points on the SF-36 Pain dimension [ 95 % confidence interval ( CI ) -1.3 to 12.5 ] in favour of the acupuncture group at 12 months , and 8 points ( 95 % CI 0.7 to 15.3 ) at 24 months . No evidence of heterogeneity of effect was found for the different acupuncturists . Patients receiving acupuncture care did not report any serious or life-threatening events . No significant treatment effect was found for any of the SF-36 dimensions other than Pain , or for the PPI or the ODI . Patients receiving acupuncture care reported a significantly greater reduction in worry about their back pain at 12 and 24 months compared with the usual care group . At 24 months , the acupuncture care group was significantly more likely to report 12 months pain free and less likely to report the use of medication for pain relief . The acupuncture service was found to be cost-effective at 24 months ; the estimated cost per quality -adjusted ( QALY ) was 4241 pounds sterling ( 95 % CI 191 pounds sterling to 28,026 pounds sterling ) using the SF-6D scoring algorithm based on responses to the SF-36 , and 3598 pounds sterling ( 95 % CI 189 pounds sterling to 22,035 pounds sterling ) using the EQ-5D health status instrument . The NHS costs were greater in the acupuncture care group than in the usual care group . However , the additional re source use was less than the costs of the acupuncture treatment itself , suggesting that some usual care re source use was offset . CONCLUSIONS Traditional acupuncture care delivered in a primary care setting was safe and acceptable to patients with non-specific low back pain . Acupuncture care and usual care were both associated with clinical ly significant improvement at 12- and 24-month follow-up . Acupuncture care was significantly more effective in reducing bodily pain than usual care at 24-month follow-up . No benefits relating to function or disability were identified . GP referral to a service providing traditional acupuncture care offers a cost-effective intervention for reducing low back pain over a 2-year period . Further research is needed to examine many aspects of this treatment including its impact compared with other possible short-term packages of care ( such as massage , chiropractic or physiotherapy ) , various aspects of cost-effectiveness , value to patients and implementation protocol Objective The authors sought to determine whether a series of needle acupuncture treatments produced long-term relief of chronic low back pain . Design A blinded placebo-controlled study with an independent observer . The patients were r and omized to receive manual acupuncture , electroacupuncture , or active placebo ( mock transcutaneous electrical nerve stimulation ) . Subjects were examined and monitored by an investigator who was blinded to the treatment given . Setting A tertiary-level pain clinic at a Swedish university hospital . Patients Fifty consecutive patients ( 33 women , 17 men ; mean age , 49.8 years ) with chronic low back pain ( mean pain duration , 9.5 years ) and without rhizopathy or history of acupuncture treatment were included in the study . Interventions Treatments were given once per week for 8 weeks . Two further treatments were given during the follow-up assessment period of 6 months or longer . Outcome Measures The independent observer made a global assessment of the patients 1 , 3 , and 6 months after treatment . The patients kept pain diaries to score pain intensity twice daily , analgesic intake , and quality of sleep daily , and activity level weekly . Results At the 1-month independent assessment , 16 of 34 patients in the acupuncture groups and 2 of 16 patients in the placebo group showed improvement ( p < 0.05 ) . At the 6-month follow-up assessment , 14 of 34 patients in the acupuncture groups and 2 of 16 patients in the placebo group showed improvement ( p < 0.05 ) . A significant decrease in pain intensities occurred at 1 and 3 months in the acupuncture groups compared with the placebo group . There was a significant improvement in return to work , quality of sleep , and analgesic intake in subjects treated with acupuncture . Conclusions The authors found a long-term pain-relieving effect of needle acupuncture compared with true placebo in some patients with chronic nociceptive low back pain Study Design . A multicenter assessor-blinded r and omized clinical trial was conducted . Objectives . To investigate the difference in effectiveness of manipulative therapy and interferential therapy for patients with acute low back pain when used as sole treatments and in combination . Summary of Background Data . Both manipulative therapy and interferential therapy are commonly used treatments for low back pain . Evidence for the effectiveness of manipulative therapy is available only for the short-term . There is limited evidence for interferential therapy , and no study has investigated the effectiveness of manipulative therapy combined with interferential therapy . Methods . Consenting subjects ( n = 240 ) recruited following referral by physicians to physiotherapy departments in the ( government-funded ) National Health Service in Northern Irel and were r and omly assigned to receive a copy of the Back Book and either manipulative therapy ( MT ; n = 80 ) , interferential therapy ( IFT ; n = 80 ) , or a combination of manipulative therapy and interferential therapy ( CT ; n = 80 ) . The primary outcome was a change in functional disability on the Rol and Morris Disability Question naire . Follow-up question naires were posted at discharge and at 6 and 12 months . Results . The groups were balanced at baseline for low back pain and demographic characteristics . At discharge all interventions significantly reduced functional disability ( Rol and Morris scale , MT : −4.53 ; 95 % CI , −5.7 to −3.3 vs. IFT : −3.56 ; 95 % CI , −4.8 to −2.4 vs. CT : −4.65 ; 95 % CI , −5.8 to −3.5 ; P = 0.38 ) and pain ( McGill question naire , MT : −5.12 ; 95 % CI , −7.7 to −2.5 vs. IFT : −5.87 ; 95 % CI , −8.5 to −3.3 vs. CT : −6.64 ; 95 % CI , −9.2 to −4.1 ; P = 0.72 ) and increased quality of life ( SF-36 Role-Physical , MT : 28.6 ; 95 % CI , 18.3 to 38.9 vs. IFT : 31.4 ; 95 % CI , 21.2 to 41.5 vs. CT : 30 ; 95 % CI , 19.9 to 40 ; P = 0.93 ) to the same degree and maintained these improvements at 6 and 12 months . No significant differences were found between groups for reported LBP recurrence , work absenteeism , medication consumption , exercise participation , or healthcare use at 12 months ( P > 0.05 ) . Conclusions . For acute low back pain , there was no difference between the effects of a combined manipulative therapy and interferential therapy package and either manipulative therapy or interferential therapy alone Context In this r and omized , controlled trial , spinal manipulation plus exercise produced outcomes for low back pain similar to those produced by exercise alone . Yet , some patients did respond to spinal manipulation , and it would be helpful for doctors to be able to identify such patients . Contribution Patients were most likely to benefit from spinal manipulation if they met 4 of 5 of the following criteria : symptom duration less than 16 days , no symptoms distal to knee , score less than 19 on a fear-avoidance measure , at least 1 hypomobile lumbar segment , and at least 1 hip with more than 35 degrees of internal rotation . Implication s Clinicians may be able to use these criteria to identify patients with low back pain who are good c and i date s for spinal manipulation . The Editors Next to the common cold , low back pain is the most common reason that individuals visit a physician 's office ( 1 ) . Billions of dollars in medical expenditures and lost labor costs for this condition are incurred each year ( 2 , 3 ) . Attempts to identify effective interventions for individuals with low back pain have been largely unsuccessful ( 4 ) . In particular , conflicting evidence exists about the effectiveness of spinal manipulation ; some r and omized trials have shown a benefit , while other trials have not ( 5 - 7 ) . These conflicting conclusions are reflected in the various recommendations in national clinical practice guidelines , with some recommending manipulation and others not ( 8) . The variety of conclusions in trials of manipulation may be attributable to the failure of research ers to adequately consider the importance of classification . Using broad inclusion criteria results in a heterogeneous sample that may include many patients for whom no benefit is expected , thus masking the intervention 's true value ( 9 , 10 ) . Consequently , developing methods for matching patients with low back pain to treatments that are most likely to benefit them has become an important research priority ( 11 ) . Clinical prediction rules are tools design ed to assist clinicians in decision making when caring for patients ( 12 ) . Several clinical prediction rules have been developed and vali date d to improve clinical decision making for the use of imaging in patients with ankle , knee , cervical spine , or minor head injuries ( 13 - 16 ) . Few studies have attempted to develop rules that establish prognosis on the basis of outcome from a specific intervention , such as spinal manipulation . Recently , Flynn and colleagues ( 17 ) developed a clinical prediction rule for identifying patients with low back pain who are likely to benefit from manipulation . They examined a series of patients with low back pain who received a manipulation intervention . Five factors formed the most parsimonious set of predictors for identifying patients who achieved at least 50 % improvement in disability within 1 week with a maximum of 2 manipulation interventions ( Table 1 ) ( 17 ) . The positive likelihood ratio among patients who met at least 4 of 5 of the criteria was 24.4 ( 95 % CI , 4.6 to 139.4 ) . Table 1 . Five Criteria in the Spinal Manipulation Clinical Prediction Rule Clinical prediction rules must be vali date d in separate population s before being recommended for widespread implementation ( 18 ) . A clinical prediction rule for identifying which patients with low back pain are most likely to respond to manipulation could improve clinical efficiency and re source utilization . Thus , we aim ed to vali date the spinal manipulation clinical prediction rule in a multicenter trial . Methods We considered consecutive patients with a primary symptom of low back pain who were referred to physical therapy for participation . We used 14 physical therapists at 8 clinics in various U.S. regions and setting s ( 2 academic medical centers and smaller outpatient practice setting s ) . Most participating sites were health care facilities within the U.S. Air Force . Each site 's institutional review board approved the study before we began recruitment and data collection . Inclusion criteria were age 18 to 60 years ; a primary symptom of low back pain , with or without referral into the lower extremity ; and an Oswestry Disability Question naire ( ODQ ) score of at least 30 % . We excluded patients who had red flags for a serious spinal condition ( for example , tumor , compression fracture , or infection ) , those who had signs consistent with nerve root compression ( that is , positive straight-leg increase < 45 degrees or diminished reflexes , sensation , or lower-extremity strength ) , those who were pregnant , or those who had previous surgery to the lumbar spine or buttock . These criteria are consistent with those used in Flynn and colleagues ' study ( 17 ) and were design ed to include patients without a contraindication to manipulation . Once patients were admitted to the study , we used intention-to-treat principles , and no patient was removed for nonadherence . History and Physical Examination Before r and omization , patients completed several self-report measures and then received a st and ardized history and physical examination . We collected demographic information , including age and sex ; medical history ; and location and nature of symptoms . Self-report measures included a body diagram to assess the symptom distribution ( 19 ) . We used an 11-point pain-rating scale ranging from 0 ( no pain ) to 10 ( worst imaginable pain ) to assess current pain intensity and the best and worst level of pain during the last 24 hours ( 20 ) . We used the average of the 3 ratings . We used the Fear-Avoidance Beliefs Question naire ( FABQ ) to quantify the patient 's fear of pain and beliefs about avoiding activity ( 21 ) . Previous studies have found a high level of testretest reliability for both the FABQ physical activity and work subscales ( 22 ) . Fearavoidance beliefs have been associated with current and future disability and work loss in patients with acute ( 23 ) and chronic ( 24 ) low back pain . The modified ODQ is a region-specific disability scale for patients with low back pain ( 25 ) that has high levels of reliability , validity , and responsiveness ( 26 ) . Physical examination measures included lumbar active range of motion ( 27 ) and various tests purported to identify dysfunction in the lumbopelvic region ( 28 ) . Complete details of the physical examination are described elsewhere ( 26 ) . Specific components pertinent to validation of the rule were assessment s of segmental mobility and hip internal rotation range of motion , the performance of which is described in Appendix 1 and Appendix 3 video . Each physical therapist received a detailed manual that operationally defined each examination and treatment procedure and was trained in the study procedures by an investigator before data collection began . Supplement . Appendix 3 video : A Clinical Prediction Rule To Identify Patients with Low Back Pain Most Likely To Benefit from Spinal Manipulation Determining Status on the Clinical Prediction Rule A physical therapist who was blinded to the patients ' treatment group assignment assessed the 5 criteria in the rule ( Table 1 , Appendix 1 , and Appendix 3 video ) . To further minimize bias , examiners were not instructed in the rule 's criteria and were unaware of the patient 's status on the rule . After completion of the study , an examiner who was blinded to the patient 's treatment assignment determined the patient 's status on the rule by using the results of the baseline examination . As was done in the initial study ( 17 ) , we classified patients as positive if they met at least 4 of 5 criteria and were therefore likely to respond to manipulation . We classified patients with 3 or fewer criteria as negative . An examiner who was blinded to the patient 's status on the rule repeated the history and physical examination 1 and 4 weeks after r and omization . Patients also completed a 6-month follow-up postal question naire to assess disability , work status , and health care utilization . Treatment Groups We used a r and om-number generator to generate a r and omization list before the study began . We prepared individual , sequentially numbered index cards with the r and omization assignments . We folded the cards and placed them in sealed envelopes . After the baseline examination , the physical therapist who conducted the examination opened the next envelope , indicating the treatment group assignment . We r and omly assigned patients to 1 of 2 groups : 1 ) spinal manipulation plus an exercise program ( manipulation group ) or 2 ) an exervideocise program alone ( exercise group ) . Patients in both groups attended physical therapy twice during the first week and then once a week for the next 3 weeks , for a total of 5 sessions . We initiated treatment immediately after completion of the baseline examination , unless prohibited by time constraints ; in that case the first treatment session took place 24 to 48 hours after the baseline examination . All patients received an exercise instruction booklet that outlined the proper performance and frequency of each exercise and were instructed to perform their assigned exercise program once daily on the days that they did not attend therapy . On the basis of the benefits associated with remaining active ( 29 ) , patients in both groups were given advice to maintain usual activity within the limits of pain . Manipulation Group The treatment received by the manipulation group differed from that of the exercise group during the first 2 physical therapy sessions . During these 2 sessions , patients received high-velocity thrust spinal manipulation and a range-of-motion exercise only . First , the physical therapist performed the manipulation by using the same technique used by Flynn and colleagues ( 17 ) . Appendix 2 describes and Figure 1 and Appendix 3 video illustrate the procedures used to perform the manipulation technique . Figure 1 . Manipulative intervention used in developing and validating the spinal manipulation clinical prediction rule . Exercise Group We treated patients in the exercise group with a low-stress BACKGROUND Americans with low back pain have been helped to return to work by multidisciplinary intensive treatment programs . Whether this treatment method will succeed in countries with a more generous social welfare system , where the incentive to return to work might be less , is not proven . OBJECTIVES To evaluate a Danish program of functional restoration combined with behavioral support . METHODS Patients who had experienced at least 6 months of disabling low back pain were r and omly assigned to either a 3-week intensive treatment program ( n = 55 ) or an untreated control group ( n = 51 ) . RESULTS Of the 106 patients r and omized , 94 ( 89 % ) returned for a 4-month follow-up visit . At that time , 29 ( 64 % ) of the 45 treated patients were able to work , compared with 14 of 49 ( 29 % ) in the control group . The treated patients had used fewer days of sick leave ( P < .02 ) , had contacted health care . professionals fewer times ( P < .001 ) , and had lower pain and disability scores . CONCLUSIONS Although such programs are expensive , they can reduce pension expenditures , sick leave days , health care contacts , and pain OBJECTIVE To assess the effectiveness of low-intensity laser therapy in the treatment of musculoskeletal low back pain . DESIGN A double-masked , placebo-controlled , r and omized clinical trial . SETTING A physical medicine and rehabilitation clinic . PARTICIPANTS Sixty-three ambulatory men and women between the ages of 18 and 70yrs with symptomatic nonradiating low back pain of more than 30 days ' duration and normal neurologic examination results . INTERVENTION Subjects were bloc r and omized into two groups with a computer-generated schedule . All underwent irradiation for 90 seconds at eight symmetric points along the lumbosacral spine three times a week for 4 weeks by a masked therapist . The sole difference between the groups was that the probes of a 1.06 microm neodymium : yttrium-aluminum-garnet laser emitted 542mW/cm2 for the treated subjects and were inactive for the control subjects . MAIN OUTCOME MEASURES Subject 's perception of benefit , level of function as assessed by the Oswestry Disability Question naire , and lumbar mobility . RESULTS The treated group had a time-dependent improvement in two of the three outcome measures : perception of benefit and level of function . These results were most marked at the midpoint evaluation ( p < .005 , p < .01 ) and end of treatment ( p < .017 , p < .001 ) but tended to lessen at the 1-month follow-up ( p < .10 , p < .004 ) . Lumbar mobility did not differ between the groups at any time . All tests were two- sample t tests with unequal variances . CONCLUSIONS Treatment with low-intensity 1.06 microm laser irradiation produced a moderate reduction in pain and improvement in function in patients with musculoskeletal low back pain . Benefits , however , were limited and decreased with time . Further research is warranted OBJECTIVE To determine the efficacy of interferential therapy ( IFT ) electrode placement technique compared with a control treatment in subjects with acute low back pain ( LBP ) . DESIGN Single-blind , r and omized , controlled trial with a 3-month follow-up . SETTING Outpatient physiotherapy departments in hospital and university setting s. PATIENTS A r and om sample of 60 eligible patients with back pain ( 28 men , 32 women ) were recruited by general practitioners and self-referral for physiotherapy treatment and r and omly assigned to 1 of 3 groups . INTERVENTIONS ( 1 ) " IFT painful area " and The Back Book , ( 2 ) " IFT spinal nerve " and The Back Book , and ( 3 ) " Control , " The Back Book only . St and ardized IFT stimulation parameters were used : carrier frequency 3.85 kHz ; 140 Hz constant ; pulse duration 130 micros ; 30 minutes ' duration . MAIN OUTCOME MEASURES Pain Rating Index , Rol and -Morris Disability Question naire ( RMDQ ) , and EuroQol were completed by subjects pretreatment , at discharge , and 3-month follow-up . RESULTS All groups had significant improvements in all outcomes at follow-up . Subjects managed by IFT spinal nerve and The Back Book displayed both a statistically significant ( p = .030 ) and clinical ly meaningful reduction in functional disability ( RMDQ ) , compared with management via IFT painful area and The Back Book combined or The Back Book alone . CONCLUSIONS The findings showed that IFT electrode placement technique affects LBP-specific functional disability , providing preliminary implication s for future clinical studies In this controlled prospect i ve study of the Auto-traction method for the treatment of lumbago-sciatica , 82 patients were r and omly allocated to either treatment with Auto-traction for up to three 1-hour sessions in 1 week , or they were given a corset and advised to rest . The orthopaedic surgeons participating in the study worked at six different hospitals and all had limited experience of the Auto-traction method obtained during a 1-week course . All patients were clinical ly evaluated by an independent observer who also performed the follow-up examinations 1 and 3 weeks after the treatment sessions . In addition a 3-month follow-up was performed by letter . The Auto-traction method gave prompt relief of pain and a normalizing of the SLR test more often than treatment with only a corset and rest . The difference between the two treatment groups was statistically significant . The immediate difference noted between the treatment groups had decreased slightly at 3 weeks but was still statistically significant at this time The study evaluated the manual treatment of dysfunction of the pelvic joints . This is one of many condition causing low back pain . In 1987 - 1988 a general practitioner with special knowledge of physical examination and manual treatment of lumbar and pelvic dysfunctions made a survey of patients with acute or subacute low back pain as the main cause of the patient-to-doctor contact . Patients with defined criteria of pelvic joint dysfunction ( n = 46 ) were r and omized . After dropouts and exclusions , 18 patients with defined criteria of pelvic joint dysfunction received manual treatment , while 21 patients with similar dysfunction served as controls and received placebo treatment in a form of massage . Both groups were seen only once to evaluate whether a single treatment might be sufficient . After a period of three weeks , evaluation was made by an independent observer . Subjective pain measurement and a mobility test showed no significant difference . Sick-leave and consumption of analgesics ( both decided by patient ) were significantly less in the treatment group Low back pain ( LBP ) is a very common problem in primary care and a major cause of disability . There is no evidence for the efficacy of therapeutic modalities such as ultrasound in LBP In a r and omized , single blind placebo controlled clinical trial , we aim ed to evaluate the effect of continuous ultrasound ( US ) in patients with non specific LBP Of the fifty eight patients recruited , 10 patients ( 8 women and 2 men ) r and omly allocated to ultrasound ( n=5 ) or placebo controlled ( n=5 ) groups . The patients were treated by either US or sham-US for ten sessions , three days per week , every other day . The outcome measures were Functional Rating Index ( FRI ) , Hmax/Mmax ratio and range of motion ( ROM ) , which were measured at baseline , after 5 treatment sessions and at the end of treatment . To analyze the data , The Mann Whitney U test and Wilcoxon Signed Rank test were used . After treatment , both US and placebo groups showed statistically significant decrease in FRI scores indicating improvement in functional ability ( p = 0.042 and p = 0.043 , respectively ) . The mean changes of FRI during the second five treatment sessions and after the end of treatment was significantly better in the US group than in the placebo group ( p = 0.016 and p = 0.032 , respectively ) . Before and after treatment , the mean H reflex latency and Hmax/Mmax ratio , right and left side were similar in the groups ( p > 0.05 ) , and no significant changes were observed in the treatment groups ( p > 0.05 ) . After treatment , the extension and lateral flexion range of motion significantly increased in the US group ( p = 0.04 ) , but the back movements in the placebo group did not show significant changes ( p > 0.05 ) . The present study supports the significant effect of US on LBP , and suggests that US may improve the functional ability of patients with non specific low back pain |
344 | 29,897,913 | Conclusions Patients with SLE had lower BMD than healthy controls .
Moreover , SLE patients with VF had lower BMD than patients without VF .
However , our data did not show that GCT therapy had an impact on BMD | Background Observational studies have indicated a high but heterogeneous prevalence of low bone mineral density ( BMD ) and vertebral fractures ( VF ) in patients with systemic lupus erythematosus ( SLE ) .
Therefore , the objectives of this systematic review and meta-regression were : 1 ) to compare BMD between SLE patients and healthy controls and 2 ) to evaluate the relationship between BMD and glucocorticoid therapy and VF in SLE patients . | Systemic lupus erythematosus ( SLE ) is an autoimmune disease characterized by chronic inflammation . Different studies have shown decreased bone mineral density ( BMD ) in patients with SLE . The objective of this study was to investigate the prevalence and possible risk factors of low BMD in untreated female patients with SLE in Chinese population . A total of 119 untreated female patients with SLE were included . BMD was measured at lumbar spine and at total hip by dual-energy X-ray absorptiometry . The associations between decreased BMD and demographic variables , clinical variables , and bone metabolism variables were analyzed . These SLE patients had the following characteristics : mean age was 32.6 ± 11.9 years , mean disease duration was 22.1 ± 34.5 months , and mean SLEDAI was 11.4 ± 5.4 . Osteopenia was present in 31.1 % of the patients and osteoporosis in 8.5 % . A significant negative association between low density lipoprotein cholesterol ( LDL-c ) and BMD at the lumbar spine ( correlation coefficient = −0.242 ; P = 0.023 ) and total hip ( correlation coefficient = −0.259 ; P = 0.019 ) was shown . These results seem to indicate that increased LDL-c may be an important risk factor for low BMD at lumbar spine and total hip in untreated female SLE patients The aim of this study was to evaluate possible associations between potential risk factors and the occurrence of established vertebral fractures ( VF ) in Mexican patients with systemic lupus erythematosus ( SLE ) . Consecutive patients with SLE were enrolled in a prospect i ve , observational study from 2006 to 2015 . Information on potential risk factors , including demographics , clinical data , and bone mineral density ( BMD ) at the lumbar spine and hip on dual-energy X-ray absorptiometry was collected at baseline and follow-up . Semiquantitative analysis was used to determine incident VF on lateral thoracic and lumbar radiographs , defined as any vertebral body grade d normal at baseline and at least mildly deformed ( 20–25 % reduction or more in any vertebral height ) during follow-up . Differences in baseline characteristics were assessed in patients with and without new radiographic VF . Of 110 SLE patients included , with a median follow-up of 8 ( IQR 8–9 ) years , 22 ( 20 % ) had radiographic VF at baseline ; 35 ( 32 % ) patients had a new VF . The annual incidence rate of new morphometric VF was 3.5 ( 95 % CI 2.4–4.91 ) per 100 patient/years . Most fractures were mild or moderate and biconcave shaped . Incident VF were significantly associated with baseline BMD at the total hip and longer disease duration . Cumulative glucocorticoid dose , postmenopausal status , and previous prevalent VF were not associated with VF . In this SLE cohort in daily clinical practice , new VF were frequently present in SLE patients , especially those with longer disease duration and low-hip BMD Fractures and subsequent morbidity determine the impact of established postmenopausal osteoporosis . Health-related quality of life ( HRQOL ) has become an important outcome criterion in the assessment and follow-up of osteoporotic patients . As part of the baseline measurements of the Multiple Outcomes of Raloxifene Evaluation ( MORE ) study , HRQOL was assessed in 751 osteoporotic ( bone mineral density [ BMD ] T score > or = -2.5 ) women from Europe with or without vertebral fractures ( VFX ) . This was done using the quality of life question naire of the European Foundation for Osteoporosis ( QUALEFFO ) , Nottingham Health Profile ( NHP ) and the EQ-5D ( former EuroQol ) . QUALEFFO contains questions in five domains : pain , physical function , social function , general health perception , and mental function . Each domain score and QUALEFFO total scores are expressed on a 100-point scale , with 0 corresponding to the best HRQOL . In comparison with patients without VFX , those with VFX were older ( 66.2 + /- 5.9 years vs. 68.8 + /- 6.3 years ; p < 0.001 ) , had higher prevalence of nonvertebral fractures ( 25 % vs. 36 % ; p = 0.002 ) , and higher QUALEFFO scores ( worse HRQOL ; total score , 26 + /- 14 vs. 36 + /- 17 ; p < 0.001 ) . QUALEFFO scores increased progressively with increasing number of VFX , especially lumbar fractures ( p < 0.001 ) . Patients with a single VFX already had a significant increase in QUALEFFO scores ( p < 0.05 ) . Similar , though weaker , associations were seen for NHP and EQ-5D scores . This study confirms decreased HRQOL for patients with prevalent VFX . In osteoporotic patients , QUALEFFO scores change in relation to the number of VFX . QUALEFFO is suitable for clinical studies in patients with postmenopausal osteoporosis OBJECTIVE To evaluate predictors of vertebral fractures , including a threshold for bone mineral density ( BMD ) , in patients receiving oral glucocorticoids ( GCs ) . METHODS Data were obtained from 2 r and omized clinical trials ( prevention and treatment trials of risedronate ) using similar methods , but different inclusion criteria were applied with regard to prior exposure to GCs . Predictors of vertebral fracture in the placebo group were identified using Cox regression with forward selection . The BMD threshold analysis involved a comparison of the 1-year fracture risk in postmenopausal women receiving placebo in the GC trials with that in postmenopausal women not taking GCs in 3 other trials . RESULTS The study population comprised 306 patients with baseline and 1-year followup data on vertebral fractures ( 111 receiving placebo and 195 receiving risedronate ) . In the placebo group , the statistically significant predictors of incident fracture were the baseline lumbar spine BMD ( for each 1-point decrease in T score , relative risk [ RR ] 1.85 , 95 % confidence interval [ 95 % CI ] 1.06 - 3.21 ) and the daily GC dose ( for each 10-mg dose increase , RR 1.62 , 95 % CI 1.11 - 2.36 ) . In the BMD threshold analysis , compared with nonusers of GCs , patients receiving GCs were younger , had a higher BMD at baseline , and had fewer prevalent fractures ; nevertheless , the risk of fracture was higher in the GC users compared with nonusers ( adjusted RR 5.67 , 95 % CI 2.57 - 12.54 ) . The increased risk of fracture was observed in GC users regardless of whether osteoporosis was present . CONCLUSION The daily , but not cumulative , GC dose was found to be a strong predictor of vertebral fracture in patients receiving GCs . At similar levels of BMD , postmenopausal women taking GCs , as compared with nonusers of GCs , had considerably higher risks of fracture |
345 | 30,964,558 | In the field , CPSS was more sensitive than MedPACS and LAPSS , but had similar sensitivity to that of MASS ; and MASS was more sensitive than LAPSS .
In the field , CPSS had consistently the highest sensitivity and , therefore , should be preferred to other scales .
In the ER , ROSIER should be the test of choice , as it was evaluated in more studies than FAST and showed consistently high sensitivity . | BACKGROUND Rapid and accurate detection of stroke by paramedics or other emergency clinicians at the time of first contact is crucial for timely initiation of appropriate treatment .
Several stroke recognition scales have been developed to support the initial triage .
However , their accuracy remains uncertain and there is no agreement which of the scales perform better .
OBJECTIVES To systematic ally identify and review the evidence pertaining to the test accuracy of vali date d stroke recognition scales , as used in a prehospital or emergency room ( ER ) setting to screen people suspected of having stroke . | BACKGROUND Improving access to thrombolytic therapy for patients with ischemic stroke is challenging . We assessed a prehospital process based on firemen rescuers under strict medical direction , aim ed at facilitating thrombolysis of eligible patients . METHODS This was a prospect i ve observational study conducted over 4 months in Paris , France . Prehospital patients with suspected stroke were included after telephone consultation with a physician . If the time since the onset of symptoms was less than 6 hours , patients were transported directly to a neurovascular unit ( NVU ) ; if symptom onset was more than 6 hours ago , they were transported to an emergency department ( ED ) . Confirmation of stroke diagnosis , the rate of thrombolysis , and the time intervals between the call and hospital arrival and imaging were assessed . Comparison used Fisher exact test . RESULTS Of the 271 patients transported to an NVU , 218 were diagnosed with a stroke ( 166 with ischemic stroke ) , 69 received thrombolytic therapy , and the mean stroke-thrombolysis interval was 150 minutes . Of 64 patients admitted to the ED , 36 patients had a stroke ( ischemic , 24 ) . None were thrombolysed . Globally , 36 % of ischemic strokes were thrombolysed ( 27 % of all strokes diagnosed ) . The mean interval call-hospital was 65 minutes ( ED vs NVU , P = .61 ) . The interval call-imaging was 202 minutes ( interquartile range , 105.5 - 254.5 ) for ED and 92 minutes ( interquartile range , 77 - 116 ) for NVU ( P < .001 ) . CONCLUSIONS The prehospital management of stroke by rescuers , under strict medical direction , seemed to be feasible and effective for selection of patients with stroke in an urban environment and may improve the access to thrombolysis Background Stroke recognition tools have been shown to improve diagnostic accuracy in adults . Development of a similar tool in children is needed to reduce lag time to diagnosis . A critical first step is to determine whether adult stoke scales can be applied in childhood stroke . Our objective was to assess the applicability of adult stroke scales in childhood arterial ischemic stroke ( AIS ) Methods Children aged 1 month to < 18 years with radiologically confirmed acute AIS who presented to a tertiary emergency department ( ED ) ( 2003 to 2008 ) were identified retrospectively . Signs , symptoms , risk factors and initial management were extracted . Two adult stroke recognition tools ; ROSIER ( Recognition of Stroke in the Emergency Room ) and FAST ( Face Arm Speech Test ) scales were applied retrospectively to all patients to determine test sensitivity . Results 47 children with AIS were identified . 34 had anterior , 12 had posterior and 1 child had anterior and posterior circulation infa rcts . Median age was 9 years and 51 % were male . Median time from symptom onset to ED presentation was 21 hours but one third of children presented within 6 hours . The most common presenting stroke symptoms were arm ( 63 % ) , face ( 62 % ) , leg weakness ( 57 % ) , speech disturbance ( 46 % ) and headache ( 46 % ) . The most common signs were arm ( 61 % ) , face ( 70 % ) or leg weakness ( 57 % ) and dysarthria ( 34 % ) . 36 ( 78 % ) of children had at least one positive variable on FAST and 38 ( 81 % ) had a positive score of ≥1 on the ROSIER scale . Positive scores were less likely in children with posterior circulation stroke . Conclusion The presenting features of pediatric stroke appear similar to adult strokes . Two adult stroke recognition tools have fair to good sensitivity in radiologically confirmed childhood AIS but require further development and modification . Specificity of the tools also needs to be determined in a prospect i ve cohort of children with stroke and non-stroke brain attacks Abstract We prospect ively verified whether an ad-hoc question naire administered by phone supports pre-hospital suspicion of stroke in the order to reduce the time before care is given . Form June 1996 to May 1997 , physicians of the Emergency Medical Service in the area of Bergamo , Italy asked all people calling for a patient with symptoms and signs suggesting a cerebral vascular injury to immediately answer some questions on common symptoms and signs of stroke . The medical records of the patients hospitalized at Ospedali Riuniti of Bergamo were review ed at the end of the study by a single neurologist , skilled in stroke management and blinded to the question naires . Sensitivity and specificity , in addition to positive and negative predictive values , of single questions versus final diagnosis were assessed . Logistic regression analysis was also performed to identify those questions useful to suspect strokes . We collected 143 valid question naires , related to 63 men and 80 women , aged 34–99 years ( mean , 71.8 years ) . The question concerning headache had the lowest sensitivity and specificity , respectively 57.1 % and 36.5 % , and teh question concerning leg palsy had the highest sensitivity and specificity , respectively 82.0 % and 52.4 % . Multivariate analysis identified questions on facial and leg palsy as independent predictors of a final diagnosis of stroke . A few questions on motor deficits proposed by emergency medical service operators may be useful in the pre-hospital identification of stroke patients . Concordance of any questions versus final diagnosis of stroke was , however , far to be satisfying . Thus , our experience supports the need for an educational program to improve the efficiency of a pre-hospital diagnosis of stroke IMPORTANCE R and omized clinical trials suggest the benefit of intravenous tissue-type plasminogen activator ( tPA ) in acute ischemic stroke is time dependent . However , modest sample sizes have limited characterization of the extent to which onset to treatment ( OTT ) time influences outcome ; and the generalizability of findings to clinical practice is uncertain . OBJECTIVE To evaluate the degree to which OTT time is associated with outcome among patients with acute ischemic stroke treated with intraveneous tPA . DESIGN , SETTING , AND PATIENTS Data were analyzed from 58,353 patients with acute ischemic stroke treated with tPA within 4.5 hours of symptom onset in 1395 hospitals participating in the Get With The Guidelines -Stroke Program , April 2003 to March 2012 . MAIN OUTCOMES AND MEASURES Relationship between OTT time and in-hospital mortality , symptomatic intracranial hemorrhage , ambulatory status at discharge , and discharge destination . RESULTS Among the 58,353 tPA-treated patients , median age was 72 years , 50.3 % were women , median OTT time was 144 minutes ( interquartile range , 115 - 170 ) , 9.3 % ( 5404 ) had OTT time of 0 to 90 minutes , 77.2 % ( 45,029 ) had OTT time of 91 to 180 minutes , and 13.6 % ( 7920 ) had OTT time of 181 to 270 minutes . Median pretreatment National Institutes of Health Stroke Scale documented in 87.7 % of patients was 11 ( interquartile range , 6 - 17 ) . Patient factors most strongly associated with shorter OTT included greater stroke severity ( odds ratio [ OR ] , 2.8 ; 95 % CI , 2.5 - 3.1 per 5-point increase ) , arrival by ambulance ( OR , 5.9 ; 95 % CI , 4.5 - 7.3 ) , and arrival during regular hours ( OR , 4.6 ; 95 % CI , 3.8 - 5.4 ) . Overall , there were 5142 ( 8.8 % ) in-hospital deaths , 2873 ( 4.9 % ) patients had intracranial hemorrhage , 19,491 ( 33.4 % ) patients achieved independent ambulation at hospital discharge , and 22,541 ( 38.6 % ) patients were discharged to home . Faster OTT , in 15-minute increments , was associated with reduced in-hospital mortality ( OR , 0.96 ; 95 % CI , 0.95 - 0.98 ; P < .001 ) , reduced symptomatic intracranial hemorrhage ( OR , 0.96 ; 95 % CI , 0.95 - 0.98 ; P < .001 ) , increased achievement of independent ambulation at discharge ( OR , 1.04 ; 95 % CI , 1.03 - 1.05 ; P < .001 ) , and increased discharge to home ( OR , 1.03 ; 95 % CI , 1.02 - 1.04 ; P < .001 ) . CONCLUSIONS AND RELEVANCE In a registry representing US clinical practice , earlier thrombolytic treatment was associated with reduced mortality and symptomatic intracranial hemorrhage , and higher rates of independent ambulation at discharge and discharge to home following acute ischemic stroke . These findings support intensive efforts to accelerate hospital presentation and thrombolytic treatment in patients with stroke Background Stroke is a major cause of death and leading cause of disability in the United States . To maximize a stroke patient 's chances of receiving thrombolytic treatment for acute ischemic stroke , it is important to improve prehospital recognition of stroke . However , it is known from published reports that emergency medical dispatchers ( EMDs ) using Card 28 of the Medical Priority Dispatch System protocol s recognize stroke poorly . Therefore , to improve EMD 's recognition of stroke , the National Association of Emergency Medical Dispatchers recently design ed a new diagnostic stroke tool ( Cincinnati Stroke Scale -CSS ) to be used with Card 28 . The objective of this study is to determine whether the addition of CSS improves diagnostic accuracy of stroke triage . Methods / Design This prospect i ve experimental study will be conducted during a one-year period in the 911 call center of Santa Clara County , CA . We will include callers aged ≥ 18 years with a chief complaint suggestive of stroke and second party callers ( by-st and er or family who are in close proximity to the patient and can administer the tool ) ≥ 18 years of age . Life threatening calls will be excluded from the study . Card 28 questions will be administered to subjects who meet study criteria . After completion of Card 28 , CSS tool will be administered to all calls . EMDs will record their initial assessment of a cerebro-vascular accident ( stroke ) after completion of Card 28 and their final assessment after completion of CSS . These assessment s will be compared with the hospital discharge diagnosis ( ICD-9 codes ) recorded in the Office of Statewide Health Planning and Development ( OSHPD ) data base after linking the EMD data base and OSHPD data base using probabilistic linkage . The primary analysis will compare the sensitivity of the two stroke protocol s using logistic regression and generalizing estimating equations to account for clustering by EMDs . To detect a 15 % difference in sensitivity between the two groups with 80 % power , we will enroll a total of 370 subjects in this trial . Discussion A three week pilot study was performed which demonstrated the feasibility of implementation of the study protocol Background s : Our aim was to confirm the utility of paramedics using the Kurashiki Prehospital Stroke Scale ( KPSS ) , with a maximum score of 13 , for patients who may be eligible for administration of intravenous tissue plasminogen activator ( IV t-PA ) . Methods : The subjects comprised acute stroke and transient ischemic attack ( TIA ) patients transferred to our hospital by paramedics . We analyzed correlations between KPSS and the National Institutes of Health Stroke Scale ( NIHSS ) . Patients admitted within 3 h of onset were categorized into 2 groups : KPSS ≧4 and KPSS < 4 . We compared the proportion of patients receiving IV t-PA between the groups . Results : Among 430 consecutive patients ( mean age = 73 years ; 266 men ) , paramedics recorded KPSS for 256 patients ( 59.5 % ) . Excellent correlation was observed between KPSS and NIHSS in all 256 patients ( R = 0.766 ; p < 0.001 ) and in 94 patients ( ischemic stroke and TIA with symptoms on admission ) admitted within 3 h of onset ( R = 0.706 ; p < 0.001 ) . Among these 94 patients , IV t-PA was more frequently given in the KPSS ≧4 group ( 30 of 58 patients , 51.7 % ) than in the KPSS < 4 group ( 5 of 36 patients , 13.9 % ; p < 0.001 ) . Arterial occlusion was more frequently observed in the KPSS ≧4 group ( 57.9 vs. 31.4 % , p = 0.018 ) . KPSS ≧4 was independently associated with administration of IV t-PA ( odds ratio = 4.7 ; 95 % confidence interval = 1.5–14.6 , p = 0.008 ) . Conclusion : Reliable concordance between KPSS and NIHSS was found in acute stroke and TIA patients . KPSS ≧4 represents a good score to indicate prospect i ve t-PA patients among those admitted within 3 h of stroke onset Background and Purpose — Recent innovations such as CT installation in ambulances may lead to earlier start of stroke-specific treatments . However , such technically complex mobile facilities require effective methods of correctly identifying patients before deployment . We aim ed to develop and vali date a new dispatcher identification algorithm for stroke emergencies . Methods — Dispatcher identification algorithm for stroke emergencies was informed by systematic qualitative analysis of the content of emergency calls to ambulance dispatchers for patients with stroke or transient ischemic attack ( N=117 ) and other neurological ( N=39 ) and nonneurological ( N=51 ) diseases ( Part A ) . After training of dispatchers , sensitivity and predictive values were determined prospect ively in patients admitted to Charité hospitals by using the discharge diagnosis as reference st and ard ( Part B ) . Results — Part A : Dysphasic/dysarthric symptoms ( 33 % ) , unilateral symptoms ( 22 % ) and explicitly stated suspicion of stroke ( 47 % ) were typically identified in patients with stroke but infrequently in nonstroke cases ( all < 10 % ) . Convulsive symptoms ( 41 % ) were frequent in other neurological diseases but not strokes ( 3 % ) . Pain ( 26 % ) and breathlessness ( 31 % ) were often expressed in nonneurological emergencies ( 6 % and 7 % in strokes ) . Part B : Between October 15 and December 16 , 2010 , 5774 patients were admitted by ambulance with 246 coded with final stroke diagnoses . Sensitivity of dispatcher identification algorithm for stroke emergencies for detecting stroke was 53.3 % and positive predictive value was 47.8 % for stroke and 59.1 % for stroke and transient ischemic attack . Of all 275 patients with stroke dispatcher codes , 215 ( 78.5 % ) were confirmed with neurological diagnosis . Conclusions — Using dispatcher identification algorithm for stroke emergencies , more than half of all patients with stroke admitted by ambulance were correctly identified by dispatchers . Most false-positive stroke codes had other neurological diagnoses Aim : To determine the utility of the Recognition of Stroke in the Emergency Room ( ROSIER ) scale as a stroke recognition tool among Chinese patients in the prehospital setting . Material s and Methods : Compared with the Cincinnati Prehospital Stroke Scale ( CPSS ) , emergency physicians prospect ively used the ROSIER as a stroke recognition tool on suspected patients in the prehospital setting . And , the final discharge diagnosis of stroke or transient ischemic attack made by neurologists , after assessment and review of clinical symptomatology and brain imaging findings , was used as the reference st and ard for diagnosis in the study . Then , the ROSIER and the CPSS like sensitivity ( Se ) , specificity ( Sp ) , positive predictive value ( PPV ) , negative predictive value ( NPV ) , related coefficient ( r ) and Kappa value were calculated . Results : In this study , 540 of 582 suspected stroke patients met the study criteria . The CPSS showed a diagnostic Se of 88.77 % ( 95 % confidence intervals [ CI ] 86.11–91.43 % ) , Sp of 68.79 % ( 95 % CI 64.88–72.70 % ) , PPV of 87.40 % ( 95 % CI 85.97–88.83 % ) , NPV of 71.52 % ( 95 % CI 67.71–75.33 % ) and r of 0.503 . Relatively , the ROSIER showed a diagnostic Se of 89.97 % ( 95 % CI 87.44–92.64 % ) , Sp of 83.23 % ( 95 % CI 80.08–86.38 % ) , PPV of 92.66 % ( 95 % CI 90.46–94.86 % ) , NPV of 77.91 % ( 95 % CI 74.41–81.41 % ) and r of 0.584 . According to the final discharge diagnosis , both the ROSIER and the CPSS were associated with the final discharge diagnosis ( P < 0.05).The Kappa statistic value of the ROSIER and the CPSS were 0.718 and 0.582 , respectively . However , there was no statistical significance of the positive rate between the ROSIER and the CPSS in this study ( P > 0.05 ) . Conclusions : The ROSIER is a sensitive and specific stroke recognition tool for health providers ’ use among Chinese patients in the prehospital setting . However , it can not be used to confidently rule out or identify stroke as a diagnosis . Comprehensive clinical assessment and further examination on potential stroke patients are still important and can not be replaced . When it is difficult to objective ly complete the ROSIER for patients , the CPSS could replace it in the prehospital setting Purpose The severity of a stroke can not be described by widely used prehospital stroke scales . We investigated the usefulness of the Kurashiki Prehospital Stroke Scale ( KPSS ) for assessing the severity of stroke , compared to the National Institutes of Health Stroke Scale ( NIHSS ) , in c and i date patients for intravenous or intra-arterial thrombolysis who arrived at the hospital within 6 hours of symptom onset . Material s and Methods We retrospectively analyzed a prospect i ve registry data base of consecutive patients included in the Emergency Stroke Therapy program . In the emergency department , the KPSS was assessed by emergency medical technicians . A cutoff KPSS score was estimated for c and i date s of thrombolysis by comparing KPSS and NIHSS scores , as well as for patients who actually received thrombolytic therapy . Clinical outcomes were compared between patients around the estimated cut-off . The independent predictors of outcomes were determined using multivariate logistic regression analysis . Results Excellent correlations were demonstrated between KPSS and NIHSS within 6 hours ( R=0.869 ) and 3 hours ( R=0.879 ) of hospital admission . The optimal threshold value was a score of 3 on the KPSS in patients within 3 hours and 6 hours by Youden 's methods . Significant associations with a KPSS score ≥3 were revealed for actual intravenous administration of tissue plasminogen activator ( IV-tPA ) usage [ odds ratio ( OR ) 125.598 ; 95 % confidence interval ( CI ) 16.443 - 959.368 , p<0.0001 ] and actual IV-tPA or intra-arterial urokinase ( IA-UK ) usage ( OR 58.733 ; 95 % CI 17.272 - 199.721 , p<0.0001 ) . Conclusion The KPSS is an effective prehospital stroke scale for identifying c and i date s for IV-tPA and IA-UK , as indicated by excellent correlation with the NIHSS , in the assessment of stroke severity in acute ischemic stroke Despite benefit in acute ischaemic stroke , less than 3 % of patients receive tissue plasminogen activator ( tPA ) in Australia . The FASTER ( Face , Arm , Speech , Time , Emergency Response ) protocol was constructed to reduce pre-hospital and Emergency Department ( ED ) delays and improve access to thrombolysis . This study aim ed to determine if introduction of the FASTER protocol increases use of tPA using a prospect i ve pre- and post-intervention cohort design in a metropolitan hospital . A pre-hospital assessment tool was used by ambulance services to screen potential tPA c and i date s. The acute stroke team was contacted , hospital bypass allowed , triage and CT radiology alerted , and the patient rapidly assessed on arrival to ED . Data were collected prospect ively during the first 6 months of the new pathway and compared to a 6-month period 12 months prior to protocol initiation . In the 6 months following protocol introduction , 115 patients presented within 24 hours of onset of an ischaemic stroke : 22 ( 19 % ) received thrombolysis , significantly greater than five ( 7 % ) of 67 patients over the control period , p=0.03 . Overall , 42 patients were referred via the FASTER pathway , with 21 of these receiving tPA ( 50 % ) . One inpatient stroke was also treated . Only two referrals ( < 5 % ) were stroke mimics . Introduction of the FASTER pathway also significantly reduced time to thrombolysis and time to admission to the stroke unit . Therefore , fast-track referral of potential tPA patients involving the ambulance services and streamlined hospital assessment is effective and efficient in improving patient access to thrombolysis We design ed a 15-item neurologic examination stroke scale for use in acute stroke therapy trials . In a study of 24 stroke patients , interrater reliability for the scale was found to be high ( mean kappa = 0.69 ) , and test-retest reliability was also high ( mean kappa = 0.66 - 0.77 ) . Test-retest reliability did not differ significantly among a neurologist , a neurology house officer , a neurology nurse , or an emergency department nurse . The stroke scale validity was assessed by comparing the scale scores obtained prospect ively on 65 acute stroke patients to the patients ' infa rct ion size as measured by computed tomography scan at 1 week and to the patients ' clinical outcome as determined at 3 months . These correlations ( scale-lesion size r = 0.68 , scale- outcome r = 0.79 ) suggested acceptable examination and scale validity . Of the 15 test items , the most interrater reliable item ( pupillary response ) had low validity . Less reliable items such as upper or lower extremity motor function were more valid . We discuss methods for improving the reliability and validity of brief examination scales to be used in stroke therapy trials Summary Background Thrombolysis is of net benefit in patients with acute ischaemic stroke , who are younger than 80 years of age and are treated within 4·5 h of onset . The third International Stroke Trial ( IST-3 ) sought to determine whether a wider range of patients might benefit up to 6 h from stroke onset . Methods In this international , multicentre , r and omised , open-treatment trial , patients were allocated to 0·9 mg/kg intravenous recombinant tissue plasminogen activator ( rt-PA ) or to control . The primary analysis was of the proportion of patients alive and independent , as defined by an Oxford H and icap Score ( OHS ) of 0–2 at 6 months . The study is registered , IS RCT N25765518 . Findings 3035 patients were enrolled by 156 hospitals in 12 countries . All of these patients were included in the analyses ( 1515 in the rt-PA group vs 1520 in the control group ) , of whom 1617 ( 53 % ) were older than 80 years of age . At 6 months , 554 ( 37 % ) patients in the rt-PA group versus 534 ( 35 % ) in the control group were alive and independent ( OHS 0–2 ; adjusted odds ratio [ OR ] 1·13 , 95 % CI 0·95–1·35 , p=0·181 ; a non-significant absolute increase of 14/1000 , 95 % CI −20 to 48 ) . An ordinal analysis showed a significant shift in OHS scores ; common OR 1·27 ( 95 % CI 1·10–1·47 , p=0·001 ) . Fatal or non-fatal symptomatic intracranial haemorrhage within 7 days occurred in 104 ( 7 % ) patients in the rt-PA group versus 16 ( 1 % ) in the control group ( adjusted OR 6·94 , 95 % CI 4·07–11·8 ; absolute excess 58/1000 , 95 % CI 44–72 ) . More deaths occurred within 7 days in the rt-PA group ( 163 [ 11 % ] ) than in the control group ( 107 [ 7 % ] , adjusted OR 1·60 , 95 % CI 1·22–2·08 , p=0·001 ; absolute increase 37/1000 , 95 % CI 17–57 ) , but between 7 days and 6 months there were fewer deaths in the rt-PA group than in the control group , so that by 6 months , similar numbers , in total , had died ( 408 [ 27 % ] in the rt-PA group vs 407 [ 27 % ] in the control group ) . Interpretation For the types of patient recruited in IST-3 , despite the early hazards , thrombolysis within 6 h improved functional outcome . Benefit did not seem to be diminished in elderly patients . Funding UK Medical Research Council , Health Foundation UK , Stroke Association UK , Research Council of Norway , Arbetsmarknadens Partners Forsakringsbolag ( AFA ) Insurances Sweden , Swedish Heart Lung Fund , The Foundation of Marianne and Marcus Wallenberg , Polish Ministry of Science and Education , the Australian Heart Foundation , Australian National Health and Medical Research Council ( NHMRC ) , Swiss National Research Foundation , Swiss Heart Foundation , Assessorato alla Sanita , Regione dell'Umbria , Italy , and Danube University BACKGROUND Intravenous thrombolysis with alteplase is the only approved treatment for acute ischemic stroke , but its efficacy and safety when administered more than 3 hours after the onset of symptoms have not been established . We tested the efficacy and safety of alteplase administered between 3 and 4.5 hours after the onset of a stroke . METHODS After exclusion of patients with a brain hemorrhage or major infa rct ion , as detected on a computed tomographic scan , we r and omly assigned patients with acute ischemic stroke in a 1:1 double-blind fashion to receive treatment with intravenous alteplase ( 0.9 mg per kilogram of body weight ) or placebo . The primary end point was disability at 90 days , dichotomized as a favorable outcome ( a score of 0 or 1 on the modified Rankin scale , which has a range of 0 to 6 , with 0 indicating no symptoms at all and 6 indicating death ) or an unfavorable outcome ( a score of 2 to 6 on the modified Rankin scale ) . The secondary end point was a global outcome analysis of four neurologic and disability scores combined . Safety end points included death , symptomatic intracranial hemorrhage , and other serious adverse events . RESULTS We enrolled a total of 821 patients in the study and r and omly assigned 418 to the alteplase group and 403 to the placebo group . The median time for the administration of alteplase was 3 hours 59 minutes . More patients had a favorable outcome with alteplase than with placebo ( 52.4 % vs. 45.2 % ; odds ratio , 1.34 ; 95 % confidence interval [ CI ] , 1.02 to 1.76 ; P=0.04 ) . In the global analysis , the outcome was also improved with alteplase as compared with placebo ( odds ratio , 1.28 ; 95 % CI , 1.00 to 1.65 ; P<0.05 ) . The incidence of intracranial hemorrhage was higher with alteplase than with placebo ( for any intracranial hemorrhage , 27.0 % vs. 17.6 % ; P=0.001 ; for symptomatic intracranial hemorrhage , 2.4 % vs. 0.2 % ; P=0.008 ) . Mortality did not differ significantly between the alteplase and placebo groups ( 7.7 % and 8.4 % , respectively ; P=0.68 ) . There was no significant difference in the rate of other serious adverse events . CONCLUSIONS As compared with placebo , intravenous alteplase administered between 3 and 4.5 hours after the onset of symptoms significantly improved clinical outcomes in patients with acute ischemic stroke ; alteplase was more frequently associated with symptomatic intracranial hemorrhage . ( Clinical Trials.gov number , NCT00153036 . Background and Purpose — We aim ed to develop and vali date a simple prehospital stroke scale to predict the presence of large vessel occlusion ( LVO ) in patients with acute stroke . Methods — The Rapid Arterial oCclusion Evaluation ( RACE ) scale was design ed based on the National Institutes of Health Stroke Scale ( NIHSS ) items with a higher predictive value of LVO on a retrospective cohort of 654 patients with acute ischemic stroke : facial palsy ( scored 0–2 ) , arm motor function ( 0–2 ) , leg motor function ( 0–2 ) , gaze ( 0–1 ) , and aphasia or agnosia ( 0–2 ) . Thereafter , the RACE scale was vali date d prospect ively in the field by trained medical emergency technicians in 357 consecutive patients transferred by Emergency Medical Services to our Comprehensive Stroke Center . Neurologists evaluated stroke severity at admission and LVO was diagnosed by transcranial duplex , computed tomography , or MR angiography . Receiver operating curve , sensitivity , specificity , and global accuracy of the RACE scale were analyzed to evaluate its predictive value for LVO . Results — In the prospect i ve cohort , the RACE scale showed a strong correlation with NIHSS ( r=0.76 ; P<0.001 ) . LVO was detected in 76 of 357 patients ( 21 % ) . Receiver operating curves showed a similar capacity to predict LVO of the RACE scale compared with the NIHSS ( area under the curve 0.82 and 0.85 , respectively ) . A RACE scale ≥5 had sensitivity 0.85 , specificity 0.68 , positive predictive value 0.42 , and negative predictive value 0.94 for detecting LVO . Conclusions — The RACE scale is a simple tool that can accurately assess stroke severity and identify patients with acute stroke with large artery occlusion at prehospital setting by medical emergency technicians STUDY OBJECTIVE We conduct a prospect i ve independent validation of the San Francisco Syncope Rule to identify emergency department ( ED ) syncope patients with short-term serious outcomes . METHODS This was a prospect i ve observational cohort study of adult patients presenting to a university hospital ED with acute syncope or near syncope . Patients meeting inclusion criteria as defined in the San Francisco Syncope Rule derivation were evaluated for 5 previously derived predictor variables : abnormal ECG result , shortness of breath , hematocrit level less than 30 % , triage systolic blood pressure less than 90 mm Hg , and history of congestive heart failure . Hospital admission occurred at the discretion of the emergency physician , independent of the decision rule . Follow-up occurred through contact with the inpatient attending physician for admitted patients and by telephone contact with patients not hospitalized or those hospitalized and discharged before day 7 . Predetermined outcome measures as defined by the San Francisco Syncope Rule were death , myocardial infa rct ion , arrhythmia , pulmonary embolism , stroke , subarachnoid hemorrhage , significant hemorrhage , or any condition causing or likely to cause a return ED visit and hospitalization for a related event . RESULTS Complete predictor and follow-up data were available for 713 of 743 ( 96 % ) enrolled patients . Sixty-one of 713 ( 9 % ) patients met predetermined criteria for serious outcome . Sixteen of 61 ( 26 % ; 95 % confidence interval [ CI ] 16 % to 39 % ) patients with a serious outcome were not identified as high risk by the rule . Rule performance to predict serious outcomes was sensitivity 74 % ( 95 % CI 61 % to 84 % ) , specificity 57 % ( 95 % CI 53 % to 61 % ) ; negative likelihood ratio 0.5 ( 95 % CI 0.3 to 0.7 ) and positive likelihood ratio 1.7 ( 95 % CI 1.4 to 2.0 ) . CONCLUSION In this independent validation study , sensitivity and negative likelihood ratio of the San Francisco Syncope Rule were substantially lower than reported in the original studies and suggest that the rule has limited generalizability OBJECTIVE To develop an abbreviated and practical neurologic scale that could assist emergency medical services or triage personnel in identifying patients with stroke . METHODS A prospect i ve , observational , cohort study was performed at university-based EDs . Participants were 74 patients treated in a thrombolytic stroke trial and 225 consecutive non-stroke patients evaluated during 4 r and om 12-hour shifts in the ED . Scores on the NIH Stroke Scale were obtained for all patients by physicians . Items of this scale were modified and recoded to a binomial ( normal or abnormal ) scale . Serial univariate analyses using chi 2 were performed to rank items . Recursive partitioning was then performed to develop the decision rule for predicting the presence of stroke . RESULTS Three items identified 100 % of patients with stroke : facial palsy , motor arm , and dysarthria . An Abbreviated NIH Stroke Scale based on these items had a sensitivity of 100 % and a specificity of 92 % . A proposed Out-of-hospital NIH Stroke Scale consisting of facial palsy , motor arm , and a combination of dysarthria and best language items ( abnormal speech ) had a sensitivity of 100 % and a specificity of 88 % . CONCLUSION Using the derivation data set , a proposed Out-of-hospital NIH Stroke Scale had a high sensitivity and specificity for identifying patients with stroke when performed by physicians in this group of 299 ED patients . Prospect i ve studies of other health care professionals using the scale in the out-of-hospital arena are needed Background and Purpose — Establishment of stroke centers , combined with accurate paramedic diagnosis and rapid transport , is essential to deliver acute stroke therapy . We wanted to measure and improve paramedic and hospital performance through implementation of the Brain Attack Coalition and American Stroke Association guidelines . Methods — Pre-intervention and active-intervention phases with parallel data measurement points were used . The study involved six hospitals comprising the majority of acute-stroke admissions in Houston , Tex . Hospital , paramedic , and patient data were collected prospect ively pre-intervention and during the active-intervention phase on all suspected acute-stroke patients admitted by Houston Fire Department-Emergency Medical Services . A multilevel educational intervention included paramedic , hospital , and community education . Paramedic diagnostic accuracy , hospital-performance efficiency , and thrombolytic treatment rates were the main outcome measures of the study . Results — Four hundred forty-six patients ( 74 per month ) were transported in the pre-intervention phase to participating hospitals ( 59.8 % of all suspected stroke patients transported city wide by Houston Fire Department — Emergency Medical Services ) , compared with 1072 patients ( 89 per month , or 68.7 % ) transported in the active-intervention phase ( P<0.001 ) . Accuracy of paramedic diagnosis of stroke increased from 61 % to 79 % . Admission within 2 hours of symptom onset increased from 58 % to 62 % ( P=0.002 ) . Thrombolysis rates increased in 4 of 6 centers , with 1 post- tissue plasminogen activator hemorrhage ( 3.7 % ) reported . Conclusions — A multilevel educational program improves rapid hospitalization and paramedic diagnostic accuracy and increases the number of patients presenting for evaluation within the 3-hour tissue plasminogen activator window . Stroke center development supports safe thrombolytic practice in community setting Background and Purpose — Emergency medical dispatchers play an important role in optimizing stroke care if they are able to accurately identify calls regarding acute cerebrovascular disease . This study was undertaken to assess the diagnostic accuracy of the current national protocol guiding dispatcher question ing of 911 callers to identify stroke ( QA Guide version 11.1 of the National Academy Medical Priority Dispatch System ) . Methods — We identified all Los Angeles Fire Department paramedic transports of patients to University of California Los Angeles Medical Center during the 12-month period from January to December 2005 in a prospect ively maintained data base . Dispatcher-assigned Medical Priority Dispatch System codes for each of these patient transports were abstract ed from the paramedic run sheets and compared to final hospital discharge diagnosis . Results — Among 3474 transported patients , 96 ( 2.8 % ) had a final diagnosis of stroke or transient ischemic attack . Dispatchers assigned a code of potential stroke to 44.8 % of patients with a final discharge diagnosis of stroke or TIA . Dispatcher identification of stroke showed a sensitivity of 0.41 , specificity of 0.96 , positive predictive value of 0.45 , and negative predictive value of 0.95 . Conclusions — Dispatcher recognition of stroke calls using the widely employed Medical Priority Dispatch System algorithm is suboptimal , with failure to identify more than half of stroke patients as likely stroke . Revisions to the current national dispatcher structured interview and symptom identification algorithm for stroke may facilitate more accurate recognition of stroke by emergency medical dispatchers Background and Purpose The objective of this study was to determine the performance of the Recognition Of Stroke In the Emergency Room ( ROSIER ) scale in risk-stratifying Chinese patients with suspected stroke in Hong Kong . Methods This was a prospect i ve cohort study in an urban academic emergency department ( ED ) over a 7-month period . Patients over 18 years of age with suspected stroke were recruited between June 2011 and December 2011 . ROSIER scale assessment was performed in the ED triage area . Logistic regression analysis was used to estimate the impacts of diagnostic variables , including ROSIER scale , past history and ED characteristics . Findings 715 suspected stroke patients were recruited for assessment , of whom 371 ( 52 % ) had acute cerebrovascular disease ( 302 ischaemic strokes , 24 transient ischaemic attacks ( TIA ) , 45 intracerebral haemorrhages ) , and 344 ( 48 % ) had other illnesses i.e. stroke mimics . Common stroke mimics were spinal neuropathy , dementia , labyrinthitis and sepsis . The suggested cut-off score of>0 for the ROSIER scale for stroke diagnosis gave a sensitivity of 87 % ( 95%CI 83–90 ) , a specificity of 41 % ( 95%CI 36–47 ) , a positive predictive value of 62 % ( 95%CI 57–66 ) , and a negative predictive value of 75 % ( 95%CI 68–81 ) , and the AUC was 0.723 . The overall accuracy at cut off>0 was 65 % i.e. (323 + 141)/715 . Interpretation The ROSIER scale was not as effective at differentiating acute stroke from stroke mimics in Chinese patients in Hong Kong as it was in the original studies , primarily due to a much lower specificity . If the ROSIER scale is to be clinical ly useful in Chinese suspected stroke patients , it requires further refinement BACKGROUND AND PURPOSE Reliable identification of stroke patients in the field by prehospital personnel could expedite delivery of acute stroke therapy . The Los Angeles Prehospital Stroke Screen ( LAPSS ) is a 1-page instrument design ed to allow prehospital personnel to rapidly identify acute stroke patients in the field . We performed a prospect i ve , in-the-field validation study of the LAPSS . METHODS Paramedics assigned to 3 University of California at Los Angeles-based advanced life support units were trained and certified in use of the LAPSS . Over 7 months , paramedics completed the LAPSS on noncomatose , nontrauma patients with complaints suggestive of neurological disease . LAPSS form stroke identification results were compared with emergency department and final hospital discharge diagnoses . Sensitivity , specificity , positive predictive value , negative predictive value , accuracy , and likelihood ratios were calculated for LAPSS identification of ischemic stroke , currently symptomatic transient ischemic attack , and intracerebral hemorrhage . RESULTS Of a total of 1298 runs , 34 % were for nontraumatic , noncomatose neurologically relevant complaints . Thirty-six of these patients ( 3 % of all transports ) had a final diagnosis of acute symptomatic cerebrovascular disease ( 21 ischemic strokes , 7 transient ischemic attacks , and 8 intracerebral hemorrhages ) . LAPSS forms were completed on 206 patients . Paramedic performance when completing the LAPSS demonstrated sensitivity of 91 % ( 95 % CI , 76 % to 98 % ) , specificity of 97 % ( 95 % CI , 93 % to 99 % ) , positive predictive value of 86 % ( 95 % CI , 70 % to 95 % ) , and negative predictive value of 98 % ( 95 % CI , 95 % to 99 % ) . With correction for the 4 documentation errors , positive predictive value increased to 97 % ( 95 % CI , 84 % to 99 % ) . CONCLUSIONS The LAPSS allows prehospital personnel to identify patients with acute cerebral ischemia and intracerebral hemorrhage with a high degree of sensitivity and specificity Background and Purpose — Previous studies have shown poor public knowledge of stroke warning signs . The current public education message adopted by the American Heart Association lists 5 stroke warning signs ( “ suddens ” ) . Another message called FAST ( face , arm , speech , time ) could be easier to remember , but it does not contain as many stroke symptoms . We sought to assess the percentage of stroke/transient ischemic attack ( TIA ) patients identified by both public awareness messages by examining presenting symptoms of all stroke/TIA patients from a large , biracial population in 1999 . Methods — Cases of stroke who presented to an emergency department or were directly admitted were ascertained at all local hospitals by screening of ICD-9 codes 430 to 436 , and prospect i ve screening of emergency department admission logs , in 1999 . Study nurses abstract ed initial presenting symptoms from the medical record . All-cause 30-day case-fatality was calculated . Results — During 1999 , 3498 stroke/TIA patients ( 17 % black , 56 % female ) presented to an emergency department . Of these events , 11.1 % had presenting symptoms not included in FAST , whereas 0.1 % had presenting symptoms not included in the suddens . The FAST message performed much better for ischemic stroke and TIA than for hemorrhage , missing 8.9 % of the ischemic strokes and 8.2 % of the TIAs , versus 30.6 % of intracerebral hemorrhage/subarachnoid hemorrhage cases . Case-fatality in patients missed by FAST was similar to patients with FAST symptoms ( 9.0 % versus 11.6 % , P=0.15 ) . Conclusions — Within our population , we found that the FAST message identified 88.9 % of stroke/TIA patients . The FAST message performed better for ischemic stroke and TIA than for hemorrhagic stroke . Whether the FAST message is easier to recall for the public than the “ suddens ” message has yet to be determined Background The National Institute of Neurological Disorders and Stroke ( NINDS ) rt-PA Stroke Study showed a similar percentage of intracranial hemorrhage and good outcome in patients 3 months after stroke treatment given 0 to 90 minutes and 91 to 180 minutes after stroke onset . At 24 hours after stroke onset more patients treated 0 to 90 compared to 91 to 180 minutes after stroke onset had improved by four or more points on the NIH Stroke Scale ( NIHSS ) . The authors performed further analyses to characterize the relationship of onset-to-treatment time ( OTT ) to outcome at 3 months , early improvement at 24 hours , and intracranial hemorrhage within 36 hours . Methods Univariate analyses identified potentially confounding variables associated with OTT that could mask an OTT – treatment interaction . Tests for OTT – treatment interactions adjusting for potential masking confounders were performed . An OTT – treatment interaction was considered significant if p ≤ 0.10 , implying that treatment effectiveness was related to OTT . Results For 24-hour improvement , there were no masking confounders identified and there was an OTT – treatment interaction ( p = 0.08 ) . For 3-month favorable outcome , the NIHSS met criteria for a masking confounder . After adjusting for NIHSS as a covariate , an OTT – treatment interaction was detected ( p = 0.09 ) : the adjusted OR ( 95 % CI ) for a favorable 3-month outcome associated with recombinant tissue-type plasminogen activator ( rt-PA ) was 2.11 ( 1.33 to 3.35 ) in the 0 to 90 minute stratum and 1.69 ( 1.09 to 2.62 ) in the 91 to 180 minute stratum . In the group treated with rt-PA , after adjusting for baseline NIHSS , an effect of OTT on the occurrence of intracranial hemorrhage was not detected . Conclusions If the NINDS rt-PA Stroke Trial treatment protocol is followed , this analysis suggests that patients treated 0 to 90 minutes from stroke onset with rt-PA have an increased odds of improvement at 24 hours and favorable 3-month outcome compared to patients treated later than 90 minutes . No effect of OTT on intracranial hemorrhage was detected within the group treated with rt-PA , possibly due to low power Background : The emergency medical service is design ed to recognize and transfer critically ill patients . Evidence -based practice has rarely been emphasized in the emergency medical service field , especially in the dispatch center . Aims : To identify the effect of the Cincinnati Prehospital Stroke Scale ( CPSS ) on telephone triage of stroke patients by telephone triage nurses at the emergency medical dispatch center and to compare CPSS with the National Guidelines for Telephone Triage Tool ( NGTT ) . Methods : A quasi-empirical study was conducted from June 2013 to June 2014 . The setting of the study was the Mashhad dispatch center of the EMS . Two hundred and forty-six patients were r and omly allocated to the CPSS intervention group ( n = 121 ) and the NGTT control group ( n = 125 ) . True triage , triage error and odds ratio were statistically reported . Results : The mean age of the patients was 70.9 ± 12.7 years . Of all the cases , 77.7 and 65.6 % of patients in the intervention and the control groups , respectively , were accurately triaged . Under-triage cases were 10.7 and 13.6 % of the patients in the intervention and the control groups . Odds ratio was 1.14 ( 95 % confidence interval 0.62–2.07 ) for the CPSS compared with the NGTT . Conclusion : CPSS is more efficient for use by telephone triage nurses in identifying stroke . The use of CPSS assists nurses by reducing the triage error and supports the evidence -based care . It needs to be developed to cover signs and symptoms of posterior-circulation stroke patients OBJECTIVE Early stroke recognition optimizes patients ' opportunities to benefit from therapeutic options . Prehospital stroke recognition is suboptimal . If 9 - 1 - 1 dispatchers used stroke- identification tools , prehospital stroke recognition might occur more rapidly and accurately . The Cincinnati Prehospital Stroke Scale ( CPSS ) is a brief , effective tool used by emergency medical services and hospital personnel to identify stroke . The study 's goal was to determine whether laypersons could be instructed to use the CPSS over the telephone . METHODS Adult visitors ( laypersons ) to a tertiary care emergency department were enrolled . Using a mock patient , laypersons were instructed to use the CPSS via telephone by an investigator simulating a 9 - 1 - 1 dispatcher . The patient r and omly portrayed clinical ly normal and abnormal patient types . The layperson 's ability to convey CPSS instructions to the patient and relay findings to the investigator was scored . RESULTS Seventy laypersons were enrolled ( 35 each for normal and abnormal patient types ) . Average age was 48 years , 63 % were female , and 40 % never attended college . Facial droop and speech instructions were administered with 100 % accuracy . Arm drift instructions were administered with 99 % accuracy . Layperson accuracies for interpreting findings were 93 % for facial droop , 93 % for arm drift , and 97 % for speech . Overall , stroke symptoms were detected with 94 % sensitivity ( 95 % CI 87 , 100 ) and 83 % specificity ( 95 % CI 70 , 95 ) . CONCLUSION Laypersons correctly administered and interpreted the CPSS when directed to do so over the telephone by a trained investigator . These findings suggest that the CPSS may be a useful tool in early prehospital detection of stroke by dispatchers Background and Purpose — The Cincinnati Prehospital Stroke Scale ( CPSS ) is recommended for emergency medical services use in identifying patients with stroke . Data evaluating its performance in the field are limited . We assessed the impact of training and use of the CPSS on the accuracy of paramedics ’ stroke patient identification and on-scene time . Methods — A 1-hour interactive educational presentation on the use of the CPSS was conducted for paramedics transporting patients to an academic medical center . Patients with stroke/transient ischemic attack ( TIA ) were identified retrospectively from paramedic records and were compared with the hospital ’s prospect i ve stroke registry for the year before and after the training . Results — There were 154 patients with suspected stroke/transient ischemic attack identified ( 56 % women , 53 % white , 44 % black , mean age 67±16 years ) . There was no difference in paramedics ’ use of the CPSS ( 37.5 % versus 23.8 % , P=0.123 ) or accuracy of stroke/TIA patient identification ( 40.5 % versus 38.9 % , P=0.859 ) before and after training . Of responsive patients identified by paramedics as having a stroke/TIA , 57 % had an abnormality in at least one CPSS item with no effect on on-scene time ( 17±6 minutes with a normal versus 18±6 minutes with an abnormal CPSS , P=0.492 ) . Those with a final diagnosis of stroke/TIA ( n=61 , 40 % ) more frequently had at least one abnormal CPSS item ( 70 % versus 30 % , P=0.008 , sensitivity 0.71 , specificity 0.52 ) with 49 % of patients with an abnormality having a discharge diagnosis of stroke/TIA . Conclusions — Paramedic training in the CPSS , or its use , had no impact on the accuracy of their identification of patients with stroke/TIA or on-scene time BACKGROUND There is much uncertainty about the effects of early lowering of elevated blood pressure ( BP ) after acute intracerebral haemorrhage ( ICH ) . Our aim was to assess the safety and efficiency of this treatment , as a run-in phase to a larger trial . METHODS Patients who had acute spontaneous ICH diagnosed by CT within 6 h of onset , elevated systolic BP ( 150 - 220 mm Hg ) , and no definite indication or contraindication to treatment were r and omly assigned to early intensive lowering of BP ( target systolic BP 140 mm Hg ; n=203 ) or st and ard guideline -based management of BP ( target systolic BP 180 mm Hg ; n=201 ) . The primary efficacy endpoint was proportional change in haematoma volume at 24 h ; secondary efficacy outcomes included other measurements of haematoma volume . Safety and clinical outcomes were assessed for up to 90 days . Analysis was by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00226096 . FINDINGS Baseline characteristics of patients were similar between groups , but mean haematoma volumes were smaller in the guideline group ( 12.7 mL , SD 11.6 ) than in the intensive group ( 14.2 mL , SD 14.5 ) . From r and omisation to 1 h , mean systolic BP was 153 mm Hg in the intensive group and 167 mm Hg in the guideline group ( difference 13.3 mm Hg , 95 % CI 8.9 - 17.6 mm Hg ; p<0.0001 ) ; from 1 h to 24 h , BP was 146 mm Hg in the intensive group and 157 mm Hg in the guideline group ( 10.8 mm Hg , 95 % CI 7.7 - 13.9 mm Hg ; p<0.0001 ) . Mean proportional haematoma growth was 36.3 % in the guideline group and 13.7 % in the intensive group ( difference 22.6 % , 95 % CI 0.6 - 44.5 % ; p=0.04 ) at 24 h. After adjustment for initial haematoma volume and time from onset to CT , median haematoma growth differed between the groups with p=0.06 ; the absolute difference in volume between groups was 1.7 mL ( 95 % CI -0.5 to 3.9 , p=0.13 ) . Relative risk of haematoma growth > or=33 % or > or=12.5 mL was 36 % lower ( 95 % CI 0 - 59 % , p=0.05 ) in the intensive group than in the guideline group . The absolute risk reduction was 8 % ( 95 % CI -1.0 to 17 % , p=0.05 ) . Intensive BP-lowering treatment did not alter the risks of adverse events or secondary clinical outcomes at 90 days . INTERPRETATION Early intensive BP-lowering treatment is clinical ly feasible , well tolerated , and seems to reduce haematoma growth in ICH . A large r and omised trial is needed to define the effects on clinical outcomes across a broad range of patients with ICH . FUNDING National Health and Medical Research Council of Australia BACKGROUND Despite the usefulness of the Cincinnati Prehospital Stroke Scale ( CPSS ) for rapid recognition of acute stroke , its ability to assess stroke severity is unclear . We investigated the usefulness of CPSS for assessment of stroke severity by comparing CPSS and National Institutes of Health Stroke Scale ( NIHSS ) scores in patients who were c and i date s for thrombolytic therapy at hospital admission within 6 hours of symptom onset . METHODS We conducted a retrospective analysis of a prospect i ve registry data base of consecutive patients included in the brain salvage through emergency stroke therapy program . In the emergency department , CPSS score was determined by emergency medical technicians . A CPSS cut-off score was estimated for c and i date s of thrombolytic therapy by comparing CPSS and NIHSS scores of patients who actually received thrombolytic therapy . Clinical outcomes were compared among patients with scores near the cut-off . Independent predictors of outcome were evaluated by multivariate logistic regression analysis . RESULTS Strong correlations were observed between CPSS and NIHSS scores within 3 hours ( R = 0.778 ) and 6 hours ( R = 0.769 ) of symptom onset . The optimal cut-off score was 2 for CPSS was associated with actual usage of intravenous tissue plasminogen activator ( odds ratio [ OR ] 34.455 ; 95 % confidence interval [ CI ] 7.924 - 149.817 , P < .0001 ) and actual usage of thrombolytic therapy overall ( intravenous tissue plasminogen activator or intra-arterial urokinase ) ( OR 36.310 ; 95 % CI 10.826 - 121.782 , P < .0001 ) . CONCLUSION The CPSS is an effective prehospital stroke scale for the determination of stroke severity and identification of c and i date s for thrombolytic therapy OBJECTIVE The authors have previously shown that San Francisco paramedics without specific training in stroke recognition identified acute stroke victims with a 61 % sensitivity and a 77 % positive predictive value ( PPV ) . The authors implemented an educational program on stroke to improve paramedic accuracy in stroke recognition . METHODS Twenty-two paramedics volunteered to attend a four-hour seminar about stroke and then were followed prospect ively for six months . All encounters with adult patients who were evaluated by both trained and untrained paramedics and were transported to two university hospitals were review ed . Subjects were identified by paramedic assessment as stroke/transient ischemic attack ( TIA ) and /or final hospital discharge diagnosis of stroke/TIA after detailed chart review . Sensitivity and PPV for paramedic identification of stroke were calculated . RESULTS During the prospect i ve six-month phase , 84 confirmed stroke patients were transported to the target hospitals . Of the 32 who were transported by trained paramedics , all but three were identified as having stroke/TIA , result ing in a sensitivity of 91 % . This is significantly higher than the 61 % previously found ( p=0.01 ) . Nontrained paramedics also increased their sensitivity to 90 % . Thirty-eight false-positive patients were identified , result ing in PPVs of 64 % for trained paramedics and 69 % for all other paramedics . CONCLUSIONS Institution of an educational stroke program was associated with a significant increase in sensitivity in stroke identification by the paramedics ; however , educational influences outside this training program may have contributed to the increased sensitivity . Better education for paramedics , combined with rapid response to stroke victims once identified , may result in improved care for victims of acute stroke The st and ard of care for acute thromboembolic stroke is changing rapidly with the advent of new pharmacologic therapies . The deterioration of focal cerebral ischemia to infa rct ion can be lessened with timely restoration of cerebral blood flow . As pharmacologic therapy of acute stroke evolves , emergency physicians will increasingly facilitate its implementation . The purpose of this study was to eluci date those factors significantly affecting the acute stroke patient 's emergency department ( ED ) evaluation time . The pretreatment ED evaluations of 20 patients entered in an ongoing trial of a fibrinolytic agent ( ancrod ) for acute ischemic stroke were review ed . Pretreatment screening factors included the assessment of hematologic status , concurrent illness , and potential neoplastic disease or cerebral hemorrhage as the etiology for the neurological deficit . The following factors had a statistically significant effect on pretreatment evaluation time ( range , 2.6 to 11.4 hours ) by multiple linear regression analysis : time from arrival until bleeding time completed ( P less than .005 ) , time from arrangement of computed head tomography until its completion ( P less than .05 ) , chosen site of treatment ( ED v neurological step-down unit ; P less than .005 ) , order of patient entry ( P less than .01 ) , and time from arrival until completion of fibrinogen level assay ( P less than .05 ) . These results emphasize the need to coordinate and streamline the clinical evaluation process . The use of the ED as the site of treatment , abbreviating the time until pharmacologic therapy , has not been previously documented . Expedient completion of an evaluation compatible with safe pharmacologic therapy of acute ischemic stroke will dictate the time of definitive therapy . These results should assist other institutions considering rapid pharmacologic therapy for acute ischemic stroke Rationale Access to intravenous thrombolysis for acute ischaemic stroke is limited worldwide , particularly in regional and rural areas including in Australia . We are testing the effectiveness of a new rural Prehospital Acute Stroke Triage protocol that includes prehospital assessment and rapid transport of patients from a rural catchment to the major stroke centre in Newcastle , NSW , Australia . The local district hospitals within the rural catchment do not have the capability or infrastructure to deliver acute stroke thrombolysis . The trial has relevance to stroke clinicians , health service managers and planners responsible for rural population s. Aims To implement a system of rapid prehospital assessment and facilitated transport that will significantly increase stroke thrombolysis rates to 10 % of ischaemic stroke cases in the rural catchment . Vali date an eight-point modified National Institutes of Health Stroke Scale for use by paramedics in the prehospital setting to assess patients ' potential eligibility for stroke thrombolysis . Design The joint project between the John Hunter Hospital Acute Stroke Team and the Ambulance Service of NSW will use a prospect i ve cohort with an historical control group . Tools and protocol s have been developed and education undertaken for ambulance field and operations centre personnel . These include a cut-down eight-item National Institutes of Health Stroke Scale ( Hunter NIHSS-8 ) score to be used in the field by paramedics and a transport decision matrix to expedite transport for a suspected stroke patient ( road or road plus air transport ) . Outcomes The primary outcome measure will be the rate of intravenous tissue plasminogen activator delivery for those who suffer an ischaemic stroke following protocol implementation , in comparison with historical rates over a corresponding period prior to implementation , for residents within the catchment . Sixty cases are required in the postimplementation time epoch to demonstrate a statistically significant absolute increase in thrombolysis rates for ischaemic strokes from < 1 % to 10 % , ( power of 80 % , α error of 0.05 ) . The major secondary outcome will be inter-rater reliability of the Hunter NIHSS-8 Objective To compare the diagnostic value of the Cincinnati Prehospital Stroke Scale , the Face Arm Speech Test , the Los Angeles Prehospital Stroke Screen and the Melbourne Ambulance Stroke Screen for identifying patients with an acute stroke in a prehospital setting in Belgium . Methods A prospect i ve study was performed , using a question naire for every primarily transported patient within emergency medial service with relevant neurological complaints . Exclusion criteria were : patients below 18 years , trauma victims , Glasgow Coma Scale of less than 8 or transported to another hospital . The question naire is a comprehension of different stroke scales . Results The Face Arm Speech Test and Cincinnati Prehospital Stroke Scale demonstrate a high sensitivity ( 95 % ) but a lower specificity ( 33 % ) . The sensitivity of the Los Angeles Prehospital Stroke Screen and Melbourne Ambulance Stroke Screen was lower ( 74 % ) , but the specificity increased ( 83 and 67 % ) . Items investigating unilateral facial paralysis and unilateral loss/absence of motor response in upper extremities seemed to be most discriminating between the stroke group ( 68–78 % ) and the nonstroke group ( 17 % ) , suggesting that items related to clinical assessment are more important in stroke recognition than history items . Combination of all clinical parameters of the different scores result ed in a sensitivity and specificity of 95 and 83 % , respectively . Conclusion The results obtained in this study are comparable with earlier investigations . Given the limitations of the study , we could not identify the most adequate stroke scale . History items seem to be less relevant compared with clinical assessment . Further research is needed to determine the most adequate stroke scale OBJECTIVES The therapeutic window for intervention in acute cerebral ischemia is brief . Prehospital identification of acute stroke patients and paramedic administration of neuroprotective agents may soon become critical components of successful acute stroke treatment . This preliminary study sought to demonstrate that a new prehospital screening instrument , the Los Angeles Prehospital Stroke Screen ( LAPSS ) , sensitively identifies acute stroke patients . Further , the study evaluated the potential time savings that could be achieved by paramedic administration of neuroprotective agents in the field . METHODS The authors design ed a simple stroke screening tool for use by prehospital personnel , emphasizing motor deficits . They then tested instrument performance and time savings retrospectively , employing data from patients enrolled within six hours of symptom onset in r and omized stroke trials at three university-associated paramedic receiving hospitals . RESULTS Fifty of 83 patients enrolled in hyperacute stroke trials arrived by ambulance , including 41 with ischemic infa rcts and seven with hemorrhages . Of the 41 with acute ischemic stroke , 38 ( 93 % ) would have been accurately identified by the LAPSS . For these 38 patients , 1 hour and 50 minutes would have been saved had neuroprotective drug been administered by paramedics at the time of transport vs the actual time of study agent administration in the emergency department . CONCLUSIONS The LAPSS sensitively identifies ambulance-arriving acute stroke patients , and a substantial time savings will potentially occur if neuroprotective agents are administered by paramedics in the field . The LAPSS is a promising tool that may enable paramedic recognition of stroke with a high degree of sensitivity and simplicity in a short period of time Background : Paramedics require an effective prehospital tool to eliminate stroke mimics and to assist in the identification of suitable c and i date s for thrombolytic therapy . The Faster Access to Stroke Therapies study combined two vali date d stroke assessment tools ( the Los Angeles Prehospital Stroke Screen , LAPSS , and the Cincinnati Prehospital Stroke Scale , CPSS ) to form the Melbourne Ambulance Stroke Screen ( MASS ) , and performed an in-field validation by Australian paramedics . Methods : Over a 12-month period , 18 paramedics participated in the Faster Access to Stroke Therapies study and prospect ively collected data contained in the MASS on all stroke dispatches , and for other patients with a focal neurological deficit . Sensitivity and specificity analysis of the LAPSS , CPSS and MASS was calculated and equivalence analysis performed . Results : Paramedics completed 100 MASS assessment s for 73 ( 73 % ) stroke/transient ischemic attack patients and 27 ( 27 % ) stroke mimics . The sensitivity of the MASS ( 90 % , 95 % CI : 81–96 % ) showed statistical equivalence to the sensitivity of the CPSS ( 95 % , p = 0.45 ) and superiority to the LAPSS ( 78 % , p = 0.008 ) . The specificity of the MASS ( 74 % , 95 % CI : 53–88 % ) was equivalent to that of the LAPSS ( 85 % , p = 0.25 ) and superior to the CPSS ( 54 % , p = 0.007 ) . All patients misidentified by the MASS ( 7 strokes , 7 mimics ) were ineligible for thrombolytic therapy . Conclusion : The MASS is simple to use , with accurate prehospital identification of stroke . It distinguishes stroke mimics , with good recognition of suitable patients for thrombolytic therapy Background and Purpose — Acute blood pressure ( BP ) reduction aim ed at attenuation of intracerebral hemorrhage ( ICH ) expansion might also compromise cerebral blood flow ( CBF ) . We tested the hypothesis that CBF in acute ICH patients is unaffected by BP reduction . Methods — Patients with spontaneous ICH < 24 hours after onset and systolic BP > 150 mm Hg were r and omly assigned to an intravenous antihypertensive treatment protocol targeting a systolic BP of < 150 mm Hg ( n=39 ) or < 180 mm Hg ( n=36 ) . Patients underwent computed tomography perfusion imaging 2 hours postr and omization . The primary end point was perihematoma relative ( relative CBF ) . Results — Treatment groups were balanced with respect to baseline systolic BP : 182±20 mm Hg ( < 150 mm Hg target group ) versus 184±25 mm Hg ( < 180 mm Hg target group ; P=0.60 ) , and for hematoma volume : 25.6±30.8 versus 26.9±25.2 mL ( P=0.66 ) . Mean systolic BP 2 hours after r and omization was significantly lower in the < 150 mm Hg target group ( 140±19 vs 162±12 mm Hg ; P<0.001 ) . Perihematoma CBF ( 38.7±11.9 mL/100 g per minute ) was lower than in contralateral homologous regions ( 44.1±11.1 mL/100 g per minute ; P<0.001 ) in all patients . The primary end point of perihematoma relative CBF in the < 150 mm Hg target group ( 0.86±0.12 ) was not significantly lower than that in the < 180 mm Hg group ( 0.89±0.09 ; P=0.19 ; absolute difference , 0.03 ; 95 % confidence interval −0.018 to 0.078 ) . There was no relationship between the magnitude of BP change and perihematoma relative CBF in the < 150 mm Hg ( R=0.00005 ; 95 % confidence interval , −0.001 to 0.001 ) or < 180 mm Hg target groups ( R=0.000 ; 95 % confidence interval , −0.001 to 0.001 ) . Conclusions — Rapid BP lowering after a moderate volume of ICH does not reduce perihematoma CBF . These physiological data indicate that acute BP reduction does not precipitate cerebral ischemia in ICH patients . Clinical Trial Registration Information— URL : http:// clinical trials.gov . Unique Identifier : NCT00963976 |
346 | 18,646,166 | There is a need for high quality r and omised controlled trials to determine the effectiveness of psychosocial interventions in pregnant women enrolled in alcohol treatment programs | BACKGROUND Excessive alcohol use during pregnancy has been associated with adverse maternal and neonatal effects .
It is therefore important to develop and evaluate effective interventions during this important time in a woman 's life .
To our knowledge there have been no systematic review s of r and omised control trials ( RCT ) in this population .
OBJECTIVES To evaluate the effectiveness of psychosocial interventions in pregnant women enrolled in alcohol treatment programs for improving birth and neonatal outcomes , maternal abstinence and treatment retention . | OBJECTIVE : To test the effectiveness of a brief intervention in the reduction of prenatal alcohol consumption by women when a partner is included . METHODS : R and omized trial of a single session brief intervention given by the study nurse or principal investigator for 304 pregnant women and their partners . The women had positive T-ACE ( Tolerance , Annoyed , Cut down , Eye-opener , an alcohol screening test ) results and were at risk for alcohol consumption while pregnant . All completed initial diagnostic and postpartum interviews . RESULTS : Fewer than 20 % of participants ( median 11.5 weeks of gestation ) were abstinent at study enrollment , averaging more than 1.5 drinks per episode . Nearly 30 % had 2 or more drinks at a time while pregnant . Prenatal alcohol use declined in both the treatment and control groups after study enrollment , based on a 95 % follow-up rate . Factors associated with increased prenatal alcohol use after r and omization included more years of education , extent of previous alcohol consumption , and temptation to drink in social situations . Brief interventions for prenatal alcohol reduced subsequent consumption most significantly for the women with the highest consumption initially ( regression coefficient , b = −0.163 , st and ard error ( b ) = 0.063 , P < .01 ) . Moreover , the effects of the brief intervention were significantly enhanced when a partner participated ( b = −0.932 , st and ard error ( b ) = 0.468 ) , P < .05 ) . CONCLUSION : Pregnant women with the highest levels of alcohol use reduced their drinking most after a brief intervention that included their partners . Recommendations include consistent screening for prenatal alcohol use followed by diagnostic assessment when indicated , and if confirmed by other studies , a patient-partner brief intervention for the heaviest drinkers . LEVEL OF EVIDENCE : OBJECTIVE To identify perinatal factors that are predictive of disruption in primary caregiving among infants of substance abusing women . METHOD A r and omized longitudinal cohort study . One hundred and fifty two mother/infant dyads were assessed for evidence of disruption of primary caregiving or neglect during the first 18 months of life , defined by mother 's inability to provide care . Data analyzed included neonatal characteristics , urine toxicology at delivery , maternal history of drug use , maternal depression , social support , and social and health history . RESULTS Sixty-six infants ( 43.4 % ) had disruption in their primary care during the first 18 months of their life , 86 infants ( 56.6 % ) remained in the care of their mothers . Women who were younger , were heroin users , had two or more children , had other children in foster care , and reported depressive symptoms were least likely to provide ongoing primary care for their infant . CONCLUSIONS Although all infants born to substance abusing women are at a high risk for disruption in the continuity of their primary caregiving , maternal demographic and psychosocial factors present at delivery can predict which infants are likely to experience an early disruption in their primary caregiving . Identifying these families can enable health care providers to monitor them more closely and , when appropriate , encourage support from the extended family OBJECTIVE To examine the effectiveness of home visiting by paraprofessionals and by nurses as separate means of improving maternal and child health when both types of visitors are trained in a program model that has demonstrated effectiveness when delivered by nurses . METHODS A r and omized , controlled trial was conducted in public- and private-care setting s in Denver , Colorado . One thous and one hundred seventy-eight consecutive pregnant women with no previous live births who were eligible for Medicaid or who had no private health insurance were invited to participate . Seven hundred thirty-five women were r and omized to control , paraprofessional , or nurse conditions . Nurses completed an average of 6.5 home visits during pregnancy and 21 visits from birth to the children 's second birthdays . Paraprofessionals completed an average of 6.3 home visits during pregnancy and 16 visits from birth to the children 's second birthdays . The main outcomes consisted of changes in women 's urine cotinine over the course of pregnancy ; women 's use of ancillary services during pregnancy ; subsequent pregnancies and births , educational achievement , workforce participation , and use of welfare ; mother-infant responsive interaction ; families ' home environments ; infants ' emotional vulnerability in response to fear stimuli and low emotional vitality in response to joy and anger stimuli ; and children 's language and mental development , temperament , and behavioral problems . RESULTS Paraprofessional-visited mother-child pairs in which the mother had low psychological re sources interacted with one another more responsively than their control-group counterparts ( 99.45 vs 97.54 st and ard score points ) . There were no other statistically significant paraprofessional effects . In contrast to their control-group counterparts , nurse-visited smokers had greater reductions in cotinine levels from intake to the end of pregnancy ( 259.0 vs 12.32 ng/mL ) ; by the study child 's second birthday , women visited by nurses had fewer subsequent pregnancies ( 29 % vs 41 % ) and births ( 12 % vs 19 % ) ; they delayed subsequent pregnancies for longer intervals ; and during the second year after the birth of their first child , they worked more than women in the control group ( 6.83 vs 5.65 months ) . Nurse-visited mother-child pairs interacted with one another more responsively than those in the control group ( 100.31 vs 98.99 st and ard score points ) . At 6 months of age , nurse-visited infants , in contrast to their control-group counterparts , were less likely to exhibit emotional vulnerability in response to fear stimuli ( 16 % vs 25 % ) and nurse-visited infants born to women with low psychological re sources were less likely to exhibit low emotional vitality in response to joy and anger stimuli ( 24 % vs 40 % and 13 % vs 33 % ) . At 21 months , nurse-visited children born to women with low psychological re sources were less likely to exhibit language delays ( 7 % vs 18 % ) ; and at 24 months , they exhibited superior mental development ( 90.18 vs 86.20 Mental Development Index scores ) than their control-group counterparts . There were no statistically significant program effects for the nurses on women 's use of ancillary prenatal services , educational achievement , use of welfare , or their children 's temperament or behavior problems . For most outcomes on which either visitor produced significant effects , the paraprofessionals typically had effects that were about half the size of those produced by nurses . CONCLUSIONS When trained in a model program of prenatal and infancy home visiting , paraprofessionals produced small effects that rarely achieved statistical or clinical significance ; the absence of statistical significance for some outcomes is probably attributable to limited statistical power to detect small effects . Nurses produced significant effects on a wide range of maternal and child outcomes CONTEXT Maternal use of cocaine during pregnancy remains a significant public health problem , particularly in urban areas of the United States and among women of low socioeconomic status . Few longitudinal studies have examined cocaine-exposed infants , however , and findings are contradictory because of method ologic limitations . OBJECTIVE To assess the effects of prenatal cocaine exposure on child developmental outcomes . DESIGN Longitudinal , prospect i ve , masked , comparison birth cohort study with recruitment in 1994 - 1996 . SETTING Obstetric unit of a large US urban teaching hospital . PARTICIPANTS Four hundred fifteen consecutively enrolled infants ( 218 cocaine-exposed and 197 unexposed ) identified from a high-risk , low-socioeconomic status , primarily black ( 80 % ) population screened through clinical interview and urine and meconium sample s for drug use . The retention rate was 94 % at 2 years of age . MAIN OUTCOME MEASURES The Bayley Mental and Motor Scales of Infant Development , assessed at 6.5 , 12 , and 24 months of corrected age . RESULTS Controlled for confounding variables , cocaine exposure had significant effects on cognitive development , accounting for a 6-point deficit in Bayley Mental and Motor Scales of Infant Development scores at 2 years , with cocaine-exposed children twice as likely to have significant delay ( mental development index < 80 ) ( odds ratio , 1.98 ; 95 % confidence interval , 1.21 - 3.24 ; P = .006 ) . For motor outcomes , there were no significant cocaine effects . CONCLUSIONS Cocaine-exposed children had significant cognitive deficits and a doubling of the rate of developmental delay during the first 2 years of life . Because 2-year outcomes are predictive of later cognitive outcomes , it is possible that these children will continue to have learning difficulties at school age BACKGROUND Studies suggest that 14 % of women age 18 to 40 drink alcohol above recommended limits . Of special concern is the increasing use of alcohol by women during pregnancy . This article reports 48 month follow-up data from a sub analysis of a trial for early alcohol treatment ( Project TrEAT ) focused on women of childbearing age . METHODS Project TrEAT was conducted in the offices of 64 primary care , community-based physicians from 10 Wisconsin counties . Of 5979 female patients ages 18 to 40 who were screened for problem drinking , 205 were r and omized into an experimental group ( n = 103 ) or control group ( n = 102 ) . The intervention consisted of two 15 min , physician-delivered counseling visits that included advice , education , and contracting by using a scripted workbook . A total of 174 subjects ( 85 % ) completed the 48 month follow-up procedures . RESULTS No significant differences were found between the experimental and control groups at baseline for alcohol use , age , socioeconomic status , smoking , depression or anxiety , conduct disorder , lifetime drug use , or health care utilization . The trial found a significant treatment effect in reducing both 7 day alcohol use ( p = 0.0039 ) and binge drinking episodes ( p = 0.0021 ) over the 48 month follow-up period . Women in the experimental group who became pregnant during the follow-up period had the most dramatic decreases in alcohol use . A logistic regression model based on a 20 % or greater reduction in drinking found an odds ratio of 1.93 ( confidence interval 1.07 - 3.46 ) in the sample exposed to physician intervention . Age , smoking , depression , conduct disorder , antisocial personality disorder , and illicit drug use did not reduce drinking significantly . No significant differences were found in health care utilization and health status between groups . CONCLUSIONS This trial provides the first direct evidence that brief intervention is associated with sustained reductions in alcohol consumption by women of childbearing age . The results have enormous implication s for the U.S. health care system This study was conducted to determine whether health education material s were more effective when written at a lower rather than a higher reading level . Women ( n = 252 ) who visited public health maternity clinics selected either English- or Spanish- language health design ed to discourage alcohol use , depending on whether the women preferred to read English or Spanish . The material s were written on the third and the 10th- grade reading levels . The women were r and omly assigned to receive material s written on one of the two levels . Then participants completed the pre-test , read the health education material and were post-tested immediately . Among English-speaking participants , the material written at the lower reading level was shown to be more effective . Whereas among Spanish-speaking participants , test scores were unchanged after reading either health education material . Overall , we recommend that health care providers design or purchase material s that are easy-to-read and provide face-to-face counseling about abstaining from alcohol . Providers should not rely on written material s to communicate important messages when working with pregnant women AIMS To assess the impact of a brief intervention on antepartum alcohol consumption . DESIGN A r and omized clinical trial . SETTING The obstetrics practice s of the Brigham and Women 's Hospital in Boston , MA , USA . PARTICIPANTS Two hundred and fifty eligible women initiating prenatal care . INTERVENTION A comprehensive assessment of alcohol use ( assessment only , AO ) or the same comprehensive assessment with a brief intervention ( BI ) . MEASUREMENT Demographic background and obstetric history of subjects , current and lifetime use of alcohol and substances , composite Addiction Severity Index scores , and antepartum alcohol use . FINDINGS Of the 250 , 247 ( 99 % ) subjects provided information on their antepartum drinking . Both the AO and BI groups had reductions in antepartum alcohol consumption , but differences in reductions by group were not statistically significant ( p > 0.05 ) . Risk of antepartum drinking after either the AO or BI was increased nearly threefold if the subject had any prenatal alcohol consumption before assessment ( p = 0.0001 ) . For the 143 subjects who were abstinent pre- assessment , however , those who received the BI maintained higher rates of abstinence ( 86 % versus 72 % , p = 0.04 ) . CONCLUSIONS After a comprehensive assessment of alcohol use , subjects in both the AO and BI groups reduced their antepartum alcohol consumption . The importance of screening for prenatal alcohol use is underscored by the findings that any prenatal alcohol consumption increases the risk of continued antepartum drinking The fact that women of childbearing age make up a large proportion of the alcohol and other drug using population has gained national attention . Since treatment for addicted pregnant women and women with children has become a federal priority , treatment programs of various modalities have opened their doors to this population . One promising treatment modality is the therapeutic community ( TC ) . This article briefly describes Amity , a TC for women and children that provides long-term residential TC treatment for addicted pregnant women and women with children . Amity currently has 65 women and 50 children living together in treatment on a 23-acre ranch . Descriptive data including demographic information and data on violence are presented . Preliminary outcome data are detailed , comparing drop out and treatment completion on such variables as alcohol and other drug use , rearrest , employment , child custody , and involvement in support groups . A pattern of behavior involving experiences in violent episodes and alcohol and other drug use is illuminated and discussed . Ideas for further research are suggested This article summarizes the proceedings of a symposium at the 2005 Research Society on Alcoholism , Santa Barbara , California . The purpose of the symposium was to address challenges that arise in translating evidence for efficacy of alcohol brief intervention ( BI ) into diverse clinical setting s and population s by review ing the literature and describing 4 research studies . Dr. Saitz review ed the limitations in evidence for efficacy of BIs and then described results of a r and omized clinical trial of brief motivational intervention for medical in patients drinking risky amounts . Dr. Svikis presented alternative methods for identifying pregnant women in prenatal care at risk for alcohol and drug problems ( including nicotine and caffeine ) and BIs to reduce or eliminate use . Dr. D'Onofrio discussed results of a r and omized trial of the brief negotiated interview in emergency department patients . Dr. Kraemer presented results of a decision analytic and computer-simulation model regarding the cost-effectiveness of alcohol screening and intervention in primary care setting s. Finally , Dr. Perl discussed the salient issues and suggested future directions for work in the area of alcohol BI OBJECTIVE Cost-effective interventions are needed for counseling pregnant drinkers , in order to reduce risk of fetal alcohol effects . METHOD 42 pregnant women who reported alcohol consumption participated in this pilot study of motivational interviewing . Following a comprehensive alcohol use assessment , the participants were r and omly assigned to receive either written information about the risks related to drinking during pregnancy or a one-hour motivational interview . The motivational interview was an empathic , client-centered , but directive session focusing on the health of the participants ' unborn babies . RESULTS At the end of a 2-month follow-up period , the 34 women ( 81 % ) who remained in the study showed a significant reduction in alcohol consumption and peak intoxication levels . Women who had reported the highest blood alcohol concentration ( BAC ) levels during early pregnancy showed a significantly greater reduction in their estimated BACs at follow-up ( during later pregnancy ) if assigned to the treatment rather than the control condition . CONCLUSIONS Motivational interviewing shows promise as a specific intervention for initiating a reduction in drinking among pregnant women who are at greatest risk . Simpler assessment and advice may suffice for women with lower initial consumption levels This study tested a cognitive-behavioral intervention for reducing alcohol consumption among economically disadvantaged pregnant women . The intervention included a 10-minute educational session and a nine-step self-help manual . Women attending public health maternity clinics completed a screening question naire , a pretest question naire , were r and omly assigned to receive the self-help intervention or usual clinic care , and completed a posttest question naire . A higher alcohol quit rate was observed among the intervention participants ( 88 % ) than controls ( 69 % ) . The effect was strongest for " light " drinkers , African-Americans , and non-Protestants . This approach may be useful in clinics where staff time is limited OBJECTIVE To assess alcohol use by pregnant women in three underprivileged areas of the Western Cape . DESIGN Data were collected from subjects , selected in a r and omised manner , during a single , structured interview . SUBJECTS AND SETTING Interviews were conducted among pregnant women voluntarily attending selected antenatal clinics in the George/Oudtshoorn , Vredenburg/Saldanha , and Cape Metropole areas of the Western Cape . OUTCOME MEASURES On completion of the interview , women at risk were counselled with regard to the dangers of prenatal alcohol exposure to the fetus . RESULTS 42.8 % of the women in the sample admitted to varying degrees of alcohol ingestion during the current pregnancy . The reported alcohol intake of over 55 % of these women , i.e. 23.7 % of the sample , was sufficient to place their unborn children at high risk for the fetal alcohol syndrome ( FAS ) . These heavy drinkers followed a pattern of binge drinking over weekends and showed a marked preference for beer . Combined alcohol and tobacco use occurred in 29.6 % of the sample . Only one subject admitted to using marijuana . CONCLUSION The data in this study confirm that a high rate of alcohol and tobacco use prevails among pregnant women in poorer communities of the Western Cape . Extrapolating from experience , as many as 9.5 % of the sample may produce children with FAS |
347 | 25,019,297 | The clinical significance of these statistical findings is uncertain but it is likely that the outcomes were clinical ly significant for some , but not all , participants .
Delivery system design interventions These interventions did not significantly affect adherence or daily hours of hearing aid use in the short to medium term , or adverse effects in the long term .
There was no evidence of a statistically or clinical ly significant effect on hearing h and icap , hearing aid benefit or the use of verbal communication strategies in the short to medium term .
There is some low to very low quality evidence to support the use of self management support and complex interventions combining self management support and delivery system design in adult auditory rehabilitation . | BACKGROUND Acquired adult-onset hearing loss is a common long-term condition for which the most common intervention is hearing aid fitting .
However , up to 40 % of people fitted with a hearing aid either fail to use it or may not gain optimal benefit from it .
OBJECTIVES To assess the long-term effectiveness of interventions to promote the use of hearing aids in adults with acquired hearing loss fitted with at least one hearing aid . | This paper addresses the development and effectiveness of a home education program . The program , design ed for hearing-impaired elders and their significant others ( SO ) , deals with communication strategies and speech reading . Participants were r and omly assigned to a training group ( hearing aid fitting + home education program ) or a control group ( hearing aid fitting ) . The training group included 24 hearing-impaired subjects and 24 SO 's . Controls were 24 affected individuals and 22 SO 's . Question naires addressing emotional response , communication strategies and the IOI-HA , IOI-AI and IOI-SO were used . A repeated measures analysis of variance was applied to test group differences between pre , post , and 6-months follow-up measures . Increased awareness of benefits of speech reading and improved interaction with the SO were observed in the training group only ( p < 0.05 ) . No group difference on ‘ emotional response ’ was found . IOI-AI and IOI-SO demonstrated favorable attitudes towards the program . Follow-up measures showed improved quality of life and satisfaction in the training group , while a decrease was observed among the controls ( p < 0.05 ) . Some effects differed between first-time and experienced hearing aid users . Addition of services to amplification and involvement of the SO are relevant in aural rehabilitation BACKGROUND Audiologic rehabilitation aims to improve communication for people with hearing impairment . Education is widely regarded as an integral part of rehabilitation , but the effect of the delivery method of an educational program on the experience of hearing problems has rarely been investigated in controlled trials . PURPOSE The purpose of this study was to examine the short-term effects of complementing an educational program for hearing aid users with telephone consultations , delivered through weekly discussion s with the subjects about information obtained from a book on hearing and hearing aids . RESEARCH DESIGN This study used a r and omized , controlled design . STUDY SAMPLE In total , 69 hearing aid users were r and omly assigned to an intervention group ( n = 33 ) or a control group ( n = 36 ) . INTERVENTION The intervention group had access to a book and received weekly topic-based reading instructions related to the different chapters of the book . Five telephone calls were made to the members of the intervention group . During the calls , an audiologist discussed new information with the participant as needed . The control participants also read the book , but they did not discuss the contents of the book with a professional . DATA COLLECTION AND ANALYSIS The Hearing H and icap Inventory for the Elderly ( HHIE ) , the Hospital Anxiety and Depression Scale ( HADS ) , and the International Outcome Inventory for Hearing Aids ( IOI-HA ) were used to measure the outcomes of this study . RESULTS Participants in the intervention group had a reduction in self-reported hearing h and icap , while there were no significant changes in the control group . In the intervention group , 45 % of the participants showed an improvement of ≥36 % on the HHIE , while only 17 % of the control group showed an improvement of ≥36 % . There were also improvements on the HADS total and the depression subscale for the intervention group . No changes occurred on the IOI-HA . CONCLUSIONS Reading about hearing and hearing aids can reduce the hearing h and icap and reported anxiety in hearing aid users . In this study , discussing the content of the book that was provided with a professional during weekly telephone consultations and having weekly home assignments further improved emotional well-being , as demonstrated by the HHIE ( emotional scale ) and HADS ( depression scale ) , but these activities had no effect on hearing aid outcomes as measured by the IOI-HA Results of this study demonstrate the advantages of both pre- and postfitting hearing aid orientation ( HAO ) sessions . This study demonstrated that HAO counseling is helpful in expediting hearing aid benefit and satisfaction through the education of our clients and that this benefit and satisfaction is age dependent as measured by the Glasgow Hearing Aid Benefit Profile ( GHABP ) ( Gatehouse , 1997 ) . Patients with greater initial disability , as identified by item 1 of the GHABP , receive significant benefit from prefitting and /or postfitting counseling as compared to patients receiving no counseling . Implication s of these findings are discussed OBJECTIVE To determine whether hearing loss is associated with incident all-cause dementia and Alzheimer disease ( AD ) . DESIGN Prospect i ve study of 639 individuals who underwent audiometric testing and were dementia free in 1990 to 1994 . Hearing loss was defined by a pure-tone average of hearing thresholds at 0.5 , 1 , 2 , and 4 kHz in the better-hearing ear ( normal , < 25 dB [ n = 455 ] ; mild loss , 25 - 40 dB [ n = 125 ] ; moderate loss , 41 - 70 dB [ n = 53 ] ; and severe loss , > 70 dB [ n = 6 ] ) . Diagnosis of incident dementia was made by consensus diagnostic conference . Cox proportional hazards models were used to model time to incident dementia according to severity of hearing loss and were adjusted for age , sex , race , education , diabetes mellitus , smoking , and hypertension . SETTING Baltimore Longitudinal Study of Aging . PARTICIPANTS Six hundred thirty-nine individuals aged 36 to 90 years . MAIN OUTCOME MEASURE Incident cases of all-cause dementia and AD until May 31 , 2008 . RESULTS During a median follow-up of 11.9 years , 58 cases of incident all-cause dementia were diagnosed , of which 37 cases were AD . The risk of incident all-cause dementia increased log linearly with the severity of baseline hearing loss ( 1.27 per 10-dB loss ; 95 % confidence interval , 1.06 - 1.50 ) . Compared with normal hearing , the hazard ratio ( 95 % confidence interval ) for incident all-cause dementia was 1.89 ( 1.00 - 3.58 ) for mild hearing loss , 3.00 ( 1.43 - 6.30 ) for moderate hearing loss , and 4.94 ( 1.09 - 22.40 ) for severe hearing loss . The risk of incident AD also increased with baseline hearing loss ( 1.20 per 10 dB of hearing loss ) but with a wider confidence interval ( 0.94 - 1.53 ) . CONCLUSIONS Hearing loss is independently associated with incident all-cause dementia . Whether hearing loss is a marker for early-stage dementia or is actually a modifiable risk factor for dementia deserves further study Background Hearing impairment is the most common body system disability in veterans . In 2008 , nearly 520,000 veterans had a disability for hearing loss through the Department of Veterans Affairs ( VA ) . Changes in eligibility for hearing aid services , along with the aging population , contributed to a greater than 300 % increase in the number of hearing aids dispensed from 1996 to 2006 . In 2006 , the VA committed to having no wait times for patient visits while providing quality clinical ly-appropriate care . One approach to achieving this goal is the use of group visits as an alternative to individual visits . We sought to determine : 1 ) if group hearing aid fitting and follow-up visits were at least as effective as individual visits , and 2 ) whether group visits lead to cost savings through the six month period after the hearing aid fitting . We describe the rationale , design , and characteristics of the baseline cohort of the first r and omized clinical trial to study the impact of group versus individual hearing aid fitting and follow-up visits . Methods Participants were recruited from the VA Puget Sound Health Care System Audiology Clinic . Eligible patients had no previous hearing aid use and monaural or binaural air-conduction hearing aids were ordered at the evaluation visit . Participants were r and omized to receive the hearing aid fitting and the hearing aid follow-up in an individual or group visit . The primary outcomes were hearing-related function , measured with the first module of the Effectiveness of Aural Rehabilitation ( Inner EAR ) , and hearing aid adherence . We tracked the total cost of planned and unplanned audiology visits over the 6-month interval after the hearing aid fitting . Discussion A cohort of 659 participants was r and omized to receive group or individual hearing aid fitting and follow-up visits . Baseline demographic and self-reported health status and hearing-related measures were evenly distributed across the treatment arms . Outcomes after the 6-month follow-up period are needed to determine if group visits were as least as good as those for individual visits and will be reported in subsequent publication . Trial Registration UNLABELLED It is of paramount importance to install hearing rehabilitation programs for the elderly . AIM To check the efficacy of a forma auditory training program for elderly patients fitted with hearing aids for at least three months , by means of speech recognition tests and self- assessment question naires . METHODS Longitudinal contemporary cohort study . We selected 13 elderly hearing aid users , using intra-canal hearing aids in both ears , from both genders , with average age of 65.3 years . This group was r and omly divided in Experiment Group and Control Group . The Experiment Group underwent seven formal auditory training sessions , aim ing at stimulating their hearing skills for hearing closing , memory , attention , background figure and binaural integration . The participants were assessed by three behavioral tests and one self assessment question naire . RESULTS The elderly from the Experiment Group had significantly better performance in the assessment s after auditory training in comparison to the Control Group . CONCLUSION The formal auditory training program in a soundproof booth , associated with the use of hearing aids , improves speech recognition performance and reduces the perception of auditory h and icap for the elderly who use intra-canal hearing aids The purpose of this study was to determine whether periodic clinician-initiated telephone contact would reduce the number of unresolved complaints and increase satisfaction , use , and perceived benefit at 4 mo postfitting . Thirty subjects were contacted at 6 , 9 , and 12 wk postfitting to address questions and to encourage them to return to the clinic to resolve hearing aid-related problems . A control group of 30 subjects was encouraged to contact the center if problems arose at the time of dispensing only . All subjects were interviewed at 4 mo following receipt of the aids , and were sent the Hearing H and icap Inventory for the Elderly at the same time as well as at the time of dispensing . Results revealed a significant reduction in perceived h and icap in general , but no significant difference between groups on measures of satisfaction , use , or benefit . There was no significant difference between groups in the number of unresolved complaints at the time of the interview ; however , a trend toward fewer complaints in the experimental group was noted . A significantly greater number of complaints were raised for the first time in the control group than in the experimental group at the time of the interview , indicating that more problems remained unaddressed in the absence of clinician-initiated intervention . Therefore , the continued investigation of aggressive , and efficient , postfitting management schemes is warranted PURPOSE To evaluate teleconsultation 's efficacy for hearing aid fitting . METHODS Fifty hearing impaired individuals with ages ranging from 39 to 88 years and mean audiometric thresholds between 30 and 68.75 dBHL participated in this study . Participants were divided into two groups ( stratified r and omization ) : control group ( n=25 ) , su bmi tted to face-to-face procedures , and experimental group ( n=25 ) , su bmi tted to synchronous teleconsultation with interactive video and remote applicative control . The hearing aids were programmed and verified ( with microphone probe ) , and the subjects received instructions regarding use and care for the device . Time taken for the procedures was measured . Following the consultations , an evaluator ( blind to the groups ) applied the Hearing in Noise Test ( HINT-Brazil ) . Approximately one month after consultations , the daily time of hearing aid use was verified , and the International Outcome Inventory for Hearing Aids ( IOI-HA ) was administered . RESULTS A greater time for programming and verification and a smaller time for orientation were observed for the experimental group . No difference was found between groups for the total consultation time . The real ear measures ' matching to their respective targets was similar for both groups . No difference was observed between groups for the HINT results ( silence and noise ) , the daily amount of use of hearing aids in hours , and the IOI-HA scores . CONCLUSION Teleconsultation is an efficient procedure for hearing aid programming , verification and fitting when face-to-face services are not available Nineteen elderly hearing impaired subjects participated in an experimental treatment study and received either behavioural hearing tactics or served as untreated controls . Treatment was supplied in the form of a self-help treatment manual supplied with telephone contacts during 4 consecutive weeks . The treatment manual included applied relaxation , communication strategies training , advice to relatives , information , and coping skills . Assessment s ( pre-post ) were conducted in a structured interview measuring coping behaviour . In order to evoke behavioural compensation small acoustic provocations were included in the interview . Pre-post assessment s also included question naires , daily registered hearing problems , and hours of daily hearing aid use . Results showed significant beneficial effects in favour of the treatment in terms of self-assessed problems and behaviour change BACKGROUND Reduced hearing in elderly people is important because it is disabling and potentially treatable . We aim ed to assess the prevalence of reduced hearing in elderly people and levels of ownership of hearing aids and use . METHODS We have done a cross-sectional survey of people aged at least 75 years in 106 family practice s in the UK . We obtained self-reported data on hearing difficulties for 32,656 people and gave 14,877 a whispered voice test ( response rate 78 % ) . FINDINGS 2537 ( 8 % ) of 32,656 participants reported a lot of difficulty hearing and 13,630 ( 42 % ) a little or a lot of difficulty . 3795 ( 26 % ) of 14877 participants who completed the whispered voice test ( 95 % CI 23 - 29 ) failed the test , the proportion rising sharply with age . Following wax removal , 343 passed a retest , leaving 3452 ( 23 % , 20 - 26 ) who failed the test , even after wax removal if present . 998 ( 46 % ) of 2180 people wearing a hearing aid at the time of testing failed the whispered voice test . More than half the people who failed the test did not own a hearing aid . 2200 ( 60 % ) of 3846 people who owned a hearing aid said they used it regularly . Level of use was strongly related to perceived benefit . INTERPRETATION Reduced hearing is common and provision of hearing aids inadequate in elderly people . Many people who own a hearing aid do not use it regularly , and even when wearing their aid many still have socially disabling levels of hearing loss . A major source of morbidity in elderly people could be alleviated by improvements in detection and management of reduced hearing Twenty-four elderly hearing impaired Ss participated in an experimental treatment study and received either behavioural group treatment or served as untreated controls . The treatment package included applied relaxation , video self-modelling , exposure , information and various coping skills . Assessment s ( pre-post ) were conducted using a structured video-interview measuring coping behaviour . In order to evoke behavioural compensation small acoustic provocations were included in the interview . The edited videos were then rated blindly by two trained observers . Pre-post assessment s also included daily registered hearing problems on visual analogue scales and a question naire . Finally , a one month follow-up blind telephone interview was conducted . Results showed significant beneficial effects in favour of the treatment package and support the implementation of a behavioural approach in audiological rehabilitation research Effects of behavioral counselling of subjects with an acquired hearing loss were evaluated in an experimental design . The study included a group of 20 hearing-impaired subjects who were assessed and r and omly allocated to a treatment or control group . Behavioural counselling , individualized according to the results of functional analysis , was then given to 10 subjects and included the teaching of ' hearing tactics ' . The groups were measured three times , pre-counselling and post-counselling and at a 15-month follow-up , after which treatment results were analysed . Significant ( time x treatment ) interactions were followed by post-hoc testing revealing that the treated group had improved in several areas of functioning while controls had not . These results were in agreement with interview data . The findings indicate that a behavioural counselling approach to hearing tactics is beneficial in the underst and ing and rehabilitation of hearing loss , especially over time PURPOSE To screen hearing and evaluate outcomes in community-dwelling older adults . METHOD Three thous and and twenty-five adults responded to an invitation to be screened by question naire , otoscopy , and pure-tone audiometry . Pure-tone average ( PTA ) > 35 dB HL in the worse ear , unilateral hearing loss , or otoscopic findings were the criteria for referral for services . A question naire related to compliance with referral recommendations was completed by telephone interview for 160 r and omly selected participants after 1 - 2 years from referral . RESULTS The referral rate for audiologic/hearing aid evaluation was 46 % , and referral for cerumen removal/medical evaluation was 17 % . Of the people referred for audiologic/hearing aid evaluation , 18 % tried a hearing aid ; 2 years later , 11 % were using a hearing aid . Screening recommendations affected participants ' decision to seek help . Study participants stated that the screening was helpful , it should be offered to everybody , and they would participate in future screenings . CONCLUSION Although adult hearing screening offered timely identification of hearing loss for adults seeking help , follow-up with hearing aid treatment was low |
348 | 22,162,004 | We then discuss the functional roles of the striato-thalamo-cortical and mesolimbic circuits , ending with the conclusion that both these pathways are indeed involved in emotional processing | Parkinson 's disease provides a useful model for study ing the neural substrates of emotional processing .
The striato-thalamo-cortical circuits , like the mesolimbic dopamine system that modulates their function , are thought to be involved in emotional processing .
As Parkinson 's disease is histopathologically characterized by the selective , progressive , and chronic degeneration of the nigrostriatal and mesocorticolimbic dopamine systems , it can therefore serve as a model for assessing the functional role of these circuits in humans .
In the present review , we begin by providing a synopsis of the emotional disturbances observed in Parkinson 's disease . | Appetitive aggression occurs in the context of re source /dominance disputes in a wide variety of species . Hence , the possibility arises that a specific neural system may have evolved to detect and coordinate responses to this specific form of challenge or threat . The dopamine system has been implicated in the processing of signals of aggression in social-agonistic encounters in several species . Here we report that dopaminergic antagonism in healthy male volunteers , following acute administration of the dopamine D2-class receptor antagonist sulpiride , leads to a selective disruption in the recognition of facial expressions of anger ( signals of appetitive aggression in humans ) , but leaves intact recognition of other emotions and the matching of unfamiliar faces Amphetamine , a potent monoaminergic agonist , has pronounced effects on emotional behavior in humans , including the generation of fear and anxiety . Recent animal studies have demonstrated the importance of monoamines , especially dopamine , in modulating the response of the amygdala , a key brain region involved in the perception of fearful and threatening stimuli , and the generation of appropriate physiological and behavioral responses . We have explored the possibility that the anxiogenic effect of amphetamine in humans reflects the drug 's influence on the activity of the amygdala . In a double-blind placebo controlled study , fMRI revealed that dextroamphetamine potentiated the response of the amygdala during the perceptual processing of angry and fearful facial expressions . Our results provide the first evidence of a specific neural substrate for the anxiogenic effects of amphetamine and are consistent with animal models of dopaminergic activation of the amygdala Recent findings point to a perceptive impairment of emotional facial expressions in patients diagnosed with Parkinson disease ( PD ) . In these patients , administration of dopamine can modulate emotional facial recognition . We used fMRI to investigate differences in the functional activation in response to emotional and nonemotional gestures between PD patients and age-matched healthy controls ( HC ) . In addition , we used PET to evaluate the striatal dopamine transporter availability ( DAT ) with [11C]d-threo-methylpheni date in the patient group . Patients showed an average decrease to 26 % in DAT when compared to age-corrected healthy references . Reduction in the DAT of the left putamen correlated not only with motor impairment but also with errors in emotional gesture recognition . In comparison to HC , PD patients showed a specific decrease in activation related to emotional gesture observation in the left ventrolateral prefrontal cortex ( VLPFC ) and the right superior temporal sulcus . Moreover , the less DAT present in the left putamen , the lower the activation in the left VLPFC . We conclude that a loss of dopaminergic neurotransmission in the putamen results in a reduction of ventrolateral prefrontal access involved in the recognition of emotional gestures In this study , individuals with Parkinson ’s disease were tested as a model for basal ganglia dysfunction to infer how these structures contribute to the processing of emotional speech tone ( emotional prosody ) . Nondemented individuals with and without Parkinson ’s disease ( n = 21/group ) completed neuropsychological tests and tasks that required them to process the meaning of emotional prosody in various ways ( discrimination , identification , emotional feature rating ) . Individuals with basal ganglia disease exhibited abnormally reduced sensitivity to the emotional significance of prosody in a range of context s , a deficit that could not be attributed to changes in mood , emotional-symbolic processing , or estimated frontal lobe cognitive re source limitations in most conditions . On the basis of these and broader findings in the literature , it is argued that the basal ganglia provide a critical mechanism for reinforcing the behavioral significance of prosodic patterns and other temporal representations derived from cue sequences ( Lieberman , 2000 ) , facilitating cortical elaboration of these events In addition to classic motor signs and symptoms , Parkinson 's disease ( PD ) is characterized by neuropsychological and emotional deficits , including a blunted emotional response . In the present study , we explored both the neural basis of abnormal emotional behavior in PD and the physiological effects of dopaminergic therapy on the response of the amygdala , a central structure in emotion processing . PD patients and matched normal controls ( NCs ) were studied with blood oxygenation level-dependent functional magnetic resonance imaging during a paradigm that involved perceptual processing of fearful stimuli . PD patients were studied twice , once during a relatively hypodopaminergic state ( i.e. , ≥12 hr after their last dose of dopamimetic treatment ) and again during a dopamine-replete state . The imaging data revealed a robust bilateral amygdala response in NCs that was absent in PD patients during the hypodopaminergic state . Dopamine repletion partially restored this response in PD patients . Our results demonstrate an abnormal amygdala response in PD that may underlie the emotional deficits accompanying the disease . Furthermore , consistent with findings in experimental animal paradigms , our results providein vivo evidence of the role of dopamine in modulating the response of the amygdala to sensory information in human subjects The amygdala exhibits significant pathological changes in Parkinson 's disease , including atrophy and Lewy body ( LB ) formation . Amygdala pathology has been suggested to contribute to some clinical features of Parkinson 's disease , including deficits of olfaction and facial expression . The degree of neuronal loss in amygdala subnuclei and the relationship with LB formation in non-demented Parkinson 's disease cases have not been examined previously . Using stereological methods , the volume of neurones and the number of neurones in amygdala subdivisions were estimated in 18 prospect ively studied , non-demented patients with Parkinson 's disease and 16 age- and sex-matched controls . Careful exclusion ( all cortical disease ) and inclusion ( non-demented , levodopa-responsive , idiopathic Parkinson 's disease or controls ) criteria were applied . Seven Parkinson 's disease cases experienced well-formed visual hallucinations many years after disease onset , while nine Parkinson 's disease cases and three controls were treated for depression . Anatomically , the amygdala was subdivided into the lateral nucleus , the basal ( basolateral and basomedial ) nuclei and the corticomedial ( central , medial and cortical nuclei ) complex . LB and Lewy neurites were identified by immunohistochemistry for alpha-synuclein and ubiquitin and were assessed semiquantitatively . LB were found throughout the amygdala in Parkinson 's disease , being present in approximately 4 % of neurones . Total amygdala volume was reduced by 20 % in Parkinson 's disease ( P = 0.02 ) and LB concentrated in the cortical and basolateral nuclei . Lewy neurites were present in most cases but did not correlate with any structural or functional variable . Amygdala volume loss was largely due to a 30 % reduction in volume ( P = 0.01 ) and the total estimated number of neurones ( P = 0.007 ) in the corticomedial complex . The degree of neurone loss and the proportion of LB-containing neurones in the cortical nucleus within this complex were constant across Parkinson 's disease cases and neither variable was related to disease duration ( R(2 ) < 0.03 ; P > 0.5 ) . The cortical nucleus has major olfactory connections and its degeneration is likely to contribute to the early selective anosmia common in Parkinson 's disease . There was a small reduction in neuronal density in the basolateral nucleus in all Parkinson 's disease cases , but no consistent volume or cell loss within this region . However , the proportion of LB-containing neurones in the basolateral nucleus was nearly doubled in cases that exhibited visual hallucinations , suggesting that neuronal dysfunction in this nucleus contributes to this late clinical feature . Detailed quantitation of the other amygdala subdivisions failed to reveal any other substantial anomalies or any associations with depression . Thus , the impact of Parkinson 's disease on the amygdala is highly selective and correlates with both early and late clinical features Impaired social cognition is a core feature of autism . There is much evidence showing people with autism use a different cognitive style than controls for face-processing . We tested if people with autism would show differential activation of social brain areas during a face-processing task . Thirteen adults with high-functioning autism or Asperger Syndrome ( HFA/AS ) and 13 matched controls . We used fMRI to investigate ' social brain ' activity during perception of fearful faces . We employed stimuli known to reliably activate the amygdala and other social brain areas , and ROI analyses to investigate brain areas responding to facial threat as well as those showing a linear response to varying threat intensities . We predicted : ( 1 ) the HFA/AS group would show differential activation ( as opposed to merely deficits ) of the social brain compared to controls and ( 2 ) that social brain areas would respond to varied intensity of fear in the control group , but not the HFA/AS group . Both predictions were confirmed . The controls showed greater activation in the left amygdala and left orbito-frontal cortex , while the HFA/AS group showed greater activation in the anterior cingulate gyrus and superior temporal cortex . The control group also showed varying responses in social brain areas to varying intensities of fearful expression , including differential activations in the left and right amygdala . This response in the social brain was absent in the HFA/AS group . HFA/AS are associated with different patterns of activation of social brain areas during fearful emotion processing , and the absence in the HFA/AS brain of a response to varying emotional intensity We previously found that patients with Parkinson 's disease ( PD ) were impaired with respect to recognition of fear and disgust in facial expressions . To investigate the neural mechanisms that underlie this impairment , we recorded visual event-related potentials ( ERPs ) in response to the viewing of fearful facial expressions . Ten normal elderly volunteers and nine patients with PD were studied . Fearful , surprised , and neutral facial expressions were presented r and omly for 500 ms each , with a probability of 0.1 , 0.1 , and 0.8 , respectively . The locations of the components of the ERPs were analyzed using a scalp-skull-brain/dipole tracing method . The ERPs elicited in response to the facial stimuli consisted of a negative peak ( N1 ) , two positive peaks , and a subsequent slow negative shift . For N1 , the equivalent current dipoles were concentrated in the fusiform gyrus , right superior temporal gyrus , parahippocampal gyrus , cingulate cortex , and cerebellum , in normal subjects . In response to the fearful stimulus , dipoles were also generated from the amygdala in seven out of 10 normal subjects . In contrast , in patients with PD , N1 was centered bilaterally in the angular gyrus and supramarginal gyrus , and there was no neuronal activity in the amygdala . After N1 , dipoles moved toward the frontal region in normal subjects , whereas they remained in the parietal lobes in patients with PD . These results suggest that neither the amygdala nor the temporal visual-associated cortices are involved in responding to fearful expressions in patients with PD . Corticostriatal connections may be variably affected by a lack of dopamine or by pathological changes in the amygdala . Thus , somatosensory recruitment may overcome the mild cognitive emotional deficits that are present in patients with PD owing to a dysfunction of the amygdala Recent neuroimaging studies have demonstrated abnormal central emotional processing in psychiatric disorders . The dopamine ( DA ) systems and serotonin ( 5-HT ) systems are the main target of psychopharmacotherapy . DA D2 receptor antagonists and selective serotonin reuptake inhibitors ( SSRIs ) are widely used in psychiatric practice . Investigating the effects of these drugs on emotional processing should lead to a better underst and ing of the pathophysiology and pharmacotherapy of neuropsychiatric disorders . We aim ed to examine effects of dopaminergic and serotonergic manipulation on neural responses to unpleasant pictures in healthy volunteers using pharmacological fMRI . Thirteen healthy male subjects participated in a single-blind , r and omized , placebo-controlled design study . Each subject participated in three fMRI sessions . In each session , participants were orally administered either 25 mg of sultopride or 50 mg of fluvoxamine or placebo prior to scanning , and neural responses to unpleasant and neutral pictures were recorded . Despite no significant differences being found in the subjective ratings of affective pictures across three sessions , compared to placebo , acute treatments of DA D2 receptor antagonists and SSRIs commonly attenuated the amygdala activity , although both treatments had slightly different modulatory effects on other components of the neural circuit of emotional processing . This study has shown that even acute treatment of drugs that manipulate neurotransmitter systems could affect brain activation associated with emotional processing in human brain . At the same time , our findings suggest that pharmacological fMRI could be a powerful tool for investigating the neurophysiological properties of drugs targeting neuropsychiatric disorders Objective : A link between the brain dopaminergic ( DA ) system and emotional processing seems to be supported by the DA nature of neural systems surrounding emotional recognition , the occurrence of emotional deficits in medical disorders involving a DA dysfunction , and the effect of DA agonists or antagonists on emotional processing . The authors tested the influence of levodopa administration on emotional processing in a functional MRI ( fMRI ) study of 10 elderly volunteers . Methods : A placebo-controlled , cross-over experimental design was used . Subjects received either levodopa ( 100 mg ) or placebo in 2 fMRI sessions . Performance was evaluated with a passive facial emotion perception test . Results : During the placebo situation , the region-of-interest ( ROI ) analysis showed that emotional processing activated the bilateral amygdala . In levodopa volunteers , this activation was missing . The statistical comparison between the 2 situations ( emotional vs control condition ) revealed a highly significant reduction in activation of the bilateral amygdala for the levodopa fMRI session ( P corrected < 0.0001 in the left and P = 0.002 in the right amygdala ) . Conclusion : These results suggest that administration of levodopa to healthy volunteers directly or indirectly impairs the amygdalar activation during the emotional perception task . The authors hypothesized that amygdala activation may conform to an inverted U-shaped function in relation to changing dopamine levels |
349 | 20,221,676 | Conclusions The findings here echo previous systematic review s supporting exercise as providing positive health benefits and training alone as not being effective . | Introduction Health care work is dangerous and multiple interventions have been tested to reduce the occupational hazards .
Methods A systematic review of the literature used a best evidence synthesis approach to address the general question “ Do occupational safety and health interventions in health care setting s have an effect on musculoskeletal health status ? ” | The aim of the present study was to compare the effect of increased aerobic capacity versus muscle strength rehabilitation of female hospital staff with long-lasting musculoskeletal back pain . Seventy-nine women agreed to participate in the intervention study . After a medical examination , 65 individuals were assigned to one of three balanced groups : Endurance training ( aerobic capacity promoting training : ET : n = 22 ) , strength promotion exercise ( SP : n = 24 ) or a control group ( CON : n = 19 ) . The active groups met twice a week for 60 minutes of exercise over 15 weeks . Aerobic capacity ( VO2max ) and musculoskeletal pain were measured immediately before ( T1 ) and after the intervention period ( T2 ) . Aerobic capacity significantly increased in the ET group , whereas no change was observed in the SP group , and a significant reduction was found in the CON group from T1 to T2 . Musculoskeletal pain was significantly reduced in both intervention groups , whereas minor changes were observed in the control group . Results from a 7-month follow-up ( T3 ) survey confirmed the beneficial effects of interventions on musculoskeletal pain . In conclusion , improved aerobic capacity appeared not to be a necessary mechanism in musculoskeletal back pain reduction BACKGROUND High rates of work-related injuries are seen among health care workers involved in lifting and transferring patients . We studied the effects of a participatory worker-management ergonomics team among hospital orderlies . METHODS This prospect i ve intervention trial examined work injuries and other outcomes before and after the intervention , with other hospital employees used as a concurrent control . All orderlies in a 1,200-bed urban hospital were studied using passively collected data ( mean employment during study period 100 - 110 orderlies ) ; 67 orderlies ( preintervention ) and 88 orderlies ( postintervention ) also completed a question naire . The intervention was the formation of a participatory ergonomics team with three orderlies , one supervisor , and technical advisors . This team design ed and implemented changes in training and work practice s. RESULTS The 2-year postintervention period was marked by decreased risks of work injury ( RR = 0.50 , 95 % CI 0.35 - 0.72 ) , lost time injury ( RR = 0.26 , 95 % CI 0.14 - 0.48 ) , and injury with three or more days of time loss ( RR = 0.19 , 95 % CI 0.07 - 0.53 ) . Total lost days declined from 136.2 to 23.0 annually per 100 full-time worker equivalents ( FTE ) . Annual workers ' compensation costs declined from $ 237/FTE to $ 139/FTE . The proportion of workers with musculoskeletal symptoms declined and there were statistically significant improvements in job satisfaction , perceived psychosocial stressors , and social support among the orderlies . CONCLUSION Substantial improvements in health and safety were seen following implementation of a participatory ergonomics program The aim of this Intervention was to evaluate the effect of training on patient-h and ling skills and prospect ively to assess the effect of skill on subsequent back pain and back injuries in nursing . Of a total of 255 nurses , 199 were assessed for their skill in patient-h and ling . One-half ( control group ) received traditional training in patient-h and ling , and the other half ( trained group ) received a curriculum of instruction totaling 40 hours . The skills of both groups were assessed on graduation . The control group was rated as less competent in patient-h and ling . Nurses in both groups were question ed about the prevalence of back pain and incidence of back injuries in the first year after graduation . In multiple regression analysis , the major risk Indicators for back injuries were poor patient-h and ling skill , low numbers of repetitions in the sit-up test , and high work-load scores . High score on the hysteria scale of Middlesex Hospital Question naire was a risk Indicator for all kinds of back pain . Though back pain was Independent of patient-h and ling skill , those rated as “ bad ” or “ poor ” had more back injuries ( 24 % ) than those who had been rated as “ good ” or “ excellent ” ( 2 % ) ( P < 0.001 ) , but the difference between the trained and control groups was not statistically significant . It was concluded that back Injuries may be prevented by the teaching of patient-h and ling skills A clinical trial , aim ed at secondary prevention of low-back pain , was performed in 142 hospital employees reporting at least three annual episodes of this condition . Participants were r and omly assigned to one of three groups : a calisthenics program ( CAL ) for 3 months with biweekly sessions of flexion exercises , a back school program ( 5 sessions ) , and a control group . The effectiveness of the two intervention programs was evaluated over a 1-year period . Baseline preintervention data and evaluation at the end of 3 months of intervention and after an additional 6 months were collected . A monthly surveillance for the whole year showed a mean of 4.5 “ painful months ” in the CAL group versus 7.3 and 7.4 months in the back school and control groups , respectively ( P < 0.0001 ) . The superiority of the CAL group was achieved partly because of the significant increase in trunk forward flexion and to initial increment in abdominal muscle strength . The increased trunk flexion was associated with the rate of participation in the CAL sessions . Further research is needed to answer the question of “ intensity versus type of exercise ” by comparing different intervention programs , with similar intensity Back injuries are a serious problem for nursing personnel who perform frequent patient-h and ling activities . Common prevention strategies include body mechanics education , technique training , and ergonomic interventions such as the introduction of assistive equipment . This investigation assessed and compared the effectiveness of two patient-h and ling approaches to reducing injury risk . One strategy involved using improved patient-h and ling technique with existing equipment , and the other approach aim ed at eliminating manual patient h and ling through the use of additional mechanical and other assistive equipment . Both intervention arms received training in back care , patient assessment , and use of the equipment available on their particular wards . An analysis of compliance with interventions and the effects of patient-h and ling methods on both peak and cumulative spinal compression and shear during various tasks was conducted . Results showed greater compliance with interventions that incorporated new assistive patient-h and ling equipment , as opposed to those consisting of education and technique training alone . In several tasks , subjects who were untrained or non-compliant with interventions experienced significantly higher peak spinal loading . However , patient-h and ling tasks conducted with the aid of assistive equipment took substantially longer than those performed manually . This , along with variations in techniques , led to increases in cumulative spinal loading with the use of patient-h and ling equipment on some tasks . Thus , the use of mechanical assistive devices may not always be the best approach to reducing back injuries in all situations . No single intervention can be recommended ; instead all patient-h and ling tasks should be examined separately to determine which methods maximize reductions in both peak and cumulative lumbar forces during a manoeuver Back pain and injury are a widespread problem for direct care providers and can lead to disability and job loss . Although most intervention studies focus on the number of reported injuries as the outcome variable , pain is a leading indicator of impending injury . More secondary prevention interventions focusing on early detection and treatment of pain are needed to reduce injuries . The primary aim of this study was to assess the feasibility and effect size of a cognitive behavioral therapy ( CBT ) intervention to reduce the measures of back pain , stress , and disability in direct care providers working with back pain . The secondary aim was to assess the association between affect and outcome variables , particularly unscheduled work absence , which is a component of disability . This r and omized clinical trial recruited 32 registered nurses and nursing assistants with a history of back pain in the past year and assigned them to either an intervention or a control group . The CBT intervention was a weekly stress and pain management session over 6 weeks led by a clinical psychologist . Data for both groups were collected at baseline and at 6 weeks , with work absence data caused by back pain self-reported for 12 weeks . Pain intensity scores declined in the intervention group , indicating a large effect . However , stress scores increased . Depression scores accounted for one-third of the variance in hours absent because of back pain . Although there was a high dropout rate in the intervention group , a cognitive-behavioral intervention shows promise as a secondary prevention intervention PROBLEM STATEMENT Nurses have one of the highest rates of work-related musculoskeletal injury of any profession . Over the past 30 years , efforts to reduce work-related musculoskeletal disorders in nurses have been largely unsuccessful . SPECIFIC AIMS The primary goal of this program was to create safer working environments for nursing staff who provide direct patient care . Our first objective was to design and implement a multifaceted program that successfully integrated evidence -based practice , technology , and safety improvement . The second objective was to evaluate the impact of the program on injury rate , lost and modified work days , job satisfaction , self-reported unsafe patient h and ling acts , level of support for program , staff and patient acceptance , program effectiveness , costs , and return on investment . INTERVENTION The intervention included six program elements : ( 1 ) Ergonomic Assessment Protocol , ( 2 ) Patient H and ling Assessment Criteria and Decision Algorithms , ( 3 ) Peer Leader role , " Back Injury Re source Nurses " , ( 4 ) State-of-the-art Equipment , ( 5 ) After Action Review s , and ( 6 ) No Lift Policy . METHODS A pre-/post design without a control group was used to evaluate the effectiveness of a patient care ergonomics program on 23 high risk units ( 19 nursing home care units and 4 spinal cord injury units ) in 7 facilities . Injury rates , lost work days , modified work days , job satisfaction , staff , and patient acceptance , program effectiveness , and program costs/savings were compared over two nine month periods : pre-intervention ( May 2001-January 2002 ) and post-intervention ( March 2002-November 2002 ) . Data were collected prospect ively through surveys , weekly process logs , injury logs , and cost logs . RESULTS The program elements result ed in a statistically significant decrease in the rate of musculoskeletal injuries as well as the number of modified duty days taken per injury . While the total number of lost workdays decreased by 18 % post-intervention , this difference was not statistically significant . There were statistically significant increases in two subscales of job satisfaction : professional status and tasks requirements . Self-reports by nursing staff revealed a statistically significant decrease in the number of ' unsafe ' patient h and ling practice s performed daily . Nurses ranked program elements they deemed to be " extremely effective " : equipment was rated as most effective ( 96 % ) , followed by No Lift Policy ( 68 % ) , peer leader education program ( 66 % ) , ergonomic assessment protocol ( 59 % ) , patient h and ling assessment criteria and decision algorithms ( 55 % ) , and lastly after action review s ( 41 % ) . Perceived support and interest for the program started at a high level for managers and nursing staff and remained very high throughout the program implementation . Patient acceptance was moderate when the program started but increased to very high by the end of the program . Although the ease and success of program implementation initially varied between and within the facilities , after six months there was strong evidence of support at all levels . The initial capital investment for patient h and ling equipment was recovered in approximately 3.75 years based on annual post-intervention savings of over $ 200,000/year in workers ' compensation expenses and cost savings associated with reduced lost and modified work days and worker compensation . CONCLUSIONS This multi-faceted program result ed in an overall lower injury rate , fewer modified duty days taken per injury , and significant cost savings . The program was well accepted by patients , nursing staff , and administrators . Given the significant increases in two job satisfaction subscales ( professional status and task requirements ) , it is possible that nurse recruitment and retention could be positively impacted The aim of this study was to evaluate the effect of a transfer technique education programme ( TT ) alone or in combination with physical fitness training ( TTPT ) compared with a control group , who followed their usual routine . Eleven clinical hospital wards were cluster r and omised to either intervention ( six wards ) or to control ( five wards ) . The intervention cluster was individually r and omised to TT ( 55 nurses ) and TTPT ( 50 nurses ) , control ( 76 nurses ) . The transfer technique programme was a 4-d course of train-the-trainers to teach transfer technique to their colleagues . The physical training consisted of supervised physical fitness training 1 h twice per week for 8 weeks . Implementing transfer technique alone or in combination with physical fitness training among a hospital nursing staff did not , when compared to a control group , show any statistical differences according to self-reported low back pain ( LBP ) , pain level , disability and sick leave at a 12-month follow-up . However , the individual r and omised intervention subgroup ( transfer technique/physical training ) significantly improved the LBP-disability ( p = 0.001 ) . Although weakened by a high withdrawal rate , teaching transfer technique to nurses in a hospital setting needs to be thoroughly considered . Other priorities such as physical training may be taken into consideration . The current study supports the findings of other studies that introducing transfer technique alone has no effect in targeting LBP . However , physical training seems to have an influence in minimising the LBP consequences and may be important in the discussion of how to prevent LBP or the recurrence of LBP among nursing personnel The personnel at a geriatric hospital were r and omized into two groups . One group was allowed to exercise during working hours to improve back muscle strength , endurance , and coordination . The other group did not participate in the exercise program and received no further advice or information . After 13 months , the training group had increased back muscle strength . One subject had been absent from work 28 days in the training group whereas 12 subjects had been absent 155 days from work because of low back pain in the control group ( P<0.004 ) . The back pain complaints and intensity of back pain in the training group also decreased in a statistically significant way . Every hour spent by the physiotherapist on the training group reduced the work absence among the participants by 1.3 days , result ing in a cost/benefit ratio greater than 10 Study Design . R and omized controlled trial ( RCT ) . Objectives . To compare the effectiveness of training and equipment to reduce musculoskeletal injuries , increase comfort , and reduce physical dem and s on staff performing patient lifts and transfers at a large acute care hospital . Summary of Background Data . Back injury to nursing staff during patient h and ling tasks is a major issue in health care . The value of mechanical assistive devices in reducing injuries to these workers is unclear . Methods . This three-armed RCT consisted of a “ control arm , ” a “ safe lifting ” arm , and a “ no strenuous lifting ” arm . A medical , surgical , and rehabilitation ward were each r and omly assigned to each arm . Both intervention arms received intensive training in back care , patient assessment , and h and ling techniques . Hence , the “ safe lifting ” arm used improved patient h and ling techniques using manual equipment , whereas the “ no strenuous lifting ” arm aim ed to eliminate manual patient h and ling through use of additional mechanical and other assistive equipment . Results . Frequency of manual patient h and ling tasks was significantly decreased on the “ no strenuous lifting ” arm . Self-perceived work fatigue , back and shoulder pain , safety , and frequency and intensity of physical discomfort associated with patient h and ling tasks were improved on both intervention arms , but staff on the mechanical equipment arm showed greater improvements . Musculoskeletal injury rates were not significantly altered . Conclusions . The “ no strenuous lifting ” program , which combined training with assured availability of mechanical and other assistive patient h and ling equipment , most effectively improved comfort with patient h and ling , decreased staff fatigue , and decreased physical dem and s. The fact that injury rates were not statistically significantly reduced may reflect the less sensitive nature of this indicator compared with the subjective indicators Study Design . R and omized controlled trial . Objective . To evaluate the effectiveness of an ergonomic and psychosocial intervention in reducing low back pain ( LBP ) among health care workers . Summary of Background Data . LBP and injuries are reported frequently among health care workers worldwide . Improvement of person-transfer techniques is the preferred tool in the prevention of both . Although popular , to our knowledge , any effect has not been documented in controlled trials . Methods . Study participants were eldercare workers from 19 eldercare groups r and omly assigned to the transfer technique , stress management , or reference arm . A total of 163 individuals ( 79 % of the source population ) participated in both baseline and follow-up after 2 years . Outcome was intra-individual change in rating of LBP during the past 3 and 12 months . Results . We found no difference in LBP in any of the intervention arms over the study period . Conclusion . The study showed no effect of a transfer technique or stress management program targeting LBP . Thus , there is a need for discussing other priorities in the prevention of LBP among health care workers A prospect i ve epidemiologic study was conducted in two units ( 140 beds and 57 nursing assistants ) of a nursing home to demonstrate the efficacy of an ergonomic intervention strategy to reduce back stress to nursing personnel . The total programme involved the following : determining patient h and ling tasks perceived to be most stressful by the nursing assistants ( NAs ) ; performing an ergonomic evaluation of these tasks ; and conducting a laboratory study to select patient transferring devices perceived to produce less physical stress than existing manual patient-h and ling methods . The intervention phase included training NAs in the use of these devices , modifying toilets and shower rooms , and applying techniques to patient care . Immediately after completing the intervention programme , a post-intervention analysis ( which lasted eight months in unit 1 and four months in unit 2 ) was performed . A biomechanical evaluation of the physical dem and s required to perform stressful patient-h and ling tasks showed that the mean compressive force on the L5/S1 disc , the mean h and force required to make a transfer , and the strength requirements ( expressed as percentage female population capable ) were 1964 N , 122 N , and 83 % after intervention as compared to 4751 N , 312 N , and 41 % before intervention . Subjectively , the mean rating of perceived exertion was less than ' very light ' after intervention as compared to between ' somewhat hard ' and ' hard ' before intervention . Overall , the mean acceptability rates for the walking belt and the mechanical hoist were 81 % and 87 % for patient transfers . The incidence rate for back injuries prior to the intervention , 83 per 200,000 work-hours , decreased to 47 per 200,000 work-hours after the intervention . There were no injuries result ing in lost or restricted work days during the last four months of the post-intervention . It is concluded that an appropriate ergonomic intervention programme offers great promise in reducing physical stress and risk of low-back pain to nursing personnel . However , large-scale studies in different nursing homes are needed to confirm the above findings A physical training intervention was carried out on 75 nurses and nursing aides working irregular shifts to determine the effects of such an intervention on health , sleep-wakefulness and adaptation to shiftwork . The study design and changes in physical fitness , fatigue , sleep and psychosomatic symptoms are examined . Training ( T ) and control ( C ) groups were built r and omly from matched sets of subjects . Question naire , laboratory and field studies were done before and after a controlled physical training programme lasting four months . Maximal oxygen consumption and muscle strength increased and heart rates at rest and at work decreased significantly in the T but not in the C group . General fatique during the shift cycle , and fatigue during the night shifts were reduced , whereas fatigue during the evening shifts increased owing to the intervention . Sleep length increased slightly and musculoskeletal symptoms were reduced . The results suggest that moderate physical training increases the physical fitness of fe Study Design . A prospect i ve cohort . Objectives . To investigate the prevalence of back pain from entering the nursing school through 5 years in nursing and the determinants and modifiers of back pain and disability . Summary of Background Data . Physical loading , psychologic characteristics , and several other factors have been associated with back pain at work in earlier studies . Because of the lack of the prework entry morbidity data , the nature of the associations between these exposures and the symptoms is unclear . That previous back pain is a predictor of later pain underlines the importance to have pre-employment data in investigations of the role of exposures at work . Methods . Female nursing students ( n = 174 ) were followed for 7.5 years . Data on constitutional and behavioral factors , occupational exposures , and back-related symptoms and disability were collected . Back pain was grouped into “ sciatic , ” “ sudden , ” or “ other ” and related disability . Results . The lifetime cumulative prevalence of back pain increased from 31 % at entry to nursing school to 72 % at the end of the school and further to 82 % after 5 years as a nurse . The 1-year prevalence of any back pain was 54 % for the first year in nursing school , 57 % for the first year as a nurse , and 64 % for the fifth year as a nurse . In multivariate analyses , other back pain and related disability as a nurse were associated with back pain history at the entry to nursing school ( odds ratio , 7.1 ; 95 % confidence interval , 1.5–34 ; and 3.6 ; 1.2–11 , respectively ) , and working in twisted/bent positions ( odds ratio , 6.2 ; 95 % confidence interval , 1.7–23 ; and 7.5 ; 2.9–20 , respectively ) . Sudden back pain was not associated with any of the studied risk factors . Sciatic back pain was associated only with working positions ( odds ratio , 6.9 ; 95 % confidence interval , 2.1–23 ) . Conclusions . Lifetime prevalence of back pain increased sharply during nursing school but slowly after that . Back pain at entering the nursing school wasa predictor for back-related pain and disability . Self- reported occupational physical work load was associated with back pain and related disability . The nature of the association is unclear , but it is likely that back pain is exacerbated during nursing |
350 | 29,198,648 | Although the literature supports technicians performing advanced roles in the pharmacy , result ing in either improved patient outcomes or opportunities for pharmacists to engage in additional clinical services , the benefits to the technician were primarily indirect , such as an increase in job satisfaction or a more desirable work schedule .
If a technician is to take on additional roles that require completion of a formalized training or educational program , benefits that are more tangible may help to inspire technicians to pursue these roles | OBJECTIVES To summarize the findings of a literature search on advancing the role of pharmacy technicians , including the types of training identified and the potential costs and benefits to both the technician and the pharmacy . | OBJECTIVES To assess the cost-effectiveness of the 6-month Team Education and Adherence Monitoring ( TEAM ) intervention for black patients with hypertension in community pharmacies using prospect ively collected cost data . DESIGN Cost-effectiveness analysis of a cluster-r and omized trial . SETTING Twenty-eight chain pharmacies in 5 Wisconsin cities from December 2006 to February 2009 . PARTICIPANTS Five hundred seventy-six black patients with uncontrolled hypertension . INTERVENTION Pharmacists and pharmacy technicians using novel tools for improving adherence and feedback to patients and physicians as compared to information-only control group . MAIN OUTCOME MEASURES Incremental cost analysis of variable costs from the pharmacy perspective captured prospect ively at the participant level . Outcomes ( effect measures ) were 6-month refill adherence , changes in systolic blood pressure ( SBP ) and diastolic blood pressure ( DBP ) , and proportion of patients achieving blood pressure ( BP ) control . RESULTS Mean cost of intervention personnel time and tools was $ 104.8 ± $ 45.2 . Incremental variable costs per millimeter of mercury decrease in SBP and DBP were $ 22.2 ± 16.3 and $ 66.0 ± 228.4 , respectively . The cost of helping 1 more person achieve the BP goal ( < 140/90 mm Hg ) was $ 665.2 ± 265.2 ; the cost of helping 1 more person achieve good refill adherence was $ 463.3 ± 110.7 . Prescription drug costs were higher for the TEAM group ( $ 392.8 [ SD = 396.3 ] versus $ 307.0 [ SD = 295.2 ] ; P = 0.02 ) . The startup cost for pharmacy furniture , equipment , and privacy screen was $ 168 per pharmacy . CONCLUSION Our r and omized , practice -based intervention demonstrates that community pharmacists can implement a cost-effective intervention to improve hypertension control in blacks . This approach imposes a nominal expense at the pharmacy level that can be integrated into the ongoing pharmacist-patient relationship , and can enhance clinical and behavioral outcomes OBJECTIVE To assess the effectiveness and sustainability of a 6-month Team Education and Adherence Monitoring ( TEAM ) intervention for black patients with hypertension in community chain pharmacies . DESIGN Cluster r and omized trial . SETTING 28 chain pharmacies ( 14 TEAM and 14 control ) in five Wisconsin cities from December 2006 to February 2009 . PARTICIPANTS 576 black patients with hypertension . INTERVENTION Trained pharmacist-technician teams implemented a 6-month intervention using scheduled visits , Brief Medication Question naires ( BMQs ) , and novel toolkits for facilitating medication adherence and pharmacist feedback to patients and physicians . Control participants received patient information only . MAIN OUTCOME MEASURES Refill adherence ( ≥80 % days covered ) and changes in systolic blood pressure ( SBP ) , diastolic blood pressure , and blood pressure control using blinded assessment s at 6 and 12 months . RESULTS At baseline , all patients had blood pressure of 140/90 mm Hg or more . Of those eligible , 79 % activated the intervention ( mean 4.25 visits ) . Compared with control participants at 6 months , TEAM participants achieved greater improvements in refill adherence ( 60 % vs. 34 % , P < 0.001 ) , SBP ( -12.62 vs. -5.31 mm Hg , P < 0.001 ) , and blood pressure control ( 50 % vs. 36 % , P = 0.01 ) . Six months after intervention discontinuation , TEAM participants showed sustained improvements in refill adherence ( P < 0.001 ) and SBP ( P = 0.004 ) , though the difference in blood pressure control was not significant ( P < 0.05 ) compared with control participants . Analysis of intervention fidelity showed that patients who received the full intervention during months 1 through 6 achieved significantly greater 6- and 12-month improvements in refill adherence and blood pressure control compared with control participants . CONCLUSION A team-based intervention involving community chain pharmacists , pharmacy technicians , and novel toolkits led to significant and sustained improvements in refill adherence and SBP in black patients with hypertension The impact on the care of breast cancer patients , of a pharmacy technician-led medication review and counselling clinic , provided in an outpatient setting , was investigated using a controlled r and omised study . Compared to the controls , clinic patients showed a significantly improved level of underst and ing of their chemotherapy support medication ( 95 % CI for difference in mean knowledge rating scores=2.165–2.826 , P<0.001 ) and a significant reduction in the median number of support items required ( two compared to five in the control , P<0.001 ) . This result ed in a significant reduction in mean medication expenditure per patient ( £ 26.70 vs £ 10.20 , 95 % CI for the mean difference in cost £ 6.72–£26.26 , P<0.001 ) . The clinic was also associated with significant reductions in chemotherapy delays ( P<0.001 ) and dose reductions due to side effects ( P=0.003 ) . Other benefits from the clinic were a reduction in pharmacy dispensing time and a highly significant reduction in pharmacy time spent resolving post-clinic prescription queries ( P<0.001 ) . Taking into account the initial technician training cost , the scheme represented an annual saving to the Trust of over £ 15 000 . The clinic serves as a model for those wishing to improve outpatient services to breast cancer patients Background Medication errors occur regularly in surgical patients , especially due to transfer problems at the time of hospital admission . A method for decreasing the error rate is medication reconciliation by hospital pharmacists as part of a preoperative clinic . The role of pharmacy technicians in this process has not been studied . Objective To study the use of pharmacy technicians in medication reconciliation by measuring the effect of early reconciliation in the preoperative clinic on medication and allergy discrepancies and on inadvertent continuation of antithrombotics . A secondary objective was to study the effect of community pharmacist follow-up on recommendations to discontinue antithrombotic therapy . Methods During the pre intervention measurement period , patients received usual care by anesthesiologists , who recorded the medication and documented allergies of the patient . The intervention consisted of the addition of a pharmacy technician to the preoperative screening clinic to perform the same tasks as anesthesiologists as related to medication reconciliation . If necessary , the patient was advised on stopping the antithrombotic . On the day that the patient was supposed to stop the antithrombotic , that person 's community pharmacist contacted the patient to determine whether this had been done . The main outcome measures were the proportions of patients with one or more medication discrepancy , one or more allergy discrepancy , and one or more antithrombotic error . Results In the preintervention period , 204 patients were evaluated ; 93 were included in the postintervention analysis . The proportion of patients with one or more medication discrepancy ( RR 0.29 ; 95 % CI 0.12 to 0.71 ) was statistically significantly reduced in the postintervention group . The proportions of patients with one or more allergy discrepancy ( RR 0.76 ; 95 % CI 0.35 to 1.64 ) and one or more antithrombotic errors ( RR 0.18 ; 95 % CI 0.02 to 1.33 ) were reduced , but not significantly . Follow-up by the community pharmacist did not identify any patients who had not followed the preoperative clinic 's advice on temporarily withholding their antithrombotics . Conclusions The results of this study show that pharmacy technicians can be successfully assigned to a preoperative clinic , result ing in a statistically significant decrease in medication discrepancies The accuracies with which pharmacists and technicians checked medications in a unit dose distribution system were compared . The study was conducted at three large hospitals in Washington State . From August through October 1991 , technicians filled unit dose medication drawers and pharmacists verified the accuracy of each fill ( pharmacist verification period ) . From November 1991 through January 1992 , technicians who had undergone special training verified the accuracy with which medication drawers were filled by other technicians ( technician verification period ) . For each study period , two error rates were estimated : the frequency with which the pharmacists or technicians identified dispensing errors and the frequency of verification errors identified by the investigators in a final independent check . A total of 143,952 unit doses were dispensed during the pharmacist verification period , of which 49,718 were r and omly analyzed for accuracy . A total of 151,721 doses were dispensed during the technician intervention period , of which 55,470 were assessed . The mean + /- S.E. daily rates of dispensing-error identification by pharmacists ( 0.0125 + /- 0.0069 % ) and technicians ( 0.0119 + /- 0.0001 ) did not differ significantly . While pharmacists overlooked more errors ( 107 ) than technicians ( 50 ) , the percentage of such missed errors classified as potentially serious did not differ significantly between the groups ( 25.2 % versus 32.0 % , respectively ) . Pharmacy technicians who underwent special training were able to verify medications in a unit dose distribution system without compromising the accuracy of dispensing |
351 | 21,176,321 | OPTIONS continuous antibiotic prophylaxis , post-coital antibiotic prophylaxis , and acute self-treatment are all efficient alternatives to prevent recurrent urinary tract infection . | OBJECTIVE to provide an up date of the definition , epidemiology , clinical presentation , investigation , treatment , and prevention of recurrent urinary tract infections in women .
Vaginal estrogen and cranberry juice can also be effective prophylaxis alternatives . | We conducted a r and omized , double-blind , placebo-controlled study to determine the efficacy of postcoital antibiotic prophylaxis in healthy young women prone to recurrent urinary tract infections . Sixteen patients were r and omized to receive postcoital administration of a combination product of trimethoprim and sulfamethoxazole , while 11 received postcoital placebo . The treatment groups were similar with respect to age , parity , diaphragm use , history of lifetime urinary tract infections , frequency of intercourse , and number of lifetime sexual partners . In over 6 months of observation , postcoital administration of trimethoprim-sulfamethoxazole was highly effective in preventing recurrent urinary tract infections . Nine of 11 patients who took the placebo developed urinary tract infections ( infection rate , 3.6 per patient-year ) , compared with only two of 16 patients who received postcoital trimethoprim-sulfamethoxazole ( infection rate , 0.3 per patient-year ) . Postcoital administration of trimethoprim-sulfamethoxazole was effective in patients with both low ( two or fewer times per week ) and high ( three or more times per week ) intercourse frequencies . Side effects were few and compliance was excellent . We conclude that postcoital trimethoprim-sulfamethoxazole is a safe , effective , and inexpensive approach to management of recurrent urinary tract infections in young women PURPOSE We evaluated and compared the efficacy of post-intercourse and daily oral ciprofloxacin prophylaxis against recurrent lower urinary tract infections in 135 sexually active premenopausal women . MATERIAL S AND METHODS Post-intercourse ( group 1 , 70 patients ) and daily ( group 2 , 65 patients ) prophylactic regimens of 125 mg . ciprofloxacin were started following a curative , conventional treatment of the initial acute urinary tract infection . Prophylaxis was maintained for 12 months and during this period patients were followed clinical ly and bacteriologically with urine and introital sample s. Patients were subsequently followed for an additional year after the end of preventive treatment . RESULTS While 3.67 urinary tract infections per patient in group 1 and 3.74 in group 2 occurred during an identical mean time of 12.2 months before start of the corresponding prophylactic regimen , only 0.043 infection per patient in group 1 and 0.031 in group 2 developed during prophylaxis ( p < 0.0001 ) . Before prophylaxis 86 % of the vaginal vestibule cultures yielded gram-negative Enterobacteriaceae , equally distributed between both treatment arms , compared to 5.6 % and 2.5 % during postcoital and daily prophylaxis , respectively . The overall improvement in the incidence of the urinary infections per patient and the rate of introital colonization with enteric gram-negative bacteria was maintained after the end of prophylaxis , with a mean incidence of infections of 0.44 per patient ( occurring in 34 % of the total patient population ) , while 36 % of all women had abnormal introital colonization . CONCLUSIONS Long-term post-intercourse prophylaxis with ciprofloxacin proved to be equally effective as daily prophylaxis , and the major advantage of the former therapy was use of only a third of the amount of drug consumed in daily prophylaxis To study once-daily antimicrobial prophylaxis of urinary tract infections , we gave trimethoprim-sulfamethoxazole ( 40 mg/200 mg ) , trimethoprim ( 100 mg ) , nitrofurantoin macrocrystals ( 100 mg ) , or placebo to 60 women for 6 months . During prophylaxis , infections per patient year were comparable in the groups receiving trimethoprim ( 0.0 ) , nitrofurantoin ( 0.14 ) , or trimethoprim-sulfamethoxazole ( 0.15 ) and occurred less frequently than in patients receiving placebo ( 2.8 ; P less than 0.001 , placebo versus each drug regimen ) . The effectiveness of prophylaxis was limited to the 6 months that antimicrobials were given , and infections were more likely to develop after prophylaxis in women who had three or more infections in the year before prophylaxis ( P less than 0.005 ) . Further , women whose preprophylaxis infection was positive for antibody-coated bacteria were more likely to have same-strain relapse when infections recurred ( P = 0.001 ) . Emergence of trimethoprim-resistant Escherichia coli was rare , but non-E. coli infections occurred more often after prophylaxis ( P less than 0.05 ) . Prophylaxis with these drugs is effective , well tolerated , and did not produce emergence of resistant E. coli but may predispose to non-E. coli urinary tract infections after its discontinuation BACKGROUND cranberry juice is often given to older people in hospital to prevent urinary tract infection ( UTI ) , although there is little evidence to support its use . OBJECTIVE to assess whether cranberry juice ingestion is effective in reducing UTIs in older people in hospital . DESIGN r and omised , placebo-controlled , double-blind trial . SETTING Medicine for the Elderly assessment and rehabilitation hospital wards . SUBJECTS 376 older patients in hospital . METHODS participants were r and omised to daily ingestion of 300 ml of cranberry juice or matching placebo beverage . The primary outcome was time to onset of first UTI . Secondary outcomes were adherence to beverage drinking , courses of antibiotics prescribed , and organisms responsible for UTIs . RESULTS a total of 21/376 ( 5.6 % ) participants developed a symptomatic UTI : 14/189 in the placebo group and 7/187 in the cranberry juice group . These between-group differences were not significant , relative risk ( RR ) 0.51 [ 95 % CI 0.21 - 1.22 , P = 0.122 ) . Although there were significantly fewer infections with Escherichia coli in the cranberry group ( 13 versus 4 ) RR 0.31 [ 95 % CI 0.10 - 0.94 , P = 0.027 ] , this should be interpreted with caution as it was a secondary outcome . CONCLUSION despite having the largest sample size of any clinical trial yet to have examined the effect of cranberry juice ingestion , the actual infection rate observed was lower than anticipated , making the study underpowered . This study has confirmed the acceptability of cranberry juice to older people . Larger trials are now required to determine whether it is effective in reducing UTIs in older hospital patients We compared the efficacy and safety of estriol-containing vaginal pessary use with those of oral nitrofurantoin macrocrystal ( NM ) therapy for preventing urinary tract infection ( UTI ) in postmenopausal women with recurrent UTI . Over a period of 9 months , 86 women received an estriol-containing vaginal pessary ( 0.5 mg estriol ) twice weekly , and 85 women received NM ( 100 mg ) once daily . We recorded 124 episodes of UTI in women who received estriol-releasing pessaries and 48 episodes of UTI in women treated with NM ( P=.0003 ) . Twenty-eight women ( 32.6 % ) who received estriol had no episodes of UTI versus 41 women ( 48.2 % ) in the NM group . There was a significant increase in the number of superficial cells in women who received estriol , whereas in the NM group , no such changes occurred . However , there was no change in the extent of Lactobacillus colonization and in the vaginal pH in women who received estriol . Use of an estriol-containing pessary is less effective than oral NM therapy in the prevention of bacteriuria in postmenopausal women because of its failure to restore the population of lactobacilli and to reduce the vaginal pH in these women OBJECTIVE The primary objective was to detect a difference in time until the first recurrence of urinary tract infection during treatment with an estradiol-releasing silicone vaginal ring ( Estring ; Pharmacia & Upjohn , Inc , Uppsala , Sweden ) compared with no estrogen treatment . The secondary objective was to detect any differences in improvement of urethral and vaginal mucosal atrophy and in the subjective assessment of urogenital symptoms . The study also sought to detect a difference in decrease of vaginal pH to < 5.5 and to record adverse events . STUDY DESIGN This was a multicenter , r and omized , open , parallel-group study with an untreated control group . Postmenopausal women with recurrent symptomatic , bacteriologically confirmed urinary tract infections were r and omly assigned to receive either Estring ( 2 mg estradiol ) or no estrogen treatment . One ring was carried vaginally for 12 weeks . The duration of treatment was 36 weeks for the Estring group and either 36 weeks or until the first recurrence for the control group . Both intent-to-treat and per- protocol analyses were performed to evaluate efficacy , whereas the safety analysis was limited to the intent-to-treat group . The primary variable was analyzed by survival analysis with the Kaplan-Meier method for estimating the survival density function . To compare the survival curves for the 2 treatment groups a log-rank test was performed for time until first recurrence . RESULTS A total of 108 women were r and omly assigned , 53 to the Estring group and 55 to the control group . The cumulative proportion of women remaining free of urinary tract infection was significantly higher in the Estring group than in the control group ( P = .008 ) . After 36 weeks of study the cumulative likelihood of remaining free of disease was approximately 45 % in the women with the vaginal ring compared with approximately 20 % in the control group . Estring lowered vaginal pH , and the time to first recurrence was effectively prolonged by Estring treatment . Vaginal and , to a lesser extent , urethral mucosal cells were significantly more mature in the Estring group . No unexpected adverse events were found . CONCLUSION Estring is useful to prolong the time to next recurrence among postmenopausal women with recurrent urinary tract infection and to decrease the number of recurrences per year . The silicone vaginal ring also has a clinical ly significant ability to alleviate other postmenopausal urogenital symptoms . Estring is safe and well tolerated OBJECTIVE To evaluate the efficacy of vesical instillation of hyaluronic acid against recurrent urinary tract infections . METHODS Twenty women with a history of recurrent urinary tract infections each received 9 intravesical instillations of hyaluronic acid over 6 months . Their status was assessed prospect ively over 47.6 weeks and compared with a retrospective review of patient charts covering 36.2+/-6.2 weeks . RESULTS The total numbers of urinary tract infections were 67 before and 10 after treatment ( p<0.001 ) . Thirteen patients ( 65 % ) were free of recurrences until the end of the study . One had a recurrence during treatment , and 6 ( 30 % ) during follow-up . The number of infections per year per patient was reduced from 4.99+/-0.92 to 0.56+/-0.82 ( p<0.001 ) . In women with recurrences , time to recurrence was 178.3+/-25.5 days , compared with 76.7+/-24.6 days before treatment ( p<0.001 ) . CONCLUSION Intravesical instillation of hyaluronic acid is effective in preventing recurrent urinary tract infections BACKGROUND Dysuria is one of the most common presenting complaints of young women , and urinalysis is one of the most common laboratory tests performed . Despite the fact that the midstream clean-catch technique is commonly used for urine collection , contaminated urine cultures occur with distressing regularity . The midstream clean-catch technique is time-consuming to explain , frequently not performed correctly by patients , costly for supplies , often embarrassing for patients and staff , and of unproven benefit . Therefore , we design ed a study to compare various methods of obtaining specimens for culture from acutely dysuric young women . METHODS A total of 242 consecutive female patients who presented with symptoms suggestive of a urinary tract infection were r and omized into 3 groups . The first group ( n = 77 ) was instructed to urinate into a clean container . No cleansing was done , and the specimen was not obtained midstream . The second group ( n = 84 ) was instructed to collect a midstream urine sample with perineal cleansing and spreading of the labia . In an attempt to decrease contamination from the vagina , the third group ( n = 81 ) was given the same instructions as group 2 , with the addition of using a vaginal tampon . Contamination rates were calculated for all 3 groups . RESULTS Contamination rates for the 3 groups were nearly identical ( 29 % , 32 % , and 31 % , respectively ) . Comparing the no-cleansing group with the combined cleansing , midstream groups also showed no difference in contamination rates ( 28.6 % and 31.5 % , respectively , with P = .65 ) . CONCLUSIONS In young , outpatient women with symptoms suggestive of a urinary tract infection , the midstream clean-catch technique does not decrease contamination rates BACKGROUND Recurrent urinary tract infections are a problem for many postmenopausal women . Estrogen replacement restores atrophic mucosa , lowers vaginal pH , and may prevent urinary tract infections . METHODS We enrolled 93 postmenopausal women with a history of recurrent urinary tract infections in a r and omized , double-blind , placebo-controlled trial of a topically applied intravaginal estriol cream . Midstream urine cultures were obtained at enrollment , monthly for eight months , and whenever urinary symptoms occurred . Vaginal cultures and pH measurements were obtained at entry and after one and eight months . The women were assigned to receive either estriol ( n = 50 ) or placebo ( n = 43 ) , both administered intravaginally ; 36 and 24 , respectively , completed the eight months of follow-up . RESULTS The incidence of urinary tract infection in the group given estriol was significantly reduced as compared with that in the group given placebo ( 0.5 vs. 5.9 episodes per patient-year , P < 0.001 ) . Survival analysis showed that more of the women in the estriol group than in the placebo group remained free of urinary tract infection ( P < 0.001 ) . Lactobacilli were absent in all vaginal cultures before treatment and reappeared after one month in 22 of 36 estriol-treated women ( 61 percent ) but in none of the 24 placebo recipients ( P < 0.001 ) . With estriol the mean vaginal pH declined from 5.5 to 3.8 ( P < 0.001 ) , whereas there was no significant change with placebo . The rate of vaginal colonization with Enterobacteriaceae fell from 67 percent to 31 percent in estriol recipients but was virtually unchanged ( from 67 to 63 percent ) in the placebo recipients ( P < 0.005 ) . Side effects were minor , but caused 10 estriol recipients ( 28 percent ) and 4 placebo recipients ( 17 percent ) to discontinue treatment . CONCLUSIONS The intravaginal administration of estriol prevents recurrent urinary tract infection in postmenopausal women , probably by modifying the vaginal flora Abstract Objective : To determine whether recurrences of urinary tract infection can be prevented with cranberry-lingonberry juice or with Lactobacillus GG drink . Design : Open , r and omised controlled 12 month follow up trial . Setting : Health centres for university students and staff of university hospital . Participants : 150 women with urinary tract infection caused by Escherichia coli r and omly allocated into three groups . Interventions : 50 ml of cranberry-lingonberry juice concentrate daily for six months or 100 ml of lactobacillus drink five days a week for one year , or no intervention . Main outcome measure : First recurrence of symptomatic urinary tract infection , defined as bacterial growth ≥105 colony forming units/ml in a clean voided midstream urine specimen . Results : The cumulative rate of first recurrence of urinary tract infection during the 12 month follow up differed significantly between the groups ( P=0.048 ) . At six months , eight ( 16 % ) women in the cranberry group , 19 ( 39 % ) in the lactobacillus group , and 18 ( 36 % ) in the control group had had at least one recurrence . This is a 20 % reduction in absolute risk in the cranberry group compared with the control group ( 95 % confidence interval 3 % to 36 % , P=0.023 , number needed to treat=5 , 95 % confidence interval 3 to 34 ) . Conclusion : Regular drinking of cranberry juice but not lactobacillus seems to reduce the recurrence of urinary tract infection . What is already known on this topic Up to 60 % of women will have a urinary tract infection and a third of them will have several recurrences Vaccinium berries and products containing lactobacilli may affect the coliform bacteria that cause urinary tract infection What this study adds 50 ml of cranberry-lingonberry juice concentrate daily reduced recurrences of symptomatic urinary tract infection by about half compared with the control group Lactobacillus GG drink had no effect on recurrence Self treatment with cranberry juice may reduce the need for antimicrobials for recurrent urinary tract PURPOSE To estimate the annual incidence , cumulative probability of presumed urinary tract infection ( UTI ) by age , and the social costs . METHODS Analysis of a r and om digit dialing survey of 2000 women in the United States . RESULTS 10.8 percent ( 95 % CI : 9.4 , 12.1 % ) of women aged 18 and older reported at least one presumed UTI during the past 12 months , with the majority of the cases occurring among women with a history of two or more UTI episodes in their life . We estimate that by age 24 , one-third of women will have at least one physician-diagnosed UTI that was treated with prescription medication . Overall , an estimated 11.3 million women in the United States had at least one presumed UTI treated with antibiotics in 1995 . We estimate the annual cost of UTI cases with prescriptions to be $ 1.6 billion in 1995 . If the costs occurring after 1995 are discounted at 5 % annually , the total cost over 20 years has a present value of $ 25.5 billion . CONCLUSION If a vaccine were developed that would prevent either initial or recurrent UTI the net benefits to society would be substantial , even at a developmental cost of one billion dollars Abstract Objective : Todetermine whether antibacterial effects of cranberry extract will reduce or eliminate bacteriuria and pyuria in persans with spinal cord injury ( SCI ) . Design : R and omized , double – blind , placebo – controlled study . Participants : Participants were people with SCI residing in the community who were 1 year or Ionger postinjury with neuragenie bladder managed by intermittent catheterization or external collection device and a baseline urine culture demonstrating at least 105colanies per milliliter of bacteria . Methods : Each participant ingested 2 g of concentrated cranberry juice or placebo in capsule form daily for 6 months . Baseline urinalysis and cultures were performed at the time of the initial clinic visit and monthly for 6 months . Microbiologic data were evaluated using analysis of variance with repeated measures . Results : Twenty – six persans received cranberry extract and 22 persans received placebo . There were no differences or trends detected between participants and controls with respect to number of urine specimens with bacterial counts of at least 104 colanies per milliliter , types and numbers of different bacterial species , numbers of urinary leukocytes , urinary pH , or episodes of symptomatic urinary tract infection . Conclusion : Cranberry extract taken in ca psule form did not reduce bact eriuria and pyuria in persans with SCI and can not be recommended as a means to treat these conditions PURPOSE To determine , from a societal perspective , the effectiveness and cost effectiveness of concentrated cranberry tablets , versus cranberry juice , versus placebo used as prophylaxis against lower urinary tract infection ( UTI ) in adult women . MATERIAL S AND METHODS One hundred fifty sexually active women aged 21 through 72 years were r and omized for one year to one of three groups of prophylaxis : placebo juice + placebo tablets versus placebo juice + cranberry tablets , versus cranberry juice + placebo tablets . Tablets were taken twice daily , juice 250 ml three times daily . Outcome measures were : ( 1 ) a > 50 % decrease in symptomatic UTI 's per year ( symptoms + > or= 100 000 single organisms/ml ) and ( 2 ) a > 50 % decrease in annual antibiotic consumption . Cost effectiveness was calculated as dollar cost per urinary tract infection prevented . Stochastic tree decision analytic modeling was used to identify specific clinical scenarios for cost savings . RESULTS Both cranberry juice and cranberry tablets statistically significantly decreased the number of patients experiencing at least 1 symptomatic UTI/year ( to 20 % and 18 % respectively ) compared with placebo ( to 32 % ) ( p<0.05 ) . The mean annual cost of prophylaxis was $ 624 and $ 1400 for cranberry tablets and juice respectively . Cost savings were greatest when patients experienced > 2 symptomatic UTI 's per year ( assuming 3 days antibiotic coverage ) and had > 2 days of missed work or required protective undergarments for urgency incontinence . Total antibiotic consumption was less annually in both treatment groups compared with placebo . Cost effectiveness ratios demonstrated cranberry tablets were twice as cost effective as organic juice for prevention . CONCLUSIONS Cranberry tablets provided the most cost-effective prevention for UTI OBJECTIVES The aim of this r and omized double-blind trial was to compare two 400 mg pefloxacin regimens either once-a-week or once-a-month applied for 48 weeks for the prophylaxis of recurrent urinary tract infection in women . METHODS The main outcome measures were symptomatic and bacteriological reinfections during the period of prophylaxis and rates of reinfections during the three months of surveillance following the end of prophylaxis . 361 women of 18 to 51 years of age suffering from recurrent lower urinary tract infection were r and omly allocated to receive pefloxacin 400 mg once-a-week ( group A : n = 185 ) or 400 mg once-a-month ( groupe B : n = 176 ) for 48 weeks . RESULTS Seventeen of the 185 patients in group A ( 9.1 % ) and 52/176 patients in group B ( 29.5 % ) experienced at least one reinfection during the period of prophylaxis ( p < 0.0001 ) . The rates of reinfection during the three months of surveillance following the end of the treatment were not significantly different between the two groups with 14/101 ( 13.8 % ) patients with at least a reinfection in group A and 8/75 patients ( 10.6 % ) in group B ( p = 0.51 ) . In group A , 49/174 ( 28.1 % ) patients reported at least an adverse event compared with 33/169 ( 19.5 % ) patients in group B ( p = 0.06 ) . CONCLUSIONS Once-a-week treatment with 400 mg of pefloxacin can be considered as a new effective and well tolerated approach for the prophylaxis of recurrent urinary tract infection in women and does not entail excessive emergence of pefloxacin resistant bacteria , even after 48 weeks of treatment BACKGROUND Although acute urinary tract infections are common in young women , the associated risk factors have not been defined prospect ively . METHODS We recruited sexually active young women who were starting a new method of contraception at a university health center or a health maintenance organization ( HMO ) and monitored them for six months for symptomatic urinary tract infections . Daily diaries and serial interviews were used to collect data on potential risk factors . RESULTS Among 796 women , the incidence of urinary tract infections per person-year was 0.7 in the university cohort ( mean age , 23 years ; n = 348 ) and 0.5 in the HMO cohort ( mean age , 29 ; n = 448 ) . In both cohorts , there were strong dose-response relations between the risk of infection and both recent use of a diaphragm with spermicide ( respective relative risks for one , three , and five days of use in the past week , 1.42 , 2.83 , and 5.68 in the university cohort , P<0.001 ; and 1.29 , 2.14 , and 3.54 in the HMO cohort , P=0.04 ) and recent sexual intercourse ( respective relative risks for one , three , and five days with intercourse in the past week , 1.37 , 2.56 , and 4.81 in the university cohort , P<0.001 ; and 1.24 , 1.91 , and 2.96 in the HMO cohort , P=0.002 ) . The risk of acute infection was also associated with a history of recurrent infection ( relative risk , 5.58 in the university group and 2.10 in the HMO group ) but not with cervical-cap use , ABO-blood-group nonsecretor phenotype , or delayed postcoital voiding . CONCLUSIONS Among sexually active young women the incidence of symptomatic urinary tract infection is high , and the risk is strongly and independently associated with recent sexual intercourse , recent use of a diaphragm with spermicide , and a history of recurrent urinary tract infections PURPOSE To describe the incidence of and risk factors for acute cystitis among nondiabetic and diabetic postmenopausal women . METHODS We conducted a population -based , prospect i ve cohort study of 1017 postmenopausal women , aged 55 to 75 years , who were enrolled in a health maintenance organization and followed for 2 years . A wide range of behavioral and physiologic exposures were assessed at baseline interview and follow-up clinic visits ; the main outcome measure was microbiologically confirmed acute symptomatic cystitis . Follow-up was 87 % at 12 months and 81 % at 24 months . RESULTS During 1773 person-years of follow-up , 138 symptomatic urinary tract infections occurred ( incidence , 0.07 per person-year ) . Independent predictors of infection included insulin-treated diabetes ( hazard ratio [ HR ] = 3.4 ; 95 % confidence interval [ CI ] : 1.7 to 7.0 ) and a lifetime history of urinary tract infection ( HR for six or more infections = 6.9 ; 95 % CI : 3.5 to 13.6 ) . Borderline associations included a history of vaginal estrogen cream use in the last month ( HR = 1.8 ; 95 % CI : 1.0 to 3.4 ) , a history of kidney stones ( HR = 1.9 ; 95 % CI : 1.0 to 3.7 ) , and asymptomatic bacteriuria at baseline ( HR = 1.8 ; 95 % CI : 0.9 to 3.5 ) . Sexual activity , urinary incontinence , parity , postcoital urination , vaginal dryness , use of cranberry juice , vaginal bacterial flora , and postvoid residual bladder volume were not associated with incident acute cystitis after multivariable adjustment . CONCLUSION Insulin-treated diabetes is a potentially modifiable risk factor for incident acute cystitis among postmenopausal women , whereas a lifetime history of urinary tract infection was the strongest predictor . Use of oral or vaginal estrogen was not protective , and a wide range of behavioral and physiologic factors was not associated with acute cystitis episodes in this generally healthy sample BACKGROUND There is a paucity of data on the efficacy of nitrofurantoin for the treatment of acute uncomplicated cystitis in regimens shorter than 7 days . Evidence -based use of this drug is increasingly important as trimethoprim-sulfamethoxazole resistance among uropathogens increases . METHODS To assess the efficacy of nitrofurantoin vs trimethoprim-sulfamethoxazole , 338 women aged 18 to 45 years with acute uncomplicated cystitis were r and omized to open-label treatment with either trimethoprim-sulfamethoxazole , 1 double-strength tablet twice daily for 3 days , or nitrofurantoin , 100 mg twice daily for 5 days . Clinical cure 30 days after therapy was the main outcome measure . Secondary outcomes included clinical and microbiological cure rates 5 to 9 days after therapy and , for trimethoprim-sulfamethoxazole-treated women , clinical cure stratified by the trimethoprim-sulfamethoxazole susceptibility of the uropathogen . RESULTS Clinical cure was achieved in 79 % of the trimethoprim-sulfamethoxazole group and in 84 % of the nitrofurantoin group , for a difference of -5 % ( 95 % confidence interval , -13 % to 4 % ) . Clinical and microbiological cure rates at the first follow-up visit were also equivalent between the 2 groups . In the trimethoprim-sulfamethoxazole arm , 7 of 17 women ( 41 % ) with a trimethoprim-sulfamethoxazole-nonsusceptible isolate had a clinical cure compared with 84 % of women with a trimethoprim-sulfamethoxazole-susceptible isolate ( P < .001 ) . CONCLUSION A 5-day course of nitrofurantoin is equivalent clinical ly and microbiologically to a 3-day course of trimethoprim-sulfamethoxazole and should be considered an effective fluoroquinolone-sparing alternative for the treatment of acute cystitis in women The increasing microbial antibiotic resistance motivates research for non-antibiotic treatment alternatives . In recurrent urinary tract infections ( UTIs ) , ' bacterial interference ' has attracted interest as a possible alternative treatment option . The observation that asymptomatic bacteriuria ( ABU ) protects against recurrent UTI has prompted clinical trials with deliberate colonization of the human urinary tract as an alternative approach in patients with recurrent UTI . The strain used for colonization , the ABU isolate Escherichia coli 83972 , has been shown to cause symptom-free colonizations for long periods of time . Patients on long-term colonization report a subjective benefit , and UTI treatments are rare in colonized patients . This report presents an up date on open long-term E. coli 83972 colonization trials and describes the design of an ongoing r and omized trial Changes in the indigenous vaginal microflora with uropathogenic bacteria can predispose women to frequently recurring bacterial cystitis . Lactobacilli used as probiotics have played an important role in preventing the colonization of pathogenic bacteria in the vagina . A prospect i ve clinical pilot study was performed to confirm the safety and effectiveness of Lactobacillus vaginal suppositories against the recurrence of bacterial urinary tract infection ( UTI ) . The patients enrolled in the study were instructed to administer vaginal suppositories containing the strain Lactobacillus crispatus GAI 98322 . A significant reduction in the number of recurrences was noted , without any adverse complication ( P=0.0007 ) . The administration of vaginal suppositories containing L. crispatus GAI 98332 seemed to be a safe and promising treatment for the prevention of recurrent UTI Many women remain susceptible to ascending urinary tract infections ( UTIs ) despite the absence of a demonstrable anatomic abnormality [ 1 ] . Repeated treatment with antibiotics is often necessary for these women but may lead to adverse reactions and infection with antibiotic-resistant organisms [ 2 ] . On the basis of concepts of mucosal immunity in the genitourinary tract [ 3 - 5 ] , we have been working to develop an effective mucosally applied vaginal immunogen to help prevent ascending UTIs . After a trial in nonhuman primates , we carried out and reported two previous clinical trials in susceptible women [ 6 - 8 ] . We are now reporting on a clinical trial to extend the time period of protection through use of the same multivalent vaginal immunogen and through immunogen boosts given at 4week intervals OBJECTIVE To examine whether vaginal application of Lactobacillus casei v. rhamnosus reduces the reinfection rate in cystitis-prone women . DESIGN A controlled , r and omized , double-blind clinical trial . SETTING Division for General Practice , University of Bergen , Norway . INTERVENTION Vaginal application of lactobacilli twice weekly . SUBJECTS 47 women , aged 18 - 50 years , reporting three or more episodes of distal urinary symptoms during the previous 12 months , of which at least one episode had been medically verified as a lower UTI . MAIN OUTCOME MEASURE The incidence rate of lower UTI during 6 months ' follow-up . RESULTS No difference in infection rate between the two groups ; the incidence rate ratio between the treatment group and the placebo group was 1.41 ( 95 % confidence interval 0.88 - 1.98 ) . Lactobacilli were not found more frequently periurethrally in the treatment group than in the control group . CONCLUSION It is still uncertain whether vaginal application of lactobacilli reduces the infection rate in cystitis-prone women Acute lower urinary tract infections ( UTIs ) are common in adult women , and as many as 6 % of members of the adult female population experience 3 or more episodes during a given year.1 In 1995 , an estimated 11.3 million women in the United States received antibiotic treatment for at least 1 presumed UTI , result ing in associated costs of $ 1.6 billion during that year.2 Women with frequently recurrent cystitis may need prophylactic antibacterial treatment . However , such treatment may result in development of antimicrobial resistance , which is a medical problem of increasing concern.3 A recent study indicated that the rate of cystitis among cystitis-prone women treated with acupuncture was one third the rate among untreated women and half the rate among women treated by sham acupuncture ( shallow needling outside known acupuncture points).4 In the present study , we sought to evaluate the effect of acupuncture treatment in preventing uncomplicated recurrent lower UTIs among adult nonpregnant women To define host factors associated with an increased risk of recurrent urinary tract infection ( RUTI ) , a case-control study was conducted in 2 population s : university women and health maintenance organization enrollees . Case patients were 229 women 18 - 30 years old with RUTIs ; control subjects were 253 r and omly selected women with no RUTI history . In a multivariate model , independent risk factors for RUTI included recent 1-month intercourse frequency ( odds ratio [ OR ] , 5.8 ; 95 % confidence interval [ CI ] , 3.1 - 10.6 for 4 - 8 episodes ) , 12-month spermicide use ( OR , 1.8 ; 95 % CI , 1.1 - 2.9 ) , and new sex partner during the past year ( OR , 1.9 ; 95 % CI , 1.2 - 3.2 ) . Two newly identified risk factors were age at first urinary tract infection ( UTI ) < /=15 years ( OR , 3.9 ; 95 % CI , 1.9 - 8.0 ) and UTI history in the mother ( OR , 2.3 ; 95 % CI , 1.5 - 3.7 ) . Blood group and secretor phenotype were not associated with RUTI . In young women , risk factors for sporadic UTI are also risk factors for recurrence . Two predictors suggest that genetic/long-term environmental exposures also predispose to RUTI OBJECTIVE To evaluate the effect of acupuncture in the prevention of recurrent lower urinary tract infection ( UTI ) in adult women . DESIGN A controlled clinical trial with three arms : an acupuncture group , a sham-acupuncture group , and an untreated control group . Patients were followed for 6 months . SETTING An acupuncture clinic in Bergen , Norway . SUBJECTS Sixty-seven adult women with a history of recurrent lower UTI . MAIN OUTCOME MEASURES Acute lower UTIs during the 6-month observation period . RESULTS Eighty-five percent were free of lower UTI during the 6-month observation period in the acupuncture group , compared with 58 % in the sham group ( p < 0.05 ) , and 36 % in the control group ( p < 0.01 ) . There were half as many episodes of lower UTI per person-half-year in the acupuncture group as in the sham group , and a third as many as in the control group ( p < 0.05 ) . CONCLUSION Acupuncture seems a worthwhile alternative in the prevention of recurring lower UTI in women BACKGROUND Within-household transmission of extraintestinal pathogenic Escherichia coli ( ExPEC ) may contribute to the pathogenesis of urinary tract infection ( UTI ) , but this is poorly understood . METHODS A woman with acute UTI , 4 human household members who cohabited with her , and the family 's pet dog underwent prospect i ve longitudinal surveillance for colonizing E. coli for 7 - 9 weeks after the woman 's UTI episode . Unique clones were resolved by r and om amplified polymorphic DNA and pulsed-field gel electrophoresis analysis . Virulence genes , phylogenetic group , and O types were defined by PCR . Comparisons with reference strains were made using r and om amplified polymorphic DNA profiling . RESULTS Serial fecal and urine sample s from the 6 household members yielded 7 unique E. coli clones ( 4 of which were ExPEC and 3 of which were non-ExPEC ) . For 3 clones , extensive among-host sharing was evident in patterns suggesting host-to-host transmission . The mother 's UTI clone , which represented E. coli O1:K1:H7 , was the clone that was most extensively shared ( in 5 hosts , including the dog ) and most frequently recovered ( in 45 % of sample s and at all 3 time points ) . The other 3 ExPEC clones corresponded with E. coli O6:K2:H1 , O1:K1:H7 , and O2:F10,F48 . CONCLUSIONS E. coli clones , including ExPEC , can be extensively shared among human and animal household members in the absence of sexual contact and in patterns suggesting host-to-host transmission |
352 | 24,660,200 | CONCLUSIONS Immediately and conventionally loaded single-implant crowns are equally successful regarding implant survival and marginal bone loss .
Immediately and conventionally loaded implants do not appear to differently affect the papilla height during the first year of loading .
Due to the heterogeneity of the time point of baseline measurements and contradictory findings in the studies , it is difficult to draw clear conclusions regarding the recession of the buccal mucosa . | PURPOSE To test whether or not immediate loading of single-implant crowns renders different results from early and conventional loading with respect to implant survival , marginal bone loss , stability of peri-implant soft tissue , esthetics , and patient satisfaction . | OBJECTIVES the aim of this r and omized-controlled clinical trial was to compare the objective and subjective esthetic outcomes of two types of screwed-retained single-implant crowns . MATERIAL S AND METHODS participants were r and omly assigned to the test ( all-ceramic ) and control [ porcelain-fused-to-ceramic ( PFM ) ] groups and were seen under investigation at baseline ( B ) , crown insertion ( CI ) , 1-year follow-up ( 1Y ) , and 2-year follow-up ( 2Y ) . Objective parameters were assessed by an intra-oral digital photograph ( 1:1 ratio ) , a study cast , a st and ardized radiograph , periodontal/peri-implant measurements , and question naires were obtained for the subjective parameters . In addition , pink esthetic score ( PES ) and white esthetic score ( WES ) were calculated for both groups . For the subjective evaluation , a visual analogue scale ( VAS ) question naire was used to assess the level of patient satisfaction regarding the esthetic outcome . Then , nine expert clinicians visually inspected and assessed subjective evaluation at the professional level . Statistical analysis was used to compare between groups and investigational appointments . RESULTS twenty patients were included in the study , 10 allocated to the all-ceramic group and 10 to the PFM group . No statistically significant differences were observed for the objective measurements comparing the test and control groups . Minor chipping of the ceramic veneering material was observed in the two patients of control group . The mean difference for all groups comparing objective parameters revealed an increase of papilla height between time points . A slight recession ( 0.26 mm ) of the peri-implant mucosal margin at the implant site was observed between 1Y and 2Y . Mean values for PES and WES were 13.9 and 13.1 for the PFM group and for the all-ceramic group , respectively . These values were not statistically significant . Implant crown volume , outline , translucency , and characterization showed major discrepancies with the contra-lateral natural teeth . As for subjective parameters , VAS patients ' responses regarding their perceptions of the esthetic outcome showed no statistical differences between groups and clinicians ' accuracy scores were 50 % and 47 % for PFM and all-ceramic crowns , respectively . CONCLUSION PFM and all-ceramic single-implant restorations may be indistinguishable from each other regarding the objective /subjective assessment of esthetic integration . The material chosen for fabricating an implant crown per se does not ensure an optimal esthetic outcome if other esthetic parameters are not present OBJECTIVES The aim of this study was to evaluate the aesthetics of implant-supported single-tooth replacements using different augmentation procedures in a prospect i ve study with the use of an objective rating index and with a subjective patient question naire , and to compare the results with each other . MATERIAL AND METHODS Ninety-three patients with a single-tooth gap in the anterior zone of the maxilla were selected for the study . All patients had a local bone defect that needed augmentation before placement of an endosseous implant with sufficient initial stability . Aesthetics of the implant-supported crown and adjacent mucosa was rated by a prosthodontist 1 year after placement of the porcelain crown . Aesthetics was rated using the Implant Crown Aesthetic Index . A subjective appreciation of the final result was assessed with a patient question naire . RESULTS The Implant Crown Aesthetic Index reveals a mean overall score of 4.8 , with an acceptable result in 66 % of the cases . Results of the satisfaction question naire reveal a mean overall score of 8.5 with an acceptable result in 100 % of the cases . There is no correlation between results of the Index and the question naire for the overall and the crown score . The patients ' opinion and the professionals ' opinion about the peri-implant mucosa do show a significant correlation . CONCLUSIONS The peri-implant mucosa is rated as less satisfactory than the implant-supported crown by both the dental professional and patients . The dental professional was less satisfied with respect to the total result and results of the crown than the patients PURPOSE To compare the outcome of immediately loaded single implants inserted with medium ( from 25 to 35 Ncm ) or high insertion torques ( > 80 Ncm ) . MATERIAL S AND METHODS Fifty patients received two single non-adjacent implants , each r and omly inserted flapless with a torque between 25 to 35 Ncm or > 80 Ncm according to a split-mouth design . Non-occluding temporary crowns were immediately placed on provisional abutments and definitive crowns were delivered after 6 weeks . Patients were followed for 6 months after initial loading . Outcome measures were crown/implant failures , complications , peri-implant marginal bone level changes , postoperative pain and presence of peri-implant apical radiolucency . RESULTS No drop-out occurred . Seven implants inserted with a torque between 25 to 35 Ncm failed versus none of the implants inserted with a torque > 35 Ncm . With the exception of crown/implant failures ( exact McNemar significance P = 0.0156 , difference in proportions : -0.12 ; 95 % CI -0.21 to -0.02 ) there were no statistically significant differences between groups for the other outcome measures . CONCLUSIONS It is preferable to insert single implants with a high insertion torque ( > 80 Ncm ) , to minimise early implant failures , when loading them immediately OBJECTIVES The aim of the present study was to evaluate the outcome of immediate functional loading of implants in single-tooth replacement using two different installation procedures . MATERIAL AND METHODS One hundred and fifty-one subjects , who required single-tooth rehabilitation in the area of 15 - 25 and 35 - 45 , were enrolled in eight private clinics in Italy . The implant sites were r and omly allocated to one of the following treatment groups . In the control group , in which a st and ard preparation procedure for implant placement and submerged healing of the implant was used , abutment connection and loading of the implants were performed 3 months after installation . In the test group 1 , a st and ard preparation procedure for the implant placement and immediate functional loading of implant was carried out . In the test 2 group , however , a modified implant installation procedure ( osteotome technique ) was used followed by immediate functional loading of the implant . Clinical and radiographic examinations were performed at 3 and 12 months of follow-up at all sites . RESULTS Three implants ( 5.5 % ) from the test 2 group ( osteotome preparation ) and one ( 2 % ) from the test 1 group ( conventional drill preparation ) failed to integrate and were removed one and three months after implant installation . The mean marginal bone loss assessed at 12 months was 0.31 mm ( test 1 ) , 0.25 mm ( test 2 ) and 0.38 mm ( control ) ( no statistically significant differences were found between the three treatment groups . ) CONCLUSION It is suggested that immediate functional loading of implants that are placed with a conventional installation technique and with sufficient primary stability may be considered as a valid treatment alternative in a single-tooth replacement AIM The purpose of this prospect i ve study was to evaluate radiographic , clinical and aesthetic outcomes and patient satisfaction of cases treated with platform-switched single implant restorations in the aesthetic region of the maxilla . Furthermore , the influence of an augmentation procedure 3 months before implant placement and the type of restoration ( screw-retained vs. cement-retained ) was evaluated . MATERIAL AND METHODS Sixty patients with a missing anterior tooth in the maxilla were treated with a Straumann Bone Level Implant . Bone augmentation was performed in 29 patients at 3 months before implant placement . Implants were loaded after 3 months of submerged healing . Follow-up was conducted at 7 and 18 months after implant placement . Peri-implant mucosa and implant crown aesthetic outcomes were determined using the Implant Crown Aesthetic Index ( ICAI ) and the Pink Esthetic Score-White Esthetic Score ( PES-WES ) . RESULTS No implants were lost . At 18 months after implant placement , mean bone level change was -0.10 ± 0.27 mm and mean probing pocket depth was 2.57 mm . No differences were found between augmented and nonaugmented sites ( P = 0.28 ) . The ICAI indicated satisfactory mucosa and crown aesthetics in 67 % and 75 % of the cases , respectively , while the PES score was 14.4 . ICAI mucosa ( P = 0.004 ) and PES ( P = 0.02 ) scores were significantly less favourable for augmented sites compared with nonaugmented sites . Patient satisfaction was high ( 8.9 ± 1.1 on VAS-score ) . CONCLUSIONS From the present prospect i ve , clinical study , it can be concluded that the Straumann Bone Level Implant shows an excellent survival rate , marginal bone stability and good clinical and aesthetic results . Bone augmentation before implant placement does not lead to more marginal bone loss . However , less favourable pink aesthetic outcomes were found in augmented sites compared with nonaugmented sites , while no differences were found between cement-retained and screw-retained restorations PURPOSE The primary goal of this stratified r and omized controlled trial ( S RCT ) was to compare the stability of dental implants placed under three different loading regimens during the first 16 weeks of healing following implant placement . Implants were loaded immediately , early ( 6 weeks ) , or with conventional/delayed timing ( 12 weeks ) . Secondary outcomes were to compare marginal bone adaptation for 3 years after placement . MATERIAL S AND METHODS Single posterior implant sites in the maxilla or m and ible were examined . The insertion torque value was the primary determinant of load assignment . Resonance frequency analysis was performed at follow-up appointments for the first 16 weeks ( with results provided as implant stability quotients [ ISQs ] ) . Marginal bone levels were assessed via radiographs . RESULTS Forty patients each received a single 4.0-mm diameter dental implant between 2004 and 2007 . One implant failure occurred in Lekholm and Zarb type 4 bone with insertion torque value ( ITV ) of < 8.1 Ncm ; the cumulative success rate was 97.5 % . All implants , when classified by bone and loading type , increased in stability over time , with a minor reduction of 1.3 ISQ units seen at 4 weeks in the immediate loading group . The mean marginal bone loss over 3 years was 0.22 mm . The mean ITVs at implant placement for bone types 1 and 2 ( grouped together ) , 3 , and 4 were 32 , 17 , and 10 , respectively , and were significantly different ( P < .05 ) . CONCLUSIONS ITV was a good objective measure of bone type . Using an ITV of 20 Ncm as the determinant for immediate loading and an ITV of 10 Ncm or greater as the determinant for early loading provided long-term success for this implant and led to no negative changes in tissue response . All bone type groups and loading groups showed no reduction in stability during the first 4 months of healing PURPOSE The possibility of expediting dental implant therapy by early or immediate loading protocol s requires long-term clinical investigation . The aim of this prospect i ve cohort trial was to determine the 3-year implant success rate and prosthesis complications associated with functional loading 3 weeks after 1-stage placement of Astra Tech single-tooth implants replacing maxillary anterior teeth . A secondary objective was to determine peri-implant tissue responses at these implants . MATERIAL S AND METHODS The peri-implant bone and mucosal conditions of 43 implants in 39 subjects were radiographically and clinical ly measured 3 years after implant placement . RESULTS Of the 48 patients originally treated , 39 patients and 43 implants were examined at the 3-year time point . Three of 54 implants failed within the first year . No additional failures were recorded since the 12-month reporting period . Peri-implant bone levels were stable for the 3-year period following implant placement . The change in marginal bone levels after 3 years was 0.42 + /- 0.59 mm . Papilla growth was measured at 1 and 3 years ( 0.61 + /- 0.95 mm and 0.74 + /- 0.79 mm , respectively ) . The buccal peri-implant tissue dimensions at the gingival zenith also increased at 1 and 3 years ( 0.34 + /- 0.94 mm and 0.51 + /- 1.42 mm , respectively ) . No abutment screw loosening or fracture occurred . DISCUSSION AND CONCLUSIONS Early loading of endosseous dental implants placed in healed ridges offers select benefits to clinicians and their patients AIM this study compared the outcome of immediate non-occlusal loading with conventional loading for single implants in the maxillary aesthetic zone . It was hypothesized that immediate non-occlusal loading is not inferior to conventional loading . MATERIAL S AND METHODS sixty-two patients with a missing maxillary anterior tooth were r and omly assigned to be treated with an implant that was either restored with a non-occluding temporary crown within 24 h after implant placement ( the " immediate group " ) or was restored according to a two-stage procedure after 3 months ( the " conventional group " ) . All implants were installed in healed sites . Follow-up visits were conducted after 6 and 18 months post-implant placement . Outcome measures were radiographic marginal bone-level changes , survival , soft tissue aspects ( probing depth , plaque , bleeding , soft tissue level ) , aesthetics and patient satisfaction . RESULTS no significant differences were found between both study groups regarding marginal bone loss ( immediate group 0.91 ± 0.61 mm , conventional group 0.90 ± 0.57 mm ) , survival ( immediate group 96.8 % : one implant lost , conventional group 100 % ) , soft tissue aspects , aesthetic outcome and patient satisfaction . CONCLUSION within the limitations of this study ( sample size , follow-up duration ) , it was demonstrated that , for single implants in the anterior maxilla , the outcome of immediate non-occlusal loading was not less favourable than conventional loading Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more OBJECTIVES The aim of this prospect i ve study was to evaluate dimensional alterations of the peri-implant tissues at single-tooth restorations from the time of implant placement to 1-year post-loading . MATERIAL AND METHODS Eleven patients , aged 18 - 36 years , subjected to single-tooth replacements with implant-supported restorations ( Brånemark implant system ) in the maxillary anterior region were included in the analysis . The implant installation was performed as a two-stage procedure with a 6-month healing interval . Bone dimensions were determined by direct assessment s immediately following implant placement and at abutment connection . The prosthetic restoration was placed approximately 1 month after abutment surgery . Radiographic and clinical examinations were performed at crown placement and at 1-year post-loading . Assessment s of the soft tissues at the implant site and at the neighboring teeth were performed before and during implant placement , before abutment connection , after crown placement and at the 1-year follow-up examination . Mean values and st and ard deviations were calculated for each variable and interval , with the subject as the statistical unit . RESULTS At the time of abutment connection , a mean loss of bone height at the facial and lingual aspect of the implant amounting to 0.7 - 1.3 mm ( P < 0.05 ) was recorded , whereas no significant change was noted at proximal sites . A mean reduction of 0.4 mm of the labial bone thickness was observed between implant placement and the second-stage surgery . The radiographic bone-to-implant level showed a mean loss of 0.9 mm between abutment connection and crown placement ( P<0.05 ) and a further 0.7 mm loss at 1 year ( P < 0.05 ) . The thickness of the labial mucosa was increased at crown placement followed by a slight remission at 1 year . During the corresponding interval , a mean apical displacement of the labial soft tissue margin of 0.6 mm had taken place ( P < 0.05 ) . A papilla fill of > or = 50 % was observed at a frequency of 32 % at crown placement and 86 % at 1 year . CONCLUSIONS The results demonstrated that following implant surgery remodeling takes place , which is manifested in diminished bone dimensions , both horizontally and vertically , at the facial aspect of the implant . The observed soft tissue alterations after the crown placement may affect the esthetic appeal of the restorative therapy BACKGROUND Early implant placement is one of the treatment options after tooth extraction . Implant surgery is performed after a healing period of 4 to 8 weeks and combined with a simultaneous contour augmentation using the guided bone regeneration technique to rebuild stable esthetic facial hard- and soft-tissue contours . METHODS In this prospect i ve study , 20 patients were treated with an implant-born single crown and followed for 3 years . Clinical , radiologic , and esthetic parameters were recorded to assess treatment outcomes . RESULTS At the 3-year examination , all 20 implants were successfully integrated , demonstrating ankylotic stability and healthy peri-implant soft tissues as documented by st and ard clinical parameters . Esthetic outcomes were assessed by the pink esthetic score ( PES ) and white esthetic score ( WES ) and confirmed pleasing results overall . WES values were slightly superior to PES values . Periapical radiographs showed minimal crestal bone loss around used bone-level implants with a mean bone loss of 0.18 mm at 3 years . Only two implants revealed bone loss between 0.5 and 1.0 mm . One of these implants had minor mucosal recession < 1.0 mm . CONCLUSIONS This prospect i ve study evaluates the concept of early implant placement and demonstrated successful tissue integration for all 20 implants and stable bone-crest levels around implant-abutment interfaces according to the platform-switching concept . The midterm 3-year follow-up revealed pleasing esthetic outcomes and stable facial soft tissues . The risk of mucosal recession was low , with only one patient showing minor recession of the facial mucosa . These encouraging results need to be confirmed with a 5-year follow-up examination PURPOSE The aim of this study was to report a clinical comparative assessment of crestal bone level change around single implants in fresh extraction sockets in the esthetic zone of the maxilla either immediately loaded or loaded after a delay . MATERIAL S AND METHODS Forty patients were included in a prospect i ve , r and omized study . All patients required 1 tooth extraction ( ie , 1 tooth with a hopeless prognosis ) and were r and omized into either the test group or the control group . Implants were positioned immediately after tooth extraction and were loaded immediately in the test group ( 20 implants ) and after 3 months in the control group ( 20 implants ) . The implant site was prepared , with at least 4 mm of sound apical bone below the implant apex , and the coronal margin of the implant was placed at the buccal level of the bone crest . All implants were 13 mm long ; 30 implants had a diameter of 5 mm , and 10 had a diameter of 3.75 mm . Radiographic examinations were made at baseline , at 6 months , and at 24 months . To compare the mean values between test and control group , a paired t test was performed ( considered statistically significant at P < .05 ) . RESULTS After a 24-month follow-up period , a cumulative survival rate of 100 % was reported for all implants . The control group result ed in a mean mesial bone loss of 1.16 + /- 0.32 mm and a mean distal bone loss of 1.17 + /- 0.41 ( mean bone loss , 1.16 + /- 0.51 mm ) . The test group result ed in a mesial bone loss of 0.93 + /- 0.51 mm and a distal bone loss of 1.1 + /- 0.27 mm ( mean bone loss , 1.02 + /- 0.53 mm ) . No statistically significant difference between control and test groups ( P > .05 ) was found . CONCLUSION The success rate and radiographic results of immediate restorations of dental implants placed in fresh extraction sockets were comparable to those obtained in delayed loading group PURPOSE This prospect i ve r and omized controlled trial aim ed to compare single implant-supported m and ibular molar restorations using either an immediate or a delayed loading protocol . MATERIAL S AND METHODS Thirty subjects requiring single m and ibular molar replacement were consecutively treated . One implant was placed in each patient . Fifteen subjects were assigned to delayed loading protocol and 15 to immediate loading protocol according to a r and omization table . After insertion , the delayed loaded implants were connected to a healing abutment and restored after 3 to 4 months of healing without loading . The immediately loaded implants were loaded within 24 hours of surgery with a provisional restoration . The interim prosthesis was placed in centric occlusion . All contacts in lateral excursions were eliminated . At implant placement the maximum value of insertion torque was recorded . Radiographic bone level change was measured on periapical radiographs obtained at the time of implant placement and 12 months after loading . Means of the 2 groups were compared by Student t test and analysis of variance ( ANOVA ) . The level of significance was set at .05 . RESULTS No implants were lost in the delayed loading group ( 0/15 ) , whereas 1 implant failed ( 1/15 ) in the immediate loading group . No differences were observed in relation to implant length or insertion torque between the groups . The average radiographic bone level change after 1 year of function was 1.2 + /- 0.55 mm ( range , 0.5 to 2.6 mm ) and 0.77 + /- 0.38 mm ( range , 0.29 to 1.23 mm ) for the delayed loaded and the immediately loaded implants , respectively . The difference in radiographic bone level change between the delayed and immediate loading groups was statistically significant ( P = .022 ; CI = -0.79 to -0.06 ; Student t test ) . CONCLUSIONS Immediate loading of wide-diameter implants supporting single restorations in m and ibular molar sites seems to be a suitable clinical option . Moreover , the radiographic bone level change observed after 12 months of loading was significantly less for immediately loaded implants PURPOSE This 1-year prospect i ve study evaluated the implant success rate , peri-implant tissue response , and esthetic outcome of immediately placed and provisionalized maxillary anterior single implants . MATERIAL S AND METHODS Thirty-five patients ( 8 men , 27 women ) with a mean age of 36.5 years ( range 18 to 65 ) were included in this study . Thirty-five threaded , hydroxyapatite-coated implants were placed and provisionalized immediately after each failing tooth had been removed . The definitive restoration was placed 6 months later . The patients were evaluated clinical ly and radiographically at implant placement and at 3 , 6 , and 12 months after implant placement . RESULTS At 12 months , all implants remained osseointegrated . The mean marginal bone change from the time of implant placement to 12 months was -0.26 + /- 0.40 mm mesially and -0.22 + /- 0.28 mm distally . No significant differences in the Plaque Index scores were noted at different time intervals . The mean midfacial gingival level and mesial and distal papilla level changes from pretreatment to 12 months were -0.55 + /- 0.53 mm , -0.53 + /- 0.39 mm , and -0.39 + /- 0.40 mm , respectively . All patients were very satisfied with the esthetic outcome and none had noticed any changes at the gingival level . DISCUSSION Although marginal bone and gingival level changes were statistically significant from pretreatment to 12 months of follow-up , they were well within clinical expectations . CONCLUSION The results of this study suggest that favorable implant success rates , peri-implant tissue responses , and esthetic outcomes can be achieved with immediately placed and provisionalized maxillary anterior single implants AIM The purpose of this prospect i ve multicenter clinical study was to compare 3 years implant survival , bone and soft tissue changes following immediate loading using single Osseospeed ( ™ ) implants ( Astra Tech AB , Mölndal , Sweden ) installed in healed ridges or extraction sockets . MATERIAL AND METHODS Implants were provisionally restored the day of surgery using cemented acrylic crowns out of full occlusion . The provisional crowns were replaced after 12 weeks by full-ceramic crowns . Implant survival , bone levels , soft tissue levels and peri-implant health were monitored up to 3 years . RESULTS 55 patients ( 22 men , 33 women ; mean age 45 ) had the implant installed in extraction sockets and 58 patients ( 25 men , 33 women ; mean age 42 ) received conventional implant treatment in healed ridges . Three implants failed in the extraction group and one implant failed in the healed group , all failures occurred before the final crown placement . No further losses occurred during 3 years , giving a statistically comparable survival rate of 94.6 % and 98.3 % , respectively . The total bone loss after 3 years , compared to implant placement was 0.4 mm ( SD 1.5 ) in healed sites , whilst the immediate sites showed a bone gain of 1.6 mm ( SD 2.4 ) due to bone fill in the alveolus . Papillae retracted with 0.3 and 0.0 mm in the period of provisionalization , but grew back after final crown was placed with 0.3 and 0.5 mm in extraction and healed sites respectively after 3 years . Plaque and inflammation scores were very low throughout the study time , irrespective of treatment modality . CONCLUSIONS Immediate implants restored at the day of surgery show comparable risk for implant failure , bone loss and midfacial soft tissue recession compared to conventionally installed implants . The 3-years results suggest both hard and soft tissue stability AIM The aim of this study was to compare the clinical outcome of submerged vs. non-submerged tapered implants placed into fresh extraction sockets . MATERIAL S AND METHODS A prospect i ve , controlled , multicenter , r and omized , clinical trial has been performed in two centers in Rome and Torino ( Italy ) . Thirty healthy patients were recruited according to the following inclusion criteria : need for an immediate post extraction implant , ages between 18 and 70 , horizontal defect depth < 2 mm , smokers < 10 cigarettes/day and absence of any circumstance or condition that could represent contraindications to implant surgery . The patients were r and omly allocated to submerged or non-submerged treatment groups immediately after flap elevation and tooth extraction . Submerged implants were exposed 8 weeks after the first surgery ; all implants were loaded with provisional restorations 12 weeks after the first surgery and with definitive restoration 12 weeks thereafter . Clinical and radiographic parameters were evaluated at baseline , at implant loading and at the 1-year follow-up visit . RESULTS The results showed statistically significant differences between the two groups in the mean value of keratinized tissue ( KT ) height after surgery that was significantly reduced for submerged implants when compared with transmucosal implants ( mean reduction of KT at year follow-up : T group 0.2 mm , S group 1.3 mm ; P=0.007 ) . CONCLUSION Similar outcomes were found for submerged and non-submerged implants placed in fresh extraction sockets with a horizontal peri-implant defect smaller than 2 mm , except for a reduction of KT in the submerged group . Either with a submerged or a non-submerged procedure , 1 mm of mean soft tissue recession is seen after 1 year when compared with the pre- extraction situation BACKGROUND Conventional implant protocol s advocate a two-stage technique with a load-free , submerged healing period . Recent studies suggest that immediate restoration of single implants may be a viable treatment option . PURPOSE The purpose of this study was to evaluate prosthodontic and aesthetic peri-implant mucosal outcomes of immediately restored , Southern single-tapered implants in the anterior maxilla after 1 year . MATERIAL S AND METHODS Participants ( mean age : 43.25 years ; range : 23 - 71 years ) satisfying specified inclusion criteria were r and omly allocated to conventional two-stage restoration ( control group ; n=14 ) and immediate restoration groups ( test group ; n = 14 ) in a r and omized controlled clinical trial . Tapered , roughened-surface Southern implants were placed using a st and ardized technique , and implant level bone impressions were made . Provisional screw-retained crowns , out of occlusion , were placed at second-stage surgery after 26 weeks for the conventional restoration group , and within 4 hours of implant placement for the immediate restoration group . Both groups had definitive screw-retained metal-ceramic crowns placed in occlusion 8 weeks later . Peri-implant mucosal response and papilla index were recorded 4 weeks after definitive crown placement to allow for mucosal maturation and at 1 year . Prosthodontic and aesthetic outcomes were assessed using established criteria . RESULTS There were no significant differences within , or between , the control and test groups for age , gender , bone quality or quantity , implant stability measurements at surgery , or implant length . There were no significant differences in the implant success rate as determined by radiographic bone loss and stability tests after 1 year . There were no significant differences in prosthodontic maintenance , peri-implant mucosal response , and papilla index between the two groups over 1 year . CONCLUSIONS Tapered , roughened-surface implants immediately restored with single provisional crowns at surgery and definitive crowns 8 weeks later were as prosthodontically and aesthetically successful as conventionally restored two-stage implants during the first year of service . Restoring single implants immediately with screw-retained crowns is an efficient procedure , but the short-term outcome is by no means superior to a conventional two-stage approach PURPOSE The objective of this prospect i ve study was to assess the overall outcome of immediate single implant treatment in the anterior maxilla after a 3-year observation period . MATERIAL AND METHODS Thirty consecutively treated patients with a thick gingival biotype , ideal gingival level/contour and intact socket walls at the time of tooth extraction were treated for single-tooth replacement in the aesthetic zone by two experienced clinicians . Treatment included minimal mucoperiosteal flap elevation , immediate implant placement ( NobelReplace TiUnite ( ® ) ) , insertion of a grafting material between the implant and the socket wall and connection of a screw-retained provisional restoration . The latter was replaced by a cemented crown 6 months thereafter . Patients were clinical ly and radiographically re-examined after 3 years to assess implant survival , complications and hard and soft tissue conditions . The aesthetic outcome was objective ly rated using the Pink Esthetic Score ( PES ) and White Esthetic Score ( WES ) by a blinded clinician who had not been involved in the treatment . RESULTS Twenty-five patients could be re-evaluated after 3 years . One early implant failure had occurred result ing in an implant survival rate of 96 % . Radiographic examination yielded on average 1.13 mm mesial , respectively 0.86 mm distal bone loss . The clinical conditions showed fairly low peri-implant plaque ( 18 % ) and bleeding ( 24 % ) and mean probing depth was 3.17 mm . Mean mesial/distal papilla shrinkage and midfacial soft tissue recession in reference to the pre-operative status accounted for 0.05 , 0.08 and 0.34 mm , respectively . Between the 1- and 3-year re assessment mesial papillae showed significant re-growth ( 0.36 mm ; p=0.015 ) . Advanced midfacial recession ( > 1 mm ) was found in 2/25 ( 8 % ) cases . Five ( 21 % ) cases were aesthetic failures ( PES<8 and /or WES<6 ) and 5/24 ( 21 % ) showed an ( almost ) perfect outcome ( PES≥12 and WES≥9 ) . The remainder ( 14/24 or 58 % ) demonstrated acceptable aesthetics . CONCLUSIONS The proposed strategy seems a valuable and predictable treatment option for well-selected patients in the mid-long term as shown by almost full papillary re-growth and a low risk for advanced midfacial recession PURPOSE This study evaluated the survival parameters of single-tooth implants through clinical and radiographic analysis . MATERIAL S AND METHODS Implants were restored within a 24-hour period with a provisional crown design ed to receive an occlusal masticatory load . This approach was compared to implants restored after a healing period ( the control group ) . Forty-six implants were placed in 23 patients who were each treated with 2 Frialit-2 implants placed in sites between the second premolar in the maxilla or m and ible . The manufacturer 's recommended formal surgical procedure was followed , and primary stability was st and ardized with a minimum insertion torque of 20 Ncm . The sites were r and omly selected , and the clinical and radiographic parameters were st and ardized with individual templates . RESULTS Data were collected at 24 h , and at 1 , 3 , 6 , 12 , 18 , and 24 months . The experimental group included 10 failed implants ; 9 of the failed implants had been placed with an insertion torque of 20 Ncm . One implant from the control group failed during the 24-month follow-up period . The survival rate was independent of implant length , site position , and bone quality and quantity . Relative risk for implant failure was associated with insertion torque ( relative risk 0.79 [ CI : 0.66 - 0.930 ] ; Cox regression ) ( P < or = .007 ) , in the experimental group but was not significant for those in the control group ( ie , implants placed after a healing period ; relative risk 0.78 [ CI : 0.34 - 1.78 ] ; Cox regression ) ( P < or = .057 ) . To achieve osseointegration , it was found that an insertion torque above 32 Ncm was necessary ( chi2= 15.68 ; P < or = .004 ) . DISCUSSION A careful evaluation is necessary for a better underst and ing of the survival rates of immediately loaded implants . In this study , insertion torque was associated with the potential for risk , which can be decreased by 20 % per 9.8 Ncm added . CONCLUSION Given these results , and considering the number of patients treated , immediate provisional crowns should only be proposed with early loading if an appropriate initial insertion torque has been applied PURPOSE The literature suggests that predictable integration can be achieved when dental implant placement is combined with immediate fixed provisional restoration in a variety of clinical situations . Fewer data are available , however , regarding outcomes for immediate provisional restoration of implants in the edentulous maxilla . This report presents 1-year data acquired from a long-term prospect i ve clinical trial design ed to assess outcomes following the immediate provisional fixed restoration of implants in the atrophic edentulous maxilla without the use of bone augmentation . MATERIAL S AND METHODS Fifty-one subjects diagnosed with an atrophic edentulous maxilla received a total of 306 implants ( six implants per subject ) followed by fixed provisional restoration within 24 hours of implant placement . No subjects underwent grafting to enhance bone volume in preparation for implant treatment . Data acquired included bone quantity and quality , implant dimensions , implant locations , and implant placement stability . Subjects returned for 1-year follow-up examinations to assess implant integration and restoration function . Periapical radiographs were obtained and compared to baseline images to assess marginal bone height maintenance . RESULTS At the 3-month follow-up examination , 294 of 306 implants placed in 51 subjects were found to be integrated . This represents a cumulative implant survival rate of 96 % . At the 1-year follow-up examination , mean marginal bone loss of 0.5 mm was noted , with no further loss of implants . CONCLUSIONS These results support the contention that predictable long-term outcomes may be obtained for the atrophic edentulous maxilla when treated with an implant rehabilitation protocol that includes immediate fixed provisional restoration without the use of bone grafting . This strategy offers a promising treatment alternative for the patient with an atrophic edentulous maxilla AIM The objective of the present study was to assess implant survival rate , hard and soft tissue response and aesthetic outcome 1 year after immediate placement and provisionalization of single-tooth implants in the pre-maxilla . All patients underwent the same strategy , that is mucoperiosteal flap elevation , immediate implant placement , insertion of a grafting material between the implant and the socket wall and the connection of a screw-retained provisional restoration . MATERIAL AND METHODS Thirty consecutive patients were treated for single-tooth replacement in the aesthetic zone by means of immediate implant placement and provisionalization . Reasons for tooth loss included caries , periodontitis or trauma . At 6 months , provisional crowns were replaced by the permanent ones . Clinical and radiographic evaluation was completed at 1 , 3 , 6 and 12 months to assess implant survival and complications , hard and soft tissue parameters and patient 's aesthetic satisfaction . RESULTS One implant had failed at 1 month of follow-up , result ing in an implant survival rate of 97 % . Radiographic examination yielded 0.98 mm mesial , respectively , 0.78 mm distal bone loss . Midfacial soft tissue recession and mesial/distal papilla shrinkage were 0.53 , 0.41 and 0.31 mm , respectively . Patient 's aesthetic satisfaction was 93 % . CONCLUSIONS The preliminary results suggest that the proposed strategy can be considered to be a valuable treatment option in well-selected patients PURPOSE This is a follow-up of an earlier 1-year prospect i ve study on implant success rates and the peri-implant response after immediate placement and provisionalization of single implants in the esthetic zone . The effects of gingival biotype on the peri-implant tissues were also evaluated . MATERIAL S AND METHODS Thirty-five patients were evaluated clinical ly and radiographically at presurgical examination ( T0 ) , immediately after immediate implant placement and provisionalization ( T1 ) , 1 year after implant surgery ( T2 ) , and the latest follow-up appointment ( T3 ) . Data were analyzed using t tests and repeated- measures analysis of variance at the significance level of alpha = .05 . RESULTS After a mean follow-up time of 4 years ( range , 2 to 8.2 years ) , all implants remained in function . At T3 , the mean mesial and distal marginal bone level changes were significantly greater than those observed at T2 . At T3 , the mean mesial and distal papilla level changes were significantly smaller than those observed at T2 , whereas the mean facial gingival level change was significantly greater than that observed at T2 . Sites with a thick gingival biotype exhibited significantly smaller changes in facial gingival levels than sites with a thin gingival biotype at both T2 and T3 . CONCLUSIONS Favorable implant success rates and peri-implant tissue responses can be achieved with this procedure . While the results suggest the possibility of spontaneous papilla regeneration over time following this procedure , continuing recession of the facial gingival tissue was also observed . The effect of gingival biotype on peri-implant tissue response seemed to be limited only to facial gingival recession and did not influence interproximal papilla or proximal marginal bone levels UNLABELLED The aim of this 1-year prospect i ve controlled clinical trial was to evaluate the effect of early loading of ITI solid screw titanium implants with a s and blasted and acid-etched ( SLA ) surface on clinical and radiographic parameters . MATERIAL AND METHODS Twenty-seven consecutively admitted patients presenting bilateral edentulous posterior m and ibular areas and in need of prosthetic reconstruction were recruited . Sixty-seven ITI st and ard solid screw implants with an SLA surface , a diameter of 4.1 mm and a length of 8 , 10 or 12 mm were installed bilaterally in molar and premolar areas according to a one-stage surgical protocol . One week ( test ) and 5 weeks ( control ) after implant placement , solid ITI prosthetic abutments were connected using a torque of 35 N cm . No provisional restoration was fabricated . Two weeks ( test ) and 6 weeks ( control ) after implant placement , porcelain-fused-to-metal single-tooth crowns were cemented . Clinical measurements were obtained at day 0 and 2 , 6 , 12 , 24 and 52 weeks thereafter . Periapical radiographs were taken immediately after implant placement , after 6 weeks and at the 1-year examination . RESULTS After 1 year , implant survival was 100 % . Two test and one control implants rotated at the time of abutment connection and were left unloaded for 12 additional weeks . At the 1-year examination , no statistically significant differences were found between the test and control sites with respect to pocket probing depths ( 2.6 mm + /- 0.5 vs. 2.7 mm + /- 0.5 ) , mean clinical attachment levels ( 3.1 mm + /- 0.4 vs. 3.2 mm + /- 0.5 ) , mean percentages of sites bleeding on probing ( 9.7 % vs. 8.3 % ) , mean widths of keratinized mucosa ( 1.8 mm + /- 0.4 vs. 1.9 mm + /- 0.5 ) , mean PerioTest values ( -1.4 PTV + /- 0.9 vs. -1.6 PTV + /- 0.8 ) or mean crestal bone loss measurements ( 0.57 mm + /- 0.49 vs. 0.72 mm + /- 0.50 ) . CONCLUSION Based on these results , loading of titanium implants with an SLA surface as early as 2 weeks did not appear to jeopardize the osseointegration healing process in the posterior m and ible . Furthermore , implants rotating at 35 N cm , if left unloaded for additional 12 weeks , did not negatively affect clinical and radiographic outcomes OBJECTIVES The aim of this prospect i ve clinical study was to evaluate the clinical outcomes of dental implants placed in the m and ibular molar sites and immediately functionally restored compared with conventionally loaded controls in an in-patient study . MATERIAL AND METHODS Twenty-four dental implants were placed in 12 patients who had first molar loss bilaterally in the m and ibular area . One site of the patient was determined as immediately loaded ( IL ) and the other side was conventionally loaded ( CL ) . Resonance frequency analyses for implant stability measurements , radiographic examinations for marginal bone levels and peri-implant evaluations were performed during the clinical follow-up appointments within 12 months . RESULTS During the 12-month follow-up period , only one implant was lost in the IL group . The mean implant stability quotient values were 74.18+/-5.72 and 75.18+/-3.51 for Groups IL and CL at surgery , respectively , and the corresponding values were 75.36+/-5.88 and 75.64+/-4.84 at 1-year recall , respectively . The difference was not statistically significant between the two groups during the 12-month study period ( P>0.05 ) . When peri-implant parameters were evaluated , excellent peri-implant health was demonstrated during the 1-year observation period and all implants showed less than 1 mm of marginal bone resorption during the first year . CONCLUSIONS In the present study , immediate functionally loading did not negatively affect implant stability , marginal bone levels and peri-implant health when compared with conventional loading of single-tooth implants BACKGROUND Implant-supported single-tooth replacements are an increasingly used method to replace teeth , especially in young patients . Therefore , long-term validation of different treatment modalities with different implant systems is of great importance . PURPOSE The aim of the present study was to make a biologic , technical , and aesthetic evaluation of single-tooth replacement supported by the Astra Tech implant ( Astra Tech AB , Mölndal , Sweden ) during a 5-year period . MATERIAL S AND METHODS Twenty patients were divided into two consecutively treated groups . In group A the implants were placed " early " in the extraction sockets , and st and ard single-tooth abutments were used . In group B the implants were placed " delayed , " and preparable abutments were used . Clinical examinations including registration of plaque , bleeding , crown lengths , soft tissue marginal level , papilla height , complications , and radiography were performed yearly . At the 3-year control examination the patient and a dentist evaluated aesthetic appearance with a visual analog scale . RESULTS An implant survival rate of 100 % and a crown survival rate of 95 % over a period of 5 years were found . The mean loss of marginal bone adjacent to implants and neighboring teeth was less than 0.5 mm during the 5-year period , and there was no significant difference after crown placement between the treatment modality for group A and that for B. There were fewer clinical complications and repairs in group B than in group A. Soft tissue dimensions were more natural around implant crowns in group B as compared to group A , but this was not reflected in the patients ' satisfaction with aesthetic appearance . On the other h and the dentist judged the restorations in group B higher concerning aesthetics than in group A. CONCLUSION Implant-supported single-tooth replacement with the Astra Tech system is a reliable treatment result ing in a good 5-year prognosis and only few complications OBJECTIVE The immediate single-tooth implant has become a viable treatment option . However , the impact of the restorative procedure on esthetics is currently unclear . The goal of this study was to compare the soft tissue outline at immediate implants following two restorative protocol s : immediate connection of a temporary crown or submerged healing during which a removable partial denture is used . MATERIAL AND METHODS A 1-year single-blind r and omized clinical study was performed in 49 patients . Twenty-four patients were assigned to the immediate restoration group and 25 to the delayed restoration group . Clinical and radiographic evaluations of soft and hard tissues were carried out after 3 , 6 and 12 months . RESULTS Implant survival , bone remodeling , probing depth and bleeding tendency were not influenced by the restorative protocol . Delayed restoration result ed in initial papilla loss taking up to 1 year to attain comparable height as for immediate restoration . Midfacial recession was systematic ally 2.5 - 3 times higher following delayed restoration pointing to a 0.75 mm additional loss in comparison with immediate restoration after 1 year . CONCLUSIONS If the primary implant stability permits it , immediate single-tooth implants should be instantly provisionalized in the interest of optimal midfacial esthetics PURPOSE To compare the efficacy of immediate nonocclusal loading ( test group ) versus early loading ( control group ) in partially edentulous patients . MATERIAL S AND METHODS Fifty-two patients in 5 Italian private practice s were r and omized to 1 of the treatments : 25 to the immediately loaded group and 27 to the early loaded group . To be immediately loaded , single implants had to be inserted with a torque of > 30 Ncm , and splinted implants had to be inserted with a torque of > 20 Ncm . Implants in the immediately loaded group were provided with full acrylic resin nonoccluding temporary restorations within 48 hours after placement . After 2 months , full occluding provisional restorations were provided . Implants in the early loading group were not submerged and were loaded after 2 months . At 8 months , provisional restorations were replaced with definitive metal-ceramic prostheses . Outcome measures were prosthesis and implant failures as well as biologic and prosthetic complications recorded by nonblinded assessors . The Fisher exact test was used to compare the proportion of implant failures . RESULTS Fifty-two implants were placed in the immediately loaded group and 52 in the early loaded group . No dropouts or complications occurred up to 14 months postinsertion . One single implant failed in the immediately loaded group 2 months after placement . There was no statistically difference for the tested outcome measures between the 2 procedures ( P > .99 ) . CONCLUSIONS The results of this r and omized controlled clinical trial with 25 patients rehabilitated with immediately restored nonocclusally loaded implant-supported prostheses compared to 27 patients restored 2 months following placement suggest that there are no major clinical differences in implant survival between these 2 protocol s. No biologic or prosthetic complications occurred AIM To evaluate the peri-implant tissues in patients with two adjacent implant crowns in the aesthetic zone , treated with either two adjacent implants with a scalloped platform or with a flat platform . MATERIAL AND METHODS Forty patients were r and omly allocated to : ( 1 ) a " scalloped implant group " : 20 patients treated with two adjacent implants with a scalloped platform , and ( 2 ) a " flat implant group " : 20 patients treated with two adjacent implants with a flat platform . Clinical and radiographic examinations were performed during a 1-year follow-up period to assess hard and soft tissue changes . RESULTS The scalloped implant group showed significantly more marginal bone loss ( scalloped : 2.7±1.4 mm , flat : 0.9±0.8 mm ) and more inter-implant bone crest loss ( scalloped : 1.8±1.4 , flat : 1.0±0.9 mm ) than the flat implant group . There was no significant difference between the groups with regard to the papilla index and patients ' satisfaction . CONCLUSION After 1 year of function , there was more bone loss around scalloped implants than around flat implants . With regard to the presence of papilla , there were no differences between the groups . With both applied implant design s , it is difficult to establish a predictable and harmonious aesthetic result , especially regarding the peri-implant mucosa . Patients were very satisfied with the aesthetic outcome of the adjacent implants irrespective of the treatment concept applied BACKGROUND This 2-year r and omized clinical trial compared bone regeneration and esthetic outcome between immediate and conventional loading of dental implants placed immediately after extraction in patients with a history of periodontal disease . METHODS Patients were r and omly assigned to receive immediate implants with either immediate loading or conventional loading after 3 months . Both groups received a periodontal flap , tooth extraction , implant placement , allograft bone , and membrane placement . The immediate loading group received a temporary crown . In the conventional loading group primary closure was achieved . All patients were followed up at 3 , 6 , 12 , and 24 months . Evaluation included radiographic bone changes , papillary esthetic outcome , and implant survival rate . RESULTS Seventy-two patients were recruited into the study . However , 60 patients received immediate implant placement after extraction : 30 with conventional loading and 30 with immediate loading . In the immediate loading group the implant survival rate at 2 years was 96.7 % , and the mean bone gain was 1.19 mm . The corresponding figures in the conventional loading group were 93.3 % and 1 mm . The gain in bone level occurred mainly from baseline to 1 year postoperatively in both groups ( P < 0.001 ) . The papilla index decreased from baseline to 1 year in both groups ( P < 0.001 ) and changed only slightly thereafter . There were no significant differences between the two groups in the amount of bone gain or papilla index change during 2 years . CONCLUSIONS Immediate loading of a single implant placed in a fresh extraction site in periodontally compromised patients result ed in similar bone gain and soft tissue esthetic outcomes compared to delayed loading . Primary closure and delayed loading to ensure bone regeneration around implants were not critical in this study PURPOSE This clinical study aim ed to assess the dimensional stability of peri-implant soft tissues around immediately placed and restored implants in the maxillary esthetic zone . MATERIAL S AND METHODS Twelve systemically healthy patients presenting with a hopeless maxillary central incisor were selected . Provisional restorations were delivered immediately after tooth extraction and implant placement . Periimplant soft tissue dimensions were measured either by direct clinical examination or evaluation of study casts . Measurements were performed before extraction ; immediately after implant and restoration placement ; and 6 weeks , 3 months , 6 months , 12 months , and 18 months postoperatively . The distances assessed were : tip of the mesial papilla to the mesioincisal edge of the adjacent central incisor , tip of the distal papilla to the mesioincisal edge of the adjacent lateral incisor , and the length of the clinical crown of the definitive restoration . RESULTS All patients completed the study , and no implants failed within the 18-month follow-up period ( 100 % survival rate ) . No statistical differences were observed in the distances between the incisal edge of the adjacent teeth and the mesial and distal papilla tips ( P = .303 and .099 , respectively ) at any follow-up appointment . Likewise , there were no alterations in the definitive clinical crown dimensions during the follow-up period ( P = .406 ) . CONCLUSION The findings of this 18-month prospect i ve study indicate that , within the selection criteria and technique presented in this study , immediate implants with immediate restorations can be a predictable option for the replacement of teeth in the esthetic zone , providing stability to the peri-implant soft tissue BACKGROUND The aim of this study was to compare the bone loss pattern and soft tissue healing of immediately versus one-stage loaded 3.0-mm-diameter implants in cases involving a single missing lateral maxillary incisor . METHODS Sixty patients with a missing lateral incisor in the maxilla were r and omized to one of the treatments : 30 patients in the immediate-restoration group and 30 patients in the one-stage group . All implants were placed in healed sites and had to be inserted with a torque > 25 Ncm . The implants in the immediate-restoration group were fitted with a non-occluding temporary crown on the day of surgery . Both groups received a full occluding final crown 6 months after surgery . Mean marginal bone loss , probing depth , and bleeding on probing were assessed at 6- , 12- , 24- , and 36-month follow-up examinations by a masked examiner . RESULTS Sixty 3.0-mm-diameter implants were placed between July 2003 and February 2006 ; 27 ( 45.0 % ) were in men , and 33 ( 55.0 % ) were in women . All implants osseointegrated and were clinical ly stable at the 6-month follow-up . No statistically significant differences were observed for bleeding or plaque index . No implant fractures occurred . At the 36-month follow-up , the accumulated mean marginal bone loss and probing depth were 0.85 + /- 0.71 mm and 1.91 + /- 0.59 mm , respectively , for the immediate-loading group ( n = 30 ) and 0.75 + /- 0.63 mm and 2.27 + /- 0.81 mm , respectively , for the one-stage group ( n = 30 ) . There was no statistically significant difference ( P > 0.05 ) for the tested outcome measures between the two procedures . CONCLUSIONS In the rehabilitation of a single missing lateral maxillary incisor , no statistically significant difference was assessed between immediately and one-stage restored small-diameter implants with regard to implant survival , mean marginal bone loss , and probing depth . Three-millimeter-diameter implants proved to be a predictable treatment option in our test and control groups if a strict clinical protocol was followed PURPOSE The purpose of the present study was to compare the clinical and radiographic outcomes of single implants immediately placed and restored with two different implant-abutment connections . MATERIAL S AND METHODS Forty subjects requiring single maxillary premolar replacement were consecutively included in this study and prospect ively followed for 12 months . One implant was placed at the time of tooth extraction and immediately restored in each patient . Subjects were r and omly selected to receive either prosthetic abutments with a Morse taper connection and a platform switch ( test group ) or conventional abutments with an internal connection and a matching diameter ( control group ) . A provisional screw-retained crown was positioned and adjusted for nonfunctional loading within 24 hours . Four months later , the definitive crowns were delivered . Periodontal parameters and clinical and radiographic measurements of soft and hard tissue levels were recorded at the moment of prosthesis placement and at 4 and 12 months afterward . Means of the two groups were compared using paired and independent- sample t tests ( P = .05 ) . RESULTS Of the 40 patients recruited , 38 ( 24 women and 14 men ) completed the study . No implants were lost in the control group , whereas one implant failed in the test group . At the 12-month examination , no statistically significant differences were seen between the two groups for periodontal parameters , marginal soft tissue level change , or papilla height ( P > .05 ) , but greater marginal bone loss was observed at the control sites ( 0.51 ± 0.24 mm ) compared to the test sites ( 0.2 ± 0.17 mm ) ( P = .0004 ) . CONCLUSION Although the control group demonstrated a slight increase in marginal bone loss compared to the test group , the peri-implant soft tissues were very stable with both types of implant-abutment connection after 12 months of loading OBJECTIVES Recent investigations have focused on patients ' subjective assessment of implant treatment . The aim of this study was to compare the patients ' experience of surgical and prosthetic procedures , as well as satisfaction with function and aesthetics following single-tooth replacements mounted to early vs. delayed placed dental implants . MATERIAL AND METHODS Forty-six patients were treated with a single-tooth implant in the anterior or premolar region . Twenty-three implants were placed on average 10 days after tooth extraction ( I m ) , while 23 implants were placed approximately 3 months after tooth extraction ( De ) . Forty-one patients completed a question naire regarding the treatment using visual analog scales ( VAS ) and check boxes 16 - 18 months after delivery of the restoration . RESULTS In all , 90 % of the respondents rated 88 or higher on the VAS regarding satisfaction with the crown . Satisfaction with the restoration in general and the appearance was significantly greater in the I m group than in the De group ( 96 vs. 93 ; P<0.02 ) . Assessment of the implant surgery was not significantly different between the delayed-immediate and the delayed group . Approximately 25 % of the patients experienced unpleasantness in relation to the prosthetic procedures , and in 8 of 11 cases , impression taking was the cause . When evaluating satisfaction with the overall implant treatment , the VAS scores for the delayed-immediate group were significantly higher than for the delayed group ( 96 vs. 90 ; P<0.02 ) . CONCLUSION The patients in the present study were highly satisfied with the outcome of the treatment and experienced it to be without significant unpleasantness irrespective of the treatment concept OBJECTIVES To assess in a r and omized- clinical trial the influence of three augmentation techniques ( chinbone with or without a Bio-Gide membrane and Bio-Oss with a Bio-Gide membrane ) on the clinical and radiographic characteristics of hard and soft tissues around implants and adjacent teeth in the reconstructed maxillary anterior region , up to 1 year after functional loading . MATERIAL S AND METHODS Ninety-three patients requesting single-tooth replacement and presenting with a horizontal ( bucco-palatinal ) bone deficiency were included . After augmentation , 93 ITI-Esthetic(Plus ) implants were placed . Clinical variables , st and ardized photographs and radiographs were analysed to assess the impact on the levels of the marginal gingiva ( MGL ) and marginal bone ( MBL ) around implants and adjacent teeth , viz at pre-augmentation , pre-implantation ( TPI ) and 1 ( T(1 ) ) and 12 ( T(12 ) ) months after final crown placement . RESULTS Implant survival was 97.8 % . No significant differences were observed in the treatment outcomes of the three augmentation modalities . Combining the three modalities , a slight but significant increase in the implants approximal pocket depth was found between T(1 ) and T(12 ) . Approximal bone loss at the implant between T(1 ) and T(12 ) was 0.14 + /- 0.76 mm ( mesial ) and 0.14 + /- 0.47 mm ( distal ) ; the approximal MGL slightly increased ( mesial : 0.24 + /- 0.46 mm , distal : 0.25 + /- 0.66 mm ) , and the buccal MGL decreased ( 0.11 + /- 0.61 mm ) . Bone loss at the adjacent teeth , although minor , was significant between TPI and T(1 ) . No correlations were observed in changes of MBL and MGL . CONCLUSIONS None of the three applied augmentation technique procedures influenced the characteristics of the MGL and MBL or the implant survival of single-tooth replacements . Peri-implant hard and soft tissues were very stable in the first year after loading PURPOSE The aim of this study is to assess the impact of insertion torque and implant neck design on peri-implant bone levels and gain insights into dynamic crestal tissue alterations by radiological , clinical , and biochemical examinations . MATERIAL AND METHODS In this prospect i ve trial , a total of 84 implants ( four implants in each patient ) in the interforaminal region of 21 edentulous m and ibles were r and omly alternated according to a split-mouth design . Implant placement was performed using different insertion torques ( ≤20 Ncm vs > 50 Ncm ) . In each group , one machined and one anodized implant neck design ( 1.5 mm length ) was used in the same jaw side . Evaluation of peri-implant tissues involved radiological , clinical examination and immunoassays for interleukin-1β . RESULTS No significant influence of insertion torque or implant neck design on peri-implant bone level was found . Protein levels of interleukin-1β in the peri-implant crevicular fluid revealed no difference between both insertion torque groups and different neck design s. CONCLUSION Interactive effects of insertion torque and neck surface modification may exist ; however , no clinical ly significant differences in marginal bone resorption after 1 year could be observed in the edentulous anterior m and ible |
353 | 22,796,896 | Marked heterogeneity in case definitions for recent HCV infection was observed . | BACKGROUND & AIMS Case definitions for recent hepatitis C virus ( HCV ) infection vary considerably between studies .
The aim of this systematic review was to characterize case definitions for recent HCV and explore the heterogeneity in studies performed to date . | BACKGROUND In people who are infected with the hepatitis C virus ( HCV ) chronic infection often develops and is difficult to eradicate . We sought to determine whether treatment during the acute phase could prevent the development of chronic infection . METHODS Between 1998 and 2001 , we identified 44 patients throughout Germany who had acute hepatitis C. Patients received 5 million U of interferon alfa-2b subcutaneously daily for 4 weeks and then three times per week for another 20 weeks . Serum HCV RNA levels were measured before and during therapy and 24 weeks after the end of therapy . RESULTS The mean age of the 44 patients was 36 years ; 25 were women . Nine became infected with HCV through intravenous drug use , 14 through a needle-stick injury , 7 through medical procedures , and 10 through sexual contact ; the mode of infection could not be determined in 4 . The average time from infection to the first signs or symptoms of hepatitis was 54 days , and the average time from infection until the start of therapy was 89 days . At the end of both therapy and follow-up , 43 patients ( 98 percent ) had undetectable levels of HCV RNA in serum and normal serum alanine aminotransferase levels . Levels of HCV RNA became undetectable after an average of 3.2 weeks of treatment . Therapy was well tolerated in all but one patient , who stopped therapy after 12 weeks because of side effects . CONCLUSIONS Treatment of acute hepatitis C with interferon alfa-2b prevents chronic infection BACKGROUND The natural outcome of infection with hepatitis C virus ( HCV ) varies substantially among individuals . However , little is known about host and viral factors associated with a self-limiting or chronic evolution of HCV infection . METHODS From 1 January 2001 through 31 December 2008 , a consecutive series of 65 patients from Rio de Janeiro , Brazil , with a well-documented diagnosis of acute HCV infection , acquired via various routes , were enrolled in this study . Patients were prospect ively followed up for a median of 40 months after the estimated date of HCV infection with serial measurements of serum alanine aminotransferase , HCV RNA , and anti-HCV antibodies . Spontaneous viral clearance ( SVC ) was defined as undetectable levels of HCV RNA in serum , in the absence of treatment , for 3 consecutive HCV polymerase chain reaction tests within the first 6 months of follow-up . Cox proportional hazards regression was used to identify host and viral predictors of SVC . RESULTS The cumulative rate of SVC was 44.6 % ( 95 % confidence interval , 32.3%-57.5 % ) . Compared with chronic HCV evolution , patients with self-limiting disease had significantly lower peak levels of anti-HCV antibodies ( median , 109.0 vs 86.7 optical density-to-cutoff ratio [ od/co ] ; P<.02 ) , experienced disease symptoms more frequently ( 69.4 % vs 100 % ; P<.001 ) , and had lower viral load at first clinical presentation ( median , 4.3 vs 0.0 log copies ; P=.01 ) . In multivariate analyses , low peak anti-HCV level ( < 93.5 od/co ) was the only independent predictor for SVC ; the hazard ratio compared with high anti-HCV levels ( > or = 93.5 od/co ) was 2.62 ( 95 % confidence interval , 1.11 - 6.19 ; P=.03 ) . CONCLUSION Our data suggest that low levels of anti-HCV antibodies during the acute phase of HCV infection are independently related to spontaneous viral clearance Objective An epidemic of acute hepatitis C virus ( HCV ) infection in HIV-positive men-who-have-sex-with-men ( MSM ) is emerging in Europe , Australia and the USA . The aim of this study was to characterise the natural history of primary HCV in this setting and to assess host and viral factors which predict spontaneous clearance . Methods This prospect i ve longitudinal cohort study was carried out in 112 HIV-positive patients who were followed in a single centre ( the St Mary 's Acute HCV Cohort ) . Plasma and peripheral blood mononuclear cells ( P BMC s ) were obtained at monthly intervals for 3 months and at 3-monthly intervals thereafter for a median of 45 months ( IQR=29–69 months ) . The primary end point was spontaneous clearance of HCV . Cox regression was used to assess the impact of clinical and virological variables on outcome , including liver function , CD4 count , rate of HCV RNA decline , T cell response and clonal sequence evolution within the HCV E2 envelope gene . Results 15 % of patients cleared HCV spontaneously , while 85 % progressed towards chronicity . The latter group included a significant proportion of ‘ fluctuating ’ progressors ( 37.5 % ) , in whom a fall followed by a rise ( > 1 log10 ) in viraemia was observed . This was associated with superinfection with new HCV strains and partially effective T cell responses . Spontaneous clearance was strongly associated with a 2.2 log10 viral load drop within 100 days of infection ( HR=1.78 ; p<0.0001 ) , elevated bilirubin ( ≥40 μmol/l ; HR=5.04 ; p=0.006 ) , elevated alanine aminotransferase ( ALT ; ≥1000 IU/ml ; HR=2.62 ; p=0.048 ) and baseline CD4 count ≥650 × 106/l ( HR=2.66 ; p=0.045 ) , and only occurred in patients with genotype 1 infection . Evolution to spontaneous clearance occurred in patients with low viral diversity in the presence of an early multispecific T cell response . Conclusions Spontaneous clearance of acute HCV in HIV-positive men can be predicted by a rapid decline in viral load , high CD4 count , elevated bilirubin and ALT , and is associated with low viral diversity and strong T cell responses Hepatitis C virus ( HCV ) is an important cause of liver disease throughout the world . However , the natural history and pathogenesis of this infection is still not completely understood . The aim of this study was to characterize the evolution of incident , asymptomatic HCV infection in a community-based population in Japan . The Miyazaki Cohort Study is a prospect i ve study of adult residents in two villages , one of which has a very high prevalence of HCV . Nine hundred and seventy-three people from this village were enrolled in the cohort between 1984 and 1995 , with antibodies to HCV ( anti-HCV ) found in 23 % . During subsequent visits to annual health screens , new HCV seroconverters were identified among susceptible individuals , and their sequential sample s were tested for anti-HCV , HCV-RNA , and HCV core antigen . Fourteen participants ( six males , eight females ) acquired anti-HCV during the first 11 years of study follow-up , at an incidence rate of 362 per 100 000 person-years . Detectable HCV-RNA and high anti-HCV titres ( > 1:2048 ) were observed for more than 5 years following seroconversion in 80 % ( 8/10 ) of seroconverters with sufficient information , indicating the development of persistent infection in these subjects . Three ( 37.5 % ) of the eight sero converters with persistent infection had fairly consistent , albeit mild , alanine aminotransferase elevations ( 30 - 130 IU/L ) during the study . Anti-HCV seroconversions occurred at a very high rate in this community-based population in Japan , in which this infection is endemic . Persistence also developed at a high frequency among the cases of newly acquired infection , although the associated liver enzyme abnormalities were mild UNLABELLED Hepatitis C virus (HCV)/human immunodeficiency virus ( HIV ) coinfection poses a difficult therapeutic problem . Response to HCV-specific therapy is variable but might be influenced by host genetic factors , including polymorphisms of cytokine genes . Here , we studied whether interleukin-6 ( IL-6 ) C174 G gene polymorphism affects the response to antiviral treatment in HCV-infected HIV-positive subjects . We determined IL-6 genotypes in HIV-positive patients with acute ( n = 52 ) and chronic ( n = 60 ) hepatitis C treated with pegylated interferon-alpha . Two hundred ten HCV monoinfected , 197 HIV monoinfected , and 100 healthy individuals were studied as controls . Patients were classified into high and low producers according to IL-6 genotypes . Rates of sustained virological responses ( SVRs ) were compared between the IL-6 genotypes . Signal transducer and activator of transcription three phosphorylation was analyzed by Western blot in HCV core-transfected human hepatoma cell line ( HUH7 ) cells . Distribution of IL-6 genotypes did not differ significantly between the study groups . SVR was achieved in 63 % of HIV/HCV coinfected patients . Carriers of the IL-6 high producer ( HP ) genotype had significantly higher SVR rates than patients with an IL-6 low producer genotype ( 70.1 % versus 52 % ; P < 0.002 ) . This effect was seen in both HIV-positive patients with acute ( 74 % versus 33 % ; P < 0.05 ) and chronic ( 66 % versus 33 % ; P < 0.05 ) hepatitis C. Multivariate analysis confirmed IL-6 HP carriage as an independent positive predictor for SVR ( Odd 's ratio 6.1 ; P = 0.004 ) . This effect corresponds to the in vitro observation that in HCV core-transfected HUH7 cells , IL-6 overcomes the HCV core-mediated inhibition of STAT3 activation . CONCLUSION Response rates to HCV-specific treatment are higher in HCV/HIV-positive patients carrying the IL-6 HP genotype , which might be because of IL-6 mediated STAT3 activation The aim of this study was to analyze the clinical performance of a new enzyme immunoassay ( EIA ) for hepatitis C virus ( HCV ) core antigen in comparison with the reverse transcription polymerase chain reaction ( RT‐PCR ) . A total of 310 patients with acute or chronic hepatitis C , and 132 HCV‐negative controls were studied . Chemiluminescence EIA with monoclonal anti‐HCV core antigen was used , and qualitative and quantitative commercial RT‐PCRs and an in‐house nested RT‐PCR were performed . Compared with nested RT‐PCR , the core antigen assay showed 97 % sensitivity and 100 % specificity in 75 patients with chronic hepatitis C and 132 controls . HCV core antigen was positive in 16 ( 94 % ) of 17 patients with acute hepatitis C at initial consultation . In 3 persons prospect ively followed , core antigen was detected in the first available ( 1‐3 weeks ) post‐transfusion sample . In 167 anti‐HCV – positive individuals , 129 ( 77 % ) were viremic ; core antigen was detected in 126 ( 98 % ) compared with 129 ( 100 % ) for nested RT‐PCR and 121 ( 94 % ) for the commercial RT‐PCR . In 48 patients with chronic hepatitis C treated with interferon alfa , the concentration of core antigen before treatment was significantly ( P < .002 ) lower in patients with sustained response than in nonresponders . All responders had a sustained loss of core antigen , whereas all nonresponders remained core antigen positive . The concentrations of HCV core antigen and HCV RNA correlated significantly ( n = 48 , r = .627 , P < .001 ) . In conclusion , the HCV core antigen assay is useful for the diagnosis of acute and chronic hepatitis C , and for predicting and monitoring the effect of interferon alfa treatment OBJECTIVE Treating acute hepatitis C ( HCV ) in injection drug users ( IDUs ) is complicated by a high prevalence of psychiatric comorbidities that may lead to increased risk for depressive complications of interferon treatment . Effective screening strategies are needed to help non-psychiatric clinicians identify depressive disorders . METHODS Thirty IDUs with acute HCV completed the Beck Depression Inventory ( BDI ) , underwent a psychiatric examination , and were r and omized to 24 weeks of pegylated interferon treatment ( IFA ) or observation ( OBS ) . Sensitivity , specificity , positive ( PPV ) and negative predictive values ( NPV ) of the BDI for diagnosing depression ( with a cutoff > 10 ) were calculated . The psychiatrist 's diagnosis was used as the gold st and ard . Depression severity was assessed over time with the BDI . RESULTS Forty-seven percent of individuals met criteria for a depressive disorder . Sensitivity ( 91 % ) and NPV ( 92 % ) were high for the BDI ; specificity ( 58 % ) and PPV ( 56 % ) were low . BDI worsened in 2 patients completing the study ( one IFA , one OBS ) ; two IFA patients were discontinued for possible depression-related complications . At baseline , subject-rated fatigue was associated with alanine aminotransferase level . CONCLUSION The BDI is an adequate tool for ruling out depressive disorders in active IDUs with acute HCV , but specificity is low . Psychiatric consultation is recommended for all active IDUs being considered for acute HCV treatment BACKGROUND Young injection drug users ( IDUs ) are at very high risk of hepatitis C virus ( HCV ) infection . Using a time scale starting at first injection , we studied the period of HCV susceptibility after initiation into drug injection among street-involved IDUs . METHODS A prospect i ve cohort study was carried out among street youth from 2001 to 2005 . Semiannual interviews included completion of an interviewer-administered question naire and collection of blood sample s for HCV antibody testing . HCV-negative subjects currently injecting drugs ( last six months ) were included in the analyses . Follow-up started at first question naire where current injection was reported and ended at seroconversion or at last question naire . Poisson regression was used to assess the predictive power of time elapsed since initiation on incidence rate . Kaplan-Meier technique was used to estimate cumulative infection probabilities . RESULTS Among the 858 cohort participants , 145 were injecting at baseline and 60 were injecting at a subsequent question naire ( 45 youth had started injection and 15 had resumed injection ) . Mean age was 20 years and 62 % were males . In the 395 person-years of follow-up , 61 subjects contracted HCV . The HCV incidence rate increased from 16.1/100 person-years during the first year following first injection to 22.4 in the third year , and then decreased to 7.2 in years 7 - 13 ( p=0.02 ) . Median time to seroconversion after first injection was 3.3 years . CONCLUSION The first years after first injection is the period during which vulnerability to HCV is greatest . Our results show the importance of intervening with new IDUs to optimize the chances to successfully prevent infection BACKGROUND Sexually transmitted acute hepatitis C among HIV-positive homosexual men has been noted as an emerging epidemic . METHODS Forty-seven patients with mainly sexually acquired , acute hepatitis C were enrolled in this prospect i ve , multicentre trial , and 36 of these patients were treated within the acute phase of hepatitis C infection with pegylated interferon ( peg-IFN ) therapy . RESULTS Early treatment result ed in sustained virological response in 61 % of patients . Peg-IFN alone showed similar treatment response rates and lower incidence of anaemia compared with peg-IFN+ribavirin combination therapy . Higher treatment response rates were observed in patients treated over 48 weeks compared with 24 weeks . CONCLUSIONS Treatment of hepatitis C in HIV-positive individuals in the acute phase of infection leads to high rates of sustained virological response . Optimal time and mode of therapy have yet to be defined BACKGROUND & AIMS Immune responses during the first few months of acute hepatitis C virus ( HCV ) infection seem crucial for viral control , but the relationship of these responses to natural history is poorly characterized . METHODS This prospect i ve study investigated the HCV-specific CD4(+ ) and cytokine responses in patients with acute HCV hepatitis with or without Schistosoma mansoni coinfection , a parasitic infection with T helper ( Th ) 2 immune bias . HCV-specific CD4(+ ) proliferative responses and cytokine production in peripheral blood mononuclear cells were correlated with liver biopsy results at 6 months and at the end of follow-up . RESULTS Whereas 5 of 15 patients with HCV alone recovered from acute HCV , all ( 17 of 17 ) patients with S. mansoni coinfection progressed to histologically proven chronic hepatitis . Coinfected patients had either absent or transient weak HCV-specific CD4(+ ) responses with Th0/Th2 cytokine production . The magnitude of the HCV-specific CD4(+ ) response at week 12 was inversely correlated with the fibrosis progression rate in chronically infected patients . CONCLUSIONS Patients with acute hepatitis C and schistosomiasis coinfection can not clear viremia and show rapid progression once chronic infection is established . This rapid progression is associated with a strong Th2 response in peripheral immune responses , suggesting that early development of vigorous Th1 responses not only facilitates clearance but delays disease progression Spontaneous resolution of acute hepatitis C virus infection can not be predicted , and chronic evolution of the disease occurs in a majority of cases . To assess the efficacy and safety of peginterferon alpha-2b administered for 8 , 12 , or 24 weeks in patients with acute hepatitis C virus infection a total of 161 patients were identified with acute hepatitis C virus infection . Of these , 30 patients refused treatment but were retained in the study as a nonr and omized comparison group . Of the 131 patients who consented to treatment , 29 patients spontaneously resolved , leaving 102 patients r and omly assigned to peginterferon alpha-2b ( 1.5 microg/kg ) for 8 weeks ( group A ; n=34 ) , 12 weeks ( group B ; n=34 ) , and 24 weeks ( group C ; n=34 ) . The primary end point was sustained virologic response . An intent-to-treat analysis was used for efficacy and safety end points . Sustained virologic response was achieved in 23/34 ( 67.6 % ) , 28/34 ( 82.4 % ) , and 31/34 ( 91.2 % ) of patients in groups A , B , and C , respectively ; all had undetectable hepatitis C virus RNA 48 weeks after the end of therapy . Treatment for 8 or 12 weeks was effective in genotypes 2 , 3 , and 4 , whereas genotype 1 required 24 weeks of therapy . The 8- and 12-week regimens were associated with fewer adverse events compared with the 24-week regimen . In conclusion , peginterferon alpha-2b effectively induces high sustained virologic response rates in patients with acute hepatitis C virus infection , thus preventing development of chronic hepatitis C. Duration of treatment should be further optimized based on genotype and rapid virologic response at week 4 BACKGROUND / AIMS Interferon ( IFN ) monotherapy significantly reduces the chronicity rate of acute hepatitis C ( AHC ) but optimal regimen and treatment timing remain undefined . The aim of this study was to assess the efficacy of a 6-month course of pegylated IFN ( PEG-IFN ) alpha-2b monotherapy in AHC patients and to investigate if IFN treatment initiated after 12 weeks from clinical presentation , still achieved a high response rate . METHODS Sixteen AHC patients still viremic after 12 weeks from the onset were treated with PEG-IFN alpha-2b ( 1.5 mcg/kg once weekly ) for 6 months and followed for at least 12 months . Response to therapy was defined as normal ALT values and undetectable HCV RNA ( < 50 IU/ml ) at the end of therapy , after 6 ( sustained response ) and 12 months follow-up ( long-term response ) . RESULTS At the end of treatment , HCV RNA was undetectable in 15/16 patients while ALT normalized in 14/16 patients . After 6 and 12 months follow-up , 15/16 patients ( 94 % ) showed virological and biochemical response . CONCLUSIONS A 6-month course of PEG-IFN alpha-2b is effective in inducing resolution of AHC in 94 % of patients . Our results provide a rationale for delaying treatment for 12 weeks , targeting only patients who fail to clear the virus spontaneously and truly requiring therapy without loss of efficacy BACKGROUND Acute hepatitis C virus ( HCV ) infection is often asymptomatic ; thus , its epidemiology and natural history are difficult to define . METHODS Acute HCV infection was identified on the basis of HCV seroconversion within 1 year ( n=45 ) , new anti-HCV seropositivity with clinical acute hepatitis ( n=21 ) , or HCV strain sequencing after an iatrogenic exposure ( n=1 ) . Risk factors were assessed with a baseline question naire , and participants were followed up prospect ively with serial measurement of viral loads . RESULTS Of 67 persons with acute HCV infection , most were asymptomatic ( 64 % ) and injection drug users ( 66 % ) . Thirteen had an unknown mode of transmission ; of these , 11 reported high-risk sexual behavior . Ten acquired acute HCV infection within 3 months of an iatrogenic exposure ; 3 had confirmed iatrogenic infection , and 4 had no other risk factors identified . The spontaneous viral clearance rate after 6 months of infection was 18 % ( 95 % confidence interval , 11%-31 % ) . The rate of viral clearance varied significantly by sex ( 34 % vs. 3 % for women vs. men ; P<.001 ) . CONCLUSIONS High-risk sexual or iatrogenic exposures may be important contemporary risk factors for HCV infection . The spontaneous viral clearance rate ( 18 % ) in this contemporary study was similar to that reported for past studies of transfusion-associated HCV infection . Women were more likely to clear acute HCV infection than men Objective : An epidemic of acute hepatitis C virus ( HCV ) infection among HIV-positive men who have sex with men is occurring in urban centers in Western Europe and the United States . Early diagnosis and treatment of HCV results in improved sustained virological response rates . This study compared the sensitivity of reverse transcriptase PCR ( RT – PCR ) versus antibody screening for the diagnosis of early HCV infection in HIV-positive patients and estimated the length of time from HCV infection to the development of anti-HCV antibodies . Design : Patients from the St Mary 's Acute Hepatitis C Cohort ( SMACC ) were recruited retrospectively and prospect ively between 2004 and 2008 . Methods : Archived plasma sample s , obtained at 1–3 monthly intervals for routine monitoring of HIV viral load were assayed retrospectively for HCV in order to assess the sensitivity of RT – PCR and enzyme-linked immunosorbent assay ( ELISA ) . Results : Forty-three HIV-positive patients with early HCV infection were identified . The median CD4 cell count was 570 cells/μl . The median alanine transaminase at the time of the first positive HCV PCR was 65 IU/ml . At this time , 75 % of patients had a negative HCV antibody test . Three months later , 37 % of patients still had a negative result . After 9 months , 10 % of patients had a negative test and 5 % remained negative after 1 year . Conclusion / discussion : Delayed seroconversion in HIV-positive individuals with acute HCV may result in delayed diagnosis and treatment . Where there is a clinical suspicion of recent HCV infection , for example , elevated alanine transaminase levels , HIV-infected patients should be screened for HCV RNA by RT – PCR BACKGROUND Data on the incidence of hepatitis C virus ( HCV ) infection among human immunodeficiency virus (HIV)-infected persons are sparse . It is controversial whether and how frequently HCV is transmitted by unprotected sexual intercourse . METHODS We assessed the HCV seroprevalence and incidence of HCV infection in the Swiss HIV Cohort Study between 1988 and 2004 . We investigated the association of HCV seroconversion with mode of HIV acquisition , sex , injection drug use ( IDU ) , and constancy of condom use . Data on condom use or unsafe sexual behavior were prospect ively collected between 2000 and 2004 . RESULTS The overall seroprevalence of HCV infection was 33 % among a total of 7899 eligible participants and 90 % among persons reporting IDU . We observed 104 HCV seroconversions among 3327 participants during a total follow-up time of 16,305 person-years , corresponding to an incidence of 0.64 cases per 100 person-years . The incidence among participants with a history of IDU was 7.4 cases per 100 person-years , compared with 0.23 cases per 100 person-years in patients without such a history ( P<.001 ) . In men who had sex with men ( MSM ) without a history of IDU who reported unsafe sex , the incidence was 0.7 cases per 100 person-years , compared with 0.2 cases per 100 person-years in those not reporting unsafe sex ( P=.02 ) , corresponding to an incidence rate ratio of 3.5 ( 95 % confidence interval , 1.2 - 10.0 ) . The hazard of acquiring HCV infection was elevated among younger participants who were MSM . CONCLUSIONS HCV infection incidence in the Swiss HIV Cohort Study was mainly associated with IDU . In HIV-infected MSM , HCV infection was associated with unsafe sex From February 2002 , all the consecutive patients referring to the Department of Infectious Diseases , University of Turin , who were diagnosed as having acute HCV hepatitis were included in a prospect i ve cohort study to evaluate if a 3-month course of Peg-Interferon alpha-2b ( 1.5 microg/kg once weekly ) is effective to decrease the risk of progression to chronic disease . ALT and HCV-RNA measurements were scheduled at week 4 and 12 during treatment , and 24 weeks after the end of therapy . As of April 2003 , ten patients were enrolled in the study . As to HCV genotype , seven patients had type 1 and 3 type non-1 . At entry , median HCV-RNA level was 129500 ( range : 3000 - 3100000 copies/mL ) and six patients were symptomatic . Treatment was given within 20 days ( range : 8 - 30 ) of the ALT peak . All patients completing 4 weeks ( n = 9 ) and 12 weeks of treatment ( n = 7 ) had undetectable HCV-RNA . Five patients who completed the 24-week follow-up after the end of treatment had a sustained viral response with ALT levels within normal range . Therapy was well tolerated in all patients . Even if our data are not definitive , our results show that once-weekly administration of Peg-interferon alfa-2b in patients with acute HCV infection may be an effective and convenient regimen Acute hepatitis C often progresses to chronic infection . We undertook a r and omized controlled trial to determine whether short-term therapy with interferon ( IFN ) during acute hepatitis C is effective in preventing the development of chronic hepatitis . Thirty patients with acute hepatitis C were r and omized into 1 of 2 treatment groups . IFN therapy was initiated 8 weeks after the onset of acute hepatitis in the early-intervention group and after 1 year of observation in the late-intervention group . Short-term therapy consisted of natural IFN-alfa ( 6 million units ) administered on consecutive days for a period of 4 weeks . Any signs of recrudescence of disease were immediately followed by interval IFN therapy ( 3 times weekly for 20 weeks ) . In the early-intervention group , short-term therapy was associated with a sustained virological response in 13 of 15 patients ( 87 % ) . Follow-up treatment was associated with a sustained virological response in both of the remaining 2 patients ( 100 % ) . The sustained virological response rate was significantly higher in the early-intervention group ( 87 % , 13 of 15 patients after short-term therapy alone , and 100 % , 15 of 15 patients after short-term with or without follow-up therapy ) than in the late-intervention group ( 40 % , 6 of 15 patients after short-term therapy alone , and 53 % , 8 of 15 patients after short-term therapy with or without follow-up therapy , P = .021 and P = .006 , respectively ) . In conclusion , short-term ( 4 weeks ) IFN treatment of patients with acute hepatitis C may be associated with satisfactory results , if initiated at an early stage of the disease PURPOSE Risk factors for hepatitis C virus ( HCV ) infection have rarely been estimated using incident case-control studies in the " general " population . We undertook a case-control study of incident HCV infection to identify persistent modes of transmission in France . METHODS Two types of case- patients were included : ( 1 ) repeat blood donors who seroconverted between 1998 and 2001 ( with a last negative third-generation test reported from 1995 or after ) and ( 2 ) seroconverters referred to hepatology departments in 2000 through 2001 . For each case-patient , four age- and sex-matched controls were r and omly selected from the population of occurrence . Data on risk factors were recorded for each case-patient 's and matched control 's referent exposure period ( between last negative and first positive tests ) . RESULTS Sixty-four case- patients and 227 controls were included . In univariate analysis , endoscopy ( matched odds ratios [ mORs ] = 8.0 ; 95 % confidence intervals [ CI ] = 2.3 - 27.2 ) , general anesthesia ( mOR = 5.6 ; 95 % CI = 2.2 - 14.7 ) , tattooing or body piercing ( mOR = 8.8 ; 95 % CI = 1.7 - 44.1 ) , and intravenous ( IV ) drug use ( p < 0.0001 ; mOR not defined ) were associated with HCV seroconversion . In multivariate analysis , risk factors associated with HCV seroconversion were drug use ( adjusted OR [ aOR ] = 109.0 ; 95 % CI = 11.7 - 1015.8 ) , digestive endoscopy ( aOR = 5.7 ; CI = 1.4 - 23.8 ) , and invasive radiology procedures ( aOR = 11.6 ; CI = 1.7 - 78.5 ) . CONCLUSIONS The results showed the continuing major role of IV drug use and suggested that transmission related to invasive health care remained a potential source of new HCV infection between 1995 and 2001 AIMS To determine the incidence of hepatitis C virus ( HCV ) infection and identify risk factors for seroconversion . DESIGN Prospect i ve cohort study . Participants were recruited through direct approaches , street-based outreach , methadone and sexual health clinics and needle and syringe programmes . SETTING Urban , regional and rural setting s in New South Wales , Australia . PARTICIPANTS Injecting drug users ( IDUs ) ( n = 584 ) were screened and tested for exposure to HCV . Between 1999 and 2002 antibody HCV negative IDUs ( n = 368 ) were enrolled and followed-up every 3 - 6 months until seroconversion or study completion . MEASUREMENTS Interviewer-administered baseline and follow-up question naires consisted of 131 items and included demographics , drug use and risk behaviour . Approximately 10 cc of whole blood was drawn at each visit . Specimens were stored at -70C and serology performed using one or two third-generation enzyme-linked immunosorbent assays and polymerase chain reaction testing . FINDINGS Sixty-eight seroconversions were observed and incidence was 30.8 per 100 person-years , with incidence in IDUs injecting < 1 year , 133 per 100 person-years . Independent predictors of seroconversion were female gender , duration of injecting , injecting cocaine , shared use of filters and recruitment strategy . CONCLUSIONS Women , new initiates and IDUs recruited via outreach appear to be at increased risk of infection . Results confirm the significance of cocaine injection as a risk factor and provide the first evidence outside North America of the link between shared use of drug preparation equipment and incident HCV infection . Prevention efforts should attempt to raise awareness of the risks associated with drug sharing and , in particular , the role of potentially contaminated syringes in HCV infection Acute hepatitis C virus ( HCV ) infection evolves to chronicity in 50 - 84 % cases . Treatment with interferon-alpha ( IFN-alpha ) was repeatedly found to provide sustained cure rates higher than that in chronic HCV infection , but the optimal treatment strategy has not yet been defined . In a multicentre open-label study , we investigated the therapeutic performance of a short course of pegylated ( peg ) IFN-alpha in patients with acute HCV hepatitis . Peg IFN-alpha2b , 1.0 - 1.5 micro g/kg weekly , was administered for 12 weeks . Forty-six patients were enrolled ; 26 of them were intravenous drug users . Eleven patients had jaundice . Treatment was started within 1 - 90 days from the peak alanine aminotransferase . Treatment was well tolerated with a single dropout ( 2 % ) . Thirty-three of 46 patients ( 72 % ) had a sustained virological response ( SVR ) after a 6 months post-treatment follow-up , 8 ( 17 % ) relapsed after treatment and 4 were nonresponders ( 9 % ) . A lower peak viraemia , receiving at least 1.2 micro g/kg of peg IFN-alpha , and a negative HCV-RNA at week 4 and week 12 were predictors of SVR . Thus , in patients with early ( week 4 ) viral response , a short course of peg IFN-alpha at a weekly dose > 1.2 micro g/kg , may be a valuable option for the treatment of acute HCV hepatitis The incidence of hepatitis C ( HCV ) infection and associated risk factors were prospect ively assessed in a cohort of 6,734 Egyptians from 2 rural villages who were negative for antibodies to HCV ( anti-HCV ) . Initial and follow-up sera were tested for anti-HCV by enzyme immunoassay ( EIA ) , and possible incident cases were confirmed by using the microparticle enzyme immunoassay ( MEIA ) and tested for HCV RNA . All follow-up serum sample s converting from negative to positive without detectable HCV-RNA were further tested by recombinant immunoblot assay . Over an average of 1.6 years , asymptomatic anti-HCV seroconversion occurred in 33 people ( 3.1/1,000 person-years [ PY ] ) , including 28 ( 6.8/1,000 PY ) in the Nile Delta village ( AES ) , where prevalence was 24 % and 5 ( 0.8/1,000 PY ) in the Upper Egypt village ( baseline prevalence of 9 % ) . The strongest predictor of incident HCV was having an anti-HCV-positive family member . Among those that did , incidence was 5.8/1,000 PY , compared ( P < .001 ) with 1.0/1,000 PY ; 27 of 33 incident cases had an anti-HCV-positive family member . Parenteral exposures increased the risk of HCV but were not statistically significant ; 67 % of seroconverters were younger than 20 years of age , and the highest incidence rate ( 14.1/1,000 PY ) was in children younger than 10 who were living in AES households with an anti-HCV-positive parent . In conclusion , young children would especially benefit from measures reducing exposures or preventing infection with HCV Objectives : To explore the parameters of specific immunity to hepatitis C virus ( HCV ) associated with virus clearance during acute HCV infection in HIV coinfection . Methods : HIV-infected patients without prior HCV infection were prospect ively enrolled for acute hepatitis C and followed up over 15 months . HCV-specific T cells were assessed by proliferation , ELISpot , intracellular cytokine staining and pentamer assays . Pegylated-interferon-α and ribavirin were proposed if HCV persisted at M3 . Results : Thirty eight acutely HCV-infected HIV-positive patients were enrolled . HCV genotypes were predominantly 4 and 1 . Five patients ( 13 % ) showed spontaneous clearance and 20 initiated treatment , of whom 13 ( 65 % ) showed sustained virologic responses . Before M3 , HCV-specific proliferative responses observed in 35 % cases , were associated with lower HCV viral load ( P = 0.04 ) and predictive of spontaneous clearance ( P = 0.02 ) , particularly anti-NS4 responses ( P = 0.03 ) . These HCV-specific proliferative responses were associated with HIV-p24-specific responses ( P = 0.002 ) independently from the HIV stage . Interferon-γ-producing T cells specific for HCV were detectable ex vivo in 81 % cases but at low intensity ( < 150 spot forming cells/106 peripheral blood mononuclear cells ) and were independent of the HCV outcome . Low frequencies of pentamer-positive HCV-specific CD8 + cells ( 0.01–0.05 % ) detected in nine of 12 patients were mainly effector-memory PD-1-negative T cells . Twelve days of HCV-specific in-vitro culture induced amplification of CD4 T cells coproducing interleukin-2 and interferon-γ but rarely of CD8 T cells . Conclusion : Acute HCV infection in HIV-coinfected patients is characterized by a low rate of spontaneous clearance and weak HCV-specific memory T cells , not strictly related to HIV-induced immune defects , and which correlate with virus clearance The kinetics of intrahepatic hepatitis C virus (HCV)-specific CD4(+ ) T cell responses and their role in progression of fibrosis have not previously been characterized . Subjects with HCV/Schistosoma mansoni coinfection have a more rapid progression of HCV liver fibrosis than do those with HCV infection alone . The present prospect i ve longitudinal study compared the liver histology , HCV-specific intrahepatic and peripheral CD4(+ ) T cell proliferative responses , and cytokines ( enzyme-linked immunospot ) in 48 subjects with unresolved acute HCV infection with or without S. mansoni coinfection , at 6 - 10 months after acute infection and at the end of follow-up ( 96+/-8.7 months ) , and the findings were correlated to the rate of progression of fibrosis per year . Coinfected subjects had significant worsening of fibrosis , compared with subjects with HCV infection alone . At baseline , subjects with HCV infection alone had stronger multispecific intrahepatic HCV-specific CD4(+ ) T helper 1 responses than did coinfected subjects , who had either no responses or weak , narrowly focused responses , and , over time , these T cell responses were maintained only in the liver . The rate of progression of fibrosis and virus load inversely correlated with intrahepatic HCV-specific CD4(+ ) T cell response . The present prospect i ve analysis indicates that enhancement of progression of liver fibrosis is associated with failure to develop early , multispecific , HCV-specific CD4(+ ) Th1 responses , suggesting that novel therapeutic approaches inducing strong cellular immune responses might limit subsequent liver damage in individuals with chronic hepatitis OBJECTIVE To identify modes of HCV transmission during an outbreak of HCV infection in a hemodialysis unit . DESIGN An epidemiologic study , virologic analysis , assessment of infection control practice s and procedures , and technical examination of products and dialysis machines . SETTING A private hemodialysis unit treating approximately 70 patients . PATIENTS Detection of HCV RNA by PCR was performed among patients receiving dialysis in 2001 . Case- patients were patients who had a first positive result for HCV RNA between January 2001 and January 2002 and either acute hepatitis , a seroconversion for HCV antibodies , or a previous negative result . Three control- patients were r and omly selected per case-patient . RESULTS Of the 61 patients treated in the unit in 2001 and not infected with HCV , 22 ( 36.1 % ) became case- patients with onset from May 2001 to January 2002 for an incidence density rate of 70 per 100 patient-years . Phylogenic analysis identified four distinct HCV groups and an index case-patient for each with a similar virus among patients already known to be infected . No multidose medication vials or material was shared between patients . Connection to a dialysis machine by a nurse who had connected an HCV-infected patient " just before " or " one patient before " increased the risk of HCV infection , whereas using the same dialysis machine after a patient infected with HCV did not . Understaffing , lack of training , and breaches in infection control were documented . Direct observation of practice s revealed frequent flooding of blood into the double filter on the arterial pressure tubing set . CONCLUSIONS During this outbreak , HCV transmission was mainly patient to patient via healthcare workers ' h and s. However , transmission via dialysis machines because of possible contamination of internal components could not be excluded A large prospect i ve study was carried out from 1997 to 2000 in 25 French hemodialysis units including 1,323 patients to determine the incidence of hepatitis C virus ( HCV ) infection . Monthly testing of alanine aminotransferase ( ALT ) activity , and assessment of HCV RNA and anti-HCV antibodies if the ALT activity was elevated , identified 14 new infections in 7 different units , giving an incidence of 0.4 % new HCV infections per year . Molecular analyses and epidemiological data indicated that five patients became infected with HCV outside the unit where they were dialyzed , while the nine remaining patients acquired HCV from infected patients on dialysis during the same shift at the same unit . HCV was cleared in six of the seven ( 85.7 % ) patients with acute hepatitis C who were given st and ard doses of alpha-interferon ( alpha-IFN ) . The persistence of nosocomial transmission of HCV in hemodialysis units emphasizes the need to implement infection control practice s. Identifying new infections is crucial because alpha-IFN treatment results in long term clearance of HCV RNA in a large proportion of patients Objective : To evaluate treatment outcome of acute hepatitis C virus ( HCV ) in HIV-positive individuals . Design : Open-label , prospect i ve study conducted in London , January 1997-December 2003 . Methods : Patients in whom acute HCV infection had been diagnosed had sequential HCV RNA levels measured at 0 , 4 , 12 , 24 , 32 , and 48 weeks . If HCV RNA positive at 12 weeks , patients were offered pegylated interferon α-2b 1.5 μg/kg/wk and ribavirin 800 - 1200 mg/d for 24 weeks . Patients with increasing HCV RNA titers were offered treatment earlier . Results : Fifty male homosexuals with a mean age 37 years were identified : 44 from abnormal liver function test results , 4 from sexual contact with an HCV-positive partner , and 2 at HIV seroconversion . Overall , 12 individuals became HCV RNA negative spontaneously . This was significantly associated with high baseline median CD4 + count ( P = 0.029 ) , CD4 + count > 500 cells/mm3 ( P = 0.017 ) , and lower HCV RNA titers ( P = 0.017 ) . Only 27 patients accepted treatment , 16 ( 59 % ) of whom reached sustained virologic response . This was associated with higher peak mean alanine aminotransferase ( P < 0.001 ) and higher baseline CD4 % ( P = 0.041 ) . Conclusions : Sustained virologic response rates in HIV-positive patients treated for acute HCV infection are lower than in HIV-negative subjects . Because a high percentage of individuals seroconvert spontaneously , treatment should be delayed until after 12 weeks BACKGROUND / AIMS We investigated whether serial determination of IgM to HCV core protein ( HCV IgM ) may be useful to identify acute hepatitis C ( AHC ) and to distinguish this disease from reactivation of chronic hepatitis C ( r-CHC ) . METHODS We enrolled 35 consecutive patients with AHC identified by seroconversion to anti-HCV and 31 consecutive patients who had been anti-HCV positive for at least six months at the time of reactivation . Titres of HCV IgM were calculated as Index values by a commercially available enzyme immunoassay . RESULTS During the early phase of the illness we observed a wide variation in the HCV IgM Index values in all patients in the AHC group and consistent values in all cases in the r-CHC group . The HCV viral load determined soon after the onset of symptoms was of no use in identifying AHC.Twenty-three patients in the AHC group were observed as out patients for 6 - 30 months ; of these , 10 became plasma HCV-RNA negative within the third month of observation , but three showed a subsequent reactivation of HCV infection . CONCLUSIONS Our data indicate that the detection of high and variable titres of HCV IgM in the early phase of the illness may identify acute hepatitis C and allow early antiviral treatment In order to underst and the parameters associated with resolved hepatitis C virus (HCV)-infection , we analysed the HCV-specific T-cell responses longitudinally in 13 injecting drug-users ( IDUs ) with a prospect ively identified acute HCV infection . Seven IDUs cleared HCV and six IDUs remained chronically infected . T-cell responses were followed in the period needed to resolve and a comparable time span in chronic carriers . Ex vivo T-cell responses were measured using interferon-gamma Elispot assays after stimulation with overlapping peptide pools spanning the complete HCV genome . CD4 + memory-T-cell responses were determined after 12-day stimulation with HCV proteins . The maximum response was compared between individuals . The T-cell responses measured directly ex vivo were weak but significantly higher in resolvers compared to chronic carriers , whereas the CD4 + memory-T-cell response was not different between resolvers and chronic carriers . However , HCV Core protein was targeted more often in chronic carriers compared to individuals resolving HCV infection . CD4 + T-cell responses predominantly targeting nonstructural proteins were associated with resolved HCV infection . Interestingly , observation of memory-T-cell responses present before the documented HCV-seroconversion suggests that reinfections in IDUs occur often . The presence of these responses however , were not predictive for the outcome of infection . However , a transition of the HCV-specific CD4 + memory-T-cell response from targeting Core to targeting nonstructural proteins during onset of infection was associated with a favourable outcome . Therefore , the specificity of the CD4 + memory-T-cell responses measured after 12-day expansion seems most predictive of resolved infection Early treatment of acute hepatitis C with interferon alpha-2b for 24 weeks prevents chronic infection in almost all patients . Because pegylated interferons have replaced conventional interferon in the therapy of chronic hepatitis C , the aim of this study was to analyze the efficacy of an early treatment of acute hepatitis C with peginterferon alpha-2b . Between February 2001 and February 2004 , 89 individuals with acute HCV infection were recruited at 53 different centers in Germany . Patients received 1.5 microg/kg peginterferon alpha-2b for 24 weeks ; treatment was initiated after a median of 76 days after infection ( range 14 - 150 ) . End-of-treatment response and sustained virological response were defined as undetectable HCV RNA at the end of therapy and after 24 weeks of follow-up , respectively . In the total study population , virological response was 82 % at the end of treatment and 71 % at the end of follow-up . Of 89 individuals , 65 ( 73 % ) were adherent to therapy , receiving 80 % of the interferon dosage within 80 % of the scheduled treatment duration . End-of-treatment and sustained virological response rates in this sub population were 94 % and 89 % , respectively . A maximum alanine aminotransferase level of more than 500 U/L prior to therapy was the only factor associated with successful treatment . In conclusion , in acute HCV infection , early treatment with peginterferon alpha-2b leads to high virological response rates in individuals who are adherent to treatment . The high number of dropouts underlines the importance of thorough patient selection and close monitoring during therapy . Thus , future studies should identify factors predicting spontaneous viral clearance to avoid unnecessary therapy In view of the high rate of chronicity of acute hepatitis C and the low efficacy of interferon ( IFN ) treatment in advanced liver disease , it may be beneficial to treat patients during the acute phase of the infection . Here we assessed the effects of variable-dose IFNalpha-2b treatment in haemodialysis patients with acute hepatitis C virus ( HCV ) infection , and identified factors that may predict response to this therapy . The study population included 67 patients , but 14 were excluded due to side-effects or because they were lost to follow-up . Seventeen patients who received no specific treatment were used as controls ( Group 1 ) . Sixteen and 20 patients received low-(3 MU ) and high-dose ( 6 - 10 MU ) IFNalpha-2b three times weekly for 3 months ( Groups 2 and 3 , respectively ) . Virological end-of-treatment response ( ETR ) was observed in 1 ( 5.6 % ) , 13 ( 56.5 % ) , and 17 ( 65.4 % ) patients in Groups 1 , 2 , and 3 , respectively , and virological sustained response ( SR ) was observed in 1 ( 5.6 % ) , 6 ( 26.1 % ) , and 13 ( 50 % ) patients in the three groups . The rates of virological ETR and SR in the treated groups were significantly higher than those of the control group ( P < 0.01 for all comparisons ) . In multivariate logistic regression analysis , single str and ed confirmational polymorphysm ( SSCP ) b and number ( P=0.02 ) was the only factor that was significantly associated with virological SR . In conclusion , IFN-alpha treatment initiated during the acute phase of HCV infection is associated with a higher rate of virological ETR and SR . This study suggested that quasispecies heterogeneity has predictive value with regard to virological SR The diagnosis of acute hepatitis C virus ( HCV ) infection is not straightforward ; few people exhibit clinical symptoms and genome/antigen detection techniques do not indicate when infection had occurred . Here , a strategy to detect HCV RNA in the absence of antibody ( ' window-period ' ) for diagnosis of acute infection is assessed . The sentinel surveillance of hepatitis testing study was used to retrospectively identify anti-HCV negative sample s from high-risk individuals ( 2002 - 2003 ) , for testing singly for HCV RNA . Additional sample s were identified prospect ively ( 2005 ) and tested in pools for HCV RNA . Positive sample s were genotyped . Incidence and costs of adopting the pooling strategy were estimated . In the retrospective study , 8/390 ( 2.1 % ) sample s were confirmed HCV RNA positive , anti-HCV negative . Prospect ively , 3237 sample s were tested in 325 pools . Five positive pools identified four confirmed HCV RNA positive patients ( one false positive ) . Estimated incidence was 12.9 per 100 person-years in injecting drug users ( IDUs ) ( retrospective study ) and 3.7 per 100 person-years among drug/alcohol services and prison attendees ( prospect i ve study ) . Estimated costs were pound 850 per positive sample , in areas of higher risk . The yield from a window-period strategy depends upon the population tested . Pooled HCV RNA testing of anti-HCV negative sample s from the current IDUs is realistic and relatively inexpensive to identify recently infected individuals BACKGROUND Early treatment of acute HCV infection has been shown to improve virological response rates in HIV-positive patients ; however , details on when and how to best treat acute HCV infection remain unclear at present . METHODS In this European multicentre cohort study , HIV-positive patients with acute HCV infection were offered immediate or delayed anti-HCV therapy , pegylated interferon or pegylated interferon plus ribavirin combination therapy for 24 or 48 weeks , depending on the local protocol . The main outcome measure was the rate of sustained virological response ( SVR ) . RESULTS A total of 150 HIV-infected men with acute HCV were enrolled between 2001 and 2006 , 111 of whom received anti-HCV therapy . The predominant HCV genotype was type 1 and was present in 71 ( 64 % ) patients . Patients were treated with pegylated interferon ( n=14 ) or pegylated interferon plus ribavirin ( n=97 ) , with a median duration of treatment of 25 weeks . SVR was obtained in 62 % ( 95 % confidence interval 52 - 71 ) of patients . There was no difference in SVR by genotype , CD4(+ ) T-cell count , HIV RNA , HCV RNA , alanine aminotransferase levels or use of ribavirin . Negative HCV RNA at weeks 4 and 12 were strong predictors of SVR . CONCLUSIONS High rates of SVR ( 62 % ) were obtained in HIV-coinfected patients with acute HCV infection undergoing early anti-HCV treatment using pegylated interferon alone or in combination with ribavirin . Treatment response at weeks 4 and 12 might be of help to further guide treatment duration . Urgent prospect i ve studies are needed to further determine the optimal treatment regimen and the duration of therapy ABSTRACT Innate CD56pos natural killer ( NK ) and natural T ( NT ) cells comprise important hepatic antiviral effector lymphocytes whose activity is fine-tuned through surface NK receptors ( NKRs ) . Dysregulation of NKRs in patients with long-st and ing hepatitis C virus ( HCV ) infection has been shown , but little is known regarding NKRs in acute infection . Treatment-naïve patients with acute HCV ( n = 22 ) , including 10 with spontaneous recovery , were prospect ively studied . CD56pos NT levels were reduced early in acute HCV infection and did not fluctuate over time . In resolving HCV infection , NT cells with a more activated phenotype ( lower CD158A and higher natural cytotoxicity receptor expression ) at baseline pre date d spontaneous recovery . Moreover , NKG2A expression on CD56 + NT cells correlated directly with circulating HCV RNA levels . Deficient interleukin-13 ( IL-13 ) production by NT cells and reduced IL-2-activated killing ( LAK ) at baseline were associated with the ultimate development of persistence . These results indicate a previously unappreciated role for NT cells in acute HCV infection and identify a potential target for pharmacologic manipulation Individuals infected with human immunodeficiency virus type 1 ( HIV-1 ) are frequently coinfected with hepatitis C virus ( HCV ) . Acute HCV infection is often asymptomatic and poorly understood . We conducted a historical prospect i ve study of HCV antibody and viremia in plasma sample s obtained during 1994 - 1999 from a cohort of initially HIV-1-infected , HCV-uninfected women and from HIV-1-HCV-uninfected women . Twenty-two ( 1.5 % ) of 1517 experienced seroconversion . Of these , 14 ( 64 % ) truly acquired a new infection as assessed by enzyme immunoassay response and new-onset viremia . The incidence rate in HIV-1-infected women was 2.7 cases per 1000 person-years ; it was 3.3 cases per 1000 person-years in HIV-1-seronegative women ( relative risk , 1.21 ; P=.75 ) . Acquisition of HCV was associated with any history of drug use ( P<.01 ) . Five of 12 viremic , seroconverting individuals cleared viremia . Incident HCV infection among HIV-1-infected and HIV-1-uninfected women was low . It was linked to drug use and commonly resolved Background Although risk factors and useful preventive measures are largely known , specific data about the course and prognosis of acute hepatitis C among healthcare workers is lacking . Aim To analyze the data , course , and outcome of a series of patients with occupationally transmitted acute hepatitis C in France . Methods and setting An observational multicenter study based on two consecutive acute hepatitis C cohorts , retrospective then prospect i ve , registered between 1993 and 2007 , mostly in general hospitals . Results A cohort of 23 patients with occupationally transmitted hepatitis C virus ( HCV ) was set up . Occupational accident registration was done in 14 ( 61 % ) cases . They were mainly women ( n=14 ) , with a mean age of 43 years . The disease was diagnosed during surveillance after exposure in 16 patients , and nine had hyperbilirubinemia . Early treatment was applied to nine of them , with eight who sustained viral response ( SVR ) . Fourteen underwent surveillance : spontaneous viral clearance occurred in nine of them , with two relapses . Five patients with persistent HCV RNA 12 weeks after the diagnosis were then treated , with four SVR . Conclusion Information and prevention of healthcare workers concerning occupational HCV transmission need to be improved , and all blood-exposure accidents should be registered . Spontaneous viral clearance occurred in half of the patients . Antiviral treatment was highly effective , with a SVR of 86 % We identified 15 patients with acute hepatitis C ( AHC ) among 29 healthy volunteers participating in 2 consecutive pharmacokinetics studies . Molecular techniques were used to determine the relatedness of viral strains , whereas clinical and virologic follow‐up was started to establish the course and outcome of the acute infection . After presentation , serum liver enzymes and HCV RNA were monitored weekly for 4 months , then monthly for at least 12 months . Liver biopsy was performed 6 to 12 months after AHC diagnosis . Phylogenetic analysis of coding regions for the envelope glycoproteins E1 and E2 was performed . At presentation , all 15 patients tested HCV RNA – positive and had HCV genotype 2c . Phylogenetic analysis indicated a common source of infection . Fourteen patients agreed to be followed prospect ively . Infection resolved spontaneously in 8 patients , HCV RNA becoming undetectable by 4 to 5 months after the presumed time of infection in 5 of them and by 8 , 13 , and 24 months in the remaining 3 . Six patients developed chronic infection . Liver biopsies performed in 9 subjects who were HCV RNA – positive 6 months after AHC diagnosis revealed that the prevalent histologic finding was lobular inflammation . In conclusion , our homogeneous cohort showed a wide spectrum of clinical , virologic and histologic features , and , more importantly , short‐term outcome differed noticeably despite the common source of infection BACKGROUND & AIMS Acute hepatitis C infection progresses to chronic infection in up to 80 % of infected persons . Reports from Europe indicate that early treatment of acute hepatitis C infection produces sustained virologic response rates as high as 80%-98 % . However , the outcome of acute hepatitis C infection in United States cohorts is not well-characterized . METHODS We describe the clinical course of 28 episodes of acute hepatitis C infection in 24 persons at our institution . RESULTS Of the 28 infections , 7 episodes resolved spontaneously . Of the remaining 21 episodes , 16 were treated , and 5 did not receive treatment . Of the 16 treated episodes , 4 received interferon and ribavirin , 11 received pegylated interferon and ribavirin , and 1 was treated initially with interferon monotherapy followed by pegylated interferon monotherapy . Among those episodes treated with interferon , 3 of 4 experienced sustained virologic response . Among those episodes treated with pegylated interferon , all 12 achieved SVR . In total , 15 of 16 treated patients ( 94 % ) experienced SVR . In all , 18 of the 24 patients ( 75 % ) experienced spontaneous or treatment-induced sustained virologic clearance . CONCLUSIONS Our experience with treated and untreated acute HCV infection is comparable to that observed in Europe . Patients treated with antiviral therapy had an excellent response . R and omized trials to investigate immediate versus delayed treatment of acute hepatitis C infection are warranted . In view of these strongly positive outcomes , increased vigilance for acute hepatitis C becomes essential AIMS Chronic liver disease develops in the majority of non-uremic patients with hepatitis C virus ( HCV ) infection . The aim of this study was to analyze the evolution towards chronic hepatopathy in 19 cases of acute hepatitis C observed in hemodialysis patients from 1990 to 2001 . METHODS A prospect i ve follow-up study on HCV infection was conducted in 3 HD units from April 1990 to June 2001 to study clinical outcomes after acute hepatitis C. A total of 781 patients were tested monthly for alanine aminotransferase and anti-HCV in serum . In this period , 19 patients suffered from acute hepatitis C. Evolution to chronic liver disease in the follow-up was evaluated by means of biochemical ( increased ALT ) and virological criteria ( HCV-RNA+ ) . The transmission mechanism , the apparition of anti-HCV , clinical manifestations and mortality were also investigated . RESULTS In 15 ( 78.9 % ) of the 19 patients , the viremia remained positive ( chronic viremia ) and 11 patients ( 57.8 % ) evolved to chronic liver disease ( chronic viremia and high transaminase levels ) with a median follow-up of 3 years ( range 1 - 6 ) . Five of them who underwent liver biopsies had histologic signs of chronic active hepatitis . One of them ( 5.2 % ) evolved to liver cirrhosis in the follow-up . In 4 out of 19 patients ( 21 % ) the HCV infection resolved . Although 7 ( 36.8 % ) of them died in the follow-up , acute hepatitis C infection was not a short-term independent risk factor of death . CONCLUSIONS Three years after acute hepatitis C , 87.5 % of the hemodialysis patients remained HCV-RNA positive and 56.2 % evolved to chronic liver disease . It is important to stress that HCV infection spontaneously cleared in 4 out of 19 patients ( 21 % ) UNLABELLED An estimated 170 million people worldwide carry the hepatitis C virus ( HCV ) , and in more developed countries the prevalence and incidence of HCV is particularly high among injecting drug users ( IDUs ) . Spontaneous clearance of HCV infection and reinfection is well recognized but the level of protection against further infection conferred by HCV infection and clearance remains uncertain . We conducted a prospect i ve study of HCV infection in IDUs recruited in Melbourne , Australia , using a much shorter median testing interval than in previous studies . Incidences of naive infection and reinfection were calculated by the person-year method and Cox proportional hazards regression used to adjust for covariates . A significantly higher HCV incidence rate was measured in previously infected IDUs ( 46.8 % per year ) compared with HCV-naive IDUs ( 15.5 % per year ) . The hazard ratio for previously infected IDUs compared to HCV-naive IDUs , after adjustment for time-dependent covariates , was 2.54 ( 95 % confidence interval , 1.11 - 5.78 , P > |z| < 0.05 ) . Viral persistence after reinfection appeared similar to that following naive infection . CONCLUSION Our data suggest that HCV infection in IDUs is more likely following prior infection and clearance than in HCV-naive individuals , implying no increased immunity against further infection . This result has important implication s for the future development of an HCV vaccine BACKGROUND AND AIM The aim of this study was to examine whether particular hepatitis C virus ( HCV ) subtypes are spreading among injecting drug users ( IDUs ) in Yamaguchi prefecture , on the south-western tip of the isl and of Honshu in Japan , as found in European countries . METHODS We prospect ively enrolled acute hepatitis C patients from January 2001 to March 2003 . E2 gene sequences of HCV isolates from IDUs with acute hepatitis C were phylogenetically compared to those from 30 chronic hepatitis C patients with the same HCV subtypes who had or did not have a history of intravenous drug use . RESULTS Nine of 11 patients ( 82 % ) with acute hepatitis C were IDUs . The HCV subtypes were 2a in four and 2b in five , which contrasted with the high prevalence of subtype 1b in patients with chronic liver diseases in Japan . IDUs with acute hepatitis C ( 22.0 + /- 2.4 years old ) were significantly younger than those with chronic hepatitis C ( 49.5 + /- 9.5 years old ) for subtype 2a ( P = 0.0005 ) , but not for subtype 2b ( 25.6 + /- 5.4 vs 28.1 + /- 2.4 years old ) . Some HCV isolates of subtype 2b from IDUs with acute hepatitis C were phylogenetically related to those from IDUs with chronic hepatitis C. By contrast , there was no phylogenetic segregation of HCV in IDUs with subtype 2a . HCV isolates from non-IDUs were genetically divergent from each other and those from IDUs , irrespective of the HCV subtype . CONCLUSION Hepatitis C virus of the non-1b subtype , particularly subtype 2b , seemed to be transmitted between IDUs very recently in Yamaguchi prefecture , Japan The present study examined reasons for the high incidence of hepatitis C virus ( HCV ) infection among young injection drug users ( IDUs ) . IDUs < 30 years old who tested negative for HCV antibody were enrolled in a prospect i ve cohort . Risk factors for seroconversion were examined using time-dependent regression analyses : 48 of 195 IDUs seroconverted to HCV , for an incidence rate of 25.1/100 person-years ( 95 % confidence interval , 18.7 - 32.9/100 person-years ) . Independent risk factors included sharing needles with an HCV-infected sex partner ( borderline statistical significance , P=.11 ) or a person who was not a sex partner , sharing nonsterile drug-preparation equipment , pooling money with another IDU to buy drugs , and exchanging sex for money . Ubiquitous behaviors among young IDUs , such as the forming of injecting or sexual partnerships and consequent sharing of needles and drug preparation equipment , are risk factors for HCV . Interventions to reduce HCV transmission must recognize the importance of relationships on injecting risk BACKGROUND The outcome of acute hepatitis C is determined by early host-virus interactions , particularly involving the antiviral T-cell response . OBJECTIVES To identify early prognostic markers of spontaneous resolution of acute hepatitis C by performing a comprehensive analysis of viral and immunological factors during the natural course of acute HCV infection and reinfection . STUDY DESIGN 20 patients were investigated prospect ively during acute HC or confirmed reinfection and 18 of them during follow up after spontaneous or treatment-induced elimination of the virus and resolution of the disease . Multiparameter flow cytometry was used to functionally characterize virus-specific CD4(+ ) T-cell responses relative to the virologic outcome . RESULTS Parallel immunologic and virologic monitoring of patients with acute HC identified distinct patterns of host-virus interaction related to HCV persistence or clearance . The highest frequency of antiviral Th1 cytokine-producing CD4(+ ) T-cells was observed in patients with HCV reinfection , preceding rapid viral clearance within 3 weeks after disease onset . In all patients who subsequently cleared viremia , CD4(+ ) T-cells produced Th1 cytokines following stimulation with non-structural HCV antigens ( NS3 and NS4 ) . In contrast , a chronic course of disease was associated with the absence of antiviral Th1 cytokine producing cells from the first weeks after onset of disease ( acute persistent HC ) , or with fluctuating RNA levels ( yo-yo pattern ) and gradual waning of antiviral Th1 cells . CONCLUSIONS The results highlight the variability of immune response pattern in acute hepatitis C. Most importantly , " acute persistent hepatitis C " and a lack of TH1 effector cells within the first months of acute hepatitis C represent efficacious predictors of viral persistence and could thus be used as criteria in selecting c and i date s for early antiviral treatment UNLABELLED Acute hepatitis C continues to be a concern in men who have sex with men ( MSM ) , and its optimal management has yet to be established . In this study , the clinical , biological , and therapeutic data of 53 human immunodeficiency virus (HIV)-infected MSM included in a multicenter prospect i ve study on acute hepatitis C in 2006 - 2007 were retrospectively collected and analyzed . The mean hepatitis C virus ( HCV ) viral load at diagnosis was 5.8 ± 1.1 log(10 ) IU/mL ( genotype 4 , n = 28 ; genotype 1 , n = 14 , genotype 3 , n = 7 ) . The cumulative rates of spontaneous HCV clearance were 11.0 % and 16.5 % 3 and 6 months after diagnosis , respectively . Forty patients were treated , 38 of whom received pegylated interferon and ribavirin . The mean duration of HCV therapy was 39 ± 17 weeks ( 24 ± 4 weeks in 14 cases ) . On treatment , 18/36 ( 50.0 % ; 95 % confidence interval 34.3 - 65.7 ) patients had undetectable HCV RNA at week 4 ( RVR ) , and 32/39 ( 82.1 % ; 95 confidence interval 70.0 - 94.1 ) achieved sustained virological response ( SVR ) . SVR did not correlate with pretreatment parameters , including HCV genotype , but correlated with RVR ( predictive positive value of 94.4 % ) and with effective duration of HCV therapy ( 64.3 % for 24 ± 4 weeks versus 92.0 % for longer treatment ; P = 0.03 ) . CONCLUSION The low rate of spontaneous clearance and the high SVR rates argue for early HCV therapy following diagnosis of acute hepatitis C in HIV-infected MSM . Pegylated interferon and ribavirin seem to be the best option . The duration of treatment should be modulated according to RVR , with a 24-week course for patients presenting RVR and a 48-week course for those who do not , irrespectively of HCV genotype BACKGROUND Outbreaks of sexually transmitted hepatitis C virus ( HCV ) infection have been reported among human immunodeficiency virus (HIV)-infected men who have sex with men in Europe , Australia , and New York . Whether this is occurring across the United States is unknown . METHODS We determined incidence of HCV infection during 1996 - 2008 among male participants of the AIDS Clinical Trial Group Longitudinal Linked R and omized Trials cohort , a long-term study of HIV-infected persons r and omized into selected US-based clinical trials . We evaluated associations with self-reported injection drug use ( IDU ) , time-varying CD4(+ ) cell count , and HIV RNA level with use of multivariate Poisson regression . No sexual or non-IDU risk factor data was available . RESULTS A total of 1830 men had an initial negative HCV antibody test result and at least 1 subsequent HCV antibody test result , contributing > 7000 person-years . At the time of the initial negative HCV antibody test result , 94 % of men were receiving highly active antiretroviral therapy ( HAART ) and 6 % reported current or prior IDU . Thirty-six seroconverted , with overall incidence of .51 cases per 100 person-years ( 95 % confidence interval , .36-.70 ) . Mean age at seroconversion was 46 years . Seroconversion was associated with IDU ( 25 % of seroconverters reported IDU history vs 5 % of nonseroconverters ; P < .001 ) , whereas 75 % ( n = 27 ) of seroconverters reported no IDU ( incidence , 2.67 cases per 100 person-years among IDUs , .40 cases per 100 person-years among non-IDUs ) . Seroconversion was associated with HIV RNA level > 400 copies/mL ( 44 % at time of antibody positivity vs 21 % at time of last negative antibody test result ; P = .02 ) but not with CD4(+ ) cell count . CONCLUSIONS Incident HCV infection occurs in HIV-infected men involved in US HIV therapeutic trials , primarily through nonparenteral means , despite engagement in care and HAART . HCV antibody development was not related to immune status but was associated with inadequate HIV suppression . At-risk HIV-infected persons should have access to HCV surveillance BACKGROUND AND AIM Hepatitis C treatment uptake in Australia is low . We describe the rate of acute hepatitis C treatment in the Australian state of Victoria by linking the central ized passive notifications system for hepatitis C with the Australian Trial in Acute Hepatitis C ( ATAHC ) , a nationwide clinical trial aim ed at providing people with newly acquired hepatitis C with 24 weeks ' pegylated interferon monotherapy . METHODS M and atory notifications of clinical or laboratory evidence of hepatitis C were further investigated for evidence of newly acquired infection . Followed-up individuals were then screened for eligibility for the ATAHC study ( which included documented hepatitis C antibody positivity within the previous 6 months ) and offered acute hepatitis C treatment if this was the case . We examined the first 18 months of the recruitment . RESULTS A total of 4591 hepatitis C cases were notified with 414 ( 9 % ) of these flagged as being potentially newly acquired . Through follow-up of doctors and patients , 160 of these were confirmed as newly acquired ; 87 of these 160 ( 54 % ) were potentially eligible for ATAHC and were referred to ATAHC research ers . Fourteen ( 16 % ) were successfully enrolled in ATAHC . Eight individuals commenced acute hepatitis C treatment during this period . CONCLUSION The use of hepatitis C surveillance system has been successful in identifying cases of newly acquired hepatitis C which are often difficult to identify in a clinical setting . In addition , marginalized patients who may otherwise never have been referred to a clinic are able to access hepatitis C treatment and specialist services . Despite this , only eight out of 87 eligible individuals ( 9 % ) began acute hepatitis C treatment ABSTRACT Acute hepatitis C virus ( HCV ) is typically defined as new viremia and antibody seroconversion . Rates and immunologic correlates of hepatitis C clearance have therefore been based on clearance of viremia only in individuals who initially had an antibody response . We sought to characterize the immunological correlates of clearance in patients with acute hepatitis C and their sexual contacts . We prospect ively determined CD4 + and CD8 + cytotoxic T-lymphocyte responses in index patients with acute HCV and their sexual contacts who developed acute infection , either with or without spontaneous clearance , as well as those contacts who never developed viremia . Responses were measured using proliferation and ELISpot assays for CD4 + and CD8 + responses . We demonstrate in this prospect i ve study that cellular immune responses can develop in exposed but persistently aviremic and antibody-negative individuals as well as those individuals with spontaneous clearance of acute HCV . These findings lend further credence to the importance of cellular immune responses in recovery from HCV and suggest that low exposure to HCV may lead to development of HCV-specific immune responses without ongoing HCV replication . This finding has important implication s for HCV vaccine and therapeutic development Background Interferon monotherapy significantly reduces the chronicity rate of acute hepatitis C in nonuremic patients . In this clinical study , we evaluated the efficacy and tolerance of interferon-&agr ; therapy for acute hepatitis C in hemodialysis patients . Methods Patients with acute hepatitis C , established on the basis of seroconversion to anti-hepatitis C virus and the presence of hepatitis C virus RNA , received a low dose of interferon-&agr ; ( 3 MU three times per week ) for 12 months or a high dose ( 5 MU three times per week , preceded by a daily induction dose ) for 6 months . Response to treatment was defined as undetectable hepatitis C virus RNA at the end of treatment and sustained virological response was defined as persistent negative hepatitis C virus RNA 6 months after the end of treatment . Results Twenty-three patients were treated , 16 with a low dose of interferon-&agr ; and seven with a high dose . At the end of treatment , hepatitis C virus RNA was undetectable in 16/23 patients ( 70 % ) . Of these , 6/23 patients ( 26 % ) relapsed and 10/23 ( 43 % ) maintained a sustained virological response ( 38 % in lower doses vs. 57 % in higher doses ) . Treatment was well tolerated and only three patients discontinued therapy ( 13 % ) . Conclusion Interferon-&agr ; within the first year after acute hepatitis C in hemodialysis patients was found to be safe and effective , inducing a sustained virological response in 43 % of cases . This study supports the routine indication of acute hepatitis C treatment with interferon-&agr ; for hemodialysis patients , and higher doses administered for a shorter period of time should be tried according to the tolerance of the patients Most patients with an acute infection of hepatitis C virus ( HCV ) will develop chronic hepatitis , and only about 15 - 20 % of the cases will resolve spontaneously . The mechanism for the different outcomes in patients with acute HCV infection remains unclear . HCV genotype has been recognized as an important factor affecting the clinical course and outcome of chronic hepatitis C patients . In order to evaluate the role of HCV genotype in the clinical course and outcome of acute posttransfusion hepatitis C , 67 patients with acute posttransfusion hepatitis C from a prospect i ve study of posttransfusion non-A , non-B hepatitis were enrolled . Thirty-nine patients ( 58.2 % ) were HCV genotype 1b . Among the 67 patients with acute posttransfusion hepatitis C , 53 ( 79.1 % ) progressed to chronic hepatitis . Significantly more patients with genotype 1b than non-1b genotypes developed chronic hepatitis ( 89.7 % vs. 64.3 % ; P = 0.019 ) . There was no significant difference in gender , mean age , amount of transfused blood , hepatitis symptoms , jaundice , incubation period , peak serum alanine transaminase , or serum HCV RNA titer between patients with HCV genotype 1b and non-1b infections . Patients who developed chronic hepatitis had a significantly greater incidence of genotype 1b infection ( 66.0 % vs. 28.6 % ; P = 0.013 ) and a longer incubation period ( 7.3 weeks vs. 5.4 weeks ; P = 0.052 ) than patients whose infection was resolved . Patients with a genotype 1b infection that resolved itself spontaneously all had an incubation period of less than 6 weeks . Multivariate logistic regression analysis revealed that genotype 1b and an incubation period > or = 6 weeks were significant predictive factors for the development of chronic hepatitis . Therefore , the HCV genotype can influence the outcome of patients with acute HCV infection Injection drug use is the leading risk factor for infection with hepatitis C virus , and interferon ( IFN ) treatment in this context is associated with a poor rate of adherence . In this article , we review our experience with injection drug users with acute hepatitis C who are treated with pegylated IFN- alpha -2b for 12 weeks . Acute hepatitis C was diagnosed according to st and ardized criteria , and patients were treated with a median dosage of IFN- alpha -2b of 1.33 microg/kg per week . A sustained virological response was achieved in 17 ( 74 % ) of 23 patients . A sustained virological response was achieved in 14 ( 87 % ) of 16 patients treated with a dosage of > or=1.33 microg/kg per week and in 3 ( 43 % ) of 7 patients treated with a lower dosage . Sustained virological response was significantly associated only with a pegylated IFN- alpha -2b dosage > or=1.33 microg/kg per week ( P=.022 ) . A 12-week regimen of pegylated IFN to treat injection drug users with hepatitis C has a compliance that is much higher than that reported with a 24-week regimen . Adverse effects are minimal if patients are carefully selected BACKGROUND Hepatitis C virus ( HCV ) infection , clearance , and reinfection are best studied in injection drug users ( IDUs ) , who have the highest incidence of HCV and are likely to represent most infections . METHODS A prospect i ve cohort of HCV-negative young IDUs was followed up from January 2000 to September 2007 , to identify acute and incident HCV and prospect ively study infection outcomes . RESULTS Among 1,191 young IDUs screened , 731 ( 61.4 % ) were HCV negative , and 520 ( 71.1 % ) of the 731 were enrolled into follow-up . Cumulative HCV incidence was 26.7/100 person-years of observation ( 95 % confidence interval [ CI ] , 21.5 - 31.6 ) . Of 135 acute/incident HCV infections , 95 ( 70.4 % ) were followed ; 20 ( 21.1 % ) of the 95 infections cleared . Women had a significantly higher incidence of viral clearance than did men ( age-adjusted hazard ratio , 2.91 [ 95 % CI , 1.68 - 5.03 ] ) and also showed a faster rate of early HCV viremia decline ( P < .01 ) . The estimated reinfection rate was 24.6/100 person-years of observation ( 95 % CI , 11.7 - 51.6 ) . Among 7 individuals , multiple episodes of HCV reinfection and reclearance were observed . CONCLUSIONS In this large sample of young IDUs , females show demonstrative differences in their rates of viral clearance and kinetics of early viral decline . Recurring reinfection and reclearance suggest possible protection against persistent infection . These results should inform HCV clinical care and vaccine development Aim : To evaluate the efficacy of early interferon α‐2b in non‐post‐transfusion acute hepatitis C virus : a prospect i ve study with historical comparison BACKGROUND & AIMS Acute hepatitis C virus infection accounts for approximately 20 % of cases of acute hepatitis today . The aim of this study was to define the natural course of the disease and to contribute to the development of treatment strategies for acute hepatitis C virus . METHODS The diagnosis of acute hepatitis C virus in 60 patients was based on seroconversion to anti-hepatitis C virus antibodies or clinical and biochemical criteria and on the presence of hepatitis C virus RNA in the first serum sample . RESULTS Fifty-one of 60 ( 85 % ) patients presented with symptomatic acute hepatitis C virus . In the natural ( untreated ) course of acute symptomatic hepatitis C ( n = 46 ) , spontaneous clearance was observed in 24 patients ( 52 % ) , usually within 12 weeks after the onset of symptoms , whereas all asymptomatic patients ( n = 9 ) developed chronic hepatitis C. The start of antiviral therapy ( interferon-alpha with or without ribavirin ) beyond 3 months after the onset of acute hepatitis induced sustained viral clearance in 80 % of treated patients . CONCLUSIONS The management of acute hepatitis C has to take into account the high rate of spontaneous viral clearance within 12 weeks after the onset of symptomatic disease . Treatment of only those patients who remain hepatitis C virus RNA positive for more than 3 months after the onset of disease led to an overall viral clearance ( self-limited and treatment induced ) in 91 % of patients , and unnecessary treatment was avoided in those with spontaneous viral clearance . Patients with asymptomatic acute hepatitis C virus infection are unlikely to clear the infection spontaneously and should be treated as early as possible BACKGROUND Acute hepatitis C has a high chronicity rate which appears to be significantly reduced by early antiviral treatment . However , it is unclear if all acutely infected patients should be treated , and when . In this prospect i ve study , patients with a well-documented diagnosis of acute hepatitis C were evaluated to define the natural course , the rate of chronicity , and host and virus-related factors which might predict a self-limiting or chronic evolution requiring early antiviral treatment . METHODS From 1995 to 2000 , 40 consecutive patients with a community-acquired AHC were enrolled . Liver tests , anti-hepatitis C virus antibodies and hepatitis C virus RNA levels were monitored . Median follow-up was 35 months ( range 12 - 68 ) . RESULTS A total of 24/40 patients had symptomatic disease including 20 with jaundice ; 13/40 patients had prompt serum hepatitis C virus RNA clearance and ALT normalisation within 12 weeks ; in 12/13 patients this pattern remained unchanged during follow-up . Overall , 27/40 patients remained hepatitis C virus RNA positive with fluctuating ALT levels . Older age and jaundice were predictive of resolution whereas there was no correlation with other host factors , viral genotype or viral load . CONCLUSIONS Our data demonstrate that spontaneous resolution can occur in about 30 % of AHC patients . This favourable outcome rarely occurs in patients with anicteric AHC or in those with jaundice but with persistent viremia for more than 12 weeks from onset ; early antiviral treatment for these patients may avoid or reduce chronicity BACKGROUND Hemodialysis patients are at risk of hepatitis C virus ( HCV ) infection . However , little is known about the efficacy and safety of pegylated interferon ( IFN ) therapy for hemodialysis patients with acute hepatitis C. METHODS From 2005 through 2008 , 35 hemodialysis patients with acute hepatitis C who did not have spontaneous clearance of HCV by 16 weeks were treated with pegylated IFN alfa-2a at a dosage of 135 microg weekly for 24 weeks . In contrast , 7 patients with clearance of HCV by 16 weeks were under observation only . Thirty-six hemodialysis patients from 2002 - 2005 who had acute hepatitis C but did not receive treatment served as historical controls . The primary efficacy and safety end points were sustained virologic response ( undetectable HCV RNA levels at 24 weeks after therapy ) by intention-to-treat analysis and treatment-related withdrawal . RESULTS The rate of sustained virologic response in the treatment group was significantly higher than the rate of spontaneous HCV clearance in the control group ( 88.6 % vs 16.7 % ; P < .001 ) . Two patients ( 5.7 % ) prematurely terminated treatment at 8 and 10 weeks because of constitutional symptoms , and both did not have sustained virologic response . All but one patient had rapid virologic response ( undetectable HCV RNA levels at 4 weeks of therapy ) , and all patients who received > 12 weeks of therapy had early and end-of-treatment virologic responses . All patients who had clearance of HCV by 16 weeks had undetectable HCV RNA levels until the end of follow-up . CONCLUSIONS Pegylated IFN alfa-2a monotherapy is safe and efficacious for hemodialysis patients with acute hepatitis C. It is suggested that patients without spontaneous clearance of HCV by week 16 should receive therapy BACKGROUND More than two-thirds of hepatitis C virus ( HCV ) infections in Western countries are caused by injection drug use , but prospect i ve clinical data regarding the most common mode of HCV acquisition are rare , in part because acute-phase HCV infection is usually asymptomatic . METHODS To characterize acute-phase HCV infection , 179 HCV antibody-negative injection drug users were prospect ively evaluated ; 62 ( 34 % ) of these patients had seroconverted . Twenty of the participants who seroconverted had long-term follow-up with consistent monthly sampling before and after seroconversion , allowing detailed study . RESULTS The first indication of HCV infection was the presence of HCV RNA in serum , which preceded elevation of alanine transaminase levels and total bilirubin levels to > or = 2 times baseline in 45 % and 77 % of patients , respectively . No subjects had jaundice . The median time from initial viremia to seroconversion was 36 days ( range , 32 - 46 days ) . In one instance , viremia was detected 434 days before seroconversion . However , in no other case was HCV RNA detected > 63 days before seroconversion . In subjects with viral persistence , a stable level of HCV RNA in the blood was noted in some subjects within 60 days after the initial detection of viremia , but in others , it was not apparent until > 1 year later . In subjects with long-term viral clearance , HCV became persistently undetectable as early as 94 and as late as 620 days after initial viremia . CONCLUSIONS These data underscore the importance of nucleic acid screening of blood donations to prevent HCV transmission and of long-term follow-up to ascertain whether there is viral persistence , at least among injection drug users Objectives : To determine the incidence of diagnosed newly acquired hepatitis C virus ( HCV ) in HIV-positive men who have sex with men ( MSM ) across London and Brighton in order to inform public health interventions . Methods : Cases were defined as MSM attending London and Brighton HIV/genitourinary medicine clinics from January 2002 to June 2006 , with HCV PCR RNA or antibody positive , and a negative HCV test in the previous three years . The yearly number of cases and HCV screening policy in MSM were examined . A negative binomial regression model was used to estimate HCV incidence density rate ratio and 95 % CI . Results : 20 out of 38 clinics provided information , covering 84 % of the HIV-positive MSM workload in London and 100 % in Brighton . The estimated overall incidence was 9.05 per 1000 HIV-positive MSM patient-years . It increased from 6.86 per 1000 in 2002 to 11.58 per 1000 during January – June 2006 . Incidence at clinics ranged from 0 to 15.4 ( median 6.52 ) per 1000 HIV-positive MSM patient-years . There was some evidence of difference in the incidence and trend ( p = 0.02 ) in each clinic . The average annual rise in incidence of HCV was 20 % ( 95 % CI 4 % to 39 % , p = 0.001 ) . There was little evidence of such transmission among MSM with negative or unknown HIV status . Conclusions : HCV incidence clearly increased among HIV-positive MSM in London and Brighton during January 2002 to June 2006 . Prospect i ve enhanced surveillance of HCV in MSM , including HIV status and behavioural risk factors , is recommended to help inform control measures and better determine the frequency of transmission in all MSM Serial liver biopsies are the gold st and ard by which the progression of fibrosis is evaluated . This longitudinal cohort study assessed the different rates in the progression of fibrosis using serial liver biopsies and serum fibrosis markers YKL‐40 and PIIINP and the cytokines , transforming growth factor beta ( TGF‐β ) and tumor necrosis factor alpha ( TNF−α ) . A 10‐year cohort study was performed in patients with hepatitis C virus ( HCV ) alone or HCV and schistosomiasis . Patients were enrolled at the time of acute HCV infection and prospect ively evaluated with two liver biopsies ( at entry and end of follow‐up ) , and true rates in the progression of fibrosis were calculated per year . Serum YKL‐40 , N‐terminal propeptide of collagen III ( PIIINP ) , TGF‐β , and TNF‐α were measured , as well as the expression of TGF‐β , TNF‐α , and YKL‐40 mRNA in liver tissue . A significant increase in the progression rates of fibrosis occurred in the coinfected group ( 0.61 ± 0.13 ) compared with the HCV monoinfection group ( 0.1 ± 0.06 ; P < .001 ) ) . The progression of fibrosis rate/year had a direct linear correlation for YKL‐40 ( r = 0.892 , P < .001 ) and for PIIINP ( r = 0.577 , P < .01 ) . YKL‐40 showed a linear correlation with TGF‐β ( r = 0.897 , P < .001 ) . Hepatic mRNA levels of YKL‐40 and TGF‐β correlated with the serum levels , confirming a hepatic source for the elevated serum levels . In conclusion , serial cytokine and fibrosis markers can accurately determine the rate at which fibrosis is progressing , identifying both those with rapid fibrosis and those with stable disease . ( HEPATOLOGY 2006;43:771–779 . Objectives To analyze the data ( epidemiology , mode of transmission , course , and outcome ) of a large series of patients with acute hepatitis C ( AHC ) in France . Methods Prospect i ve multicenter register , observational study . Results A cohort of 126 patients with AHC was prospect ively enrolled between 1999 and 2007 . Fifteen ( 12 % ) were HIV coinfected . Suspected modes of hepatitis C virus transmission were drug use ( 38 % ) , sexual contact ( 21 % ) , nosocomial transmission ( 18 % ) , and occupational exposure ( 12 % ) . For 40 % of the patients , AHC was revealed by jaundice . Spontaneous viral clearance occurred in 40 % of the 72 patients observed for 3 months without treatment . Only jaundice and nosocomial/occupational transmission were predictive of spontaneous viral clearance . Ninety patients were treated with st and ard or pegylated interferon-&agr ; alone ( 58 % ) or in combination with ribavirin ( 42 % ) , for 24 weeks or less in 90 % . In intention-to-treat , a sustained viral response was obtained in 58 of 78 ( 74 % ) hepatitis C virus monoinfected patients [ 19 of 22 ( 86 % ) with 24 weeks of pegylated interferon-&agr ; alone ] , but only six of 12 ( 50 % ) of HIV coinfected patients . Conclusion AHC remains rare , and drug and sexual transmission are predominant . A 3-month follow-up after diagnosis avoids treatment for four out of 10 patients . Antiviral treatment is highly effective , 24 weeks of pegylated interferon-&agr ; alone being a good option BACKGROUND & AIMS Patients with acute hepatitis C virus ( HCV ) infection who receive treatment achieve high rates of sustained virologic response ( SVR ) , but few studies have examined outcomes among injecting drug users ( IDUs ) . We evaluated the efficacy of treatment of recent HCV infection in IDUs with acute and early chronic HCV . METHODS We analyzed data from the Australian Trial in Acute Hepatitis C-a prospect i ve study of the natural history and treatment outcomes of patients with recent HCV infection . Participants eligible for the study had their first anti-HCV antibody-positive test result within the past 6 months and either acute clinical HCV within the past 12 months or documented anti-HCV seroconversion within 24 months . Participants with HCV received pegylated interferon-alfa-2a ( 180 microg/wk , n = 74 ) ; those with HCV/human immunodeficiency virus ( HIV ) co-infection received pegylated interferon-alfa-2a ( 180 microg/wk ) with ribavirin ( n = 35 ) for 24 weeks . RESULTS From June 2004 to February 2008 , 167 participants were enrolled in the Australian Trial in Acute Hepatitis C ; 79 % had injected drugs in the previous 6 months . Among 74 with only HCV , the SVRs were 55 % and 72 % by intention-to-treat and per- protocol analysis , respectively . In multivariate analyses , baseline factors independently associated with lower SVR included decreased social functioning and current opiate pharmacotherapy . Adherent participants had higher SVR rates ( 63 % vs 29 % ; P = .025 ) . Of the 35 participants with HCV/HIV co-infection , the SVRs were 74 % and 75 % by intention-to-treat and per- protocol analysis , respectively . CONCLUSIONS Treatment of recent HCV infection among IDUs , including those with HIV co-infection , is effective . Strategies to engage socially marginalized individuals and increase adherence should improve treatment outcomes in this population |
354 | 29,807,743 | Based on the available RCTs , LLLT has a significant role in the clinical treatment of DS .
However , the results of PDT were similar to those of conventional antifungal therapies | Denture stomatitis ( DS ) is an inflammatory oral lesion that occurs mostly in elderly denture wearers and that can negatively affect their quality of life .
The conventional treatment plan for DS is topical or systemic fungicidal drug therapy , which are not without side effects .
Purpose .
The purpose of this systematic review was to evaluate the clinical outcomes of using low‐level laser therapy ( LLLT ) or photodynamic therapy ( PDT ) in the treatment of DS by review ing high‐ quality published articles . | OBJECTIVE The aim of this study was to monitor therapeutic response by determining the level of proinflammatory cytokines TNF-alpha and IL-6 in whole unstimulated saliva in patients with denture stomatitis ( DS ) , before and after laser phototherapy ( LPT ) . BACKGROUND DS is an inflammatory condition that occurs in subjects who wear dentures , and it is a common oral mucosal lesion . A potential noninvasive treatment for DS patients is LPT . MATERIAL S AND METHODS A sample consisting of 40 consecutive subjects was selected on a voluntary basis from patients who presented for the diagnosis and treatment of DS at the Oral Medicine Unit of the Medical Faculty at the University of Rijeka . A clinical examination was performed according to the st and ard clinical criteria . Lesions described as palatal inflammation were diagnosed as Newton type II denture stomatitis . The patients were r and omly assigned to either an experimental group ( 20 patients receiving real LPT ) or a control group ( 20 patients receiving inactive/placebo laser treatment ) . In order to determine the salivary levels of TNF-alpha and IL-6 , ELISA ( Sigma Immunochemicals , St Louis , MO ) was performed . RESULTS Following treatment with LPT for 4 wk , the levels of TNF-alpha and IL-6 decreased significantly ( p < 0.001 ) and were significantly different from controls ( p < 0.001 ) . CONCLUSION The results of this study suggest that LPT may be an efficacious choice of therapy BACKGROUND AND OBJECTIVE Denture stomatitis ( DS ) is a common inflammatory condition that affects denture wearers . The aim of this study was to examine , in vivo , the effect of diode laser irradiation on fungal growth in both the palatal mucosa and in denture base material s , in denture wearing patients . STUDY DESIGN / MATERIAL S AND METHODS In total , 70 patients with clinical study design evidence of DS participated in this parallel , single blind , and placebo controlled study . The subjects were r and omly assigned to one of four different treatment regimens : ( 1 ) irradiation with a 685 nm wavelength laser for 10 minutes ( 30 mW ) ; ( 2 ) irradiation with a 830 nm wavelength laser for 5 minutes ( 60 mW ) . A semiconductor diode laser , BTL-2000 ( BTL-2 Dravotnicka Technika , Prague , Czech Republic ) , was used in both treatment cases using an energy density of 3.0 J/cm(2 ) and a continuous working mode for five consecutive days ; ( 3 ) placebo-sham irradiation of patients ; ( 4 ) antimicotic-self treatment of patient 's palatal mucosa with an antifungal oral gel and the use of an antiseptic solution for their dentures . The effect of laser light on fungal growth in vivo was evaluated after final treatment using the swab method and a semi-quantitative estimation of C and ida albicans colonies cultivated on agar plates . RESULTS A fungicidal effect was achieved in the laser treated and antimicotic treated groups , whereas most subjects in the placebo group were found to have unchanged conditions on both their palate ( P = 0,004 ) and dentures ( P < 0,001 ) . CONCLUSIONS Light from a low-power laser ( LLLT ) may be valuable in the treatment of DS . This is of great importance since the rate of recurrence of disease is high , whereas an optimal treatment modality has not yet been found OBJECTIVE The aim was to assess the efficacy of antimicrobial photodynamic therapy ( aPDT ) in the inactivation of oral fungal colonization among cigarette smokers and non-smokers with denture stomatitis ( DS ) . METHODS A question naire was used to gather demographic information . Clinical oral examination was performed to determine location of denture in the jaws and oral erythematous lesions . Presence of fungal hyphae in smokers and non-smokers was confirmed using exfoliative cytology . In both groups , aPDT was performed and colony forming units per milliliter ( CFU/ml ) were assessed i m both groups at 3-months follow-up . Level of significance was et at P<0.05 . RESULTS Twenty-two males with DS ( 12 smokers and 10 non-smokers ) were included . The mean ages of smokers and non-smokers was 73.8±2.5 and 70.5±1.2years , respectively . The duration and daily frequency of cigarette smoking was 20.6±4.5years and 12.3±1.5 cigarettes daily , respectively . Smokers and non-smokers had been wearing complete dentures since 6.2±0.8 and 5.8±0.4years , respectively . At 3-months follow-up , there was a statistically significant decrease in the mean fungal CFU/ml among smokers ( 25.5±8.3 CFU/ml ) compared with their respective baseline values 106.7±6.3 CFU/ml ( P<0.01 ) . Among non-smokers , the mean CFU/ml values were 12.7±0.8 CFU/ml compared with their respective baseline values ( 93.6±8.4 CFU/ml ) ( P<0.01 ) . At 3-months follow-up , fungal CFU/ml levels were statistically significantly higher among smokers ( 25.5±8.3 CFU/ml ) compared with non-smokers ( 12.7±0.8 CFU/ml ) ( P<0.05 ) . CONCLUSION aPDT is effective in the inactivation of oral fungal colonization among cigarette smokers and non-smokers with . The role of denture is also emphasized PURPOSE Photodynamic therapy ( PDT ) appears to be an effective method for the in vitro and in vivo inactivation of C and ida spp . , but no clinical trials in this context have yet been conducted . The aim of this study was to compare the effect of oral miconazole gel to PDT combined with low-power laser ( LPL ) therapy in the treatment of denture stomatitis . MATERIAL S AND METHODS Forty participants with clinical and microbiological diagnoses of type II denture stomatitis were r and omly allocated to two treatment groups ( PDT and miconazole gel ) , each with 20 individuals . The PDT group was su bmi tted to one session of methylene blue-mediated PDT plus two sessions of low-laser therapy twice a week for 15 days . The miconazole group was su bmi tted to the drug four times a day for 15 days . RESULTS Forty percent of the patients achieved clinical and microbiological resolution of denture stomatitis after methylene blue-mediated photodynamic inactivation followed by low-laser therapy . The cure rate associated with miconazole was 80 % ( p < 0.05 ) . Fifteen days after the end of treatment , the recurrence rate was 25 % in patients treated with PDT combined with LPL therapy and 12.5 % in patients treated with miconazole . CONCLUSION Miconazole gel provides better results than a protocol combining methylene blue-mediated PDT and LPL therapy in the treatment of type II denture stomatitis STATEMENT OF PROBLEM Mucosal inflammation under dentures causes problems for prosthodontists and patients . PURPOSE OF STUDY This study evaluated the effectiveness of a low-energy laser used in the treatment of denture-induced mucosal lesions in comparison with other conventional methods . MATERIAL AND METHODS Eighteen men were selected and divided into three groups of six according to the treatment applied : denture removal , relined dentures with temporary tissue treatment , and application of laser irradiation for the lesions while continuing to wear the dentures . Oral hygiene and nutrition were maintained during the study . Clinical , histologic , and densitometric assessment s were used to evaluate the three treatment methods . RESULTS The results revealed that lesions in the group treated with laser irradiation were clinical ly superior in healing when compared with the other groups . Histologic evidence of the therapeutic effect of lasers in healing denture-induced mucosal lesions was demonstrated . Densitometric evaluation showed an increase in the optical density of alveolar bone underneath the irradiated lesions compared with untreated lesions . CONCLUSION These findings suggest the effect of therapeutic laser treatment on both soft tissue and bone with subsequent improvement of denture foundation after treatment of denture-induced mucosal lesions PURPOSE To evaluate the antiseptic properties of five different disinfectant techniques on three different peri-implantitis ( PI ) associated biofilms . METHODS 90 implant titanium disks , with the same thickness and diameter , were prepared and r and omly divided into 18 groups ( n = 5 ) based on the microbiota strains ( S. aureus , S. epidermidis and C. albicans ) and using the following disinfectant techniques : soft laser therapy , photodynamic therapy ( PDT ) , 0.12 % NaOCl , 0.2 % chlorhexidine , 3 % H2O2 , and control groups . After forming a protein layer on disk surfaces , the specimens were exposed to the microbial suspensions . After decontamination according to design ated techniques , 2 % Trypsin protease was administered to isolate the surviving microorganisms . Muller Hinton agar culture was used for microbiota growth . After 48-hour incubation , the st and ard colony forming unit ( CFU ) was assayed and the collected data were analyzed by Kruskal-Wallis and Mann-Whitney tests at a significance level of 0.05 . RESULTS The highest amount of CFU/ml values was shown by C. albicans , which was subjected to PDT ( 25.12 ± 30.23 ) . The least disinfecting efficacy on S. epidermidis was demonstrated by the laser group ( all P-values ≤ 0.01 ) . Nevertheless , all of the groups exhibited significant differences with the control groups ( all P-values < 0.01 ) . CLINICAL SIGNIFICANCE None of the studied disinfectant techniques had the highest lethal effects on all of the tested microbiotas . Therefore , a combination of these disinfectant techniques , for instance PDT ⁺ 3 % H2O2 or 0.2 % chlorhexidine , is recommended Photodynamic therapy ( PDT ) is a promising treatment for oral c and idoses . Its use as an alternative to antifungals prevents several adverse effects , including microbial resistance . However , most PDT protocol s do not employ devices and consumables commonly available in dental practice , thus influencing treatment affordability . This study aim ed to determine the efficacy of a PDT method based on light curing units ’ blue LEDs combined to a plaque-disclosing composition ( 5 % erythrosine ) against C. albicans in culture and in a murine model of oral c and idosis . St and ard and resistant fungal strains were tested in vitro in planktonic and biofilm forms . PDT ( pre-irradiation time periods : 30 and 60 s ; irradiation time : 3 min ) was compared to control conditions without light and /or erythrosine . Mice with induced oral c and idosis ( n = 40 ) r and omly received PDT or similar control conditions with subsequent C. albicans count . These mice underwent histological analysis , as well as 12 healthy mice su bmi tted to experimental treatments . PDT completely inactivated C. albicans planktonic cells and biofilm . Control conditions presented minor differences ( ANOVA , p < 0.05 ) , with mean values ranging from 5.2 to 6.8 log10 ( UFC/mL ) . Infected mice presented no significant difference in C. albicans counts consequent to treatments ( ANOVA , p = 0.721 ) , although the PDT protocol was able to enhance the inflammatory infiltrate in healthy mice . It can be concluded that the tested PDT protocol can inactivate C. albicans but still needs further investigation in order to achieve efficacy and safety The aim of this study was to evaluate the effectiveness of photodynamic therapy ( PDT ) for the disinfection of complete dentures . Biofilm sample s were collected from dentures of 60 denture users who were r and omly divided into four experimental groups ( n = 15 each ) : subjects whose maxillary dentures were sprayed with 50 and 100 mg/l of Photogem ® suspension ( groups P50S and P100S ) and patients whose maxillary dentures were treated with 50 and 100 mg/l of Photogem ® gel ( groups P50 G and P100 G ) . Dentures with photosensitizers were left in the dark for 30 min ( pre-irradiation time ) and then irradiated with blue LED light at 37.5 J/cm2 ( 26 min ) . Denture sample s were taken with sterile cotton swab before ( left side surfaces ) and after ( right side surfaces ) PDT . All microbial material was diluted and plated on selective media for C and ida spp . , Staphylococcus mutans spp . , streptococci and a non-selective media . After incubation ( 48 h/37 ° C ) , the number of colony-forming units ( cfu/ml ) was counted . Microorganisms grown on selective media were identified using biochemical methods before and after PDT . The data were su bmi tted to McNemar and Kruskal – Wallis tests ( α = 0.05 ) . No growth after PDT was observed in 60 , 53 , 47 , and 40 % of dentures from P100 G , P50 G , P100S , and P50S groups , respectively . When evidence of microorganisms ’ growth was observed , PDT regimens eliminated over 90 % of microorganisms on dentures . This clinical study showed that PDT was effective for disinfecting dentures UNLABELLED The effectiveness of microwave disinfection of maxillary complete dentures on the treatment of C and ida-related denture stomatitis was evaluated . Patients ( n = 60 ) were r and omly assigned to one of four treatment groups of 15 subjects each ; CONTROL GROUP patients performed the routine denture care ; Mw group : patients had their upper denture microwaved ( 650 W per 6 min ) three times per week for 30 days ; group MwMz : patients received the treatment of Mw group in conjunction with topical application of miconazole three times per day for 30 days ; group Mz : patients received the antifungal therapy of group MwMz . Cytological smears and mycological cultures were taken from the dentures and the palates of all patients before treatment at day 15 and 30 of treatment and at follow-up ( days 60 and 90 ) . The effectiveness of the treatments was evaluated by Kruskal-Wallis and Mann-Whitney tests . Microbial and clinical analysis of the control group demonstrated no significant decrease in the c and idal infection over the clinical trial . Smears and cultures of palates and dentures of the groups Mw and MwMz exhibited absence of C and ida at day 15 and 30 of treatment . On day 60 and 90 , few mycelial forms were observed on 11 denture smears ( 36.6 % ) from groups Mw and MwMz , but not on the palatal smears . Miconazole ( group Mz ) neither caused significant reduction of palatal inflammation nor eradicated C and ida from the dentures and palates . Microwaving dentures was effective for the treatment of denture stomatitis . The recurrence of C and ida on microwaved dentures at follow-up was dramatically reduced The aim of this study was to investigate if coherence length is of importance in laser phototherapy . Twenty patients with moderate periodontitis were selected . After oral hygiene instructions , scaling and root planing ( SRP ) , one side of the upper jaw was r and omly selected for HeNe ( 632.8 nm , 3 mW ) or InGaAlP ( 650 nm , 3 mW ) laser irradiation . One week after SRP , the following parameters were measured : pocket depth , gingival index , plaque index , gingival crevicular fluid volume , matrix metalloproteinase ( MMP-8 ) , interleukin ( IL-8 ) and subgingival microflora . The irradiation ( 180 s per point , energy 0.54 J ) was then performed once a week for 6 weeks . At the follow up examination , all clinical parameters had improved significantly in both groups . A more pronounced decrease of clinical inflammation was observed after HeNe treatment . MMP-8 levels were considerably reduced on the HeNe side , while there was no difference for IL-8 or microflora . Coherence length appears to be an important factor in laser phototherapy This study sought to evaluate the effect of low-level laser treatment combined with scaling and root planing ( SRP ) on gingival tissue levels of TNF-alpha in subjects with periodontal disease . Eighty gingival papilla biopsy sample s were obtained from 60 patients diagnosed with chronic advanced periodontitis ; r and omly assigned to three treatment groups ( n = 20 ) , as well as 20 subjects with no periodontal disease ( group A ) . Group B received SRP on a single quadrant/day for four consecutive days . On day 5 , all quadrants were rescaled . Groups C and D received the same treatment as group B plus laser application with the low-level diode laser ( 630–670 nm , 1.875 J/cm2 ) for five and ten consecutive days , respectively . Papilla biopsies were obtained from subjects and evaluated by ELISA for levels of TNF-alpha . The values in the control group were 5.2 ± 3.21 pg/mg and baseline values for the examined groups were 46.01 ± 16.69 . Significantly decreased level of TNF-alpha for groups C and D was found after treatment , while group B demonstrated reduction of TNF-alpha of 31.34 % . The results of this study show suppression of TNF-alpha in gingival tissue after low-level laser treatment as adjunct to SRP . Data may suggest beneficial anti-inflammatory effects of the laser treatment when used as adjunctive periodontal treatment In this r and omized clinical trial , the clinical and mycological efficacy of Photodynamic Therapy ( PDT ) was compared with that of topical antifungal therapy for the treatment of denture stomatitis ( DS ) and the prevalence of C and ida species was identified . Patients were r and omly assigned to one of two groups ( n = 20 each ) ; in the nystatin ( NYT ) group patients received topical treatment with nystatin ( 100,000 IU ) four times daily for 15 days and in the PDT group the denture and palate of patients were sprayed with 500 mg/L of Photogem ( ® ) , and after 30 min of incubation , were illuminated by light emitting-diode light at 455 nm ( 37.5 and 122 J/cm(2 ) , respectively ) three times a week for 15 days . Mycological cultures taken from dentures and palates and st and ard photographs of the palates were taken at baseline ( day 0 ) , at the end of the treatment ( day 15 ) and at the follow-up time intervals ( days 30 , 60 and 90 ) . Colonies were quantified ( CFU/mL ) and identified by biochemical tests . Data were analysed by Fisher 's exact test , analysis of variance and Tukey tests and κ test ( α = 0.05 ) . Both treatments significantly reduced the CFU/mL at the end of the treatments and on day 30 of the follow-up period ( p < 0.05 ) . The NYT and PDT groups showed clinical success rates of 53 % and 45 % , respectively . C and ida albicans was the most prevalent species identified . PDT was as effective as topical nystatin in the treatment of DS |
355 | 31,414,194 | Exercise is an efficacious and safe add-on therapeutic intervention showing a medium-sized effect on QoL and a large effect on mood in patients with chronic brain disorders , with a positive dose – response correlation .
Exercise also improved several cognitive domains with small but significant effects | null | null |
356 | 31,426,825 | Studies generally indicated high satisfaction with toolkits , but the perceived usefulness of individual tools varied .
Conclusions The review documents publicly available toolkits and their components .
High satisfaction with toolkits can be achieved but the usefulness of individual tools may vary . | Background The objective was to conduct a systematic review of toolkit evaluations intended to spread interventions to improve healthcare quality .
We aim ed to determine the components , uptake , and effectiveness of publicly available toolkits . | OBJECTIVE A performance improvement continuing medical education ( PI CME ) activity was design ed to assist clinicians with accurately identifying and appropriately managing persistent pain in long-term care facility ( LTCF ) residents . DESIGN Volunteer LTCFs participated in a three-stage PI CME model consisting of : 1 ) baseline assessment , 2 ) implementation of practice improvement interventions , and 3 ) re assessment . Expert faculty chose performance measures and interventions for the activity . A champion was design ated ateach LTCF to collect resident charts and enter data into an online data base . SETTING Eight LTCFs located across the United States participated in the activity . PATIENTS Fifty resident charts were r and omly selected by each LTCF champion ( 25 for stage 1 and 25 for stage 3 ) ; a total of 350 charts were review ed . INTERVENTIONS In addition to a toolkit containing numerous performance improvement re sources , an in-service meeting led by an expert faculty member was conducted at each LTCF . OUTCOME MEASURES Stage 3 data were collected 6 weeks after implementation of interventions and compared with stage 1 baseline data to measure change in performance . RESULTS Aggregate data collected from seven LTCFs completing the PI CME activity through stage 3 revealed improvements from baseline in four of five performance measures . CONCLUSIONS This CME activity allowed for collection of data demonstrating performance improvement in persistent pain management . The tools used as part of the intervention ( available at http://www.achlpicme.org/LTC/toolkit ) may help other clinicians enhance their management of LTCF residents with persistent pain Background The diversity of quality improvement interventions ( QIIs ) has impeded the use of evidence review to advance quality improvement activities . An agreed-upon framework for identifying QII articles would facilitate evidence review and consensus around best practice s. Aim To adapt and test evidence review methods for identifying empirical QII evaluations that would be suitable for assessing QII effectiveness , impact or success . Design Literature search with measurement of multilevel inter-rater agreement and review of disagreement . Methods Ten journals ( 2005 - 2007 ) were search ed electronically and the output was screened based on title and abstract . Three pairs of review ers then independently rated 22 articles , r and omly selected from the screened list . Kappa statistics and percentage agreement were assessed . 12 stakeholders in quality improvement , including QII experts and journal editors , rated and discussed publications about which review ers disagreed . Results The level of agreement among review ers for identifying empirical evaluations of QII development , implementation or results was 73 % ( with a paradoxically low kappa of 0.041 ) . Discussion by raters and stakeholders regarding how to improve agreement focused on three controversial article selection issues : no data on patient health , provider behaviour or process of care outcomes ; no evidence for adaptation of an intervention to a local context ; and a design using only observational methods , as correlational analyses , with no comparison group . Conclusion The level of review er agreement was only moderate . Reliable identification of relevant articles is an initial step in assessing published evidence . Advancement in quality improvement will depend on the theory- and consensus-based development and testing of a generalizable framework for identifying QII evaluations Objective Continuous quality improvement ( CQI ) methods are foundational approaches to improving healthcare delivery . Publications using the term CQI , however , are method ologically heterogeneous , and labels other than CQI are used to signify relevant approaches . St and ards for identifying the use of CQI based on its key method ological features could enable more effective learning across quality improvement ( QI ) efforts . The objective was to identify essential method ological features for recognizing CQI . Design Previous work with a 12-member international expert panel identified reliably abstract ed CQI method ological features . We tested which features met rigorous a priori st and ards as essential features of CQI using a three-phase online modified-Delphi process . Setting Primarily United States and Canada . Participants 119 QI experts r and omly assigned into four on-line panels . Intervention(s ) Participants rated CQI features and discussed their answers using online , anonymous and asynchronous discussion boards . We analyzed ratings quantitatively and discussion threads qualitatively . Main outcome measure(s ) Panel consensus on definitional CQI features . Results Seventy-nine ( 66 % ) panelists completed the process . Thirty-three completers self-identified as QI research ers , 18 as QI practitioners and 28 as both equally . The features ‘ systematic data guided activities , ’ ‘ design ing with local conditions in mind ’ and ‘ iterative development and testing ’ met a priori st and ards as essential CQI features . Qualitative analyses showed cross-cutting themes focused on differences between QI and CQI . Conclusions We found consensus among a broad group of CQI research ers and practitioners on three features as essential for identifying QI work more specifically as ‘ CQI . ’ All three features are needed as a minimum st and ard for recognizing CQI methods BACKGROUND Challenges exist in implementing evidence -based strategies , reaching high compliance , and achieving desired outcomes . The rapid adoption of a publicly available toolkit featuring routine universal decolonization of intensive care unit ( ICU ) patients may affect catheter-related bloodstream infections . METHODS Implementation of universal decolonization-treatment of all ICU patients with chlorhexidine bathing and nasal mupirocin-used a prerelease version of a publicly available toolkit . Implementation in 136 adult ICUs in 95 acute care hospitals across the United States was supported by planning and deployment tactics coordinated by a central infection prevention team using toolkit re sources , along with coaching calls and engagement of key stakeholders . Operational and process measures derived from a common electronic health record system provided real-time feedback about performance . Healthcare-associated central line-associated bloodstream infections ( CLABSIs ) , using National Healthcare Safety Network surveillance definitions and comparing the preimplementation period of January 2011 through December 2012 to the postimplementation period of July 2013 through February 2014 , were assessed via a Poisson generalized linear mixed model regression for CLABSI events . RESULTS Implementation of universal decolonization was completed within 6 months . The estimated rate of CLABSI decreased by 23.5 % ( 95 % confidence interval , 9.8%-35.1 % ; P = .001 ) . There was no evidence of a trend over time in either the pre- or postimplementation period . Adjusting for seasonality and number of beds did not material ly affect these results . CONCLUSIONS Dissemination of universal decolonization of ICU patients was accomplished quickly in a large community health system and was associated with declines in CLABSI consistent with published clinical trial findings BACKGROUND Both targeted decolonization and universal decolonization of patients in intensive care units ( ICUs ) are c and i date strategies to prevent health care-associated infections , particularly those caused by methicillin-resistant Staphylococcus aureus ( MRSA ) . METHODS We conducted a pragmatic , cluster-r and omized trial . Hospitals were r and omly assigned to one of three strategies , with all adult ICUs in a given hospital assigned to the same strategy . Group 1 implemented MRSA screening and isolation ; group 2 , targeted decolonization ( i.e. , screening , isolation , and decolonization of MRSA carriers ) ; and group 3 , universal decolonization ( i.e. , no screening , and decolonization of all patients ) . Proportional-hazards models were used to assess differences in infection reductions across the study groups , with clustering according to hospital . RESULTS A total of 43 hospitals ( including 74 ICUs and 74,256 patients during the intervention period ) underwent r and omization . In the intervention period versus the baseline period , modeled hazard ratios for MRSA clinical isolates were 0.92 for screening and isolation ( crude rate , 3.2 vs. 3.4 isolates per 1000 days ) , 0.75 for targeted decolonization ( 3.2 vs. 4.3 isolates per 1000 days ) , and 0.63 for universal decolonization ( 2.1 vs. 3.4 isolates per 1000 days ) ( P=0.01 for test of all groups being equal ) . In the intervention versus baseline periods , hazard ratios for bloodstream infection with any pathogen in the three groups were 0.99 ( crude rate , 4.1 vs. 4.2 infections per 1000 days ) , 0.78 ( 3.7 vs. 4.8 infections per 1000 days ) , and 0.56 ( 3.6 vs. 6.1 infections per 1000 days ) , respectively ( P<0.001 for test of all groups being equal ) . Universal decolonization result ed in a significantly greater reduction in the rate of all bloodstream infections than either targeted decolonization or screening and isolation . One bloodstream infection was prevented per 54 patients who underwent decolonization . The reductions in rates of MRSA bloodstream infection were similar to those of all bloodstream infections , but the difference was not significant . Adverse events , which occurred in 7 patients , were mild and related to chlorhexidine . CONCLUSIONS In routine ICU practice , universal decolonization was more effective than targeted decolonization or screening and isolation in reducing rates of MRSA clinical isolates and bloodstream infection from any pathogen . ( Funded by the Agency for Healthcare Research and the Centers for Disease Control and Prevention ; REDUCE MRSA Clinical Trials.gov number , NCT00980980 ) CONTEXT Falls cause injury and death for persons of all ages , but risk of falls increases markedly with age . Hospitalization further increases risk , yet no evidence exists to support short-stay hospital-based fall prevention strategies to reduce patient falls . OBJECTIVE To investigate whether a fall prevention tool kit ( FPTK ) using health information technology ( HIT ) decreases patient falls in hospitals . DESIGN , SETTING , AND PATIENTS Cluster r and omized study conducted January 1 , 2009 , through June 30 , 2009 , comparing patient fall rates in 4 urban US hospitals in units that received usual care ( 4 units and 5104 patients ) or the intervention ( 4 units and 5160 patients ) . INTERVENTION The FPTK integrated existing communication and workflow patterns into the HIT application . Based on a valid fall risk assessment scale completed by a nurse , the FPTK software tailored fall prevention interventions to address patients ' specific determinants of fall risk . The FPTK produced bed posters composed of brief text with an accompanying icon , patient education h and outs , and plans of care , all communicating patient-specific alerts to key stakeholders . MAIN OUTCOME MEASURES The primary outcome was patient falls per 1000 patient-days adjusted for site and patient care unit . A secondary outcome was fall-related injuries . RESULTS During the 6-month intervention period , the number of patients with falls differed between control ( n = 87 ) and intervention ( n = 67 ) units ( P=.02 ) . Site-adjusted fall rates were significantly higher in control units ( 4.18 [ 95 % confidence interval { CI } , 3.45 - 5.06 ] per 1000 patient-days ) than in intervention units ( 3.15 [ 95 % CI , 2.54 - 3.90 ] per 1000 patient-days ; P = .04 ) . The FPTK was found to be particularly effective with patients aged 65 years or older ( adjusted rate difference , 2.08 [ 95 % CI , 0.61 - 3.56 ] per 1000 patient-days ; P = .003 ) . No significant effect was noted in fall-related injuries . CONCLUSION The use of a fall prevention tool kit in hospital units compared with usual care significantly reduced rate of falls . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00675935 BACKGROUND Since the 2008 inception of universal childhood influenza vaccination , national rates have risen more dramatically among younger children than older children and reported rates across racial/ethnic groups are inconsistent . Interventions may be needed to address age and racial disparities to achieve the recommended childhood influenza vaccination target of 70 % . PURPOSE To evaluate an intervention to increase childhood influenza vaccination across age and racial groups . METHODS In 2011 - 2012 , a total of 20 primary care practice s treating children were r and omly assigned to the intervention and control arms of a cluster r and omized controlled trial to increase childhood influenza vaccination uptake using a toolkit and other strategies including early delivery of donated vaccine , in-service staff meetings , and publicity . RESULTS The average vaccination differences from pre-intervention to the intervention year were significantly larger in the intervention arm ( n=10 practice s ) than the control arm ( n=10 practice s ) ; for children aged 9 - 18 years ( 11.1 pct pts intervention vs 4.3 pct pts control , p<0.05 ) ; for non-white children ( 16.7 pct pts intervention vs 4.6 pct pts control , p<0.001 ) ; and overall ( 9.9 pct pts intervention vs 4.2 pct pts control , p<0.01 ) . In multi-level modeling that accounted for person- and practice -level variables and the interactions among age , race , and intervention , the likelihood of vaccination increased with younger age group ( 6 - 23 months ) ; white race ; commercial insurance ; the practice 's pre-intervention vaccination rate ; and being in the intervention arm . Estimates of the interaction terms indicated that the intervention increased the likelihood of vaccination for non-white children in all age groups and white children aged 9 - 18 years . CONCLUSIONS A multi- strategy intervention that includes a practice improvement toolkit can significantly improve influenza vaccination uptake across age and racial groups without targeting specific groups , especially in practice s with large percentages of minority children Objectives : Substance use screening is a recommended component of routine healthcare for adolescents . A 2008 survey of Massachusetts primary care physicians found high rates of screening , but low rates of vali date d tool use , leading to the concern that physicians may be missing substance use-related problems and disorders . In an effort to improve practice , a cross-disciplinary group developed and distributed an adolescent screening , brief intervention , and referral to treatment toolkit in 2009 . A new survey of Massachusetts primary care physicians was conducted in 2014 ; this report describes its findings , and compares them to those from 2008 . Methods : A survey was mailed to a r and omly selected sample of Massachusetts primary care physicians listed in the state Board of Registration in Medicine data base . Item response frequencies were computed . Multiple logistic regression modeling was used to compare 2008 and 2014 responses , while controlling for any demographic differences between sample s. Results : Pediatrician respondents in 2014 ( analysis N = 130 ) reported a high rate of annually screening patients for alcohol use ( 96.2 % ) , but only 56.2 % reported using a vali date d screening tool . Rates of screening and vali date d tool use were higher in 2014 than 2008 . Insufficient knowledge as a reported barrier to screening decreased from 2008 to 2014 . However , lack of time or staff re sources remained key perceived barriers to screening . Conclusions : Our findings suggest that adolescent alcohol use screening practice s among Massachusetts pediatricians have improved in recent years , during a time of national and statewide efforts to educate physicians . However , opportunities for practice improvement remain PURPOSE To increase childhood influenza vaccination rates using a toolkit and early vaccine delivery in a r and omized cluster trial . METHODS Twenty primary care practice s treating children ( range for n=536 - 8183 ) were r and omly assigned to Intervention and Control arms to test the effectiveness of an evidence -based practice improvement toolkit ( 4 Pillars Toolkit ) and early vaccine supplies for use among disadvantaged children on influenza vaccination rates among children 6 months-18 years . Follow-up staff meetings and surveys were used to assess use and acceptability of the intervention strategies in the Intervention arm . Rates for the 2010 - 2011 and 2011 - 2012 influenza seasons were compared . Two-level generalized linear mixed modeling was used to evaluate outcomes . RESULTS Overall increases in influenza vaccination rates were significantly greater in the Intervention arm ( 7.9 percentage points ) compared with the Control arm ( 4.4 percentage points ; P<0.034 ) . These rate changes represent 4522 additional doses in the Intervention arm vs. 1390 additional doses in the Control arm . This effect of the intervention was observed despite the fact that rates increased significantly in both arms - 8/10 Intervention ( all P<0.001 ) and 7/10 Control sites ( P-values=0.04 to < 0.001 ) . Rates in two Intervention sites with pre-intervention vaccination rates > 58 % did not significantly increase . In regression analyses , a child 's likelihood of being vaccinated was significantly higher with : younger age , white race ( Odds ratio [OR]=1.29 ; 95 % confidence interval [CI]=1.23 - 1.34 ) , having commercial insurance ( OR=1.30 ; 95%CI=1.25 - 1.35 ) , higher pre-intervention practice vaccination rate ( OR=1.25 ; 95%CI=1.16 - 1.34 ) , and being in the Intervention arm ( OR=1.23 ; 95%CI=1.01 - 1.50 ) . Early delivery of influenza vaccine was rated by Intervention practice s as an effective strategy for raising rates . CONCLUSIONS Implementation of a multi- strategy toolkit and early vaccine supplies can significantly improve influenza vaccination rates among children in primary care practice s but the effect may be less pronounced in practice s with moderate to high existing vaccination rates . Clinical trial registry name/number : From Innovation to Solutions : Childhood Influenza/NCT01664793 This study assessed the usability and desired enhancements for the MacArthur Foundation ’s Depression and Primary Care ( MDPC ) Web site to determine if re sources for integrated depression care that are disseminated through the Web site are incorporated into routine clinical care . Since its launch in 2003 , more than 20,000 users registered as members of the MDPC website to read and download depression care re sources . Subjects were r and omly selected from MDPC Web site users who had previously downloaded the depression toolkit . Web-based survey , which was administered anonymously , included the following domains : ( 1 ) socio-demographic data , ( 2 ) confidence in managing depression ( 3 ) Web site content and design features , ( 4 ) desired enhancements to Web site and content , ( 5 ) use of re sources downloaded from the Web site , and ( 6 ) importance of depression care re sources . Of the 3,478 r and omly selected participants , 666 ( 19.1 % ) responded . Web site content was rated “ good ” or “ excellent ” for screening and diagnosis ( 84.3 % ) , treatment ( 69.8 % ) , patient education ( 66.2 % ) , and care management ( 66.9 % ) . The Patient Health Question naire-9 ( PHQ-9 ) was rated “ very useful ” by 68.3 % ; 47.1 % reported using it in at least 25 % of encounters with patients who are depressed . PHQ-9 use was significantly associated with higher self-confidence in managing depression ( P = 0.05 ) . Evidence -based re sources for depression care can be disseminated effectively through a dedicated Web site and may help clinicians incorporate effective care models into routine practice Background : Nursing documentation is the record of care that is planned and given to patients , yet it is often missing or incomplete . A study of translating results from nurses ’ assessment s of fall risk into tailored interventions using health information technology was used to examine nursing documentation of risk assessment , plans to manage those risks , and interventions to prevent falls . Objective : The aim of this study was to evaluate the effectiveness of an electronic fall prevention toolkit for promoting documentation of fall risk status and planned and completed fall prevention interventions . Methods : Nursing documentation related to fall risk and prevention was review ed in 30 % of r and omly selected medical records for patients on the eight study units ( four intervention units ; 5,267 patients ) and four usual care units ( 5,116 patients ) during three separate study visits . Results : Patients on the intervention units were more likely to have fall risk documented ( 89 % vs. 64 % , p < .0001 ) . There were significantly more comprehensive plans of care for the patients on the interventions documented , although no differences were found related to documentation of completed interventions compared with usual care unit patient records . Discussion : The documentation of fall risk status and planned interventions tailored to patient-specific areas of risk was significantly better on the intervention units that used the fall prevention toolkit as compared with usual care units . Improved documentation quality did not extend to the documentation of completed interventions Background . The Centers for Disease Control and Prevention ’s ( CDC ) “ Heads Up ” toolkit was design ed to educate physicians about concussion , but it has not been well studied . This study proposed to evaluate the effect of receiving the toolkit on physician concussion knowledge . Methods . The authors obtained a sample of physicians from the American Medical Association masterfile and r and omly selected half to be mailed the CDC ’s “ Heads Up ” toolkit . All physicians were then sent a survey on concussion knowledge . Data were analyzed to evaluate the effect of the toolkit on concussion knowledge . Results . The survey was completed by 414 physicians ( 183 intervention , 231 control ) . There were no differences in general concussion knowledge between intervention and control groups , but physicians in the intervention group were significantly less likely to recommend next day return to play after a concussion ( adjusted odds ratio = 0.31 , 95 % confidence interval = 0.12 - 0.76 ) . Conclusions . Mailing the CDC ’s “ Heads Up ” toolkit appears to affect physicians ’ recommendations regarding returning to play after a concussion Background Practitioners in the Veterans Health Administration ( VHA ) identified comprehensive weight management as a high priority in early 2001 . Program Design The MOVE ! Weight-Management Program for Veterans was developed on the basis of published guidelines from the National Institutes of Health and other organizations . Testing of program feasibility occurred at 17 VHA sites , and the program was refined during early implementation throughout 2005 . Evaluation MOVE ! has been implemented at nearly all VHA medical centers . By June 2008 , more than 100,000 patients had participated in MOVE ! during more than 500,000 visits . An evaluation based on an established framework is under way . Conclusion MOVE ! is an example of the large-scale translation of research into practice . It has the potential to reduce the burden of disease from obesity and related conditions Context Emergency department visits and rehospitalizations are common after hospital discharge . Contribution This trial demonstrated that a nurse discharge advocate and clinical pharmacist working together to coordinate hospital discharge , educate patients , and reconcile medications led to fewer follow-up emergency visits and rehospitalizations than usual care alone . Caution The trial was conducted at a single center , and not all eligible patients were enrolled . Implication A systematic approach to hospital discharges can reduce unnecessary health service use . The Editors One in 5 hospitalizations is complicated by postdischarge adverse events ( 1 , 2 ) , some of which may lead to preventable emergency department visits or readmissions . Despite this finding , hospital discharge procedures have not been st and ardized ( 3 ) . In addition , the declining presence of primary care providers ( PCPs ) in hospitals has not been adequately accompanied by systems to ensure that patient data are transferred to subsequent caregivers ( 4 , 5 ) . For example , discharge summaries frequently lack critical data and are not sent to the PCP in a timely fashion ( 6 , 7 ) , result ing in outpatient clinicians being unaware of test results that were pending at discharge ( 8) and evaluations that were scheduled to be done after discharge not being completed ( 9 ) . Similarly , patients are often left unprepared at discharge ; many do not underst and their discharge medications and can not recall their chief diagnoses ( 10 ) . With more than 32 million adult discharges in the United States each year ( 11 ) , these deficiencies in the transition of care increase illness , unnecessary hospital utilization , and cost . Some peridischarge interventions have shown a reduction in hospital readmission rates and cost ( 1214 ) , emergency department visits ( 15 ) , and postdischarge adverse events ( 16 ) , whereas some have shown little or no effect ( 1720 ) . Peridischarge interventions have also shown improved PCP follow-up and outpatient work-ups ( 21 ) and higher patient satisfaction ( 15 ) . Most of these studies have focused on specific diagnoses ( 14 , 22 , 23 ) or highly selected population s , such as geriatric adults ( 12 , 13 , 19 , 24 ) . Some have focused on specific aspects of the discharge , such as increasing access to primary care follow-up ( 25 ) , connecting with transitional nursing services ( 26 ) , or improving patients ' ability to advocate for themselves after discharge ( 12 ) . To date , no study has evaluated a st and ardized discharge intervention that includes patient education , comprehensive discharge planning , and postdischarge telephone reinforcement in a general medical population . In 2004 , we began an in-depth examination of hospital discharge , for which we design ed a package of services to minimize discharge failuresa process called reengineered discharge ( RED ) ( Table 1 ) ( 3 , 27 ) . We did a r and omized , controlled trial to evaluate the clinical effect of implementing RED among patients admitted to a general medical service . Table 1 . Components of Reengineered Hospital Discharge Methods Setting and Participants We conducted a 2-group , r and omized , controlled trial of English-speaking patients 18 years of age or older who were admitted to the medical teaching service of Boston Medical Center , Boston , Massachusettsa large , urban , safety-net hospital with an ethnically diverse patient population . Patients had to have a telephone , be able to comprehend study details and the consent process in English , and have plans to be discharged to a U.S. community . We did not enroll patients if they were admitted from a skilled nursing facility or other hospital , transferred to a different hospital service before enrollment , admitted for a planned hospitalization , were on hospital pre caution s or suicide watch , or were deaf or blind . Boston University 's institutional review board approved all study activities . R and omization Each morning , a list of admitted patients was review ed for initial eligibility ( hospital location , age , date and time of admission , and previous enrollment ) . Last names of potential participants were ranked by using a r and om-number sequence to determine the order in which to approach patients for enrollment . A trained research assistant then approached each patient and further determined eligibility according to inclusion and exclusion criteria ( Figure 1 ) . Figure 1 . Study flow diagram . * Patients did not meet inclusion criteria if they were admitted from or planned discharge to an institutional setting ( n= 74 ) , planned hospitalization ( n= 3 ) or discharge to a non-U.S. community ( n= 5 ) , were transferred to different hospital service ( n= 8) , did not speak English ( n= 371 ) or have a telephone ( n= 71 ) , were on hospital pre caution s ( n= 274 ) or suicide watch with a sitter ( n= 10 ) , were unable to consent ( n= 181 ) , had sickle cell disease as the admitting diagnosis ( n= 38 ) , had privacy status ( n= 8) , were deaf or blind ( n= 2 ) , or other ( n= 4 ) . Usual care participants did not meet eligibility criteria if they were discharged to a nursing facility ( n= 28 ) , were transferred to another hospital service ( n= 1 ) , were previously enrolled ( n= 1 ) , died during index admission ( n= 2 ) , requested to be removed ( n= 5 ) , or other ( n= 3 ) . Intervention participants did not meet eligibility criteria if they were discharged to a nursing facility ( n= 21 ) , were transferred to another hospital service ( n= 6 ) , died during index admission ( n= 1 ) , requested to be removed ( n= 2 ) , or other ( n= 8) . 107 intervention participants did not receive a reinforcement call because they could not be reached by telephone ( n= 93 ) , they were readmitted the same or next day ( n= 2 ) , there was no staffing coverage ( n= 8) , or other ( n= 4 ) . By using block r and omization ( 28 ) with varying block sizes of 6 and 8 , we r and omly arranged index cards indicating either the usual care or intervention group . We placed the cards in opaque envelopes labeled consecutively with study numbers . We assigned eligible participants who consented to enrollment to a study group by revealing the concealed index card . This process continued until 2 participants were enrolled each day of the week ( or 3 participants if the first 2 participants were r and omly assigned to the usual care group ) . This protocol ensured that research assistants could not selectively choose potential participants for enrollment or predict assignment . Participants r and omly assigned to usual care received no further intervention . There were 40 participants in the usual care group and 38 in the intervention group who were enrolled but no longer met inclusion criteria at discharge ( most commonly because they were discharged to a nursing facility ) . Because the primary analysis was by intention to treat , we included these participants in the analysis , with the exception of those who died before index discharge , requested to be removed , or were previously enrolled ( Figure 1 ) . Interventions Nurse discharge advocates ( DAs ) carried out all aspects of the in-hospital intervention . We hired 6 part-time DAs to work with intervention participants to ensure coverage by 1 DA 7 days a week , 5 hours a day . We trained all DAs to deliver the RED intervention by using a manual containing detailed scripts , observation of relevant clinical interactions , and simulated practice sessions . The primary goals of the DA were to coordinate the discharge plan with the hospital team and educate and prepare the participant for discharge . At admission , the DA completed the RED intervention components outlined in Table 1 . Additional information about the DA training manual is published elsewhere ( 3 ) and can be found on our Web site ( www.bu.edu/fammed/projectred/index.html ) . With information collected from the hospital team and the participant , the DA created the after-hospital care plan ( AHCP ) , which contained medical provider contact information , date s for appointments and tests , an appointment calendar , a color-coded medication schedule , a list of tests with pending results at discharge , an illustrated description of the discharge diagnosis , and information about what to do if a problem arises . Information for the AHCP was manually entered into a Microsoft Word ( Microsoft , Redmond , Washington ) template , printed , and spiral-bound to produce an individualized , color booklet design ed to be accessible to individuals with limited health literacy . By using scripts from the training manual , the DA used a teach-back methodology ( 29 ) to review the contents of the AHCP with the participant . On the day of discharge , the AHCP and discharge summary were faxed to the PCP . A clinical pharmacist telephoned the participants 2 to 4 days after the index discharge to reinforce the discharge plan by using a scripted interview . The pharmacist had access to the AHCP and hospital discharge summary and , over several days , made at least 3 attempts to reach each participant . The pharmacist asked participants to bring their medications to the telephone to review them and address medication-related problems ; the pharmacist communicated these issues to the PCP or DA . Outcomes Measures and Follow-up At the time of recruitment , research assistants collected baseline data , including sociodemographic characteristics ; the Short Form-12 Health Survey , Version 2 ( 30 ) ; the depression subscale from the Patient Health Question naire-9 ( 31 ) ; and the Rapid Estimate of Adult Literacy in Medicine ( 32 ) . We calculated the Charlson Comorbidity Index score by using primary and secondary diagnoses recorded on the index admission discharge summary ( 33 ) . We determined the number of hospital admissions and emergency department visits in the 6 months before index admission through medical record review ( Boston Medical Center hospital utilization ) and participant report ( all other hospital utilization ) . The primary end point was the rate of hospital utilizationthe total number of emergency department visits and readmissions per participant within 30 days of the index discharge . OBJECTIVE Influenza vaccination rates among some groups of children remain below the Healthy People 2020 goal of 70 % . Multi strategy interventions to increase childhood influenza vaccination have not been evaluated recently . METHODS Twenty pediatric and family medicine practice s were r and omly assigned to receive the intervention in either year 1 or year 2 . This study focuses on influenza vaccine uptake in the 10 year 1 intervention sites during intervention and the following maintenance year . The intervention included the 4 Pillars Immunization Toolkit-a practice improvement toolkit , early delivery of donated vaccine for disadvantaged children , staff education , and feedback on progress . During the maintenance year , practice s were not assisted or contacted , except to complete follow-up surveys . Student 's t tests assessed vaccine uptake of children aged 6 months to 18 years , and multilevel regression modeling in repeated measures determined variables related to the likelihood of vaccination . RESULTS Influenza vaccine uptake increased 12.4 percentage points ( PP ; P < .01 ) during active intervention and uptake was sustained ( + 0.4 PP ; P > .05 ) during maintenance , for an average change of 12.7 PP over all sites , increasing from 42.2 % at baseline to 54.9 % ( P < .001 ) during maintenance . In regression modeling that controlled for age , race , and insurance , likelihood of vaccination was greater during intervention than baseline ( odds ratio 1.47 ; 95 % confidence interval 1.44 - 1.50 ; P < .001 ) and greater during maintenance than baseline ( odds ratio 1.50 ; 95 % confidence interval 1.47 - 1.54 ; P < .001 ) . CONCLUSIONS In primary care practice s , a multi strategy intervention that included the 4 Pillars Immunization Toolkit , early delivery of vaccine , and feedback was associated with significant improvements in childhood influenza vaccination rates that were maintained 1 year after active intervention ABSTRACT Objective : Few studies have examined the effectiveness of shared decision making ( SDM ) in clinical practice . This study evaluated the impact of SDM on quality of life and symptom control in children with asthma . Methods : We conducted a prospect i ve 3-year study in six community-based practice s serving a low-income patient population . Practice s received training on SDM using an evidence -based toolkit . Patients aged 2–17 with a diagnosis of asthma were identified from scheduling and billing data . At approximate 6-month intervals , patients completed a survey consisting of the Mini Pediatric Asthma Quality of Life Question naire ( range 1–7 ) and the control domain of the Pediatric Asthma Therapy Assessment Question naire ( range 0–7 ) . We used propensity scores to match 46 children receiving SDM to 46 children receiving usual care with decision support . Included children had completed a baseline survey and at least one follow-up survey . R and om coefficient models incorporated repeated measures to assess the effect of SDM on asthma quality of life and asthma control . Results : The sample was primarily of non-White patients ( 94.6 % ) with Medicaid insurance ( 92.4 % ) . Receipt of SDM using an evidence -based toolkit was associated with higher asthma quality of life [ mean difference 0.9 ; 95 % confidence interval ( CI ) 0.4–1.4 ] and fewer asthma control problems ( mean difference −0.9 ; 95 % CI −1.6–−0.2 ) compared to usual care with decision support . Conclusions : Implementation of SDM within clinical practice s using a st and ardized toolkit is associated with improved asthma quality of life and asthma control for low-income children with asthma when compared to usual care with decision support |
357 | 18,254,065 | The substantial heterogeneity between trials was not explained by duration of follow-up , type of control , type of relaxation therapy or baseline blood pressure .
In view of the poor quality of included trials and unexplained variation between trials , the evidence in favour of causal association between relaxation and blood pressure reduction is weak .
Some of the apparent benefit of relaxation was probably due to aspects of treatment unrelated to relaxation | BACKGROUND Lifestyle interventions are often recommended as initial treatment for mild hypertension , but the efficacy of relaxation therapies is unclear .
OBJECTIVES To evaluate the effects of relaxation therapies on cardiovascular outcomes and blood pressure in people with elevated blood pressure . | Tai Chi , a moving meditation , is examined for its efficacy in post-stressor recovery . Forty-eight male and 48 female Tai Chi practitioners were r and omly assigned to four treatment groups : Tai Chi , brisk walking , mediation and neutral reading . Mental arithmetic and other difficult tests were chosen as mental challenges , and a stressful film was used to produce emotional disturbance . Tai Chi and the other treatments were applied after these stressors . After all treatments , the salivary cortisol level dropped significantly , and the mood states were also improved . In general the stress-reduction effect of Tai Chi characterized moderate physical exercise . Heart rate , blood pressure , and urinary catecholamine changes for Tai Chi were found to be similar to those for walking at a speed of 6 km/hr . Although Tai Chi appeared to be superior to neutral reading in the reduction of state anxiety and the enhancement of vigour , this effect could be partially accounted for by the subjects ' high expectations about gains from Tai Chi . Approaches controlling for expectancy level are recommended for further assessment Abstract Ten volunteer subjects each attended four training sessions of 1 hr , during which they were instructed to raise or lower blood pressure . They were provided with immediate analogue feedback of pulse wave velocity from a PDP-12 computer , and successful performance was rewarded with money . Significant differences in PWV between Increase and Decrease conditions were produced , the mean divergence in the final trial being equivalent to 11 mm Hg . These changes were accompanied by adjustments in heart rate and respiration rate , and did not improve with repeated sessions — indeed on some measures deterioration in performance was observed . Neither analysis from the initial baseline nor from the pre-trial level , appears to reflect the precise effects of feedback . Different methods of assessment are discussed , together with the use of PWV as a measure of blood pressure in such experiments Abstract Muscle relaxation and noncontinuous biofeedback were investigated as potential nonpharmaceutical treatments for essential hypertension . The two procedures were compared to a waiting list control group . Predictions were made regarding the overall treatment effect , sessions within treatment effect , and periods within session effect . The results of this experiment reveal that biofeedback significantly lowers diastolic blood pressure between pre measures and post measures . It was also shown that muscle relaxation has a significant effect upon lowering diastolic and systolic blood pressures between pre measures and post measures and has a significant effect upon lowering diastolic and systolic blood pressures as subjects progress from the first period of a treatment session to the last period of a treatment session Meditation training appears to be a promising psychological approach to the control of hypertension . However , most studies to date have had serious deficiencies . This study attempted to correct many of these deficiencies . Forty-one unmedicated hypertensives referred by general practitioners were r and omly allocated to three groups . The treatment group ( SRELAX ) underwent training procedures based on Transcendental Meditation ; a placebo control group ( NSRELAX ) underwent identical training but without a mantra . Both procedures were compared with a no-treatment control group . The results showed modest reductions in blood pressure in both SRELAX and NSRELAX groups , compared with the no-treatment controls , with diastolic percentage reductions reaching significance ( p<0.05 ) . There was considerable subject variation in response , with overall a mean decline in diastolic blood pressure of 8–10 % on 3-month follow-up . Possible indicators to predict the response of subjects are considered and reasons for the similarity in the effectiveness of the SRELAX and NSRELAX conditions are discussed In order to assess the effectiveness of the thermal biofeedback training combined with the progressive muscle relaxation therapy in the treatment of patients with essential hypertension , blood pressure decline was measured on the treatment group who had the combined thermal biofeedback and progressive muscle relaxation training ( N = 11 ) , and on the control group who had only the progressive muscle relaxation training ( N = 8) . Baseline blood pressure was measured four times for two weeks on both groups . For the treatment group , blood pressure was measured twice before and after each of eight sessions of thermal biofeedback training for four weeks . For the control group , blood pressure was measured every two visits to a clinic for progressive muscle relaxation self-training twice before and after the self-training . A significant decline of the systolic blood pressure by 20.6 mmHg and of the diastolic blood pressure by 14.4 mmhg was observed in the treatment group . There was a tendency for both blood pressures to increase in the control group To examine the relative cost-effectiveness of single versus multiple patient education strategies to reduce hypertension , we assigned patients to seven intervention groups and to a usual-care control group using a r and omized factorial design . We compared cost-effectiveness measures for single , double , and triple combinations of ( a ) a clinic exit interview with patients to clarify their medical regimens , ( b ) an educational meeting with a member of the patient 's family to aid in management at home , and ( c ) a series of small group sessions to help patients overcome personal barriers to management . We observed consistent results for six different effectiveness measures under a variety of decision-making rules . Our results suggest that in the absence of targeting of multiple interventions to systematic ally selected high-risk patients , multiple intervention combinations are not more cost-effective than single interventions We have investigated prospect ively the efficacy of two nonpharmacologic relaxation techniques in the therapy of anxiety . A simple , meditational relaxation technique ( MT ) that elicits the changes of decreased sympathetic nervous system activity was compared to a self-hypnosis technique ( HT ) in which relaxation , with or without altered perceptions , was suggested . 32 patients with anxiety neurosis were divided into 2 groups on the basis of their responsivity to hypnosis : moderate-high and low responsivity . The MT or HT was then r and omly assigned separately to each member of the two responsivity groups . Thus , 4 treatment groups were studied : moderate-high responsivity MT ; low responsivity MT ; moderate-high responsivity HT ; and low responsivity HT . The low responsivity HT group , by definition largely incapable of achieving the altered perceptions essential to hypnosis , was design ed as the control group . Patients were instructed to practice the assigned technique daily for 8 weeks . Change in anxiety was determined by three types of evaluation : psychiatric assessment ; physiologic testing ; and self- assessment . There was essentially no difference between the two techniques in therapeutic efficacy according to these evaluations . Psychiatric assessment revealed overall improvement in 34 % of the patients and the self-rating assessment indicated improvement in 63 % of the population . Patients who had moderate-high hypnotic responsivity , independent of the technique used , significantly improved on psychiatric assessment ( p = 0.05 ) and decreased average systolic blood pressure from 126.1 to 122.5 mm Hg over the 8-week period ( p = 0.048 ) . The responsivity scores at the higher end of the hypnotic responsivity spectrum were proportionately correlated to greater decreases in systolic blood pressure ( p = 0.075 ) and to improvement by psychiatric assessment ( p = 0.003 ) . There was , however , no consistent relation between hypnotic responsivity and the other assessment s made , such as diastolic blood pressure , oxygen consumption , heart rate and the self-rating question naires . The meditational and self-hypnosis techniques employed in this investigation are simple to use and effective in the therapy of anxiety To study the effects of caffeine on serum lipids and blood pressure , we conducted a double-blind , r and omized trial with two parallel groups in 69 young , healthy subjects . After a 3-wk run-in period , subjects were r and omly assigned to one of two groups receiving either 4 - 6 140-mL cups filtered decaffeinated coffee per day and an equal number of pills containing 75 mg caffeine or 4 - 6 140-mL cups filtered decaffeinated coffee per day and an equal number of placebo pills , for 9 wk . In both groups caffeine intake from other sources was not allowed . The main finding of this study is that abstinence from caffeine for a period of 9 wk has no effect on either serum lipids or blood pressure Twenty-nine patients who had been treated with antihypertensive medication for at least the preceding 6 months were r and omly assigned to ( 1 ) therapistconducted , face-to-face progressive , deep-muscle relaxation training for 10 weekly sessions , or ( 2 ) progressive deep-muscle relaxation therapy conducted mainly by home use of audio cassettes , or ( 3 ) nonspecific individual psychotherapy for 10 weekly sessions . No differences between the groups were found immediately after therapy ; however , the therapist-conducted relaxation therapy group showed the greatest changes : −17.8 mm Hg systolic , −9.7 mm Hg diastolic at 6 months follow-up . Some significant trends in results among the three therapists were also found . No correlation existed between blood pressure changes and changes in dopamine-β-hydroxylase ( DbH ) levels To study the effects of device-guided breathing on office systolic blood pressure ( SBP ) , five centers r and omized 149 untrained hypertensives ( 50 % male , age 59+/-10 years , baseline blood pressure 150+/-9/86+/-9 mm Hg , 77 % taking drug therapy ) . One half received a device to guide slow breathing ; all received a home blood pressure monitor and only simple , written instructions . The changes in office SBP ( adjusted for office-to-home difference in baseline SBP and accumulated time spent in slow breathing , guided and measured by the device ) were significantly ( p<0.001 for trend ) correlated with accumulated time spent in slow breathing . Greater decreases in SBP ( -15.0+/-1.8 vs. -7.3+/-1.9 mm Hg ) were observed for those who spent more ( vs. less ) than 180 minutes over 8 weeks in slow breathing , as well as those who just monitored their blood pressure at home ( -9.2+/-1.6 mm Hg ) . Thus , even without training , hypertensive patients who receive a device to guide slow breathing significantly lowered their office SBP if the total time spent in slow breathing over 8 weeks exceeded a " threshold " value of 180 minutes OBJECTIVE To test the efficacy of individualized stress management for primary hypertension in a r and omized clinical trial with the use of ambulatory blood pressure ( BP ) measures . METHODS Men and women aged 28 to 75 years with mean ambulatory BP greater than 140/90 mm Hg received 10 hours of individualized stress management by means of semist and ardized treatment components . They were r and omly assigned to immediate treatment ( n = 27 ) or a wait list control group ( n = 33 ) . Participants on the wait list were subsequently offered treatment . Six-month follow-up data were available from 36 of the 45 participants who completed treatment . Measures were 24-hour ambulatory BP , lipid levels , weight , and psychological measures . RESULTS Blood pressure was significantly reduced in the immediate treatment group and did not change in control subjects ( -6.1 vs + 0.9 mm Hg for systolic and -4.3 vs + 0.0 mm Hg for diastolic pressure ) . When the wait list control group was later treated , BP was similarly reduced by -7.8 and -5.2 mm Hg , and for the combined sample , total change at follow-up was -10.8 and -8.5 mm Hg . Level of BP at the beginning of treatment was correlated with BP change ( r = 0.45 [ P<.001 ] and 0.51 [ P<.001 ] , respectively ) , and amount of systolic BP change was positively correlated with reduction in psychological stress ( r = 0.34 ) and change in anger coping styles ( r = 0.35 - 0.41 ) . CONCLUSIONS Individualized stress management is associated with ambulatory BP reduction . The effects were replicated and further improved by follow-up . Reductions in psychological stress and improved anger coping appear to mediate the reductions in BP change OBJECTIVE The objective of the study was to compare blood pressure ( BP ) biofeedback treatment ( BF ) effects between white-coat hypertension and essential hypertension . METHODS Fifteen white-coat hypertensive out- patients and 23 essential hypertensive out- patients were r and omly assigned to groups A or B. Subjects in group A underwent BF once a week for a total of four sessions . Those in group B visited the clinic only to measure BP and later underwent the same BF . RESULTS In group A , BPs of white-coat hypertensives and essential hypertensives were significantly reduced by 22/11 and 14/8 mmHg , respectively . In group B , they were unchanged during the same period but later suppressed by BF . Under BF , pulse and respiratory rates were significantly higher , and elevation of diastolic BP due to mental stress testing was better suppressed in white-coat hypertensives than in essential hypertensives . CONCLUSION This treatment was effective in both types of hypertension , and pressor response to stress seems to be important in the differentiated BF effect The contribution of training procedures design ed to alter individuals ' psychological responses to stressful life stimuli to the reduction of blood-pressure levels of hypertensives was evaluated . The treatment consisted of a set of coping skill-building experiences . Forty-one black males , mildly to moderately hypertensive and under medical supervision in an outpatient cardiovascular unit of a veterans ' hospital , participated . Subjects were r and omly assigned to one of three groups : Cognitive Self-Management Training ( CSM ) , Attention Placebo Control , and Current Clinic Conditions Control . The dependent measures were the State Anxiety Scale , Trait Anxiety Scale , Coping Strategic Inventory , systolic blood pressure , and diastolic blood pressure . Subjects in the CSM group reported significant increases in the use of cognitive coping strategies in their lives and demonstrated significant decreases in measured levels of state anxiety and systolic blood pressure . Promising reductions of diastolic blood pressure ratings were obtained as well Abstract Our aim was to replicate a study of the Benson relaxation technique [ 1 ] using respiration as well as a wider representation of cardiovascular variables , including heart rate and blood pressure , to see whether ( a ) these variables are decreased by the relaxation response , and ( b ) whether subjects respond across these variables as would be expected by the concept of an “ integrated relaxation response ” . In an own-control comparison , 18 subjects were given two periods of reading ( a relatively neutral , non-relaxing control ) with two periods of relaxation in a sequence of 12-minute phases ( A-B-A-B ) : ( 1 ) The relaxation produced significant mean decreases in respiration rate , as had been reported [ 1 ] . ( 2 ) Significant , but small , effects were found for heart rate , but no effect for blood pressure . ( 3 ) Some bases for the variation were explored : ( a ) heart rate differences were predicted by initial rating of attitude toward the relaxation procedure , ( b ) amount of prior incidental practice did not predict amount of response , ( c ) differences in initial blood pressure were unrelated to improvement . ( 4 ) No evidence was found to support the concept of a relaxation response in terms of only decreases in the measured physiological systems , but rather these data are more consistent with theories emphasizing that individual relaxation response patterns may differ somewhat from person to person In this study , a stress management program based on cognitive behavioural therapy principles was compared with a Kundaliniyoga program . A study sample of 26 women and 7 men from a large Swedish company were divided r and omly into 2 groups for each of the different forms of intervention ; a total of 4 groups . The groups were instructed by trained group leaders and 10 sessions were held with each of groups , over a period of 4 months . Psychological ( self‐rated stress and stress behaviour , anger , exhaustion , quality of life ) and physiological ( blood pressure , heart rate , urinary catecholamines , salivary cortisol ) measurements obtained before and after treatment showed significant improvements on most of the variables in both groups as well as medium‐to‐high effect sizes . However , no significant difference was found between the 2 programs . The results indicate that both cognitive behaviour therapy and yoga are promising stress management techniques To determine the effect of relaxation training on the frequency of intake of pro re nata medication for relief of tension and to compare the difference between live and taped instructions of this training 60 patients on PRN minor tranquilizers and sedatives in one nursing unit were studied . Subjects were r and omly assigned to three groups : group A , control ; group B , live instruction ; group C , taped instruction . Dependent variables monitored were : 1 ) frequency of intake of PRN medication ; 2 ) pre- and postinstruction change in blood pressure , pulse , and respiration ; 3 ) change in the Taylor Manifest Anxiety Scale ; and 4 ) change on the Minnesota Multiphasic Personality Inventory score . Although no significant difference was found between method of relaxation training , there was evidence that group B surpassed group C in terms of benefit of the treatment . Physiologic variables as well as MMPI scales K , I , and VII yielded better results for group B. Not all variables demonstrated significant differences . Groups B and C were more similar at the conclusion of the study than had been anticipated — perhaps because subjects responded favorably to inclusion in the study regardless of method of training In order to assess the effects of a Behavioral Treatment Program in the control of primary hypertension , twenty one unmedicated hypertensives were r and omly allocated to three groups : first , a treatment group ( BHG ) receiving a Behavioral Treatment which included : deep muscle relaxation , peripheral temperature Biofeedback and anxiety management training ; second , the placebo attention control group ( PHG ) and third , a control group of hypertensives too ( CHG ) . Additionally , were compared with seven normotensives subjects ( CNG ) . The post-treatment measures showed a significant reduction ( p < 0.001 ) in systolic and diastolic values only in the ( BHG ) . In a six months follow-up the ( BHG ) group still showed a significant reduction in the systolic and diastolic BP ( p < 0.02 ; p < 0.01 ) . Moreover individual variations in response to treatment were observed in this group , ( BHG ) This study examined the effect of a relaxation technique on plasma lipids , weight , blood pressure , and blood glucose . Sixteen outpatient males were r and omly assigned to control or experimental groups . The experimental group was taught a relaxation technique that they used throughout the study . The control group was started in a reading program . Subjects were followed by a nurse practitioner and dietitian for eight weeks . Results revealed a significant reduction in systolic blood pressure and a marginally significant reduction in low density lipoprotein ( LDL ) cholesterol in the experimental group . Both control and experimental groups self-reported high compliance with diet and adherence to prescribed intervention . State anxiety was found to be inversely related to changes in total cholesterol and LDL cholesterol Phase II of the Trials of Hypertension Prevention is a multicenter , r and omized , controlled trial design ed to determine the efficacy of weight loss and reduction of sodium intake for lowering blood pressure and incidence of hypertension among persons with high-normal levels of blood pressure . The 2 x 2 factorial study design includes weight loss alone , restricted sodium intake alone , the combination of weight loss and sodium restriction , and a control group . Nine clinical centers used a variety of recruitment strategies to enroll 2382 participants over 17 months , which exceeded the sample size goal of 2250 . Among r and omized participants , 21 % were minorities and 34 % were women . Overall , direct mail generated the most r and omized participants ( 73 % ) , followed by community screening ( 12 % ) and media advertisement ( 11 % ) . Referrals from community health care providers yielded few participants . Prescreening improved overall efficiency and reduced costs . Participants who were more likely to drop out voluntarily during the three-visit screening regimen tended to be younger , single , male , smokers , and less educated & NA ; Eighteen male hypertensives on diuretic medication between the ages of 37 and 60 were studied in a double‐blind , r and omized , crossover design under three conditions : 200 mg of caffeine and mental arithmetic ; placebo and mental arithmetic ; and 200 mg of caffeine alone . Systolic and diastolic blood pressure , heart rate , and skin conductance were recorded . During rest , caffeine compared to placebo increased blood pressure by 8/6 mm Hg , but had no effect on heart rate or skin conductance . During mental arithmetic , the combined effect of mental stress and caffeine led to a further increase of 17/7 mm Hg , reaching a pressure level of 163/100 mm Hg . Heart rate and skin conductance were increased above their prior caffeine levels . There were no significant differences between the blood pressure response to mental arithmetic with caffeine and that response to mental arithmetic with a placebo , which may have been due to the fact that the hypertensives were already responding at ceiling level during the mental stressor Objective : To examine the efficacy of a new device , which slows and regularises breathing , as a non-pharmacological treatment of hypertension and thus to evaluate the contribution of breathing modulation in the blood pressure ( BP ) reduction . Design and setting : R and omised , double-blind controlled study , carried out in three urban family practice clinics in Israel . Patients : Sixty-five male and female hypertensives , either receiving antihypertensive drug therapy or unmedicated . Four patients dropped out at the beginning of the study .Intervention : Self treatment at home , 10 minutes daily for 8 consecutive weeks , using either the device ( n = 32 ) , which guides the user towards slow and regular breathing using musical sound patterns , or a Walkman , with which patients listened to quiet music ( n = 29 ) . Medication was unchanged 2 months prior to and during the study period . Main outcome measures : Systolic BP , diastolic BP and mean arterial pressure ( MAP ) changes from baseline . Results : BP reduction in the device group was significantly greater than a predetermined ‘ clinical ly meaningful threshold ’ of 10.0 , 5.0 and 6.7 mm Hg for the systolic BP , diastolic BP and MAP respectively ( P = 0.035 , P = 0.0002 and P = 0.001 ) . Treatment with the device reduced systolic BP , diastolic BP and MAP by 15.2 , 10.0 and 11.7 mm Hg respectively , as compared to 11.3 , 5.6 and 7.5 mm Hg ( P = 0.14 , P = 0.008 , P = 0.03 ) with the Walkman . Six months after treatment had stopped , diastolic BP reduction in the device group remained greater than the ‘ threshold ’ ( P < 0.02 ) and also greater than in the walkman group ( P = 0.001 ) . Conclusions : The device was found to be efficacious in reducing high BP during 2 months of self-treatment by patients at home . Breathing pattern modification appears to be an important component in this reduction In the present study , we evaluated the effect of a nonevaluative social support intervention ( pet ownership ) on blood pressure response to mental stress before and during ACE inhibitor therapy . Forty-eight hypertensive individuals participated in an experiment at home and in the physician ’s office . Participants were r and omized to an experimental group with assignment of pet ownership in addition to lisinopril ( 20 mg/d ) or to a control group with only lisinopril ( 20 mg/d ) . On each study day , blood pressure , heart rate , and plasma renin activity were recorded at baseline and after each mental stressor ( serial subtraction and speech ) . Before drug therapy , mean responses to mental stress did not differ significantly between experimental and control groups in heart rate ( 94 [ SD 6.8 ] versus 93 [ 6.8 ] bpm ) , systolic blood pressure ( 182 [ 8.0 ] versus 181 [ 8.3 ] mm Hg ) , diastolic blood pressure ( 120 [ 6.6 ] versus 119 [ 7.9 ] mm Hg ) , or plasma renin activity ( 9.4 [ 0.59 ] versus 9.3 [ 0.57 ] ng · mL−1 · h−1 ) . Lisinopril therapy lowered resting blood pressure by ≈35/20 mm Hg in both groups , but responses to mental stress were significantly lower among pet owners relative to those who only received lisinopril ( P < 0.0001 ; heart rate 81 [ 6.3 ] versus 91 [ 6.5 ] bpm , systolic blood pressure 131 [ 6.8 ] versus 141 [ 7.8 ] mm Hg , diastolic blood pressure 92 [ 6.3 ] versus 100 [ 6.8 ] mm Hg , and plasma renin activity 13.9 [ 0.92 ] versus 16.1 [ 0.58 ] ng · mL−1 · h−1 ) . We conclude that ACE inhibitor therapy alone lowers resting blood pressure , whereas increased social support through pet ownership lowers blood pressure response to mental stress The purpose of the present study was to test the effectiveness of a cognitive-behavioral intervention as an adjunctive treatment of hypertension . To qualify for the study , subjects had to have an unmedicated clinic diastolic blood pressure > or = 95 mm Hg . After qualification , minimal drug requirements were established using a diuretic and a beta-blocker to control blood pressure at < or = 90 mm Hg . Subjects were then r and omized into a 6-week cognitive-behavioral intervention or a measurements -only control group . After the treatment phase , medication levels were reduced in all subjects by means of a systematic stepdown procedure . Subjects were followed for 1 year after the stepdown was completed . Addition of the cognitive-behavioral intervention was twice as effective as the control procedure in reducing drug requirements . At 12-months follow-up , 73 % of the treatment group were at lower levels of medication than at the time of r and omization , compared to 35 % in the control group . Moreover , 55 % of the treatment group remained completely free of medication , compared to 30 % of the control group , at the 12-month follow-up . The reductions in medication were associated with maintained controlled levels of clinic , ambulatory , and home blood pressure . The addition of a st and ardized and inexpensive group-administered cognitive-behavioral intervention to the drug treatment of hypertension is beneficial as an adjunctive treatment in reducing drug requirements for patients with hypertension , thereby reducing the costs and potential side effects of antihypertensive medications The purpose of this study was to determine whether stress management training reduces blood pressure ( BP ) variability in hypertensive patients . Previous literature suggests that cardiovascular risk is not only a function of BP levels , but also of BP variability , and this partially depends on changes induced by the stress of everyday life . The authors reanalyzed data from a previous study of 43 male patients with essential hypertension who were r and omly assigned to 2 groups ( stress management training and waiting list ) . Patients in the stress management group lowered their self-measured BP variability significantly from pretreatment to the 4-month follow-up examination , showing a mean reduction of 2.6/1.5 mm Hg in the st and ard deviation of systolic/diastolic BP ( SBP/DBP ) , and a mean decrease of 1.84/1.59 % in the coefficient of variation of SBP/DBP . For SBP , these reductions were significantly greater than those showed by the control group . These results suggest that stress management training is effective in reducing day-to-day BP variability , providing an additional reduction in cardiovascular risk for hypertensive patients Forty non-meditators were r and omly assigned to 4 experimental cells devised to control for order and expectation effects . The subjects ( all female ) were continuously monitored on 7 physiological measures during both meditation and rest . Each subject was her own control in an ' abab ' experimental paradigm comparing meditation to rest . The subjects , meditating for the first time , showed marginally lower psychophysiological arousal during the meditation than rest condition for systolic blood pressure , heart rate , skin conductance level and digital skin temperature . Deliberately fostering positive expectations of meditation was associated with lower physiological arousal in terms of diastolic and systolic blood pressure , heart rate and skin conductance level Hypertension increases the morbidity and mortality in man . Extensive actuary data have shown that increase in mortality is directly proportional to the severity of blood pressure . In spite of diagnostic advances in recent years , the etiology of hypertension still remains relatively obscure . The vast majority of patients fall into the category of & dquo;essential hypertension&dquo ; and specific therapy is not available for these cases . Drugs are therefore necessary for these patients . The antihypertensive drugs available so far are by no means ideal and have many disadvantages . Any new method for reducing blood pressure is , therefore , most welcome . Management of hypertension by measures other than drugs has been envisaged by Bilgutay et al.1 In this communication , we present a new approach , the management of hypertension with & dquo;shavasan,&dquo & NA ; We determined the effect of relaxation therapy for hypertension in patients whose blood pressure remained elevated despite the use of antihypertensive medication . The effect was assessed in multiple setting s , including the relaxation therapist 's office , the Hypertension Clinic , and the patient 's natural environment , the latter using 24‐hour automated ambulatory blood pressure measures . Nineteen patients were r and omized either to temperature biofeedback‐assisted relaxation or to an attention control , “ stress education . ” Antihypertensive medication was kept constant . In the behavioral therapist 's office , blood pressure decreased in equivalent amounts with both treatments . Hypertension Clinic nurse blood pressure remained stable or increased with both treatments , but again there was no difference between treatments . Ambulatory blood pressure increased with relaxation therapy and decreased with stress education , the effect being significant for diastolic pressure . The effects on ambulatory blood pressure were limited to the waking hours . The only variable that showed superior effects for relaxation therapy was physician‐determined blood pressure . These results call into question the generalizability of the effects of relaxation therapy from one setting to another Casual blood pressures and measures of cardiovascular and behavioral reactions to neutral and confrontive interactions were obtained from 13 essential hypertensive patients who received training in anger management and 9 no-treatment control patients . At pre- and posttraining , heart rate ( HR ) and blood pressure ( BP ) were measured ( a ) at rest and ( b ) during role-play interactions consisting of neutral and confrontation scenes . Behavioral responses were also coded for each interaction . For treatment subjects , a 6-week program in anger management was conducted , which included relaxation training , self-statement modification , and role-play assertiveness training . Treatment subjects exhibited significantly lower casual DBPs at posttraining ( M=90.2 mm Hg ) than control subjects ( M=95.7 mm Hg ) . Posttreatment casual SBPs for treatment and control subjects were not significantly different . Treatment subjects exhibited significantly more assertive skill and lesser DBP reactivity at posttreatment than their control counterparts during the confrontive interaction but not during the neutral role-play interaction Predictability of the psychic outcome for two cardiac rehabilitation programmes was investigated in 119 myocardial infa rct ion patients . They were r and omly assigned to either a five-week daily exercise training or to an identical training in combination with six sessions of relaxation therapy , individually . The psychic outcome was constructed as a composite measure of change on six psychological question naires . The aim was to determine the predictive qualities of base-line : ( 1 ) clinical data ; ( 2 ) exercise testing ; ( 3 ) psychosocial information derived from interview ; and ( 4 ) vali date d psychological question naires and whether the kind of rehabilitation programme has any influence on the predictive qualities of the variables . The psychic outcome turned out to be highly predictable ( multiple correlation of 0.72 ) . Predictors of relatively high importance were age , work-status and job-level , followed by mild heart failure , diastolic blood pressure and heart rate , all of them dependent upon the kind of treatment . It implies that the type of rehabilitation programme modified the effect of the determinants of psychic outcome . This research strategy is promising and deserves to be stimulated in order to build rehabilitation programmes tailored to the needs and abilities of the individual patient We hypothesise that routinely applied short sessions of slow and regular breathing can lower blood pressure ( BP ) . Using a new technology BIM ( Breathe with Interactive Music ) , hypertensive patients were guided towards slow and regular breathing . The present study evaluates the efficacy of the BIM in lowering BP . We studied 33 patients ( 23M/10F ) , aged 25–75 years , with uncontrolled BP . Patients were r and omised into either active treatment with the BIM ( n = 18 ) or a control treatment with a Walkman ( n = 15 ) . Treatment at home included either musically-guided breathing exercises with the BIM or listening to quiet music played by a Walkman for 10 min daily for 8 weeks . BP and heart rate were measured both at the clinic and at home with an Omron IC BP monitor . Clinic BP levels were measured at baseline , and after 4 and 8 weeks of treatment . Home BP measurements were taken daily , morning and evening , throughout the study . The two groups were matched by initial BP , age , gender , body mass index and medication status . The BP change at the clinic was −7.5/−4.0 mm Hg in the active treatment group , vs −2.9/−1.5 mm Hg in the control group ( P = 0.001 for systolic BP ) . Analysis of home-measured data showed an average BP change of −5.0/−2.7 mm Hg in the active treatment group and −1.2/+0.9 mm Hg in the control group . Ten out of 18 ( 56 % ) were defined as responders in the active treatment group but only two out of 14 ( 14 % ) in the control group ( P = 0.02 ) . Thus , breathing exercise guided by the BIM device for 10 min daily is an effective non-pharmacological modality to reduce BP & NA ; To examine how various aspects of attentional functioning are affected by autonomic self‐regulation procedures , this study compared the effect of two treatment programs ( EMG and thermal biofeedback used in conjunction with various somatic and cognitive relaxation/self‐regulation strategies , and Benson 's Relaxation Response procedure ) and a Waiting List control group for essential hypertensive adults on three , perhaps overlapping , attentional dimensions : the capacity to disembed figure from ground ( Embedded Figures Test , Block Design , and Picture Completion WAIS subtests ) ; the capacity to voluntarily deploy attention ( Digit Span subtest of the WAIS ) , and capacity to sustain attention or become absorbed ( as measured by the Tellegen Absorption Scale ) . Thirty essential hypertensive men and women were r and omly placed in one of the three groups . Attentional dimensions were assessed before and after the 10‐week treatment program ( or waiting period ) and the relationship between blood pressure and attentional changes were assessed . The only group to evidence significant blood pressure reduction , the “ Biofeedback Group , ” became significantly more Field Independent as measured by the EFT ( p less than 0.001 ) and the Block Design measure ( p less than 0.01 ) and evidence d a strong trend in the same direction on the Picture Completion measure ( p less than 0.052 , NS ) . No other significant pre‐post attentional changes were found . A Pearson product correlation revealed that changes in diastolic blood pressure were significantly correlated with changes in EFT ( r = 0.54 , p less than 0.0001 ) and the Picture Completion measure ( r = 0.32 , p less than 0.05 ) . The cognitive effect of autonomic self‐regulation is discussed . In addition , the possible role of attention in autonomic self‐regulation is examined BACKGROUND Psychosocial stress has been implicated in the disproportionately higher rates of hypertension among African Americans . This r and omized controlled trial compared the effects of two stress reduction techniques and a health education control program on hypertension during a period of 1 year in African-American men and women ( N = 150 , mean age 49 + /- 10 years , mean blood pressure ( BP ) = 142/95 mm Hg ) at an urban community health center . METHODS Interventions included 20 min twice a day of Transcendental Meditation ( TM ) or progressive muscle relaxation ( PMR ) , or participation in conventional health education ( HE ) classes . All subjects continued usual medical care . Outcomes assessed were systolic BP and diastolic BP at 3 , 6 , 9 , and 12 months after treatment , analyzed by repeated measures ANCOVA . RESULTS The TM group showed decreases in systolic BP/diastolic BP of -3.1/-5.7 mm Hg compared to -0.5/-2.9 mm Hg for PMR or HE , ( P = .12 to .17 for systolic BP , P = .01 for diastolic BP ) . In addition the TM group demonstrated reduced use of antihypertensive medication relative to increases for PMR ( P = .001 ) and HE ( P = .09 ) groups . Group analysis by gender showed that women practicing TM had decreased BP ( -7.3/-6.9 mm Hg ) significantly more than women practicing PMR ( 0.7/-2.7 mm Hg ) or HE ( -.07/-3.0 mm Hg ) ( P .01 to .03 ) . The change in men praticing TM ( 0.2 /-4.7 mm Hg ) was greater than men practicing HE ( -0.9/-2.0 mm Hg ) for diastolic BP only ( P = .09 , ) and not different from PMR men ( -2.0/-3.1 ) . CONCLUSIONS A selected stress reduction approach , the Transcendental Meditation program , may be useful as an adjunct in the long-term treatment of hypertension in African Americans & NA ; The efficacy and the mechanisms of action of two behavioral treatments for essential hypertension were compared : cognitive group therapy for anger control and biofeedback for heart rate control . The cognitive therapy aim ed at lowering the “ general anger ” level and helping overt expression of “ anger out ; ” heart rate biofeedback aim ed at slowing heart rate in stress situations . Ninety‐seven essential hypertensive patients were r and omly assigned to three groups ; after 20 dropouts , 77 patients fully participated in the study : cognitive treatment ( N = 30 ) , biofeedback ( N = 27 ) , and control ( no treatment , N = 20 ) . The treatments were held in 17 weekly sessions ; during treatment , blood pressure was measured once a month , and during follow‐up after 1 and 6 months . The anger level and heart rate control were assessed at the beginning and the end of treatment . The main results were : 1 ) a significant decrease of blood pressure for both treatments as compared with control , 2 ) a significant decrease of blood pressure with heart rate biofeedback as compared with cognitive therapy , and 3 ) a better control in anger achieved with cognitive therapy and a lesser control in heart rate as compared with biofeedback On screening 192 men and women aged 35 - 64 were identified as having two or more of the following risk factors : blood pressure greater than or equal to 140/90 mm Hg , plasma cholesterol concentration greater than or equal to 6.3 mmol/l ( 243.6 mg/100 ml ) , and current smoking habit greater than or equal to 10 cigarettes a day . They were r and omly allocated to a group for modification of behaviour or to serve as controls . Both groups were given health education leaflets containing advice to stop smoking , to reduce animal fats in the diet , and on the importance of reducing blood pressure . In addition , the treatment group had group sessions of one hour a week for eight weeks in which they were taught breathing exercises , relaxation , and meditation and about managing stress . It had previously been found that after eight weeks and eight months there was a significantly greater reduction in both systolic and diastolic blood pressures in the group taught to relax compared with the control group . After four years of follow up these differences in blood pressure were maintained . Plasma cholesterol concentration and the number of cigarettes smoked were lower in the treatment group at eight weeks and eight months but not at the four year follow up . At four years more subjects in the control group reported having had angina and treatment for hypertension and its complications . Incidence of ischaemic heart disease , fatal myocardial infa rct ion , or electrocardiographic evidence of ischaemia was significantly greater in the control group . If the results of this study could be obtained in a larger study the financial and health care implication s would be enormous We have conducted a cross-cultural ( USA and USSR ) comparison of thermal biofeedback ( TBF ) and autogenic training ( AT ) to a self-relaxation control condition in 59 unmedicated males with mild hypertension . Identical assessment and treatment protocol s were carried out in both setting s ( Albany , New York , and Moscow ) . Treatments were delivered in small groups on an outpatient basis twice per week for 10 weeks . Results showed comparable , significant ( p less than .05 ) , short-term decreases ( M = 8.5 mm Hg ) in diastolic blood pressure ( DBP ) for both treatments at both sites . However , the Soviet patients , starting with significantly ( p less than .01 ) higher systolic blood pressures ( SBPs ) , showed significant decreases ( M = 12.8 mm Hg ) in SBP , whereas the American patients did not change appreciably ( M = 4.6 mm Hg ) . During follow-up , the treated Soviet patients showed significantly ( p less than .05 ) better maintenance of treatment effects , from 3 months to 1 year , than did the American patients . At 1 year , 75 % of the treated Soviet patients had DBPs less than 90 mm Hg , whereas only 24 % of the American patients had comparable DBPs & NA ; This industry‐based r and omized study compared the effects of behavioral treatment ( BT ) and blood pressure monitoring ( BPM ) on blood pressure ( BP ) change in 158 unmedicated persons with mild hypertension ( diastolic blood pressure 90 to 104 mm Hg ) . Participants recruited by a three‐stage screening were r and omly assigned to BT or BPM groups and stratified by entry diastolic blood pressure ( DBP ) , age , and sex . BT participants received relaxation training , with or without the addition of biofeedback , cognitive restructuring , and health behavior change components . During the study , all participants were followed by their usual care physicians and received medical advice . At 18 weeks into the study , after the BT groups completed training , both the BT and BPM groups showed significant reductions in systolic blood pressure ( SBP ) and DBP assessed in the company medical clinic ( 7.4 and 9.0 mm Hg SBP and 4.5 and 5.9 mm Hg DBP , respectively ) . These reductions were maintained throughout the 36‐week follow‐up period . Reductions in BP assessed at the participants ' worksite were similar for BT and BPM participants throughout most of the trial , indicating little advantage to the inclusion of behavioral interventions over monitoring alone . Differences in BP changes observed among participants receiving various combinations of behavioral treatment components indicated that the cognitive restructuring component reduced SBP in the worksite by an additional 5.4 mm Hg ( p less than 0.05 ) . Possible explanations for the BP changes observed in the BPM group and implication s of the results for the treatment of unmedicated mild hypertensives are discussed Exercise and relaxation decrease blood pressure . Qigong is a traditional Chinese exercise consisting of breathing and gentle movements . We conducted a r and omised controlled trial to study the effect of Guolin qigong on blood pressure . In all , 88 patients with mild essential hypertension were recruited from the community and r and omised to Goulin qigong or conventional exercise for 16 weeks . The main outcome measurements were blood pressure , health status ( SF-36 scores ) , Beck Anxiety and Depression Inventory scores . In the qigong group , blood pressure decreased significantly from 146.3±7.8/93.0±4.1 mmHg at baseline to 135.5±10.0/87.1±7.7 mmHg at week 16 . In the exercise group , blood pressure also decreased significantly from 140.9±10.9/93.1±3.5 mmHg to 129.7±11.1/86.0±7.0 mmHg . Heart rate , weight , BMI , waist circumference , total cholesterol , renin and 24 h urinary albumin excretion significantly decreased in both groups after 16 weeks . General health , bodily pain , social functioning and depression also improved in both groups . No significant differences between qigong and conventional exercise were found . In conclusion , Guolin qigong and conventional exercise have similar effects on blood pressure in patients with mild hypertension . While no additional benefits were identified , it is nevertheless an alternative to conventional exercise in the nondrug treatment of hypertension Few studies of psychological interventions for essential hypertension have incorporated comprehensive coping skills treatment programs , evaluated the efficacy of such programs against credible , minimally effective controls , examined the effects of these interventions on pressor responses , or clarified the nature of person by treatment interactions . The present study examined the relative effectiveness of multimodal stress management training and a minimally effective treatment control ( i.e. GSR biofeedback training ) in the treatment of essential hypertensives ' blood pressure at rest and in response to simulated stressful interpersonal situations . At the conclusion of an 8 week training period , stress management participants exhibited reliably lower resting diastolic blood pressure and tended to exhibit lower systolic pressure than controls . The former condition maintained their lower pressures through a 6-month follow-up period , but decreases in controls over follow-up rendered the conditions equivalent in blood pressure . No differences between conditions emerged in analyses on pressor responses . Stress management training was somewhat more effective for individuals scoring low rather than high on measures of trait anxiety and irritability In this r and omized trial patients with non-insulin-dependent diabetes were allocated to one of four programs : a minimal instruction program ( n=59 ) . an education program of individual visits ( n=57 ) , an education program incorporating a group education course ( n=66 ) , and a behavioral program ( n=59 ) . Individual and group education programs had higher attrition rates than the behavioral and minimal programs . The four programs , which involved different amounts of patient contact time , delivery format , and instructional strategies . all produced reductions in HbA atid BMI , with no significant differences between the programs . There were no differences between groups over three time periods in total cholesterol , HDL cholesterol , systolic blood pressure , or proportion of patients consulting an ophthalmologist . The behavioral program ploduced a greater reduction in diastolic blood pressure over 12 months that the education programs and a greater reduction in the cholesterol risk ratio over 3 months than the other programs . The behavioral program patients were more likely to have visited a podiatrist after 6 months and reported higher satisfaction Our objective was to test the short-term efficacy and feasibility of two stress-reduction approaches for the treatment of hypertension in older African Americans , focusing on subgroup analysis by sex and by high and low risk on six measures of hypertension risk : psychosocial stress , obesity , alcohol use , physical inactivity , dietary sodium-potassium ratio , and a composite measure . The study involved a follow-up subgroup analysis of a 3-month r and omized , controlled , single-blind trial conducted in a primary care , inner-city health center . Subjects were 127 African American men and women , aged 55 to 85 years , with diastolic pressure of 90 to 104 mm Hg and systolic pressure less than or equal to 179 mm Hg . Of these , 16 did not complete follow-up blood pressure measurements . Mental and physical stress-reduction approaches-the Transcendental Meditation technique and progressive muscle relaxation , respectively-were compared with a life-style modification education control and with each other . Both systolic and diastolic pressures changed from baseline to follow-up for both sexes and for high and low risk level ( defined by median split ) on the six measures of hypertension risk . Compared with education control subjects , women practicing the Transcendental Meditation technique showed adjusted declines in systolic ( 10.4 mm Hg , P < .01 ) and diastolic ( 5.9 mm Hg , P < .01 ) pressures . Men in this treatment group also declined in both systolic ( 12.7 mm Hg , P < .01 ) and diastolic ( 8.1 mm Hg , P < .001 ) pressures compared with control subjects . Women practicing muscle relaxation did not show a significant decrease compared with control subjects , and men declined significantly in diastolic pressure only ( 6.2 mm Hg , P < .01 ) . For the measure of psychosocial stress , both the high and low risk subgroups using the Transcendental Meditation technique declined in systolic ( high risk , P = .0003 ; low , P = .06 ) and diastolic ( high risk , P = .001 ; low , P = .008 ) pressures compared with control subjects , whereas for muscle relaxation , blood pressure dropped significantly only in the high risk subgroup and only for systolic pressure ( P = .03 ) compared with control subjects . For each of the other five risk measures , Transcendental Meditation subjects in both the high and low risk groups declined significantly in systolic and diastolic pressures compared with control subjects . Effects of stress reduction on blood pressure were found to generalize to both sexes and diverse risk factor subgroups and were significantly greater in the Transcendental Meditation treatment group . These effects ( along with high compliance ) even in individuals with multiple risk factors for hypertension clearly warrant longer-term investigation in this and other population BACKGROUND Even though the effectiveness of mediation and relaxation skills is controversial in blood pressure control , extensive field studies are limited . A national study targeting 50 communities r and omly selected from northern Taiwan was conducted to test and compare the effectiveness of hypertension control incorporating three strategies . METHODS Five hundred ninety hypertensives identified from 3,128 adults at a screening survey among the 50 communities were invited to participate in the study and were r and omly assigned to three treatment modalities , ( a ) relaxation techniques training at home , ( b ) routine blood pressure measurement by a health professional , and ( c ) reading self-learning packages , or to a control group . RESULTS After a 2-month intervention period , the three treatment groups showed a significant reduction in systolic blood pressure levels compared with the control group ( 11.0 mm Hg for group 1 , 9.2 mm Hg for group 2 , and 5.1 mm Hg for group 3 ) . The relaxation group had the most significant reduction in systolic blood pressure levels , followed by the routine blood pressure monitoring group and the self-learning group . However , the effect of relaxation training at home was not significantly greater than routine blood pressure measurement by a health professional The present study examined the effects of asking subjects to keep their blood-pressure level low while in the presence of an arousing stimulus . It was hypothesized that , without assistance , subjects ' attempts to keep their blood pressure low would actually produce increases in blood pressure , as compared to subjects simply asked to respond naturally to the arousing stimulus . Fifty male subjects watched a videotape containing a neutral ( nonarousing ) section and an erotic section while their blood pressure was recorded by means of an automated blood-pressure monitoring device . Some of the subjects were asked to relax and keep their blood pressure low during the erotic parts of the videotape ; the rest of the subjects were asked to respond naturally . The results confirmed the hypothesis , suggesting that urging people to relax can be counterproductive if they do not also receive systematic instruction on how to relax or control blood pressure . Implication s for health messages in the mass media and physician-patient interactions are discussed The present study compared the effectiveness of three procedures in the treatment of 34 individuals with essential hypertension : ( 1 ) stress management training plus relaxation imagery , which consisted of an adaptation of existing stress management techniques in conjunction with extensive relaxation training using relaxation imagery ; ( 2 ) relaxation imagery alone ; and ( 3 ) weekly blood pressure checks . The relaxation imagery technique involved visualization of a relaxing image along with concentration on suggestions of relaxation , heaviness , and warmth . Treatment was individualized and lasted 8 weeks . Results indicated stress management plus relaxation imagery and relaxation imagery alone were significantly more effective than blood pressure checks in reducing systolic and diastolic blood pressures during treatment and in maintaining diastolic blood pressure reductions during follow-up . However , no significant differences were found between the two treatment procedures . Clinical implication s of these findings are discussed One hundred and one patients , 70 experimental and 31 controls , with a diagnosis of essential hypertension , were examined for the effects of group relaxation training and thermal biofeedback on blood pressure and on other psychophysiologic measures : heart rate , forehead muscle tension , finger temperature , depression , anxiety , plasma aldosterone , plasma renin activity , and plasma and urinary cortisol . Eighty percent of the participants were medicated . Treatment yielded a short-term success rate , defined as a decrease in mean arterial pressure of 5 mm Hg , of 49 % in the experimental group . Other significant short-term changes included a reduction of forehead muscle tension , state anxiety , plasma aldosterone , and increased finger temperature . Follow-up measurements were made approximately 10 months after treatment in 36 patients , 51 % of the treatment completers . Twenty of the 36 were short-term treatment failures , while 16 were treatment succeeders . Thirty-seven percent of the short-term succeeders continued to meet blood pressure criterion at follow-up . In short-term succeeders , continued practice of relaxation may influence long-term maintenance of decreased blood pressure . It is suggested that group relaxation training can be beneficial for short-term and long-term adjunctive treatment of essential hypertension in selected individuals The purpose of this program of research was to explore the use of muscle stretching procedures in relaxation training with a clinical population . In the first controlled study , stretching exercises for four muscle groups ( obicularis occuli , sternocleidomastoid/trapezius , triceps/pectoralis major , and forearm/wrist flexors ) were prepared . A group of people using these procedures ( SR , N = 8) was compared to a group using the Bernstein and Borkovec ( 1973 ) tense-release ( TR ; N = 8) techniques for those same muscle groups , as well as compared to an appropriate group of controls ( WL ; N = 8) . Assessment of physiological ( multi-site EMG ) and subjective ( emotions , muscle tension , and self-efficacy ) responses showed that persons in the SR displayed less sadness , less self-reported muscle tension at four sites , and less EMG activity on the r.masseter than persons in the TR group . In the second study , 15 subjects were administered an exp and ed version of the SR relaxation procedures . Results showed that all subjects reported significant decreases in self-reported levels of muscle tension ; muscle tension responders showed lowered trapezius EMG and respiration rates and cardiovascular responders showed lowered diastolic blood pressure . The results are discussed in terms of the utility of relaxation procedures based primarily on muscle stretching exercises for lowering subjective and objective states of arousal A ten-week yoga program was implemented with sixty-one white and forty-five low-income black elders at two community sites , along with a pretest-posttest control group research design with r and om assignment at each site . White elders attended class regularly , practice d yoga on their own on a daily basis , improved psychological well-being , and lowered their systolic blood pressure level , in comparison to a control group . Black elders , on the other h and , attended the once-a-week class regularly but did not practice on their own on a daily basis . Thus , they did not improve psychological well-being nor reduce blood pressure level in comparison to a control group . Social analysts suggest that low-income minority elders need more frequent contact with structured leadership in order to adhere to a daily routine that may lead to psychological and physical change . Other directions for controlled follow-up studies are suggested Phase II of the Trials of Hypertension Prevention ( TOHP ) is a multicenter , r and omized trial sponsored by the National Heart , Lung , and Blood Institute design ed to test whether weight loss alone , sodium reduction alone , or the combination of weight loss and sodium reduction will decrease diastolic ( DBP ) and systolic blood pressure ( SBP ) as well as the incidence of hypertension ( DBP > or = 90 mm Hg , SBP > or = 140 mm Hg , and /or use of antihypertensive medications ) in subjects with high-normal DBP ( 83 to 89 mm Hg ) and SBP less than 140 mm Hg at entry . These interventions were chosen for longer-term testing with end points including hypertension prevention as well as blood pressure ( BP ) change based on their demonstrated short-term efficacy in reducing BP in phase I of TOHP . The phase II study population is comprised of 2382 participants ( 1566 men and 816 women ) who are 110 to 165 % of desirable body weight , allocated at r and om to the four treatment arms using a 2 x 2 factorial design . The trial has 80 % power to detect an overall treatment effect on DBP of 1.2 mm Hg for weight loss or sodium reduction and a difference of 1.6 mm Hg between the combined intervention and placebo groups . BP observers are blinded to participant treatment assignments . Participants will be followed for 3 to 4 years . This trial may have important public policy implication s concerning the ability of life-style modifications to reduce BP and prevent the development of hypertension over the long term , thereby avoiding the need for drug therapy which while effective is costly and may have side effects OBJECTIVE The aim of this study is to examine the efficacy of progressive muscle relaxation ( PMR ) on change in blood pressure , lung parameters and heart rate in female adolescent asthmatics . METHOD In a prospect i ve , r and omized , double-blind , controlled study , adolescent female asthmatics ( n=31 ) were tested to find out how the systolic blood pressure ( SBP ) , forced expiratory volume in the first second ( FEV(1 ) ) , peak expiratory flow ( PEF ) and heart rate change after PMR . The control group ( CG ; n=30 ) received a placebo intervention . RESULTS A significant reduction in SBP and a significant increase in the FEV(1 ) and PEF were observed after PMR . The heart rate showed a significant increase in the coefficient of variation ( CV ) , root-mean-square of successive differences ( RMSSD ) and at the high frequency ( HF ) range , in addition to a significant reduction at the low and middle frequency ( LF and MF , respectively ) ranges . CONCLUSION PMR appears to be effective in improvement of blood pressure , lung parameter and heart rate in adolescent female asthmatics This study investigated the effectiveness of Qigong on blood pressure and several blood lipids , such as high-density lipoprotein ( HDL ) cholesterol , Apolipoprotein A1 ( APO-A1 ) , total cholesterol ( TC ) , and triglycerides ( TG ) in hypertensive patients . Thirty-six patients were r and omly divided into either the Qigong group , or a wait-listed control group . Blood pressures decreased significantly after eight weeks of Qigong . The levels of TC , HDL , and APO-A1 were changed significantly in the Qigong group post-treatment compared with before treatment . In summary . Qigong acts as an antihypertensive and may reduce blood pressure by the modulation of lipid metabolism Controlled studies have demonstrated that relaxation training can lead to significant in-clinic blood pressure ( BP ) reductions in patients with essential hypertension . We examined the BP-lowering effect of relaxation training during the working day . Forty-two patients being treated for essential hypertension with diastolic BPs greater than 90 mm Hg were r and omized into either a relaxation training program or no treatment . Multiple BP measurements were made during the working hours , using an ambulatory monitoring device , before and after training . Significant work-site differences between groups were evident after treatment both for systolic and diastolic pressures . These results suggest that relaxation therapy leads to a reduction in BP that is evident in the natural environment , providing new evidence that the procedure is a useful adjunct to the treatment of hypertensive patients Phase I of the Trials of Hypertension Prevention was design ed to test the effectiveness and safety of three life-style ( weight loss , sodium restriction , and stress management ) and four nutrition supplement ( calcium , magnesium , potassium , and fish oil ) interventions in reducing diastolic blood pressure ( DBP ) in persons with a high-normal blood pressure . A total of 2182 persons with a DBP between 80 and 89 mm Hg met the eligibility criteria for participation in phase I and were r and omized to one of the active intervention or control treatment groups . Most were white ( 82 % ) , male ( 70 % ) , married ( 76 % ) , nonsmoking ( 88 % ) , college graduate ( 53 % ) , full-time employees ( 91 % ) . The average blood pressure prior to entry into the trial was 124.9 mm Hg systolic and 83.8 mm Hg diastolic . A variety of baseline observations , including sociodemographic characteristics , personal and family medical history , health habits , diet , and biologic measurements , were documented before r and omization and compared among the seven active intervention and control groups . As might be expected in a r and omized trial of this sample size , the distribution of measured baseline characteristics was virtually identical in the treated and control groups . Based on this finding and the knowledge that r and omization procedures were implemented without deviation from the phase I protocol , it is probable that unknown potential confounders were also equally distributed at entry into the study . Given the achievement of high rates of follow-up , subsequent differences in blood pressure are unlikely to have been due to baseline differences between the active treatment and control groups , and can probably be attributed to effects of the active interventions The associations of diastolic blood pressure ( DBP ) with stroke and with coronary heart disease ( CHD ) were investigated in nine major prospect i ve observational studies : total 420,000 individuals , 843 strokes , and 4856 CHD events , 6 - 25 ( mean 10 ) years of follow-up . The combined results demonstrate positive , continuous , and apparently independent associations , with no significant heterogeneity of effect among different studies . Within the range of DBP studied ( about 70 - 110 mm Hg ) , there was no evidence of any " threshold " below which lower levels of DBP were not associated with lower risks of stroke and of CHD . Previous analyses have described the uncorrected associations of DBP measured just at " baseline " with subsequent disease rates . But , because of the diluting effects of r and om fluctuations in DBP , these substantially underestimate the true associations of the usual DBP ( ie , an individual 's long-term average DBP ) with disease . After correction for this " regression dilution " bias , prolonged differences in usual DBP of 5 , 7.5 , and 10 mm Hg were respectively associated with at least 34 % , 46 % , and 56 % less stroke and at least 21 % , 29 % , and 37 % less CHD . These associations are about 60 % greater than in previous uncorrected analyses . ( This regression dilution bias is quite general , so analogous corrections to the relations of cholesterol to CHD or of various other risk factors to CHD or to other diseases would likewise increase their estimated strengths . ) The DBP results suggest that for the large majority of individuals , whether conventionally " hypertensive " or " normotensive " , a lower blood pressure should eventually confer a lower risk of vascular disease OBJECTIVE --To establish whether stress management had a larger effect than a control treatment on resting blood pressure , ambulatory blood pressure , and left ventricular mass . DESIGN --A 12 week baseline period of habituation to measurement of blood pressure was followed by r and omisation to either stress management or mild exercise for six months and follow up six months later . SETTING --General practice , district general hospital , and medical school . PATIENTS --Of the 184 patients aged under 60 with mild primary hypertension who entered the baseline habituation period , 88 were excluded because they failed to meet the entry criteria or they withdrew from the study . The remaining 46 men and 50 women underwent treatment . INTERVENTIONS --10 clinical sessions and daily practice at home of either stress management based on relaxation or non-aerobic stretching exercises . Mildly stressful 15 minute interviews before and after treatment . MAIN OUTCOME MEASURES --Diastolic and systolic blood pressure in the clinic and during 12 hours of ambulatory recording , and left ventricular mass measured by echocardiography . RESULTS --The patients ' blood pressure fell during habituation ( systolic pressure from 152 mmHg to 140 mmHg , diastolic pressure from 98 to 93 mm Hg ) , but neither resting nor ambulatory blood pressure was changed by the treatments . Left ventricular mass was also unchanged . Blood pressure rose during the stressful interview , but this rise was reduced by stress management ( systolic pressure rose by 7.4 mmHg before treatment and by 3.7 mmHg after treatment ) . CONCLUSION --Stress management of a type advocated for treating mild primary hypertension is ineffective in lowering blood pressure in patients who are well habituated to measuring blood pressure & NA ; This article reports the findings of a study design ed to evaluate the long‐term effectiveness of an industry‐based relaxation training program in the treatment of hypertensives whose blood pressures were not well controlled by antihypertensive medication . Following a three‐stage screening process , 137 participants were r and omly allocated to either relaxation training ( RT ) or to blood pressure monitoring ( BPM ) at two worksites . Participants continued to receive medical care from their primary physicians during the course of the study . The advantage for participants receiving RT , in terms of mean blood pressure changes , was modest and of short duration . However , a larger proportion of participants in the RT group came into good control ( blood pressures below 90 mm Hg ) than in the BPM group following treatment ( 69.4 % vs 41.5 % , p less than 0.001 ) . This advantage continued to 24 months ' follow‐up ( 63.9 % vs 47.7 % , p less than 0.05 ) . At 30 months ' follow‐up there was no significant difference between the groups ( 75.0 % vs 70.8 % ) . Within‐group analyses revealed that the BPM group also achieved significant blood pressure lowering which was maintained during the study . The largest initial difference between the two groups was for individuals whose entry diastolic blood pressures were most out of control despite several years of pharmacologic treatment . No difference was found between the two groups in the prescription of antihypertensive medication This study investigated the effects of meditation/relaxation on physiological responses during the performance of a fine motor and a gross motor task . A pretest-posttest control group , r and omized-blocks design was used to study a group of 16 meditators and a group of 16 nonmeditators , subgroups of each who relaxed prior to performing on a pursuit-rotor tracking device as a fine motor task and to performing the Luft cycle ergometer protocol to a heart rate of 70 % of age-adjusted maximum heart rate as a gross motor task . During each of these tasks heart rate , systolic blood pressure , rate-pressure-product , and EMG activity of the frontalis muscle were monitored . No significant difference in the performance of either the fine motor or the gross motor task was noted for persons practicing meditation and persons who were nonmeditators but were given the opportunity to relax prior to a motor task . Likewise , no significant difference was noted in the pattern of response to the imposed fine motor or gross motor task by meditators or relaxed nonmeditators Fifty-two pharmacologically treated hypertensive patients were r and omized to one of four treatment groups : ( 1 ) diastolic blood pressure biofeedback , ( 2 ) progressive deep muscle relaxation training , ( 3 ) self-directed relaxation training , or ( 4 ) medication alone . Data collection occurred during baseline , treatment , and 1-year follow-up phases in a laboratory , a medical clinic , and the patient 's own home . Patients from all four groups combined showed mean blood pressure reductions of −10.2/−5.5 mm Hg on clinic recordings and −2.4/−.7 mm Hg on home recordings , which were maintained throughout the follow-up period . There were no significant differences among the four groups in terms of blood pressure reduction . Patients given adjunctive behavioral treatment showed significantly larger reductions in medication usage compared to patients treated with medication alone , but there were no significant differences among the three behaviorally treated groups . Patients who showed medication reductions did not show subsequent blood pressure elevation . The results suggest that combined behavioral and pharmacological therapy may be superior to pharmacological therapy alone in the treatment of essential hypertension Objective To study the effects of moderate doses of fish oil on blood pressure and high-density lipoprotein (HDL)-cholesterol . Methods The participants were 350 normotensive men and women aged 30–54 years who were enrolled from seven academic medical centers in phase I of the Trials of Hypertension Prevention . They were r and omly assigned to receive placebo or 6 g purified fish oil once a day , which supplied 3 g n-3 polyunsaturated fatty acids for 6 months . Results Baseline blood pressure was ( mean ± SD ) 123±9/81 ±5mmHg . The mean differences in the blood pressure changes between the fish oil and placebo groups were not statistically significant . There was no tendency for fish oil to reduce blood pressure more in subjects with baseline blood pressures in the upper versus the lower quartile ( 132/87 versus 114/75 mmHg ) , low habitual fish consumption ( 0.4 versus 2.9 times a week ) or low baseline plasma levels of n-3 fatty acids . Fish oil increased HDL2-cholesterol significantly compared with the placebo group . Subgroup analysis showed this effect to be significant in the women but not in the men . Increases in serum phospholipid n-3 fatty acids were significantly correlated with increases in HDL2-cholesterol and decreases in systolic blood pressure . Conclusion Moderate amounts of fish oil ( 6g/day ) are unlikely to lower blood pressure in normotensive persons , but may increase HDL2-cholesterol , particularly in women We compared the effects of relaxation therapy in hypertensive patients taking placebo , a beta-blocker ( atenolol , 100 mg/d ) , or a diuretic ( chlorthalidone , 50 mg/d ) , and we also compared the effects of relaxation therapy with the effects of the latter two drugs alone . Blood pressures were measured not only in the relaxation therapists ' office and at a hypertension clinic , but also in the patient 's environment by means of 24-hour ambulatory blood pressure recordings . The effect of relaxation therapy , while statistically significant , was modest . There was no generalization of effect to ambulatory blood pressure . Atenolol was significantly more effective than relaxation in reducing both systolic and diastolic pressure . Chlorthalidone was significantly more effective than relaxation in reducing systolic but not diastolic pressure in the hypertension clinic only . The long-term effects of relaxation were independent of concomitant drug use , but within the actual relaxation sessions blood pressure dropped further during chlorthalidone than during placebo or atenolol treatment & NA ; In this industrial‐based study we compared the blood pressure (BP)‐lowering effectiveness of relaxation , a beta blocker , and the combined use of these two treatments in 47 untreated , mildly hypertensive blue collar steel workers . Using a r and omized two by two factorial design , patients received either nadolol or placebo drug daily , and either a relaxation training or an education program , each lasting 8 weeks . A pre‐intervention and post‐intervention stress test measured response of heart rate and BP to mental and physical tasks . BP assessment s were done at baseline , post‐intervention , 1 month , and 3 month follow‐up . Change in several self‐report measures was determined . Results showed that beta blocker was more effective in lowering BP than placebo , but relaxation was not more effective in lowering BP than health education . The combined effect of beta blocker and relaxation was not superior to beta blocker alone . Compliance with relaxation practice was not superior to compliance with medication . We conclude that pharmacologic treatment is superior to the relaxation therapy tested Can direct change in state of consciousness through specific mental techniques extend human life and reverse age-related declines ? To address this question , 73 residents of 8 homes for the elderly ( mean age = 81 years ) were r and omly assigned among no treatment and 3 treatments highly similar in external structure and expectations : the Transcendental Meditation ( TM ) program , mindfulness training ( MF ) in active distinction making , or a relaxation ( low mindfulness ) program . A planned comparison indicated that the " restful alert " TM group improved most , followed by MF , in contrast to relaxation and no-treatment groups , on paired associate learning ; 2 measures of cognitive flexibility ; mental health ; systolic blood pressure ; and ratings of behavioral flexibility , aging , and treatment efficacy . The MF group improved most , followed by TM , on perceived control and word fluency . After 3 years , survival rate was 100 % for TM and 87.5 % for MF in contrast to lower rates for other groups Thirty-two male and female hypertensives , 34 to 65 yr of age , systolic blood pressure ( SBP ) less than 200 mmHg and diastolic blood pressure ( DBP ) between 90 and 109 mmHg , were r and omly allocated to receive either relaxation and stress management ( experimental condition ) or mild physical exercise ( control condition ) . Half the participants were taking antihypertensive drugs , which were constant for six months prior to the study and controlled during the study . Outcome measures included various measures of blood pressure in the clinic and at home , cardiovascular responsiveness , moods and 24-hr urinary adrenaline and noradrenaline . The study schedule consisted of 3-months baseline , 10 weeks treatment and 3-months follow-up . Relaxation was superior to the control procedure in reducing blood pressure as assessed by nurses blind to the participants ' treatment at post-treatment for DBP and at follow-up for DBP and SBP 34 hypertensive patients were assigned at r and om either to six weeks ' treatment by yoga relaxation methods with bio-feedback or to placebo therapy ( general relaxation ) . Both groups showed a reduction in blood-pressure ( from 168/100 to 141/84 mm . Hg in the treated group and from 169/101 to 160/96 mm Hg in the control group ) . The difference was highly significant . The control group was then trained in yoga relaxation , and their blood-pressure fell to that of the other group ( now used as controls ) Background Home training in self-lowering of blood pressure using continuous blood pressure feedback has not previously been reported . Enhancement of laboratory-learned skills was hypothesized on the basis of outcomes from other intellectual , emotional and physical endeavours . Objective To examine the supplementary effect of home blood pressure biofeedback training . Design Thirty unmedicated , mild hypertensives participated in a r and omized , double-blinded , modified contingency placebo-controlled study . Method After suitable screening and baseline blood pressure measurements subjects undertook eight laboratory biofeedback sessions and then 12 home training sessions over 4 weeks using continuous finger blood pressure monitoring . Results In the laboratory those being administered active therapy ( n = 16 ) lowered systolic pressures by 5 ± 5.4 mmHg compared with a lowering of 4 ± 4.2 mmHg with placebo ( NS ) . During the fourth week at home lowering for the active group ( 11 ± 8 mmHg ) was greater than that with placebo ( 4 ± 6.2 mmHg , P = 0.017 ) . Arm-cuff blood pressures were not statistically different for groups and with time but that of the active group was lower by 9 ± 15.4/7 ± 10.2 mmHg , which is a clinical ly relevant change , after home biofeedback . Conclusions The efficacy of self-lowering of systolic blood pressure in mild hypertensives by continuous feedback was enhanced by 6 mmHg with 4 weeks of practice at home . St and ard arm-cuff blood pressure was reduced by a clinical ly relevant amount . The home environment proved cost effective for this ‘ high-tech ’ approach On the basis of medical officers diagnosis , thirty three ( N = 33 ) hypertensives , aged 35 - 65 years , from Govt . General Hospital , Pondicherry , were examined with four variables viz , systolic and diastolic blood pressure , pulse rate and body weight . The subjects were r and omly assigned into three groups . The exp . group-I underwent selected yoga practice s , exp . group-II received medical treatment by the physician of the said hospital and the control group did not participate in any of the treatment stimuli . Yoga imparted in the morning and in the evening with 1 hr/session . day-1 for a total period of 11-weeks . Medical treatment comprised drug intake every day for the whole experimental period . The result of pre-post test with ANCOVA revealed that both the treatment stimuli ( i.e. , yoga and drug ) were effective in controlling the variables of hypertension Thirty-one patients receiving medical treatment for essential hypertension were r and omly distributed into three groups : ( 1 ) relaxation therapy , ( 2 ) nonspecific therapy , and ( 3 ) medical treatment only . The nonspecific therapy group spent the same amount of time with the therapists as the relaxation group but was not given a specific therapy . Blood pressures were measured at a different time and in a different place from the behavioral treatments . The relaxation therapy group showed a significant reduction in blood pressure postreatment compared with the nonspecific therapy and medical treatment only groups , even when those patients whose medication was increased were excluded from the data analysis . At follow-up six months post-treatment , the relaxation group showed a slight decrement in treatment effects , while both the nonspecific therapy and medical treatment only groups showed continued improvement ; thus , there was not a significant difference between groups Thirty borderline essential hypertensives were r and omly assigned to a portable constant-cuff blood pressure feedback technique or meditation-relaxation . Each technique was taught in the laboratory , then practice d twice daily at home for four weeks . Subjects mailed daily records of their progress . Seven feedback and ten meditation-relaxation subjects completed the program . Both techniques produced significant systolic and diastolic reductions within practice sessions and diastolic reductions over weeks of training . Neither technique improved reductions nor reduced initial systolic pressure levels over the four weeks . Differences between biofeedback and meditation-relaxation in within-session pressure reductions were not significant & NA ; The present study describes a 16‐week trial of the use of a combination of biofeedback and relaxation techniques for the treatment of hypertension . Twenty‐two hypertensive patients were r and omly allocated to one of three groups : ( 1 ) diastolic blood pressure feedback , electromyographic feedback , and verbal relaxation ; ( 2 ) sham blood pressure feedback ; and ( 3 ) no treatment . For the 14 patients completing active treatment during an initial or crossover period , the average changes in blood pressure as measured outside the laboratory were minimal ( 0/−1 and + 1/0 mm Hg , supine and st and ing , respectively ) . Average blood pressure reduction in the laboratory was no greater with active than with sham blood pressure feedback ( −3/−2 vs. −5/−2 mm Hg ) . One subject , however , after showing no change in blood pressure during sham feedback , achieved pronounced and prolonged improvement following active treatment . Overall results do not support the usefulness of these techniques as primary therapy in most hypertensives OBJECTIVES To evaluate effects of Hatha yoga and Omkar meditation on cardiorespiratory performance , psychologic profile , and melatonin secretion . SUBJECTS AND METHODS Thirty healthy men in the age group of 25 - 35 years volunteered for the study . They were r and omly divided in two groups of 15 each . Group 1 subjects served as controls and performed body flexibility exercises for 40 minutes and slow running for 20 minutes during morning hours and played games for 60 minutes during evening hours daily for 3 months . Group 2 subjects practice d selected yogic asanas ( postures ) for 45 minutes and pranayama for 15 minutes during the morning , whereas during the evening hours these subjects performed preparatory yogic postures for 15 minutes , pranayama for 15 minutes , and meditation for 30 minutes daily , for 3 months . Orthostatic tolerance , heart rate , blood pressure , respiratory rate , dynamic lung function ( such as forced vital capacity , forced expiratory volume in 1 second , forced expiratory volume percentage , peak expiratory flow rate , and maximum voluntary ventilation ) , and psychologic profile were measured before and after 3 months of yogic practice s. Serial blood sample s were drawn at various time intervals to study effects of these yogic practice s and Omkar meditation on melatonin levels . RESULTS Yogic practice s for 3 months result ed in an improvement in cardiorespiratory performance and psychologic profile . The plasma melatonin also showed an increase after three months of yogic practice s. The systolic blood pressure , diastolic blood pressure , mean arterial pressure , and orthostatic tolerance did not show any significant correlation with plasma melatonin . However , the maximum night time melatonin levels in yoga group showed a significant correlation ( r = 0.71 , p < 0.05 ) with well-being score . CONCLUSION These observations suggest that yogic practice s can be used as psychophysiologic stimuli to increase endogenous secretion of melatonin , which , in turn , might be responsible for improved sense of well-being Cardiovascular responses to stress reactivity has been proposed as a risk factor for hypertension . In this study , we evaluated the effects of stress reduction on both laboratory cardiovascular reactivity and ambulatory blood pressure in real life on 39 normotensive male subjects who were pretested for ambulatory blood pressure and cardiovascular reactivity to stress using a battery of laboratory stressors . Thereafter , subjects were r and omly assigned to practice either the Transcendental Meditation ( TM ) technique or a cognitive-based stress education control ( SEC ) for four months . After 4 months , there was no change in cardiovascular response to stressors between the TM and control groups . However , the subjects regularly practicing TM demonstrated a significant reduction of 9 mm Hg ( p < .04 ) in average ambulatory DBP compared to controls . Since ambulatory BP monitoring has been shown to be a better predictor of cardiovascular complications of hypertension than clinic BP , this finding may have important implication s for primary prevention of CVD in normotensive subjects Abstract During the course of a controlled comparison of thermal biofeedback and progressive muscle relaxation as treatments for essential hypertension three studies investigating the relationship of process variables to outcome were conducted . The three variables investigated were expectancies , skill acquisition , and home practice . For patients receiving progressive muscle relaxation , perceptions of deep relaxation during treatment sessions were most strongly related to outcome . For thermal biofeedback patients , expectancies and skill acquisition variables were both related to outcome . Frequency of home practice was related to successful outcome for both treatment groups Effects of progressive muscle relaxation ( PMR ) and of attention control were investigated in a prospect i ve r and omized trial of borderline or mild hypertensive patients . Both groups received placebo and had the same number of clinic return visits . After 22 weeks the average mean home BP in PMR decreased 3 mm Hg , whereas in controls BP increased 2 mm Hg . Progressive muscle relaxation had no significant effect on the clinic BP . The response to PMR was not uniform . Responders were characterized by faster heart rates and higher plasma norepinephrine levels . The responders also showed a decrease of anxiety scores during the trial . Progressive muscle relaxation is a time-consuming procedure . Blood pressure responses do not substantially exceed the placebo effects in unselected patients . However , relaxation may be suitable for young , anxious patients with mild hypertension who have a high resting sympathetic tone Twenty-one patients with essential hypertension were r and omly allocated to eight 1-hour sessions of meditation training , meditation plus biofeedback-aided relaxation , or a no-treatment control group . Statistically significant falls in systolic and diastolic blood pressure occurred after both training programs , although overall reductions in blood pressure were not significantly greater in either program than in the control group . Meditation plus biofeedback-aided relaxation produced falls in diastolic blood pressure earlier in the training program than did meditation alone . All patients practice d meditation regularly between training sessions : The amount of practice did not correlate with the amount of blood pressure reduction after training . On question naire measures of psychological symptoms and personality , sex differences emerged , with females showing significant abnormalities in hostility scores and males showing significantly raised levels of somatopsychic symptoms . In females , outward-directed hostility fell significantly and assertiveness increased after training , but in males , somatopsychic symptoms were unchanged Ninety patients with essential hypertension were followed for 5 years . Initially the patients were r and omized into two groups : ( a ) an experimental group consisting of 44 patients who received autogenic training and ( b ) a control group of 46 patients who did not receive any behavioral intervention . By the end of the follow-up period , the experimental group was significantly different from the control group , with reduced blood pressure ( by 5.8 mm Hg systolic and 3.2 mm Hg diastolic vs. 4.3 mm Hg systolic and 2.0 mm Hg diastolic ) , a smaller increase in left-ventricular myocardial mass ( 14.6 g vs. 38.2 g ) , improved psychological indices , and a decrease in the number of sick days of leave . Autogenic training appeared to be more effective in patients with mild hypertension than in those with moderate hypertension and the results were comparable with those obtained with regular medication AIMS OF STUDY To study effect of yoga on the physiological , psychological well being , psychomotor parameter and modifying cardiovascular risk factors in mild to moderate hypertensive patients . METHODS Twenty patients ( 16 males , 4 females ) in the age group of 35 to 55 years with mild to moderate essential hypertension underwent yogic practice s daily for one hour for three months . Biochemical , physiological and psychological parameters were studied prior and following period of three months of yoga practice s , biochemical parameters included , blood glucose , lipid profile , catecholmines , MDA , Vit . C cholinesterase and urinary VMA . Psychological evaluation was done by using personal orientation inventory and subjective well being . RESULTS Results showed decrease in blood pressure and drug score modifying risk factors , i.e. blood glucose , cholesterol and triglycerides decreased overall improvement in subjective well being and quality of life . There was decrease in VMA catecholamine , and decrease MDA level suggestive decrease sympathetic activity and oxidant stress . CONCLUSION Yoga can play an important role in risk modification for cardiovascular diseases in mild to moderate hypertension In groups of hypertensives blood-pressure ( BP ) reductions after relaxation training ( RT ) are generally moderate . One possibility to explain this relative weakness of RT follows from the observation of large interindividual differences in BP response after RT . In a first study we observed this same variability of BP response after RT in normotensives . Subsequently a method was developed to predict individual BP response after RT . The validity of this method was then established in three sample s of normotensives : both systolic and diastolic BP changes appear to be predictable after progressive relaxation as well as after autogenic training To see whether general practitioners could effectively carry out training in relaxation and management of stress to reduce mild hypertension a study was carried out with a sub sample of phase 2 of the Medical Research Council 's treatment of mild hypertension trial.1 In the main mild hypertension trial patients had been receiving either an active drug or placebo for six years . In phase 2 a sub sample of these patients were r and omly allocated either to continue or to stop receiving the active drug or placebo . In a further sub sample patients were again r and omised to receive or not to receive relaxation therapy . This factorial design presented an additional opportunity to assess whether patients controlled with active drugs might have their blood pressure maintained by this behavioural therapy once drug treatment was stopped and to assess whether blood pressure might be further reduced by this therapy in patients who had been under regular medical supervision for as long as six years and who had already received non-pharmacological advice . The therapy was conducted by general practitioners in group sessions once a week for eight weeks . The training in relaxation was accompanied by galvanic skin resistance biofeedback . At one year follow up blood pressure in the relaxation subgroups was either maintained ( in the group who had stopped receiving drugs ) or reduced further ( in the group who had continued receiving drugs and in both placebo groups ) , while in the control group it had increased in all the subgroups , but particularly in those who had stopped receiving drugs . Differences in changes in blood pressure between the relaxation and control groups were significant . There were five new cardiovascular events , including evidence of myocardial ischaemia in blindly coded electrocardiograms in the control group , compared with one in the treatment group . General practitioners , if motivated , can successfully apply this technique of training those with mild hypertension in relaxation and management of stress People with two or more of serum cholesterol > 6.3 mole/l , systoiic blood pressure > I40 mm Hg , and smoking > 10 cigarettes per day , were r and omly allocated to a biofeedback or control group . The biofeedback group received 8 weekly training sessions . Both groups received health education literature . At follow-up after eight weeks , the biofeedback group , when compared to the control group , had a significantly greater fall in blood pressure , in cigarette smoking , and , to a lesser extent , in plasma cholesterol . Therewas evidence of an effect of biofeedback on plasma renin activity , and possibly on plasma noradrenaline We examined 117 out patients ( 20- to 45-year-old men ) with mild essential hypertension before treatment , after the main treatment course ( 6 weeks ) , and at 12-month follow-up . The patients were r and omized into two major groups : ( a ) a treatment group that received autogenic training ( 23 patients ) , biofeedback ( 24 patients ) , or breathing-relaxation training ( 23 patients ) and ( b ) a control group that consisted of 24 patients who did not receive any intervention and 23 patients who were treated with a " psychological placebo . " Clinical , psychological , and psychophysiological data from all patients who were offered relaxation therapy were analyzed . By the end of follow-up , and compared to the control group , the treatment group demonstrated a significant reduction in systolic and diastolic blood pressures , peripheral vascular resistance , and hypertensive response to emotional stress , and an improvement in psychological adaptation , quality of life , and capacity for work . Comparative analysis of the efficacy of different relaxation methods revealed that biofeedback and breathing-relaxation training result ed in the greatest reduction in blood pressure . The antihypertensive effect of relaxation therapy correlated positively with pretreatment blood pressure levels and negatively with the duration of illness and certain psychological features To determine the effectiveness of a yoga program on blood pressure and stress , a group of hypertensive patients in Thail and were studied , with the experimental group showing significantly decreased mean stress scores and blood pressure , heart rate , and body mass index levels compared with the control group . Further studies are suggested to determine the effects of yoga on hypertension in Thail and The effects of self-monitoring of blood pressure on the control of hypertension were examined in this study . Failure of patients to comply with treatment is presumably attributable in part to the fact that hypertension usually is asymptomatic until complications develop . Self-monitoring might make visible an otherwise asymptomatic condition , and thereby increase motivation . One hundred hypertensive patients beginning outpatient treatment were r and omly assigned to experimental and control groups . Subjects were given a sphygmomanometer and instructed in its use . Both groups were given similar antihypertensive medications . After six months of treatment , mean systolic pressure was significantly lower ( 11.4 mm Hg , p<0.05 ) in the experimental than in the control subjects . However , the mean baseline systolic pressure in the control group was 3.9 mm Hg less than that of the experimental group . If this value is subtracted from the difference between the last mean systolic pressures in the two groups , the 7.5 mm Hg difference is seen as a very modest effect of self-monitoring . Diastolic blood pressure was insignificantly lower for experimental subjects . Compared to the potent effectiveness of drugs in reducing blood pressure , self-monitoring was of little value Forty three patients with essential hypertension participated in a study on the effectiveness of stress-management training for essential hypertension . After 6–9 clinic and 48 self-measured readings of systolic and diastolic blood pressures ( SBP and DBP ) , 22 patients were treated with a program based on education , relaxation , and problem-solving training ; and another 21 patients were assigned to a waiting list control group . At post-treatment , mean reductions of clinic BP ( 17/13 mm Hg vs. 6.9/4.7 mm Hg for SBP/DBP ) , percentages of subjects who achieved at least a 5 mm Hg reduction ( 86/86 % vs. 48/48 % for SBP/DBP ) and percentages of subjects who in addition achieved a normotensive level ( 59/68 % vs. 29/14 % for SBP/DBP ) were significantly higher in the treated group than in the control group . Concerning self-measured BP , the effectiveness of the stress-management training was not so considerable ( mean reductions of 3.6/2.4 mm Hg and percentages of subjects who achieved a 5 mm Hg reduction of 52/38 % for SBP/DBP ) , but it was significant and maintained in a 4-month follow-up assessment ( mean reductions of 4/2 mm Hg and percentages of subjects who achieved a 5 mm Hg reduction of 48/33 % for SBP/DBP ) . It is suggested that stress-management training can be beneficial for treatment of essential hypertension A total of 90 patients with hypertension were examined after a 5-year interval using echocardiography and the psychological MMPI test . During the first study all the patients were r and omized into 2 groups : the study group of 44 patients who were given autogenic training and the control group of 46 patients without psychological intervention . An analysis of the patients ' status over 5 yrs . showed that in a labile course of disease a less pronounced progression of disease , more favorable changes of hemodynamics indices ( absence of an increase in the myocardium left ventricular mass ) , a reduced level of neurotization and a reduced number of days of temporary disability were observed in the study group as compared to the control group . In Stage IIB hypertension psychological intervention result ed in improved psychological status , increasing the patient 's motivation to treatment and working capacity This study investigated the role of nonspecific treatment factors in the behavioral control of essential hypertension . Forty-eight subjects with mild hypertension were r and omly assigned to one of three conditions : ( 1 ) subject-alone relaxation therapy ; ( 2 ) couples-relaxation therapy ; or ( 3 ) couples-cognitive therapy . The third condition , which provided instruction in cognitive methods of stress reduction , controlled for the effects of positive treatment expectancy and other nonspecific factors . At the end of 8 weeks , subjects in all three conditions showed significant reductions in systolic and diastolic blood pressure , which were maintained at 1 and 5 months post-treatment . However , no significant differences in effectiveness were observed among conditions at any assessment period . Although the results of this study did not unequivocally demonstrate that a positive treatment expectancy is a sufficient condition for blood pressure reduction , they do raise questions concerning whether relaxation therapy is a necessary condition In a study undertaken to evaluate the clinical effectiveness of two behavioral treatments for essential hypertension ( biofeedback on arterial pulse-wave velocity and progressive relaxation ) 24 hypertensive subjects were r and omly assigned to either a relaxation or biofeedback treatment group for 5 weekly sessions . In a second stage of the study 16 of the original subjects received both biofeedback and relaxation treatments during 5 additional weekly sessions . Results indicated that biofeedback and relaxation were equally effective in initial lowering of blood pressure in hypertensives . Although biofeedback training led to superior reductions at the 3-mo . follow-up point , after 1 yr . the blood pressures of both groups were not only equal but well below those presented at the beginning of the study 48 essential hypertensives were r and omly assigned to ( 1 ) a behavioral treatment ( n = 20 ) , ( 2 ) a pharmacological treatment ( n = 20 ) , or ( 3 ) self recordings of BP ( n = 8) . Group 1 and 2 showed during 1 year of therapy comparable significant decreases of systolic and diastolic BP , whilst group 3 showed significant increases after 3 months of therapy OBJECTIVES The purpose of this study was to investigate the impact of practicing qigong on middle-age subjects with essential hypertension . Impacts on blood pressure , reported self-efficacy , perceived benefit , and emotion were observed . DESIGN Thirty-six ( 36 ) adult volunteers were assigned to either a waiting list control or a qigong group that practice d two 30-minute qigong programs per week over 8 consecutive weeks . RESULTS Systolic and diastolic blood pressure was significantly reduced in members of the qigong group after 8 weeks of exercise . Significant improvements in self-efficacy and other cognitive perceptual efficacy variables were also documented in the qigong group compared to the original situation described above . CONCLUSIONS This pilot study demonstrates the positive effects of practicing qigong on controlling blood pressure and enhancing perceptions of self-efficacy Unmedicated mildly hypertensive Type A men were r and omly allocated to one of three conditions : stress management intervention training ( N = 15 ) , Type A management ( N = 15 ) , and delayed Type A management intervention . Significantly greater reductions in blood pressure at rest and during the Type A structured interview were found following the active interventions than during the minimal treatment control period of the delayed intervention . Type A management was more successful in changing a number of Type A behaviours , including anger , hostility and global Type A behaviour . Changes on measures of anger-in , -out , hostility , and SI ratings of Type A behaviour were associated with changes in systolic and diastolic blood pressure reactivity during interview Thirty subjects with essential hypertension were assigned r and omly to either a no treatment control , education , or education with relaxation training group . Independent blood pressure recordings were collected by medical staff at pretest , posttest , and 8-week follow-up . Results suggest a significant interaction between treatment and time for the dependent physiological measure , systolic blood pressure . During the pretest to follow-up period , the control group averaged a 5.9 mm . Hg . increase , the education with relaxation group an 8.8 mm . Hg . decrease , and the education group a 14.9 mm . Hg . decrease in systolic blood pressure . There was no significant difference in group means for diastolic blood pressure within groups over time . As measured at follow-up , education appeared more effective in reducing systolic blood pressure than education with relaxation training . More than one-third of subjects associated unpleasant side effects with their antihypertensive medication . Almost all treatment subjects rated the education and relaxation as helpful for underst and ing and managing their hypertension OBJECTIVE --To determine the long term effects of relaxation therapy on 24 hour ambulatory intra-arterial blood pressure in patients with mild untreated and uncomplicated hypertension . DESIGN --Four week screening period followed by r and omisation to receive either relaxation therapy or non-specific counselling for one year . Ambulatory intra-arterial blood pressure was measured before and after treatment . SETTING --Outpatient clinic in Amsterdam 's university hospital . SUBJECTS--35 Subjects aged 20 - 60 who were being treated by general practitioners for hypertension but were referred to take part in the study . At three consecutive screening visits all subjects had a diastolic blood pressure without treatment of 95 - 110 mm Hg . Subjects were excluded if they had damaged target organs , secondary hypertension , diabetes mellitus , a cholesterol concentration greater than 8 mmol/l , or a history of malignant hypertension . INTERVENTIONS --The group allocated to relaxation therapy was trained for eight weeks ( one hour a week ) in muscle relaxation , yoga exercises , and stress management and continued exercising twice daily for one year with monthly visits to the clinic . The control group had the same attendance schedule but had no training and were requested just to sit and relax twice a day . All subjects were asked not to change their diet or physical activity . MAIN OUTCOME MEASURE -- Changes in ambulatory intra-arterial blood pressure after one year of relaxation therapy or non-specific counselling . RESULTS --Mean urinary sodium excretion , serum concentration of cholesterol , and body weight did not change in either group . Diastolic pressures measured by sphygmomanometry were 2 and 3 mm Hg lower in subjects in the relaxation group and control group respectively at the one year follow up compared with initial readings . The mean diastolic ambulatory intra-arterial pressure during the daytime had not changed after one year in either group , but small treatment effects could not be excluded : the mean change for the relaxation group was -1 mm Hg ( 95 % confidence interval -6 to 3.9 mm Hg ) and for the control group -0.4 mm Hg ( -5.3 to 4.6 mm Hg ) . Mean ambulatory pressure in the evening also had not changed over the year , and in both groups nighttime pressure was 5 mm Hg higher . The variability in blood pressure was the same at both measurements . CONCLUSIONS --Relaxation therapy was an ineffective method of lowering 24 hour blood pressure , being no more beneficial than non-specific advice , support , and reassurance -- themselves ineffective as a treatment for hypertension In the first of two studies , 42 unmedicated mild hypertensives completed either 16 sessions of thermal biofeedback ( TBF ) training for h and ( 7 sessions ) and foot ( 9 sessions ) warming or 8 weeks of monitoring BPs at home . There was a trend ( p<.10 ) for more of those treated ( 57.1 % ) to have DBPs lower than 90 mm Hg than for those only monitoring BPs at home ( 33 % ) . Analyses of clinic BP values from r and om zero sphygmomanometer measurements , from 24-hour ambulatory BP monitoring , and from home BP measurements made by the patient showed no advantage for treatment versus BP monitoring . Sixteen of the 21 patients in BP monitoring were later treated . Analyses of treatment effects across all treated subjects by gender revealed a significant ( p=.02 ) decrease in DBP for treated female subjects ( n=13 ) but not for males ( n=24 ) . In the second study the 22 initial treatment successes , that is , those whose DBP was below 90 mm Hg at posttreatment ( 59.4 % of those who completed treatment ) , were r and omized to an intensive follow-up ( monthly visits for 6 months , then visits every two months ) emphasizing regular home practice with an electronic TBF device or regular follow-up ( visits every 3 months ) . Twelve of the 22 were still normotensive at 12 months . There were no differences at any point during the follow-up between the two conditions in success rate or BPs despite a numerical advantage in reported frequency of home practice by those in the intensive follow-up condition Employees of a large industry were screened for the presence of coronary risk factors . A total of 204 employees , aged 35 - 64 years , with two or more such factors ( serum cholesterol concentration greater than or equal to 6.3 mmol/l ( 243.6 mg/100 ml ) , blood pressure greater than or equal to 140/90 mm Hg , and current cigarette consumption greater than or equal to 10 cigarettes a day ) were r and omly allocated to a biofeedback group receiving training in relaxation and management of stress or a control group . Both groups received simple health education literature . After eight weeks of training , and again eight months later , the biofeedback group showed a significantly greater fall in systolic and diastolic blood pressures than the control group ( p less than 0.001 ) . Plasma renin activity and plasma aldosterone concentration were measured in a sub sample at entry to the study and again at eight weeks and eight months ; both showed a greater reduction in the biofeedback compared with the control group at eight weeks ' follow-up . The greater reduction in blood pressure in the subjects in the biofeedback group compared with the control group ( 11.0 mm Hg systolic and 8.8 mm Hg diastolic ) , persisting eight months after the training , suggests that relaxation-based behavioural methods might be offered as a first-time treatment to patients with mild hypertension The effects of progressive muscle relaxation ( PMR ) on anxiety and perceptions of personal control over health status are evaluated in this study . After collection of baseline data , 22 hypertensive clients received relaxation training in a series of weekly group sessions followed by individual monitoring sessions over a 6-week period . The 22 hypertensive clients in the control group received blood pressure monitoring , weight checks , and health counseling but were given no relaxation training during the study period . The group instructed in relaxation exhibited significantly lower anxiety than the control group at 4-month followup . After training , the relaxation group also scored significantly higher than the control group on beliefs in personal control of health and lower in beliefs that chance or luck affected health outcomes . At followup , the groups did not differ significantly on perceived influence of powerful others over health status . Findings support the potential usefulness of relaxation training in modifying affective and cognitive characteristics of hypertensive clients Phase II of the Trials of Hypertension Prevention ( TOHP II ) is a multicenter , controlled clinical trial design ed to test whether weight loss , a reduced sodium intake , or a combination of weight loss and a reduced sodium intake will lower blood pressure ( BP ) and prevent the occurrence of hypertension . The study population consists of middle-aged , moderately overweight individuals with a diastolic BP between 83 and 89 mm Hg . Of the 2382 r and omized participants , 816 ( 34 % ) are female and 494 ( 21 % ) are from a racial or ethnic minority background . At baseline , mean dietary intakes of sodium , based on measurements of 24-hour urinary excretion , were 199 mmol/d in men and 154 mmol/d in women . The average body mass index was 30.9 kg/m2 . Across the four r and omized groups , there was no substantial imbalance in the distribution of baseline variables ; however , the mean age in the four groups was slightly but significantly different ( range : 43.2 to 44.2 years , P = 0.02 ) . A comparison of baseline characteristics of TOHP II participants with those of participants in three other primary prevention trials reveals a high level of mean dietary sodium intake in each study . Data reported in this article indicate that any subsequent differences in BP among the r and omized groups are unlikely to result from maldistribution of known confounding variables at baseline . Finally , because of the high prevalence of overweight and excessive sodium intake in the United States , results from TOHP II should be broadly applicable to the general population This article reports the results of a pilot study testing the effects of two stress management interventions on blood pressure ( BP ) and stress-related variables in employed African American women . Thirty-three women with mean age 44.8 ± 7.6 years were r and omly assigned to a cognitive mediation group ( n = 10 ) , a relaxation group ( n = 12 ) , or a delayed treatment control group ( n = 11 ) . The participants in the two stress management groups participated in a 10-week intervention ; the delayed treatment control group received BP monitoring during the 10-week period . Measures included BP , the State-Trait Anger Expression Inventory , Personal Strain , and Coping Re sources . Although no significant Group × Time effects were found in BP , anger , or personal strain , several of the outcome measures appear to be sensitive and showed cell means in the hypothesized direction . Further study of the effects of stress management interventions on BP and stress , with a larger sample , is warranted OBJECTIVE To test the short-term feasibility and efficacy of seven nonpharmacologic interventions in persons with high normal diastolic blood pressure . DESIGN R and omized control multicenter trials . SETTING Volunteers recruited from the community , treated and followed up at special clinics . PARTICIPANTS Of 16,821 screenees , 2182 men and women , aged 30 through 54 years , with diastolic blood pressure from 80 through 89 mm Hg were selected . Of these , 50 did not return for follow-up blood pressure measurements . INTERVENTIONS Three life-style change groups ( weight reduction , sodium reduction , and stress management ) were each compared with unmasked nonintervention controls over 18 months . Four nutritional supplement groups ( calcium , magnesium , potassium , and fish oil ) were each compared singly , in double-blind fashion , with placebo controls over 6 months . MAIN OUTCOME MEASURES Primary : change in diastolic blood pressure from baseline to final follow-up , measured by blinded observers . Secondary : changes in systolic blood pressure and intervention compliance measures . RESULTS Weight reduction intervention produced weight loss of 3.9 kg ( P less than .01 ) , diastolic blood pressure change of -2.3 mm Hg ( P less than .01 ) , and systolic blood pressure change of -2.9 mm Hg ( P less than .01 ) . Sodium reduction interventions lowered urinary sodium excretion by 44 mmol/24 h ( P less than .01 ) , diastolic blood pressure by 0.9 mm Hg ( P less than .05 ) , and systolic blood pressure by 1.7 mm Hg ( P less than .01 ) . Despite good compliance , neither stress management nor nutritional supplements reduced diastolic blood pressure or systolic blood pressure significantly ( P greater than .05 ) . CONCLUSIONS Weight reduction is the most effective of the strategies tested for reducing blood pressure in normotensive persons . Sodium reduction is also effective . The long-term effects of weight reduction and sodium reduction , alone and in combination , require further evaluation & NA ; This study tested the efficacy of relaxation therapy as sole treatment for mild hypertension in 110 men and women recruited from a five‐stage worksite blood pressure screening program . Participants were r and omized to 12‐weeks of relaxation therapy or support therapy . Outcome blood pressure assessment s made by assessors who were unaware of group allocation revealed similar decreases in both treatment groups at post‐treatment and 6‐month follow‐up . While body weight did not change , alcohol consumption decreased similarly in both groups , and alcohol consumption was positively correlated with both absolute diastolic blood pressure and change in diastolic blood pressure at outcome . In conclusion , a superior blood pressure effect was not associated with relaxation therapy ; however , alcohol consumption decreased in both treatment groups , suggesting that both interventions facilitated changes in health risk behaviors and indirectly on blood pressure level The purpose of this investigation was to determine the effectiveness of a stress management program ( SMP ) . The research question was : What effect does a SMP have on the stress response of full time graduate nursing students ? A secondary purpose was to determine personal and professional stressors experienced by graduate nursing students and their coping strategies . The SMP consisted of eight weekly one-hour sessions of demonstration and practice of the relaxation response , imagery , and diaphragmatic breathing . Caffeine intake was also reduced . The subjects were 30 female graduate nursing students between the ages of 25 - 43 . They were r and omly assigned to an experimental and a control group . Data collection consisted of weekly Palmar Sweat Prints ( PSP ) , blood pressure measurements , and a Weekly Self-Report ( WSR ) , design ed to monitor adherence to the SMP by the experimental group and perceived stress and coping strategies of both groups . The A-State Anxiety Question naire and Rahe 's Recent Life Changes Question naire ( RRLQ ) utilized a pre-/post-test design . Three of the four indicators demonstrated no significant differences in the stress response . The PSP indicated a significant difference ( .05 ) . RRLQ suggested no significant differences in the lives of the subjects of both groups . The WSR showed significantly more professionally generated stressors than personally generated stressors . The control group reported significantly less strategies for coping with stress than the experimental group . Although the SMP was not practice d as suggested , its presence in one 's cognitive repertoire significantly affects stress response and coping . Implication s of this study are numerous . ( ABSTRACT TRUNCATED AT 250 WORDS Abstract The study was conducted to assess the efficacy of Anxiety Management Training as an adjunctive treatment for essential hypertension . Twenty-one patients with essential hypertension , all but one of whom were on antihypertension medication , were r and omly assigned either to an Anxiety Management Training condition or a waiting-list control condition . At the time of a posttest assessment session , compared to subjects in the control condition , subjects in the Anxiety Management Training condition manifested a decrease in resting systolic and diastolic blood pressure and a decrease in systolic and diastolic blood pressure following a stressful task . At the time of a follow-up assessment session , subjects in the Anxiety Management Training condition not only manifested good maintenance of reduced blood pressure but also exhibited a further decrease in resting systolic blood pressure and a decrease in systolic blood pressure during the stressful task Abstract A wakeful hypometabolic state may be induced by simple , non-cultic mental techniques or by traditional meditational practice s. The hypometabolic state seems to represent an integrated hypothalamic response ( " relaxation response " ) which is consistent with a state of decreased sympathetic-nervous-system activity . A prospect i ve investigation was design ed to test whether regular elicitation of the relaxation response might lower blood-pressures in hypertensive patients who were maintained on constant antihypertensive therapy . Fourteen people were investigated . During the control period of 5.6 weeks , blood-pressures did not change significantly from day to day and averaged 145.6 mm . Hg systolic and 91.9 mm . Hg diastolic . During the experimental period of 20 weeks , systolic blood-pressures decreased to 135.0 mm . Hg ( |
358 | 25,979,567 | There was little investigation into the predictors of adherence , with symptom relief or induction being the primary goal of most of the studies .
This review indicates that predictors of dietary adherence are rarely considered in research regarding functional bowel disorders . | Functional bowel disorders such as irritable bowel syndrome are commonly experienced within the population , and have an adverse impact on emotions , physical well-being , social activity , and occupational output .
Adherence to a restricted diet can reduce symptoms , which in turn leads to increased quality of life and well-being .
The aim of this review was to assess the extent to which predictors of dietary adherence have been considered in studies relating to functional bowel disorders and following a restricted diet .
This was done firstly by examining such studies which contained a measure or indicator of adherence , and then by examining predictors of adherence within and between studies . | Background : Patients with irritable bowel syndrome ( IBS ) often feel they have some form of dietary intolerance and frequently try exclusion diets . Tests attempting to predict food sensitivity in IBS have been disappointing but none has utilised IgG antibodies . Aims : To assess the therapeutic potential of dietary elimination based on the presence of IgG antibodies to food . Patients : A total of 150 out patients with IBS were r and omised to receive , for three months , either a diet excluding all foods to which they had raised IgG antibodies ( enzyme linked immunosorbant assay test ) or a sham diet excluding the same number of foods but not those to which they had antibodies . Methods : Primary outcome measures were change in IBS symptom severity and global rating scores . Non-colonic symptomatology , quality of life , and anxiety/depression were secondary outcomes . Intention to treat analysis was undertaken using a generalised linear model . Results : After 12 weeks , the true diet result ed in a 10 % greater reduction in symptom score than the sham diet ( mean difference 39 ( 95 % confidence intervals ( CI ) 5–72 ) ; p = 0.024 ) with this value increasing to 26 % in fully compliant patients ( difference 98 ( 95 % CI 52–144 ) ; p<0.001 ) . Global rating also significantly improved in the true diet group as a whole ( p = 0.048 , NNT = 9 ) and even more in compliant patients ( p = 0.006 , NNT = 2.5 ) . All other outcomes showed trends favouring the true diet . Relaxing the diet led to a 24 % greater deterioration in symptoms in those on the true diet ( difference 52 ( 95 % CI 18–88 ) ; p = 0.003 ) . Conclusion : Food elimination based on IgG antibodies may be effective in reducing IBS symptoms and is worthy of further biomedical research BACKGROUND The cause of irritable bowel syndrome ( IBS ) is unknown . It may follow gastroenteritis and be associated with an abnormal gut flora and with food intolerance . Our study was design ed to assess whether these factors were associated with colonic malfermentation . METHODS We carried out a crossover controlled trial of a st and ard diet and an exclusion diet matched for macronutrients in six female IBS patients and six female controls . During the final 72 h on each diet , faecal excretion of fat , nitrogen , starch , and non-starch polysaccharide NSP was measured , and total excretion of hydrogen and methane collected over 24 h in a purpose -built 1.4 m3 whole-body calorimeter . Breath hydrogen and methane excretion were then measured for 3 h after 20 g oral lactulose . FINDINGS The maximum rate of gas excretion was significantly greater in patients than in controls ( 2.4 mL/min IQR 1.7 - 2.6 vs 0.6 , 0.4 - 1.1 ) . Although total gas production in patients was not greater than in controls ( median 527 mL/24 h IQR 387 - 660 vs 412 , 234 - 507 ) , hydrogen production was higher ( 332 , 318 - 478 vs 162 , 126 - 217 , p=0.009 ) . In patients , the exclusion diet reduced symptoms and produced a fall in maximum gas excretion ( 0.5 mL/min IQR 0.3 - 0.7 ) . After lactulose , breath hydrogen was greater on the st and ard than on the exclusion diet . INTERPRETATION Colonic-gas production , particularly of hydrogen , is greater in patients with IBS than in controls , and both symptoms and gas production are reduced by an exclusion diet . This reduction may be associated with alterations in the activity of hydrogen-consuming bacteria . Fermentation may be an important factor in the pathogenesis of IBS BACKGROUND & AIMS Celiac disease is an increasingly prevalent disorder . To monitor response to treatment in clinical and research setting s , it is essential to accurately measure gluten-free diet ( GFD ) adherence in a st and ardized manner . The aim of this study was to develop a valid and reliable Celiac Dietary Adherence Test ( CDAT ) . METHODS Items and domains believed to be essential for successful GFD adherence were used to develop an 85-item survey with input from patient focus groups . The survey was administered to 200 individuals with biopsy-proven celiac disease who underwent st and ardized dietician evaluation ( SDE ) and serologic testing . RESULTS Of the initial 85 items , 41 were correlated highly with the SDE ( P < .01 ) . Responses for all 200 participants for the 41 items were entered into a single data base . Computer-generated r and omization produced a derivation cohort of 120 subjects and a validation cohort of 80 . By using the derivation cohort , a 7-item question naire was developed using logistic regression . The additive score based on these items was correlated highly with the SDE in both the derivation and validation cohorts ( P < .001 ) and performed significantly better than immunoglobulin A tissue transglutaminase titers in receiver operating characteristic curve analysis with areas under the curve of 0.830 and 0.652 , respectively . CONCLUSIONS The CDAT is a clinical ly relevant , easily administered , 7-item instrument that allows for st and ardized evaluation of GFD adherence and is superior to tissue transglutaminase serology . The CDAT may be useful in both research and clinical setting We reported previously that consumption of one cup of milk ( 240 mL ) per day produced negligible symptoms in lactase-nonpersistent ( LNP ) individuals self-described as being severely lactose intolerant . We hypothesized that such LNP individuals could also tolerate two cups of milk per day if taken in two widely divided doses with food , and that psychologic factors play a role in perceptions of lactose intolerance . The Minnesota Multiphasic Personality Inventory 2 ( MMPI-2 ) was administered to 19 LNP subjects self-described as markedly lactose intolerant ( S-LNP ) , 13 LNP subjects who denied lactose intolerance ( A-LNP ) , and 10 lactase-persistent individuals who believed they were lactose intolerant ( S-LP ) . Symptoms were recorded when LNP subjects ingested 240 mL regular or lactose-hydrolyzed milk twice daily for 7 d in a double-blind crossover study . The results showed that neither LNP group had a significant increase in symptoms ( P < 0.05 ) during the regular compared with the lactose-hydrolyzed milk periods . However , S-LNP subjects reported significantly greater gaseous symptoms than did the A-LNP subjects during both treatment periods . The MMPI-2 showed a high score on the " lie " validity scale for S-LNP subjects . We conclude that LNP subjects tolerate two cups of milk per day without appreciable symptoms . S-LNP subjects have underlying flatulence that is misattributed to lactose intolerance . MMPI-2 results were of question able validity because of the high rate of dissimulation by LNP subjects OBJECTIVE The aim of this r and omized pilot study was to examine whether the addition of motivational interviewing strategies to a behavioral obesity intervention enhances adherence and glucose control in older obese women with NIDDM . RESEARCH DESIGN AND METHODS Twenty-two older obese women ( 41 % black ) with NIDDM were r and omly assigned to 1 ) a st and ard 16-week group behavioral weight-control program that provided instruction in diet , exercise , and behavioral modification or 2 ) the same group behavioral program with three individualized motivational interviewing sessions added . RESULTS The motivational group attended significantly more group meetings ( 13.3 vs. 8.9 ) , completed significantly more food diaries ( 15.2 vs. 10.1 ) , and recorded blood glucose significantly more often ( 46.0 vs. 32.2 days ) than the st and ard group . Further , participants in the motivational group had significantly better glucose control post-treatment ( 9.8 vs. 10.8 % ) . Although both groups demonstrated significant weight loss , no differences were apparent between groups . CONCLUSIONS These results suggest that augmenting a st and ard behavioral treatment program for obese women with NIDDM with a motivational interviewing component may significantly enhance adherence to program recommendations and glycemic control . Preliminary data warrant further investigation with larger sample s and a longer follow-up Twenty-six patients with irritable bowel syndrome entered a controlled trial of diets with a high or low wheat-fibre content . After 6 weeks on the high-wheat fibre regimen there was significant improvement in symptoms and an objective change in colonic motor activity . No such improvement occurred on the low-fibre regimen . Patients with irritable bowel syndrome should be encouraged to increase their daily intake of wheat fibre BACKGROUND & AIMS A diet low in fermentable oligosaccharides , disaccharides , monosaccharides , and polyols ( FODMAPs ) often is used to manage functional gastrointestinal symptoms in patients with irritable bowel syndrome ( IBS ) , yet there is limited evidence of its efficacy , compared with a normal Western diet . We investigated the effects of a diet low in FODMAPs compared with an Australian diet , in a r and omized , controlled , single-blind , cross-over trial of patients with IBS . METHODS In a study of 30 patients with IBS and 8 healthy individuals ( controls , matched for demographics and diet ) , we collected dietary data from subjects for 1 habitual week . Participants then r and omly were assigned to groups that received 21 days of either a diet low in FODMAPs or a typical Australian diet , followed by a washout period of at least 21 days , before crossing over to the alternate diet . Daily symptoms were rated using a 0- to 100-mm visual analogue scale . Almost all food was provided during the interventional diet periods , with a goal of less than 0.5 g intake of FODMAPs per meal for the low-FODMAP diet . All stools were collected from days 17 - 21 and assessed for frequency , weight , water content , and King 's Stool Chart rating . RESULTS Subjects with IBS had lower overall gastrointestinal symptom scores ( 22.8 ; 95 % confidence interval , 16.7 - 28.8 mm ) while on a diet low in FODMAPs , compared with the Australian diet ( 44.9 ; 95 % confidence interval , 36.6 - 53.1 mm ; P < .001 ) and the subjects ' habitual diet . Bloating , pain , and passage of wind also were reduced while IBS patients were on the low-FODMAP diet . Symptoms were minimal and unaltered by either diet among controls . Patients of all IBS subtypes had greater satisfaction with stool consistency while on the low-FODMAP diet , but diarrhea-predominant IBS was the only subtype with altered fecal frequency and King 's Stool Chart scores . CONCLUSIONS In a controlled , cross-over study of patients with IBS , a diet low in FODMAPs effectively reduced functional gastrointestinal symptoms . This high- quality evidence supports its use as a first-line therapy . CLINICAL TRIAL NUMBER ACTRN12612001185853 BACKGROUND & AIMS Observational studies suggest dietary fructose restriction might lead to sustained symptomatic response in patients with irritable bowel syndrome ( IBS ) and fructose malabsorption . The aims of this study were first to determine whether the efficacy of this dietary change is due to dietary fructose restriction and second to define whether symptom relief was specific to free fructose or to poorly absorbed short-chain carbohydrates in general . METHODS The double-blinded , r and omized , quadruple arm , placebo-controlled rechallenge trial took place in the general community . The 25 patients who had responded to dietary change were provided all food , low in free fructose and fructans , for the duration of the study . Patients were r and omly challenged by grade d dose introduction of fructose , fructans , alone or in combination , or glucose taken as drinks with meals for maximum test period of 2 weeks , with at least 10-day washout period between . For the main outcome measures , symptoms were monitored by daily diary entries and responses to a global symptom question . RESULTS Seventy percent of patients receiving fructose , 77 % receiving fructans , and 79 % receiving a mixture reported symptoms were not adequately controlled , compared with 14 % receiving glucose ( P < or = 0.002 , McNemar test ) . Similarly , the severity of overall and individual symptoms was significantly and markedly less for glucose than other substances . Symptoms were induced in a dose-dependent manner and mimicked previous IBS symptoms . CONCLUSIONS In patients with IBS and fructose malabsorption , dietary restriction of fructose and /or fructans is likely to be responsible for symptomatic improvement , suggesting efficacy is due to restriction of poorly absorbed short-chain carbohydrates in general BACKGROUND & AIMS Depression has a complex association with cardiometabolic risk , both directly as an independent factor and indirectly through mediating effects on other risk factors such as BMI , diet , physical activity , and smoking . Since changes to many cardiometabolic risk factors involve behaviour change , the rise in depression prevalence as a major global health issue may present further challenges to long-term behaviour change to reduce such risk . This study investigated associations between depression scores and participation in a community-based weight management intervention trial . METHODS A group of 64 overweight ( BMI > 27 ) , otherwise healthy adults , were recruited and r and omised to follow either their usual diet , or an isocaloric diet in which saturated fat was replaced with monounsaturated fat ( MUFA ) , to a target of 50 % total fat , by adding macadamia nuts to the diet . Subjects were assessed for depressive symptoms at baseline and at ten weeks using the Beck Depression Inventory ( BDI-II ) . Both control and intervention groups received advice on National Guidelines for Physical Activity and adhered to the same protocol for food diary completion and trial consultations . Anthropometric and clinical measurements ( cholesterol , inflammatory mediators ) also were taken at baseline and 10 weeks . RESULTS During the recruitment phase , pre-existing diagnosed major depression was one of a range of reasons for initial exclusion of volunteers from the trial . Amongst enrolled participants , there was a significant correlation ( R = -0.38 , p < 0.05 ) between BDI-II scores at baseline and duration of participation in the trial . Subjects with a baseline BDI ≥10 ( moderate to severe depression symptoms ) were more likely to dropout of the trial before week 10 ( p < 0.001 ) . BDI-II scores in the intervention ( MUFA ) diet group decreased , but increased in the control group over the 10-week period . Univariate analysis of variance confirmed these observations ( adjusted R(2 ) = 0.257 , p = 0.01 ) . Body weight remained static over the 10-week period in the intervention group , corresponding to a relative increase in the control group ( adjusted R(2 ) = 0.097 , p = 0.064 ) . CONCLUSIONS Depression symptoms have the potential to affect enrolment in and adherence to dietbased risk reduction interventions , and may consequently influence the generalisability of such trials . Depression scores may therefore be useful for characterising , screening and allocating subjects to appropriate treatment pathways Lactose malabsorption may induce abdominal symptoms indistinguishable from those of the irritable bowel syndrome ( IBS ) , however the exact relationship between the two conditions and the optimal differential diagnostic workup are still to be defined . We prospect ively studied the prevalence of lactose malabsorption ( by means of a hydrogen breath test ) and the clinical effect of a long-term lactose-free diet in 230 consecutive patients with a suggested diagnosis of irritable bowel syndrome , no organic disease of the GI tract , and no history of milk intolerance . Lactose malabsorption was diagnosed in 157 patients ( 68.2 % ) . In 48 ( 43.6 % ) of the 110 patients who complied with the diet symptoms subsided , in 43 they were somewhat reduced and in 17 they remained unchanged . Symptoms never fully subsided in lactose malabsorbers non-compliant with the diet or in normal lactose absorbers who adhered to a lactose-free regimen . Partial improvement was observed in 20 % of these subjects . No relation was demonstrated between pre-trial symptoms and the outcome of the diet . The occurrence of symptoms during the lactose breath test strongly suggested a favorable response to diet , but did not help in predicting whether symptoms would subside or be reduced . Conversely , their absence during the test was not associated with an acceptable negative predictive value . The high prevalence of lactose malabsorption in the patients under study suggests that in Italy IBS and lactose malabsorption are frequently associated . A test for diagnosing lactose malabsorption should always be included in the diagnostic workup for IBS and a long-term lactose-free regimen recommended if the test is positive BACKGROUND Ingestion of a large dose of the milk sugar lactose -- for example , the 50-g load in 1 liter of milk -- causes symptoms such as abdominal pain , diarrhea , bloating , and flatulence in the majority of people with lactose malabsorption . It is uncertain whether the ingestion of more common doses of lactose , such as the amount in 240 ml ( 8 oz ) of milk , causes symptoms . Some people insist that even smaller quantities of milk , such as the amount used with cereal or coffee , cause severe gastrointestinal distress . METHODS In a r and omized , double-blind , crossover trial , we evaluated gastrointestinal symptoms in 30 people ( mean age , 29.4 years ; range , 18 to 50 ) who reported severe lactose intolerance and said they consistently had symptoms after ingesting less than 240 ml of milk . The ability to digest lactose was assessed by measuring the subjects ' end-alveolar hydrogen concentration after they ingested 15 g of lactose in 250 ml of water . Subjects then received either 240 ml of lactose-hydrolyzed milk containing 2 percent fat or 240 ml of milk containing 2 percent fat and sweetened with aspartame to approximate the taste of lactose-hydrolyzed milk ; each type of milk was administered daily with breakfast for a one-week period . Using a st and ardized scale , subjects rated the occurrence and severity of bloating , abdominal pain , diarrhea , and flatus and recorded each passage of flatus . RESULTS Twenty-one participants were classified as having lactose malabsorption and nine as being able to absorb lactose . During the study periods , gastrointestinal symptoms were minimal ( mean symptom-severity scores for bloating , abdominal pain , diarrhea , and flatus between 0.1 and 1.2 [ 1 indicated trivial symptoms ; and 2 , mild symptoms ] ) . When the periods were compared , there were no statistically significant differences in the severity of these four gastrointestinal symptoms . For the lactose-malabsorption group , the mean ( + /- SEM ) difference in episodes of flatus per day was 2.5 + /- 1.1 ( 95 percent confidence interval , 0.2 to 4.8 ) . Daily dietary records indicated a high degree of compliance , with no additional sources of lactose reported . CONCLUSIONS People who identify themselves as severely lactose-intolerant may mistakenly attribute a variety of abdominal symptoms to lactose intolerance . When lactose intake is limited to the equivalent of 240 ml of milk or less a day , symptoms are likely to be negligible and the use of lactose-digestive aids unnecessary BACKGROUND The widespread of serologic diagnosis for celiac disease has brought about an epidemiologic shift . Little up-to- date information is available on relevant epidemiologic issues regarding diagnosis , information , and therapy . OBJECTIVE To examine forms of presentation , diagnostic difficulties , follow-up , information sources , and treatment-related issues regarding celiac disease . METHOD A cross-sectional observational study using a self-completed question naire . RESULTS Seventy-three adult patients were included ; 15.0 % of cases were diagnosed over 60 years of age . Most were non-smokers ( 91.8 % ) . The rate of first-degree relatives with celiac sprue was 10.9 % . The disease had a classic presentation in only 54.7 % of cases . A functional gastrointestinal disorder was initially suspected in 42.4 % of patients . Diet adherence is adequate , with unintentional lack of compliance in 15.5 % of patients . Diet results in absent or improved symptoms in virtually all patients , but most of them consider compliance a challenge . Forty percent had difficulty finding gluten-free food , and 50.8 % had problems in labelling recognition . CONCLUSIONS Celiac disease presents at any age , has a great variety of manifestations , and responds very well to gluten-free diet . It is crucial that patients be highly motivated and informed , and that they know for certain which foods and manufactured products are to be to used . Therefore , adequate control will result from coordination and cooperation regarding all re sources involved , including medical care , and information provided by associations and other sources such as the Web BACKGROUND AND AIMS : Causes of chronic watery diarrhea are multiple . There is not definite scientific evidence about which are the recommended explorations to be performed in the diagnostic workup of patients with functional diarrhea . The aim was to assess prospect ively the presence of gluten-sensitive enteropathy , bile acid malabsorption , and sugar malabsorption in consecutive patients with chronic watery diarrhea of obscure origin fulfilling Rome II criteria of functional disease . METHODS : A total of 62 patients with chronic watery diarrhea , defined as more than 3 loose or liquid bowel movements a day for at least 4 wk and a stool weight > 200 g/day were included . The following tests were performed : ( a ) HLA-DQ2/DQ8 genotyping , and if positive , endoscopic biopsies from distal duodenum were obtained , and intestinal damage assessed ; ( b ) SeHCAT ( Se-homotaurocholate ) abdominal retention test ; ( c ) small bowel follow-through ; and ( d ) hydrogen breath test ( lactose , fructose + sorbitol ) . Gluten- or sugar-free diet , or cholestyramine was administered according to results . Functional disease was diagnosed if all tests performed were normal or if either there was no response to specific therapy or diarrhea relapsed during a 12-month follow-up . RESULTS : Bile acid malabsorption was considered to be the cause of diarrhea in 28 ( 45.2 % ) patients , sugar malabsorption in 10 ( 16.1 % ) , gluten-sensitive enteropathy in 10 ( 16.1 % ) , and both bile acid and sugar malabsorption in 2 patients . Twelve ( 19.4 % ) patients remained without a specific diagnosis and were considered as functional bowel disease . Diarrhea stopped in the 50 patients after specific treatment , decreasing the daily stool number from 5.4 ± 0.3 to 1.5 ± 0.1 ( P < 0.0005 ) , without relapse after the 12-months follow-up . CONCLUSIONS : The diagnosis of functional disease in patients with chronic watery diarrhea should be performed with caution since in most cases there is an organic cause that justifies diarrhea Food hypersensitivity as a cause of abdominal symptoms was investigated by means of exclusion diets and double-blind food provocation in patients with irritable bowel syndrome . Twenty-seven patients entered the study ; nineteen complied with dietary manipulation . Food hypersensitivity as a cause of their presenting symptoms was confirmed by double-blind food provocation in only three patients , who also had evidence of associated atopic disease and positive skin tests to common inhalant allergens . Evidence of minor psychiatric disorder was found in twelve of fourteen patients examined by an independent psychiatrist BACKGROUND & AIMS Patients with non-celiac gluten sensitivity ( NCGS ) do not have celiac disease but their symptoms improve when they are placed on gluten-free diets . We investigated the specific effects of gluten after dietary reduction of fermentable , poorly absorbed , short-chain carbohydrates ( fermentable , oligo- , di- , monosaccharides , and polyols [ FODMAPs ] ) in subjects believed to have NCGS . METHODS We performed a double-blind cross-over trial of 37 subjects ( aged 24 - 61 y , 6 men ) with NCGS and irritable bowel syndrome ( based on Rome III criteria ) , but not celiac disease . Participants were r and omly assigned to groups given a 2-week diet of reduced FODMAPs , and were then placed on high-gluten ( 16 g gluten/d ) , low-gluten ( 2 g gluten/d and 14 g whey protein/d ) , or control ( 16 g whey protein/d ) diets for 1 week , followed by a washout period of at least 2 weeks . We assessed serum and fecal markers of intestinal inflammation/injury and immune activation , and indices of fatigue . Twenty-two participants then crossed over to groups given gluten ( 16 g/d ) , whey ( 16 g/d ) , or control ( no additional protein ) diets for 3 days . Symptoms were evaluated by visual analogue scales . RESULTS In all participants , gastrointestinal symptoms consistently and significantly improved during reduced FODMAP intake , but significantly worsened to a similar degree when their diets included gluten or whey protein . Gluten-specific effects were observed in only 8 % of participants . There were no diet-specific changes in any biomarker . During the 3-day rechallenge , participants ' symptoms increased by similar levels among groups . Gluten-specific gastrointestinal effects were not reproduced . An order effect was observed . CONCLUSIONS In a placebo-controlled , cross-over rechallenge study , we found no evidence of specific or dose-dependent effects of gluten in patients with NCGS placed diets low in FODMAPs BACKGROUND In a significant number of patients affected by the irritable bowel syndrome , an adverse reaction to food is proposed to be a causative factor . A diet that eliminates the offending foods is the obvious treatment for such adverse reactions . Compliance with a dietetic regimen is often poor and sometimes not completely free from risks . METHODS Since the diarrheic type of irritable bowel syndrome seems mainly affected by food intolerance , and previous observations suggested that oral cromolyn sodium is effective in such patients , a multicenter therapeutic trial in the diarrheic type of irritable bowel syndrome was carried out in 346 of 409 patients with this disease , to evaluate the effects of oral cromolyn sodium and compare its efficacy with that of an elimination diet . RESULTS Symptoms related to the irritable bowel syndrome improved in 60 % of patients treated with elimination diet and in 67 % of those treated with oral cromolyn sodium ( 1500 mg/day ) for 1 month . Moreover , in both groups clinical results were significantly better in the patients positive to the skin prick test than in the negative ones . CONCLUSIONS These results confirm the high prevalence of adverse reactions to foods in diarrheic irritable bowel syndrome and the usefulness of cromolyn sodium treatment in these patients OBJECTIVE To identify characteristics of hemodialysis patients most likely to experience difficulty adhering to sodium restrictions associated with their dietary regimen . DESIGN Secondary analysis using baseline data from an ongoing r and omized clinical trial examining the effects of a technology-supported behavioral intervention on dietary sodium intake in hemodialysis patients . SETTING Thirteen dialysis centers in southwestern Pennsylvania . SUBJECTS We included 122 participants ( 61 % women ; 48 % African American ) aged 61 ± 14 years undergoing maintenance , intermittent hemodialysis for end-stage renal disease . MAIN OUTCOME MEASURES Normalized dietary sodium intake , adjusted interdialytic weight gain , perceived problems , and self-efficacy for restricting dietary sodium . RESULTS Younger participants were more likely to report problems managing their hemodialysis diet and low self-efficacy for restricting sodium intake . Consistent with these findings , younger participants had a higher median sodium intake and higher average adjusted interdialytic weight gain . Females reported more problems managing their diet . Race , time on dialysis , and perceived income adequacy did not seem to influence outcome measures . CONCLUSION Our findings suggest that patients who are younger and female encounter more difficulty adhering to the hemodialysis regimen . Hence , there may be a need to individualize counseling and interventions for these individuals . Further investigation is needed to underst and the independent effects of age and gender on adherence to hemodialysis dietary recommendations and perceived self-efficacy BACKGROUND & AIMS Patients with diarrhea-predominant irritable bowel syndrome ( IBS-D ) anecdotally report symptom improvement after initiating a very low-carbohydrate diet ( VLCD ) . This study prospect ively evaluated a VLCD in IBS-D. METHODS Participants with moderate to severe IBS-D were provided a 2-week st and ard diet , then 4 weeks of a VLCD ( 20 g carbohydrates/d ) . A responder was defined as having adequate relief of gastrointestinal symptoms for 2 or more weeks during the VLCD . Changes in abdominal pain , stool habits , and quality of life also were measured . RESULTS Of the 17 participants enrolled , 13 completed the study and all met the responder definition , with 10 ( 77 % ) reporting adequate relief for all 4 VLCD weeks . Stool frequency decreased ( 2.6 + /- 0.8/d to 1.4 + /- 0.6/d ; P < .001 ) . Stool consistency improved from diarrheal to normal form ( Bristol Stool Score , 5.3 + /- 0.7 to 3.8 + /- 1.2 ; P < .001 ) . Pain scores and quality -of-life measures significantly improved . Outcomes were independent of weight loss . CONCLUSIONS A VLCD provides adequate relief , and improves abdominal pain , stool habits , and quality of life in BACKGROUND AND AIM Current treatment for irritable bowel syndrome ( IBS ) is suboptimal . Fermentable oligo- , di- , mono-saccharides and polyols ( FODMAPs ) may trigger gastrointestinal symptoms in IBS patients . Our aim was to determine whether a low FODMAP diet improves symptoms in IBS patients . METHODS Irritable bowel syndrome patients , who had performed hydrogen/methane breath testing for fructose and lactose malabsorption and had received dietary advice regarding the low FODMAP diet , were included . The effect of low FODMAP diet was prospect ively evaluated using a symptom question naire . Furthermore , questions about adherence and satisfaction with symptom improvement , dietary advice and diet were assessed . RESULTS Ninety patients with a mean follow up of 15.7 months were studied . Most symptoms including abdominal pain , bloating , flatulence and diarrhoea significantly improved ( p < 0.001 for all ) . 75.6 % , 37.8 % and 13.3 % of patients had fructose , lactose malabsorption or small intestinal bacterial overgrowth respectively . Fructose malabsorption was significantly associated with symptom improvement ( abdominal pain odds ratio ( OR ) 7.09 [ 95 % confidence interval ( CI ) 2.01 - 25.0 ] , bloating OR 8.71 ( 95 % CI 2.76 - 27.5 ) , flatulence OR 7.64 ( 95 % CI 2.53 - 23.0 ) and diarrhoea OR 3.39 ( 95 % CI 1.17 - 9.78 ) , p < 0.029 for all ) . Most patients ( 75.6 % ) were adherent to the diet , which was associated with symptom improvement ( abdominal pain , bloating , flatulence and diarrhoea all significantly associated with adherence , r > 0.27 , p < 0.011 ) . Most patients ( 72.1 % ) were satisfied with their symptoms . CONCLUSIONS The low FODMAP diet shows efficacy for IBS patients . The current strategy of breath testing and dietary advice provides a good basis to underst and and adhere to the diet |
359 | 28,450,123 | Comprehensive and intensive behavioral interventions can result in clinical ly significant , albeit modest , weight loss in this obese sub population but may not result significant improvements in other cardiometabolic risk factors . | Moderate and severe obesity ( BMI ≥35 kg/m2 ) affect 15 % of US adults , with a projected increase over the next two decades .
This study review s evidence of behavioral lifestyle interventions for weight loss in this population . | BACKGROUND The effects of a carbohydrate-restricted diet on weight loss and risk factors for atherosclerosis have been incompletely assessed . METHODS We r and omly assigned 132 severely obese subjects ( including 77 blacks and 23 women ) with a mean body-mass index of 43 and a high prevalence of diabetes ( 39 percent ) or the metabolic syndrome ( 43 percent ) to a carbohydrate-restricted ( low-carbohydrate ) diet or a calorie- and fat-restricted ( low-fat ) diet . RESULTS Seventy-nine subjects completed the six-month study . An analysis including all subjects , with the last observation carried forward for those who dropped out , showed that subjects on the low-carbohydrate diet lost more weight than those on the low-fat diet ( mean [ + /-SD ] , -5.8+/-8.6 kg vs. -1.9+/-4.2 kg ; P=0.002 ) and had greater decreases in triglyceride levels ( mean , -20+/-43 percent vs. -4+/-31 percent ; P=0.001 ) , irrespective of the use or nonuse of hypoglycemic or lipid-lowering medications . Insulin sensitivity , measured only in subjects without diabetes , also improved more among subjects on the low-carbohydrate diet ( 6+/-9 percent vs. -3+/-8 percent , P=0.01 ) . The amount of weight lost ( P<0.001 ) and assignment to the low-carbohydrate diet ( P=0.01 ) were independent predictors of improvement in triglyceride levels and insulin sensitivity . CONCLUSIONS Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie- and fat-restricted diet , with a relative improvement in insulin sensitivity and triglyceride levels , even after adjustment for the amount of weight lost . This finding should be interpreted with caution , given the small magnitude of overall and between-group differences in weight loss in these markedly obese subjects and the short duration of the study . Future studies evaluating long-term cardiovascular outcomes are needed before a carbohydrate-restricted diet can be endorsed Context In 2003 , the authors reported that severely obese adults lost more weight and had better serum lipid patterns after 6 months of a low-carbohydrate diet rather than a conventional low-fat diet . Contribution After 1 year , these same patients still had more favorable triglyceride and high-density lipoprotein cholesterol levels on the low-carbohydrate diet than on the conventional diet . However , weight loss and the other metabolic parameters were similar in the 2 diet groups . Caution s The effect of the modest improvements in high-density lipoprotein cholesterol and triglyceride levels on the development of diabetes and cardiovascular disease is unknown . The Editors The prevalence of obesity and its associated metabolic abnormalities has increased markedly over the past 2 decades ( 1 , 2 ) . Although guidelines to follow a highcomplex carbohydrate , low-fat , energy-deficient diet to achieve weight loss are generally accepted ( 3 ) , considerable public interest has focused on low-carbohydrate diets ( 4 ) . We recently reported that persons with severe obesity lost more weight and had greater improvements in triglyceride levels , insulin sensitivity , and glycemic control after 6 months of a low-carbohydrate diet as compared with a conventional weight loss diet based on calorie and fat restriction ( 5 ) . However , these findings were preliminary because of the short duration of that study ( 6 ) . A simultaneously published study by Foster and colleagues suggested that persons on a low-carbohydrate diet tended to regain weight by 1 year ( 7 ) . These findings were limited , however , because few participants completed the study and because the study used a self-help approach , which is less effective than direct counseling for maintaining weight loss ( 8) . Foster and colleagues also excluded persons with diabetes , which is highly prevalent in the obese population . During the development of this study , we decided to analyze and report preliminary results at 6 months and final results at 1 year . We thought that the short-term results would be important , given the high-risk nature of our study sample , but that long-term outcomes would provide more information about the sustainability of any diet-related outcomes . We now report our findings 1 year after r and omization to a low-carbohydrate diet versus a low-fat weight loss diet ( conventional diet ) in severely obese adults with a high prevalence of diabetes or the metabolic syndrome . Methods Study Participants The study design has been previously described ( 5 ) . Participants were recruited from the outpatient practice s of the Philadelphia Veterans Affairs Medical Center and included persons 18 years of age and older with a body mass index ( BMI ) of 35 kg/m2 or greater . The exclusion criteria were a serum creatinine level greater than 133 mol/L ( > 1.5 mg/dL ) , hepatic disease , severe life-limiting medical illness , inability to self-monitor glucose levels , or active use of a weight loss program or weight loss medication . Between May 2001 and November 2001 , 132 persons were r and omly assigned to either a low-carbohydrate diet ( n = 64 ) or a conventional diet ( n = 68 ) . The Institutional Review Committee at the Philadelphia Veterans Affairs Medical Center approved the study , and all participants provided written informed consent . Interventions Diet groups met in weekly counseling sessions for 4 weeks , followed by 11 monthly sessions . Participants on the low-carbohydrate diet were instructed only to reduce carbohydrate intake to less than 30 g per day . Participants on the conventional diet were instructed to reduce caloric intake by 500 calories per day , with less than 30 % of calories derived from fat , in accordance with the National Heart , Lung , and Blood Institute guidelines ( 3 ) . Outcome Measures We collected data , including weight ( single calibrated scale , SR Instruments , Inc. , Tonaw and a , New York ) , medical history ( self-reported ) , and blood pressure , at baseline , 6 months , and 1 year . Fasting blood specimens were obtained for glucose , hemoglobin A1c , and serum lipid levels ( Synchron LX20 , Beckman Coulter , Inc. , Fullerton , California ) . Low-density lipoprotein ( LDL ) cholesterol level was calculated by using the Friedewald formula ( 9 ) . We defined the presence of diabetes by a historical fasting blood glucose level greater than 6.94 mmol/L ( > 125 mg/dL ) or use of antidiabetic medications . The metabolic syndrome was considered present if a participant had 3 or more of the following ( 10 ) : central obesity , fasting blood glucose level of 6.11 mmol/L ( 110 mg/dL ) or greater , fasting triglyceride level of 1.70 mmol/L ( 150 mg/dL ) or greater , high-density lipoprotein ( HDL ) cholesterol level less than 1.04 mmol/L ( < 40 mg/dL ) for men or less than 1.30 mmol/L ( < 50 mg/dL ) for women , blood pressure of 130/85 mm Hg or greater , or antihypertensive therapy . We assumed that all participants had central obesity because of the uniform severity of their obesity ( BMI range , 35.0 to 79.4 kg/m2 ) . Serum insulin was measured by radioimmunoassay ( Laboratory Corporation of America Holdings [ LabCorp ] , Burlington , North Carolina ] ) . Insulin resistance in nondiabetic persons was estimated by the quantitative insulin sensitivity check ( QUICK ) index : 1/[(log ( fasting insulin ( U/mL ) ) + ( log fasting glucose(mg/dL ) ) ] . Statistical Analysis Our primary end point was total weight loss at 1 year . Secondary analyses included the change from baseline in serum lipid levels , insulin sensitivity , and glycemic control . We estimated that we would need 100 persons ( 50 per group ) , assuming a 2-sided type I error of 5 % , for the study to have 80 % power to detect a 5-kg greater mean weight loss in the low-carbohydrate group than in the conventional diet group . These calculations were based on an anticipated maximum weight loss by 6 months , with weight stabilization in both diet groups between 6 months and 1 year . To compensate for an anticipated dropout rate of 25 % , we set our enrollment target at 135 persons . R and omization was performed by using a pre-established algorithm generated from a r and om set of numbers that was constructed and held in a separate center and concealed from those enrolling persons during r and omization . We used stratified r and omization , with blocking within strata , to ensure assignment of approximately equal numbers of women , diabetic persons , and severely obese persons ( BMI 40 kg/m2 ) to each study group . Changes in weight , dietary intake , and metabolic data were compared between the 2 diets by r and om-coefficient analysis ( 11 ) . This type of analysis was selected to allow for a variable number of observations for participants and to take into account that the repeated observations of the outcome variables over time for individuals were correlated . The r and om-coefficient analysis model takes these correlations into account by allowing the intercept to vary r and omly among persons . We used a restricted maximum likelihood analysis , which assumed that changes were distributed according to a bivariate normal distribution and that data were missing at r and om . The outcome variables were changes from baseline in weight , dietary macronutrient consumption , and metabolic measurements . For all of these analyses , the covariates included an indicator variable for time ( 6 months and 1 year ) , diet group , and a diet group by time interaction term . This diet group by time interaction term was kept in the model , regardless of its statistical significance ( P = 0.063 for the weight loss analysis ) . Separate analyses to adjust for baseline differences between diet groups were also made by entering the following covariates to each of these models : age ; race ( white or African American ) ; sex ; baseline BMI ; baseline caloric intake ; and the presence or absence of hypertension , use of lipid-lowering therapy , diabetes , active smoking , and sleep apnea ( 12 ) . All variables were assessed for normality before entry into the analyses . Triglyceride , insulin , and glucose levels were skewed and thus were log-transformed before the analyses . Baseline differences between diet groups were compared by chi-square analysis for dichotomous variables and by the unpaired t-test for continuous variables . All P values are 2-sided , and a P value of 0.05 was considered statistically significant . Analyses were performed with SPSS statistical software , version 11.1 ( SPSS , Inc. , Chicago , Illinois ) . Missing Data Of the 132 enrolled persons , follow-up was done at 6 months for 79 persons and at 1 year for 87 persons . For measurements at 6 months , we retrieved weights on an additional 16 persons on the low-carbohydrate diet and 23 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 6.6 1.2 months ) . For measurements at 1 year , we retrieved weights on 18 persons on the low-carbohydrate diet and 21 persons on the conventional diet ( total , 39 persons at a mean [ SD ] of 13.5 3.2 months ) . Thus , we had 6-month weights on 118 of 132 persons ( 89 % ) and 1-year weights on 126 of 132 persons ( 96 % ) . Of the 18 persons who missed the 6-month visit but returned for the 1-year visit ( 6 in the low-carbohydrate group and 12 in the conventional diet group ) , all but 2 had 6-month weights retrieved from medical records . Of the 6 persons for whom no 1-year weights were available , 2 were in the low-carbohydrate group and 4 in the conventional diet group . The weights retrieved from medical records were obtained on scales that were different from those used for the study and were probably obtained in a nonuniform manner with regard to clothing . We used several approaches to h and le the 45 participants with missing data for diet recall and metabolic measurements . For the primary analysis by r and om-coefficient analysis , we assumed data were missing at r and om . To verify this assumption , we performed sensitivity analyses based on comparisons of baseline characteristics and weight loss differences between those who dropped out and those who completed the study . We also performed 2 additional sensitivity Background Recent research identifies unhealthful weight-control behaviors ( fasting , vomiting , or laxative abuse ) induced by a negative experience of the body , as the common antecedents of both obesity and eating disorders . In particular , according to the allocentric lock hypothesis , individuals with obesity may be locked to an allocentric ( observer view ) negative memory of the body that is no longer up date d by contrasting egocentric representations driven by perception . In other words , these patients may be locked to an allocentric negative representation of their body that their sensory inputs are no longer able to up date even after a dem and ing diet and a significant weight loss . Objective To test the brief and long-term clinical efficacy of an enhanced cognitive-behavioral therapy including a virtual reality protocol aim ed at unlocking the negative memory of the body ( ECT ) in morbidly obese patients with binge eating disorders ( BED ) compared with st and ard cognitive behavior therapy ( CBT ) and an inpatient multimodal treatment ( IP ) on weight loss , weight loss maintenance , BED remission , and body satisfaction improvement , including psychonutritional groups , a low-calorie diet ( 1200 kcal/day ) , and physical training . Methods 90 obese ( BMI > 40 ) female patients with BED upon referral to an obesity rehabilitation center were r and omly assigned to conditions ( 31 to ECT , 30 to CBT , and 29 to IP ) . Before treatment completion , 24 patients discharged themselves from hospital ( 4 in ECT , 10 in CBT , and 10 in IP ) . The remaining 66 in patients received either 15 sessions of ECT , 15 sessions of CBT , or no additional treatment over a 5-week usual care inpatient regimen ( IP ) . ECT and CBT treatments were administered by 3 licensed psychotherapists , and patients were blinded to conditions . At start , upon completion of the inpatient treatment , and at 1-year follow-up , patients ' weight , number of binge eating episodes during the previous month , and body satisfaction were assessed by self-report question naires and compared across conditions . 22 patients who received all sessions did not provide follow-up data ( 9 in ECT , 6 in CBT , and 7 in IP ) . Results Only ECT was effective at improving weight loss at 1-year follow-up . Conversely , control participants regained on average most of the weight they had lost during the inpatient program . Binge eating episodes decreased to zero during the inpatient program but were reported again in all the three groups at 1-year follow-up . However , a substantial regain was observed only in the group who received the inpatient program alone , while both ECT and CBT were successful in maintaining a low rate of monthly binge eating episodes . Conclusions Despite study limitations , findings support the hypothesis that the integration of a VR-based treatment , aim ed at both unlocking the negative memory of the body and at modifying its behavioral and emotional correlates , may improve the long-term outcome of a treatment for obese BED patients . As expected , the VR-based treatment , in comparison with the st and ard CBT approach , was able to better prevent weight regain but not to better manage binge eating episodes . Trial Registration International St and ard R and omized Controlled Trial Number ( IS RCT N ) : 59019572 ; http://www.controlled-trials.com/IS RCT N59019572 ( Archived by WebCite at http://www.webcitation.org/6GxHxAR2 G For many , obesity is just a problem of energy input and expenditure : more energy input than expenditure . However , the clinical practice and epidemiological data clearly show that weight control is more complex than expected by this simple equation . This is particularly true in morbid obesity , a form of severe obesity in which a person 's Body Mass Index ( BMI , kg/m(2 ) ) is over 40 . If we compare the definitions and diagnostic criteria for " dependence " and " addiction " with the situation of many severe obese subjects , it is apparent that they match very well . Further , different neurological studies confirm this similarity : both addiction and obesity patients have a deficiency of dopamine receptors . Nevertheless , when we compare many of the actual obesity treatments with the ones used in the area of addictions it is possible to find relevant differences : obesity treatments neither consider different levels of type and intensity of care , nor a multidimensional approach . To overcome these limitations , in this paper we propose a bio-psychosocial approach in which the genetic influence ( lack of dopamine receptors ) is matched by psychosocial issues ( pressure for thinness and diet as main body image dissatisfaction treatment ) . Further , the paper outlines how this approach may influence the treatment options , by focusing both on the lessons coming from actual addiction treatment and the opportunities offered by virtual reality . Finally , the paper presents and discusses the outcome of a controlled trial , based on the proposed approach , including a 6-month follow-up ( 211 morbid obese females with a BMI of > 40 and a documented history of failures BACKGROUND In the 2.8 years of the Diabetes Prevention Program ( DPP ) r and omised clinical trial , diabetes incidence in high-risk adults was reduced by 58 % with intensive lifestyle intervention and by 31 % with metformin , compared with placebo . We investigated the persistence of these effects in the long term . METHODS All active DPP participants were eligible for continued follow-up . 2766 of 3150 ( 88 % ) enrolled for a median additional follow-up of 5.7 years ( IQR 5.5 - 5.8 ) . 910 participants were from the lifestyle , 924 from the metformin , and 932 were from the original placebo groups . On the basis of the benefits from the intensive lifestyle intervention in the DPP , all three groups were offered group-implemented lifestyle intervention . Metformin treatment was continued in the original metformin group ( 850 mg twice daily as tolerated ) , with participants unmasked to assignment , and the original lifestyle intervention group was offered additional lifestyle support . The primary outcome was development of diabetes according to American Diabetes Association criteria . Analysis was by intention-to-treat . This study is registered with Clinical Trials.gov , number NCT00038727 . FINDINGS During the 10.0-year ( IQR 9.0 - 10.5 ) follow-up since r and omisation to DPP , the original lifestyle group lost , then partly regained weight . The modest weight loss with metformin was maintained . Diabetes incidence rates during the DPP were 4.8 cases per 100 person-years ( 95 % CI 4.1 - 5.7 ) in the intensive lifestyle intervention group , 7.8 ( 6.8 - 8.8 ) in the metformin group , and 11.0 ( 9.8 - 12.3 ) in the placebo group . Diabetes incidence rates in this follow-up study were similar between treatment groups : 5.9 per 100 person-years ( 5.1 - 6.8 ) for lifestyle , 4.9 ( 4.2 - 5.7 ) for metformin , and 5.6 ( 4.8 - 6.5 ) for placebo . Diabetes incidence in the 10 years since DPP r and omisation was reduced by 34 % ( 24 - 42 ) in the lifestyle group and 18 % ( 7 - 28 ) in the metformin group compared with placebo . INTERPRETATION During follow-up after DPP , incidences in the former placebo and metformin groups fell to equal those in the former lifestyle group , but the cumulative incidence of diabetes remained lowest in the lifestyle group . Prevention or delay of diabetes with lifestyle intervention or metformin can persist for at least 10 years . FUNDING National Institute of Diabetes and Digestive and Kidney Diseases ( NIDDK ) Background . Weight lost by obese patients is almost always regained over time . Extended treatment may improve maintenance , but solid evidence is lacking . Purpose . We determined effectiveness of maintenance therapy after a weight loss program . Methods . Together 201 patients ( mean age 47 years and BMI 42 kg/m2 , 71 % women ) were r and omly assigned to either a 17-week weight loss program followed by a one-year maintenance program or to a weight loss program without subsequent maintenance intervention . The weight loss program included behavior modification and a very-low-calorie diet , and maintenance program behavior modification . The primary outcome measure was percentage of patients with 5 % or more weight loss at the end of maintenance ( week 69 ) and one year later ( week 121 ) . Secondary outcomes were weight related changes in lifestyle and quality of life . Results . At week 69 , 52 % of the patients with and 44 % of those without maintenance program had lost weight ≥5 % , P = 0.40 , and , at week 121 , 33 % and 34 % , P = 0.77 , respectively . At week 121 secondary outcomes did not differ between the groups among those successfully followed up . Conclusions . This one-year maintenance program was not effective in preventing weight regain in severely obese patients . Trial Registration . This trial is registered under clinical trials.gov Identifier : NCT00590655 OBJECTIVE : To compare treatment effectiveness of psychodynamic and behavioral in-patient treatment of patients with severe obesity . DESIGN : R and omized longitudinal study of obese patients ( BMI ≥35 kg/m2 ) r and omly assigned to behavioral or to psychodynamic psychosomatic rehabilitation . SUBJECTS : Ninety eight , mostly female ( 88 % ) , obese patients ( age 20–64 y , BMI 36–74 kg/m2 ) . MEASUREMENTS : St and ardized self-report scales on distress ( SCL-90R ) , eating behavior ( FEV ) , interpersonal problems ( IIP ) , body image ( FKB-20 ) , life satisfaction ( IRES ) . RESULTS : During the 6 weeks of in-patient treatment patients lost an average of 5.4 kg ( 4.3 % ) in the behavioral ( n=46 ) and 6.2 kg ( 4.7 % ) in the psychodynamic setting ( n=52 ) . In both setting s , a significant improvement was also found for eating behavior , well-being , body image and life satisfaction . Weight reduction was more pronounced for those with a higher weight at onset , more distress in public at admission , and a longer treatment . CONCLUSION : Despite considerable differences in the behavioral vs psychodynamic treatment setting s , both were equally effective . However , some common treatment elements were perceived differently by patients in the two setting s. Analysis of the follow-up data will hopefully provide evidence as to which patients benefit more from which approach Objective Weight reduction improves several obesity-related health conditions . We aim ed to compare the effect of bariatric surgery and comprehensive lifestyle intervention on type 2 diabetes and obesity-related cardiovascular risk factors . Design One-year controlled clinical trial ( Clinical Trials.gov identifier NCT00273104 ) . Methods Morbidly obese subjects ( 19–66 years , mean ( s.d . ) body mass index 45.1 kg/m2 ( 5.6 ) , 103 women ) were treated with either Roux-en-Y gastric bypass surgery ( n=80 ) or intensive lifestyle intervention at a rehabilitation centre ( n=66 ) . The dropout rate within both groups was 5 % . Results Among the 76 completers in the surgery group and the 63 completers in the lifestyle group , mean ( s.d . ) 1-year weight loss was 30 % ( 8) and 8 % ( 9 ) respectively . Beneficial effects on glucose metabolism , blood pressure , lipids and low- grade inflammation were observed in both groups . Remission rates of type 2 diabetes and hypertension were significantly higher in the surgery group than the lifestyle intervention group ; 70 vs 33 % , P=0.027 , and 49 vs 23 % , P=0.016 . The improvements in glycaemic control and blood pressure were mediated by weight reduction . The surgery group experienced a significantly greater reduction in the prevalence of metabolic syndrome , albuminuria and electrocardiographic left ventricular hypertrophy than the lifestyle group . Gastrointestinal symptoms and symptomatic postpr and ial hypoglycaemia developed more frequently after gastric bypass surgery than after lifestyle intervention . There were no deaths . Conclusions Type 2 diabetes and obesity-related cardiovascular risk factors were improved after both treatment strategies . However , the improvements were greatest in those patients treated with gastric bypass surgery The aim of this study ( duration : 12 months ) was to compare different integrated therapeutic approaches for the therapy of Binge Eating Disorder ( BED ) . A sample of 65 female severely obese BED was r and omly divided into 3 groups : the first one was treated by Cognitive-Behavioural Therapy ( CBT ) alone ; the second one was treated by SSRI antidepressant therapy ( fluoxetine ) alone ; the remaining was treated by a combination of CBT plus fluoxetine . All groups received group nutritional training and individual dietary counselling . The initial fluoxetine dose ( 20 mg/day ) was adjusted ( up to 60 mg/day ) according to frequency of binge eating . During the first 4 weeks , all subjects underwent an in-patient dietary treatment aim ed to achieve at least a 5 % weight loss , which was continued during the out-patient treatment phase . At the beginning and at the end of the therapy the patients were evaluated by the Minnesota Multiphasic Personality — 2 and by the Eating Disorder Inventory — 2 . The results showed that the two groups which underwent psychotherapy result ed in a better outcome — in terms of number of bingeing episodes , maintenance of weight loss reduction from baseline and psychological well being — than the group treated with pharmacological therapy alone . Finally , the study underlines the importance of a multidisciplinary approach to the treatment of Binge Eating Disorder OBJECTIVE The Diabetes Prevention Program ( DPP ) showed that intensive lifestyle intervention reduced the risk of diabetes by 58 % . This paper examines demographic , psychosocial , and behavioral factors related to achieving weight loss and physical activity goals in the DPP lifestyle participants . RESEARCH METHODS AND PROCEDURES Lifestyle participants ( n = 1079 ; mean age = 50.6 , BMI = 33.9 , 68 % female , and 46 % from minority groups ) had goals of 7 % weight loss and 150 min/wk of physical activity . Goal achievement was assessed at the end of the 16-session core curriculum ( approximately week 24 ) and the final intervention visit ( mean = 3.2 years ) as a function of demographic , psychosocial , and behavioral variables . RESULTS Forty-nine percent met the weight loss goal and 74 % met the activity goal initially , while 37 % and 67 % , respectively , met these goals long-term . Men and those with lower initial BMI were more likely to meet activity but not weight loss goals . Hispanic , Asian , and Native Americans were more likely to meet the long-term activity goals , and whites were more likely to meet the initial weight loss goal . In multivariate analyses , meeting the long-term weight loss goal and both activity goals increased with age , while psychosocial and depression measures were unrelated to goal achievement . Dietary self-monitoring was positively related to meeting both weight loss and activity goals , and meeting the activity goal was positively related to meeting the weight loss goal . Participants who met initial goals were 1.5 to 3.0 times more likely to meet these goals long-term . DISCUSSION Success at meeting the weight loss and activity goals increased with age . Initial success predicted long-term success . Self-monitoring and meeting activity goals were related to achieving and sustaining weight loss BACKGROUND Very-low-energy diets ( VLEDs ) together with behavior therapy ( BT ) are widely used in the treatment of morbid obesity , but there is no evidence of their long-term effectiveness as compared with behavior therapy alone . METHODS Fifty-nine morbidly obese patients ( 25 men and 34 women ; mean weight , 132.8 + /- 20.7 kg ; mean age , 43.1 + /- 9.2 years ) were treated with combined therapy of VLED and BT or BT alone . No maintenance program was used . Eighty-seven percent of eligible patients were contacted 4.8 to 6.2 years after the program . RESULTS During treatment , 56 % of patients dropped out of the VLED + BT group and 28 % from the BT group ( P = .03 ) . High scores on the Symptom Checklist-90R before treatment predicted dropout from the VLED+BT group , but not from BT . At the end of therapy , mean weight change was -22.9 kg in the VLED+BT group and -8.9 kg in the BT group ( P < .001 ) . The overall weight change from pretreatment to the 5-year follow-up was greater in the VLED+BT group than in the BT group ( -16.9 kg vs -4.9 kg , respectively ; P = .03 ) . Men succeeded better in the VLED+BT group than in BT . Among the dropouts , the mean weight change from baseline was + 5.2 kg in the VLED+BT group and + 13.0 kg in the BT group . CONCLUSIONS Our data suggest that in the treatment of morbid obesity , VLED combined with BT may produce a better 5-year maintenance than BT alone , especially among men . A satisfactory weight loss can be achieved without a maintenance program ABSTRACT . Severely obese men and women ( body mass index ≥ 35 ≤ 55 kg/m2 ; Mage = 44.8 years , SD = 9.3 ) were r and omly assigned to a 6-month physical activity support treatment paired with either nutrition education ( n = 83 ) or cognitive-behavioral nutrition ( n = 82 ) methods for weight loss . Both groups had significant improvements in physical activity , fatigue , self-regulation for eating , and fruit and vegetable intake . Compared to those in the nutrition education group , participants in the behavioral group demonstrated greater overall increases in fruit and vegetable intake and physical activity . These group differences were associated with changes that occurred after Month 3 . Increased physical activity predicted reduced fatigue , β = −.19 , p = .01 . A reciprocal relationship between the mediators of that relationship , which were changes in self-regulation and fruit and vegetable intake , was identified . There was significantly greater weight loss over six months in the behavioral nutrition group when contrasted with the nutrition education group . Self-regulation for eating and fruit and vegetable intake were significant predictors of weight loss over both three and six months . Findings enabled a better underst and ing of psychosocial effects on temporal aspects of weight loss and may lead to more effective behavioral treatments for weight loss BACKGROUND Type 2 diabetes affects approximately 8 percent of adults in the United States . Some risk factors -- elevated plasma glucose concentrations in the fasting state and after an oral glucose load , overweight , and a sedentary lifestyle -- are potentially reversible . We hypothesized that modifying these factors with a lifestyle-intervention program or the administration of metformin would prevent or delay the development of diabetes . METHODS We r and omly assigned 3234 nondiabetic persons with elevated fasting and post-load plasma glucose concentrations to placebo , metformin ( 850 mg twice daily ) , or a lifestyle-modification program with the goals of at least a 7 percent weight loss and at least 150 minutes of physical activity per week . The mean age of the participants was 51 years , and the mean body-mass index ( the weight in kilograms divided by the square of the height in meters ) was 34.0 ; 68 percent were women , and 45 percent were members of minority groups . RESULTS The average follow-up was 2.8 years . The incidence of diabetes was 11.0 , 7.8 , and 4.8 cases per 100 person-years in the placebo , metformin , and lifestyle groups , respectively . The lifestyle intervention reduced the incidence by 58 percent ( 95 percent confidence interval , 48 to 66 percent ) and metformin by 31 percent ( 95 percent confidence interval , 17 to 43 percent ) , as compared with placebo ; the lifestyle intervention was significantly more effective than metformin . To prevent one case of diabetes during a period of three years , 6.9 persons would have to participate in the lifestyle-intervention program , and 13.9 would have to receive metformin . CONCLUSIONS Lifestyle changes and treatment with metformin both reduced the incidence of diabetes in persons at high risk . The lifestyle intervention was more effective than metformin Background : The objective of this study was to compare the effectiveness of psychodynamic and behavioral inpatient treatments of severely obese patients regarding weight and distress . Methods : In a longitudinal study obese patients ( body mass index , BMI ≧35 ) were r and omly assigned to behavioral or to psychodynamic inpatient treatment . Mostly female ( n = 267 ; 85 % ) obese patients with psychiatric and somatic comorbidity ( age 20–64 years , BMI 35–74 ) were examined with st and ardized self-report scales on distress ( SCL-90R ) , interpersonal problems ( Inventory of Interpersonal Problems ) , eating behavior ( Fragebogen zum Essverhalten ) and body image ( Fragebogen zum Körperbild ) . Results : During 49 days ( mean ) of inpatient treatment , patients lost an average of 5.6 kg ( 4.4 % ) in the behavioral ( n = 130 ) and 5.7 kg ( 4.4 % ) in the psychodynamic setting ( n = 137 ) . In both setting s , eating behavior , well-being and body image also improved significantly . One year after discharge , return rate was 73 % . Forty percent had further reduced their weight ( by more than 5 % compared to intake ) , 36 % had regained weight , but were still below intake level , and another 24 % had increased weight above intake . Conclusion : Behavioral and psychodynamic treatments were equally effective reducing weight and distress over 1 year OBJECTIVE Conflicting evidence exists as to weight loss produced by diets with different carbohydrate/protein ratio . The aim was to compare the long-term effects of high-protein vs. high-carbohydrate diet ( HPD , HCD ) , combined with cognitive behavior therapy ( CBT ) . DESIGN AND METHODS In a r and omized trial , 88 obese participants ( mean age , 46.7 ; mean BMI , 45.6 kg m(-2 ) ) were enrolled in a 3-week inpatient and 48-week outpatient treatment , with continuous CBT during the study period . All subjects consumed a restricted diet ( 1,200 kcal day(-1 ) for women , 1,500 for men ; 20 % energy from fat , < 10 % saturated fat ) . HPD derived 34 % energy from proteins , 46 % from carbohydrates ; HCD 17 % from proteins , 64 % from carbohydrates . The primary outcome was 1-year percent weight loss . Secondary outcomes were attrition rates and changes in cardiovascular risk factors and psychological profile . RESULTS Attrition rates were similar between groups ( 25.6 % ) . In the intention-to-treat analysis , weight loss averaged 15.0 % in HPD and 13.3 % in HCD at 1 year , without any difference throughout the study period . Both diets produced a similar improvement in secondary outcomes . CONCLUSIONS The relative carbohydrate and protein content of the diet , when combined with intensive CBT , does not significantly affect attrition rate , weight loss and psychosocial outcome in patients with severe obesity Background Few studies have looked at non-surgical alternatives for morbid obese patients . This study aims to compare 1-year weight loss and changes in risk factors and comorbidities after bariatric surgery and three conservative treatments . Methods Patients with morbid obesity ( BMI > 40 or BMI > 35 kg/m2 plus comorbidities ) on waiting list for bariatric surgery , were non-r and omly allocated to ( A ) bariatric surgery or to one of three conservative treatments ; ( B ) residential intermittent program ; ( C ) commercial weight loss camp and ( D ) hospital outpatient program . Body weight , risk factors and comorbidities were assessed at baseline and 1 year . Results Of 206 participants , 179 completed the study . All treatments result ed in significant weight loss , but bariatric surgery ( 40 ± 14 kg , 31 ± 9 % ) led to the largest weight loss ( P < 0.0001 ) . There were no differences in weight loss between B and C ( 22 ± 13 kg , 15 ± 8 % vs. 18 ± 12 kg , 13 ± 8 % ) , but these result ed in larger weight loss compared with D ( 7 ± 10 kg , 5 ± 8 % ) . There were no differences in changes in total or LDL cholesterol , triacylglycerols or glucose between groups ; however , the increase in HDL cholesterol was significantly larger in groups A and C. There were no differences in comorbidities resolution between groups A and B , C and D combined ( except hypertension , which was better in group A ) . Conclusion In conclusion , although bariatric surgery leads to a greater weight loss at 1 year compared with conservative treatment , in patients with morbid obesity , clinical significant weight loss and similar improvements in risk factors and comorbidities resolution can also be achieved with lifestyle interventions |
360 | 21,375,444 | Zolmitriptan and rizatriptan were superior to placebo in most studies .
Almotriptan demonstrated a high profile of tolerability .
All studies have reported a good triptan safety profile .
Triptans are an important option in the symptomatic treatment of childhood and adolescent migraine | Abortive drugs used for migraine in children and adolescents are usually the same as those used in adults .
Only a few studies have assessed the efficacy of triptans other than sumatriptan in pediatric migraine .
This systematic review describes the evidence concerning the efficacy and tolerability of these triptans . | An open , prospect i ve study was undertaken to assess the efficacy and safety of subcutaneous sumatriptan in 17 children , ages 6 to 16 years , with severe , recurrent migraine . A 6-mg dose was used in 15 patients and relieved headache within 1 hour in six and by 2 hours in five others . Two smaller children received a 3-mg dose and both were headache-free within 2 hours . Most also reported marked improvement in associated symptoms such as nausea and photophobia . Four subjects had no clinical improvement after a 6-mg dose . Side effects , such as neck pressure , were brief and mild . These findings suggest that subcutaneous sumatriptan can be both effective and safe as an abortive agent in juvenile migraine , but the appropriate dose in smaller children will need further investigation Objective . To compare the efficacy and tolerability of sumatriptan nasal spray ( NS ; 5 mg , 10 mg , and 20 mg ) with placebo for the treatment of acute migraine in adolescents . Methods . A r and omized , double-blind , placebo-controlled , single-attack study was conducted in 653 US adolescents ( 12–17 years of age ) . Patients with at least a 6-month history of migraine , who met International Headache Society criteria for migraine ( with or without aura ) were eligible for participation . Headache relief 2 hours postdose , complete relief , presence or absence of associated symptoms , headache recurrence , and use of rescue medications were recorded . The primary efficacy endpoint was headache relief 2 hours postdose sumatriptan NS ( 20 mg ) versus placebo . Safety and tolerability were assessed by examining adverse events , changes in electrocardiograms , vital signs , physical examinations , and clinical laboratory tests . Results . Headache relief 1 hour postdose was significantly greater for patients using 10 mg ( 56 % ) and 20 mg ( 56 % ) of sumatriptan NS compared with placebo ( 41 % ) . Headache relief 2 hours postdose was significantly greater for patients using 5 mg of sumatriptan NS ( 66 % ) compared with placebo ( 53 % ) , and approached statistical significance for 20 mg ( 63 % ) compared with placebo ( 53 % ) . Complete relief 2 hours postdose was significantly greater for patients using 20 mg of sumatriptan NS compared with placebo ( 36 % vs 25 % , respectively ) . Each dose of sumatriptan ( 5 mg , 10 mg , and 20 mg ) was superior to placebo with respect to the cumulative percentages of patients first reporting headache relief within 2 hours of dosing ( Kaplan-Meier ) . The sumatriptan 20-mg dose was superior to placebo with respect to the cumulative percentages of patients first reporting complete relief within 2 hours of dosing ( Kaplan-Meier ) . Photophobia and phonophobia were significantly reduced 2 hours postdose for sumatriptan NS ( 20 mg ) , compared with placebo ( 36 % vs 48 % and 25 % vs 44 % , respectively ) . Taste disturbance was the most commonly reported adverse event ( 2 % , 19 % , 30 % , and 26 % for placebo , 5 mg , 10 mg , and 20 mg , respectively ) . No drug-related serious adverse events or clinical ly relevant changes in laboratory parameters , electrocardiograms , or vital signs were reported . Conclusions . Sumatriptan NS is effective and well-tolerated for the treatment of acute migraine in adolescents , with the 20-mg dose providing the best overall efficacy and tolerability profiles BACKGROUND Eletriptan is a potent 5-HT(1B/1D ) agonist with proven efficacy in the acute treatment of migraine in adults . OBJECTIVE To evaluate the efficacy and tolerability of eletriptan 40 mg versus placebo in adolescent patients ( aged 12 - 17 ) . METHODS A multicenter , double-blind , parallel-group , placebo-controlled trial was conducted comparing 40 mg of oral eletriptan with placebo for the treatment of migraine in adolescent patients . The primary efficacy endpoint was 2-hour headache response , and a number of secondary endpoints were also evaluated . An exploratory analysis evaluated which clinical and demographic characteristics might be correlated with high placebo response . RESULTS Of 274 patients who treated a migraine attack , 267 were evaluated for efficacy ( n = 138 eletriptan ; n = 129 placebo ) at 2 hours post-dose . There was no significant difference in 2-hour headache response for eletriptan 40 mg versus placebo ( 57 % vs 57 % ) , and no significant improvements were observed for any of the outcomes at 1 or 2 hours post-dose . By contrast , there was a significant advantage for eletriptan 40 mg in reducing headache recurrence within 24 hours post-dose ( 11 % vs 25 % , P= .028 ) , and post hoc analyses showed statistically significant differences for sustained headache response rates ( 52 % vs 39 % ; P= .04 ) and sustained pain-free response rates ( 22 % vs 10 % ; P= .013 ) . The strongest clinical predictor of placebo response was triptan-naïve status ( i.e. , no previous use of any triptan ) . Eletriptan 40 mg was well tolerated in this population , and the profile of adverse events was similar to that observed in Phase III trials in adult patients . CONCLUSIONS The high placebo response rates reported here for 1- and 2-hour outcomes are in accordance with other studies of triptans in adolescent patients . The evaluation of treatment effect in adolescent migraine might benefit from use of more stringent outcome measures , such as headache recurrence , sustained headache response , and sustained pain-free response at 24 hours post-dose Frovatriptan is a selective 5-HT(1B/1D ) receptor agonist available for acute treatment of migraine in adults ( 18 years and older ) . The objective of this study was to determine key pharmacokinetic parameters of frovatriptan in adolescent migraineurs after a single 2.5-mg oral dose and to compare these results with those from an earlier study completed in adults . Subjects were stratified by age ( 12 - 14 and 15 - 17 years ) and gender , and serial blood and urine sample s were collected over 48 hours . A total of 25 subjects ( 13 male , 12 female ) completed the study . Pharmacokinetic profiles for adolescent subjects were similar to those observed in adults . The median tmax ranged from 2 ( male subjects ) to 3 ( female subjects ) hours . The AUC0 - 24h and Cmax were slightly lower in adolescent subjects as compared with adults . As seen in adults , AUC0 - 24h and Cmax values were approximately 2-fold higher in females than in their male counterparts ( AUC mean range 40.5 - 59.8 ng x h/mL vs 21.2 - 23.5 ng x h/mL and Cmax mean range 4.02 - 6.14 vs ng x h/mL 2.52 - 2.99 ng/mL , in female and male adolescent subjects , respectively ) . Elimination was biphasic , with an approximate terminal elimination half-life ( t(1/2 ) ) between 12.2 and 25.5 hours . Renal clearance was similar in adolescents and adults , being somewhat higher in female than male subjects . Frovatriptan was well tolerated with no serious or treatment-related adverse effects . In addition , there were no clinical ly significant changes in safety parameters . Overall , the pharmacokinetic profile of frovatriptan in adolescents ( 12 - 17 years ) is similar to that seen in adults , and dosing adjustments are unlikely to be needed OBJECTIVE The objective of this study was to determine the 1-year tolerability and efficacy of sumatriptan nasal spray ( NS ) at doses of 5 , 10 , and 20 mg for the treatment of acute migraine in adolescents . METHODS This was a prospect i ve , multicenter , open-label , 1-year , multiple-attack study . Adolescents ( aged 12 - 17 years ) with a > or = 6-month history of migraine with or without aura , 2 to 8 moderate or severe migraines per month , and a typical migraine duration of > or = 4 hours were eligible for participation . After initial treatment with sumatriptan 10 mg , the dose could be adjusted down to 5 mg or up to 20 mg at the investigator 's discretion to optimize tolerability or efficacy . Patients could treat an unlimited number of moderate or severe migraine attacks , provided there was a 24-hour headache-free period between treated attacks and a 2-hour period between doses of sumatriptan NS . A second dose of sumatriptan NS was available for headache recurrence 2 to 24 hours after initial treatment ; no more than 2 doses could be used within a 24-hour period . Adverse events , vital signs , electrocardiographic and physical findings , and laboratory variables were assessed . Headache response ( reduction of moderate/severe predose pain to mild/no pain ) and pain-free response ( reduction of moderate/severe predose pain to no pain ) were reported by patients 2 hours after dosing . RESULTS A total of 437 patients treated > or = 1 migraine ; 3272 total attacks were treated , with 3675 drug exposures ( mean , 1.1 dose/attack ) . Patients had a mean age of 14.1 years , 91 % were white , and 53 % were female . Seven patients used the 5-mg dose ; meaningful conclusions concerning this dose could not be made . Drug-related adverse events were reported in 33 % of attacks with the 10-mg dose and 31 % with the 20-mg dose ; most were related to taste disturbance . Adverse events did not increase with a second dose or over time . Four percent ( 16/437 ) of patients withdrew due to drug-related adverse events . One serious adverse event , a facial-nerve ischemic event ( 10-mg dose ) , was considered drug related . No drug-related changes in vital signs or electrocardiographic findings were observed . Headache response 2 hours after dosing was reported by 76 % of patients taking the 10-mg dose and 72 % of those taking the 20-mg dose . Pain-free response 2 hours after dosing was reported by 43 % and 40 % of patients in the 10- and 20-mg groups , respectively . CONCLUSIONS Based on these results , sumatriptan NS at doses of 10 and 20 mg was well tolerated and effective in the 1-year treatment of multiple migraine attacks in adolescents Oral sumatriptan is an effective acute treatment for migraine in adults , but its efficacy in children is still undetermined . Twenty-three children , aged 8.3 to 16.4 years , took both sumatriptan and placebo in a r and omized , double-blind , placebo-controlled , crossover trial . The primary endpoint was a ≥50 % decrease in pain intensity on a 100-mm visual analogue scale at 2 hours . Other endpoints of efficacy were pain intensity difference ( PID ) , showing pain relief at each time point ; summed pain intensity differences ( SPIDs ) , estimating overall pain relief ; and preference . Two hours after sumatriptan , 7 of 23 reached the primary endpoint , and after placebo , 5 of 23 ( difference 9 % , 95 % CI for difference , −21 to 38 % ; p = ns ) . Within 2 hours , the headache disappeared completely in 5 of 23 children after sumatriptan and in 2 of 23 children after placebo ( p = ns ) . Median PIDs were slightly better for sumatriptan between 0.5 and 4 hours ( p = ns ) . Median SPIDs increased almost identically up to 2 hours . Thereafter , median SPIDs for placebo remained practically constant , whereas for sumatriptan , the improvement continued . At 4 hours , the median SPID for sumatriptan was 2.4 times as high as for placebo . However , the maximum differences between median SPIDs at 4 hours ( 38.5 , 95 % CI , −75.8 to 57.5 ; Wilcoxon signed rank test , p = 0.4 ) or at any other point were not statistically significant . Of the 23 children , 13 preferred sumatriptan and 2 placebo ( sign test , p = 0.004 ) . The failure of this and previous controlled studies suggests that the response of children to sumatriptan may be different from adults Objective .—To assess the tolerability and effectiveness of nasal sumatriptan in the treatment of migraine in 5‐ to 12‐year‐old children OBJECTIVE To compare the efficacy and tolerability of sumatriptan nasal spray ( NS ) ( 5 , 20 mg ) versus placebo in the acute treatment of migraine in adolescent subjects . BACKGROUND Currently , no triptan is approved in the United States for the treatment of migraine in adolescent subjects ( 12 to 17 years ) . In a previous r and omized , placebo-controlled study of 510 adolescent subjects , sumatriptan NS at 5 , 10 , and 20 mg doses was well tolerated . However , the primary efficacy analysis for headache relief with 20 mg at 2 hours did not demonstrate statistical significance ( P = .059 ) . A second study was initiated to evaluate the efficacy of sumatriptan NS in this population . METHODS This was a r and omized ( 1:1:1 ) , placebo-controlled , double-blind , parallel-group study . Overall , 738 adolescent subjects ( mean age : 14 years ) with > or = 6-month history of migraine ( with or without aura ) self-treated a single attack of moderate or severe migraine . The primary endpoints were headache relief at 1 hour and sustained relief from 1 to 24 hours . Pain-free rates , presence/absence of associated symptoms , headache recurrence , and use of rescue medications were also assessed . Tolerability was based on adverse events ( AEs ) and vital signs . RESULTS Sumatriptan NS 20 mg provided greater headache relief than placebo at 30 minutes ( 42 % vs. 33 % , respectively ; P = .046 ) and 2 hours ( 68 % vs. 58 % ; P = .025 ) postdose , but did not reach statistical significance at 1 hour ( 61 % vs. 52 % ; P = .087 ) or for sustained headache relief from 1 to 24 hours ( P = .061 ) . Significant differences ( P < .05 ) in favor of sumatriptan NS 20 mg over placebo were observed for several secondary efficacy endpoints including sustained relief from 2 to 24 hours . In general , sumatriptan NS 5 mg percentages were slightly higher than placebo but the differences did not reach statistical significance . Both doses of sumatriptan NS were well tolerated . No AEs were serious or led to study withdrawal . The most common event was taste disturbance ( 2 % , placebo ; 19 % , sumatriptan NS 5 mg ; 25 % , sumatriptan NS 20 mg ) . CONCLUSIONS This study suggests that sumatriptan may be beneficial to some adolescents and is generally well tolerated in the acute treatment of migraine in this population The objective was to investigate the safety and efficacy of almotriptan in patients aged 11–17 years old with acute migraine . Fifteen patients aged 11–17 with a history of migraine with or without aura were treated with almotriptan . Reduction in headache severity , disability and adverse effects were studied . Almotriptan in doses ranging from 6.25 to 12.5 mg was well tolerated . There were virtually no adverse effects except for one case of transient mild stiffness . Of the 15 patients , only 2 demonstrated no efficacy without adverse effects . In the other 13 patients , not only was almotriptan effective , but again , no significant adverse effects were reported . Almotriptan is probably safe and effective in patients aged 11–17 . This small open – label pilot study should support the feasibility of a large r and omised controlled study to demonstrate tolerability and efficacy of almotriptan in children and adolescents with episodic migraine Objective .—This 1‐year , open‐label , multicenter study was design ed to assess the long‐term tolerability and efficacy of sumatriptan nasal spray 20 mg in adolescent patients with migraine OBJECTIVE The objective of this r and omized , double-blind , placebo-controlled study was to evaluate the efficacy and tolerability of the zolmitriptan conventional tablet at three different doses for the treatment of a single migraine attack in adolescents . BACKGROUND Preliminary data from an open-label study suggested that the zolmitriptan conventional tablet could be effective in the treatment of acute migraine in adolescent patients . METHODS Migraine patients aged 12 to 17 years ( n = 850 ) were r and omized to receive zolmitriptan 2.5 , 5 , or 10 mg , or placebo for treatment of a single migraine attack . Patients recorded migraine headache intensity before and after treatment using a 4-point scale . RESULTS There was no statistically significant improvement between zolmitriptan 10 mg ( 2 x 5 mg tablet ) and placebo for the primary efficacy variable , headache response at 2 hours , nor any of the secondary variables tested . Two-hour headache response rates were 54 % , 53 % , and 57 % for zolmitriptan 10 , 5 , and 2.5 mg , respectively , and 58 % for placebo . Two-hour pain-free rates were 25 % , 19 % , and 23 % for zolmitriptan 10 , 5 , and 2.5 mg , respectively , and 20 % for placebo . Zolmitriptan was well tolerated , with a tolerability profile similar to the pattern seen in adults . CONCLUSION The similar efficacy between zolmitriptan and placebo appears to be the result of the high placebo response rate . This is a recognized issue in pediatric migraine studies and there is an ongoing debate on ways to address this problem . Since this study was initiated , there has been some debate on the appropriateness of the 2-hour endpoint for response rates in adolescent studies , given the shorter duration of headache pain in adolescents compared with adults . Furthermore , accurate information regarding the timeliness of treatment and reporting of headache-related information by adolescents is difficult Naratriptan is a novel 5-HT1 agonist developed to treat acute migraine . The study objective was to characterize the pharmacokinetics of oral naratriptan in adolescent migraine patients outside a migraine attack . Subjects received a single 2.5 mg naratriptan tablet . Serial serum sample s for naratriptan concentrations were collected over 24 hours . Blood pressure , pulse rate , and 12-lead ECG were recorded at baseline and at regular intervals after dosing . Seven patients --3 males and 4 females , 12 to 16 years of age -- received drug and completed the study . The geometric mean and 95 % confidence interval maximum concentration ( Cmax ) was 8.0 ng/mL ( 5.9 - 10.7 ) , elimination half-life ( t1/2 ) was 4.9 hours ( 4.5 - 5.4 ) , area under the concentration-time curve ( AUC ) was 74.6 ng.h/mL ( 56.6 - 98.2 ) , and apparent total clearance ( Cl/F ) was 558.8 mL/min ( 424.3 - 735.9 ) . The median time to maximal concentration ( tmax ) was 4 hours , with a range of 1.5 to 4 . Blood pressure , pulse rate , and ECG parameters did not change significantly from baseline . No serious adverse events or subject withdrawal after drug administration occurred . Oral naratriptan pharmacokinetic parameters in adolescents were similar to values reported in adults . Naratriptan doses for adolescents older than 12 years of age would be expected to be similar to adult doses Objective .—To examine the short‐ and long‐term efficacy and tolerability of rizatriptan 5 mg in adolescents with migraine Eighty-eight children and adolescents were prospect ively evaluated at eight specialty clinics comparing the diagnostic criteria of the International Headache Society ( IHS ) and the proposed revised ( IHS-R ) classification to the clinical diagnosis . The proposed revisions to the IHS classification for pediatric migraine include : duration -1 hour to 48 hours ; location -- bifrontal/bitemporal or unilateral ; and symptoms -- to include photophobia or phonophobia . A comparison of the diagnostic rates of pediatric migraine with and without aura of the total sample revealed IHS ( 66 % ) versus IHS-R ( 93 % ) and comparison of a subset of those patients less than 12 years of age ( n = 39 ) revealed IHS ( 49 % ) versus IHS-R ( 87 % ) . Significant improvement in the diagnostic sensitivity of migraine in the pediatric population was obtained by specific modifications to the IHS criteria pertaining to duration , location , and the symptoms of photophobia and phonophobia in an ongoing multicenter prospect i ve study . These revisions may help to form the basis for future research guidelines and for further modifications to improve the diagnostic sensitivity of pediatric migraine maintaining the IHS model OBJECTIVE . The goal was to evaluate the efficacy and tolerability of zolmitriptan nasal spray in the treatment of adolescent migraine . METHODS . The “ Double-Diamond ” study used a novel , single-blind , “ placebo challenge ” in a multicenter , r and omized , double-blind , placebo-controlled , 2-way , 2-attack , crossover design . A total of 248 US adolescent patients ( 12–17 years of age ) with an established diagnosis of migraine , with or without aura , were enrolled . A single-blind placebo challenge was used for each migraine attack . No additional medications were taken if a headache response to the initial placebo treatment was achieved at 15 minutes ; if migraine intensity remained moderate or severe , then patients treated the attack with zolmitriptan ( 5 mg ) nasal spray or placebo according to a r and omized , crossover schedule ( double-blind ) . The primary efficacy variable was headache response at 1 hour after treatment . A comprehensive range of secondary end points included sustained headache response at 2 hours . RESULTS . A total of 171 patients ( mean age : 14.2 years ; 57.3 % female ) treated ≥1 attack with study medication ( intention-to-treat population ) . The onset of significant pain relief was apparent 15 minutes after treatment with zolmitriptan nasal spray . At 1 hour after the dose , zolmitriptan nasal spray produced a higher headache response rate than did placebo ( 58.1 % vs 43.3 % ) . Zolmitriptan nasal spray was also significantly superior to placebo in improvement in pain intensity , pain-free rates , sustained resolution of headache , and resolution of associated migraine symptoms . Return to normal activities was also consistently faster with zolmitriptan nasal spray than with placebo , with less use of any escape medication . Treatment with zolmitriptan nasal spray was well tolerated . CONCLUSIONS . This novel , placebo-challenge study demonstrated that zolmitriptan nasal spray was well tolerated and provided fast and significantly effective relief of migraine symptoms in the acute treatment of adolescent migraine Data from a subgroup of adolescents ( 12 - 17 years ) entered into a one-year open-label phase of a large international study were analysed to evaluate response rates and tolerability of zolmitriptan for the acute treatment of migraine . In the open-label phase of this study , the first two migraine attacks were treated with zolmitriptan 2.5 mg and subsequent attacks with zolmitriptan 2.5 mg or 5 mg , at the patient 's discretion , for up to 12 months . Two-hour headache and pain-free responses were evaluated and adverse events were recorded . Thirty-eight adolescents treated 276 migraine attacks of any intensity . The overall headache response at 2 hours was 80 % ( 88 % and 70 % with zolmitriptan 2.5 mg and 5 mg , respectively ) , and the pain-free response was 66 % ( 76 % and 52 % for zolmitriptan 2.5 mg and 5 mg , respectively ) . Response rates were independent of whether or not migraine was associated with aura or menses . During prolonged use , patients learned to adjust the dose of zolmitriptan to effectively manage their migraine . Treatment was well tolerated . In conclusion , preliminary data indicate that zolmitriptan is effective in the acute treatment of migraine in adolescents and is well tolerated To study the epidemiology of pediatric headache , we conducted a cross-sectional study of a r and omized and proportional sample of 538 male and female students , 10 to 18 years old . They were in the 5th to 8th grade of the schools of Porto Alegre , RS Brazil . The headache disorders were classified on the basis of clinical interview as well as a physical and neurological examination using the operational diagnostic criteria of the International Headache Society ( IHS The following headache prevalences were found : lifetime , 93.2 % ; last year , 82.9 % ; last week , 31.4 % ; last 24 h , 8.9 % . Last week and last 24 h headache complaints were twice as prevalent in the female group . During the last year the prevalence of headache disorders was 72.8 % for tension-type and 9.9 % for migraine headache and was not associated with age distribution . Only the last year and last week prevalences of tension-type headache were significantly higher in the female group . The last year prevalence of headache disorder-proved to be positively associated with sex and age variables . The prevalence of headache disorders was found to be extremely high in this population group , requiring more attention on the part of investigators as a public health problem Abstract Objectives : To determine the prevalence rates of the various causes of severe headache in school-children , with special emphasis on migraine and its impact on school attendance . Design : Population based study in two stages , comprising an initial screening question naire followed by clinical interviews and examination of children with symptoms and a control group of asymptomatic children matched for age and sex . Setting : 67 primary and secondary schools in the city of Aberdeen . Subjects : 2165 children , representing a r and om sample of 10 % of schoolchildren in Aberdeen aged 5 - 15 years . Main outcome measures : ( a ) the prevalence of20migraine ( International Headache Society criteria ) and of other types of headache ; ( b ) the impact of migraine on school attendance . Results : The estimated prevalence rates of migraine and tension headache were 10.6 % ( 95 % confidence interval 9.1 to 12.3 ) and 0.9 % ( 0.5 to 1.5 ) respectively . The estimated prevalence rates for migraine without aura and migraine with aura were 7.8 % ( 95 % confidence interval 6.5 to 9.3 ) and 2.8 % ( 2.0 to 3.8 ) respectively . In addition , 10 children ( 0.7 % ) had headaches which , though lasting less than two hours , also fulfilled the International Headache Society criteria for migraine , 14 ( 0.9 % ) had tension headaches , and 20 ( 1.3 % ) had non-specific recurrent headache . The prevalence of migraine increased with age , with male preponderance in children under 12 and female preponderance thereafter . Children with migraine lost a mean of 7.8 school days a year due to all illnesses ( 2.8 days ( range 0 - 80 ) due to headache ) as compared with a mean of 3.7 days lost by controls . Conclusions : Migraine is a common cause of headache in children and causes significantly reduced school attendance Objective : To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents . Methods : A double-blind , placebo-controlled , two-way crossover trial was conducted in three hospital outpatient departments , with 8 to 17 year olds diagnosed with migraine serving as subjects ( International Headache Society 1988 ) . A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks . The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of ≥40 kg . The primary efficacy endpoint was headache relief by two grade s on a 5- grade face scale at 2 hours . Results : Eighty-three patients used both treatments and 11 only the first . At 2 hours , the primary endpoint was reached nearly twice as often after sumatriptan ( n = 53/83 ; 64 % ) as after placebo ( n = 32/83 ; 39 % ) ( p = 0.003 ) . Already at 1 hour , headache relief was seen more often after sumatriptan ( n = 42/83 ; 51 % ) than after placebo ( n = 24/83 ; 29 % ) ( p = 0.014 ) . The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses ( n = 94 ) . Other endpoints , including child ’s preference and using rescue medication , also favored sumatriptan . The most common adverse effect was a bad taste after sumatriptan , reported in 29 % ( n = 26/90 ) of the attacks . No serious adverse effects were observed . Conclusion : Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age OBJECTIVES To assess the efficacy and safety of almotriptan 6.25 mg , 12.5 mg , and 25 mg vs placebo for acute migraine treatment in adolescents . PATIENTS AND METHODS In this double-blind , placebo-controlled , parallel-group , multicenter trial , 866 patients aged 12 to 17 years with a > 1 year history of migraine ( per International Headache Society criteria ) were r and omized to treat one migraine headache with almotriptan 6.25 mg , 12.5 mg , 25 mg , or placebo . The primary efficacy endpoint was headache pain relief 2 hours after dosing , adjusted for baseline severity , with absence of nausea , photophobia , and phonophobia 2 hours after dosing as co primary endpoints . RESULTS The 2-hour pain-relief rate was significantly higher with almotriptan 25 mg compared with placebo ( 66.7 % vs 55.3 % ; P = .022 ) . The incidence of nausea , photophobia , and phonophobia at 2 hours ( adjusted for baseline pain intensity ) for the almotriptan 25 mg and placebo groups was not significantly different . The 2-hour pain-relief rates ( unadjusted ) were significantly higher with almotriptan 6.25 mg ( 71.8 % ) , 12.5 mg ( 72.9 % ) , and 25 mg ( 66.7 % ) than with placebo ( 55.3 % ; P = .001 , P < .001 , and P = .028 , respectively ) . Rates for sustained pain relief also were significantly greater with almotriptan 6.25 mg ( 67.2 % ) , 12.5 mg ( 66.9 % ) , and 25 mg ( 64.5 % ) than with placebo group ( 52.4 % ) , P < .01 for the 6.25- and 12.5-mg doses and P < .05 for the 25-mg dose . Age group sub analysis demonstrated significantly greater 2-hour pain-relief rates with all 3 doses of almotriptan compared with placebo for patients aged 15 to 17 years , a significantly lower incidence of photophobia and phonophobia at 2 hours with almotriptan 12.5 mg compared with placebo for patients aged 15 to 17 years , and a significantly lower incidence of photophobia with almotriptan 12.5 mg compared with placebo for those aged 12 to 14 years . Almotriptan treatment was well tolerated , with the most common adverse events ( > 2 % ) of nausea , dizziness , and somnolence . CONCLUSIONS Oral almotriptan was efficacious for relieving migraine headache pain in adolescents , with the 12.5-mg dose associated with the most favorable efficacy profile with respect to relieving headache pain and associated symptoms of migraine ( photophobia and phonophobia ) . Almotriptan treatment was well tolerated in this adolescent population Zolmitriptan ( Zomig , formerly 311C90 ) at doses of 0.5 - 50 mg was administered to 316 unique volunteers in clinical pharmacology studies and 2,750 unique patients in eight clinical studies of acute migraine treatment . Overall , subjects received almost 50,000 doses ; 97 % of exposures were at doses > or = 2.5 mg . In the clinical pharmacology studies , the overall incidence of subject exposures experiencing at least one adverse event was 52 % with zolmitriptan 2.5 mg ( 28 % with placebo ) . In placebo-controlled studies , the overall incidence of patients with at least one adverse event was dose-dependent for zolmitriptan over the 1 - 15 mg dose range , e.g. 42 % and 46 % with 1 and 2.5 mg , respectively and 58 % with 5 mg ( 29 % with placebo ) . Only four serious adverse events attributable to zolmitriptan were reported . In a long-term study , during which 2,058 out patients treated a total of 31,579 migraine attacks with either one or two zolmitriptan 5 mg doses over a period of up to 1 year , the number of attacks associated with at least one adverse event was similar after one ( 26 % ) and two ( 24 % ) doses . The majority ( 59 % ) of the adverse events reported in this study ( 59 % ) occurred within 2 h of dosing , were predominantly mild ( 59 % ) or moderate ( 35 % ) in intensity , of < or = 4 h duration ( 58 % ) , required no further action ( 94 % ) . In placebo-controlled studies , the percentage of patients who reported severe adverse events was similar with zolmitriptan 2.5 mg ( 4 % ) and placebo ( 5 % ) . The most frequently reported adverse events with zolmitriptan in the placebo-controlled clinical studies were asthenia , heaviness ( other than chest or neck ) , dry mouth , nausea , dizziness , somnolence , paresthesia and warm sensations . The type and severity of the adverse events was not influenced by gender ( although the frequency of reported adverse events was higher in females , as was the case in the placebo group ) , age , presence of aura prior to the attack , association of migraine with menstruation , concurrent medication , or by the addition of a second zolmitriptan dose . Zolmitriptan showed a similar tolerability profile in the long-term study , in which a low withdrawal rate due to adverse events of 8 % was observed . Zolmitriptan was not associated with an increased frequency of central nervous system-related adverse events in a comparative study of sumatriptan , despite pre- clinical and neurophysiological evidence of a dual peripheral and central action of zolmitriptan . Moreover , zolmitriptan doses of 5 - 20 mg produced no statistically significant effects on objective assessment s of psychometric function . Zolmitriptan had no clinical ly significant effects on blood pressure ( even in patients with controlled mild to moderate hypertension or impaired renal function ) , ECGs ( e.g. there was no evidence of ischemic events ) or clinical chemistry , hematological or urinalysis measurements . In summary , zolmitriptan is well tolerated , particularly at the recommended dose of 2.5 mg . Zolmitriptan has a well-defined dose-response with 2.5 mg proving highly effective and optimizing the benefit/risk ratio of treatment . Thus , zolmitriptan is well suited as an acute oral treatment for migraine in the outpatient setting The aim of the study is to evaluate the efficacy and tolerability of the five triptans that are commercially available in Italy ( zolmitriptan 2.5 mg , rizatriptan 10 mg , sumatriptan 100 mg , almotriptan 12.5 mg and eletriptan 40 mg ) . The study was conducted in single‐blind versus placebo and its duration was 18 months . At the Headache Centre of the ‘ Agostino Gemelli ’ Hospital in Rome we selected 42 patients , suffering from headache with and without aura ( International Headache Society Committee on Headache Classification , 1988 Cephalalgia 8:1–96 ) , whose headache frequency ranged between 1‐ and 4‐monthly crises . For a total of 25 crises , for every five consecutive crises , a different triptan was taken . The end‐points of the study were as follows : response at 2 h , ‘ pain free ’ at 2 h and ‘ sustained pain free ’ ( at 24 h ) . The intra‐patient consistency and the tolerability were also evaluated . Thirty patients completed the study and the statistical analysis was only applied to these patients . No substantial difference in terms of the efficacy of the triptans was noted ; all triptans were well tolerated . These results suggest the possibility of testing different triptans in the same patient in order to identify the ideal drug for every patient Objective .—To investigate the tolerability and efficacy of rizatriptan 5 mg in adolescent migraineurs |
361 | 24,508,752 | The systematic review indicated that , across different experimental pain tasks , the majority of studies reported no significant differences between boys and girls on pain-related outcomes .
These findings suggest that developmental stage may be relevant for underst and ing sex differences in pain | Sex differences in response to experimental pain are commonly reported in systematic review s in the adult literature .
The objective of the present research was to conduct a systematic review and meta- analysis of sex differences in healthy children 's responses to experimental pain ( e.g. , cold pressor , heat pain , pressure pain ) and , where possible , to conduct analyses separately for children and adolescents . | Abstract The aim of the current investigation was to compare the effects of two different attentional strategies ( focused vs. avoidance ) on how males and females respond to experimentally induced pain . One hundred healthy adults were instructed to either attend towards or away from cold pressor pain . Measures of pain tolerance , pain threshold and recovery were taken , as were self‐report measures of sensory and affective pain experiences . As expected , gender was found to moderate tolerance to pain : males were found to be more tolerant to cold pressor pain than females . With respect to the self‐report measures , males reported less sensory pain when they attended toward the pain than when they avoided it . However , a similar effect was not found in women , suggesting that attentional focusing may only be a useful strategy for males . These results are discussed in light of previous research ABSTRACT . Currently , there are no clear methods for identifying children vulnerable to frequent school absences . Our study examined relationships between gender and laboratory pain reactivity to the cold-pressor task ( CPT ) , and parent-involved school absences and self-initiated school nurse visits in 57 children ( 36 female ; ages 8–10 years ) . Using multiple regression analyses , CPT pain ratings , tolerance , and gender were analyzed in relation to nurse visits and absences collected prospect ively across 2 years . We found that higher pain ratings and female gender predicted more absences ; female gender also predicted increased nurse visits for acute complaints with documented physical findings . Our results suggest that laboratory pain reactivity is a potentially useful indicator of vulnerability to parent-involved functional impairment , as indexed by school absences , and that girls are more likely than boys to miss school and visit the nurse for acute illnesses . Limitations and pathways for further study are discussed This 2-year follow-up study examined the effects of a brief behavioral intervention on task-based coping and pain reactivity to the cold pressor task ( CPT ) . In the original study by Fanurik et al. ( 1993 ) , 64 children ( aged 8 to 10 ) whose coping style was categorized as “ attender ” or “ distracter , ” based on primary coping strategy during baseline CPT trials , received a 5-minute intervention ( attention-focusing , distraction training , or control , r and omly assigned ) . In the present study , 51 ( 32 female ) of the original sample were readministered the CPT , and their coping style and pain responsivity were reassessed . Both distracters and attenders given distraction training preferred use of distraction at follow-up . The distraction training group also demonstrated greater tolerance at follow-up compared to controls , although pain ratings did not differ by intervention group . Our findings suggest that a brief distraction intervention has long-term effects on task-based coping and experimental pain reactivity OBJECTIVE To test whether a head-mounted display helmet enhances the effectiveness of videogame distraction for children experiencing cold pressor pain . METHOD Forty-one children , aged 6 - 14 years , underwent one or two baseline cold pressor trials followed by two distraction trials in which they played the same videogame with and without the helmet in counterbalanced order . Pain threshold ( elapsed time until the child reported pain ) and pain tolerance ( total time the child kept the h and submerged in the cold water ) were measured for each cold pressor trial . RESULTS Both distraction conditions result ed in improved pain tolerance relative to baseline . Older children appeared to experience additional benefits from using the helmet , whereas younger children benefited equally from both conditions . The findings suggest that virtual reality technology can enhance the effects of distraction for some children . Research is needed to identify the characteristics of children for whom this technology is best suited Summary Quantitative sensory testing in 7‐ and 14‐year‐olds based on a priori sample size calculations revealed higher pain sensitivity in 7‐year‐olds , but no sex‐related differences and similar detection thresholds . ABSTRACT There are controversial discussion s regarding developmental‐ and sex‐related differences in somatosensory perception , which were found , eg , when comparing younger children ( 6–8 years ) , older children ( 9–12 years ) , and adolescents ( 13–16 years ) using quantitative sensory testing ( QST ) . The aim of our current study was to systematic ally assess the impact of age and sex using the QST protocol of the German Research Network on Neuropathic Pain ( DFNS ) . QST , including thermal and mechanical detection and pain thresholds , was assessed in 86 healthy 7‐year‐old children ( 42 girls and 44 boys ) and 87 healthy 14‐year‐old adolescents ( 43 girls and 44 boys ) . The sample size was calculated a priori to detect medium‐sized effects as found in the previous studies with adequate power . Developmental and sex differences were tested using univariate analysis of variance . Children were more sensitive to most pain stimuli , except cold pain stimuli , compared with adolescents , but did not differ in mechanical and thermal detection thresholds except in regard to cold stimuli . Sex had an impact only on warm detection , with girls being more sensitive . There were no interactions between age and sex . In conclusion , developmental changes during the puberty appear to influence pain perception , whereas sex effects in childhood are negligible . At present , it is not clear what brings about the differences between adult men and women that are apparent in epidemiological studies . Our results contradict the hypothesis that differences in peripheral nerve‐fiber functioning underlie sex effects OBJECTIVE To investigate the impact of experimentally manipulated state anxiety and the influence of anxiety-related variables on children 's memories for pain . METHODS A total of 110 children ( 60 boys ) between the ages of 8 and 12 years were r and omly assigned to complete a state anxiety induction task or a control task . Following experimental manipulation , children completed a laboratory pain task , pain ratings , and question naire measures of anxiety-related variables . 2 weeks later , children provided pain ratings based on their memories of the pain task . RESULTS The experimental manipulation effectively induced state anxiety ; however , pain memories did not differ between groups . Irrespective of group assignment , children with higher state anxiety had more negative pain memories . State anxiety uniquely predicted children 's pain memories over and above other well established factors . Anxiety sensitivity and trait anxiety were significant predictors of recalled pain-related fear . CONCLUSIONS These data highlight the importance of anxiety in the development of children 's memories for pain Abstract Alterations in neural activity due to pain and injury in early development may produce long‐term effects on sensory processing and future responses to pain . To investigate persistent alterations in sensory perception , we performed quantitative sensory testing ( QST ) in extremely preterm ( EP ) children ( n = 43 ) recruited from the UK EPICure cohort ( born less than 26 weeks gestation in 1995 ) and in age and sex matched term‐born controls ( TC ; n = 44 ) . EP children had a generalized decreased sensitivity to all thermal modalities , but no difference in mechanical sensitivity at the thenar eminence . EP children who also required neonatal surgery had more marked thermal hypoalgesia , but did not differ from non‐surgical EP children in the measures of neonatal brain injury or current cognitive ability . Adjacent to neonatal thoracotomy scars there was a localized decrease in both thermal and mechanical sensitivity that differed from EP children with scars relating to less invasive procedural interventions or from those without scars . No relationship was found between sensory perception thresholds and current pain experience or pain coping styles in EP or TC children . Neonatal care and surgery in EP children are associated with persistent modality‐specific changes in sensory processing . Decreases in mechanical and thermal sensitivity adjacent to scars may be related to localized tissue injury , whereas generalized decreases in thermal sensitivity but not in mechanical sensitivity suggest central ly mediated alterations in the modulation of C‐fibre nociceptor pathways , which may impact on responses to future pain or surgery The aim of this study was to compare the intra- and inter-rater reliability of pressure pain threshold ( PPT ) and manual palpation ( MP ) of orofacial structures in symptomatic and symptom-free children for temporom and ibular disorders ( TMD ) . Fourteen children reporting pain in masticatory muscles or the temporom and ibular joint and 16 symptom-free children were r and omly assessed on three different occasions : by rater-1 in the first and third session and by rater-2 in the second session . The trained raters applied algometry and MP as recommended by the Research Diagnostic Criteria for TMD . Intraclass correlation coefficients and the Kappa statistic were used to assess the levels of reliability of PPT and MP , respectively . Excellent intra- and inter-rater reliability levels were observed for PPT values at most of the examined sites for symptom-free children and excellent and moderate reliability levels for children reporting pain . For MP , moderate and poor intra-rater and inter-rater reliability levels were observed for most sites in both groups . Algometry showed higher reliability levels for both groups of children and is recommended for pain assessment in children in association with MP OBJECTIVE Using a mixed model design , this study examined the effects of interactive versus passive distraction on healthy preschool-aged children 's cold pressor pain tolerance . METHODS Sixty-one children aged 3 - 5 years were r and omly assigned to one of the following : interactive distraction , passive distraction , or no distraction control . Participants underwent a baseline cold pressor trial followed by interactive distraction trial , passive distraction trial , or second baseline trial . One or two additional trials followed . Children originally assigned to distraction received the alternate distraction intervention . Controls participated in both interactive and passive distraction trials in counterbalanced order . RESULTS Participants showed significantly higher pain tolerance during both interactive and passive distraction relative to baseline . The two distraction conditions did not differ . CONCLUSIONS Interactive and passive video game distraction appear to be effective for preschool-aged children during laboratory pain exposure . Future studies should examine whether more extensive training would enhance effects of interactive video game distraction OBJECTIVE The present study investigated parental attention and sensitivity to their child 's pain and the moderating role of child 's facial pain expressiveness and induced threat . METHODS Sixty-two parents ( 49 mothers ; 13 fathers ) of schoolchildren observed their child undergoing painful and nonpainful heat trials and were requested to rate the presence of pain after each trial . Painful versus nonpainful trials were signaled by the presence of either a yellow or blue circle ; one color served as a cue for possible pain delivery ( i.e. , conditioned pain cue ) , whereas the other served as a cue for a nonpainful trial . A subsequent visual search task ( VST ) assessed attention to pain cues by asking parents to identify a target presented within the conditioned pain cue or one of several other colored circles . Parents were r and omly assigned to a " high threat " or " low threat " group in which either threatening or neutral information about the child 's pain was provided . RESULTS Signal detection analyses indicated that parents ' ability to detect pain ( i.e. , sensitivity ) was enhanced for parents in the high-threat group and for parents whose children expressed high pain . Visual search analyses indicated attentional engagement to child pain only among parents in the high-threat group whose child showed high-pain expressiveness . In all other circumstances , a tendency to avoid pain cues was observed . CONCLUSIONS These findings attest to the importance of pain-related threat in underst and ing parent attention to child pain . Theoretical and clinical implication s and future research directions are discussed OBJECTIVE To provide an experimental investigation of the impact of maternal behavior on children 's pain experiences . METHOD Participants were 120 healthy children ( 60 boys , 60 girls ) between the ages of 8 and 12 years and their mothers . Mothers were r and omly assigned and trained to interact with their children in one of three ways while the children were exposed to lab-induced cold pressor pain : ( 1 ) a pain-promoting interaction , ( 2 ) a pain-reducing interaction , and ( 3 ) a no training control group . Training was based on behaviors presumed to have the expected impact , as based on correlational studies reported in the literature . Children 's pain experiences during the cold pressor were assessed using self-reports of intensity and affect , coding of facial activity , tolerance , and heart rate responsiveness . RESULTS Girls whose mothers interacted with them in the pain-promoting manner reported more pain than daughters of mothers in the control group , who in turn reported more pain than girls whose mothers interacted with them in the pain-reducing manner . This effect was not significant for boys . Maternal interaction type had no effect on children 's pain affect , facial activity , tolerance , or heart rate . CONCLUSIONS Results indicate that maternal behavior can have a direct impact on their daughters ' subjective reports of pain . These data support the importance of social learning factors in influencing children 's pain experiences BACKGROUND Adult studies have demonstrated that increased resting blood pressure ( BP ) levels correlate with decreased pain sensitivity . However , few studies have examined the relationship between BP and experimental pain sensitivity among children . OBJECTIVES This study investigated the association between resting BP levels and experimental pain tolerance , intensity , and unpleasantness in healthy children . We also explored whether these BP-pain relationships were age and gender dependent . METHODS Participants underwent separate 4-trial blocks of cutaneous pressure and thermal pain stimuli , and 1 trial of a cold pain stimulus in counterbalanced order . RESULTS A total of 235 healthy children ( 49.6 % female ; mean age 12.7 [ 2.9 ] years ; age range 8 - 18 years ) participated . The study revealed specific gender-based BP-pain relationships . Girls with higher resting systolic BP levels were found to have lower thermal intensity ratings than girls with lower resting systolic BP levels ; this relationship was stronger among adolescent girls than among younger girls . Among young girls ( 8 - 11 years ) , those with higher resting diastolic BP ( DBP ) levels were found to have lower cold intensity and unpleasantness as well as lower thermal intensity ratings than did young girls with lower resting DBP levels ; these DBP-pain response relationships were not seen among adolescent girls . CONCLUSIONS Age , rather than resting BP , was predictive of laboratory pain ratings in boys . The findings suggest that the relationship between BP and experimental pain is age and gender dependent . These aspects of cardiovascular relationships to pain in males and females need further attention to underst and their clinical importance & NA ; A new instrument was design ed to provide a practical clinical measure for assessing children 's pain intensity and pain affect . The pocket size measure includes a Coloured Analogue Scale ( CAS ) to assess intensity and a facial affective scale to assess the aversive component of pain . Both scales have numerical ratings on the back , so that the person administering it can quickly note the numbers that represent a child 's pain . This study was conducted to determine : the validity of the new instrument by evaluating the psychophysical properties of the intensity scale and by evaluating the discriminant validity of the intensity and affective scales . Since visual analogue scales ( VAS ) are valid and reliable measures for assessing children 's pain , children 's ability to use the new analog scale was compared with their performance on a VAS . Children 's ability to rate pain affect using an affective scale , in which the 9 faces on a Facial Affective Scale ( FAS ) are presented in an ordered sequence from least to most distressed , was compared to their performance on the original FAS , in which the same faces were presented in a r and om order . Using a parallel groups design , 104 children ( 5–16 years ; 60 female , 44 male ; 51 healthy and 53 with recurrent headaches ) were r and omized into two groups : CAS or VAS . Children used the assigned scale to complete a calibration task , in which they rated the sizes of 7 circles varying in area ( 491 , 804 , 1385 , 2923 , 3848 , 5675 and 7854 mm2 ) . The psychophysical function relating perceived circle size to actual physical size was determined for the CAS and VAS . Children 's CAS and VAS responses on the calibration task yielded similar mathematical relationships ; & PHgr;cas = 0.035I0.87 , & PHgr;vas = 0.027I0.89 , where & PHgr ; = perceived magnitude and I = stimulus intensity . The R2 values were 0.921 and 0.922 for the CAS and VAS groups , respectively . Analyses of covariance revealed no significant differences in the characteristics of these relationships , i.e. , R2 , slope , or y intercept , by scale type . Children used the same scale to complete the Children 's Pain Inventory ( CPI ) , in which they rated the intensity and affect of 16 painful events ( varying in nature and extent of tissue damage ) . Children 's CAS and VAS responses on the CPI were similar . Analyses of covariance indicated that there were no differences in either intensity or affective ratings by scale type . However , the mean number of painful events experienced by children increased significantly with age ( P = 0.0001 ) . Intensity ratings decreased significantly with age ( P = 0.002 ) , but affective ratings did not vary with age . The new instrument has equivalent psychometric properties to a 165 mm VAS . However , the CAS was rated as easier to administer and score than the VAS , so it may be more practical for routine clinical use . Since the CAS has fulfilled the first two criteria for a pain measure ( psychophysical properties and discriminant validity ) , it is ethical to proceed with the formal definitive test for construct validity , in which children from various clinical population s use the CAS scale to assess their own pain OBJECTIVES Small and large , somatic and autonomic nerve fibre functions were neurophysiologically evaluated in 33 asymptomatic neurologically free type I diabetic children and 69 age-matched healthy controls . METHODS The evaluation of large and small somatic nerve fibre function was performed by conventional nerve conduction studies , thermal specific and thermal pain sensitivity tests , as well as autonomic nerve fibre functions by sympathetic skin response and R-R interval variation assessment . RESULTS A significant difference was established between the healthy and the diabetic group . Neurophysiologically determined sub clinical neuropathy was found in 87 % of type I diabetic children . The majority of abnormal recordings were found on the lower limbs . The dysfunction of the somatic motor large nerve fibre type in the lower limbs was altered in 57 % of patients , somatic sensory large in 39 % , somatic sensory small in 45 % , and sympathetic in 45 % . The leading abnormal measure was a delayed sympathetic skin response on the foot ( 42 % of diabetic children ) followed by a reduced amplitude of sural nerve action potential ( 36 % ) . The whole spectrum of recordings showed scattered involvement of nerve functions . There was no selective susceptibility of nerve fibre types exposed to a noxious factor . CONCLUSION A complex neurophysiological assessment , including st and ard nerve conduction studies as well as psychophysical examination and autonomic nerve function tests , evaluating the function of small and large nerve fibres , is recommended for evaluating the sub clinical neuropathy in asymptomatic type I diabetic children Distraction is an intuitive way of coping with pain and is often used in children 's pain treatment programs . However , empirical evidence concerning the effectiveness of distraction is equivocal . One potential explanation might be that distraction does not work for everyone in every situation . In the current series of studies , we examined the role of pain catastrophizing as an influencing factor of distraction effectiveness . In the first study , we investigated the use of pain coping strategies ( including distraction ) in schoolchildren ( N = 828 , aged 8 - 18 years ) by means of a question naire . Results indicated that children with higher levels of pain catastrophizing reported using less distraction strategies in daily life than children with lower levels of pain catastrophizing . In the second study , a sub sample ( N = 81 , aged 9 - 18 years ) performed a painful cold pressor task ( CPT ) ( 12 ° C ) . Participants were r and omly assigned to a distraction group , in which an attention-dem and ing tone-detection task was performed during the CPT , or a control group , in which no distraction task was performed . Results showed that participants in the distraction group were engaged in the distraction task , and reported to have paid less attention to pain than participants in the control group . However , distraction was ineffective in reducing cold pressor pain , and even intensified the pain experience in high catastrophizing children . Caution may be warranted in using distraction as a ' one size fits all ' method , especially in high catastrophizing children This experimental study investigated whether preparatory sensory information was more effective in managing children 's pain when coupled with a distraction technique . Seventy-eight children aged 7 - 12 years were r and omly allocated to 1 of 4 experimental conditions . They were given either a detailed sensory description of an imminent painful event ( cold-pressor arm immersion in 10 degrees C water ) or control instructions lacking sensory information . During the cold-pressor task , half the sample received an imagery-based distraction intervention . Pain measures included immersion tolerance , self-reported pain intensity , and facial pain responses . Self-reported coping style was assessed using the Pain Coping Question naire [ Reid , G. J. , Gilbert , C. A. , & McGrath , P. J. ( 1998 ) . The pain coping question naire : Preliminary validation . Pain , 76 , 83 - 96 ] . The effects of information provision interacted with distraction for pain intensity but not pain tolerance . Children given sensory preparation reported less intense pain when this was coupled with distraction than when it was not . Children with a distraction-based coping style showed greater tolerance when assigned to a condition congruent with their coping style . These findings suggest ways to better prepare children for painful medical procedures Increased pericranial muscle tenderness is connected with tension-type headache in adults . In children , the importance of muscle tenderness in the pericranial or neck-shoulder region in the pathogenesis of different types of headache is unknown . The present study evaluated muscle tenderness in the pericranial and neck-shoulder region in children with migraine , those with tension-type headache and those without headache . An unselected population -based question naire study concerning headache was carried out in 1135 Finnish schoolchildren aged 12 years . Of them , 183 children were r and omly selected for a face-to-face interview and a clinical examination . Muscle tenderness was recorded by manual palpation and dolorimeter . Children with migraine had increased overall tenderness , recorded by manual palpation , compared with those without headache . They also self-reported tenderness in the neck-shoulder region during daily activities more often than the children of the other groups . Muscle tenderness was not associated with paediatric tension-type headache . The mean pressure pain thresholds did not differ among the three groups . However , a negative correlation between the total tenderness score and the dolorimeter score was found in each group . In conclusion , children with migraine had increased muscle tenderness at palpation of the pericranial and neck-shoulder muscles and they also reported pain symptoms in the neck-shoulder region most frequently . Instead , increased pericranial and neck-shoulder muscle tenderness was not associated with tension-type headache in children & NA ; The purpose of this study was to examine the feasibility of testing a psychological approach ( hypnosis ) to pain reduction in children using the cold pressor paradigm . Children 's pain ratings at 10 sec intervals and duration of arm immersion ( 40 sec maximum ) in 15 ° C ( n = 37 ) and 12 ° C water ( n = 29 ) were assessed in 6–12‐year‐old children during 2 baseline trials ( alternating arms ) , followed by 2 more trials after r and omization to a control or hypnosis treatment condition . Hypnosis was found to reduce pain significantly more than the control condition in both 15 ° C and 12 ° C water . Hypnotic susceptibility was not strongly related to hypnotic pain reduction . However , age was significant , with younger children showing higher pain ratings and early arm withdrawal rates and less response to hypnosis than older children . In 15 ° C water , females had higher pain ratings and early withdrawal rates than males , but this sex discrepancy disappeared in 12 ° C water . This study demonstrated the feasibility of the cold pressor paradigm for testing intervention strategies and its potential for enhancing our underst and ing of pain in children Pain assessment is particularly challenging when children are unable or unwilling to provide a self-report . Although clinicians frequently use vital signs as an adjunct to pain assessment , little evidence exists to support this practice . The purpose of this study was to explore the ability of selected physiologic variables ( peripheral skin temperature , heart rate , skin conductance activity [ SCA ] , respiratory rate , electromyogram [ EMG ] of the frontalis and right forearm muscles , and systolic and diastolic blood pressure [ BP ] ) to detect changes in children 's autonomic arousal from baseline . A one-group , repeated measures , r and omized crossover design guided the study . Chosen from a convenience sample , 100 healthy children ( ages 8 - 17 years ) served as their own controls while undergoing two levels of intervention : cold pressor pain and guided imagery . Although most physiologic responses showed changes in the expected direction , EMG , SCA , and heart rate decreased slightly during cold pressor . Few significant intercorrelations were demonstrated among the physiologic variables . SCA , forehead EMG , respiratory rate , systolic and diastolic BP detected significant changes in arousal across measures . Notably , heart rate failed to detect changes for any of the measures . Results emphasize the need for caution in interpreting heart rate as an index of comfort . Further research is needed to examine the effects of clinical pain on physiologic indices and to further examine age and sex influences . To be relevant for assessment of acute established pain , physiologic variables must also be tested for their sensitivity beyond the immediate period of autonomic arousal AIMS To determine intra- and interrater agreement of the pressure pain threshold ( PPT ) values for children reporting orofacial pain related to temporomadibular disorders and symptom-free subjects when the mean of 3 consecutive measurements or the mean of the last 2 consecutive measurements was considered . METHODS Fourteen children reporting pain in masticatory muscles or the temporom and ibular joint and 16 symptom-free children were selected at r and om from a sample of 100 children . Two trained raters used an algometer to obtain 3 consecutive measurements of PPT of the masticatory system sites . The children were evaluated in 3 sessions after a minimum period of 3 days after the initial evaluation . The intraclass correlation coefficient ( ICC ) was used to evaluate the levels of agreement . RESULTS Excellent intra- and interrater agreement was observed ( ICC > 0.75 ) for most of the structures evaluated in symptom-free children , and excellent and moderate agreement was obtained for the symptomatic group . Discarding the first of the 3 measurements increased the number of sites with ICC values classified as excellent in both groups . For evaluations performed on different days , this procedure reduced significantly the percentage of sites with ICC values classified as excellent only for the interrater agreement for the symptomatic group . CONCLUSION The lower levels of reproducibility for the measurements obtained on different days in the children who reported pain may have been related to instability of their clinical signs and symptoms , and a PPT assessment based on the mean of 3 consecutive measurements or the procedure of discarding the first measure should be considered for such evaluations , especially when they are conducted by different raters . Algometry was shown to be a reliable tool for the evaluation of pain threshold in the masticatory structures of children & NA ; This study examined the hypothesis that matching pain management interventions to children 's preferred coping methods would increase pain tolerance and decrease self‐reported pain during the cold pressor pain paradigm . Children aged 8–10 years were classified as ‘ attenders ’ ( focusing on the stimulus ) or ‘ distractors ’ ( focusing away from the stimulus ) based upon their spontaneous coping responses during a baseline exposure to the cold pressor . Children were then r and omly assigned to 1 of 3 intervention conditions ( sensory focusing , imagery , or no intervention ) and completed the cold pressor procedure again 2 weeks later . A significant interaction was found between coping style and intervention . Children who were classified as distractors demonstrated greater tolerance when taught to use imagery techniques ( a ‘ matched ’ intervention ) . Although pain ratings tended to be lower for distractors using imagery , the significant interaction result ed from an increase in ratings for the distractors using sensory focusing ( i.e. , a ‘ mismatched ’ intervention ) . Results suggest that , for distractors , interventions that are consistent with natural coping methods are most effective in enhancing abilities to cope with pain , while a mismatched intervention reduces coping abilities . The findings also suggest further study regarding how to provide effective pain intervention with attenders , since neither intervention enhanced coping in this group This study assessed the relative efficacy of two imagery-based attentional strategies for modifying pain experience in children . Children aged 7 - 14 years ( n = 120 ) were r and omly assigned to one of three conditions : distraction , sensory-focussing or control ( no imagery ) . The distraction condition prompted children to focus their attention externally ; the sensory-focussing condition prompted the child to focus internally on physical sensations . Self-report measures of pain coping style preferences and imagery ability were completed . Children 's pain tolerance and perceptions of pain intensity were assessed using a 10 degrees C cold-pressor task . Results showed pain intensity ratings after 1 min were lower for both intervention conditions than for the controls . Younger children ( 7 - 9 years ) showed higher pain tolerance in the distraction condition than in the sensory-focussing condition , whereas both interventions were equally effective for older children ( 10 - 14 years ) . Among older children , coping style interacted with the intervention type : in the sensory-focussing condition , pain tolerance was negatively associated with self-reported distraction-based coping style , whereas in the distraction condition this association was positive . The results are interpreted with reference to current models of attention . The implication s for use of attentional strategies in helping children to cope with clinical pain are discussed & NA ; To determine whether intraoral sucrose has analgesic‐like effects in pre‐pubertal children and to explore the utility of an ethical and viable laboratory test of nociceptive stimulation in this age group , 8–11‐year‐olds ( n = 42 ) underwent the cold pressor test ( CPT ) at 10 ° C on each of 2 successive days , while holding either 24 % sucrose or water in their mouths . Outcome measures used were threshold ( time at which the arm first started to hurt ) , tolerance ( when children removed their arms because they could not st and it any more ) and visual analogue scale ( VAS ) ratings of the intensity of sensation . To ensure validity of the data obtained in this age group , some responses were rejected according to established decision rules and blind to group assignment . Each measure produced interesting data but also had limitations . Threshold data that did not meet validity criteria occurred more frequently with younger children . Tolerance data was not available for a significant proportion ( 57 % ) of children , since they left their arms in the water for the maximum time allowed ( 4 min ) . This occurred more frequently on the second day of testing and with younger children . Inability to perform adequately on the VAS also occurred , but was not related to age . Holding sucrose in the mouth was associated with a significant 35 % prolongation of the children 's threshold times relative to water , but there was no detectable effect on tolerance and intensity ratings . It is concluded that the analgesic properties of intraoral sucrose , seen previously in human newborns and rat pups , may also be present in pre‐pubertal children . Further study is needed to determine whether and under what conditions this effect may be replicated . In spite of some limitations , the CPT appears to be a potentially useful tool for pediatric pain research & NA ; Altogether 553 children ( 195 first grade rs , mean age 6.8 years , and 358 third grade rs , mean age 8.7 years ) participated in the development of a self‐report measure to assess the intensity of children 's pain . The first step was the derivation , from children 's drawings of facial expressions of pain , of 5 sets of 7 schematic faces depicting changes in severity of expressed pain from no pain to the most pain possible . With the set of faces that achieved the highest agreement in pain ordering , additional studies were conducted to determine whether the set had the properties of a scale . In one study , children rank‐ordered the faces on 2 occasions , separated by 1 week . All 7 faces were correctly ranked by 64 % ( retest 1 week later , 61 % ) of grade 1 children and by 86 % ( retest 89 % ) of grade 3 children . In a second study , the faces were presented in all possible paired combinations . All 7 faces were correctly placed by 62 % ( retest 86 % ) of the younger and by 75 % ( retest 71 % ) of the older subjects . A third study asked children to place faces along scale : a procedure allowing a check on the e quality of intervals . The fourth study checked on whether pain was acting as an underlying construct for ordering the faces in memory . We asked whether children perceived the set as a scale by asking if memory for an ordered set of faces was more accurate than for a r and om set . The final study checked , with 6‐year‐old children , the test‐retest reliability of ratings for recalled experiences of pain . Overall , the faces pain scale incorporates conventions used by children , has achieved strong agreement in the rank ordering of pain , has indications that the intervals are close to equal , and is treated by children as a scale . The test‐retest data suggest that it may prove to be a reliable index over time of self‐reported pain |
362 | 24,849,544 | Conclusion Four modes of LLTH are identified in the current literature ( CHT , IHT , RSH and RTH ) , with training mode and intensity appearing to be key factors in mediating subsequent performance responses in normoxia .
Improvements in normoxic performance appear most likely following high-intensity , short-term and intermittent training ( e.g. IHT , RSH ) .
For RTH , it is unclear whether the associated adaptations are greater than those of traditional ( maximal ) resistance training programmes | Background and Objective Hypoxic training techniques are increasingly used by athletes in an attempt to improve performance in normoxic environments .
The ‘ live low-train high ( LLTH ) ’ model of hypoxic training may be of particular interest to athletes because LLTH protocol s generally involve shorter hypoxic exposures ( approximately two to five sessions per week of <3 h ) than other traditional hypoxic training techniques ( e.g. live high-train high or live high-train low ) .
However , the methods employed in LLTH studies to date vary greatly with respect to exposure times , training intensities , training modalities , degrees of hypoxia and performance outcomes assessed .
Whilst recent review s provide some insight into how LLTH may be applied to enhance performance , little attention has been given to how training intensity/modality may specifically influence subsequent performance in normoxia .
Therefore , this systematic review aims to evaluate the normoxic performance outcomes of the available LLTH literature , with a particular focus on training intensity and modality . | The aim was to investigate the effects of low-load resistant training combined with vascular occlusion or normobaric hypoxic exposure , on neuromuscular function . In a r and omised controlled trial , well-trained athletes took part in a 5-week training of knee flexor/extensor muscles in which low-load resistant exercise ( 20 % of one repetition maximum , 1-RM ) was combined with either ( 1 ) an occlusion pressure of approximately 230 mmHg ( KT , n = 10 ) , ( 2 ) hypoxic air to generate an arterial blood oxygen saturation of ~80 % ( HT , n = 10 ) , or ( 3 ) with no additional stimulus ( CT , n = 10 ) . Before and after training , participants completed the following tests : 3-s maximal voluntary contraction ( MVC3 ) , 30-s MVC , and an endurance test ( maximal number of repetitions at 20 % 1-RM , Reps20 ) . Electromyographic activity ( root mean square , RMS ) was measured during tests and the cross-sectional area ( CSA ) of the quadriceps and hamstrings was measured pre- and post-training . Relative to CT , KT , and HT showed likely increases in MVC3 ( 11.0 ± 11.9 and 15.0 ± 13.1 % , mean ± 90 % confidence interval ) , MVC30 ( 10.2 ± 9.0 and 18.3 ± 17.4 % ) , and Reps20 ( 28.9 ± 23.7 and 23.3 ± 24.0 % ) . Compared to the CT group , CSA increased in the KT ( 7.6 ± 5.8 ) and HT groups ( 5.3 ± 3.0 ) . KT had a large effect on RMS during MVC3 , compared to CT ( effect size 0.8 ) and HT ( effect size 0.8 ) . We suspect hypoxic conditions created within the muscles during vascular occlusion and hypoxic training may play a key role in these performance enhancements Abstract This study aim ed to investigate the effects of a short-term period of intermittent hypoxic training ( IHT ) on cycling performance in athletes . Nineteen participants were r and omly assigned to two groups : normoxic ( NT , n = 9 ) and intermittent hypoxic training group ( IHT , n = 10 ) . A 3-week training program ( 5 × 1 h–1 h 30 min per week ) was completed . Training sessions were performed in normoxia ( ∼30 m ) or hypoxia ( simulated altitude of 3,000 m ) for NT and IHT group , respectively . Each subject performed before ( W0 ) and after ( W4 ) the training program , three cycling tests including an incremental test to exhaustion in normoxia and hypoxia for determination of maximal aerobic power $ $ ( \ifmmode\exp and after\dot\else\exp and after\.\fi{V}{\text{O}}_{{2\max } } ) $ $ and peak power output ( PPO ) as well as a 10-min cycle time trial in normoxia ( TT ) to measure the average power output ( Paver ) . No significant difference in $ $ \ifmmode\exp and after\dot\else\exp and after\.\fi{V}{\text{O}}_{{2\max } } $ $ was observed between the two training groups before or after the training period . When measured in normoxia , the PPO significantly increased ( P < 0.05 ) by 7.2 and 6.6 % in NT and IHT groups , respectively . However , only the IHT group significantly improved ( 11.3 % ; P < 0.05 ) PPO when measured in hypoxia . The NT group improved ( P < 0.05 ) Paver in TT by 8.1 % , whereas IHT group did not show any significant difference . Intermittent training performed in hypoxia was less efficient for improving endurance performance at sea level than similar training performed in normoxia . However , IHT has the potential to assist athletes in preparation for competition at altitude This study investigates whether a 6-wk intermittent hypoxia training ( IHT ) , design ed to avoid reductions in training loads and intensities , improves the endurance performance capacity of competitive distance runners . Eighteen athletes were r and omly assigned to train in normoxia [ Nor group ; n = 9 ; maximal oxygen uptake ( VO2 max ) = 61.5 + /- 1.1 ml x kg(-1 ) x min(-1 ) ] or intermittently in hypoxia ( Hyp group ; n = 9 ; VO2 max = 64.2 + /- 1.2 ml x kg(-1 ) x min(-1 ) ) . Into their usual normoxic training schedule , athletes included two weekly high-intensity ( second ventilatory threshold ) and moderate- duration ( 24 - 40 min ) training sessions , performed either in normoxia [ inspired O2 fraction ( FiO2 ) = 20.9 % ] or in normobaric hypoxia ( FiO2 ) = 14.5 % ) . Before and after training , all athletes realized 1 ) a normoxic and hypoxic incremental test to determine VO2 max and ventilatory thresholds ( first and second ventilatory threshold ) , and 2 ) an all-out test at the pretraining minimal velocity eliciting VO2 max to determine their time to exhaustion ( T(lim ) ) and the parameters of O2 uptake ( VO2 ) kinetics . Only the Hyp group significantly improved VO2 max ( + 5 % at both FiO2 , P < 0.05 ) , without changes in blood O2-carrying capacity . Moreover , T(lim ) lengthened in the Hyp group only ( + 35 % , P < 0.001 ) , without significant modifications of VO2 kinetics . Despite similar training load , the Nor group displayed no such improvements , with unchanged VO2 max ( + 1 % , nonsignificant ) , T(lim ) ( + 10 % , nonsignificant ) , and VO2 kinetics . In addition , T(lim ) improvements in the Hyp group were not correlated with concomitant modifications of other parameters , including VO2 max or VO2 kinetics . The present IHT model , involving specific high-intensity and moderate- duration hypoxic sessions , may potentialize the metabolic stimuli of training in already trained athletes and elicit peripheral muscle adaptations , result ing in increased endurance performance capacity We hypothesized that specific muscular transcript level adaptations participate in the improvement of endurance performances following intermittent hypoxia training in endurance-trained subjects . Fifteen male high-level , long-distance runners integrated a modified living low-training high program comprising two weekly controlled training sessions performed at the second ventilatory threshold for 6 wk into their normal training schedule . The athletes were r and omly assigned to either a normoxic ( Nor ) ( inspired O2 fraction = 20.9 % , n = 6 ) or a hypoxic group exercising under normobaric hypoxia ( Hyp ) ( inspired O2 fraction = 14.5 % , n = 9 ) . Oxygen uptake and speed at second ventilatory threshold , maximal oxygen uptake ( VO2 max ) , and time to exhaustion ( Tlim ) at constant load at VO2 max velocity in normoxia and muscular levels of selected mRNAs in biopsies were determined before and after training . VO2 max ( + 5 % ) and Tlim ( + 35 % ) increased specifically in the Hyp group . At the molecular level , mRNA concentrations of the hypoxia-inducible factor 1alpha ( + 104 % ) , glucose transporter-4 ( + 32 % ) , phosphofructokinase ( + 32 % ) , peroxisome proliferator-activated receptor gamma coactivator 1alpha ( + 60 % ) , citrate synthase ( + 28 % ) , cytochrome oxidase 1 ( + 74 % ) and 4 ( + 36 % ) , carbonic anhydrase-3 ( + 74 % ) , and manganese superoxide dismutase ( + 44 % ) were significantly augmented in muscle after exercise training in Hyp only . Significant correlations were noted between muscular mRNA levels of monocarboxylate transporter-1 , carbonic anhydrase-3 , glucose transporter-4 , and Tlim only in the group of athletes who trained in hypoxia ( P < 0.05 ) . Accordingly , the addition of short hypoxic stress to the regular endurance training protocol induces transcriptional adaptations in skeletal muscle of athletic subjects . Expressional adaptations involving redox regulation and glucose uptake are being recognized as a potential molecular pathway , result ing in improved endurance performance in hypoxia-trained subjects To test the hypothesis that severe hypoxia during low-resistance/high-repetition strength training promotes muscle hypertrophy , 19 untrained males were assigned r and omly to 4 weeks of low-resistance/high-repetition knee extension exercise in either normoxia or in normobaric hypoxia ( FiO2 0.12 ) with recovery in normoxia . Before and after the training period , isokinetic strength tests were performed , muscle cross-sectional area ( MCSA ) measured ( magnetic resonance imaging ) and muscle biopsies taken . The significant increase in strength endurance capacity observed in both training groups was not matched by changes in MCSA , fibre type distribution or fibre cross-sectional area . RT-PCR revealed considerable inter-individual variations with no significant differences in the mRNA levels of hypoxia markers , glycolytic enzymes and myosin heavy chain isoforms . We found significant correlations , in the hypoxia group only , for those hypoxia marker and glycolytic enzyme mRNAs that have previously been linked to hypoxia-specific muscle adaptations . This is interpreted as a small , otherwise undetectable adaptation to the hypoxia training condition . In terms of strength parameters , there were , however , no indications that low-resistance/high-repetition training in severe hypoxia is superior to equivalent normoxic training This study was performed to explore changes in gene expression as a consequence of exercise training at two levels of intensity under normoxic and normobaric hypoxic conditions ( corresponding to an altitude of 3,850 m ) . Four groups of human subjects trained five times a week for a total of 6 wk on a bicycle ergometer . Muscle biopsies were taken , and performance tests were carried out before and after the training period . Similar increases in maximal O(2 ) uptake ( 8.3 - 13.1 % ) and maximal power output ( 11.4 - 20.8 % ) were found in all groups . RT-PCR revealed elevated mRNA concentrations of the alpha-subunit of hypoxia-inducible factor 1 ( HIF-1 ) after both high- ( + 82.4 % ) and low (+78.4%)-intensity training under hypoxic conditions . The mRNA of HIF-1alpha(736 ) , a splice variant of HIF-1alpha newly detected in human skeletal muscle , was shown to be changed in a similar pattern as HIF-1alpha . Increased mRNA contents of myoglobin ( + 72.2 % ) and vascular endothelial growth factor ( + 52.4 % ) were evoked only after high-intensity training in hypoxia . Augmented mRNA levels of oxidative enzymes , phosphofructokinase , and heat shock protein 70 were found after high-intensity training under both hypoxic and normoxic conditions . Our findings suggest that HIF-1 is specifically involved in the regulation of muscle adaptations after hypoxia training . Fine-tuning of the training response is recognized at the molecular level , and with less sensitivity also at the structural level , but not at global functional responses like maximal O(2 ) uptake or maximal power output The effects of concurrent hypoxic/endurance training on mitochondrial respiration in permeabilized fibers in trained athletes were investigated . Eighteen endurance athletes were divided into two training groups : normoxic ( Nor , n = 8) and hypoxic ( H , n = 10 ) . Three weeks ( W1-W3 ) of endurance training ( 5 sessions of 1 h to 1 h and 30 min per week ) were completed . All training sessions were performed under normoxic [ 160 Torr inspired Po(2 ) ( Pi(O(2 ) ) ) ] or hypoxic conditions ( approximately 100 Torr Pi(O(2 ) ) , approximately 3,000 m ) for Nor and H group , respectively , at the same relative intensity . Before and after the training period , an incremental test to exhaustion in normoxia was performed , muscle biopsy sample s were taken from the vastus lateralis , and mitochondrial respiration in permeabilized fibers was measured . Peak power output ( PPO ) increased by 7.2 % and 6.6 % ( P < 0.05 ) for Nor and H , respectively , whereas maximal O(2 ) uptake ( Vo(2 max ) ) remained unchanged : 58.1 + /- 0.8 vs. 61.0 + /- 1.2 ml.kg(-1).min(-1 ) and 58.5 + /- 0.7 vs. 58.3 + /- 0.6 ml.kg(-1).min(-1 ) for Nor and H , respectively , between pretraining ( W0 ) and posttraining ( W4 ) . Maximal ADP-stimulated mitochondrial respiration significantly increased for glutamate + malate ( 6.27 + /- 0.37 vs. 8.51 + /- 0.33 mumol O(2).min(-1).g dry weight(-1 ) ) and significantly decreased for palmitate + malate ( 3.88 + /- 0.23 vs. 2.77 + /- 0.08 mumol O(2).min(-1).g dry weight(-1 ) ) in the H group . In contrast , no significant differences were found for the Nor group . The findings demonstrate that 1 ) a 3-wk training period increased the PPO at sea level without any changes in Vo(2 max ) , and 2 ) a 3-wk hypoxic exercise training seems to alter the intrinsic properties of mitochondrial function , i.e. , substrate preference PURPOSE Recent studies have shown that low-intensity resistance training with vascular occlusion ( kaatsu training ) induces muscle hypertrophy . A local hypoxic environment facilitates muscle hypertrophy during kaatsu training . We postulated that muscle hypertrophy can be more efficiently induced by placing the entire body in a hypoxic environment to induce muscle hypoxia followed by resistance training . METHODS Fourteen male university students were r and omly assigned to hypoxia ( Hyp ) and normoxia ( Norm ) groups ( n = 7 per group ) . Each training session proceeded at an exercise intensity of 70 % of 1 repetition maximum ( RM ) , and comprised four sets of 10 repetitions of elbow extension and flexion . Students exercised twice weekly for 6 wk and then muscle hypertrophy was assessed by magnetic resonance imaging and muscle strength was evaluated based on 1RM . RESULTS Muscle hypertrophy was significantly greater for the Hyp-Ex ( exercised flexor of the hypoxia group ) than for the Hyp-N ( nonexercised flexor of the hypoxia group ) or Norm-Ex flexor ( P < .05 , Bonferroni correction ) . Muscle hypertrophy was significantly greater for the Hyp-Ex than the Hyp-N extensor . Muscle strength was significantly increased early ( by week 3 ) in the Hyp-Ex , but not in the Norm-Ex group . CONCLUSION This study suggests that resistance training under hypoxic conditions improves muscle strength and induces muscle hypertrophy faster than under normoxic conditions , thus representing a promising new training technique This study investigates whether adaptations of mitochondrial function accompany the improvement of endurance performance capacity observed in well-trained athletes after an intermittent hypoxic training program . Fifteen endurance-trained athletes performed two weekly training sessions on treadmill at the velocity associated with the second ventilatory threshold ( VT2 ) with inspired O2 fraction = 14.5 % [ hypoxic group ( Hyp ) , n = 8 ] or with inspired O2 fraction = 21 % [ normoxic group ( Nor ) , n = 7 ] , integrated into their usual training , for 6 wk . Before and after training , oxygen uptake ( VO2 ) and speed at VT2 , maximal VO2 ( VO2 max ) , and time to exhaustion at velocity of VO2 max ( minimal speed associated with VO2 max ) were measured , and muscle biopsies of vastus lateralis were harvested . Muscle oxidative capacities and sensitivity of mitochondrial respiration to ADP ( Km ) were evaluated on permeabilized muscle fibers . Time to exhaustion , VO2 at VT2 , and VO2 max were significantly improved in Hyp ( + 42 , + 8 , and + 5 % , respectively ) but not in Nor . No increase in muscle oxidative capacity was obtained with either training protocol . However , mitochondrial regulation shifted to a more oxidative profile in Hyp only as shown by the increased Km for ADP ( Nor : before 476 + /- 63 , after 524 + /- 62 microM , not significant ; Hyp : before 441 + /- 59 , after 694 + /- 51 microM , P < 0.05 ) . Thus including hypoxia sessions into the usual training of athletes qualitatively ameliorates mitochondrial function by increasing the respiratory control by creatine , providing a tighter integration between ATP dem and and supply The aim of the present study was to evaluate the efficacy of intermittent hypoxic training ( IHT ) with 95 % of lactate threshold workload ( WRLT ) on aerobic capacity and endurance performance in well-trained cyclists . Twenty male elite cyclists , r and omly divided into a hypoxia ( H ) group ( n=10 ; age 22 ± 2.7years ; VO2max 67.8 ± 2.5 ml·kg(-1)·min(-1 ) ; body height ( BH ) 1.78 ± 0.05 m ; body mass ( BM ) 66.7 ± 5.4 kg ; fat free mass ( FFM ) 59.3 ± 5.1 kg ; fat content ( FAT% ) 11.3 ± 2.1 % ) , and a control ( C ) group ( n = 10 ; age 23.5 ± 3 . 5years ; VO2max 67.7 ± 2.0 ml·kg(-1)·min(-1 ) ; BH 1.79 ± 3.2 m ; BM 69.2 ± 5.5 kg ; FFM 63.6 ± 4.8 kg ; FAT% 7.9 ± 1.94 % ) took part in the research project . The training program used during the experiment was the same for the both groups . For three weeks , the subjects in H group performed 3 training sessions per week in normobaric hypoxia environment ( IHT - O2 = 15 . 2 % ) . During the elemental core of the IHT session , the intensity was set at 95 % WRLT for 30-min in 1(st ) microcycle , 35-min in 2(nd ) microcycle and 40-min in 3(rd ) microcycle . The same training procedure was provided in C group , yet the intensity of the main sessions were set at 100 % WRLT in the normoxia environment . The results indicate a significant ( p < 0.05 ) increase in VO2max , VO2LT , WRmax , WRLT and change in lactate concentration ( ∆LA ) during incremental test in H group . Also a significant ( p < 0.05 ) decrease in time of the time trial was seen , associated with a significant increase ( p < 0.05 ) in average generated power ( Pavg ) and average speed ( Vavg ) during the time trial . The intermittent hypoxic training ( IHT ) applied in this research did not significantly affect the hematological variables considered : number of erythrocytes ( RBC ) , hemoglobin concentration ( HGB ) and haematocrit value ( HCT ) . Significant blood value increases ( p < 0.05 ) were only observed in MCV in H group . This data suggests that intermittent hypoxic training at lactate threshold intensity and medium duration ( 30 - 40min ) is an effective training means for improving aerobic capacity and endurance performance at sea level . Key pointsThe efficacy of the intermittent hypoxic training is mostly dependent on volume and intensity of exercise in the hypoxic environment . The observed results suggests that intermittent hypoxic training at lactate threshold intensity and medium duration ( 30 - 40min ) is an effective training means for improving aerobic capacity and endurance performance at sea level Despite enhancing cardiopulmonary and muscular fitness , the effect of hypoxic exercise training ( HE ) on hemorheological regulation remains unclear . This study investigates how HE modulates erythrocyte rheological properties and further explores the underlying mechanisms in the hemorheological alterations . Twenty-four sedentary males were r and omly divided into hypoxic ( HE ; n = 12 ) and normoxic ( NE ; n = 12 ) exercise training groups . The subjects were trained on 60 % of maximum work rate under 15 % ( HE ) or 21 % ( NE ) O(2 ) condition for 30 min daily , 5 days weekly for 5 wk . The results demonstrated that HE 1 ) downregulated CD47 and CD147 expressions on erythrocytes , 2 ) decreased actin and spectrin contents in erythrocytes , 3 ) reduced erythrocyte deformability under shear flow , and 4 ) diminished erythrocyte volume changed by hypotonic stress . Treatment of erythrocytes with H(2)O(2 ) that mimicked in vivo prooxidative status result ed in the cell shrinkage , rigidity , and phosphatidylserine exposure , whereas HE enhanced the eryptotic responses to H(2)O(2 ) . However , HE decreased the degrees of clotrimazole to blunt ionomycin-induced shrinkage , rigidity , and cytoskeleton breakdown of erythrocytes , referred to as Gardos effects . Reduced erythrocyte deformability by H(2)O(2 ) was inversely related to the erythrocyte Gardos effect on the rheological function . Conversely , NE intervention did not significantly change resting and exercise erythrocyte rheological properties . Therefore , we conclude that HE rather than NE reduces erythrocyte deformability and volume regulation , accompanied by an increase in the eryptotic response to oxidative stress . Simultaneously , this intervention depresses Gardos channel-modulated erythrocyte rheological functions . Results of this study provide further insight into erythrocyte senescence induced by HE Buchheit , M , Kuitunen , S , Voss , SC , Williams , BK , Mendez- Villanueva , A , and Bourdon , PC . Physiological strain associated with high-intensity hypoxic intervals in highly trained young runners . J Strength Cond Res 26(1 ) : 94–105 , 2012—To examine the physiological strain associated with hypoxic high intensity interval training ( HHIT ) , 8 highly trained young runners ( age , 18.6 ± 5.3 years ) r and omly performed , 5 × 3-minute intervals in either normoxic ( N , 90 % of the velocity associated with & OV0312;O2max , ν&OV0312;O2max ) or hypoxic ( H , simulated 2,400-m altitude , 84 % of ν&OV0312;O2max ) conditions . Cardiorespiratory ( ventilation [ & OV0312;E ] , oxygen consumption [ & OV0312;O2 ] , heart rate [ HR ] , oxygen saturation [ SpO2 ] ) , rating of central perceived exertion ( RPEC ) responses , changes in neutrophils , erythropoietin ( EPO ) , blood lactate ( [ La ] ) and , bicarbonate ( [ HCO−3 ] ) , vagal-related indices of HR variability ( natural logarithm of the square root of the mean of the sum of the squares of differences [ Ln rMSSD ] ) and maximal sprint and jump performances were compared after each session . Compared with N , H was associated with similar & OV0312;E ( Cohen 's d ± 90 % confidence limits , 0.0 ± 0.4 , with % chances of higher/similar/lower values of 15/61/24 ) but at least lower & OV0312;O2 ( −0.8 ± 0.4 , 0/0/100 ) , HR ( −0.4 ± 0.4 , 1/21/78 ) , and SpO2 ( −1.8 ± 0.4 , 0/0/100 ) . Rating of perceived exertion was very likely higher ( + 0.5 ± 0.4 , 92/8/0 ) . Changes in [ HCO−3 ] ( −0.6 ± 0.8 , 5/13/83 ) , [ La ] ( + 0.2 ± 0.4 , 52/42/5 ) , and EPO ( + 0.2 ± 0.4 , 55/40/5 ) were at least possibly greater after H compared with those after N , whereas changes in neutrophils were likely lower ( −0.5 ± 0.7 , 4/15/81 ) . Changes in 20-m sprint time ( + 0.20 ± 0.23 , 49/50/1 ) were possibly lower after H. There was no clear difference in the changes in Ln rMSSD ( + 0.2 ± 1.7 , 48/18/34 ) and jump ( + 0.3 ± 0.9 , 60/25/15 ) . In conclusion , although perceived as harder , HHIT is not associated with an exaggerated physiological stress in highly trained young athletes . The present results also confirm that HHIT may not be optimal for training both the cardiorespiratory and neuromuscular determinants of running performance in this population Background The purpose of this study was to determine the effects of hypoxic training on the cardiorespiratory system and skeletal muscle among well-trained endurance athletes in a r and omized cross-over design . Methods Eight junior national level competitive cyclists were separated into two groups ; Group A trained under normoxic condition ( 21 % O2 ) for 2 hours/day , 3 days/week for 3 weeks while Group B used the same training protocol under hypoxic condition ( 15 % O2 ) . After 3 weeks of each initial training condition , five weeks of self-training under usual field conditions intervened before the training condition was switched from NT to HT in Group A , from HT to NT in Group B. The subjects were tested at sea level before and after each training period . O2 uptake ( O2 ) , blood sample s , and muscle deoxygenation were measured during bicycle exercise test . Results and Discussion No changes in maximal workload , arterial O2 content , O2 at lactate threshold and O2max were observed before or after each training period . In contrast , deoxygenation change during submaximal exercise in the vastus lateralis was significantly higher at HT than NT ( p < 0.01 ) . In addition , half time of oxygenation recovery was significantly faster after HT ( 13.2 ± 2.6 sec ) than NT ( 18.8 ± 2.7 sec ) ( p < 0.001 ) . Conclusions Three weeks of HT may not give an additional performance benefit at sea level for elite competitive cyclists , even though HT may induce some physiological adaptations on muscle tissue level The purpose of the current study was to determine the acute neuroendocrine response to hypertrophy ( H ) , strength ( S ) , and power ( P ) type resistance exercise ( RE ) equated for total volume . Ten male subjects completed three RE protocol s and a rest day ( R ) using a r and omized cross-over design . The protocol s included ( 1 ) H : 4 sets of 10 repetitions in the squat at 75 % of 1RM ( 90 s rest periods ) ; ( 2 ) S : 11 sets of three repetitions at 90 % of 1RM ( 5 min rest periods ) ; and ( 3 ) P : 8 sets of 6 repetitions of jump squats at 0 % of 1RM ( 3 min rest periods ) . Total testosterone ( T ) , cortisol ( C ) , and sex hormone binding globulin ( SHBG ) were determined prior to ( PRE ) , immediately post ( IP ) , 60 min post , 24 h post , and 48 h post exercise bout . Peak force , rate of force development , and muscle activity from the vastus medialis ( VM ) and biceps femoris ( BF ) were determined during a maximal isometric squat test . A unique pattern of response was observed in T , C , and SHBG for each RE protocol . The percent change in T , C , and SHBG from PRE to IP was significantly ( p ≤ 0.05 ) greater in comparison to the R condition only after the H protocol . The percent of baseline muscle activity of the VM at IP was significantly greater following the H compared to the S protocol . These data indicate that significant acute increases in hormone concentrations are limited to H type protocol s independent of the volume of work competed . In addition , it appears the H protocol also elicits a unique pattern of muscle activity as well . RE protocol s of varying intensity and rest periods elicit strikingly different acute neuroendocrine responses which indicate a unique physiological stimulus The effects of endurance training in normoxia or in hypoxia on time to exhaustion ( Tlim ) at the work rate corresponding to peak oxygen uptake ( V̇O2peak ) were examined at sea level in 13 healthy subjects . Before and after training the subjects performed the following : ( 1 ) incremental exercises up to exhaustion to determine peak oxygen uptake in normoxia ( V̇O2peakN ) , the percentage of this value at the 4 mmol l−1 blood lactate concentration ( V̇O24%N ) and the work rate corresponding to V̇O2peakN ( PapeakN ) , ( 2 ) a 5-min 90 % PapeakN exercise followed by a 10-min passive recovery to determine the maximal blood lactate concentration ( Lamax ) measured during the recovery , and ( 3 ) a Tlim at PapeakN. Training consisted of pedalling 2 h a day , 6 days a week , for 4 weeks . Five subjects trained in normobaric hypoxia [ HT ; partial pressure of inhaled oxygen ( PIO2 ) 89 mmHg ] and eight subjects trained at the same relative work rates in normoxia ( NT ; PIO2 141 mmHg ) . The training-induced improvement of all the measured parameters were closely matched between the HT and the NT ( P>0.05 ) . Training increased Tlim by 59.7 % [ 164(40 ) s ] . The value of Tlim was related to V̇O24%N and to Lamax before and after training . Also , the training-induced improvement of Tlim was related to the concomitant decrease in Lamax . It is concluded that : ( 1 ) endurance training including continuous high-intensity exercises improves Tlim for exercises performed at the same relative ( higher absolute ) work rate after training , ( 2 ) intermittent hypoxic training has no potentiating effect on Tlim as compared with training in normoxia , and ( 3 ) the intra-individual training-induced improvement of Tlim was associated with metabolic alteration in relation to lactate accumulation Cross-sectional studies in endurance athletes have demonstrated a diminished hypoxic ventilatory response ( HVR ) compared with mountaineers or sedentary controls . Conversely , short-term altitude acclimatization may increase the HVR . The longitudinal effect of training , either at sea level or altitude , on HVR has not been previously reported . We therefore studied 21 untrained men and women before and after 5 wk of cycle ergometer training at either sea level or 2,500 m. HVR was determined using the steady-state method ( 16 ) . Minute ventilation ( VE ) was measured with a Tissot spirometer during the last minute of 5 min breathing room air , 8 % and 12 % O2 , administered in r and om order . CO2 was added at the mouth in an effort to maintain end-tidal CO2 at baseline levels . Oxyhemoglobin saturation was measured directly from arterial blood with a hemoximeter ( OSM 3 ) . HVR was defined as the positive slope of the line relating VE to O2 saturation in l.min-1%-1 . One group of subjects trained at sea level at 70 % maximal oxygen uptake ( VO2max ; N = 7 ) . A second group trained at 2,500 m in a hypobaric chamber , at the same relative exercise intensity ( i.e. , 70 % altitude VO2max ) or same absolute intensity ( same power output ) as group 1 ( N = 14 ) . Both groups trained on a bicycle ergometer for 45 min.d-1 , 5 d.wk-1 for 5 wk . ( ABSTRACT TRUNCATED AT 250 WORDS OBJECTIVES To investigate the effect of blood flow restriction or normobaric hypoxic exposure combined with low-load resistant exercise ( LRE ) , on muscular strength and endurance . DESIGN A r and omised controlled trial . METHODS Well-trained netball players ( n=30 ) took part in a 5 weeks training of knee flexor and extensor muscles in which LRE ( 20 % of one repetition maximum ) was combined with ( 1 ) an occlusion pressure of approximately 230mmHg around the upper thigh ( KT , n=10 ) , ( 2 ) hypoxic air to generate blood oxyhaemoglobin levels of approximately 80 % ( HT , n=10 ) or ( 3 ) with no additional stimulus ( CT , n=10 ) . The training was of the same intensity and amount in all groups . One to five days before and after training , participants performed a series of strength and endurance tests of the lower limbs ( 3-s maximal voluntary contraction [ MVC3 ] , area under 30-s force curve [ MVC30 ] , number of repetitions at 20 % 1RM [ Reps201RM ] ) . In addition , the cross-sectional area ( CSA ) of the quadriceps and hamstrings were measured . RESULTS Relative to CT , KT and HT increased MVC3 ( 11.0±11.9 % and 15.0±13.1 % ) , MVC30 ( 10.2±9.0 % and 18.3±17.4 % ) and Reps201RM ( 28.9±23.7 % and 23.3±24.0 % , mean±90 % confidence interval ) after training . CSA increased by 6.6±4.5 % , 6.1±5.1 % and 2.9±2.7 % in the KT , HT and CT groups respectively . CONCLUSIONS LRE in conjunction with KT or HT can provide substantial improvements in muscle strength and endurance and may be useful alternatives to traditional training practice PURPOSE Little research has been done on the physiological and performance effects of altitude training on team-sport athletes . Therefore , this study examined changes in 2000-m time-trial running performance ( TT ) , hemoglobin mass ( Hbmass ) , and intramuscular carnosine content of elite Australian Football ( AF ) players after a preseason altitude camp . METHODS Thirty elite AF players completed 19 days of living and training at either moderate altitude ( ~2130 m ; ALT , n = 21 ) or sea level ( CON , n = 9 ) . TT performance and Hbmass were assessed preintervention ( PRE ) and postintervention ( POST1 ) in both groups and at 4 wk after returning to sea level ( POST2 ) in ALT only . RESULTS Improvement in TT performance after altitude was likely 1.5 % ( ± 4.8 - 90%CL ) greater in ALT than in CON , with an individual responsiveness of 0.8 % . Improvements in TT were maintained at POST2 in ALT . Hbmass after altitude was very likely increased in ALT compared with CON ( 2.8 % ± 3.5 % ) , with an individual responsiveness of 1.3 % . Hbmass returned to baseline at POST2 . Intramuscular carnosine did not change in either gastrocnemius or soleus from PRE to POST1 . CONCLUSIONS A preseason altitude camp improved TT performance and Hbmass in elite AF players to a magnitude similar to that demonstrated by elite endurance athletes undertaking altitude training . The individual responsiveness of both TT and Hbmass was approximately half the group mean effect , indicating that most players gained benefit . The maintenance of running performance for 4 wk , despite Hbmass returning to baseline , suggests that altitude training is a valuable preparation for AF players leading into the competitive season Peak aerobic power in humans ( VO2,peak ) is markedly affected by inspired O2 tension ( FIO2 ) . The question to be answered in this study is what factor plays a major role in the limitation of muscle peak VO2 in hypoxia : arterial O2 partial pressure ( Pa , O2 ) or O2 content ( Ca , O2 ) ? Thus , cardiac output ( dye dilution with Cardio-green ) , leg blood flow ( thermodilution ) , intra-arterial blood pressure and femoral arterial-to-venous differences in blood gases were determined in nine lowl and ers studied during incremental exercise using a large ( two-legged cycle ergometer exercise : Bike ) and a small ( one-legged knee extension exercise : Knee)muscle mass in normoxia , acute hypoxia ( AH ) ( FIO2 = 0.105 ) and after 9 weeks of residence at 5260 m ( CH ) . Reducing the size of the active muscle mass blunted by 62 % the effect of hypoxia on VO2,peak in AH and abolished completely the effect of hypoxia on VO2,peak after altitude acclimatization . Acclimatization improved Bike peak exercise Pa , O2 from 34 + /- 1 in AH to 45 + /- 1 mmHg in CH(P < 0.05 ) and Knee Pa , O2 from 38 + /- 1 to 55 + /- 2 mmHg(P < 0.05 ) . Peak cardiac output and leg blood flow were reduced in hypoxia only during Bike . Acute hypoxia result ed in reduction of systemic O2 delivery ( 46 and 21 % ) and leg O2 delivery ( 47 and 26 % ) during Bike and Knee , respectively , almost matching the corresponding reduction in VO2,peak . Altitude acclimatization restored fully peak systemic and leg O(2 ) delivery in CH ( 2.69 + /- 0.27 and 1.28 + /- 0.11 l min(-1 ) , respectively ) to sea level values ( 2.65 + /- 0.15 and 1.16 + /- 0.11 l min(-1 ) , respectively ) during Knee , but not during Bike . During Knee in CH , leg oxygen delivery was similar to normoxia and , therefore , also VO2,peak in spite of a Pa , O2 of 55 mmHg . Reducing the size of the active mass improves pulmonary gas exchange during hypoxic exercise , attenuates the Bohr effect on oxygen uploading at the lungs and preserves sea level convective O2 transport to the active muscles . Thus , the altitude-acclimatized human has potentially a similar exercising capacity as at sea level when the exercise model allows for an adequate oxygen delivery ( blood flow x Ca , O2 ) , with only a minor role of Pa , O2 per se , when Pa , O2 is more than 55 mmHg PURPOSE This study examined the effect of 1 wk of normobaric intermittent hypoxic exposure ( IHE ) combined with exercise training on endurance performance at a 4300-m altitude ( HA ) . METHODS Seventeen male lowl and ers were divided into an IHE ( n = 11 ) or SHAM ( n = 6 ) group . Each completed cycle endurance testing consisting of two 20-min steady state ( SS ) exercise bouts ( at 40 % and 60 % V O2peak ) followed by a 10-min break and then a 720-kJ cycle time trial at HA before IHE or SHAM treatment ( Pre-T ) . IHE treatment consisted of a 2-h rest at a PO2 of 90 mm Hg followed by two 25-min bouts of exercise at approximately 80 % of peak HR at a PO2 of 110 mm Hg for 1 wk in a hypoxia room . SHAM treatment was identical except that the PO2 was 148 mm Hg for both rest and exercise . After IHE or SHAM treatment ( Post-T ) , all completed a second cycle endurance test at HA . HR , arterial oxygen saturation ( SaO2 ) , and RPE were obtained from the 10th to the 15th minute during the two SS exercise bouts and every 5 min during the time trial . RESULTS Seven volunteers in the IHE group could not finish the 720-kJ time trial either at Pre-T or at Post-T. Time trial analysis was limited , therefore , to the time to reach 360 kJ ( halfway point ) for all volunteers . From Pre-T to Post-T , there was no improvement in time trial performance ( min + /- SE ) in the IHE ( 62.0 + /- 4.8 to 63.7 + /- 5.2 ) or SHAM ( 60.9 + /- 6.3 to 54.2 + /- 6.8 ) group . There was no change from Pre-T to Post-T in HR , SaO2 , and RPE during the two SS exercise bouts or time trial in either group . CONCLUSIONS One week of IHE combined with exercise training does not improve endurance performance at a 4300-m altitude in male lowl and ers Oxidant generation during regular physical exercise training may influence the adaptive responses that have been shown to confer protection against oxidative stress induced by subsequent acute exercise . To examine this , we r and omly assigned 32 males to either a normoxic ( n=14 ) or a hypoxic ( n=18 ) group . During the acute phase , subjects in the hypoxic group performed two maximal cycling tests in a r and omized double-blind fashion : one under conditions of normoxia and the other under hypoxic conditions ( inspired fraction of O(2)=0.21 and 0.16 respectively ) . During the intermittent phase , the normoxic and hypoxic groups each trained for 4 weeks at the same relative exercise intensity , under conditions of normoxia and hypoxia respectively . During acute exercise under hypoxic conditions , the venous concentrations of lipid hydroperoxides and malondialdehyde were increased , despite a comparatively lower maximal oxygen uptake ( VO(2max ) ) ( P<0.05 compared with normoxia ) . The increases in lipid hydroperoxides and malondialdehyde were correlated with the exercise-induced decrease in arterial haemoglobin oxygen saturation ( r=-0.61 and r=-0.50 respectively ; P<0.05 ) , but not with VO(2max ) . Intermittent hypoxic training attenuated the increases in lipid hydroperoxides and malondialdehyde induced by acute normoxic exercise more effectively than did normoxic training , due to a selective mobilization of alpha-tocopherol ( P<0.05 ) . The latter was related to enhanced exercise-induced mobilization/oxidation of blood lipids due to a selective increase in VO(2max ) ( P<0.05 compared with normoxic group ) . We conclude that lipid peroxidation induced by acute exercise ( 1 ) increases during hypoxia ; ( 2 ) is not regulated exclusively by a mass action effect of VO(2 ) ; and ( 3 ) is selectively attenuated by regular hypoxic training . Oxidative stress may thus be considered as a biological prerequisite for adaptation to physical stress in humans This study was undertaken to test the hypothesis that endurance training in hypoxia is superior to training of the same intensity in normoxia . To avoid adaptation to hypoxia , the subjects lived under normoxic conditions when not training . A secondary objective of this study was to compare the effect of high- vs. moderate-intensity training on aerobic performance variables . Thirty-three men without prior endurance training underwent a cycle ergometer training of 6 weeks , 5 d/week , 30 minutes/d . The subjects were assigned to 4 groups , N-high , N-low , H-high and H-low based on the training criteria normoxia ( N ; corresponding to a training altitude of 600 m ) , vs. hypoxia ( H ; training altitude 3850 m ) and intensity ( high ; corresponding to 80 % and low : corresponding to 67 % of VO2max ) . VO2max measured in normoxia increased between 8.5 to 11.1 % , independent of training altitude or intensity . VO2max measured in hypoxia increased between 2.9 and 7.2 % . Hypoxia training result ed in significantly larger increases than normoxia training . Maximal power that subjects could maintain over a thirty-minute period ( measured in normoxia or hypoxia ) increased from 12.3 - 26.8 % independent of training altitude . However , subjects training at high intensity increased performance more than subjects training at a low intensity . Muscle volume of the knee-extensors as measured by magnetic resonance imaging increased significantly in the H-high group only ( + 5.0 % ) . Mitochondrial volume density measured by EM-morphometry in biopsy sample s of m. vastus lat . increased significantly in all groups with the highest increase seen in the H-high group ( + 59 % ) . Capillary length density increased significantly in the H-high group only ( + 17.2 % ) . The main finding of this study is that in previously untrained people , training in hypoxia while living at low altitude increases performance in normoxia to the same extent as training in normoxia , but leads to larger increases of aerobic performance variables when measured under hypoxic conditions . Training intensity had no effect on the gain of VO2max . On the level of skeletal muscle tissue , the combination of hypoxia with high training intensity constitutes the most effective stimulus for increasing muscle oxidative capacity This study was performed to investigate the effect of training under simulated hypoxic conditions . Hypoxia training was integrated into the normal training schedule of 12 endurance trained cyclists . Athletes were r and omly assigned to two groups and performed three additional training bouts per week for six weeks on a bicycle ergometer . One group ( HG ) trained at the anaerobic threshold under hypoxic conditions ( corresponding to an altitude of 3200 m ) while the control group ( NG ) trained at the same relative intensity at 560 m. Preceding and following the six training weeks , performance tests were performed under normoxic and hypoxic conditions . Normoxic and hypoxic .VO2max , maximal power output as well as hypoxic work-capacity were not improved after the training period . Testing under hypoxic conditions revealed a significant increase in oxygen saturation ( SpO 2 , from 67.1 + /- 2.3 % to 70.0 + /- 1.7 % ) and in maximal blood lactate concentration ( from 7.0 to 9.1 mM ) in HG only . Ferritin levels were decreased from 67.4 + /- 16.3 to 42.2 + /- 9.5 microg/l ( p < 0.05 ) in the HG and from 54.3 + /- 6.9 to 31.4+/- 8.0 microg/l ( p = 0.17 ) in the NG . Reticulocytes were significantly increased in both groups by a factor of two . In conclusion , the integration of six weeks of high intensity endurance training did not lead to improved performance in endurance trained athletes whether this training was carried out in hypoxic or normoxic conditions PURPOSE The aim of this study was to test the hypothesis that intermittent hypoxic interval training improves sea level cycling performance more than equivalent training in hypoxia or normoxia . METHODS Thirty-three well-trained cyclists and triathletes ( 25.9 + /- 2.7 yr , VO(2max ) 66.1 + /- 6.1 mL.min(-1).kg(-1 ) ) were divided into three groups : intermittent hypoxic ( IHT , N = 11 , P(I)O(2 ) of 100 mm Hg ) , intermittent hypoxic interval training ( IHIT , N = 11 ) and normoxia ( Nor , N = 11 , P(I)O(2 ) of 160 mm Hg ) and completed a 7-wk training program , consisting of two high-intensity ( 100 or 90 % relative peak power output ) interval training sessions each week . Each interval training session was performed in a laboratory on the subject 's own bicycle , in normoxic or hypoxic conditions for the Nor and the IHT group , respectively . The IHIT group performed warm-up and cool-down plus recovery from each interval in hypoxic conditions . In contrast to IHT , interval exercise bouts were performed in normoxic conditions . RESULTS Mean power output during a 10-min cycle time trial improved after the first 4 wk of training by 5.2 + /- 3.9 , 3.7 + /- 5.9 , and 5.0 + /- 3.4 % for IHIT , IHT , and Nor , respectively , without significant differences between groups . Moreover , mean power output did not show any significant improvement in the following 3 wk in any group . VO(2max ) ( L.min(-1 ) ) increased only in IHIT during the training period ( 8.7 + /- 9.1 % ; P < 0.05 ) . No changes in cycling efficiency or in hematological variables ( P > 0.05 ) were observed . CONCLUSION Four weeks of interval training induced an improvement in endurance performance . However , short-term exposure to hypoxia ( approximately 114 min.wk(-1 ) ) did not elicit a greater increase in performance or any hematological modifications |
363 | 31,885,540 | Generally , according to the review ed studies , behavioral performance is enhanced in those aspects for which both the deprived and the overtaking senses provide adequate processing re sources .
Furthermore , the behavioral enhancements observed in the overtaking sense ( i.e. , vision in the case of deafness and audition in the case of blindness ) are clearly limited by the processing re sources of the overtaking modality .
Thus , the brain regions that were previously recruited during the behavioral performance of the deprived sense now support a similar behavioral performance for the overtaking sense .
This finding suggests a more input-unspecific and processing principle-based organization of the brain . | One of the most significant effects of neural plasticity manifests in the case of sensory deprivation when cortical areas that were originally specialized for the functions of the deprived sense take over the processing of another modality .
Vision and audition represent two important senses needed to navigate through space and time .
Therefore , the current systematic review discusses the cross-modal behavioral and neural consequences of deafness and blindness by focusing on spatial and temporal processing abilities , respectively .
In addition , movement processing is evaluated as compiling both spatial and temporal information .
We examine whether the sense that is not primarily affected changes in its own properties or in the properties of the deprived modality ( i.e. , temporal processing as the main specialization of audition and spatial processing as the main specialization of vision ) . | Several studies have demonstrated enhanced auditory processing in the blind , suggesting that they compensate their visual impairment in part with greater sensitivity of the other senses . However , several physiological studies show that early visual deprivation can impact negatively on auditory spatial localization . Here we report for the first time severely impaired auditory localization in the congenitally blind : thresholds for spatially bisecting three consecutive , spatially-distributed sound sources were seriously compromised , on average 4.2-fold typical thresholds , and half performing at r and om . In agreement with previous studies , these subjects showed no deficits on simpler auditory spatial tasks or with auditory temporal bisection , suggesting that the encoding of Euclidean auditory relationships is specifically compromised in the congenitally blind . It points to the importance of visual experience in the construction and calibration of auditory spatial maps , with implication s for rehabilitation strategies for the congenitally blind We compared normally hearing individuals and congenitally deaf individuals as they monitored moving stimuli either in the periphery or in the center of the visual field . When participants monitored the peripheral visual field , greater recruitment ( as measured by functional magnetic resonance imaging ) of the motion-selective area MT/MST was observed in deaf than in hearing individuals , whereas the two groups were comparable when attending to the central visual field . This finding indicates an enhancement of visual attention to peripheral visual space in deaf individuals . Structural equation modeling was used to further characterize the nature of this plastic change in the deaf . The effective connectivity between MT/MST and the posterior parietal cortex was stronger in deaf than in hearing individuals during peripheral but not central attention . Thus , enhanced peripheral attention to moving stimuli in the deaf may be mediated by alterations of the connectivity between MT/MST and the parietal cortex , one of the primary centers for spatial representation and attention An important issue in neuroscience is the effect of visual loss on the remaining senses . Two opposing views have been advanced . On the one h and , visual loss may lead to compensatory plasticity and sharpening of the remaining senses . On the other h and , early blindness may also prevent remaining sensory modalities from a full development . In the case of sound localization , it has been reported recently that , under certain conditions , early-blind humans can localize sounds better than sighted controls . However , these studies were confined to a single sound source in the horizontal plane . This study compares sound localization of early-blind and sighted subjects in both the horizontal and vertical domain , whereas background noise was added to test more complex hearing conditions . The data show that for high signal-to-noise ( S/N ) ratios , localization by blind and sighted subjects is similar for both azimuth and elevation . At decreasing S/N ratios , the accuracy of the elevation response components deteriorated earlier than the accuracy of the azimuth component in both subject groups . However , although azimuth performance was identical for the two groups , elevation accuracy deteriorated much earlier in the blind subject group . These results indicate that auditory hypercompensation in early-blind humans does not extend to the frontal target domain , where the potential benefit of vision is maximal . Moreover , the results demonstrate for the first time that in this domain the human auditory system may require vision to optimally calibrate the elevation-related spectral pinna cues . Sensitivity to azimuth-encoding binaural difference cues , however , may be adequately calibrated in the absence of vision Evidence from functional neuroimaging studies suggests that the auditory cortex can become more responsive to visual and somatosensory stimulation following deafness , and that this occurs predominately in the right hemisphere . Extensive cross-modal plasticity in prospect i ve cochlear implant recipients is correlated with poor speech outcomes following implantation , highlighting the potential impact of central auditory plasticity on subsequent aural rehabilitation . Conversely , the effects of hearing restoration with a cochlear implant on cortical plasticity are less well understood , since the use of most neuroimaging techniques in CI recipients is either unsafe or problematic due to the electromagnetic artefacts generated by CI stimulation . Additionally , techniques such as functional magnetic resonance imaging ( fMRI ) are confounded by acoustic noise produced by the scanner that will be perceived more by hearing than by deaf individuals . Subsequently it is conceivable that auditory responses to acoustic noise produced by the MR scanner may mask auditory cortical responses to non-auditory stimulation , and render inter-group comparisons less significant . Uniquely , functional near-infrared spectroscopy ( fNIRS ) is a silent neuroimaging technique that is non-invasive and completely unaffected by the presence of a CI . Here , we used fNIRS to study temporal-lobe responses to auditory , visual and somatosensory stimuli in thirty profoundly-deaf participants and thirty normally-hearing controls . Compared with silence , acoustic noise stimuli elicited a significant group fNIRS response in the temporal region of normally-hearing individuals , which was not seen in profoundly-deaf participants . Visual motion elicited a larger group response within the right temporal lobe of profoundly-deaf participants , compared with normally-hearing controls . However , bilateral temporal lobe fNIRS activation to somatosensory stimulation was comparable in both groups . Using fNIRS these results confirm that auditory deprivation is associated with cross-modal plasticity of visual inputs to auditory cortex . Although we found no evidence for plasticity of somatosensory inputs , it is possible that our recordings may have included activation of somatosensory cortex that masked any group differences in auditory cortical responses due to the limited spatial resolution associated with fNIRS Several studies have reported that the early-blind displays higher auditory spatial abilities than the sighted . Although many studies have attempted to delineate the cortical structures that undergo functional reorganization in blind people , few have tried to determine which auditory or non-auditory processes mediate these increased auditory spatial abilities . The aim of this paper is to investigate the role of eye movements and orientation of attention in auditory localization in blind humans . Although we found , in a first experiment , that the influence of eye movements on auditory spatial localization is preserved in spite of congenital visual deprivation , the saccade influence on spatial hearing is not more pronounced in the blind than in the sighted . In a second experiment , early-blind and sighted subjects undertook a task involving discrimination of sound elevation in which auditory targets followed uninformative auditory cues on either side with an intermediate elevation . When sounds were emitted from the frontal hemifield , both groups showed similar auditory localization performance . Although the auditory cue did not affect discrimination accuracy in both groups , early-blind subjects exhibited shorter reaction times than sighted subjects when sound sources were placed at far-lateral locations . Attentional cues , however , had similar effects on both groups of subjects , suggesting that improved auditory spatial abilities are not mediated by attention orienting mechanisms In a series of three experiments , we tested whether deaf native signers process motion velocity information differently from hearing nonsigners . In Experiment 1 , participants watched radially moving dots and were asked to detect the quadrant in which the velocity of the dots had changed . Similar 79 % thresholds were observed in the two population s. In Experiments 2 and 3 , peripheral and central thresholds were assessed separately as previous studies suggest early deafness leads mainly to changes in the processing of visual peripheral information . Neither condition produced an overall population difference . These negative results were not due to a lack of sensitivity in our experiments . Indeed , as has been previously reported , deaf native signers exhibited better thresholds in the right than in the left visual field , whereas the opposite pattern was observed in the hearing . This effect appears triggered by experience with American Sign Language ( ASL ) rather than deafness per se . Overall , this study confirms that early deafness does not enhance motion processing , and suggests that most of the changes previously described in the literature are instead attributable to changes in attention , and possibly special alterations of attention-to-motion processes Previous neuroimaging studies devoted to auditory motion processing have shown the involvement of a cerebral network encompassing the temporoparietal and premotor areas . Most of these studies were based on a comparison between moving stimuli and static stimuli placed at a single location . However , moving stimuli vary in spatial location , and therefore motion detection can include both spatial localisation and motion processing . In this study , we used fMRI to compare neural processing of moving sounds and static sounds in various spatial locations in blindfolded sighted subjects . The task consisted of simultaneously determining both the nature of a sound stimulus ( pure tone or complex sound ) and the presence or absence of its movement . When movement was present , subjects had to identify its direction . This comparison of how moving and static stimuli are processed showed the involvement of the parietal lobules , the dorsal and ventral premotor cortex and the planum temporale during auditory motion processing . It also showed the specific recruitment of V5 , the visual motion area . These results suggest that the previously proposed network of auditory motion processing is distinct from the network of auditory localisation . In addition , they suggest that the occipital cortex can process non-visual stimuli and that V5 is not restricted to visual processing It is widely held that early-blind people compensate their visual loss by a general sharpening of spatial hearing . The present study reports a possible exception to this view : when the vertical position ( elevation ) of a sound source had to be localized , four out of six early-blind subjects exhibited systematic deviations in pointing , while two early-blind subjects were as accurate as sighted controls . On the other h and , blind and sighted individuals were able to judge relative positions of different sound locations with similar precision . These results suggest that visual experience may be used to accurately calibrate the relation between the vertical coordinates of auditory space and body , but is not needed to develop sufficiently high resolution of spatial hearing Studies using fMRI have demonstrated that visual stimuli activate auditory cortex in deaf subjects . Given the low temporal resolution of fMRI , it is uncertain whether this activation is associated with initial stimulus processing . Here , we used MEG in deaf and hearing subjects to evaluate whether auditory cortex , devoid of its normal input , comes to serve the visual modality early in the course of stimulus processing . In line with previous findings , visual activity was observed in the auditory cortex of deaf , but not hearing , subjects . This activity occurred within 100–400 ms of stimulus presentation and was primarily over the right hemisphere . These results add to the mounting evidence that removal of one sensory modality in humans leads to neural reorganization of the remaining modalities This functional magnetic resonance imaging study investigated the impact of early auditory deprivation and /or use of a visuospatial language [ American sign language ( ASL ) ] on the organization of neural systems important in visual motion processing by comparing hearing controls with deaf and hearing native signers . Participants monitored moving flowfields under different conditions of spatial and featural attention . Recruitment of the motion-selective area MT – MST in hearing controls was observed to be greater when attention was directed central ly and when the task was to detect motion features , confirming previous reports that the motion network is selectively modulated by different aspects of attention . More importantly , we observed marked differences in the recruitment of motion-related areas as a function of early experience . First , the lateralization of MT – MST was found to shift toward the left hemisphere in early signers , suggesting that early exposure to ASL leads to a greater reliance on the left MT – MST . Second , whereas the two hearing population s displayed more MT – MST activation under central than peripheral attention , the opposite pattern was observed in deaf signers , indicating enhanced recruitment of MT – MST during peripheral attention after early deafness . Third , deaf signers , but neither of the hearing population s , displayed increased activation of the posterior parietal cortex , supporting the view that parietal functions are modified after early auditory deprivation . Finally , only in deaf signers did attention to motion result in enhanced recruitment of the posterior superior temporal sulcus , establishing for the first time in humans that this polymodal area is modified after early sensory deprivation . Together these results highlight the functional and regional specificity of neuroplasticity in humans Early-onset blindness ( EB ) produces measurable advantages in auditory perception , attention , memory and language . Neville and Bavelier [ Neville , H. J. , & Bavelier , D. ( 2001 ) Variability of developmental plasticity . In J. L. McClell and , R. S. Siegler ( Eds . ) Mechanisms of cognitive development : Behavioral and ellon symposia on cognition ( pp . 271 - 301 ) ] hypothesized that faster temporal processing underlies many auditory compensatory effects in the blind . We tested this hypothesis by comparing early-onset blind individuals and sighted counterparts ( SC ) by assessing their rates of perceptual consolidation , the accurate perceptual representation of auditory stimuli . Firstly , we first tested both groups on a temporal-order judgment task ( TOJ ) . EB subjects had significantly lower TOJ thresholds than the SC subjects . Secondly , we assessed perceptual consolidation speed using auditory backward masking tasks , taking into account individual TOJ thresholds . Discrimination performance was unaffected at all mask delays in the EB group while the SC subjects needed a mask delay of 160 ms to perform comparably . A backward masking task using single tone stimuli found no differences between the EB and SC groups any mask delay . A simultaneous masking task demonstrated that the mask effectively impaired discrimination in EB subjects at sensory stages . These results suggest that advantages in perceptual consolidation may reflect a mechanism responsible for the short response times and better performance reported in early blind individuals across a number of complex auditory tasks Many studies have reported that blind people compensate for their visual deficit by sharpening auditory processes . Here we compare the sensitivity to echo cues between blind and sighted subjects . In the first experiment , the blind subjects were more accurate than the sighted subjects in localizing an object on the basis of echo cues . To ensure that enhanced echolocalization abilities were not only due to the fact that blind individuals are more used to consciously paying attention to echo cues and are more familiar with this kind of tasks than sighted subjects , we tested both groups of subjects in a simple azimuthal localization task of auditory stimuli . In this second experiment , we evaluated the influence of irrelevant echo signals on auditory localization by placing the subjects and the sound sources at different positions in a sound reverberant room . Results revealed that blind subjects exhibit a higher sensitivity to echo signals than sighted subjects Cross-modal plasticity in deaf subjects is still discussed controversial . We tried to figure out whether the plasticity is dependent on the extent of hearing loss . Three groups of volunteers , comprising twelve individuals each , were investigated . They were characterized by three distinctive features , one had normal hearing , the other one lost hearing and the third had only minimal residual hearing ability . All participants , except those of group one , were capable of using German Sign Language ( GSL ) . The groups were studied with functional MRI in a st and ard block design during individuals ' watching sign language videos alternating with black frame . During sign language conditions , deaf subjects revealed a significant activation of the auditory cortex in both hemispheres comprising Brodmann areas ( BA ) 42 and 22 corresponding to the secondary associative auditory areas . Additionally , activation of the angular and supramarginal gyrus was seen . Activation of the primary auditory cortex was revealed in deaf subjects with total hearing loss during sign language tasks but not in subjects with residual hearing ability . In conclusion our results indicate a cortical reorganization of the auditory cortex comprising primary auditory fields only present in subjects with total hearing loss |
364 | 22,759,840 | Overall , the functional outcome ( measured with the Constant score ) was better in the surgically treated groups than in the conservatively treated groups .
Surgical treatment of acute , displaced midshaft clavicle fractures with a plate yields a better functional outcome and lower mal- and nonunion rates than conservative treatment .
However , the clinical relevance of the observed functional benefits are question able as is the use of the shoulder outcome scores frequently employed to assess the functional outcome of clavicle fracture treatment .
When operative treatment is preferred , the number needed to treat to avoid a nonunion is high | INTRODUCTION The optimal treatment of acute , displaced midshaft clavicle fractures is controversial .
Despite lack of compelling evidence towards superior results after primary surgery , it seems that more and more patients are treated surgically .
The aim of this study was to investigate which treatment modality should be preferred in this population according to current literature . | OBJECTIVES To evaluate the outcome and satisfaction of closed treatment versus open reduction and internal fixation in comminuted clavicular fractures . METHODS Sixty patients with displaced clavicular fractures were r and omized into operative ( 29 patients ) and nonoperative ( 31 patients ) groups . Three patients in the operative group did not accept the surgery , and seven patients in the nonoperative group did not complete the one-year follow-up . Outcomes were assessed using the Disability of the Arm , Shoulder and H and ( DASH ) score , Constant shoulder score , specific questions regarding patients ' final satisfaction , physical examination , measurement of the shortening of the clavicular length , and plain radiographs . RESULTS There was one nonunion in the operative group and one in the nonoperative group . The nonunion in operative group was the result of the only infection in this group . Four malunions were developed in the operative group and nineteen malunions in the nonoperative treatment , ( p<0.001 ) . Three patients in the operative group were completely dissatisfied with their treatment . Eighteen patients in the nonoperative group were partially satisfied . Pain was the main reason for dissatisfaction in this group . The mean shortening of the clavicle was 26.5 mm in the nonoperative group and 4.0 mm in the operative group . The mean DASH score for the operative and nonoperative groups were 8.6 and 21.3 , respectively ( p<0.001 ) ; and the Constant shoulder scores were 89.8 and 78.8 ( p<0.001 ) . CONCLUSION Open reduction and internal fixation of comminuted fractures of the clavicle using a reconstruction plate is an effective treatment modality . Despite the variety of complications , this method has a higher satisfaction rate than conservative treatment BACKGROUND Recent literature supports surgical intervention for shortened , displaced , mid-shaft clavicle fractures . We present the results of a r and omized clinical trial comparing locked intramedullary fixation and plate fixation for short , displaced , mid-shaft clavicle fractures . MATERIAL S AND METHODS Local ethical approval was obtained and power analysis and sample size calculations were performed prior to commencement . Patients r and omized to 2 groups to be treated with either locked intramedullary fixation or plating . Patients regularly followed up to clinical and radiographic union . The primary outcome measure was the Constant score , secondary outcome measures included the Oxford shoulder score , union rate , and complication rates . RESULTS Seventeen patients were r and omized to locked intramedullary fixation and 15 r and omized to plating . Mean age was 29.3 years . Mean follow-up was 12.4 months . There was no significant difference in either Constant scores ( P = .365 ) or Oxford scores ( P = .773 ) . There was 100 % union in both groups . In the intramedullary group , 1 case of soft tissue irritation settled after the pin removal ; 1 pin backed out and was revised . Three superficial wound infections result ed in plate removal and 8 plates ( 53 % ) were removed . DISCUSSION Intramedullary fixation has the theoretical advantage of preserving the periosteal blood supply , but carries the morbidity of pin removal . Clavicle plates are not routinely removed but require greater exposure and may compromise periosteal blood supply . CONCLUSION Both locked intramedullary fixation and plating produce good functional results ; however , metalwork may need to be removed as a second procedure We developed a 12-item question naire for completion by patients having shoulder operations other than stabilisation . A prospect i ve study of 111 patients was undertaken before operation and at follow-up six months later . Each patient completed the new question naire and the SF36 form . Some filled in the Stanford Health Assessment Question naire ( HAQ ) . An orthopaedic surgeon assessed the Constant shoulder score . The single score derived from the question naire had a high internal consistency . Reproducibility , examined by test-retest reliability , was found to be satisfactory . The validity of the question naire was established by obtaining significant correlations in the expected direction with the Constant score and the relevant scales of the SF36 and the HAQ . Sensitivity to change was assessed by analysing the differences between the preoperative scores and those at follow-up . Changes in scores were compared with the patients ' responses to postoperative questions about their condition . The st and ardised effect size for the new question naire compared favourably with that for the SF36 and the HAQ . The new question naire was the most efficient in distinguishing patients who said that their shoulder was much better from all other patients . The shoulder question naire provides a measure of outcome for shoulder operations which is short , practical , reliable , valid and sensitive to clinical ly important changes Objectives : To compare results of primary internal fixation of acute displaced midshaft clavicle fractures with those managed nonoperatively in terms of fracture union and functional outcome . Design : Prospect i ve cohort study . Setting : Level II military trauma center . Patients / Participants : Seventy-three patients ( civilian and military ) between 20 and 50 years of age with displaced midshaft clavicle fractures were allocated either to the operative ( n = 45 ) or nonoperative ( n = 28 ) group . Intervention : Patients in the nonoperative group were managed by simple sling immobilization , whereas in the operative group , fractures were reduced and fixed with a contoured reconstruction plate . Main Outcome Measurements : The patients were actively followed up during an 18-month period . Primary outcome measures were the rates of nonunion and symptomatic malunion ; secondary outcomes included the assessment of the Constant score and the overall local complication rate . Results : The 18-month follow-up rate was 90 % . All fractures in the operative group united compared with eight nonunions ( 29 % ) in the nonoperative group ( P = 0.002 ) . Ten symptomatic malunions ( 36 % ) occurred in the nonoperative group , whereas only two ( 4 % ) were reported for the operative group ( P = 0.0008 ) . Constant shoulder scores were significantly better for the operative group at all follow-ups ( P < 0.0001 ) . All six operative complications were implant-related . Conclusions : In this prospect i ve cohort study , primary open reduction and internal plate fixation of acute displaced midshaft clavicular fractures result ed in improved outcomes and a decreased rate of nonunion and symptomatic malunion compared with nonoperative treatment Seventy-nine out- patients with midclavicular fractures were included in a prospect i ve , r and omized trial comparing treatment with a figure-of-eight b and age and a simple sling . Sixty-one patients completed the study and were reevaluated clinical ly and radiographically after 3 months . We found that treatment with a simple sling caused less discomfort and perhaps fewer complications than with the figure-of-eight b and age . The functional and cosmetic results of the two methods of treatment were identical and alignment of the healed fractures was unchanged from the initial displacement Objective : To compare elastic stable intramedullary nailing ( ESIN ) with nonoperative treatment of fully displaced midshaft clavicular fractures in adults . Design : The study was a r and omized , controlled , clinical trial . Setting : Level 1 trauma center . Patients and Methods : Sixty patients between 18 and 65 years of age participated and completed the study . They were r and omized to either operative or nonoperative treatment with a 2-year follow-up . Intervention : Thirty patients were treated with a simple shoulder sling and 30 patients with ESIN within 3 days after trauma . Main Outcome Measurement : Complications after operative and nonoperative treatments , Disabilities of the Arm , Shoulder and H and ( DASH ) score and Constant Shoulder Score for outcome measurement , and clavicular shortening . Results : Fracture union was achieved in all patients in the operative group , whereas nonunion was observed in 3 of 30 patients of the nonoperative group . Two symptomatic malunions required corrective osteotomy in the nonoperative group . Medial nail protrusion occurred in 7 cases in the operative group . Implant failure with revision surgery was necessary in 2 patients after an additional adequate trauma . DASH scores were lower in the operative group throughout the first 6 months and 2 years after trauma , with a significant difference during the first 18 weeks . Constant scores were significantly higher after 6 months and 2 years after intramedullary stabilization . Patients in the operative group showed a significant improvement of posttraumatic clavicular shortening ; they were also more satisfied with cosmetic appearance and overall outcome . Conclusions : ESIN of displaced midshaft clavicular fractures result ed in a lower rate of nonunion and delayed union , a faster return to daily activities , and a better functional outcome . Clavicular shortening was significantly lower , and overall satisfaction was higher in the operative group Operative treatment of midclavicular fractures in patients older than 60 years poses an increased risk of fixation failure . Although plating of midclavicular fractures in the elderly is still a popular fixation method , osteopenic bone may result in plate loosening and fixation failure . The purpose of this study is to prospect ively evaluate and compare the clinical outcomes of midclavicular fractures in patients older than 60 years who are treated with either a locking compression plate or nonlocking plate . Sixty-four elderly patients with midclavicular fractures were surgically treated with either a locking compression plate or nonlocking plate , which included dynamic compression plates and reconstruction plates . The locking compression plate group included 29 patients with an average age of 69.1 years . The nonlocking plate group included 35 patients with an average age of 66.3 years . Both groups were similar for age , gender , injury mechanism , fracture patterns , and confounding medical condition ( P>.5 ) . However , the locking compression plate group had lower complication rates compared to the nonlocking plate group ( P=.087 ) . In addition , the locking compression plate group had higher rates of return to work and exercise ( P=.02 , P=.016 , respectively ) . If surgery of elderly patients with midclavicular fractures is indicated , internal fixation with a locking compression plate is preferable to a nonlocking plate In a prospect i ve study , the age- and gender-specific incidence and features of clavicular fractures were studied during 1989 and 1990 . The population at risk consisted of about 200,000 individuals aged 15 or above in the county of Uppsala , Sweden . There were 187 clavicular fractures in 185 patients corresponding to an annual incidence of 50/100,000 ( males 71/100,000 , women 30/100,000 ) . Males were significantly younger and sustained comminuted fractures more often than women . The fracture incidence decreased with age in both genders , although the reduction was significant only in men . Bicycle accidents most frequently caused clavicular fractures in both genders , whereas sports activities were significantly more common in men . Right and left clavicles were almost as frequently fractured , and a direct fall on the shoulder was the most frequent mechanism of injury for both genders . There was no difference between genders in the anatomical location with about three of four fractures occurring through the middle part and one of four through the acromial part of the clavicle . Ninety-five percent healed uneventfully , while non-union developed in 5 % - evenly distributed between the middle part of the clavicle and the acromial part |
365 | 28,145,414 | Conclusions : No compelling data exist that grape polyphenols can positively influence glycemia , blood pressure or lipid levels in individuals with or without the metabolic syndrome .
Limited evidence suggests that grape polyphenols may improve insulin sensitivity | Background / Objectives : Epidemiological , in vitro and animal studies suggest that grape polyphenols , such as those present in wine , have favorable effects on the metabolic syndrome .
However , controversy remains whether treatment with grape polyphenols is effective in humans .
Here , we aim ed to systemically review the effects of grape polyphenols on metabolic syndrome components in humans . | Objective : Some epidemiological studies found a lower risk of cardiovascular disease among wine drinkers than among drinkers of other types of ethanol . This difference might be due to an effect of nonalcohol compounds in wine on important cardiovascular risk factors . The objective of this study was to compare the effect of red wine , nonalcohol compounds of red wine and placebo on established cardiovascular risk factors . Design : A parallel , four-armed intervention study .Subjects : A total of 69 healthy 38–74-y-old men and women . Interventions : Subjects were r and omised to either 1 : red wine ( males : 300 ml/day , 38.3 g alcohol/day , female subjects : 200 ml/day , 25.5 g alcohol/day ) , 2 : water+red grape extract tablets ( wine-equivalent dose ) , 3 : water+red grape extract tablets ( half dose ) , or 4 : water+placebo tablets for a period of 4 weeks . No other sources of alcohol or anthocyanin were allowed . Plasma high-density lipoprotein (HDL)-cholesterol ( HDL-C ) , low-density lipoprotein (LDL)-cholesterol ( LDL-C ) , HDL-C/LDL-C-ratio , very-low-density lipoprotein (VLDL)-triacylglycerol , total cholesterol , fibrinogen , factor VII coagulant activity ( FVIIc ) , blood pressure , and body weight were determined before and after intervention . Results : Wine consumption was associated with a significant 11–16 % increase in fasting HDL-C and 8–15 % decrease in fasting fibrinogen relative to not drinking wine . There were no significant treatment effects on fasting LDL-C , HDL-C/LDL-C-ratio , VLDL-triacylglycerol , total cholesterol , FVIIc , or blood pressure . Drinking wine was associated with relative body weight increments closely corresponding to the energy contributed by the alcohol component . Conclusion : Moderate red wine consumption for 4 weeks is associated with desirable changes in HDL-C and fibrinogen compared with drinking water with or without red grape extract . The impact of wine on the measured cardiovascular risk factors thus seems primarily explained by an alcohol effect . Our finding suggests that the putative difference in cardiac risk associated with wine vs other alcoholic beverages might be rather explained by other life-style confounders than by red wine contents of nonalcohol components . Sponsorship : This study was supported by Chr . Hansen A/S , Denmark To comprehend the results of a r and omised controlled trial ( RCT ) , readers must underst and its design , conduct , analysis , and interpretation . That goal can be achieved only through total transparency from authors . Despite several decades of educational efforts , the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to help authors improve reporting by use of a checklist and flow diagram . The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement . The checklist items pertain to the content of the Title , Abstract , Introduction , Methods , Results , and Discussion . The revised checklist includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect , or because the information is essential to judge the reliability or relevance of the findings . We intended the flow diagram to depict the passage of participants through an RCT . The revised flow diagram depicts information from four stages of a trial ( enrolment , intervention allocation , follow- up , and analysis ) . The diagram explicitly shows the number of participants , for each intervention group , included in the primary data analysis . Inclusion of these numbers allows the reader to judge whether the authors have done an intention- to-treat analysis . In sum , the CONSORT statement is intended to improve the reporting of an RCT , enabling readers to underst and a trial 's conduct and to assess the validity of its results The aim of our study was to evaluate the effect of a st and ardized formulation of a polyphenolic extract of grapes ( Leucoselect-Phytosome [ LP ] ) on low-density lipoprotein ( LDL ) susceptibility to oxidation in a group of heavy smokers . A r and omized , double-blind , crossover study was undertaken in 24 healthy male heavy smokers , aged > or = 50 years . Enrolled subjects were given 2 capsules twice daily for 4 weeks ( phase 1 ) . Each capsule contained 75 mg of a grape procyanidin extracts and soy-phosphatidlcholine or placebo consisiting of 75 mg lactose and soy-phosphatidlcholine . A wash out period of 3 weeks was then followed by 4 weeks of the opposite treatment ( phase 2 ) . Blood sample s were taken at baseline and at the end of each phase and assayed for plasma lipids and LDL susceptibility to oxidation . Compliance was good , and no adverse effects were recorded . Subjects did not show significant modification of total cholesterol ( TC ) , triglycerides ( TG ) , high-density lipoprotein-cholesterol ( HDL-C ) and LDL-C during LP treatment . Among oxidative indices , thiobarbituric acid reactive substances ( TBARS ) concentration was significantly reduced in subjects taking LP ( -14.7 % + /- 21.1 % v + 5.0 % + /- 18.1 % , P < .01 ) , and the lag phase prolonged ( + 15.4 % + /- 24.4 % v -0.1 % + /- 16.0 % , P < .05 ) compared with placebo and basal values . The antioxidant potential of grape seed extract polyphenols may prove effective in a model of oxidative stress ( smoking ) ; however more investigational data are needed before use in wider clinical setting To evaluate the effects of grape polyphenols on plasma lipids , inflammatory cytokines , and oxidative stress , 24 pre- and 20 postmenopausal women were r and omly assigned to consume 36 g of a lyophilized grape powder ( LGP ) or a placebo for 4 wk . The LGP consisted of 92 % carbohydrate and was rich in flavans , anthocyanins , quercetin , myricetin , kaempferol , and resveratrol . After a 3-wk washout period , subjects were assigned to the alternate treatment for an additional 4 wk . The placebo consisted of an equal ratio of fructose and dextrose and was similar in appearance and energy content ( 554 kJ ) to LGP . Plasma triglyceride concentrations were reduced by 15 and 6 % in pre- and postmenopausal women , respectively ( P < 0.01 ) after LGP supplementation . In addition , plasma LDL cholesterol and apolipoproteins B and E were lower due to LGP treatment ( P < 0.05 ) . Further , cholesterol ester transfer protein activity was decreased by approximately 15 % with intake of LGP ( P < 0.05 ) . In contrast to these beneficial effects on plasma lipids , LDL oxidation was not modified by LGP treatment . However , whole-body oxidative stress as measured by urinary F(2)-isoprostanes was significantly reduced after LGP supplementation . LGP also decreased the levels of plasma tumor necrosis factor-alpha , which plays a major role in the inflammation process . Through alterations in lipoprotein metabolism , oxidative stress , and inflammatory markers , LGP intake beneficially affected key risk factors for coronary heart disease in both pre- and postmenopausal women Grape seed extract ( GSE ) has in vitro antioxidant activity but whether or not it works in vivo is not clear . In a fully r and omised , crossover trial with 4-week treatment periods on 36 men and women with above-average vascular risk , we aim ed to demonstrate that 2 g/day of GSE ( 1 g of polyphenols ) alone , or with 1 g/day of added quercetin in yoghurt , favourably alters vascular function , endothelial function , and degree of oxidative damage in comparison to a control yoghurt . GSE alone improved flow-mediated dilatation determined ultrasonically by an absolute 1.1 % compared with control . There was no effect of the combination of GSE with quercetin . No other blood or urine measure was altered . Thus sufficient polyphenols from GSE appear to be absorbed to influence endothelial nitric oxide production , and GSE has the potential to favourably influence vascular function Postpr and ial lipoproteins are potentially atherogenic . The aim of this study was to eluci date whether acute consumption of red wine ( RW ) and dealcoholised red wine ( DRW ) regulates postpr and ial lipid and lipoprotein metabolism in 17 dyslipidaemic postmenopausal women . A mixed meal accompanied by either water , RW or DRW was consumed on three separate visits , in r and om order , 2 weeks apart . One fasting and 6 hourly postpr and ial blood sample s were taken for lipid analysis . Results showed no significant quantitative changes in postpr and ial apolipoprotein ( apo ) B48 levels following the consumption of DRW or RW compared to water . However , qualitatively , DRW may reduce arterial exposure to apoB48-containing lipoproteins over the 6-h postpr and ial period measured . DRW consumption did not significantly change postpr and ial TG or insulin levels . A 35 % ( p = 0.02 ) increase in postpr and ial triglyceride ( TG ) levels and a 54 % ( p = 0.02 ) increase in insulin levels were observed following RW consumption , compared to water . In conclusion , acute DRW consumption had no effect on postpr and ial lipid and lipoprotein metabolism in dyslipidaemic postmenopausal women . However , the consumption of full-compliment RW exacerbated the postpr and ial lipaemic and insulin response over the 6-h period . Collectively , our findings suggest that neither polyphenols nor red wine reduce atherosclerotic risk by acutely modulating postpr and ial lipaemia over a 6-h period Background : The consumption of a high carbohydrate diet may be associated with an increased risk of type 2 diabetes and obesity . Previous studies in vitro have revealed that grape seed extract ( GSE ) inhibited the intestinal α-glucosidases and α-pancreatic amylase that may delay carbohydrate digestion and absorption , result ing in the suppression of postpr and ial glycemia . The objective of the study was to assess whether consumption of GSE together with high carbohydrate meal affects postpr and ial glycemia in healthy participants . Material s and Methods : The study used acute , r and omized , controlled crossover design in which eight healthy subjects ( four female and four male , mean aged 21.25 ± 3.69 years ; body mass index = 20.28 ± 1.40 kg/m2 ) received high carbohydrate ( HC ) meal ( 73.6 % ) together with or without 100 and 300 mg GSE . Results : Results showed that postpr and ial plasma glucose concentrations at 15 min and 30 min after ingestion HC meal together with 100 mg GSE ( 5.33 ± 0.41 mmol/L and 5.62 ± 0.47 mmol/L , respectively ) and 300 mg GSE ( 5.27 ± 0.29 mmol/L ; 5.75 ± 0.44 mmol/L , respectively ) were significantly lower than that of HC meal ( P<0.05 ) . There was statistically significant difference in the 2 h area under the glucose response curve between HC meal and HC meal plus GSE . Conclusions : GSE reduces postpr and ial plasma glucose in healthy participants . The delayed and attenuated hyperglycemia may have a useful strategy to prevent development of diabetes in the healthy population BACKGROUND Moderate red wine has been shown to reduce cardiovascular disease ( CVD ) risk , however the effects on certain CVD risk factors are unclear . In this study we have investigated the effects of dealcoholised red wine ( DRW ) and full-complement red wine ( RW ) on several cardiovascular risk factors in mildly hypercholesterolaemic postmenopausal women . OBJECTIVES To eluci date whether the chronic consumption of red wine polyphenols improves risk factors associated with CVD in hypercholesterolaemic postmenopausal women . DESIGN Forty-five hypercholesterolaemic postmenopausal women were r and omly assigned to consume 400 mL/day of either water , DRW or RW for 6 weeks following a 4-week washout . Fasting measures of lipids , lipoproteins , insulin and glucose were taken at 0 and 6 weeks . RESULTS DRW consumption had no effect of fasting concentrations of lipids , lipoproteins , insulin and glucose . However , chronic consumption of RW significantly reduced fasting LDL cholesterol concentrations by 8 % and increased HDL cholesterol concentrations by 17 % in hypercholesterolaemic postmenopausal women . CONCLUSIONS Collectively , regular consumption of full-complement red wine reduces CVD risk by improving fasting lipid levels in hypercholesterolaemic postmenopausal women . This study uniquely demonstrated the LDL cholesterol-lowering effects of red wine in individuals at high CVD risk , which has not previously been shown OBJECTIVE To assess the clinical efficacy of nutritional amounts of grape polyphenols ( PPs ) in counteracting the metabolic alterations of high-fructose diet , including oxidative stress and insulin resistance ( IR ) , in healthy volunteers with high metabolic risk . RESEARCH DESIGN AND METHODS Thirty-eight healthy overweight/obese first-degree relatives of type 2 diabetic patients ( 18 men and 20 women ) were r and omized in a double-blind controlled trial between a grape PP ( 2 g/day ) and a placebo ( PCB ) group . Subjects were investigated at baseline and after 8 and 9 weeks of supplementation , the last 6 days of which they all received 3 g/kg fat-free mass/day of fructose . The primary end point was the protective effect of grape PPs on fructose-induced IR . RESULTS In the PCB group , fructose induced 1 ) a 20 % decrease in hepatic insulin sensitivity index ( P < 0.05 ) and an 11 % decrease in glucose infusion rate ( P < 0.05 ) as evaluated during a two-step hyperinsulinemic-euglycemic clamp , 2 ) an increase in systemic ( urinary F2-isoprostanes ) and muscle ( thiobarbituric acid – reactive substances and protein carbonylation ) oxidative stress ( P < 0.05 ) , and 3 ) a downregulation of mitochondrial genes and decreased mitochondrial respiration ( P < 0.05 ) . All the deleterious effects of fructose were fully blunted by grape PP supplementation . Antioxidative defenses , inflammatory markers , and main adipokines were affected neither by fructose nor by grape PPs . CONCLUSIONS A natural mixture of grape PPs at nutritional doses efficiently prevents fructose-induced oxidative stress and IR . The current interest in grape PP ingredients and products by the global food and nutrition industries could well make them a stepping-stone of preventive nutrition Purpose The grape and wine polyphenol resveratrol exerts cardiovascular benefits but evidence from r and omized human clinical trials is very limited . We investigated dose-depending effects of a resveratrol-containing grape supplement on stable patients with coronary artery disease ( CAD ) treated according to currently accepted guidelines for secondary prevention of cardiovascular disease . Methods In a triple-blind , r and omized , placebo-controlled , one-year follow-up , 3-arm pilot clinical trial , 75 stable-CAD patients received 350 mg/day of placebo , resveratrol-containing grape extract ( grape phenolics plus 8 mg resveratrol ) or conventional grape extract lacking resveratrol during 6 months , and a double dose for the following 6 months . Changes in circulating inflammatory and fibrinolytic biomarkers were analyzed . Moreover , the transcriptional profiling of inflammatory genes in peripheral blood mononuclear cells ( P BMC s ) was explored using microarrays and functional gene expression analysis . Results After 1 year , in contrast to the placebo and conventional grape extract groups , the resveratrol-containing grape extract group showed an increase of the anti-inflammatory serum adiponectin ( 9.6 % , p = 0.01 ) and a decrease of the thrombogenic plasminogen activator inhibitor type 1 ( PAI-1 ) ( −18.6 % , p = 0.05 ) . In addition , 6 key inflammation-related transcription factors were predicted to be significantly activated or inhibited , with 27 extracellular-space acting genes involved in inflammation , cell migration and T-cell interaction signals presenting downregulation ( p < 0.05 ) in P BMC s. No adverse effects were detected in relation to the study products . Conclusions Chronic daily consumption of a resveratrol-containing grape nutraceutical could exert cardiovascular benefits in stable-CAD patients treated according to current evidence -based st and ards , by increasing serum adiponectin , preventing PAI-1 increase and inhibiting atherothrombotic signals in P BMC Obese individuals are at an increased risk of developing CVD , hypertension , type 2 diabetes , and bacterial and viral infections when compared with the normal-weight population . In a 9-week r and omised , double-blind , cross-over study , twenty-four obese subjects aged between 20 and 60 years and with a BMI between 30 and 45 kg/m2 were fed grape or placebo powder for 3-week intervals to determine the effects of dietary grapes on blood lipid profiles , plasma inflammatory marker concentrations and immune cell function . Blood sample s were collected on days 1 and 8 for obtaining baseline information and at weeks 3 , 4 , 8 and 9 . Comprehensive chemistry panels , lipid profile analyses by NMR , measurement of plasma inflammatory marker concentrations , and analyses of cytokine production by activated T lymphocytes and monocytes were performed for each blood draw . Dietary grape powder reduced the plasma concentrations of large LDL-cholesterol and large LDL particles compared with the placebo powder ( P < 0·05 ) . The concentrations of interferon-γ , TNF-α , IL-4 and IL-10 were measured in supernatants from peripheral blood mononuclear cells ( P BMC ) activated with anti-CD3/CD28 antibodies and those of TNF-α , IL-1β , IL-6 and IL-8 were measured in supernatants from P BMC activated with lipopolysaccharide ( LPS ) . No difference in the production of T-cell cytokines was observed between the two intervention groups . The production of IL-1β and IL-6 was increased in supernatants from LPS-activated P BMC in the grape powder group compared with the placebo powder group ( P < 0·05 ) . These data suggest that dietary grapes may decrease atherogenic lipid fractions in obese individuals and increase the sensitivity of monocytes in a population at a greater risk of developing infections A positive relationship between alcohol consumption and blood pressure ( BP ) is well-established but the relative effect of specific alcoholic beverages is controversial . This study aim ed to determine whether red wine may improve vascular function and have less of an impact on blood pressure because of its high content of antioxidant vasodilator polyphenolic compounds . Healthy normotensive men entered a 4-period crossover study comparing in r and om order 4 weeks of control – abstinence with similar periods of daily consumption of red wine ( 375 mL ; 39 grams alcohol ) , de-alcoholized red wine ( 375 mL ) , or beer ( 1125 mL ; 41 grams alcohol ) . Ambulatory systolic BP and diastolic BP and heart rate ( HR ) were measured together with vascular function as assessed by flow-mediated dilatation ( FMD ) and glyceryl trinitrate-mediated ( GTNMD ) dilatation of the brachial artery . The systolic and diastolic BP and HR were not different between control – abstinence and de-alcoholized red wine . However , compared with control – abstinence , both red wine and beer increased awake systolic BP ( 2.9 and 1.9 mm Hg , respectively ; P<0.05 ) and asleep HR ( 5.0 and 4.4 bpm ; P<0.05 ) . There were no specific effects of red wine , de-alcoholized red wine , or beer on FMD or GTNMD . Daily consumption of ≈40 grams alcohol as either red wine or beer for 4 weeks results in similar increases in systolic BP and HR . De-alcoholized red wine did not lower BP , and neither red wine nor de-alcoholized red wine influenced vascular function , suggesting that red wine polyphenolics do not have a significant role in mitigating the blood pressure-elevating effects of alcohol in men BACKGROUND Few studies have investigated the effect of dietary polyphenols on the complex human gut microbiota , and they focused mainly on single polyphenol molecules and select bacterial population s. OBJECTIVE The objective was to evaluate the effect of a moderate intake of red wine polyphenols on select gut microbial groups implicated in host health benefits . DESIGN Ten healthy male volunteers underwent a r and omized , crossover , controlled intervention study . After a washout period , all of the subjects received red wine , the equivalent amount of de-alcoholized red wine , or gin for 20 d each . Total fecal DNA was su bmi tted to polymerase chain reaction(PCR)-denaturing gradient gel electrophoresis and real-time quantitative PCR to monitor and quantify changes in fecal microbiota . Several biochemical markers were measured . RESULTS The dominant bacterial composition did not remain constant over the different intake periods . Compared with baseline , the daily consumption of red wine polyphenol for 4 wk significantly increased the number of Enterococcus , Prevotella , Bacteroides , Bifidobacterium , Bacteroides uniformis , Eggerthella lenta , and Blautia coccoides-Eubacterium rectale groups ( P < 0.05 ) . In parallel , systolic and diastolic blood pressures and triglyceride , total cholesterol , HDL cholesterol , and C-reactive protein concentrations decreased significantly ( P < 0.05 ) . Moreover , changes in cholesterol and C-reactive protein concentrations were linked to changes in the bifidobacteria number . CONCLUSION This study showed that red wine consumption can significantly modulate the growth of select gut microbiota in humans , which suggests possible prebiotic benefits associated with the inclusion of red wine polyphenols in the diet . This trial was registered at controlled-trials.com as IS RCT N88720134 Objective : Although prospect i ve studies suggest light-to-moderate chronic alcohol intake protects against coronary artery disease in type 2 diabetic patients , the balance of effects on individual cardiovascular risk factors needs further assessment . We examined the effects of alcohol consumption on 24-h ambulatory blood pressure ( BP ) and heart rate ( HR ) , high-density lipoprotein cholesterol , fibrinogen , C-reactive protein , homocysteine , and glycaemic control in well controlled type 2 diabetes . Methods : Twenty-four participants aged 49–66 year were r and omized to a three-period crossover study with women drinking red wine 230 ml/day ( ∼24 g alcohol/day ) and men drinking red wine 300 ml/day ( ∼31 g alcohol/day ) , or equivalent volumes of dealcoholized red wine ( DRW ) or water , each for 4 weeks . Ambulatory BP and HR were monitored every 30 min for 24 h at the end of each period . Home blood glucose monitoring was carried out twice weekly throughout . Results : Red wine increased awake SBP and DBP relative to water by 2.5 ± 1.2 /1.9 ± 0.7 mmHg ( P = 0.033 , P = 0.008 , respectively ) , with a similar nonsignificant trend relative to DRW . Asleep DBP fell with red wine relative to DRW ( 2.0 ± 0.8 mmHg , P = 0.016 ) with a similar nonsignificant trend relative to water . Red wine increased 24-h , awake and asleep HR relative to water and DRW . Relative to DRW , red wine did not affect glycaemic control or any other cardiovascular risk factor . Conclusion : In well controlled type 2 diabetic individuals 24–31 g alcohol/day ( ∼2–3 st and ard drinks ) raises awake BP and 24-h HR and lowers asleep BP but does not otherwise favourably or adversely modify cardiovascular risk factors Polyphenols in grape and wine have been suggested to contribute to the cardiovascular health benefits of the Mediterranean lifestyle . The reported effects of grape products on blood pressure ( BP ) remain , however , equivocal . In a double-blind placebo controlled crossover study , the effect of two grape extracts on BP and vascular function was assessed in 60 untreated , mildly hypertensive subjects after four weeks intervention . Both extracts ( grape-red wine and grape alone ) had high concentrations of anthocyanins and flavonols , but the grape alone was relatively poor in catechins and procyanidins . Parameters measured included ambulatory and office BP , flow-mediated vasodilation , arterial distensibility , platelet function and plasma lipoproteins . Results showed that 24-hour ambulatory systolic/diastolic BPs were significantly lower in the grape-wine extract intervention ( 135.9 ± 1.3/84.7 ± 0.8 mmHg ; mean ± SEM ) compared to placebo ( 138.9 ± 1.3/86.6 ± 1.2 mmHg ) , predominantly during daytime . Plasma concentrations of the vasoconstrictor endothelin-1 decreased by 10 % , but other measures of vascular function were not affected . Grape juice extract alone had no effect on BP or any measures of vascular function . Polyphenol-rich food products , and may be specifically catechins and procyanidins , may thus help sustain a healthy BP and contribute to the healthy Mediterranean lifestyle The search for complementary treatments in primary prevention of cardiovascular disease ( CVD ) is a high-priority challenge . Grape and wine polyphenol resveratrol confers CV benefits , in part by exerting anti-inflammatory effects . However , the evidence in human long-term clinical trials has yet to be established . We aim ed to investigate the effects of a dietary resveratrol-rich grape supplement on the inflammatory and fibrinolytic status of subjects at high risk of CVD and treated according to current guidelines for primary prevention of CVD . Seventy-five patients undergoing primary prevention of CVD participated in this triple-blinded , r and omized , parallel , dose-response , placebo-controlled , 1-year follow-up trial . Patients , allocated in 3 groups , consumed placebo ( maltodextrin ) , a resveratrol-rich grape supplement ( resveratrol 8 mg ) , or a conventional grape supplement lacking resveratrol , for the first 6 months and a double dose for the next 6 months . In contrast to placebo and conventional grape supplement , the resveratrol-rich grape supplement significantly decreased high-sensitivity C-reactive protein ( -26 % , p = 0.03 ) , tumor necrosis factor-α ( -19.8 % , p = 0.01 ) , plasminogen activator inhibitor type 1 ( -16.8 % , p = 0.03 ) , and interleukin-6/interleukin-10 ratio ( -24 % , p = 0.04 ) and increased anti-inflammatory interleukin-10 ( 19.8 % , p = 0.00 ) . Adiponectin ( 6.5 % , p = 0.07 ) and soluble intercellular adhesion molecule-1 ( -5.7 % , p = 0.06 ) tended to increase and decrease , respectively . No adverse effects were observed in any patient . In conclusion , 1-year consumption of a resveratrol-rich grape supplement improved the inflammatory and fibrinolytic status in patients who were on statins for primary prevention of CVD and at high CVD risk ( i.e. , with diabetes or hypercholesterolemia plus ≥1 other CV risk factor ) . Our results show for the first time that a dietary intervention with grape resveratrol could complement the gold st and ard therapy in the primary prevention of CVD Hyperlipidemia can lead to atherosclerosis by lipoprotein deposition inside the vessel wall and oxidative stress induction that leads to the formation of atherosclerotic plaque . Oxidized low-density lipoprotein particles ( Ox-LDL ) have a key role in the pathogenesis of atherosclerosis . The lipid-lowering properties and antioxidants of the grape seed can be beneficial in atherosclerosis prevention . We conducted a r and omized double-blind placebo-controlled crossover clinical trial . Fifty-two mildly hyperlipidemic individuals were divided into two groups that received either 200 mg/day of the red grape seed extract ( RGSE ) or placebo for 8 weeks . After an 8-week washout period , the groups were crossed over for another 8 weeks . Lipid profiles and Ox-LDL were measured at the beginning and the end of each phase . RGSE consumption reduced total cholesterol ( -10.68±26.76 mg/dL , P=.015 ) , LDL cholesterol ( -9.66±23.92 mg/dL , P=.014 ) , and Ox-LDL ( -5.47±12.12 mg/dL , P=.008 ) . While triglyceride and very low-density lipoprotein cholesterol were decreased and high-density lipoprotein cholesterol was increased by RGSE , the changes were not statistically significant . RGSE consumption decreases Ox-LDL and has beneficial effects on lipid profile-consequently decreasing the risk of atherosclerosis and cardiovascular disorders-in mild hyperlipidemic individuals Objective : To eluci date whether the chronic consumption of dealcoholised red wine ( DRW ) ( polyphenol-rich component ) and /or red wine ( RW ) improves vascular function in hypercholesterolaemic postmenopausal women . Design , subjects and intervention : A r and omised parallel-arm study . Forty-five hypercholesterolaemic postmenopausal women were r and omised into either water , DRW or RW group for 6 weeks following a 4 week washout . Fasting measures of central haemodynamic parameters , arterial wave reflection and endothelial nitric oxide were taken at 0 and 6 weeks . Setting : Clinic in the School of Public Health , Curtin University . Results : There were no significant between group differences in arterial stiffness as measured by augmentation index ( AIx ) and augmentation pressure ( AP ) . However , a significant within group decrease in AIx ( −9 % , P=0.02 ) and AP ( −12 % , P=0.02 ) was observed following DRW consumption . No significant changes were observed in central haemodynamic parameters and endothelial nitric oxide levels following DRW and RW consumption , compared to water . Conclusions : Neither the chronic consumption of DRW nor RW improved markers of arterial stiffness , compared to control . However , the significant within group improvements in these indices following the consumption of DRW can not be overlooked and warrant further investigation . Sponsorship : Curtin University and National Heart Foundation of Australia Background There is growing evidence that oxidative stress contributes to the pathogenesis of hypertension and endothelial dysfunction . Thus , dietary antioxidants may beneficially influence blood pressure ( BP ) and endothelial function by reducing oxidative stress . Objective To determine if vitamin C and polyphenols , alone or in combination , can lower BP , improve endothelial function and reduce oxidative stress in hypertensive individuals . Design A total of 69 treated hypertensive individuals with a mean 24-h ambulatory systolic blood pressure ≥ 125 mmHg participated in a r and omized , double-blind , placebo-controlled , factorial trial . Following a 3-week washout , participants received 500 mg/day vitamin C , 1000 mg/day grape-seed polyphenols , both vitamin C and polyphenols , or neither for 6 weeks . At baseline and post-intervention , 24-h ambulatory BP , ultrasound-assessed endothelium-dependent and -independent vasodilation of the brachial artery , and markers of oxidative damage , ( plasma and urinary F2-isoprostanes , oxidized low-density lipoproteins and plasma tocopherols ) , were measured . Results A significant interaction between grape-seed and vitamin C treatments for effects on BP was observed . Vitamin C alone reduced systolic BP versus placebo ( −1.8 ± 0.8 mmHg , P = 0.03 ) , while polyphenols did not ( −1.3 ± 0.8 mmHg , P = 0.12 ) . However , treatment with the combination of vitamin C and polyphenols increased systolic BP ( 4.8 ± 0.9 mmHg versus placebo ; 6.6 ± 0.8 mmHg versus vitamin C ; 6.1 ± 0.9 mmHg versus polyphenols mmHg , each P < 0.0001 ) and diastolic BP ( 2.7 ± 0.6 mmHg , P < 0.0001 versus placebo ; 1.5 ± 0.6 mmHg , P = 0.016 versus vitamin C ; 3.2 ± 0.7 mmHg , P < 0.0001 versus polyphenols ) . Endothelium-dependent and -independent vasodilation , and markers of oxidative damage were not significantly altered . Conclusion Although the mechanism remains to be eluci date d , these results suggest caution for hypertensive subjects taking supplements containing combinations of vitamin C and polyphenols CONTEXT AND OBJECTIVE Red grape seed extract ( RGSE ) contains oligomeric proanthocyanidin complexes as a class of flavonoids . These compounds are potent antioxidants and exert many health-promoting effects . This study aim ed to determine the effects of RGSE on serum levels of triglycerides ( TG ) , total cholesterol ( TC ) , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , apolipoprotein AI ( apo-AI ) levels and paraoxonase ( PON ) activity in patients with mild to moderate hyperlipidemia ( MMH ) . DESIGN AND SETTING S A r and omized double-blind placebo-controlled clinical trial was conducted at Shahid-Modarres Hospital ( Tehran , Iran ) and Tabriz University of Medical Sciences . Seventy MMH patients were r and omly assigned to receive treatment ( 200 mg/day of RGSE ) or placebo for eight weeks . RESULTS Significant elevation in serum levels of apo-AI ( P = 0.001 ) , HDL-C ( P = 0.001 ) and PON activity ( P = 0.001 ) and marked decreases in concentrations of TC ( P = 0.015 ) , TG ( P = 0.011 ) and LDL-C ( P = 0.014 ) were found in the cases . PON activity was significantly correlated with apo-AI ( r = 0.270 ; P < 0.01 ) and HDL-C ( r = 0.45 ; P < 0.001 ) . Significant differences between the RGSE and control groups ( before and after treatment ) for TC ( P = 0.001 ) , TG ( P = 0.001 ) , PON ( P = 0.03 ) , apo-AI ( P = 0.001 ) and LDL-C ( P = 0.002 ) were seen . CONCLUSION It is possible that RGSE increases PON activity mostly through increasing HDL-C and apo-AI levels in MMH patients . It may thus have potential beneficial effects in preventing oxidative stress and atherosclerosis in these patients The objective of this study was to examine the relationship of usual current alcohol intake with systolic and diastolic pressures among young adults . Participants were 316 men and women , aged 18 to 26 years , from East Boston , Mass. At each of three weekly visits we obtained three blood pressure measurements on each subject using a r and om-zero sphygmomanometer . Using an interviewer-administered question naire , we obtained information about quantity and frequency of alcohol intake during the previous month . The lowest systolic pressure levels were in subjects consuming 1 to < 2 drinks per day . Adjusted for age , sex , and body mass index , systolic pressure was higher by 4.0 mm Hg ( 95 % confidence interval [ CI ] , 0.5 to 7.6 mm Hg ) in abstainers , 3.6 mm Hg ( 95 % CI , 0.5 to 6.6 mm Hg ) in those who drank < 1 drink per day , 0.4 mm Hg ( 95 % CI , -4.7 to 5.5 mm Hg ) in those who drank 2 to < 3 drinks per day , and 8.1 mm Hg ( 95 % CI , 2.9 to 13.4 mm Hg ) in those who drank > or = 3 drinks per day . Levels of diastolic pressure were lowest in those consuming 2 to < 3 drinks per day . Adjustment for pulse rate , smoking , medication use , and family history of hypertension did not alter the results . These results suggest a J-shaped association of alcohol intake with blood pressure level in young adults , with the lowest levels in consumers of 1 to 3 drinks per day Hypercholesterolemia , a significant cardiovascular risk factor , is prevalent in the American population . Many drugs lower circulating cholesterol levels , but they are not infrequently associated with severe side effects . Accordingly , natural means to lower cholesterol levels safely would be welcomed . We examined 40 hypercholesterolemic subjects ( total cholesterol 210 - 300 mg/dL ) in a r and omized , double-blind , placebo-controlled study . The four groups of ten subjects received either placebo bid , chromium polynicotinate ( Cr ) 200 microg bid , grape seed extract ( GSE ) 100 mg bid , or a combination of Cr and GSE at the same dosage bid . Over two months , the average percent change + /- SEM in the total cholesterol from baseline among groups was : placebo -3.5 % + /- 4 , GSE -2.5 % + /- 2 , Cr -10 % + /- 5 , and combination -16.5 % + /- 3 . The decrease in the last group was significantly different from placebo ( p < 0.01 ) . The major decrease in cholesterol concentration was in the LDL levels : placebo -3.0 % + /- 4 , GSE -1.0 % + /- 2.0 , Cr -14 % + /- 4.0 , and the combination -20 % + /- 6.0 . Again , the combination of Cr and GSE significantly decreased LDL when compared to placebo ( p<0.01 ) . HDL levels essentially did not change among the groups . Also , there was no significant difference in the triglyceride concentrations among the groups ; and no statistically significant differences were seen in the levels of autoantibodies to oxidized LDL ( Ox-LDL ) . However , the trend was for the two groups receiving GSE to have greater decreases in the latter parameter , i.e. , -30.7 % and -44.0 % in the GSE and combined groups in contrast to -17.3 % and -10.4 % in the placebo and chromium groups . We determined the number of subjects in each group who decreased autoantibodies to oxidized LDL greater than 50 % over eight weeks and found these ratios among groups : placebo = 2/9 , Cr = 1/10 , GSE = 6/10 , and combined = 3/8 . Thus , 50 % of subjects ( 9/18 ) receiving GSE had a greater than 50 % decrease in autoantibodies compared to 16 % ( 3/19 ) in the two groups not receiving GSE . No significant changes occurred in the levels of circulating homocysteine and blood pressure among the four groups . We conclude that a combination of Cr and GSE can decrease total cholesterol and LDL levels significantly . Furthermore , there was a trend to decrease the circulating autoantibodies to oxidized LDL in the two groups receiving GSE Data suggest that polyphenol-rich products may improve endothelial function and other cardiovascular health risk factors . Grape and wine contain high amounts of polyphenols , but effects of these polyphenols have hardly been investigated in isolation in r and omized controlled studies . Our objective in this study was to test the chronic effect of polyphenol-rich solids derived from either a wine grape mix or grape seed on flow-mediated dilation ( FMD ) . Blood pressure and other vascular function measures , platelet function , and blood lipids were secondary outcomes . Thirty-five healthy males were r and omized in a double-blind , placebo-controlled crossover study consisting of three 2-wk intervention periods separated by 1-wk washout periods . The test products , containing 800 mg of polyphenols , were consumed as capsules . At the end of each intervention period , effects were measured after consumption of a low-fat breakfast ( ~751 kJ , 25 % fat ) and a high-fat lunch ( ~3136 kJ , 78 % fat ) . After the low-fat breakfast , the treatments did not significantly affect FMD . The absolute difference after the wine grape solid treatment was -0.4 % ( 95 % CI = -1.8 to 0.9 ; P = 0.77 ) and after grape seed solids , 0.2 % ( 95 % CI = -1.2 to 1.5 ; P = 0.94 ) compared with after the placebo treatment . FMD effects after the high-fat lunch and effects on secondary outcomes also showed no consistent differences between both of the grape solids and placebo treatment . In conclusion , consumption of grape polyphenols has no major impact on FMD in healthy men . Future studies should address whether grape polyphenols can improve FMD and other cardiovascular health risk factors in population s with increased cardiovascular risk Dietary polyphenols , such as those from grape products , may exert beneficial effects on cardiovascular health , including anti-hypertensive effects . We investigated the effect of a specific grape seed extract ( GSE ) rich in low-molecular-weight polyphenolic compounds on ambulatory blood pressure ( ABP ) in untreated subjects with pre- and stage I hypertension . In addition , potential mechanisms that could underlie the hypothesised effect of GSE on blood pressure ( BP ) , and platelet aggregation , were explored . The study was design ed as a double-blind , placebo-controlled , r and omised , parallel-group intervention study including seventy healthy subjects with systolic BP between 120 and 159 mmHg . A 1-week run-in period was followed by an 8-week intervention period , during which subjects consumed capsules containing either 300 mg/d of GSE or a placebo ( microcrystalline cellulose ) . Before and after the intervention , daytime ABP readings , 24 h urine sample s and fasting and non-fasting blood sample s were taken . The mean baseline systolic BP was 135.8 ( SE 1.3 ) mmHg and diastolic BP was 81.5 ( SE 0.9 ) mmHg . BP values were modestly , but not significantly , affected by the polyphenol-rich GSE treatment v. placebo with an effect of - 3.0 mmHg for systolic BP ( 95 % CI - 6.5 , 0.5 ) and - 1.4 mmHg for diastolic BP ( 95 % CI - 3.5 , 0.6 ) . Vasoactive markers including endothelin-1 , NO metabolites and asymmetric dimethylarginine , plasma renin activity and platelet aggregation were not affected by the GSE intervention . Our findings show that consumption of polyphenol-rich GSE does not significantly lower ABP in untreated subjects with pre- and stage I hypertension Rationale : Experimental studies have shown a potential blood pressure ( BP ) lowering effect of red wine polyphenols , whereas the effects of ethanol and polyphenols on BP in humans are not yet clear . Objective : The aim of the present work was to evaluate the effects of red wine fractions ( alcoholic and nonalcoholic ) on BP and plasma nitric oxide ( NO ) in subjects at high cardiovascular risk . Methods and Results : Sixty-seven men at high cardiovascular risk were studied . After a 2-week run-in period , subjects were r and omized into 3 treatment periods in a crossover clinical trial , with a common background diet plus red wine ( 30 g alcohol/day ) , the equivalent amount of dealcoholized red wine , or gin ( 30 g alcohol/day ) , lasting 4 weeks each intervention . At baseline and after each intervention , anthropometrical parameters , BP and plasma NO were measured . Systolic and diastolic BP decreased significantly after the dealcoholized red wine intervention and these changes correlated with increases in plasma NO . Conclusions : Dealcoholized red wine decreases systolic and diastolic BP . Our results point out through an NO-mediated mechanism . The daily consumption of dealcoholized red wine could be useful for the prevention of low to moderate hypertension . Trial registered at controlled-trials.com : IS RCT N88720134 Background : Muscadine grape seeds have high concentrations of polyphenolic compounds with antioxidant and other properties that would be expected to have favorable effects on endothelial function . Objectives : To evaluate the effect of muscadine grape seed supplementation on endothelial function and cardiovascular risk factors in subjects with increased cardiovascular risk . Design : In a r and omized , double-blind , placebo-controlled crossover trial , 50 adults with coronary disease or ≥1 cardiac risk factor received muscadine grape seed supplementation ( 1300 mg daily ) and placebo for 4 weeks each , with a 4-week washout . Resting brachial diameter and brachial flow-mediated dilation ( FMD ) and biomarkers of inflammation , lipid peroxidation , and antioxidant capacity were determined at the beginning and end of each period and compared in mixed linear models . Results : There was no evidence of improved FMD ( % change ) with muscadine grape seed ( muscadine grape seed : pre 5.2 % ± 0.3 % , post 4.6 % ± 0.3 % , p = 0.06 ; placebo : pre 5.3 % ± 0.4 % , post 5.2 % ± 0.4 % , p = 0.82 ; p for muscadine grape seed vs. placebo = 0.25 ) . However , there was a significant increase in baseline diameter ( mm ) with muscadine grape seed supplementation ( muscadine grape seed : pre 4.05 ± 0.09 , post 4.23 ± 0.10 , p = 0.002 ; placebo : pre 4.12 ± 0.11 , post 4.12 ± 0.10 , p = 0.93 ; p for muscadine grape seed vs. placebo = 0.026 ) . All other biomarkers were not significantly altered by muscadine grape seed supplementation . Conclusions : Four weeks of muscadine grape seed supplementation in subjects with increased cardiovascular risk did not produce a statistically significant increase in brachial flow-mediated vasodilation or a significant change in other biomarkers of inflammation , lipid peroxidation , or antioxidant capacity . However , the muscadine grape seed supplement did result in a significant increase in resting brachial diameter . The clinical significance of the effect on resting diameter is not yet established . More research is warranted to fully characterize the vascular effects of this and other grape-derived nutritional supplements and to determine whether these vascular effects translate into important clinical benefits |
366 | 29,463,497 | There is a dominance of stress management-based interventions in literature due to the prominence of the model of stress and athletic injury within the area . | Objective To systematic ally review studies examining the role of psychological interventions in injury prevention .
The primary research question was : What is the real-world effectiveness of psychological intervention in preventing sports injuries ? | Cognitive behavioral stress management ( CBSM ) has previously been found to reduce fatigue , depression , and cortisol response to heavy exercise training among competitive collegiate athletes and to speed physical and psychological recovery from surgery ( 1,2 ) . Our study assessed the efficacy of a CBSM program to reduce the frequency of injury and illness among collegiate athletes in a r and omized , single-blind , controlled clinical trial . Following assessment of baseline medical history , mood state , stress , cortisol , sleep , alcohol use , and exercise training , collegiate rowers were stratified by gender and competitive level and r and omly assigned to either a control group or a CBSM group . Exercise training information and psychosocial assessment s were repeated immediately following the intervention period , and health care providers who were blinded to participant assignment recorded the frequency of medical visits and the number of days injured or ill until the end of the season . Athletes r and omly assigned to a CBSM group experienced significant reductions in the number of illness and injury days as compared to control group athletes . CBSM participants also had half the number of health service visits as did controls . The data suggest that a time-limited CBSM intervention design ed specifically for an athlete population may be an effective prophylactic treatment to reduce the incidence of injury and illness among competitive collegiate athletes Abstract We investigated the relationship between skill qualities and contact injury risk in professional rugby league players . Sixty-six professional rugby league players aged 23 ± 4 years ( mean ± s ) participated in this three-year prospect i ve study . Players underwent assessment s of tackling proficiency , dual-task draw- and -pass proficiency , reactive agility , pattern recall , and pattern prediction . The frailty model was applied to calculate the adjusted risk ratios of injury . When the players ' age and playing position were adjusted in the frailty model , the risk ratios showed that reactive agility was a predictor for the risk of injury . Players with reactive agility decision times of > 80 ms had a lower incidence ( relative risk = 0.68 , 95 % CI 0.47–0.98 , P = 0.04 ) of injuries than players with reactive agility decision times of ≤80 ms . Although there was no relationship between injury and the majority of skill qualities ( P = 0.47–0.93 ) , players with poor reactive agility performances ( specifically longer decision times ) had a lower risk of injury , suggesting that poor perceptual skill is protective against contact injuries in professional rugby league players . These players might inadvertently avoid the heavy collisions that result in injury , or at best result in partial contact that does not result in exposure to the full force of a tackle Background The influence of injuries on team performance in football has only been scarcely investigated . Aim To study the association between injury rates and team performance in the domestic league play , and in European cups , in male professional football . Methods 24 football teams from nine European countries were followed prospect ively for 11 seasons ( 2001–2012 ) , including 155 team-seasons . Individual training and match exposure and time-loss injuries were registered . To analyse the effect of injury rates on performance , a Generalised Estimating Equation was used to fit a linear regression on team-level data . Each team 's season injury rate and performance were evaluated using its own preceding season data for comparison in the analyses . Results 7792 injuries were reported during 1 026 104 exposure hours . The total injury incidence was 7.7 injuries/1000 h , injury burden 130 injury days lost/1000 h and player match availability 86 % . Lower injury burden ( p=0.011 ) and higher match availability ( p=0.031 ) were associated with higher final league ranking . Similarly , lower injury incidence ( p=0.035 ) , lower injury burden ( p<0.001 ) and higher match availability ( p<0.001 ) were associated with increased points per league match . Finally , lower injury burden ( p=0.043 ) and higher match availability ( p=0.048 ) were associated with an increase in the Union of European Football Association ( UEFA ) Season Club Coefficient , reflecting success in the UEFA Champions League or Europa League . Conclusions Injuries had a significant influence on performance in the league play and in European cups in male professional football . The findings stress the importance of injury prevention to increase a team 's chances of success Purpose The objective was to evaluate the effect of a psychological group-based injury prevention , which was implemented throughout the first season , after the second season , in Swedish elite floorball teams ( males and females ) . The secondary objective was to evaluate the effect of the intervention over the two consecutive floorball seasons as a whole . Methods Twenty-three teams in the premier leagues for males and females volunteered and were allocated to an intervention group , n = 175 players , and a control group n = 171 players . The intervention group participated in psychological skills training during the first season . The control group did not receive any alternative treatment . Neither of the groups received any intervention during the second season . All injuries were registered and documented according to time-loss definition and classified into either traumatic or overuse injuries . Results Ninety-three players ( 27 % ) sustained 119 injuries during the second season . The intervention group 0.31 ( 95 % CI 0.22–0.39 ) and the control group 0.41 ( 95 % CI 0.29–0.53 ) injuries/player . The injury incidence decreased in the intervention group and was lower than the control group . The analysis showed no statistical differences when comparing the intervention group and the control group neither after the second season nor after the two seasons together , Cohen ’s d 0.2 . Conclusion This group-based training showed a small effect size after the second year result ing in fewer injuries , especially severe injuries , in the intervention group compared to the control group . It is , therefore , important not to overlook the potential of a group-based psychological injury prevention programme . Level of incidenceII Identifying and underst and ing injury risk factors are necessary to target the injury-prone athlete and develop injury prevention measurements . The influence of psychological factors on injuries in football is poorly documented . The purpose of this 8-month prospect i ve cohort study therefore was to examine whether psychological player characteristics assessed by a self-administered question naire represent risk factors for injury . At baseline , female football players ( 14 - 16 years ) were asked to complete a detailed question naire covering player history , previous injuries , perception of success and motivational climate , life stress , anxiety and coping strategies . During the 2005 season , a total of 1430 players were followed up to record injuries . A history of a previous injury [ odds ratio (OR)=1.9 ( 1.4 ; 2.5 ) , P<0.001 ] increased the risk of a new injury to the same region . There were significant differences in disfavor for previously injured compared with non-injured players for ego orientation ( P=0.007 ) , perception of a performance climate ( P=0.003 ) and experienced stressful life events ( P<0.001 ) . However , only high life stress ( P=0.001 ) and perception of a mastery climate ( P=0.03 ) were significant risk factors for new injuries . In conclusion , a perceived mastery climate and a high level of life stress were significant predictors for new injuries in a cohort of young female football players Background The injury rate in soccer is high , and effective injury prevention methods are needed . Purpose To test the effect of a video-based awareness program on the incidence of acute injuries in soccer . Study Design R and omized control trial ; Level of evidence , 1 . Methods Participants were elite male soccer players from the top 2 divisions in Icel and . Fifteen of 20 teams completed the study : 7 intervention teams ( 127 players ) and 8 control teams ( 144 players ) chosen by r and om . Just before the start of the 2000soccer season , the intervention teams were visited with an intervention program . The program included a 15-minutepresentation with information on the injury risk of playing elite soccer , typical injuries , and their mechanisms . Then the players workedtogether in pairs and analyzed video sequences to develop preventive strategies . The 12 video sequences were selected fromthe previous Icel and ic soccer season , representing 3 typical injury mechanisms that accounted for more than half of all incidentsrecorded . During the season , team physical therapists prospect ively recorded all acute injuries , and coaches recorded trainingexposure on a special form . Injury incidence was compared between groups and between the 1999 and 2000 seasons for teamsthat participated in both seasons . Results No difference was observed in injury incidence between the intervention ( 6.6 ± 0.7 injuries per 1000 player hours ) and control groups ( 6.6 ± 0.7 injuries per 1000 player hours ) . Furthermore , there was no difference in injury location or type . Conclusion The video-based injury awareness program showed no effect on injury rate Background Ankle injury is common in football , but the circumstances surrounding them are not well characterised . Aim To investigate the rates , especially time-trends , and circumstances of ankle injuries in male professional football . Methods 27 European clubs with 1743 players were followed prospect ively between 2001/2002 and 2011/2012 . Time loss injuries and individual-player exposure during training sessions and matches were recorded . Injury rate was defined as the number of injuries/1000 h. Results A total of 1080 ankle injuries were recorded ( 13 % of all injuries ) with lateral ligament ankle sprain being the most common injury subtype ( 51 % of all ankle injuries ) . The rates of ankle injury and ankle sprain were 1/1000 h and 0.7/1000 h , respectively . The ankle sprain rate declined slightly over time during the 11-year study period ( on average 3.1%/season ) with a statistically significant seasonal trend ( p=0.041 ) . Foul play according to the referee was involved in 40 % of the match-related ankle sprains . Syndesmotic sprains and ankle impingement were uncommon causes of time loss ( 3 % each of all ankle injuries ) . Conclusions Lateral ligament ankle sprain constituted half of all ankle injuries in male professional football , whereas ankle impingement syndromes were uncommon . The ankle sprain rate decreased slightly over time , but many ankle sprains were associated with foul play . Our data extend the body of literature that provides football policy makers with a foundation to review existing rules and their enforcement CONTEXT Athletes participating in sport are exposed to a high injury risk . Previous research has found a great number of risk factors ( both physiological and psychological ) that could increase injury risk . One limitation in previous studies is that few have considered the complex interaction between psychological factors in their research design . OBJECTIVE To study whether personality , stress , and coping predicted injury occurrence in an elite soccer population based on a hypothesized model . DESIGN Prospect i ve . PARTICIPANTS 56 ( n = 38 male , n = 18 female ) Swedish Premiere League soccer players were selected based on convenience sampling . INTERVENTION Participants completed 4 question naires including the Swedish Universities Scales of Personality , Life Events Survey for Collegiate Athletes , and Brief COPE during the initial question naire administration . Subsequent to the first meeting , participants also completed the Hassle and Uplift Scale5 once per wk for a 13-wk period throughout the competitive season . MAIN OUTCOME MEASURES A path analysis was conducted examining the influence of personality traits ( ie , trait anxiety ) , state-level stressors ( ie , negative-life-event stress and daily hassles ) , and coping on injury frequency . RESULTS Results of the path analysis indicated that trait anxiety , negative-life-event stress , and daily hassle were significant predictors of injury among professional soccer players , accounting for 24 % of the variance . CONCLUSION The findings highlight the need for athletes , coaches , and medical practitioners to attempt to reduce state-level stressors , especially daily hassles , in minimizing injury risk . Educating and training athletes and coaches in proactive stress-management techniques appears warranted Motor imagery ( MI ) is the mental representation of an action without any concomitant movement . MI has been used frequently after peripheral injuries to decrease pain and facilitate rehabilitation . However , little is known about the effects of MI on muscle activation underlying the motor recovery . This study aim ed to assess the therapeutic effects of MI on the activation of lower limb muscles , as well as on the time course of functional recovery and pain after surgery of the anterior cruciate ligament ( ACL ) . Twelve patients with a torn ACL were r and omly assigned to a MI or control group , who both received a series of physiotherapy . Electromyographic activity of the quadriceps , pain , anthropometrical data , and lower limb motor ability were measured throughout a 12-session therapy . The data provided evidence that MI elicited greater muscle activation , even though imagery practice did not result in pain decrease . Muscle activation increase might originate from a redistribution of the central neuronal activity , as there was no anthropometric change in lower limb muscles after imagery practice . This study confirmed the effectiveness of integrating MI in a rehabilitation process by facilitating muscular properties recovery following motor impairment . MI may thus be considered a reliable adjunct therapy to help injured patients to recover motor functions after reconstructive surgery of ACL OBJECTIVES To investigate by use of a latent growth curve analysis framework whether athletes ' individual levels and changes in hassle and uplift levels over a 10-week period could predict injury outcome in an elite junior soccer population . DESIGN A prospect i ve design with repeated measurement points . METHODS Participants were 101 Swedish elite junior soccer players ( 67 males and 34 females ) . Ten sets of measures were taken on a weekly basis during which participants completed the Hassles and Uplifts Scale ( HUS ) . Latent growth curve models were used to examine whether the level and change in psychological stress could predict the frequency of injury over the 10-week period . RESULTS The results show that injury occurrence was significantly associated with both the initial level of daily hassle and the change in daily hassle . High initial daily hassle levels and a smaller decrease in daily hassles were associated with injury occurrence . Moreover , injury occurrence was significantly associated with a greater decrease in daily uplift . CONCLUSIONS The findings highlight the importance of focusing on state variables using prospect i ve design s and appropriate analysis of within-person change to detect complex and dynamic associations across time in injury-prediction research OBJECTIVES Several attempts to reduce the incidence of sport injuries using psychosocial interventions produced fruitful , although inconclusive results . This paper presents the effectiveness and implementation issues of a pilot 3-month stress-management and muscle relaxation program aim ed at reducing sport injury incidence . DESIGN Pre-post treatment-non treatment group comparison . PROGRAM ADMINISTRATION The program was administered by a trained psychologist on a once-a-week , 1-h session basis . PARTICIPANTS Seventy-four male soccer players from four National Youth league teams voluntarily participated . Teams were r and omly assigned to either treatment/non-treatment group . MEASURES Injury protocol , Self-monitoring cards , Athletes ' satisfaction and commitment survey , Coaches ' interview . RESULTS Group main effect and Time-Group interaction effect were both statistically significant , F(1,60 ) = 8.30 , p = 0.005 , η2p = 0.121 , with the average number of injuries larger in the post-treatment phase of non-treatment group ( p = 0.005 , η2p = 0.077 ) . There was a significant decrease in the average number of injuries for the intervention group before and after implementing the program ( p < 0.001 , η2p = 0.309 ) . CONCLUSIONS A controlled implementation of a psychosocial program was effective in reducing youth soccer sport injuries , with a high level of satisfaction and commitment from the athletes , as well as high acceptance from the coaches 20 competitive gymnasts ( 17 girls , 3 boys ; mean age , 14.4 ± 3.4 yr . ) were recruited from two clubs in Auckl and , New Zeal and . Gymnasts , who had competed at a national or international level , were divided into two groups to examine the effects of a longitudinal stress-management program on injury and stress . Those in the stress-management group took part in 12 1-hr . sessions over 24 weeks , while the control group took part in a placebo program of anthropometric measurements and lectures on nutrition . All participants completed the Life Experiences Survey and Athletic Experiences Survey at baseline , 3 mo . , 6 mo . ( end of intervention ) , and 9 mo . ( 3 mo . after completion of intervention ) . Injury data were collected prospect ively by weekly self-report over the 9-mo . study . Repeated- measures analyses of covariance with age and , where applicable , the baseline measure of the dependent variable entered as covariates , indicated no significant group or group by time effects for the scores on the two surveys , or injury scores . However , given the small sample , the statistical power of the study to detect even large effects was low . Therefore , rather than concluding that the stress-management program had no effect on training hours lost to injury or on stress , upper limits were placed on the magnitude of any effects that might exist . Further research using larger sample s is recommended |
367 | 20,008,687 | Similar significant and inverse associations were observed with decaffeinated coffee and tea and risk of incident diabetes .
High intakes of coffee , decaffeinated coffee , and tea are associated with reduced risk of diabetes . | BACKGROUND Coffee consumption has been reported to be inversely associated with risk of type 2 diabetes mellitus .
Similar associations have also been reported for decaffeinated coffee and tea .
We report herein the findings of meta-analyses for the association between coffee , decaffeinated coffee , and tea consumption with risk of diabetes . | BACKGROUND Green and black tea polyphenols have been extensively studied as cancer chemopreventive agents . Many in vitro experiments have supported their strong antioxidant activity . Additional in vivo studies are needed to examine the pharmacokinetic relation of absorption and antioxidant activity of tea polyphenols administered in the form of green or black tea or tea extract supplements . OBJECTIVE The purpose of this study was to compare the pharmacokinetic disposition of tea polyphenols and their effect on the antioxidant capacity in plasma 8 h after a bolus consumption of either green tea , black tea , or a green tea extract supplement . DESIGN Thirty healthy subjects were r and omly assigned to 3 different sequences of green tea , black tea , or a green tea extract supplement in a 3 x 3 crossover design with a 1-wk washout period in between treatments . RESULTS Flavanol absorption was enhanced when tea polyphenols were administered as a green tea supplement in capsule form and led to a small but significant increase in plasma antioxidant activity compared with when tea polyphenols were consumed as black tea or green tea . All 3 interventions provided similar amounts of (-)-epigallocatechin-3-gallate . CONCLUSIONS Our observations suggest that green tea extract supplements retain the beneficial effects of green and black tea and may be used in future chemoprevention studies to provide a large dose of tea polyphenols without the side effects of caffeine associated with green and black tea beverages BACKGROUND Increasing coffee intake was inversely associated with risk of type 2 diabetes in population s of European descent ; however , data from high-risk Asian population s are lacking as are data on tea intake in general . OBJECTIVE We investigated the prospect i ve associations between intakes of coffee , black tea , and green tea with the risk of type 2 diabetes in Singaporean Chinese men and women . DESIGN We analyzed data from 36 908 female and male participants in the Singapore Chinese Health Study aged 45 - 74 y in 1993 - 1998 who had multiple diet and lifestyle measures assessed and then were followed up between 1999 and 2004 . We used Cox regression models to investigate the association of baseline coffee and tea intakes with incident type 2 diabetes during follow-up , with adjustment for a number of possible confounding or mediating variables . RESULTS In multivariate models participants reporting > or = 4 cups of coffee/d had a 30 % reduction in risk of diabetes [ relative risk ( RR ) : 0.70 ; 95 % CI : 0.53 , 0.93 ] compared with participants who reported nondaily consumption . Participants reporting > or = 1 cup of black tea/d had a suggestive 14 % reduction in risk of diabetes ( RR : 0.86 ; 95 % CI : 0.74 , 1.00 ) compared with participants who reported 0 cups/d , and we observed no association with green tea . CONCLUSION Regular consumption of coffee and potentially black tea , but not green tea , is associated with lower risk of type 2 diabetes in Asian men and women in Singapore OBJECTIVE : To assess the effect of weight change on the relationship between coffee and tea consumption and diabetes risk . DESIGN : Prospect i ve cohort study , using data from the First National Health and Nutrition Examination Survey Epidemiologic Follow Up Study . Survival analyses were conducted using 301 selfreported cases of diabetes and eight documented diabetes deaths during an 8.4-y follow-up . SUBJECTS : A total of 7006 subjects aged 32–88 y with no reported history of diabetes were included in the study . RESULTS : For all subjects combined , increases in consumption of ground-caffeinated coffee and caffeine at baseline were followed by decreases in diabetes risk during follow-up . There were significant statistical interactions between age and consumption of caffeine ( P=0.02 ) and ground-caffeinated coffee ( P=0.03 ) . Age-stratified analysis showed that the decrease in diabetes risk only applied to ≤60-y-old subjects , for whom the decrease in diabetes risk also obtained for ground-decaffeinated coffee and regular tea . The multivariate hazard ratio ( HR ) and 95 % confidence interval for a 2 cups/day increment in the intake of ground-caffeinated coffee , ground-decaffeinated coffee and regular tea was 0.86 ( 0.75–0.99 ) , 0.58 ( 0.34–0.99 ) and 0.77 ( 0.59–1.00 ) , respectively . The diabetes risk was negatively related to the consumption in a dose – response manner . There were strong statistical interactions between prior weight change and beverage consumption for ≤60-y-old subjects . Further analysis revealed that the decrease in diabetes risk only applied to those who had lost weight , and that there was a positive dose – response relationship between diabetes risk and weight change . For example , the multivariate HR and 95 % confidence interval for > 0 vs 0 cups/day of ground-decaffeinated coffee was 0.17 ( 0.04–0.74 ) , 0.52 ( 0.19–1.42 ) , 0.77 ( 0.30–1.96 ) and 0.91 ( 0.39–2.14 ) for subgroups with weight change of ≤0 , 0–10 , 10–20 and > 20 lbs , respectively . There was no significant association between diabetes risk and consumption of instant-caffeinated coffee , instant-decaffeinated coffee or herbal tea . Caffeine intake appeared to explain some , but not all , of the diabetes-risk reduction and weight change . CONCLUSION : The negative relationship between diabetes risk and consumption of ground coffee and regular tea , observed for all NHEFS subjects , actually only applied to nonelderly adults who had previously lost weight Context Caffeine intake from coffee has been associated with a lower incidence of diabetes . Research ers have not studied the relationship of green tea , a popular beverage in Japan , where the incidence of diabetes is increasing rapidly . Contributions The authors estimated the intake of caffeine-containing beverages in a community-based survey in Japan and measured the 5-year incidence of diabetes . Greater intake of green tea or coffee was associated with a reduced incidence of diabetes . The effect of green tea was largely observed in women , was dose-related , and reflected caffeine intake . Implication s Higher intake of caffeine , whether from coffee or green tea , is associated with a lower incidence of diabetes . The Editors The prevalence of type 2 diabetes has increased worldwide , particularly in Asian countries where it was previously low ( 1 ) . In Japan , population -based studies have shown a 2-fold increase in the prevalence of diabetes during the past 2 decades , from 5 % to 10 % to 10 % to 15 % ( 2 ) . Several cohort studies done in Europe and in the United States reported an association between coffee consumption , a major source of caffeine , and reduced risk for diabetes ( 3 - 7 ) . Although these studies did not show any association between consumption of black tea and the risk for diabetes , they did not examine the effect of green or oolong teas , major sources of caffeine in Asian countries . Consumption of green tea is common in Japan ; 80 % of the population drinks green tea , and the average consumption per capita is 2 cups per day ( 8) . We wanted to determine whether there is a relationship between consumption of green tea and the risk for type 2 diabetes and , if so , whether caffeine fully accounts for this relationship . To examine these questions , we analyzed data from a large cohort study of 19487 middle-aged men and women in 25 communities across Japan . We also examined the effect of age , sex , body mass index ( BMI ) , family history , smoking status , alcohol use , magnesium intake , and physical activity on the association between this mode of caffeine consumption and risk for diabetes . Methods The Japan Collaborative Cohort Study for Evaluation of Cancer Risk ( JACC Study ) started between 1988 and 1990 . A total of 110792 individuals ( 46465 men and 64327 women ) who were 40 to 79 years of age and living in 45 communities across Japan participated in municipal health screening examinations and completed self-administered question naires regarding lifestyle and medical history of cardiovascular disease and cancer ( 9 ) . Informed consent was obtained before the completion of the question naire . Participants from 25 of the 45 communities completed 5-year follow-up surveys . Among 35690 participants ( 15177 men and 20513 women ) who were 40 to 65 years of age at baseline without a history of type 2 diabetes , stroke , coronary heart disease , or cancer , 17413 individuals ( 49 % ; 6727 men and 10686 women ) completed the 5-year follow-up question naire and provided valid responses on tea or coffee consumption and history of type 2 diabetes . The data from these 17413 individuals were used for the analyses . The mean age of the nonrespondents was 1 year younger for men ( 52.3 vs. 53.3 years of age ) and did not differ for women ( 53.1 vs. 53.0 years of age ) compared with the respondents . The mean BMI and the prevalence of a BMI of 25.0 kg/m2 or greater did not differ between the respondents and nonrespondents . Mean BMI was 22.7 kg/m2 versus 22.8 kg/m2 for men and 22.8 kg/m2 versus 22.9 kg/m2 for women , respectively ; the prevalence of overweight was 18 % versus 19 % for men and 21 % versus 22 % for women , respectively . The ethical committees at Nagoya University and the University of Tsukuba approved the study . Assessment of Consumption of Tea and Coffee and Caffeine Intake At baseline , consumption of tea and coffee was assessed by using a self-administered dietary question naire . Participants were asked to state their average consumption of green tea , black tea , oolong tea , and coffee during the previous year . They could select any of 4 frequency responses : less than once a week , about 1 to 2 times a week , about 3 to 4 times a week , and almost every day . Participants who selected the response of almost every day were also asked to state their average consumption of these beverages in number of cups per day . We classified the categories of consumption as less than 1 cup per week , 1 to 6 cups per week , 1 to 2 cups per day , 3 to 5 cups per day , and 6 or more cups per day . The highest 2 or 3 consumption categories were combined for coffee , black tea , and oolong tea because of the small number of participants in these categories . The consumption of decaffeinated coffee or tea was not recorded because these products were not commercially available in Japan in the early 1990s . The total intake of caffeine was calculated by adding the caffeine content from each specific beverage ( 1 cup for coffee or tea ) and multiplying it by the participant 's weight proportional to the frequency of caffeine use . We estimated the size of the cup for each beverage from a validation study ( 10 ) and the caffeine content per 100 mL of each beverage from the Japan Food Tables ( 11 ) . The estimated caffeine content was 153 mg per cup ( 170 mL ) of coffee , 30 mg per cup ( 200 mL ) of green tea , 51 mg per cup ( 170 mL ) of black tea , and 38 mg per cup ( 190 mL ) of oolong tea . The mean caffeine intake was 229 mg/d for men and 215 mg/d for women . Relative proportions of caffeine intake by beverage were 46 % from green tea , 44 % to 47 % from coffee , 3 % from black tea , and 4 % to 5 % from oolong tea . For reproducibility , the Spearman correlation coefficients between the 2 question naires , administered 1 year apart for 85 participants ( 8 men and 77 women ) , were 0.79 for green tea , 0.87 for coffee , 0.77 for black tea , and 0.56 for oolong tea ( 10 ) . The validity of the data was confirmed for the 85 participants by comparing the data from the question naire with those from four 3-day dietary records collected approximately 3 to 4 months apart ( 10 ) . The mean frequency of consumption of green tea was 25.4 cups per week according to the question naire and 30.1 cups per week according to four 1-week dietary records ( Spearman correlation coefficient , 0.47 ) . The respective mean frequencies were 8.0 cups and 7.1 cups per week with a correlation coefficient of 0.79 for coffee , 1.4 cups and 1.6 cups per week with a correlation coefficient of 0.70 for black tea , and 1.8 cups and 1.2 cups per week with a correlation coefficient of 0.55 for oolong tea . When we restricted the data to the 77 women , the results were essentially the same . Assessment of Diabetes Cases Participants who reported having diabetes newly diagnosed by physicians on the 5-year follow-up question naire were considered to have incident diabetes . To examine the validity of self-reporting of diabetes , we compared self-report data with laboratory findings and treatment status in a sample of 1230 men and 1837 women . We considered elevated glucose concentrations ( fasting serum glucose concentration 7.8 mmol/L [ 140 mg/dL ] or a r and omly measured concentration of 11.1 mmol/L [ 200 mg/dL ] ) or treatment with oral hypoglycemic agents or insulin to indicate new cases of diabetes . Recent criteria from the American Diabetes Association ( 12 ) were not used because the cases in our study were diagnosed before 1995 . The sensitivity of self-reporting was 70 % for men and 75 % for women ; the specificity was 95 % for men and 98 % for women . Statistical Analysis To examine potential confounding variables reported from previous studies ( 3 - 7 ) , we presented baseline characteristics according to the frequency of consumption for each beverage . Tests for trends were conducted by using the median values of confounding variables in each category of beverage ; the linear regression model was used for continuous variables , and the logistic regression model was used for categorical variables . The odds ratios for incident type 2 diabetes were calculated in each category of beverage consumption and in each quartile of caffeine intake ; less than 1 cup per week or the lowest quartile was used as the reference category . We estimated age , sex , and BMI -adjusted odds ratios and multivariable odds ratios using the logistic regression model , adjusting for age ( in years ) , sex , sex-specific quintiles of BMI ( weight in kilograms divided by the square of height in meters ) , parental history of diabetes ( yes or no ) , smoking status ( never , former , or current [ 1 to 19 , 20 to 29 , or 30 cigarettes/d ] ) , alcohol intake ( never , former , or current [ 1 to 22 , 23 to 45 , 46 to 68 , or 69 g/d ] ) , sex-specific quintiles of magnesium intake , hours of walking ( < 0.5 , 0.5 , 0.6 to 0.9 , and 1.0 h/d ) , and hours of participation in sports ( < 1 , 1 to 2 , 3 to 4 , and 5 h/wk ) . Sex-specific quintiles of BMI and magnesium intake were used because of different distributions between the sexes . We adjusted for magnesium intake because previous cohort studies indicated an inverse association between magnesium intake and risk for diabetes ( 13 , 14 ) . We conducted a test for trend by treating median values of each category of beverage or caffeine intake as continuous variables . We examined the association between caffeine intake and the risk for diabetes stratified by age group ( 40 to 54 years and 55 to 65 years ) , sex , family history of diabetes ( yes or no ) , current smoking status ( yes or no ) , current alcohol intake ( yes or no ) , magnesium intake ( below and above the sex-specific median ) , BMI ( < 25.0 kg/m2 and 25.0 kg/m2 ) , hours of walking ( < 0.5 and 0.5 h/d ) , and hours of participation in sports ( < 5 and 5 h/wk ) . The interactions with these stratified variables were tested by using cross-product terms of caffeine intake and the stratified variables . All analyses were conducted by using the SAS statistical package , version 8.2 ( SAS Institute Inc. , Cary , North Carolina ) . P values for statistical tests were 2-tailed , and 95 % CIs were estimated . Role of Context A recently published study in a Dutch population identified an association between higher coffee consumption and lower risk for type 2 diabetes mellitus but did not distinguish between intake of regular and decaffeinated coffee . Contribution This large epidemiologic study in a U.S. sample confirmed the Dutch study findings . It also found a statistically significant protective association between total caffeine intake and type 2 diabetes mellitus and a modest inverse association with decaffeinated coffee consumption . Implication s Consumption of caffeinated coffee is associated with a reduced risk for type 2 diabetes mellitus . Further studies should explore the long-term effects of caffeine on glucose metabolism . The Editors The prevalence of type 2 diabetes mellitus has increased dramatically in the past decades , and the disease now affects approximately 8 % of U.S. adults ( 1 ) . Diet and lifestyle factors are primary determinants of risk for type 2 diabetes ( 2 ) . In addition to overweight and obesity , other independent behavioral and lifestyle factors include physical inactivity , smoking , and a diet higher in glycemic load and trans fatty acids and lower in fiber and polyunsaturated fatty acids . Coffee consumption may be related to diabetes because short-term metabolic studies have suggested that caffeine adversely affects insulin sensitivity and glucose metabolism ( 3 ) . Coffee consumption is widespread ; more than 50 % of Americans drink coffee , and average per capita intake is about 2 cups per day ( 4 ) . Coffee is the primary source of caffeine intake , providing approximately 210 mg/d per person in the United States . In humans , acute administration of caffeine decreases insulin sensitivity and impairs glucose tolerance ( 3 , 5 - 8 ) . On the other h and , caffeine stimulates thermogenesis and increases energy expenditure ( 9 - 11 ) , which may facilitate weight reduction and maintenance . Because of these complex physiologic effects of caffeine and because tolerance to the humoral and hemodynamic effects of caffeine typically develops with long-term use ( 12 ) , it is difficult to extrapolate findings from short-term metabolic studies to long-term use of coffee and other caffeinated beverages . A recent epidemiologic study has found a statistically significant inverse association between coffee consumption and risk for type 2 diabetes in a sample of Dutch participants ( 13 ) . After adjustment for potential confounders , the relative risk for type 2 diabetes among participants consuming at least 7 cups of coffee per day as compared with those consuming 2 cups or less per day was 0.50 ( 95 % CI , 0.35 to 0.72 ; P < 0.001 for trend ) . The study , however , could not distinguish regular coffee from decaffeinated coffee and did not evaluate the association with total caffeine intake . In our study , we examined long-term intake of coffee and other caffeinated beverages and decaffeinated coffee in relation to incidence of type 2 diabetes in 2 large prospect i ve cohorts of men and women . In particular , we examined whether the associations were modified by smoking and body mass index . Methods Study Sample The Health Professionals Follow-up Study The Health Professionals Follow-up Study ( HPFS ) was established in 1986 when 51 529 male health professionals , including dentists , optometrists , veterinarians , osteopathic physicians , podiatrists , and pharmacists , who were 40 to 75 years of age returned a mailed question naire providing detailed information about their medical history , lifestyle , and other risk factors ( 14 ) . Information on the cohort is up date d every 2 years to identify newly diagnosed diseases . For our analysis , we excluded men with a previous diagnosis of type 2 diabetes , coronary heart disease , or cancer at baseline . Participants who did not complete more than 70 of 131 food items in the 1986 dietary question naire or had extreme scores for total daily intake of energy ( < 800 kcal or > 4200 kcal ) were excluded . After exclusions , the analysis included 41 934 eligible men who were followed from 1986 to 1998 . The Nurses ' Health Study The Nurses ' Health Study ( NHS ) was established in 1976 when 121 700 female nurses 30 to 55 years of age living in 11 large states completed a mailed question naire providing detailed information about their medical history , lifestyles , and other risk factors ( 15 ) . The information is up date d every 2 years to identify newly diagnosed diseases . In 1980 , a semiquantitative food frequency question naire was added . For our analysis , we excluded women with a previous diagnosis of type 2 diabetes , coronary heart disease , or cancer at baseline . Participants who did not complete more than 10 items on the 1980 dietary question naire or had extreme scores for total daily intake of energy ( < 500 kcal or > 3500 kcal ) were also excluded , leaving 84 276 eligible women who were followed from 1980 to 1998 . Assessment of Coffee and Caffeine Intake Vali date d dietary question naires were sent to the HPFS participants in 1986 , 1990 , and 1994 and to the NHS participants in 1980 , 1984 , 1986 , 1990 , and 1994 . In all the question naires , participants were asked how often on average during the previous year they had consumed coffee and tea . Decaffeinated coffee and different types of caffeinated soft drinks were first assessed in 1986 in the HPFS and in 1984 in the NHS . We assessed the total intake of caffeine by summing the caffeine content for a specific amount of each food during the previous year ( 1 cup for coffee or tea , one 12-ounce bottle or can for carbonated beverages , and 1 ounce for chocolate ) multiplied by a weight proportional to the frequency of its use . The participants could choose from 9 frequency responses ( never , 1 to 3 per month , 1 per week , 2 to 4 per week , 5 to 6 per week , 1 per day , 2 to 3 per day , 4 to 5 per day , and 6 or more per day ) . Using the U.S. Department of Agriculture food composition sources , we estimated that the caffeine content was 137 mg per cup of coffee , 47 mg per cup of tea , 46 mg per bottle or can of cola beverage , and 7 mg per serving of chocolate c and y. In our validation studies , high correlations were recorded for coffee and other caffeinated beverage intake assessed by the food frequency question naire and several 1-week diet records ( coffee , r = 0.78 ; tea , r = 0.93 ; and caffeinated sodas , r = 0.85 ) ( 16 ) . For these analyses , coffee consumption was categorized into 5 groups : never , less than 1 cup per day , 1 to 3 cups per day , 4 to 5 cups per day , and 6 cups or more per day . Caffeine intake was categorized into quintiles . Assessment of Diabetes Cases Participants who reported having diabetes were sent a supplementary mailed question naire that asked about symptoms , diagnostic tests , and treatment . We considered any 1 of the following criteria to represent a new case of diabetes : classic symptoms and elevated glucose levels ( fasting plasma glucose concentration 7.8 mmol/L [ 140 mg/dL ] or r and omly measured concentration 11.1 mmol/L [ 200 mg/dL ] ) ; at least 2 elevated plasma glucose concentrations on different occasions in the absence of symptoms ( plasma glucose level 11.1 mmol/L [ 200 mg/dL ] 2 or more hours after oral glucose tolerance testing ) ; or treatment with oral hypoglycemic agents or insulin . Our criteria for diabetes classification are consistent with those proposed by the National Diabetes Data Group ( 17 ) because most cases were diagnosed before 1997 . The validity of this diagnostic procedure has been verified in a sub sample of this study sample ( 18 ) . The diagnosis of type 2 diabetes was confirmed by medical records in 98 % of the participants . In addition , another sub study assessing the prevalence of undiagnosed diabetes suggested a very low rate of false-negative results ( 19 ) . Statistical Analysis We calculated the follow-up period from the return of the baseline question naires ( in 1986 for men and in 1980 for women ) to the diagnosis of type 2 diabetes , death , or the end of follow-up ( January 1998 for men and June 1998 for women ) , whichever occurred first . Incidence rates for diabetes were calculated by dividing incident cases by person-years of follow-up in each category of coffee intake . Relative risks were calculated as the rate of occurrence of type 2 diabetes in each quintile of caffeine intake divided by the corresponding rate in the lowest quintile , and 95 % CIs were calculated . To inspect potential confounding variables for the analyses , we examined baseline characteristics ( directly st and ardized to the age distribution of each cohort ) according to coffee consumption levels . We used proportional hazards models ( 20 ) to adjust for several risk factors , including age in 5 categories ( < 50 , 50 to 54 , 55 to 59 , 60 to 64 , or 65 years of age ) ; body mass index ( weight divided by height [ kg/m2 ] ) in 8 categories ( < 23 , 23 to 24 , 25 to 28 , 29 to 30 , 31 to 32 , 33 to 34 , 35 to 39 , or 40 kg/m2 ) ; physical activity ( hours of moderate or vigorous exercise in NHS or quintiles of metabolic equivalents in HPFS ) ; family history of diabetes ( yes or no ) ; hormone use ( never , current , or past [ in NHS only ] ) ; smoking status ( never , past , or current smokers [ 1 to 14 , 15 to 24 , or 25 cigarettes per day ] ) ; alcohol consumption ( 0 , 0.1 to 4.9 , 5 to 9.9 , 10 to 14.9 , or 15 g/d ) ; total calorie intake ( continuous ) ; and quintiles of trans fat , glycemic load , and cereal fiber intake . We also adjusted for magnesium intake because our previous analyses have shown an inverse association between dietary magnesium and risk for diabetes ( 21 ) . Information on covariates was up date d periodically during follow-up . We performed a test for trend by treating median values of each category of caffeine and coffee intake as continuous variables . To represent long-term intake of coffee and caffeine and to reduce measurement error , we conducted analyses using cumulative up date d caffeine and coffee intake from all question naires ( 22 ) . For example , in the NHS , diabetes incidence between 1980 and 1984 was related to the coffee intake from the 1980 Aims /hypothesisCoffee contains several substances that may affect glucose metabolism . The aim of this study was to evaluate the relationship between habitual coffee consumption and the incidence of IFG , IGT and type 2 diabetes . Methods We used cross-sectional and prospect i ve data from the population -based Hoorn Study , which included Dutch men and women aged 50–74 years . An OGTT was performed at baseline and after a mean follow-up period of 6.4 years . Associations were adjusted for potential confounders including BMI , cigarette smoking , physical activity , alcohol consumption and dietary factors . Results At baseline , a 5 cup per day higher coffee consumption was significantly associated with lower fasting insulin concentrations ( −5.6 % , 95 % CI −9.3 to −1.6 % ) and 2-h glucose concentrations ( −8.8 % , 95 % CI −11.8 to −5.6 % ) , but was not associated with lower fasting glucose concentrations ( −0.8 % , 95 % CI −2.1 to 0.6 % ) . In the prospect i ve analyses , the odds ratio ( OR ) for IGT was 0.59 ( 95 % CI 0.36–0.97 ) for 3–4 cups per day , 0.46 ( 95 % CI 0.26–0.81 ) for 5–6 cups per day , and 0.37 ( 95 % CI 0.16–0.84 ) for 7 or more cups per day , as compared with the corresponding values for the consumption of 2 or fewer cups of coffee per day ( p=0.001 for trend ) . Higher coffee consumption also tended to be associated with a lower incidence of type 2 diabetes ( OR 0.69 , CI 0.31–1.51 for ≥7 vs ≤2 cups per day , p=0.09 for trend ) , but was not associated with the incidence of IFG ( OR 1.35 , CI 0.80–2.27 for ≥7 vs ≤2 cups per day , p=0.49 for trend ) . Conclusions /interpretationOur findings indicate that habitual coffee consumption can reduce the risk of IGT , and affects post-load rather than fasting glucose metabolism CONTEXT Only a few studies of coffee consumption and diabetes mellitus ( DM ) have been reported , even though coffee is the most consumed beverage in the world . OBJECTIVE To determine the relationship between coffee consumption and the incidence of type 2 DM among Finnish individuals , who have the highest coffee consumption in the world . DESIGN , SETTING , AND PARTICIPANTS A prospect i ve study from combined surveys conducted in 1982 , 1987 , and 1992 of 6974 Finnish men and 7655 women aged 35 to 64 years without history of stroke , coronary heart disease , or DM at baseline , with 175 682 person-years of follow-up . Coffee consumption and other study parameters were determined at baseline using st and ardized measurements . MAIN OUTCOME MEASURES Hazard ratios ( HRs ) for the incidence of type 2 DM were estimated for different levels of daily coffee consumption . RESULTS During a mean follow-up of 12 years , there were 381 incident cases of type 2 DM . After adjustment for confounding factors ( age , study year , body mass index , systolic blood pressure , education , occupational , commuting and leisure-time physical activity , alcohol and tea consumption , and smoking ) , the HRs of DM associated with the amount of coffee consumed daily ( 0 - 2 , 3 - 4 , 5 - 6 , 7 - 9 , > or = 10 cups ) were 1.00 , 0.71 ( 95 % confidence interval [ CI ] , 0.48 - 1.05 ) , 0.39 ( 95 % CI , 0.25 - 0.60 ) , 0.39 ( 95 % CI , 0.20 - 0.74 ) , and 0.21 ( 95 % CI , 0.06 - 0.69 ) ( P for trend<.001 ) in women , and 1.00 , 0.73 ( 95 % CI , 0.47 - 1.13 ) , 0.70 ( 95 % CI , 0.45 - 1.05 ) , 0.67 ( 95 % CI , 0.40 - 1.12 ) , and 0.45 ( 95 % CI , 0.25 - 0.81 ) ( P for trend = .12 ) in men , respectively . In both sexes combined , the multivariate-adjusted inverse association was significant ( P for trend < .001 ) and persisted when stratified by younger and older than 50 years ; smokers and never smokers ; healthy weight , overweight , and obese participants ; alcohol drinker and nondrinker ; and participants drinking filtered and nonfiltered coffee . CONCLUSION Coffee drinking has a grade d inverse association with the risk of type 2 DM ; however , the reasons for this risk reduction associated with coffee remain unclear OBJECTIVES To examine the long-term incidence of diabetes in relation to coffee consumption in Swedish women . DESIGN Prospect i ve longitudinal cohort study . SETTING City of Göteborg , Sweden . SUBJECTS A r and om population sample of 1361 women , aged 39 - 65 years , without prior diabetes or cardiovascular disease took part in a screening study in 1979 - 1981 with question naires , physical examination and blood sampling . MAIN OUTCOME MEASURES The development of diabetes until 1999 was identified by question naires in a second screening and the Swedish hospital discharge register . RESULTS Altogether , there were 74 new cases of diabetes . The risk of developing diabetes was 475 per 100 000 person-years in women who consumed two cups of coffee or less per day , 271 in women who consumed three to four cups per day , 202 with a consumption of five to six cups per day , and 267 in drinkers of seven cups or more per day . Associated hazard ratios , after adjustment for age , smoking , low physical activity , education and body mass index were 0.55 ( 0.32 - 0.95 ) , 0.39 ( 0.20 - 0.77 ) and 0.48 ( 0.22 - 1.06 ) for daily consumption of three to four , five to six and seven cups or more , respectively , with a consumption of less than two per day as reference . Additional adjustment for serum cholesterol and triglycerides attenuated the relation between coffee and diabetes slightly , indicating a possible mediating effect on the effect of coffee by serum lipids . CONCLUSIONS The findings of the present study support the hypothesis that coffee consumption protects from the development of diabetes in women Aim /hypothesisThe aim of this study was to investigate the association between processed and other meat intake and incidence of Type 2 diabetes in a large cohort of women . Methods Incident cases of Type 2 diabetes were identified during 8 years of follow-up in a prospect i ve cohort study of 91246 U.S. women aged 26 to 46 years and being free of diabetes and other major chronic diseases at baseline in 1991 . Results We identified 741 incident cases of confirmed Type 2 diabetes during 716276 person-years of follow-up . The relative risk adjusted for potential non-dietary confounders was 1.91 ( 95 % CI : 1.42–2.57 ) in women consuming processed meat five times or more a week compared with those consuming processed meat less than once a week ( p<0.001 for trend ) . Further adjustment for intakes of magnesium , cereal fibre , glycaemic index , and caffeine or for a Western dietary pattern did not appreciably change the results and associations remained strong after further adjustment for fatty acid and cholesterol intake . Frequent consumption of bacon , hot dogs , and sausage was each associated with an increased risk of diabetes . While total red meat ( beef or lamb as main dish , pork as main dish , hamburger , beef , pork or lamb as s and wich or mixed dish ) intake was associated with an increased risk of diabetes , this association was attenuated after adjustment for magnesium , cereal fiber , glycaemic index , and caffeine ( relative risk : 1.44 ; 95 % CI : 0.92–2.24 ) . Conclusion /interpretationOur data suggest that diets high in processed meats could increase the risk for developing Type 2 diabetes OBJECTIVE To determine the efficacy of oolong tea for lowering plasma glucose in type 2 diabetic patients in Miaoli , Taiwan . RESEARCH DESIGN AND METHODS A total of 20 free-living subjects who had type 2 diabetes and took hyperglycemic drugs as prescribed were enrolled in the present study . Subjects consumed oolong tea ( 1,500 ml ) or water for 30 days each in a r and omized crossover design . Tea was not consumed for 14 days prior to treatments . RESULTS Relative to initial concentrations , oolong tea markedly lowered concentrations of plasma glucose ( from 229 + /- 53.9 to 162.2 + /- 29.7 mg/dl , P < 0.001 ) and fructosamine ( from 409.9 + /- 96.1 to 323.3 + /- 56.4 micromol/l , P < 0.01 ) , whereas the water control group had not changed ( 208.7 + /- 61.0 vs. 232.3 + /- 63.1 mg/dl for glucose and from 368.4 + /- 85.0 to 340.0 + /- 76.1 micromol/l for fructosamine ) . CONCLUSIONS Oolong tea may be an effective adjunct to oral hypoglycemic agents in the treatment of type 2 diabetes Higher habitual coffee consumption was associated with higher insulin sensitivity ( 1 ) and a lower risk for type 2 diabetes ( 2–6 ) in diverse population s. In contrast , short-term metabolic studies showed that caffeine intake can acutely lower insulin sensitivity ( 7–9 ) and increase glucose concentrations ( 10–15 ) . R and omized intervention studies are needed to examine whether tolerance to these acute effects develops after longer-term consumption ( 16 ) . We therefore examined the effects of coffee and caffeine on fasting blood concentrations of glucose and insulin over 2–4 weeks in two crossover studies in healthy volunteers . The studies were approved by the TNO Nutrition and Food Research Medical Ethics Committee , and all participants gave informed consent . The trials were originally design ed to study the effects of coffee and caffeine on plasma concentrations of homocysteine , and the study design s have been reported in detail previously ( 17,18 ) . Participants were regular coffee consumers ( more than five cups/day ) and did not have known diabetes . The first study was a 4-week crossover study that compared the effects of regular paper-filtered coffee consumption with that of coffee abstinence . A total of 40 volunteers used 1 l of coffee ( 70 g coffee grounds ) for 4 weeks and abstained from coffee for 4 weeks in r and om order . Fourteen participants did not complete the trial because of nausea and restlessness ( n = OBJECTIVE To study prospect ively the association of coffee intake with incident diabetes in the Puerto Rico Heart Health Program cohort , comprising 9824 middle-aged men ( aged 35 - 79 years ) . METHODS Of 9824 men , 3869 did not provide a fasting blood sample at baseline , 1095 had prevalent diabetes and 131 were not given fasting glucose tests at any subsequent study visit . Thus , the present analysis includes 4685 participants . Diabetes was ascertained at baseline and at two study visits between 1968 and 1975 using fasting glucose tests and self-reports of physician-diagnosed diabetes or use of insulin or hypoglycaemic medication . Logistic regression analysis was used to assess the association of coffee intake with risk of incident diabetes while adjusting for covariates ( age , BMI , physical activity , smoking , education , alcohol intake , family history of diabetes , intakes of milk and sugar ) . RESULTS Five hundred and nineteen participants met the criteria for incident diabetes . Compared with those reporting intake of 1 - 2 servings of coffee/d , coffee abstainers were at reduced risk ( OR = 0.64 ; 95 % CI 0.43 , 0.94 ) . Among coffee drinkers , there was a significant trend of decreasing risk by intake ( P = 0.02 ) ; intake of > /=4 servings/d was associated with an odds ratio of 0.75 ( 95 % CI 0.58 , 0.97 ) . CONCLUSIONS Study findings support a protective effect of coffee intake on diabetes risk , while also suggesting that abstainers may be at reduced risk At least fourteen cohort studies have documented an inverse association between coffee consumption and risk of type 2 diabetes . We examined the prospect i ve association between coffee and tea consumption and the risk of type 2 diabetes mellitus among British men ( n 4055 ) and women ( n 1768 ) from the Whitehall II cohort . During 11.7 years follow-up there were a total of 387 incident cases of diabetes confirmed by self-report of doctor 's diagnosis or glucose tolerance tests . Despite an inverse association between coffee intake and 2 h post-load glucose concentration at the baseline assessment , combined caffeinated and decaffeinated coffee ( hazard ratio ( HR ) 0.80 ; 95 % CI 0.54 , 1.18 ) or only decaffeinated coffee intake ( HR 0.65 ; 95 % CI 0.36 , 1.16 ) was not significantly associated with diabetes risk at follow-up after adjustment for possible confounders . There was an association between tea intake and diabetes ( HR 0.66 ; 95 % CI 0.61 , 1.22 ; P < 0.05 ) after adjustment for age , gender , ethnicity and social status , which was not robust to further adjustments . There was , however , an association between combined intake of tea and coffee ( two or more cups per day of both beverage ) and diabetes ( HR 0.68 ; 95 % CI 0.46 , 0.99 ; P < 0.05 ) after full adjustment . In conclusion , relatively moderate intake ( more than three cups per day ) of coffee and tea were not prospect ively associated with incidence of type 2 diabetes although there was evidence of a combined effect . The limited range of exposure and beverage consumption according to socio-economic class may explain these conflicting findings Objective : To examine joint associations of coffee consumption and other factors ( including physical activity , obesity and alcohol consumption ) with the risk of type 2 diabetes . Design : Prospect i ve follow-up study .Subjects : In all , 10 188 Finnish men and 11 197 women aged 35–74 years without a history of stroke , coronary heart disease or diabetes at baseline . Measurement : A self-administered question naire data on coffee , tea , alcohol and other food consumption , physical activity , smoking , socio-economic factors and medical history , together with measured height , weight and blood pressure using st and ardized protocol . Results : During a mean follow-up of 13.4 years , there were 964 incident cases of type 2 diabetes . Multivariate-adjusted ( age , study year , systolic blood pressure , education , smoking , physical activity , body mass index ( BMI ) and fruit , vegetable , sausage , bread , alcohol and tea consumption ) hazard ratio of type 2 diabetes in participants who drank 0–2 , 3–6 and ⩾7 cups of coffee were 1.00 , 0.77 and 0.66 ( P=0.022 for trend ) in men , 1.00 , 0.71 and 0.52 ( P=0.001 for trend ) in women , and 1.00 , 0.75 and 0.61 ( P<0.001 for trend ) in men and women combined ( adjusted also for sex ) , respectively . This inverse association was consistent in subjects with any joint levels of physical activity and BMI , and in alcohol drinkers and non-drinkers . Among obese and inactive people , coffee drinking of seven cups or more daily reduced the risk of type 2 diabetes to half . Conclusions : Coffee drinking was associated with a reduced risk of type 2 diabetes in both men and women , and this association was observed regardless of the levels of physical activity , BMI and alcohol consumption OBJECTIVE High habitual coffee consumption has been associated with a lower risk of type 2 diabetes , but data on lower levels of consumption and on different types of coffee are sparse . RESEARCH DESIGN AND METHODS This is a prospect i ve cohort study including 88,259 U.S. women of the Nurses ' Health Study II aged 26 - 46 years without history of diabetes at baseline . Consumption of coffee and other caffeine-containing foods and drinks was assessed in 1991 , 1995 , and 1999 . We documented 1,263 incident cases of confirmed type 2 diabetes between 1991 and 2001 . RESULTS After adjustment for potential confounders , the relative risk of type 2 diabetes was 0.87 ( 95 % CI 0.73 - 1.03 ) for one cup per day , 0.58 ( 0.49 - 0.68 ) for two to three cups per day , and 0.53 ( 0.41 - 0.68 ) for four or more cups per day compared with nondrinkers ( P for trend < 0.0001 ) . Associations were similar for caffeinated ( 0.87 [ 0.83 - 0.91 ] for a one-cup increment per day ) and decaffeinated ( 0.81 [ 0.73 - 0.90 ] ) coffee and for filtered ( 0.86 [ 0.82 - 0.90 ] ) and instant ( 0.83 [ 0.74 - 0.93 ] ) coffee . Tea consumption was not substantially associated with risk of type 2 diabetes ( 0.88 [ 0.64 - 1.23 ] for four or more versus no cups per day ; P for trend = 0.81 ) . CONCLUSIONS These results suggest that moderate consumption of both caffeinated and decaffeinated coffee may lower risk of type 2 diabetes in younger and middle-aged women . Coffee constituents other than caffeine may affect the development of type 2 diabetes OBJECTIVE To examine prospect ively the association between regular exercise and the subsequent development of non-insulin-dependent diabetes mellitus ( NIDDM ) . DESIGN Prospect i ve cohort study including 5 years of follow-up . PARTICIPANTS 21,271 US male physicians participating in the Physicians ' Health Study , aged 40 to 84 years and free of diagnosed diabetes mellitus , myocardial infa rct ion , cerebrovascular disease , and cancer at baseline . Morbidity follow-up was 99.7 % complete . MAIN OUTCOME MEASURE Incidence of NIDDM . RESULTS At baseline , information was obtained about frequency of vigorous exercise and other risk indicators . During 105,141 person-years of follow-up , 285 new cases of NIDDM were reported . The age-adjusted incidence of NIDDM ranged from 369 cases per 100,000 person-years in men who engaged in vigorous exercise less than once weekly to 214 cases per 100,000 person-years in those exercising at least five times per week ( P , trend , less than .001 ) . Men who exercised at least once per week had an age-adjusted relative risk ( RR ) of NIDDM of 0.64 ( 95 % Cl , 0.51 to 0.82 ; P = .0003 ) compared with those who exercised less frequently . The age-adjusted RR of NIDDM decreased with increasing frequency of exercise : 0.77 for once weekly , 0.62 for two to four times per week , and 0.58 for five or more times per week ( P , trend , .0002 ) . A significant reduction in risk of NIDDM persisted after adjustment for both age and body-mass index : RR , 0.71 ( 95 % Cl , 0.56 to 0.91 ; P = .006 ) for at least once per week compared with less than once weekly , and P , trend , .009 , for increasing frequency of exercise . Further control for smoking , hypertension , and other coronary risk factors did not material ly alter these associations . The inverse relation of exercise to risk of NIDDM was particularly pronounced among overweight men . CONCLUSIONS Exercise appears to reduce the development of NIDDM even after adjusting for body-mass index . Increased physical activity may be a promising approach to the primary prevention of NIDDM An association between psychological factors and diabetes has been suspected for a long time . However , epidemiological data on this association is limited . We investigated the association between psychological factors ( perceived mental stress and type A behavior ) and the onset of diabetes in a community-based , prospect i ve cohort study in a large number of middle-aged Japanese adults . A total of 55,826 subjects ( 24,826 men and 31,000 women ) aged 40 - 69 years were followed for 10 years . A self-administered question naire on medical conditions including diabetes and other lifestyle factors was performed at baseline and 5 and 10 years later . Psychological factors and diabetes were assessed based on the question naire results . During the 10-year follow-up period , we documented 1,601 incident cases ( 6.4 % ) of diabetes among men and 1,093 cases ( 3.5 % ) among women . The risk of diabetes increased with an increasing stress level , especially among men . Multivariate adjusted odds ratios for high stress compared with low stress were 1.36 ( 1.13 to 1.63 ) among men and 1.22 ( 0.98 to 1.51 ) among women . The risk of diabetes increased with an increasing level of type A behavior only among women . Multivariate adjusted odds ratios for high levels of type A behavior compared with low levels of type A behavior were 1.09 ( 0.94 to 1.27 ) among men and 1.22 ( 1.01 to 1.47 ) among women . We found an association between perceived mental stress and the incidence of diabetes , especially among men . We also found an association between type A behavior and the incidence of diabetes among women . In addition , inverse association between coffee consumption and the incidence of diabetes which was consistent with other studies was observed The authors analyzed data from a prospect i ve , community-based cohort to assess the risk of incident type 2 diabetes mellitus associated with coffee and sweetened beverage consumption . They included 12,204 nondiabetic , middle-aged men and women in the Atherosclerosis Risk in Communities ( ARIC ) Study ( 1987 - 1999 ) . Consumption of each beverage was assessed by food frequency question naire and classified into categories of cups per day . They found an inverse association , after adjusting for potential confounders , between increased coffee consumption and risk of type 2 diabetes mellitus in men ( for > or = 4 cups ( > or = 0.95 liter)/day compared with almost never : hazard ratio = 0.77 , p(trend ) = 0.02 ) with no significant association in women ( hazard ratio = 0.89 , p(trend ) = 0.32 ) using a combination of self-report of physician-diagnosed diabetes , diabetes treatment , and a fasting or nonfasting blood glucose test . When self-reported diabetes or diabetes treatment alone was used , a stronger and significant inverse association was seen in men and women . Sweetened beverage consumption ( men : hazard ratio = 1.03 , p(trend ) = 0.94 ; women : hazard ratio = 1.01 , p(trend ) = 0.58 ) showed no consistent association with the incidence of type 2 diabetes mellitus . In summary , increased coffee consumption was significantly associated with a decreased risk of diagnosed type 2 diabetes mellitus in community-based US adults |
368 | 23,711,482 | Our study indicates either that pain threshold is a poor marker of central sensitization or that sensitization does not play a major role in patients ' reporting of pain and disability . | Sensitization of the nervous system can present as pain hypersensitivity that may contribute to clinical pain .
In spinal pain , however , the relationship between sensory hypersensitivity and clinical pain remains unclear .
This systematic review examined the relationship between pain sensitivity measured via quantitative sensory testing ( QST ) and self-reported pain or pain-related disability in people with spinal pain . | UNLABELLED This study compared the effect of 2 specific cervical flexor muscle exercise protocol s on immediate pain relief in the cervical spine of people with chronic neck pain . In addition , the study evaluated whether these exercise protocol s elicited any systemic effects by study ing sympathetic nervous system ( SNS ) function and pain at a location distant from the cervical spine . Participants were r and omly allocated into either a cranio-cervical flexion ( CCF ) coordination exercise group ( n = 24 ) or a cervical flexion ( CF ) endurance exercise group ( n = 24 ) . Measures of pain and SNS function were recorded immediately before and after a single session of the exercise interventions . Pain measures included visual analogue scale ( VAS ) ratings of neck pain at rest and during active cervical motion and pressure pain threshold ( PPT ) and thermal pain threshold ( TPT ) recordings over the cervical spine and at a remote site on the leg . Measures of SNS function consisted of blood flow , skin conductance , skin temperature , heart rate , and blood pressure . Immediately after 1 session of exercise , there was a reasonably sized increase of 21 % ( P < .001 , d = 0.88 ) and 7.3 % ( P = .03 , d = 0.47 ) in PPT locally at the neck for the CCF exercise and the CF exercise , respectively . There were no changes in local neck TPT with either exercise . Pressure pain threshold and TPT at the leg and SNS did not change after exercise . Only the CCF exercise demonstrated a small improvement in VAS ratings during active movement ( change on 10-cm VAS : CCF , 0.42 cm ( P = .04 ) . This study shows that specific CCF therapeutic exercise is likely to provide immediate change in mechanical hyperalgesia local to the neck with translation into perceived pain relief on movement in patients with chronic neck pain . PERSPECTIVE This study showed an immediate local mechanical hypoalgesic response to specific exercise of the cervical spine . Underst and ing the pain-relieving effects of exercise will assist the clinician in prescribing the most appropriate exercise protocol s for patients with chronic neck pain Introduction . Cupping has been used since antiquity in the treatment of pain conditions . In this pilot study , we investigated the effect of traditional cupping therapy on chronic nonspecific neck pain ( CNP ) and mechanical sensory thresholds . Methods . Fifty CNP patients were r and omly assigned to treatment ( TG , n = 25 ) or waiting list control group ( WL , n = 25 ) . TG received a single cupping treatment . Pain at rest ( PR ) , pain related to movement ( PM ) , quality of life ( SF-36 ) , Neck Disability Index ( NDI ) , mechanical detection ( MDT ) , vibration detection ( MDT ) , and pressure pain thresholds ( PPT ) were measured before and three days after a single cupping treatment . Patients also kept a pain and medication diary ( PaDi , MeDi ) during the study . Results . Baseline characteristics were similar in the two groups . After cupping TG reported significantly less pain ( PR : −17.9 mm VAS , 95%CI −29.2 to −6.6 ; PM : −19.7 , 95%CI −32.2 to −7.2 ; PaDi : −1.5 points on NRS , 95%CI −2.5 to −0.4 ; all P < 0.05 ) and higher quality of life than WL ( SF-36 , Physical Functioning : 7.5 , 95%CI 1.4 to 13.5 ; Bodily Pain : 14.9 , 95%CI 4.4 to 25.4 ; Physical Component Score : 5.0 , 95%CI 1.4 to 8.5 ; all P < 0.05 ) . No significant effect was found for NDI , MDT , or VDT , but TG showed significantly higher PPT at pain- areas than WL ( in lg(kPa ) ; pain-maximum : 0.088 , 95%CI 0.029 to 0.148 , pain-adjacent : 0.118 , 95%CI 0.038 to 0.199 ; both P < 0.01 ) . Conclusion . A single application of traditional cupping might be an effective treatment for improving pain , quality of life , and hyperalgesia in CNP Hypersensitivity to a variety of sensory stimuli is a feature of persistent whiplash associated disorders ( WAD ) . However , little is known about sensory disturbances from the time of injury until transition to either recovery or symptom persistence . Quantitative sensory testing ( pressure and thermal pain thresholds , the brachial plexus provocation test ) , the sympathetic vasoconstrictor reflex and psychological distress ( GHQ‐28 ) were prospect ively measured in 76 whiplash subjects within 1 month of injury and then 2 , 3 and 6 months post‐injury . Subjects were classified at 6 months post‐injury using scores on the Neck Disability Index : recovered ( < 8 ) , mild pain and disability ( 10–28 ) or moderate/severe pain and disability ( > 30 ) . Sensory and sympathetic nervous system tests were also measured in 20 control subjects . All whiplash groups demonstrated local mechanical hyperalgesia in the cervical spine at 1 month post‐injury . This hyperalgesia persisted in those with moderate/severe symptoms at 6 months but resolved by 2 months in those who had recovered or reported persistent mild symptoms . Only those with persistent moderate/severe symptoms at 6 months demonstrated generalised hypersensitivity to all sensory tests . These changes occurred within 1 month of injury and remained unchanged throughout the study period . Whilst no significant group differences were evident for the sympathetic vasoconstrictor response , the moderate/severe group showed a tendency for diminished sympathetic reactivity . GHQ‐28 scores of the moderate/severe group were higher than those of the other two groups . The differences in GHQ‐28 did not impact on any of the sensory measures . These findings suggest that those with persistent moderate/severe symptoms at 6 months display , soon after injury , generalised hypersensitivity suggestive of changes in central pain processing mechanisms . This phenomenon did not occur in those who recover or those with persistent mild symptoms Background Current evidence suggests that spinal manipulative therapy ( SMT ) is effective in the treatment of people with low back pain ( LBP ) ; however , the corresponding mechanisms are unknown . Hypoalgesia is associated with SMT and is suggestive of specific mechanisms . Objective The primary purpose of this study was to assess the immediate effects of SMT on thermal pain perception in people with LBP . A secondary purpose was to determine whether the result ing hypoalgesia was a local effect and whether psychological influences were associated with changes in pain perception . Design This study was a r and omized controlled trial . Setting A sample of convenience was recruited from community and outpatient clinics . Participants Thirty-six people ( 10 men , 26 women ) currently experiencing LBP participated in the study . The average age of the participants was 32.39 ( SD=12.63 ) years , and the average duration of LBP was 221.79 ( SD=365.37 ) weeks . Intervention and Measurements Baseline demographic and psychological measurements were obtained , followed by quantitative sensory testing to assess temporal summation and Aδ fiber – mediated pain perception . Next , participants were r and omly assigned to ride a stationary bicycle , perform low back extension exercises , or receive SMT . Finally , the same quantitative sensory testing protocol was reassessed to determine the immediate effects of each intervention on thermal pain sensitivity . Results Hypoalgesia to Aδ fiber – mediated pain perception was not observed . Group-dependent hypoalgesia of temporal summation specific to the lumbar innervated region was observed . Pair-wise comparisons indicated significant hypoalgesia in participants who received SMT , but not in those who rode a stationary bicycle or performed low back extension exercises . Psychological factors did not significantly correlate with changes in temporal summation in participants who received SMT . Limitations Only immediate effects of SMT were measured , so the authors are unable to comment on whether the inhibition of temporal summation is a lasting effect . Furthermore , the authors are unable to comment on the relationship between their findings and changes in clinical pain . Conclusions Inhibition of Aδ fiber – mediated pain perception was similar for all groups . However , inhibition of temporal summation was observed only in participants receiving SMT , suggesting a modulation of dorsal horn excitability that was observed primarily in the lumbar innervated area OBJECTIVE Several studies have shown that exposure to opioids for short or long periods alters pain sensitivity . Little is known about changes in pain sensitivity during and after tapering of long-term prescribed opioid treatment in chronic low-back pain ( cLBP ) patients . DESIGN The goal of this prospect i ve longitudinal study was to investigate pain sensitivity in a homogeneous patient population ( cLBP patients only ) after tapering of long-term ( 17 months ) opioid use and to monitor the changes in pain sensitivity for 6 months . METHODS Pain sensitivity ( thermal sensation and thermal pain thresholds in low back and nondominant h and ) was measured by quantitative sensory testing ( QST ) at 1 day before ( T1 ) , 3 weeks after ( T2 ) , and 6 months after the start of opioid tapering ( T3 ) in 35 patients with both cLBP and opioid medication ( OP ) , 35 opioid-naïve cLBP patients ( ON ) , and 28 individuals with neither pain nor opioid intake ( HC ) . RESULTS Significant differences in heat pain thresholds were found among the three groups at all three time points ( T1 : P=0.001 , T2 : P=0.015 , T3 : P=0.008 ) , but not between the two patient groups . OP patients showed lower cold pain thresholds at T2 than ON patients and HC . At T3 , the heat pain thresholds of OP patients still remained lower than HC ( P=0.017 ) , while those of ON patients were normalized . CONCLUSIONS Our findings suggest that long-term use of opioids does not reduce pain sensitivity in cLBP patients ; opioid tapering may induce brief hyperalgesia that can be normalized over a longer period Chronic pain is often associated with hyperalgesia in cross-sectional studies . In the present study , a r and om cohort of 40-year-old individuals ( n = 264 ) from the general population was assessed for low back pain ( LBP ) status and pressure pain threshold ( PPT ) , with follow-up assessment 4 and 8 years later . Low PPT at baseline as a potential risk factor for the development of LBP was investigated longitudinally and the association between LBP and hyperalgesia was studied cross-sectionally at baseline and 8-year follow-up . Generalized ( p < 0.03 ) and localized pressure hyperalgesia ( p < 0.02 ) was found in participants with long-lasting LBP , but not with recent LBP ( p > 0.08 ) . Of the participants without recent or long-lasting LBP , those with a low PPT at baseline ( lower 10 % percentile ) had no increased risk of developing LBP ( p > 0.05 ) . The findings indicate that PPT decreases as a consequence of long-lasting pain , whereas a low PPT seems not to constitute a separate risk factor for the development of LBP Thirty patients with whiplash injuries were examined 1 to 55 months after the accidents . Pain had appeared on the day of the accident in 24 ( 80 % ) of the patients and with different delays in the remainder . The mean pain intensity was 43 mm ( SD 26 ) on a visual analogue scale ( VAS ) . All patients had pain in the neck , 17 - 33 % had headache and 6 - 17 % had pain in various regions of the arms . Thirteen patients ( 43 % ) suffered from constant pain , while 17 ( 57 % ) had pain-free periods . Muscle tenderness was higher at all tested sites compared with controls . The tolerance level to pressure pain in the index finger as well as grip strength and neck mobility was reduced compared with controls . The whiplash patients showed poorer mental well-being compared with a reference group representing the general population and compared with a group of tension-type headache patients Background In this preliminary trial we investigated the effects of dry cupping , an ancient method for treating pain syndromes , on patients with chronic non-specific neck pain . Sensory mechanical thresholds and the participants ' self-reported outcome measures of pain and quality of life were evaluated . Methods Fifty patients ( 50.5 ± 11.9 years ) were r and omised to a treatment group ( TG ) or a waiting-list control group ( WL ) . Patients in the TG received a series of 5 cupping treatments over a period of 2 weeks ; the control group did not . Self-reported outcome measures before and after the cupping series included the following : Pain at rest ( PR ) and maximal pain related to movement ( PM ) on a 100-mm visual analogue scale ( VAS ) , pain diary ( PD ) data on a 0 - 10 numeric rating scale ( NRS ) , Neck Disability Index ( NDI ) , and health-related quality of life ( SF-36 ) . In addition , the mechanical-detection thresholds ( MDT ) , vibration-detection thresholds ( VDT ) , and pressure-pain thresholds ( PPT ) were determined at pain-related and control areas . Results Patients of the TG had significantly less pain after cupping therapy than patients of the WL group ( PR : Δ-22.5 mm , p = 0.00002 ; PM : Δ-17.8 mm , p = 0.01 ) . Pain diaries ( PD ) revealed that neck pain decreased gradually in the TG patients and that pain reported by the two groups differed significantly after the fifth cupping session ( Δ-1.1 , p = 0.001 ) . There were also significant differences in the SF-36 subscales for bodily pain ( Δ13.8 , p = 0.006 ) and vitality ( Δ10.2 , p = 0.006 ) . Group differences in PPT were significant at pain-related and control areas ( all p < 0.05 ) , but were not significant for MDT or VDT . Conclusions A series of five dry cupping treatments appeared to be effective in relieving chronic non-specific neck pain . Not only subjective measures improved , but also mechanical pain sensitivity differed significantly between the two groups , suggesting that cupping has an influence on functional pain processing . Trial registration The trial was registered at clinical trials.gov ( NCT01289964 ) Objectives : To investigate sensory changes present in patients with chronic whiplash-associated disorders and chronic idiopathic neck pain using a variety of quantitative sensory tests to better underst and the pain processing mechanisms underlying persistent symptoms . Methods : A case control study was used with 29 subjects with chronic whiplash-associated disorders , 20 subjects with chronic idiopathic neck pain , and 20 pain-free volunteers . Pressure pain thresholds were measured over the articular pillars of C2-C3 , C5-C6 , the median , radial , and ulnar nerve trunks in the arm and over a remote site , the muscle belly of tibialis anterior . Heat pain thresholds , cold pain thresholds , and von Frey hair sensibility were measured over the cervical spine , tibialis anterior , and deltoid insertion . Anxiety was measured with the Short-Form of the Spielberger State Anxiety Inventory . Results : Pressure pain thresholds were decreased over cervical spine sites in both subject groups when compared with controls ( P < 0.05 ) . In the chronic whiplash-associated disorders group , pressure pain thresholds were also decreased over the tibialis anterior , median , and radial nerve trunks ( P < 0.001 ) . Heat pain thresholds were decreased and cold pain thresholds increased at all sites ( P < 0.03 ) . No differencesin heat pain thresholds or cold pain thresholds were evident in the idiopathic neck pain group at any site compared with the control group ( P > 0.27 ) . No abnormalities in von Frey hair sensibility were evident in either neck pain group ( P > 0.28 ) . Discussion : Both chronic whiplash-associated disorders and idiopathic neck pain groups were characterized by mechanical hyperalgesia over the cervical spine . Whiplash subjects showed additional widespread hypersensitivity to mechanical pressure and thermal stimuli , which was independent of state anxiety and may represent changes in central pain processing mechanisms . This may have implication s for future treatment approaches Abstract Patients with chronic whiplash associated disorders present with varied sensory , motor and psychological features . In this first instance it was question ed whether a multimodal program of physical therapies was an appropriate management to be broadly prescribed for these patients when it was known that some would have sensory features suggestive of a notable pain syndrome . A r and omised controlled trial was conducted with 71 participants with persistent neck pain following a motor vehicle crash to explore this question . Participants were r and omly allocated to receive either a multimodal physiotherapy program ( MPT ) or a self‐management program ( SMP ) ( advice and exercise ) . In the r and omisation process , participants were stratified according to the presence or not of widespread mechanical or cold hyperalgesia . The intervention period was 10 weeks and outcomes were assessed immediately following treatment . Even with the presence of sensory hypersensitivity in 72.5 % of subjects , both groups reported some relief of neck pain and disability ( Neck Disability Index ) and it was superior in the group receiving multimodal physiotherapy ( p = 0.04 ) . Post‐hoc observations however suggested that relief was marginal in the subgroup with both widespread mechanical and cold hyperalgesia . Further research is required to test the validity of this sub‐group observation and to test the effect of the intervention in the long term Objectives Deep cross-friction pressure with a finger or an elbow in the proximal gluteal region causes a sciaticlike pain along the side of the thigh and the leg as a clinical presence of referred pain ( RP ) in patients with nonspecific low back pain ( LBP ) . This study investigated the reliability and discriminative ability of experimentally provoked RP as a result of deep cross-friction with the aid of a Fischer algometer . The new clinical examination method measures the provoked RP threshold result ing in an outcome , expressed in kg/cm2 . Methods Forty two patients with subacute LBP ( 3 to 12 wk ) participated in a prospect i ve clinical trial . The outcome was assessed by means of the st and ard ( perpendicular ) pressure pain thresholds ( PPT ) measured with the aid of a Fischer algometer on both sides of the gluteus medius , the provoked RP pain thresholds ( PPT-RP ) at the location of the medial superior cluneal nerve , the Oswestry Disability Index , and the McGill Pain Question naire . The diagnostic criteria for the clinical presence of RP were determined by the patient on the pain chart drawings of the McGill Pain Question naire . The criteria for provoked RP were determined by means of PPT-RP with the aid of a Fischer algometer until the patient pointed out the RP zone in the thigh and /or the leg . Results The interobserver reliability was sufficient for both sides with and without RP ( intraclass correlation coefficient>0.97 ) . The test-retest performed independently of the observers ranking , showed a perfect reliability of the PPT-RP measurements ( intraclass correlation coefficient>0.98 ) . The PPT-RP at the level of the medial superior cluneal nerve in the subgroup with a clinical presence of RP ( N=20 ) was significantly higher ( 3.5 kg/cm2 ) than in the subgroup patients without RP ( N=22 ) . The correlation between the factor RP and the PPT-RP was high ( R=0.91 , P<0.001 ) . The clinical ly important difference between provoked and clinical presence of RP was found to be higher or lower than 5.6 kg/cm2 . The st and ard PPT measurement of the gluteus medius revealed no significant differences between the subgroups with and without RP . Conclusions This clinical study support the reliability and discriminative ability of a new method of experimentally provoked RP , using deep cross-friction pressure with the aid of a Fischer algometer in patients with LBP . The experimentally “ provoked referred pain threshold ” ( PPT-RP ) values lower than 6 kg/cm2 correspond clinical ly with the presence of a referred muscle pain area in the thigh and /or the leg . Further studies of a similar kind are nevertheless needed to confirm those conclusions and to assess the responsiveness of the provoked RP measurements in different treatment follow-up periods Background : Pneumatic pulsation therapy may combine the effects of cupping therapy and massage . This study investigated the effect of pneumatic pulsation therapy on chronic neck pain compared to st and ard medical care . Methods : 50 patients ( 79.15 % female ; 46.17 ± 12.21 years ) with chronic nonspecific neck pain were r and omized to treatment group ( TG ; n = 25 ) or control group ( CG ; n = 25 ) . The TG received 5 pneumatic pulsation treatments over a period of 2 weeks utilizing a mechanical device . Treatment was applied as a combination of moving and stationary pulsating cupping . Main outcome measure was pain intensity in pain diaries ( numerical rating scale ) . Secondary outcome measures included functional disability ( NDI ) , quality of life ( SF-36 ) , and pain at motion . Sensory thresholds , including pressure pain threshold , were measured at pain-related sites . Results : After the intervention , significant group differences occurred regarding pain intensity ( baseline : 4.12 ± 1.45 in TG and 4.20 ± 1.57 in CG ; post-intervention : 2.72 ± 1.62 in TG and 4.44 ± 1.96 in CG ; analysis of covariance : p = 0.001 ) , NDI ( baseline : 25.92 ± 8.23 and 29.83 ; post-intervention : 20.44 ± 10.17 and 28.83 ; p = 0.025 ) , and physical quality of life ( baseline : 43.85 ± 7.65 and 41.66 ± 7.09 ; post-intervention : 47.60 ± 7.93 and 40.49 ± 8.03 ; p = 0.002 ) . Further significant group differences were found for pain at motion ( p = 0.004 ) and pressure pain threshold ( p = 0.002 ) . No serious adverse events were reported . Conclusion : Pneumatic pulsation therapy appears to be a safe and effective method to relieve pain and to improve function and quality of life in patients with chronic neck pain Previous studies reported that respiratory feedback ( RFB ) aids in alleviating chronic pain . However , to date , this adjunct treatment has not been rigorously tested against non-contingent ( placebo ) feedback . Forty-two patients with chronic low back pain were r and omized to either RFB or non-contingent RFB . Both groups performed a daily 30-min home training for 15 consecutive days . A respiratory associated relaxation index ( RI ) was measured . Pain levels and a somatosensory profile were assessed before and after intervention . Additionally , pain levels were assessed 3 months after the end of intervention . Secondary outcome parameters included daily functioning , psychopathology , and suggestibility . T-tests showed higher and significant pain reductions for RFB , compared to non-contingent RFB . Between-group comparisons reached no significance . However , changes were more pronounced in the RFB condition , which was also true for the course of the RI and the psychopathological scores . This is the first study using a non-contingent respiratory placebo feedback in a r and omized , controlled design . Within this design previous positive findings of symptom reductions in patients treated with RFB could partially replicated . Nonetheless , tendencies suggest that contingent feedback patients compared to placebo patients profit more from RFB in the long run regarding reduction of chronic pain and psychological distress OBJECTIVES To compare the effects of real acupuncture to tender points for neck and shoulder pain and stiffness ( Japanese : katakori ) with those of sham acupuncture . DESIGN R and omized-controlled trial . METHODS Thirty-four volunteers from an acupuncture school with complaints of chronic pain and stiffness , who had no arm symptoms and gave informed consent , were r and omly allocated to acupuncture or sham groups . Acupuncture or sham acupuncture was applied to the tender points once a week for 3 weeks . In the acupuncture group the acupuncture needle was inserted to the muscle , then the sparrow pecking technique was applied five times . Sham acupuncture was done without insertion of the needle . Dull pain and stiffness were evaluated by visual analog scale ( VAS ) before , and every 2 days after the first needling for 1 month . Pressure pain threshold on the tender points was measured before and after each treatment . RESULTS There was no statistical difference of VAS scores between acupuncture and sham groups 9 days after the last treatment . However , the acupuncture group showed significant reduction of VAS scores immediately after and /or 1 day after the real acupuncture treatments ( P<0.01 ) . The effect tended to be prolonged after repeated treatment . Pressure pain thresholds tended to increase after real acupuncture treatment but not after sham acupuncture . CONCLUSIONS Acupuncture applied to tender points appears to have short-term effects on neck and shoulder pain and stiffness , but this study was unable to demonstrate any long-term superiority over sham acupuncture Changes in regional cerebral blood flow ( rCBF ) have previously been demonstrated in a number of cortical and subcortical regions , including the cerebellum , midbrain , thalamus , lentiform nucleus , and the insula , prefrontal , anterior cingulate , and parietal cortices , in response to experimental noxious stimuli . Increased anterior cingulate responses in patients with chronic regional pain and depression to noxious stimulation distant from the site of clinical pain have been observed . We suggested that this may represent a generalized hyperattentional response to noxious stimuli and may apply to other types of chronic regional pain . Here these techniques are extended to a group of patients with nonspecific chronic low back pain . Thirty-two subjects , 16 chronic low back pain patients and 16 controls , were studied using positron emission tomography . Thermal stimuli , corresponding to the experience of hot , mild , and moderate pain , were delivered to the back of the subject 's right h and using a thermal probe . Each subject had 12 measurements of rCBF , 4 for each stimulus . Correlation of rCBF with subjective pain experience revealed similar responses across groups in the cerebellum , midbrain ( including the PAG ) , thalamus , insula , lentiform nucleus , and midcingulate ( area 24 ' ) cortex . These regions represented the majority of activations for this study and those recorded by other imaging studies of pain . Although some small differences were observed between the groups these were not considered sufficient to suggest abnormal nociceptive processing in patients with nonspecific low back pain Abstract The effect of exercise on neck – shoulder pain was studied in 103 women with work‐related trapezius myalgia r and omized into three exercise groups and a control group . One group trained strength , the second muscular endurance and the third co‐ordination . The exercise groups met three times weekly for 10 weeks . Pain assessment was made on three visual analogue scales , indicating pain at present , pain in general and pain at worst . Pain thresholds were measured in the trapezius muscle with a pressure algometer . A pain drawing was completed . The rated pain decreased significantly ( P<0.05 ) on the VAS describing pain at worst in the strength and endurance groups . Pressure sensitivity decreased significantly ( P<0.05 ) in four triggerpoints in the exercise groups . No changes were seen in the extent of painful body area in any group . Comparison of exercisers ( n=82 ) and controls ( n=21 ) showed significantly larger pain reductions on VAS pain at present and VAS pain at worst among exercisers . All three exercise programs showed similar decreases of pain which indicates that the type of exercise is of less importance to achieve pain reduction Background and objective One-third of patients who undergo lumbar discectomy continue to suffer from persistent pain postoperatively . Greater preoperative warmth thresholds and greater preoperative cerebrospinal fluid concentrations of stable serum nitric oxide metabolites are associated with a worse outcome . The principal objective of this study was to examine the relationship between patient outcome ( defined using the Modified Stauffer – Coventry evaluating criteria ) and preoperative pain perception threshold to an electrical stimulus . Methods A prospect i ve observational pilot study of patients ( n = 39 ) was performed . Quantitative sensory testing , visual analogue scales for anxiety and pain , the Hospital Anxiety and Depression ( HADS ) Scale and the McGill Pain Question naire were completed , and serum nitric oxide metabolites were measured perioperatively . Excised disc tissue was examined histologically , and immunohistochemistry for phospholipase A2 was performed . Results Ten patients ( 26 % ) had an unsatisfactory outcome . Those with a satisfactory outcome had greater preoperative pain perception thresholds over the affected dermatome , which decreased by 2 months postoperatively . These patients also demonstrated a decrease in nitric oxide metabolites from preoperatively to 18 h postoperatively . Greater preoperative HADS scores , and greater pain intensity 4 h and 24 h postoperatively were associated with an unsatisfactory outcome . Conclusion Patients with a satisfactory outcome demonstrate a decrease in pain perception thresholds and plasma concentration of stable nitric oxide metabolites during the perioperative period . Patients with an unsatisfactory outcome following lumbar discectomy experience greater preoperative anxiety and greater pain during the early postoperative period . These findings justify a larger prospect i ve observational study |
369 | 18,298,849 | Results Quasi-experimental data indicate that allocating up to an additional hour per day of curricular time to PA programmes does not affect the academic performance of primary school students negatively , even though the time allocated to other subjects usually shows a corresponding reduction .
An additional curricular emphasis on PE may result in small absolute gains in grade point average ( GPA ) , and such findings strongly suggest a relative increase in performance per unit of academic teaching time .
Further , the overwhelmingly majority of such programmes have demonstrated an improvement in some measures of physical fitness ( PF ) .
Cross-sectional observations show a positive association between academic performance and PA , but PF does not seem to show such an association .
PA has positive influences on concentration , memory and classroom behaviour .
Data from quasi-experimental studies find support in mechanistic experiments on cognitive function , pointing to a positive relationship between PA and intellectual performance .
Conclusion Given competent providers , PA can be added to the school curriculum by taking time from other subjects without risk of hindering student academic achievement .
On the other h and , adding time to " academic " or " curricular " subjects by taking time from physical education programmes does not enhance grade s in these subjects and may be detrimental to health | Background The purpose of this paper is to review relationships of academic performance and some of its determinants to participation in school-based physical activities , including physical education ( PE ) , free school physical activity ( PA ) and school sports . | Objective : To examine the link between childhood overweight status and elementary school outcomes . Design : Prospect i ve study design : multivariate regression models examining the association between changes in overweight status and school outcomes between kindergarten entry and end of third grade , after controlling for various child , family and school characteristics . Subjects : Nationally representative sample of US children who entered kindergarten in 1998 , with longitudinal data on body mass index ( BMI ) and school outcomes at kindergarten entry and end of third grade . Measurements : Wide range of elementary school outcomes collected in each wave including academic achievement ( math and reading st and ardized test scores ) ; teacher reported internalizing and externalizing behavior problems ( BP ) , social skills ( self-control , interpersonal skills ) and approaches to learning ; school absences ; and grade repetition . Measurements of height and weight in each wave were used to compute BMI and indicators of overweight status based on CDC growth charts . A rich set of control variables capturing child , family , and school characteristics . Results : Moving from not-overweight to overweight between kindergarten entry and end of third grade was significantly associated ( P<0.05 ) with reductions in test scores , and teacher ratings of social-behavioral outcomes and approaches to learning among girls . However , this link was mostly absent among boys , with two exceptions – boys who became overweight had significantly fewer externalizing BPs ( P<0.05 ) , but more absences from school compared to boys who remained normal weight . Being always-overweight was associated with more internalizing BP among girls but fewer externalizing BPs among boys . Conclusion : Change in overweight status during the first 4 years in school is a significant risk factor for adverse school outcomes among girls but not boys . Girls who become overweight during the early school years and those who start school being overweight and remain that way may need to be monitored carefully This study investigated the relationship between adolescents ' academic performance and participation in physical activity . 232 boys and girls from Years 8–11 ( ages 13–16 years ) were r and omly selected , and their academic performance was assessed on previous examination scores in English , Mathematics , and Science . Participants were also asked to list all the sports-based physical activities in which they normally participated during a typical week and to indicate how many times per week they took part in each activity and the duration of each . Overall , no significant correlations were found , although weak negative correlations were recorded between the amount of time ( in minutes ) in sport and exercise and English scores for children ages 13 , 14 , and 16 years . A similar association was also noted for Science scores of children 16 years old PURPOSE This study was conducted to determine the effect of physical education class enrollment and physical activity on academic achievement in middle school children . METHODS Participants were 214 sixth- grade students r and omly assigned to physical education during either first or second semesters . Moderate and vigorous physical activity ( MVPA ) ( number of 30-min time blocks ) outside of school was assessed using the 3-d physical activity recall ( 3DPAR ) . The 3DPAR time blocks were converted to ordinal data with scores of 1 ( no activity ) , 2 ( some activity ) , or 3 ( activity meeting Healthy People 2010 guidelines ) . Academic achievement was assessed using grade s from four core academic classes and st and ardized test scores ( Terra Nova percentiles ) . RESULTS Grade s were similar regardless of whether students were enrolled in physical education during first or second semesters . Physical education classes averaged only 19 min of MVPA . Students who either performed some or met Healthy People 2010 guidelines for vigorous activity had significantly higher grade s ( P < 0.05 ) than students who performed no vigorous activity in both semesters . Moderate physical activity did not affect grade s. St and ardized test scores were not significantly related to physical education class enrollment or physical activity levels . CONCLUSION Although academic achievement was not significantly related to physical education enrollment , higher grade s were associated with vigorous physical activity , particularly activity meeting recommended Healthy People 2010 levels An evaluation is reported of an exercise-based approach to remediation of dyslexia-related disorders . Pupils in three years of a Warwickshire junior school were screened for risk of literacy difficulty using the Dyslexia Screening Test ( DST ) . The 35 children scoring 0.4 or over on the DST were divided r and omly into two groups matched for age and DST score . One quarter of the participants had an existing diagnosis of dyslexia , dyspraxia or ADHD . Both groups received the same treatment at school but the intervention group used the DDAT exercise programme daily at home . Performance on the DST and specialist cerebellar/vestibular and eye movement tests were assessed initially and after six months . Cerebellar/vestibular signs were substantially alleviated following the exercise treatment whereas there were no significant changes for the control group . Even after allowing for the passage of time , there were significant improvements for the intervention group in postural stability , dexterity , phonological skill , and ( one-tailed ) for naming fluency and semantic fluency . Reading fluency showed a highly significant improvement for the intervention group , and nonsense passage reading was also improved significantly . Significantly greater improvements for the intervention group than the control group occurred for dexterity , reading , verbal fluency and semantic fluency . Substantial and significant improvements ( compared with those in the previous year ) also occurred for the exercise group on national st and ardized tests of reading , writing and comprehension . It is concluded that , in addition to its direct effects on balance , dexterity and eye movement control , the benefits of the DDAT exercise treatment transferred significantly to cognitive skills underlying literacy , to the reading process , and to st and ardized national literacy attainment tests The effects of a 2-year health-related school physical education program on st and ardized academic achievement scores was assessed in 759 children who completed Metropolitan Achievement Tests before and after the program . Schools were r and omly assigned to condition : ( a ) Specialists taught the Sports , Play , and Active Recreation for Kids curriculum ; ( b ) classroom teachers were trained to implement the curriculum ; and ( c ) controls continued their usual programs . The Trained Teacher condition was superior to Control on Language , Reading , and Basic Battery . The Specialist condition was superior to Control on Reading , but inferior on Language . Despite devoting twice as many minutes per week to physical education as Controls , the health-related physical education program did not interfere with academic achievement . Health-related physical education may have favorable effects on students ' academic achievement Roy J. Shephard The value of an individually supervised physical activity program with a strong social skills component was examined for 45 students with learning disabilities ( 34 boys , 11 girls ; mean age = 9.4 ±1.1 years ) . Subjects were r and omly divided into an experimental group of 23 students who received two 90-minute exercise sessions for each of 10 weeks , and a control group of 22 students who received equal individualized attention through extra academic instruction . Scores for the Bruininks-Oseretsky test of motor proficiency , teacher ratings of social behavior , and self-perceptions of academic and nonacademic competence showed strong effects of time , but no substantial time treatment interaction . Time effects on social behaviors persisted 3 months following treatment , suggesting that they reflected extra attention , rather than an expectancy , or halo , effect . There would seem to be merit in further exploring the value of extra attention , which here was provided to students with learning disabilities by volunteers with limited formal training Studies of the health effects of a daily physical activity programme have been carried out in 10-year-old school children in Adelaide , South Australia . In the first phase ( 1978 ) observations on endurance fitness , four skin folds , blood pressure and blood lipids were made before and after a r and omized trial over a period of 14 weeks . Comparisons were made on over 500 children drawn from classes in seven Primary schools involved in an endurance fitness programme ( 1 1/4 hours per day ) , a skill programme and the previous physical education programme ( controls ) . The fitness group experienced significant gains in physical work capacity ( PWC ) and showed significant decreases in body fat compared to the other two groups . No significant differences were observed in plasma cholesterol , triglycerides and HDL cholesterol . Subsequently in the second phase ( 1980 ) observations were made on a group of 216 10-year-old children who had already experienced two years of the physical activity programme adopted after phase one . Comparison with the observations in the 10-year-old children in 1978 made prior to the intervention revealed significantly smaller skin folds and greater PWC , with lower blood pressure reaching statistical significance for diastolic pressure in boys . The findings suggest beneficial effects on health of daily physical activity programmes within existing primary school curricula . There was no evidence of any loss of academic performance as measured by arithmetic and reading tests in spite of 45 - 60 minutes ' loss of formal teaching time each day BACKGROUND Physical activity may help maintain cognitive function and decrease dementia risk , but epidemiological findings remain controversial . The aim of our study was to investigate the association between leisure-time physical activity at midlife and the subsequent development of dementia and Alzheimer 's disease ( AD ) . METHODS Participants were r and omly selected from the survivors of a population -based cohort previously surveyed in 1972 , 1977 , 1982 , or 1987 . 1449 persons ( 72.5 % ) age 65 - 79 years participated in the re-examination in 1998 ( mean follow-up , 21 years ) . 117 persons had dementia and 76 had AD . Multiple logistic regression methods were used to analyse the association between leisure-time physical activity and dementia or AD . FINDINGS Leisure-time physical activity at midlife at least twice a week was associated with a reduced risk of dementia and AD ( odds ratio [ OR ] 0.48 [ 95 % CI 0.25 - 0.91 ] and 0.38 [ 0.17 - 0.85 ] , respectively ) , even after adjustments for age , sex , education , follow-up time , locomotor disorders , APOE genotype , vascular disorders , smoking , and alcohol drinking . The associations were more pronounced among the APOE epsilon4 carriers . INTERPRETATION Leisure-time physical activity at midlife is associated with a decreased risk of dementia and AD later in life . Regular physical activity may reduce the risk or delay the onset of dementia and AD , especially among genetically susceptible individuals PURPOSE The purpose of this study was twofold : 1 ) to evaluate the effectiveness of a school-based physical activity intervention , Action Schools ! BC ( AS ! BC ) , for maintaining academic performance in a multiethnic group of elementary children , and 2 ) to determine whether boys and girls ' academic performance changed similarly after participation in AS ! BC . METHODS This was a 16-month cluster r and omized controlled trial . Ten schools were r and omized to intervention ( INT ) or usual practice ( UP ) . One INT school administered the wrong final test , and one UP school grade d their own test , so both were excluded . Thus , eight schools ( six INT , two UP ) were included in the final analysis . Children ( 143 boys , 144 girls ) in grade s 4 and 5 were recruited for the study . We used the Canadian Achievement Test ( CAT-3 ) to evaluate academic performance ( TotScore ) . Weekly teacher activity logs determined amounts of physical activity delivered by teachers to students . Physical activity was determined with the Physical Activity Question naire for Children ( PAQ-C ) . Independent t-tests compared descriptive variables between groups and between boys and girls . We used a mixed linear model to evaluate differences in TotScore at follow-up between groups and between girls and boys . RESULTS Physical activity delivered by teachers to children in INT schools was increased by 47 min x wk(-1 ) ( 139 + /- 62 vs 92 + /- 45 , P < 0.001 ) . Participants attending UP schools had significantly higher baseline TotScores than those attending INT schools . Despite this , there was no significant difference in TotScore between groups at follow-up and between boys and girls at baseline and follow-up . CONCLUSION The AS ! BC model is an attractive and feasible intervention to increase physical activity for students while maintaining levels of academic performance The purpose of the present study was to determine the efficacy of using music as a remedial strategy to enhance the reading skills of second- grade students and students who have been identified as having a specific learning disability ( SLD ) in reading . First , an intensive short-term music curriculum was design ed to target reading comprehension and vocabulary skills at the second grade level . The curriculum was then implemented in classrooms at two public schools in the Southeast . Reading skills were evaluated pre and post curriculum intervention via the vocabulary and reading comprehension subtests of the Gates-MacGinitie Reading Test for second grade . Analysis of pre/posttest data revealed that students with a specific disability in reading improved significantly from pre to post on all three subtests : word decoding ( p = .04 ) , word knowledge ( p = .01 ) , reading comprehension ( p = .01 ) , and test total ( p = .01 ) . Paired t-tests revealed that for 2nd grade students , both treatment and control classes improved significantly from pre to post on the subtests word decoding , word knowledge , and test total . While both classes made gains from pre to post on the subtest , reading comprehension , neither improved significantly . Analysis of Covariance revealed that the treatment class made greater gains pre to post than the control class on all 3 subtests ( Including reading comprehension ) , and significantly greater gains on the subtest , word knowledge ( p = .01 ) This study explored the effectiveness of progressive relaxation and large muscle exercise in improving the cognitive performance of hyperactive , impulsive males . Progressive relaxation and large muscle exercise were compared to an attentional-training placebo , a no-treatment control , and a nonhyperactive control . While no differences were found on the Continuous Performance Task , relaxation , exercise , and nonhyperactive control groups performed significantly better on the Matching Familiar Figures test than the no-treatment control . Results were suggestive of the effectiveness of both progressive relaxation and large muscle exercise in treating hyperactive , impulsive youngsters OBJECTIVES This study evaluated a health-related physical education program for fourth- and fifth- grade students design ed to increase physical activity during physical education classes and outside of school . METHODS Seven schools were assigned to three conditions in a quasi-experimental design . Health-related physical education was taught by physical education specialists or trained classroom teachers . Students from these classes were compared with those in control classes . Analyses were conducted on 955 students with complete data . RESULTS Students spent more minutes per week being physically active in specialist-led ( 40 min ) and teacher-led ( 33 min ) physical education classes than in control classes ( 18 min ; P < .001 ) . After 2 years , girls in the specialist-led condition were superior to girls in the control condition on abdominal strength and endurance ( P < .001 ) and cardiorespiratory endurance ( P < .001 ) . There were no effects on physical activity outside of school . CONCLUSIONS A health-related physical education curriculum can provide students with substantially more physical activity during physical education classes . Improved physical education classes can potentially benefit 97 % of elementary school students |
370 | 25,057,168 | The all-trials and immunotherapy-only trials analysis failed to demonstrate a STE .
A new targeted therapy trial showing a PFS difference of 3.9 months can cl aim an OS benefit in mRCC . | BACKGROUND In metastatic renal cell cancer ( mRCC ) trials , progression-free survival ( PFS ) is increasingly used instead of overall survival ( OS ) as the approval end point .
Unlike other solid tumors , there is no published demonstration of what PFS is needed across and by treatment class in mRCC .
We determine this and evaluate drug approval decisions in mRCC targeted therapy . | We performed a prospect ively r and omised clinical trial to compare the efficacy of four subcutaneous interleukin-2-(sc-IL-2 ) and sc interferon-α2a (sc-IFN-α2a)-based outpatient regimens in 379 patients with progressive metastatic renal cell carcinoma . Patients with lung metastases , an erythrocyte sedimentation rate ⩽70 mm h−1 and neutrophil counts ⩽6000 μl−1 ( group I ) were r and omised to arm A : sc-IL-2 , sc-IFN-α2a , peroral 13-cis-retinoic acid ( po-13cRA ) ( n=78 ) , or arm B : arm A plus inhaled-IL-2 ( n=65 ) . All others ( group II ) were r and omised to arm C : arm A plus intravenous 5-fluorouracil ( iv-5-FU ) ( n=116 ) , or arm D : arm A plus po-Capecitabine ( n=120 ) . Median overall survival ( OS ) was 22 months ( arm A ; 3-year OS : 29.7 % ) and 18 months ( arm B ; 3-year OS : 29.2 % ) in group I , and 18 months ( arm C ; 3-year OS : 25.7 % ) and 16 months ( arm D ; 3-year OS : 32.6 % ) in group II . There were no statistically significant differences in OS , progression-free survival , and objective response between arms A and B , and between arms C and D , respectively . Given the known therapeutic efficacy of sc-IL-2/sc-INF-α2a/po-13cRA-based outpatient chemoimmunotherapies , our results did not establish survival advantages in favour of po-Capecitabine vs iv-5-FU , and in favour of short-term inhaled-IL-2 in patients with advanced renal cell carcinoma receiving systemic cytokines This report summarizes the U.S. Food and Drug Administration ( FDA ) 's approval of temsirolimus ( Torisel ) , on May 30 , 2007 , for the treatment of advanced renal cell carcinoma ( RCC ) . Information provided includes regulatory history , study design , study results , and literature review . A multicenter , three-arm , r and omized , open-label study was conducted in previously untreated patients with poor-prognosis , advanced RCC . The study objectives were to compare overall survival ( OS ) , progression-free survival ( PFS ) , objective response rate , and safety in patients receiving interferon (IFN)-alpha versus those receiving temsirolimus alone or in combination with IFN-alpha . In the second planned interim analysis of the intent-to-treat population ( n = 626 ) , there was a statistically significant longer OS time in the temsirolimus ( 25 mg ) arm than in the IFN-alpha arm ( median , 10.9 months versus 7.3 months ; hazard ratio [ HR ] , 0.73 ; p = .0078 ) . The combination of temsirolimus ( 15 mg ) and IFN-alpha did not lead to a significant difference in OS compared with IFN-alpha alone . There was also a statistically significant longer PFS time for the temsirolimus ( 25 mg ) arm than for the IFN-alpha arm ( median , 5.5 months versus 3.1 months ; HR , 0.66 , p = .0001 ) . Common adverse reactions reported in patients receiving temsirolimus were rash , asthenia , and mucositis . Common laboratory abnormalities were anemia , hyperglycemia , hyperlipidemia , and hypertriglyceridemia . Serious but rare cases of interstitial lung disease , bowel perforation , and acute renal failure were observed . Temsirolimus has demonstrated superiority in terms of OS and PFS over IFN-alpha and provides an additional treatment option for patients with advanced RCC BACKGROUND The treatment of advanced renal cell carcinoma has been revolutionised by targeted therapy with drugs that block angiogenesis . So far , no phase 3 r and omised trials comparing the effectiveness of one targeted agent against another have been reported . We did a r and omised phase 3 study comparing axitinib , a potent and selective second-generation inhibitor of vascular endothelial growth factor ( VEGF ) receptors , with sorafenib , an approved VEGF receptor inhibitor , as second-line therapy in patients with metastatic renal cell cancer . METHODS We included patients coming from 175 sites ( hospitals and outpatient clinics ) in 22 countries aged 18 years or older with confirmed renal clear-cell carcinoma who progressed despite first-line therapy containing sunitinib , bevacizumab plus interferon-alfa , temsirolimus , or cytokines . Patients were stratified according to Eastern Cooperative Oncology Group performance status and type of previous treatment and then r and omly assigned ( 1:1 ) to either axitinib ( 5 mg twice daily ) or sorafenib ( 400 mg twice daily ) . Axitinib dose increases to 7 mg and then to 10 mg , twice daily , were allowed for those patients without hypertension or adverse reactions above grade 2 . Participants were not masked to study treatment . The primary endpoint was progression-free survival ( PFS ) and was assessed by a masked , independent radiology review and analysed by intention to treat . This trial was registered on Clinical Trials.gov , number NCT00678392 . FINDINGS A total of 723 patients were enrolled and r and omly assigned to receive axitinib ( n=361 ) or sorafenib ( n=362 ) . The median PFS was 6·7 months with axitinib compared to 4·7 months with sorafenib ( hazard ratio 0·665 ; 95 % CI 0·544 - 0·812 ; one-sided p<0·0001 ) . Treatment was discontinued because of toxic effects in 14 ( 4 % ) of 359 patients treated with axitinib and 29 ( 8 % ) of 355 patients treated with sorafenib . The most common adverse events were diarrhoea , hypertension , and fatigue in the axitinib arm , and diarrhoea , palmar-plantar erythrodysaesthesia , and alopecia in the sorafenib arm . INTERPRETATION Axitinib result ed in significantly longer PFS compared with sorafenib . Axitinib is a treatment option for second-line therapy of advanced renal cell carcinoma . FUNDING Pfizer On September 27 , 2006 , the U.S. Food and Drug Administration granted approval to panitumumab ( Vectibix , Amgen , Inc. , Thous and Oaks , CA ) for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing , metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine- , oxaliplatin- , and irinotecan-containing chemotherapy regimens . Panitumumab approval is based on the results of a single , open-label , r and omized , multinational study that enrolled 463 patients with EGFR-expressing ( at least 1 + membrane staining in > or = 1 % of tumor cells ) metastatic colorectal cancer . Patients were r and omized to either best supportive care ( BSC ) alone or BSC plus panitumumab , 6 mg/kg i.v . , every other week . The primary study endpoint was progression-free survival ( PFS ) , determined by an independent review committee that was blinded as to treatment assignment . BSC patients who progressed were eligible to receive panitumumab . The study patients ' median age was 62 years , with 40 % aged > or = 65 ; 63 % were male , 99 % were white , 86 % had a baseline Eastern Cooperative Oncology Group performance status score of 0 or 1 , and 67 % had colon cancer . The median time from diagnosis of metastases was approximately 19 months and the median number of prior therapies was 2.4 . The PFS duration was significantly longer among patients r and omized to receive panitumumab in addition to BSC ( n = 231 ) compared with BSC alone ( n = 232 ) . The median and mean PFS times were 56 and 96.4 days , respectively , for patients receiving panitumumab and 51 and 59.7 days , respectively , for patients receiving BSC alone . Nineteen partial responses ( 8 % , 95 % confidence interval [ CI ] , 5.3%-12.5 % ) were observed in panitumumab treated patients . The median duration of response was 17 weeks ( 95 % CI , 16 - 25 weeks ) . Approximately 75 % of patients in the BSC alone arm crossed over to receive panitumumab after disease progression . There was no difference in overall survival between the two study arms . The most common adverse events were skin rash , hypomagnesemia , paronychia , fatigue , abdominal pain , nausea , and diarrhea . The most serious adverse events were pulmonary fibrosis , severe dermatologic toxicity complicated by infectious sequelae and septic death , infusion reactions , abdominal pain , hypomagnesemia , nausea , vomiting , diarrhea , and constipation The relative efficacies of cytotoxic chemotherapy regimens in the treatment of advanced breast cancer are generally assessed by comparing response rates in r and omised trials . Treatment attempts to prolong survival but trials rarely demonstrate a statistically significant survival advantage : it has been argued that chemotherapy does not prolong survival . The correlation between response rates and survival has been examined by review ing 79 comparisons between arms with unequal response rates in 50 published trials of chemotherapy in advanced breast cancer . In 73 % of comparisons the group with the higher response rate also demonstrated the longer median survival ( P less than 0.001 ) . Weighted linear regression showed a statistically significant relationship between relative response rates and survival ( P less than 0.001 ) . The number of patients in a comparison did not influence this relationship Purpose : Angiogenesis is a characteristic of renal cell carcinoma . ABT-510 is an angiogenesis inhibitor that mimics the antiangiogenic properties of thrombospondin-1 . This study was design ed to assess the safety and efficacy of ABT-510 in patients with advanced renal cell carcinoma . Experimental Design : Patients with previously untreated metastatic or unresectable renal cell carcinoma were r and omized to treatment with one of two doses of ABT-510 , self-administered s.c . twice daily in 28-day treatment periods without intervening rest periods . End points were progression-free survival ( PFS ) , objective response rate , overall survival , and toxicity . Results : The objective response rate was 4 % in the 10 mg twice daily group , and there were two unconfirmed PRs in the 100 mg twice daily group . Respective median PFS was 4.2 and 3.3 months , with a 6-month PFS of 39 % and 32 % . Median overall survival was 27.8 months ( 10 mg twice daily ) and 26.1 months ( 100 mg twice daily ) . The most frequent adverse events were injection site reactions ( 84 % ) , fatigue ( 50 % ) , headache ( 20 % ) , and nausea ( 19 % ) . The incidence of treatment-related , grade 3/4 adverse events was low and included three bleeding episodes ( gastrointestinal hemorrhage , intracranial hemorrhage , and hemoptysis ) and one thrombotic event ( deep vein thrombosis ) . No deaths were attributed to ABT-510 . Conclusions : There was little evidence of clinical activity for ABT-510 , and further evaluation as a single agent for treating advanced renal cell carcinoma is not warranted . The evidence of a favorable safety profile may justify further evaluation in combination therapy PURPOSE Mature survival data and evaluation of vascular endothelial growth factor ( VEGF ) as a prognostic biomarker from the Treatment Approaches in Renal Cancer Global Evaluation Trial ( TARGET ) study in patients with renal cell carcinoma ( RCC ) are reported . PATIENTS AND METHODS Nine hundred three previously treated patients were r and omly assigned to receive sorafenib versus placebo . On demonstration of progression-free survival ( PFS ) benefit with sorafenib , patients assigned to placebo were offered sorafenib . Overall survival ( OS ) was determined at two planned interim analyses and one final analysis , with a secondary OS analysis conducted by censoring placebo patients who crossed over to sorafenib . The relationships between baseline VEGF level and prognosis and efficacy were evaluated . RESULTS The final OS of patients receiving sorafenib was comparable with that of patients receiving placebo ( 17.8 v 15.2 months , respectively ; hazard ratio [ HR ] = 0.88 ; P = .146 ) ; however , when post-cross-over placebo survival data were censored , the difference became significant ( 17.8 v 14.3 months , respectively ; HR = 0.78 ; P = .029 ) . Adverse events at 16 months after cross over were similar to those previously reported . Baseline VEGF levels correlated with Eastern Cooperative Oncology Group performance status ( P < .0001 ) , Memorial Sloan-Kettering Cancer Center score ( P < .0001 ) , and PFS and OS in univariate ( PFS , P = .0013 ; OS , P = .0009 ) and multivariate ( PFS , P = .0231 ; OS , P = .0416 ) analyses of placebo patients and with short OS by multivariate analysis of patients receiving sorafenib ( P = .0145 ) . Both high-VEGF ( P < .01 ) and low-VEGF ( P < .01 ) groups benefited from sorafenib . CONCLUSION Although an OS benefit was not seen on a primary intent-to-treat analysis , results of a secondary OS analysis censoring placebo patients demonstrated a survival advantage for those receiving sorafenib , suggesting an important cross-over effect . VEGF levels are prognostic for PFS and OS in RCC . The results of TARGET establish the efficacy and safety of sorafenib in advanced RCC This r and omized phase II study evaluated two schedules of the marine compound Plitidepsin with or without co-administration of L-carnitine in patients with renal cell carcinoma . Patients had adequate performance status and organ function . The primary endpoint was the rate of disease control ( no progression ) at 12 weeks ( RECIST ) . Other endpoints included the response rate and time dependent efficacy measures . The trial also assessed the efficacy of L-carnitine to prevent Plitidepsin-related toxicity . The two regimes given as 24 hour infusion every two weeks showed hints of antitumoral activity . Disease control at 12 weeks was 15.8 % in Arm A ( 5mg/m2 , no L-carnitine ) and 11,1 % in Arm B ( 7mg/m2 with L-carnitine ) . Two partial responses were observed in Arm A ( 19 patients ) , none in Arm B ( 20 patients ) . Both schedules had the same progression-free interval ( 2.1 months ) . The median overall survival was 7.0 and 7.6 months . The safety profile was similar in both arms of the trial and adverse events were mainly mild to moderate ( NCI CTC version 2.0 ) . Increasing the dose to 7mg/m2 did not increase the treatment efficacy but the incidence of transaminase and CPK elevations and serious AEs . Coadministration of L-carnitine did not prevent muscular toxicity or CPK-elevation associated with Plitidepsin BACKGROUND Interferon alfa is widely used for metastatic renal-cell carcinoma but has limited efficacy and tolerability . Temsirolimus , a specific inhibitor of the mammalian target of rapamycin kinase , may benefit patients with this disease . METHODS In this multicenter , phase 3 trial , we r and omly assigned 626 patients with previously untreated , poor-prognosis metastatic renal-cell carcinoma to receive 25 mg of intravenous temsirolimus weekly , 3 million U of interferon alfa ( with an increase to 18 million U ) subcutaneously three times weekly , or combination therapy with 15 mg of temsirolimus weekly plus 6 million U of interferon alfa three times weekly . The primary end point was overall survival in comparisons of the temsirolimus group and the combination-therapy group with the interferon group . RESULTS Patients who received temsirolimus alone had longer overall survival ( hazard ratio for death , 0.73 ; 95 % confidence interval [ CI ] , 0.58 to 0.92 ; P=0.008 ) and progression-free survival ( P<0.001 ) than did patients who received interferon alone . Overall survival in the combination-therapy group did not differ significantly from that in the interferon group ( hazard ratio , 0.96 ; 95 % CI , 0.76 to 1.20 ; P=0.70 ) . Median overall survival times in the interferon group , the temsirolimus group , and the combination-therapy group were 7.3 , 10.9 , and 8.4 months , respectively . Rash , peripheral edema , hyperglycemia , and hyperlipidemia were more common in the temsirolimus group , whereas asthenia was more common in the interferon group . There were fewer patients with serious adverse events in the temsirolimus group than in the interferon group ( P=0.02 ) . CONCLUSIONS As compared with interferon alfa , temsirolimus improved overall survival among patients with metastatic renal-cell carcinoma and a poor prognosis . The addition of temsirolimus to interferon did not improve survival . ( Clinical Trials.gov number , NCT00065468 [ Clinical Trials.gov ] . ) On July 31 , 2009 , the U.S. Food and Drug Administration granted approval for the use of bevacizumab ( Avastin(R ) ; Genentech , Inc. , South San Francisco , CA ) in combination with interferon (IFN)-alpha2a for the treatment of patients with metastatic renal cell carcinoma . The approval was primarily based on results from a r and omized , double-blind , placebo-controlled clinical trial . The primary efficacy endpoint , progression-free survival ( PFS ) , was assessed by investigators and by an independent review committee ( IRC ) blinded to treatment assignment . In total , 649 patients ( bevacizumab plus IFN , 327 ; placebo plus IFN , 322 ) were enrolled . The median PFS times , by investigator determination , were 10.2 months for the bevacizumab plus IFN arm and 5.4 months for the placebo plus IFN arm ( hazard ratio [ HR ] , 0.60 ; 95 % confidence interval [ CI ] , 0.49 - 0.72 ; p < .0001 ) . The IRC analysis of 569 patients with available radiographs yielded similar results ( median PFS time , 10.4 months versus 5.5 months ; HR , 0.57 ; 95 % CI , 0.45 - 0.72 ; p < .0001 ) . There was no survival advantage ( HR , 0.86 ; 95 % CI , 0.72 - 1.04 ; p = .13 ) . Support for the above results was provided by summarized results of a North American cooperative group study of bevacizumab plus IFN-alpha2b versus IFN-alpha2b alone . The median PFS times were 8.4 months versus 4.9 months in favor of the bevacizumab combination . There was no survival advantage . In the review ed trial , serious adverse events and National Cancer Institute Common Terminology Criteria for Adverse Events grade > /=3 adverse events were reported more frequently in bevacizumab-treated patients ( 31 % versus 19 % and 63 % versus 47 % , respectively ) . The most common bevacizumab-related toxicities were bleeding/hemorrhage , hypertension , proteinuria , and venous or arterial thromboembolic events Abstract Introduction : St and ard therapy for recurrent or metastatic renal carcinoma includes the biologic response modifiers interferon-alpha ( IFN-α ) and interleukin-2 ( IL-2 ) . The response rate for both agents is modest and toxicity is significant . New agents are needed . Interferon-gamma ( IFN-γ ) is a type II interferon that demonstrated promising activity in renal carcinoma in early clinical trials . In vitro data suggested synergistic activity when IFN-γ was combined with IFN-α . The Eastern Cooperative Oncology Group conducted a r and omized phase II trial to confirm the efficacy of IFN-γ as a single agent and to evaluate the efficacy and toxicity of IFN-γ in combination with IFN-α in the treatment of patients with metastatic or recurrent renal carcinomas . Material s and Methods : Ninety-five patients with recurrent or metastatic renal carcinoma were entered on trial . Patients were stratified based on risk assessment using the Elson method . Patients were r and omly assigned to receive either IFN-γ 0.1 mg/m2 weekly ( arm A ) or IFN-γ 0.3 mg/m2 iv daily × 5 every 3 wk plus IFN-α 10 MU/m2 daily ( arm B ) . Treatment efficacy was evaluated every 6 weeks . Results : Toxicity in the arm A was minimal . Significant toxicity was noted in arm B , with four cases of grade 4 neurotoxicity . No responses were seen with IFN-γ alone . Five responses ( two CR and three PR ) were noted in the combination arm for an overall response rate of 10 % . Four of five responders were classified as “ good risk . ” Median survival for arm A was 7.0 mo vs 10.4 mo for arm B. Risk stratification was significant in arm B. Conclusion : IFN-γ at this dose and schedule failed to demonstrate activity in metastatic/recurrent renal carcinoma . The combination of IFN-γ and IFN-α demonstrated a response rate similar to IFN-α alone . There was no evidence of synergy between IFN-γ and IFN-α 3502 Background : The traditional endpoint for colon adjuvant clinical trials ( CT ) is OS , with 5 years ( yrs ) used to demonstrate adequacy of follow-up ( f-u ) . A shorter-term endpoint providing both clinical ly and statistically convincing evidence to allow a comparison of treatments could significantly speed both the CT process and the translation of advances into clinical practice . METHODS Individual patient data were pooled from 15 large r and omized phase III colon adjuvant CT . Trials included 33 arms : 9 no chemotherapy control arms , 24 5-FU based chemotherapy arms , with a pooled sample size of 12,915 patients ( pts ) . The primary hypothesis was that DFS , with 3 yrs f-u , is an appropriate primary endpoint to replace OS with 5 yrs f-u in phase III colon adjuvant CT . Median f-u was 8 yrs ; 5 yr f-u was available on 93 % of patients ( pts ) . RESULTS The recurrence rate for yrs 1 - 5 was 11 % , 13 % , 7 % , 4 % , and 3 % . Median time from recurrence to death was 14 months . 95 % of pts alive and disease-free at 3 yr were alive at 5 yrs ; 86 % of pts with recurrence by 3 yrs died before 5 yrs . Overall per-pt concordance between 2 , 3 , and 4 yr DFS and 5 yr OS was 88 % , 92 % , and 92 % respectively . Across all 33 study arms , correlation between 3 yr DFS and 5 yr OS was 0.94 . Correlation of the difference in 3 yr DFS and 5 yr OS comparing control vs experimental arms within each trial was 0.88 . Within trial log-rank testing using DFS with 3 yrs of f-u versus OS with 5 yrs f-u result ed in the same conclusion in 15 of 18 cases ( 83 % ) ; all three discordant results were only marginally significant for DFS ( 0.03 < p < 0.05 ) . Differences in 5 yr OS retained 92 % of the difference in 3 yr DFS ( 95 % CI 67%-117 % ) . CONCLUSIONS In pts treated on phase III adjuvant colon CT , 3 yr DFS and 5 yr OS are highly correlated , both within pts and across trials . Within-trial comparisons of 3 yr DFS predict 5 yr OS comparisons with high concordance . These results suggest that DFS after 3 years f-u is an appropriate endpoint for adjuvant colon CTs of 5-FU-based regimens , although marginally significant 3 yr DFS improvements may not translate into significant 5 yr OS benefits . No significant financial relationships to disclose PURPOSE Sunitinib has shown antitumor activity with a manageable safety profile as metastatic renal cell carcinoma ( RCC ) treatment , when given by the st and ard intermittent schedule as well as a continuous daily dosing ( CDD ) schedule . A trial was conducted to compare the schedules . PATIENTS AND METHODS Patients with treatment-naive , clear cell advanced RCC were r and omly assigned 1:1 to receive sunitinib 50 mg/d for 4 weeks followed by 2 weeks off treatment ( schedule 4/2 ; n = 146 ) or 37.5 mg/d on the CDD schedule ( n = 146 ) for up to 2 years . The primary end point was time to tumor progression . RESULTS Median time to tumor progression was 9.9 months for schedule 4/2 and 7.1 months for the CDD schedule ( hazard ratio , 0.77 ; 95 % CI , 0.57 to 1.04 ; P = .090 ) . No significant difference was observed in overall survival ( 23.1 v 23.5 months ; P = .615 ) , commonly reported adverse events , or patient-reported kidney cancer symptoms . Schedule 4/2 was statistically superior to CDD in time to deterioration , a composite end point of death , progression , and disease-related symptoms ( P = .034 ) . CONCLUSION ; There was no benefit in efficacy or safety for continuous dosing of sunitinib compared with the approved 50 mg/d dose on schedule 4/2 . Given the numerically longer time to tumor progression with the approved 50 mg/d dose on schedule 4/2 , adherence to this dose and schedule remains the treatment goal for patients with advanced RCC PURPOSE Progression free survival ( PFS ) is increasingly used as a primary end-point in oncology clinical trials . This paper provides recommendations for optimal trial design , conduct and analysis in situations where PFS has the potential to be an acceptable end-point for regulatory approval . PATIENTS AND METHODS These recommendations are based on research performed by the Pharmaceutical Research and Manufacturers Association ( PhRMA ) sponsored PFS Working Group , including the re- analysis of 28 r and omised Phase III trials from 12 companies/institutions . RESULTS ( 1 ) In the assessment of PFS , there is a critical distinction between measurement error that results from r and om variation , which by itself tends to attenuate treatment effect , versus bias which increases the probability of a false negative or false positive finding . Investigator bias can be detected by auditing a r and om sample of patients by blinded , independent , central review ( BICR ) . ( 2 ) ITT analyses generally result ed in smaller treatment effects ( HRs closer to 1 ) than analyses that censor patients for potentially informative events ( such as starting other anti-cancer therapy ) . ( 3 ) Interval censored analyses ( ICA ) are more robust to time-evaluation bias than the log-rank test . CONCLUSION A sample based BICR audit may be employed in open or partially blinded trials and should not be required in true double-blind trials . Patients should be followed until progression even if they have discontinued treatment to be consistent with the ITT principle . ICAs should be a st and ard sensitivity analysis to assess time-evaluation bias . Implementation of these recommendations would st and ardize and in many cases simplify phase III oncology clinical trials that use a PFS primary end-point Background The purpose of the present study was to investigate the therapeutic effectiveness of interleukin-2 ( IL-2 ) and interferon ( IFN ) , either alone or in combination , in comparable groups of patients affected by advanced renal cell carcinoma ( RCC ) . Patients and methods In order to limit selection biases , treatment was allocated on a r and om basis . Patients r and omized to IL-2 alone were scheduled to receive eight rIL-2 24-hour i.v . infusion cycles , days 1 to 4 , at a daily dose of 18 x 106 IU/m2 for a total of 25 weeks . Patients r and omized to IFN alone were scheduled to receive rIFN-α at a daily dose of 6 x 106 IU/m2 , days 1 , 3 and 5 , every week for a total of 52 weeks . Patients r and omized to the combination of IFN and IL-2 were given the same drugs at the same daily doses for a total of 24 weeks . Drug dose was modified according to toxicity . Results Twenty-three percent ( 95 % CI : ± 17.5 ) of patients treated with IL-2 alone showed an objective response to treatment ( 9 % CR ) . The corresponding figures in patients treated with IFN alone or IFN plus IL-2 were 9 % ( 95 % CI : ± 11.9 ) and 9 % ( 95 % CI : ± 11.9 ) , respectively . Complete responses were observed only in patients treated with IL-2 . The median duration of response in the IL-2 arm was 18 months ( range , 9.5 - 24 ) . The duration of the two responses achieved by IFN alone was seven and nine , months , respectively . The corresponding figures in the two patients responding to the combination of IFN with IL-2 were 19 and 27 months , respectively . Total IL-2 dose appeared to be a major predictor of response . Only a minority of patients experienced grade 3 - 4 toxicity , the incidence being higher in those treated with IL-2 or IL-2 plus IFN . Conclusions Neither IFN nor IL-2 or the combination of the two appear to be very active in patients with advanced RCC , even when trial entry was restricted to patients with relatively indolent disease . This stresses the need for the development of new approaches PURPOSE A r and omized phase III trial was conducted to determine whether combination therapy with 13-cis-retinoic acid ( 13-CRA ) plus interferon alfa-2a ( IFNalpha2a ) is superior to IFNalpha2a alone in patients with advanced renal cell carcinoma ( RCC ) . PATIENTS AND METHODS Two hundred eighty-four patients were r and omized to treatment with IFNalpha2a plus 13-CRA or treatment with IFNalpha2a alone . IFNalpha2a was given daily subcutaneously , starting at a dose of 3 million units ( MU ) . The dose was escalated every 7 days from 3 to 9 MU ( by increments of 3 MU ) , unless > /= grade 2 toxicity occurred , in which case dose escalation was stopped . Patients r and omized to combination therapy were given oral 13-CRA 1 mg/kg/d plus IFNalpha2a . Quality of life ( QOL ) was assessed . RESULTS Complete or partial responses were achieved by 12 % of patients treated with IFNalpha2a plus 13-CRA and 6 % of patients treated with IFNalpha2a ( P = .14 ) . Median duration of response ( complete and partial combined ) in the group treated with the combination was 33 months ( range , 9 to 50 months ) , versus 22 months ( range , 5 to 38 months ) for the second group ( P = .03 ) . Nineteen percent of patients treated with IFNalpha2a plus 13-CRA were progression-free at 24 months , compared with 10 % of patients treated with IFNalpha2a alone ( P = .05 ) . Median survival time for all patients was 15 months , with no difference in survival between the two treatment arms ( P = .26 ) . QOL decreased during the first 8 weeks of treatment , and a partial recovery followed . Lower scores were associated with the combination therapy . CONCLUSION Response proportion and survival did not improve significantly with the addition of 13-CRA to IFNalpha2a therapy in patients with advanced RCC . 13-CRA may lengthen response to IFNalpha2a therapy in patients with IFNalpha2a-sensitive tumors . Treatment , particularly the combination therapy , was associated with a decrease in QOL PURPOSE We conducted a prospect ively r and omized clinical trial to compare the efficacy of three outpatient therapy regimens in 341 patients with progressive metastatic renal cell carcinoma . PATIENTS AND METHODS Patients were stratified according to known clinical predictors and were subsequently r and omly assigned . Treatment arms were : arm A ( n = 132 ) , subcutaneous interferon alfa-2a ( sc-IFN-alpha-2a ) , subcutaneous interleukin-2 ( sc-IL-2 ) , and intravenous ( IV ) fluorouracil ; arm B ( n = 146 ) : arm A treatment combined with per oral 13-cis-retinoic acid ; and arm C ( n = 63 ) , sc-IFN-alpha-2a and IV vinblastine . RESULTS Treatment ( according to the st and ard 8-week Hannover Atzpodien regimen ) arms A , B , and C yielded objective response rates of 31 % , 26 % , and 20 % , respectively . Arm B , but not arm A , showed a significantly improved progression-free survival ( PFS ) compared with arm C ( P = .0248 ) . Both arm A ( median overall survival , 25 months ; P = .0440 ) and arm B ( median overall survival , 27 months ; P = .0227 ) led to significantly improved overall survival ( OS ) compared with arm C ( median OS , 16 months ) . All three sc-IFN-alpha-2a-based therapies were moderately or well tolerated . CONCLUSION Our results established the safety and improved long-term therapeutic efficacy of sc-IL-2 plus sc-INF-alpha-2a-based outpatient immunochemotherapies , compared with sc-INF-alpha-2a/IV vinblastine PURPOSE The combination of interferon alfa-2a ( IFNalpha2a ) plus vinblastine ( VLB ) induces objective tumor responses in patients with advanced renal cell cancer . However , no prospect i ve r and omized trial has shown that this treatment prolongs overall survival . We compared overall survival after treatment with IFNalpha2a plus VLB versus VLB alone in patients with advanced renal cell cancer . PATIENTS AND METHODS We prospect ively r and omized 160 patients with locally advanced or metastatic renal cell cancer to receive either VLB alone or IFNalpha2a plus VLB for 12 months or until progression of disease . In both groups , VLB was administered intravenously at 0.1 mg/kg every 3 weeks , and in the combination group IFNalpha2a was administered subcutaneously at 3 million units three times a week for 1 week , and 18 million units three times a week thereafter for the second and subsequent weeks . For patients unable totolerate IFNalpha2a at 18 million units per injection , the dose was reduced to 9 million units . RESULTS Median survival was 67.6 weeks for the 79 patients receiving IFNalpha2a plus VLB and 37.8 weeks for the 81 patients treated with VLB ( P = .0049 ) . Overall response rates were 16 . 5 % for patients treated with IFNalpha2a plus VLB and 2.5 % for patients treated with VLB alone ( P = .0025 ) . Treatment with the combination was associated with constitutional symptoms and abnormalities in laboratory parameters , but no toxic deaths were reported . CONCLUSION The combination of IFNalpha2a plus VLB is superior to VLB alone in the treatment of patients with locally advanced or metastatic renal cell carcinoma . This is the first study to demonstrate that survival can be prolonged by using IFNalpha2a for these patients |
371 | 28,245,839 | We found evidence of cost-effectiveness of community health worker ( CHW ) interventions in reducing malaria and asthma , decreasing mortality of neonates and children , improving maternal health , increasing exclusive breastfeeding and improving malnutrition , and positively impacting physical health and psychomotor development amongst children .
Outcomes included disease- or condition -specific outcomes , morbidity , mortality , and generic measures ( e.g. disability-adjusted life years ( DALYs ) ) .
This is the first systematic review to assess the cost-effectiveness of community health workers in delivering child health interventions | Evidence of the cost-effectiveness of community health worker interventions is pertinent for decision-makers and programme planners who are turning to community services in order to strengthen health systems in the context of the momentum generated by strategies to support universal health care , the post-2015 Sustainable Development Goal agenda .
We conducted a systematic review of published economic evaluation studies of community health worker interventions aim ed at improving child health outcomes .
There is a need for economic evaluations of larger and integrated CHW programmes in order to achieve the post-2015 Sustainable Development Goal agenda so that appropriate re sources can be allocated to this subset of human re sources for health . | Abstract Objectives : To establish the relative cost effectiveness of postnatal support in the community in addition to the usual care provided by community midwives . Design : R and omised controlled trial with six month follow up . Setting : Recruitment in a university teaching hospital and care provided in women 's homes . Participants : 623 postnatal women allocated at r and om to intervention ( 311 ) or control ( 312 ) group . Intervention : Up to 10 home visits in the first postnatal month of up to three hours duration by a community postnatal support worker . Main outcome measure : General health status as measured by the SF-36 and risk of postnatal depression . Breast feeding rates , satisfaction with care , use of services , and personal costs . Results : At six weeks there was no significant improvement in health status among the women in the intervention group . At six weeks the mean total NHS costs were £ 635 for the intervention group and £ 456 for the control group ( P=0.001 ) . At six months figures were £ 815 and £ 639 ( P=0.001 ) . There were no differences between the groups in use of social services or personal costs . The women in the intervention group were very satisfied with the support worker visits . Conclusions : There was no health benefit of additional home visits by community postnatal support workers compared with traditional community midwifery visiting as measured by the SF-36 . There were no savings to the NHS over six months after the introduction of the community postnatal support worker service A home visit intervention program for adolescents throughout their pregnancy and during the early stages of motherhood was evaluated . The participants ( N = 90 ) were part of a larger group of adolescents treated in two health centers in a poor neighborhood in Santiago , Chile . The program was carried out by volunteer community health monitors and evaluated through an experimental , r and omized , controlled clinical trial . Cost-effectiveness was examined in comparison with st and ard health care . Results show higher scores for the intervention group on the mothers ’ mental health and nutritional state , as well as on the children ’s levels of linguistic development OBJECTIVE To describe the costs of providing support to breastfeeding low-income women and compares costs to cost offsets of the intervention . DESIGN Secondary analysis of data from a r and omized controlled trial of an intervention to promote breastfeeding among low-income women with full-term infants . SETTING A university hospital and a community hospital in Baltimore , Maryl and . PARTICIPANTS Special Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) eligible breastfeeding women ( N = 328 ) were r and omized to usual care or the community health nurse/peer counselor intervention . METHODS The research ers collected and described personnel and mileage costs over the entire duration of the intervention ( 24 weeks ) . Research ers also compared ( using t tests ) change in re sources associated with breastfeeding including the number of clinic visits , hospital nights , emergency room visits , prescriptions , and formula feedings per day up to 12 weeks . RESULTS The cost of the personnel and travel required for the intervention was $ 296 per woman . The use of medical care and number of formula feedings per day were similar for the intervention and usual care groups . When differences in use of medical care and formula feeding were statistically significant , the intervention group used fewer re sources . CONCLUSION Support for breastfeeding by community health nurses and peer counselors is partially offset by reducing medical care utilization and formula feeding costs We did a cost-effectiveness analysis alongside a cluster-r and omised controlled trial of a participatory intervention with women 's groups to improve birth outcomes in rural Nepal . The average provider cost of the women 's group intervention was US0.75 dollars per person per year ( 0.90 dollars with health-service strengthening ) in a population of 86,704 . The incremental cost per life-year saved ( LYS ) was 211 dollars ( 251 dollars ) , and expansion could rationalise on start-up costs and technical assistance , reducing the cost per LYS to 138 dollars ( 179 dollars ) . Sensitivity analysis showed a variation from 83 dollars to 263 dollars per LYS for most variables . This intervention could provide a cost-effective way of reducing neonatal deaths BACKGROUND Breastfeeding can ameliorate some of the complex health issues faced by low-income families . Women who breastfeed and their infants have lower health care costs compared with those who formula feed . Increasing the duration of breastfeeding is recognized as a national priority , particularly for low-income women . This community-based r and omized clinical trial involving low-income mothers compared usual care with an intervention comprising hospital and home visits , and telephone support by a community health nurse/peer counselor team for 6 months after delivery . METHODS Forty-one women were recruited after delivery of a full-term singleton infant and r and omly assigned to intervention or usual care groups . RESULTS Women receiving the community health intervention breastfed longer than the women receiving usual care . The infants in the intervention group had fewer sick visits and reported use of fewer medications than infants in the usual care group . The intervention cost ( $ 301/mother ) was partially offset by cost savings on formula and health care . CONCLUSIONS Community health nurse and peer counselor support can increase breastfeeding duration in low-income women , and has the potential to reduce total costs including the cost of support Background Intermittent preventive treatment for malaria in children ( IPTc ) involves the administration of a full course of an anti-malarial treatment to children under 5 years old at specified time points regardless of whether or not they are known to be infected , in areas where malaria transmission is seasonal . It is important to determine the costs associated with IPTc delivery via community based volunteers and also the potential savings to health care providers and caretakers due to malaria episodes averted as a consequence of IPTc . Methods Two thous and four hundred and fifty-one children aged 3–59 months were r and omly allocated to four groups to receive : three days of artesunate plus amodiaquine ( AS+AQ ) monthly , three days of AS+AQ bimonthly , one dose of sulphadoxine-pyrimethamine ( SP ) bi-monthly or placebo . This paper focuses on incremental cost effectiveness ratios ( ICERs ) of the three IPTc drug regimens as delivered by community based volunteers ( CBV ) in Hohoe , Ghana compared to current practice , i.e. case management in the absence of IPTc . Financial and economic costs from the publicly funded health system perspective are presented . Treatment costs borne by patients and their caretakers are also estimated to present societal costs . The costs and effects of IPTc during the intervention period were considered with and without a one year follow up . Probabilistic sensitivity analysis was undertaken to account for uncertainty . Results Economic costs per child receiving at least the first dose of each course of IPTc show SP bimonthly , at US$ 8.19 , is the cheapest to deliver , followed by AS+AQ bimonthly at US$ 10.67 and then by AS+AQ monthly at US$ 14.79 . Training , drug delivery and supervision accounted for approximately 20–30 % each of total unit costs . During the intervention period AS & AQ monthly was the most cost effective IPTc drug regimen at US$ 67.77 ( 61.71–74.75 , CI 95 % ) per malaria case averted based on intervention costs only , US$ 64.93 ( 58.92–71.92 , CI 95 % ) per malaria case averted once the provider cost savings are included and US$ 61.00 ( 54.98 , 67.99 , CI 95 % ) when direct household cost savings are also taken into account . SP bimonthly was US$ 105.35 ( 75.01–157.31 , CI 95 % ) and AS & AQ bimonthly US$ 211.80 ( 127.05–399.14 , CI 95 % ) per malaria case averted based on intervention costs only . The incidence of malaria in the post intervention period was higher in children who were < 1 year old when they received AS+AQ monthly compared to the placebo group leading to higher cost effectiveness ratios when one year follow up is included . The cost per child enrolled fell considerably when modelled to district level as compared to those encountered under trial conditions . Conclusions We demonstrate how cost-effective IPTc is using three different drug regimens and the possibilities for reducing costs further if the intervention was to be scaled up to the district level . The need for effective training , drug delivery channels and supervision to support a strong network of community based volunteers is emphasised OBJECTIVES This study aim ed to measure the effect and the total cost per woman of providing postnatal support at home , based on a Dutch model . The research hypothesis was furnished by some existing evidence that postnatal support could reduce the risk of postnatal depression and encourage breastfeeding . DESIGN The r and omised controlled trial aim ed to measure differences in health status in a group of women who were offered postnatal support from a community midwifery support worker ( SW ) compared with a control group of women who were not offered this support . Women were followed-up by postal question naire at 6 weeks and 6 months postnatally . SETTING AND SUBJECTS All women who delivered a baby at the recruiting hospital were eligible to take part in the trial if they lived within the study area , were aged 17 years or over , and could underst and English . INTERVENTION The intervention consisted of the SW offering practical and emotional support and to help women rest and recover after childbirth . The SW offered ten visits in the first 28 days postnatally , for up to 3 hours per day . The SW 's activities included housework , talking with the mother , and care for the baby or other siblings . The service was provided in addition to routine visits by the community midwife . MAIN OUTCOME MEASURES The primary outcome was the general health perception domain of the Short Form-36 at 6 weeks . Secondary outcomes were mean Edinburgh Postnatal Depression Scale ( EPDS ) , Duke Functional Social Support ( DUFSS ) scores and breastfeeding rates . RESULTS The 623 r and omised women were well-matched by group with a good response to follow-up . At 6 weeks there was no evidence of a significant difference between the two groups for the primary outcome . There was a non-significant trend for the control group to have better mean DUFSS and EPDS scores at 6 weeks . Breastfeeding rates were not significantly different at follow-up . At 6 months , both groups had similar health status . Satisfaction with the service was higher than for all other services received . The incremental cost of introducing the service comprised setting up and running the service . There were no differences between the groups in other re source use ( general practitioner contacts , hospital services , prescriptions or medicines bought for mothers and babies ) to 6-month follow-up . The total mean NHS cost to 6-month follow-up for the intervention group was pound180 per woman greater than for the control group ( confidence interval , pound79.60 , pound272.40 ) . CONCLUSIONS Although women valued the service , there was no evidence of any health benefit at the 6-week or 6-month follow-up , no difference in use of NHS services , and the additional cost of the service provision would be around pound 180 per woman OBJECTIVE To assess the cost-effectiveness of two strategies of home management of under-five fevers in Ghana - treatment using antimalarials only ( artesunate-amodiaquine - AAQ ) and combined treatment using antimalarials and antibiotics ( artesunate-amodiaquine plus amoxicillin - AAQ + AMX ) . METHODS We assessed the costs and cost-effectiveness of AAQ and AAQ + AMX compared with a control receiving st and ard care . Data were collected as part of a cluster r and omised controlled trial with a step-wedged design . Approximately , 12,000 children aged 2 - 59 months in Dangme West District in southern Ghana were covered . Community health workers delivered the interventions . Costs were analysed from societal perspective , using anaemia cases averted , under-five deaths averted and disability-adjusted life years ( DALYs ) averted as effectiveness measures . RESULTS Total economic costs for the interventions were US$ 204,394.72 ( AAQ ) and US$ 260,931.49 ( AAQ + AMX ) . Recurrent costs constituted 89 % and 90 % of the total direct costs of AAQ and AAQ + AMX , respectively . Deaths averted were 79.1 ( AAQ ) and 79.9 ( AAQ + AMX ) , with DALYs averted being 2264.79 ( AAQ ) and 2284.57 ( AAQ + AMX ) . The results show that cost per anaemia case averted were US$ 150.18 ( AAQ ) and US$ 227.49 ( AAQ + AMX ) and cost per death averted was US$ 2585.58 for AAQ and US$ 3272.20 for AAQ + AMX . Cost per DALY averted were US$ 90.25 ( AAQ ) and US$ 114.21 ( AAQ + AMX ) . CONCLUSION Both AAQ and AAQ + AMX approaches were cost-effective , each averting one DALY at less than the st and ard US$ 150 threshold recommended by the World Health Organisation . However , AAQ was more cost-effective . Home management of under-five fevers in rural setting s is cost-effective in reducing under-five mortality Early childhood programs are heralded as a way to improve children 's health and educational outcomes . However , few studies in developing countries calculate the effectiveness of quality early childhood interventions . Even fewer estimate the associated costs of such interventions . The study here looks at the costs and effectiveness of a cluster-r and omized effectiveness trial on children from birth to 24 months in rural Sindh , Pakistan . Responsive stimulation and /or enhanced nutrition interventions were integrated in the Lady Health Worker program in Pakistan . Outcomes suggest that children who receive responsive stimulation had significantly better development outcomes at 24 months than those who only received enhanced nutrition intervention . A cost-effectiveness analysis of the results verifies that early childhood interventions that include responsive stimulation are more cost effective than a nutrition intervention alone in promoting children 's early development . Costs of a responsive stimulation intervention integrated in an existing community-based service providing basic health and nutrition care is approximately US$ 4 per month per child . We discuss these findings and make recommendations about scaling up and costs for future early child development programs |
372 | 16,611,374 | Results show substantial evidence for the efficacy of n-3 oils in reducing cardiovascular mortality and one mechanism may be related to the stabilisation of vulnerable atherosclerotic plaques , although the effects on progression of atherosclerosis , haemostatic activity and vascular inflammation remain equivocal .
Promising data also exist for the efficacy of flavonoid-rich foods for improving endothelial function , although strong clinical endpoint evidence is lacking .
The variation in the efficacy of certain nutrients in CHD patients may be explained by genetics , existing risk factors , psychosocial factors and method ological issues , although these are often not adequately taken into consideration . | Epidemiological evidence suggests that the diet influences CHD risk , although the protective effects of dietary intervention for patients in diseased states has gained less attention .
Secondary care prevention strategies for patients often involves drug therapy that is expensive and can result in undesirable side effects .
Therefore , it is potentially beneficial to utilise other strategies , such as diet , in the management of CHD .
A systematic review was conducted to examine the effects of specific nutrients on progression of atherosclerosis , vascular function , haemostasis and inflammation in CHD patients . | Background —Epidemiological studies suggest that tea consumption decreases cardiovascular risk , but the mechanisms of benefit remain undefined . Endothelial dysfunction has been associated with coronary artery disease and increased oxidative stress . Some antioxidants have been shown to reverse endothelial dysfunction , and tea contains antioxidant flavonoids . Methods and Results —To test the hypothesis that tea consumption will reverse endothelial dysfunction , we r and omized 66 patients with proven coronary artery disease to consume black tea and water in a crossover design . Short-term effects were examined 2 hours after consumption of 450 mL tea or water . Long-term effects were examined after consumption of 900 mL tea or water daily for 4 weeks . Vasomotor function of the brachial artery was examined at baseline and after each intervention with vascular ultrasound . Fifty patients completed the protocol and had technically suitable ultrasound measurements . Both short- and long-term tea consumption improved endothelium- dependent flow-mediated dilation of the brachial artery , whereas consumption of water had no effect ( P < 0.001 by repeated- measures ANOVA ) . Tea consumption had no effect on endothelium-independent nitroglycerin-induced dilation . An equivalent oral dose of caffeine ( 200 mg ) had no short-term effect on flow-mediated dilation . Plasma flavonoids increased after short- and long-term tea consumption . Conclusions —Short- and long-term black tea consumption reverses endothelial vasomotor dysfunction in patients with coronary artery disease . This finding may partly explain the association between tea intake and decreased cardiovascular disease events BACKGROUND Polyunsaturated fatty acids ( PUFAs ) are intrinsic cell membrane components and closely involved in neurotransmission and receptor function . Lower omega-3 levels are associated with increased risk of coronary artery disease ( CAD ) , increases in cardiac events in CAD patients , and depression . We sought to examine relationships between depression and serum levels of omega-3 and omega-6 PUFAs in patients recovering from acute coronary syndromes ( ACS ) . METHODS We carried out a case-control study of serum PUFA levels and current major depression in 54 age- and sex-matched pairs approximately 2 months following ACS . RESULTS Depressed patients had significantly lower concentrations of total omega-3 and docosahexaenoic acid ( DHA ) , and higher ratios of arachidonic acid ( AA ) to DHA , AA to eicosapentaenoic acid ( EPA ) , and n-3 to n-6 than controls . There were no baseline differences in any potential risk or protective factors for depression . CONCLUSIONS Results are consistent with previous reports in depressed patients without CAD , and with literature concerning omega-3 levels and risk of CAD events . Dietary , genetic , and hormonal factors may all play a role in both depression and CAD . Both prospect i ve studies and r and omized trials are needed to help clarify the interrelationships Abstract —Epidemiological studies suggest that tea consumption is associated with a decreased risk of cardiovascular events , but the mechanisms of benefit remain undefined . Platelet aggregation is a precipitating event in cardiovascular disease , and tea contains antioxidant flavonoids that are known to decrease platelet aggregation in vitro . To test the effect of tea consumption on platelet aggregation , we r and omized 49 patients with coronary artery disease to either 450 mL of black tea or water consumed initially , followed by 900 mL of tea or water daily for 4 weeks in a crossover design . Ex vivo platelet aggregation in platelet-rich plasma was assessed in response to ADP and thrombin receptor-activating peptide at baseline and 2 hours and 4 weeks after beverage consumption . We observed dose-dependent platelet aggregation in response to each agonist , and neither relation was altered by acute or chronic tea consumption . Plasma flavonoids increased with acute and chronic tea consumption , indicating adequate absorption of tea flavonoids . In conclusion , these results demonstrate that acute and chronic black tea consumption does not affect ex vivo platelet aggregation in patients with coronary artery disease . These findings suggest that an effect of tea flavonoids on platelet aggregation is unlikely to be the explanation for the reduction in risk of cardiovascular events noted in epidemiological studies BACKGROUND The Lyon Diet Heart Study is a r and omized secondary prevention trial aim ed at testing whether a Mediterranean-type diet may reduce the rate of recurrence after a first myocardial infa rct ion . An intermediate analysis showed a striking protective effect after 27 months of follow-up . This report presents results of an extended follow-up ( with a mean of 46 months per patient ) and deals with the relationships of dietary patterns and traditional risk factors with recurrence . METHODS AND RESULTS Three composite outcomes ( COs ) combining either cardiac death and nonfatal myocardial infa rct ion ( CO 1 ) , or the preceding plus major secondary end points ( unstable angina , stroke , heart failure , pulmonary or peripheral embolism ) ( CO 2 ) , or the preceding plus minor events requiring hospital admission ( CO 3 ) were studied . In the Mediterranean diet group , CO 1 was reduced ( 14 events versus 44 in the prudent Western-type diet group , P=0.0001 ) , as were CO 2 ( 27 events versus 90 , P=0.0001 ) and CO 3 ( 95 events versus 180 , P=0 . 0002 ) . Adjusted risk ratios ranged from 0.28 to 0.53 . Among the traditional risk factors , total cholesterol ( 1 mmol/L being associated with an increased risk of 18 % to 28 % ) , systolic blood pressure ( 1 mm Hg being associated with an increased risk of 1 % to 2 % ) , leukocyte count ( adjusted risk ratios ranging from 1.64 to 2.86 with count > 9x10(9)/L ) , female sex ( adjusted risk ratios , 0.27 to 0 . 46 ) , and aspirin use ( adjusted risk ratios , 0.59 to 0.82 ) were each significantly and independently associated with recurrence . CONCLUSIONS The protective effect of the Mediterranean dietary pattern was maintained up to 4 years after the first infa rct ion , confirming previous intermediate analyses . Major traditional risk factors , such as high blood cholesterol and blood pressure , were shown to be independent and joint predictors of recurrence , indicating that the Mediterranean dietary pattern did not alter , at least qualitatively , the usual relationships between major risk factors and recurrence . Thus , a comprehensive strategy to decrease cardiovascular morbidity and mortality should include primarily a cardioprotective diet . It should be associated with other ( pharmacological ? ) means aim ed at reducing modifiable risk factors . Further trials combining the 2 approaches are warranted BACKGROUND Tumor necrosis factor alpha ( TNF-alpha ) mediates inflammation . High TNF-alpha production has adverse effects during disease . Polymorphisms in the TNF-alpha and lymphotoxin alpha genes influence TNF-alpha production . Fish oil suppresses TNF-alpha production and has variable antiinflammatory effects on disease . OBJECTIVE We examined the relation between TNF-alpha and lymphotoxin alpha genotypes and the ability of dietary fish oil to suppress TNF-alpha production by peripheral blood mononuclear cells ( P BMC s ) in healthy men . DESIGN Polymorphisms in the TNF-alpha ( TNF*1 and TNF*2 ) and lymphotoxin alpha ( TNFB*1 and TNFB*2 ) genes were determined in 111 healthy young men . TNF-alpha production by endotoxin-stimulated P BMC s was measured before and 12 wk after dietary supplementation with fish oil ( 6 g/d ) . RESULTS Homozygosity for TNFB*2 was 2.5 times more frequent in the highest than in the lowest tertile of inherent TNF-alpha production . The percentage of subjects in whom fish oil suppressed TNF-alpha production was lowest ( 22 % ) in the lowest tertile and doubled with each ascending tertile . In the highest and lowest tertiles , mean TNF-alpha production decreased by 43 % ( P < 0.05 ) and increased by 160 % ( P < 0.05 ) , respectively . In the lowest tertile of TNF-alpha production , only TNFB*1/TNFB*2 heterozygous subjects were responsive to the suppressive effect of fish oil . In the middle tertile , this genotype was 6 times more frequent than the other lymphotoxin alpha genotypes among responsive individuals . In the highest tertile , responsiveness to fish oil appeared unrelated to lymphotoxin alpha genotype . CONCLUSION The ability of fish oil to decrease TNF-alpha production is influenced by inherent TNF-alpha production and by polymorphisms in the TNF-alpha and lymphotoxin alpha genes BACKGROUND Higher intakes of fish and n-3 fatty acids are associated with a reduced risk of cardiovascular events and mortality . However , limited data exist on the effect of fish intake on actual measures of progression of coronary artery atherosclerosis . OBJECTIVE The aim was to examine the association between fish intake and the progression of coronary artery atherosclerosis in women with coronary artery disease . DESIGN This was a prospect i ve cohort study of postmenopausal women ( n = 229 ) participating in the Estrogen Replacement and Atherosclerosis trial . Usual fish intake was estimated at baseline with a food-frequency question naire . Quantitative coronary angiography was performed at baseline and after 3.2 + /- 0.6 ( x + /- SD ) y to evaluate changes in the mean minimum coronary artery diameter , the mean percentage of stenosis , and the development of new coronary lesions . RESULTS Compared with lower fish intakes , consumption of > or = 2 servings of fish or > or = 1 serving of tuna or dark fish per week was associated with smaller increases in the percentage of stenosis ( 4.54 + /- 1.37 % compared with -0.06 + /- 1.59 % and 5.12 + /- 1.48 % compared with 0.35 + /- 1.47 % , respectively ; P < 0.05 for both ) in diabetic women after adjustments for age , cardiovascular disease risk factors , and dietary intakes of fatty acids , cholesterol , fiber , and alcohol . These associations were not significant in nondiabetic women . Higher fish consumption was also associated with smaller decreases in minimum coronary artery diameter and fewer new lesions . CONCLUSIONS Consumption of fish is associated with a significantly reduced progression of coronary artery atherosclerosis in women with coronary artery disease OBJECTIVES To assess the impact of socio-economic status on the relationship between type of alcohol and all-cause mortality . DESIGN A prospect i ve population study . SETTING The Copenhagen City Heart Study , Denmark . SUBJECTS A total of 14,223 men and women participated in the first examination of The Copenhagen City Heart Study in 1976 - 1978 . The participants were followed up until 18th of September 2001 during which 7208 persons died . The effect of beer , wine and spirits on mortality was stratified according to levels of education , income and cohabitation , and the association was examined after controlling for intake of the other types of alcohol , and for sex , smoking , physical activity and body mass index . MAIN OUTCOME MEASURES Number and time of death from all causes . RESULTS Consumers of wine were better educated and wealthier compared with beer and spirits drinkers . The association between type of beverage and mortality was noticed to differ according to socio-economic level , especially where the apparent protective effect of wine consumption tended to be strongest in the lower income and educational groups . CONCLUSIONS This study finds the specific effects of beer , wine or spirits to moderately diverge in the socio-economic groups . Future studies addressing the association between the type of beverage and mortality may need to more thoroughly take socio-economic factors into account BACKGROUND Previous studies of diet and coronary heart disease ( CHD ) have focused on intake of nutrients rather than whole foods . Because of the findings that dietary fibre , folate and antioxidants may be protective for CHD , increased intake of vegetables has been recommended . However , due to the chemical and physical complexity of vegetables , the effects of individual nutrients may differ if eaten as whole foods . Moreover , little is known about the direct association between vegetable intake and risk of CHD . METHODS We prospect ively evaluated the relation between vegetable intake and CHD risk in the Physicians ' Health Study , a r and omized trial of aspirin and beta-carotene among 22 071 US male physicians aged 40 - 84 years in 1982 . In this analysis , we included 15 220 men without heart disease , stroke or cancer at baseline who provided information on their vegetable intake at baseline , and in the 2nd , 4th and 6th years of follow-up using a simple semiquantitative food frequency question naire including eight vegetables . We confirmed 1148 incident cases of CHD ( 387 incident cases of myocardial infa rct ion and 761 incident cases of coronary artery bypass grafting or percutaneous transluminal coronary angioplasty ) during 12 years of follow-up . RESULTS After adjusting for age , r and omized treatment , body mass index ( BMI ) , smoking , alcohol intake , physical activity , history of diabetes , history of hypertension , history of high cholesterol , and use of multivitamins , men who consumed at least 2.5 servings/day of vegetables had a relative risk ( RR ) of 0.77 ( 95 % CI : 0.60 - 0.98 ) for CHD , compared with men in the lowest category ( < 1 serving/day ) . Adjusting for the same covariates in an analysis of the overall trend that considered intake of vegetables as a continuous variable , we found a RR of 0.83 ( 95 % CI : 0.71 - 0.98 ) for risk of CHD for each additional serving/day of vegetables . The inverse relation between vegetable intake and CHD risk was more evident among men with a BMI > or = 25 ( RR = 0.71 , 95 % CI : 0.51 - 0.99 ) or current smokers ( RR = 0.40 , 95 % CI : 0.18 - 0.86 ) comparing highest to the lowest categories of intake . CONCLUSIONS Our results suggest an inverse association between vegetable intake and risk of CHD . These prospect i ve data support current dietary guidelines to increase vegetable intake for the prevention of CHD Dietary omega-3 fatty acids retard coronary atherosclerosis . Previously , we demonstrated that dietary omega-3 fatty acids reduce platelet-derived growth factor (PDGF)-A and PDGF-B mRNA levels in unstimulated , human mononuclear cells ( MNCs ) . In a r and omized , investigator-blinded intervention trial , we have now compared the effect of ingestion of 7 g/d omega-3 , omega-6 , or omega-9 fatty acids for 4 weeks versus no dietary intervention on PDGF-A , PDGF-B , heparin-bound epidermal growth factor ( HB-EGF ) , monocyte chemoattractant protein-1 ( MCP-1 ) , and interleukin-10 gene expression in unstimulated MNCs and in monocytes that were adherence-activated ex vivo in a total of 28 volunteers . In unstimulated MNCs , mRNA steady-state levels of PDGF-A , PDGF-B , and MCP-1 were reduced by 25+/-10 % , 31+/-13 % , and 40+/-14 % , respectively , after omega-3 fatty acid ingestion , as assessed by quantitative polymerase chain reaction ( all P<0.05 ) . In monocytes that were adherence-activated ex vivo for 4 and 20 hours , mRNA steady-state levels of PDGF-A , PDGF-B , and MCP-1 were reduced by 25+/-13 % , 20+/-15 % , and 30+/-8 % , respectively ( all P<0.05 ) . Interleukin-10 and HB-EGF mRNA steady-state levels were not influenced by omega-3 fatty acid ingestion . Expression of all respective mRNAs in control volunteers or in those ingesting omega-6 or omega-9 fatty acids were not altered . We conclude that human gene expression for PDGF-A , PDGF-B , and MCP-1 , factors thought relevant to atherosclerosis , is constitutive , is constant , and can be reduced only by dietary omega-3 fatty acids in unstimulated and adherence-activated monocytes OBJECTIVES This r and omized clinical trial tested whether fish oil supplements can improve human coronary atherosclerosis . BACKGROUND Epidemiologic studies of population s whose intake of oily fish is high , as well as laboratory studies of the effects of the polyunsaturated fatty acids in fish oil , support the hypothesis that fish oil is antiatherogenic . METHODS Patients with angiographically documented coronary heart disease and normal plasma lipid levels were r and omized to receive either fish oil capsules ( n = 31 ) , containing 6 g of n-3 fatty acids , or olive oil capsules ( n = 28 ) for an average duration of 28 months . Coronary atherosclerosis on angiography was quantified by computer-assisted image analysis . RESULTS Mean ( + /- SD ) baseline characteristics were age 62 + /- 7 years , plasma total cholesterol concentration 187 + /- 31 mg/dl ( 4.83 + /- 0.80 mmol/liter ) and triglyceride levels 132 + /- 70 mg/dl ( 1.51 + /- 0.80 mmol/liter ) . Fish oil lowered triglyceride levels by 30 % ( p = 0.007 ) but had no significant effects on other plasma lipoprotein levels . At the end of the trial , eicosapentaenoic acid in adipose tissue sample s was 0.91 % in the fish oil group compared with 0.20 % in the control group ( p < 0.0001 ) . At baseline , the minimal lumen diameter of coronary artery lesions ( n = 305 ) was 1.64 + /- 0.76 mm , and percent narrowing was 48 + /- 14 % . Mean minimal diameter of atherosclerotic coronary arteries decreased by 0.104 and 0.138 mm in the fish oil and control groups , respectively ( p = 0.6 between groups ) , and percent stenosis increased by 2.4 % and 2.6 % , respectively ( p = 0.8 ) . Confidence intervals exclude improvement by fish oil treatment of > 0.17 mm , or > 2.6 % . CONCLUSIONS Fish oil treatment for 2 years does not promote major favorable changes in the diameter of atherosclerotic coronary arteries T “ French Paradox ” refers to the observation that the coronary heart disease mortality rate is lower in France than in other industrialized countries with similar prevalences of coronary risk factors.1,2 This paradox has been attributed to frequent consumption of alcohol-containing beverages , which increase highdensity lipoprotein ( HDL ) cholesterol levels and inhibit platelet function.1–7 Several epidemiologic studies suggest that ingestion of red wine , which contains several hundred different types of flavonoids , is more cardioprotective than beer or spirits.1–4 Indeed , the flavonoids found in red wine and purple grape juice ( GJ ) also inhibit platelet aggregation , and in 1 study , were shown to be powerful antioxidants that improved endothelial function.8–10 In that study , however , most subjects were taking vitamin E , so it is unclear if the observed results were due solely to the flavonoids in GJ or a combination of vitamin E and GJ.10 Furthermore , a high dose of GJ was administered ( approximately 8 ml/kg/day ) for only 2 weeks . The purpose of this study was to assess the endothelial function and antioxidant effects of 2 doses of purple GJ alone and in combination with vitamin E for 8 weeks . • • • The institutional review board of the University of Wisconsin Medical School approved this study . All subjects provided informed consent before participation . Twenty-two adults with angiographically documented coronary artery disease were recruited for this study . Subjects were not allowed to take vitamin supplements for 4 weeks before enrollment or during this study , except as prescribed by the research protocol . Subjects also were prohibited from consuming fruit products , tea , or alcoholic beverages during this study . Medications could not be changed during the study . All subjects ingested purple GJ ( Welch ’s 100 % Concord Grape , Concord , Massachusetts ) for 56 days . The first 11 subjects were instructed to drink 8.0 ml/kg of GJ , twice daily . For an average 80-kg person , this was approximately 640 ml/day ( 21 ounces ) of GJ , which contained approximately 112 g of carbohydrate . The next 11 subjects were instructed to drink 4.0 ml/kg of purple GJ , once daily ( low-dose group ) . After 28 days , subjects added vitamin E ( d , l-a-tocopheryl ) 400 IU to their daily intake of GJ . Subjects ’ diaries indicated .90 % compliance with GJ and vitamin E. Endothelial function was evaluated by measuring flow-mediated vasodilation ( FMD ) of the brachial artery using B-mode ultrasound . Studies were performed at baseline and at subsequent visits on the morning of phlebotomy , after a 12-hour fast . Subjects were instructed to drink their daily dose of GJ at least 2 hours before testing . Brachial artery diameters and blood flows were measured with a 7.5-MHz linear array vascular ultrasound transducer and an Agilent Technologies 5500 Sonos ultrasound system ( Palo Alto , California ) . Increased forearm blood flow was induced by inflating a blood pressure tourniquet around the widest part of the forearm to a systolic blood pressure of 250 mm Hg for 4.5 minutes . Repeat brachial artery diameter and blood flow scans were obtained immediately and 1 minute after deflation of the tourniquet . Resting brachial artery diameter and blood flow scans were repeated 15 minutes later . Sublingual nitroglycerin ( 400 mg ) was administered and final scans were performed after 3 minutes . The brachial artery was imaged in longitudinal sections 2 to 15 cm above the elbow . Images were recorded using the digital storage and retrieval software of the ultrasound system . Vessel diameters were measured in triplicate using digital calipers ( Freel and Systems , Westfield , Indiana ) . Measurements were performed and interpreted by investigators who were blinded to subject information and study date . The brachial artery diameter was measured at end-diastole , using intima-media interfaces , or if they could not be visualized , media-adventitia interfaces , as l and marks . FMD was calculated as the ratio of the brachial artery diameter after reactive hyperemia to the baseline diameter , expressed as a percent change . Nitroglycerinmediated vasodilation was calculated in an analogous fashion . In this laboratory , intraobserver reliability for measurement of the brachial artery diameter is 0.987 , reflecting an interclass correlation coefficient across all readings and conditions.10 Lipid and glucose levels were measured using enzymatic techniques on a Hitachi 747 analyzer ( Tokyo , Japan ) using st and ard reagents ( Roche , Mannheim , Germany ) . Insulin levels were measured by radioimmunoassay . Low-density lipoprotein ( LDL ) particles were isolated from serum by sequential density ultracentrifugation between densities of 1.006 and 1.063 g/ml using a Beckman Optima ultracentrifuge ( Fullerton , California ) at 100,000 rpm ( .400,000 g ) . The LDL-containing fraction was desalted with a 2-ml column of preswollen 12 % cellulose and 0.1 mol/L From the University of Wisconsin Medical School , Madison , Wisconsin . This study was supported by an unrestricted grant from Welch ’s Foods , Inc. , Concord , Massachusetts . Dr. Stein ’s address is : Section of Cardiovascular Medicine , University of Wisconsin Medical School , 600 Highl and Avenue , H6/315 CSC ( MC 3248 ) , Madison , Wisconsin 53792 . E-mail : [email protected] . Manuscript received February 21 , 2001 ; revised manuscript received and accepted April 10 , 2001 BACKGROUND Levels of anti-oxidant polyphenols are higher in red than in white wine and are thought to contribute to the reduced cardiovascular risk associated with moderate consumption of wine observed in epidemiological studies . AIM To compare the acute effects of acute ingestion of white and red wine on endothelial function in subjects with coronary artery disease ( CAD ) . METHODS Fourteen subjects with proven CAD were r and omised to consume white and red wine with a light meal in a single blind cross-over study . Flow-mediated dilatation ( FMD ) of the brachial artery was measured using high-resolution ultrasonography . Endothelial function , lipid profile , plasma alcohol and polyphenols were measured at baseline , 60 and 360 min after wine consumption . RESULTS At baseline , FMD was similar ( white wine 1.6 + /- 1.9 % , red wine 1.8 + /- 1.7 % ) . At 360 min after ingestion of wine there was no difference in FMD , which improved nearly threefold after both wines ( white wine 4.7 + /- 2.2 % , red wine 3.4 + /- 2.9 % ; P = 0.002 ) . There was no detectable change in plasma polyphenol levels after either wine . CONCLUSIONS These data suggest that wine acutely improves endothelial function in patients with CAD . This improved endothelial function might contribute to a reduced risk of cardiovascular events Abstract Elevated plasma homocysteine is associated with increased cardiovascular risk but it remains unproven that the effect is directly causal . Folate and homocysteine metabolism are closely linked such that administration of folic acid in doses ranging from 0.2–10 mg/day lowers plasma total homocysteine ( tHcy ) by up to 25 % . Folic acid has been widely advocated as a therapy which may reduce cardiovascular risk , but the clinical benefit remains as yet unproven and the choice of dose remains unclear . The effect of folic acid on endothelial function has been investigated in patients with proven coronary heart disease ( CHD ) by measuring flow-mediated dilatation ( FMD ) in the brachial artery . Oral folic acid ( 5 mg/day ) markedly enhances endothelial function ( FMD ) and lowers homocysteine . Studies of the acute effects of folic acid have shown that this improvement occurs within the first 2–4 hours following the first dose , at which times there was no significant reduction in plasma tHcy . Administration of 5-methyltetrahydrofolate directly into the brachial artery markedly enhances FMD , an effect that is blocked by monomethyl arginine ( LNMMA ) , suggesting that the effects of folate are mediated by nitric oxide . This Review summarises studies which show that pharmacological doses of folate markedly enhance endothelial function in patients with CHD . The discordance with changes in plasma homocysteine suggests that these effects may occur by mechanisms distinct from homocysteine lowering In several studies , many nutrients in fruits and vegetables , such as dietary fiber , potassium , and antioxidants , have been associated with reduced risk for cardiovascular disease ( 1 - 5 ) . However , as review ed elsewhere ( 6 ) , most prospect i ve studies that have specifically examined intake of fruits and vegetables in relation to risk for cardiovascular disease have been small , and their results have been inconsistent . Dietary assessment s were often crude and available only at baseline , and few studies have examined the effects of specific types of vegetables or fruits . In a recent report ( 7 ) , we evaluated the association between fruit and vegetable intake and risk for ischemic stroke . We found that persons in the highest quintile of fruit and vegetable intake had a relative risk of 0.69 ( 95 % CI , 0.52 to 0.92 ) compared with the lowest quintile of intake ; moreover , a 1-serving/d increase in fruit or vegetable intake was associated with a 6 % lower risk for ischemic stroke , after controlling for st and ard cardiovascular risk factors . In the current study , we sought to evaluate the association between intake of overall and specific fruits and vegetables and incidence of coronary heart disease . Methods Study Sample The sample s for this analysis consisted of participants in the Nurses ' Health Study ( 8) and Health Professionals ' Follow-Up Study ( 1 ) . The two studies have similar design s ; in both , participants complete mailed question naires about medical history , health behaviors , and occurrence of cardiovascular and other outcomes every 2 years . The Nurses ' Health Study began in 1976 , when 121 700 female registered nurses 30 to 55 years of age were recruited ; diet was first assessed in 1980 . Health Professionals ' Follow-up Study participants were recruited in 1986 and comprise 51 529 male health professionals , including dentists , veterinarians , pharmacists , optometrists , osteopaths , and podiatrists , 40 to 75 years of age . Sample for Analysis We excluded participants with incomplete dietary assessment s or with previously diagnosed cancer , diabetes or cardiovascular disease that was reported before the first dietary assessment . We followed 84 251 eligible women during 14 years of follow-up and 42 148 eligible men during 8 years follow-up for incidence of coronary heart disease . The rate of follow-up for nonfatal events was 97 % of the total potential person-years of follow-up in both cohorts . Assessment of Coronary Heart Disease End Points Our primary end point was nonfatal myocardial infa rct ion or fatal coronary disease occurring after return of the 1980 question naire but before 1 June 1994 in women and after return of the 1986 question naire but before 1 January 1994 in men . We sought to review medical records for all such reports . Records were review ed by physicians who were blinded to the participants ' risk factor status . Myocardial infa rct ion was confirmed by using World Health Organization criteria : symptoms plus either diagnostic electrocardiographic changes or elevated levels of cardiac enzymes ( 9 ) . Infa rct ions that required hospital admission and for which confirmatory information was obtained by interview or letter , but for which no medical records were available , were design ated as probable . We included all confirmed and probable cases in our analyses because results were the same after probable cases were excluded . Deaths were identified by using state vital records and the National Death Index or were reported by next of kin and the U.S. postal system . Follow-up for deaths was more than 98 % complete [ 10 ] . Death certificates along with medical records were used to ascertain cause of death . Fatal coronary disease was categorized as definite if 1 ) it was confirmed by hospital record or autopsy or 2 ) coronary disease was listed as the cause of death on the certificate , this was the underlying and most plausible cause , and evidence of previous coronary disease was available . We did not rely on the statement of the cause of death on the death certificate alone as providing sufficient confirmation of death due to coronary heart disease . If no medical records were available , we categorized persons in whom coronary heart disease was the underlying cause on the death certificate as presumed coronary heart disease . Analyses limited to confirmed cases yielded results very similar to those obtained when all cases were included , although with less precision . Persons who experienced sudden death within 1 hour of onset of symptoms and had no plausible cause other than coronary disease were categorized as coronary heart disease cases . Fatal cases of coronary heart disease constituted 30 % of all cases of coronary heart disease among women and 33 % among men . Dietary Assessment Diet was assessed in the Nurses ' Health Study in 1980 , 1984 , 1986 , and 1990 . A 61-item semi-quantitative food-frequency question naire that included 6 fruit items , 11 vegetable items , and 3 potato items was used in 1980 . In 1984 , the question naire was exp and ed to 126 items that covered 15 fruit items and 28 vegetable items plus potatoes ; similar question naires were repeated in 1986 and 1990 . In the Health Professionals ' Follow-up Study , diet was assessed in 1986 and 1990 by using food-frequency question naires very similar to those in the 1984 Nurses ' Health Study question naire . We excluded women who left 10 or more of the 61 items blank or who had implausible scores for total food intake ( < 500 or > 3500 kcal/d ) . Men who left 70 or more of the 131 dietary questions blank or who reported daily caloric intake outside the plausible range of 800 to 4200 calories were also excluded . For each food item , a st and ard serving size was specified . Natural portion sizesfor example , one banana or a small glass of tomato juicewere used whenever possible ; otherwise a weight or volume of that item commonly consumed by the U.S. population at one meal was used . On dietary question naires , participants reported their average intake of the specified portion size ( serving ) for each food over the past year . For each food item on the question naire , nine responses were possible , ranging from never or less than once per month to six or more times per day . Detailed descriptions of the reproducibility and validity of the food frequency question naire for men and women have been published elsewhere ( 11 - 13 ) . Frequencies and portions for the individual food items were converted to average daily intake of each fruit and vegetable item for each participant . The average daily intakes of individual food items were combined to compute total fruit and vegetable intake and intakes of composite fruit and vegetable groups . Definitions of the composite groups ( all fruits , all vegetables , citrus fruit , citrus fruit juice , cruciferous vegetables , green leafy vegetables , vitamin Crich fruits and vegetables , legumes , and potatoes ) were modified for our previous study ( 7 ) by using a report by Steinmetz and colleagues ( 14 ) . Vitamin Crich fruits and vegetables were defined as those containing more than 30 mg of vitamin C per serving . We did not include potatoes , tofu and soybeans , dried beans , and lentils as vegetables ; in addition , condiments such as chili sauce and garlic that had very small portion sizes were not counted in total vegetables . When aggregating items to compute the composite items , we assumed that individual foods for which values were missing implied no intake ( 15 ) . Statistical Analysis We found 1063 incident cases of coronary heart disease among men and 1127 among women . Person-time for each participant was calculated from the date of return of the 1980 question naire in the Nurses ' Health Study or the 1986 question naire in the Health Professionals ' Follow-up Study to the first coronary heart disease event , death , or the cutoff date ( 1 June 1994 for women and 31 January 1994 for men ) , whichever occurred first . We excluded participants who reported cardiovascular disease or cancer or diabetes before completion of the baseline dietary question naires . Each participant contributed only one end point , and the cohort at risk for each 2-year follow-up period included only those who remained free of reported coronary heart disease at the beginning of each follow-up period . The study hypotheses were defined before data were collected . The analyses were performed separately in each cohort because of differences in sex and the question naires administered to the two cohorts . This approach was selected to achieve better control of confounding . We used pooled logistic regression with 2-year follow-up increments ( 16 ) to estimate relative risks ( incidence rate ratios ) and 95 % CIs within each cohort . Analyses were adjusted for age ( 5-year categories ) , smoking ( never , former , or current [ 1 to 14 cigarettes/d , 15 to 24 cigarettes/d , or 25 cigarettes/d ] ) , alcohol consumption ( five categories in women and seven categories in men ) , family history of myocardial infa rct ion ( before 65 years of age in women and before 60 years of age in men ) , body mass index ( quintiles ) ; use of multivitamin supplements , use of vitamin E , use of aspirin , physical activity ( two categories in women and quintiles in men ) , reported hypertension and hypercholesterolemia , total daily caloric intake ( 17 ) , and time period ( each 2-year follow-up period ) . Among women , we also controlled for postmenopausal hormone use . We up date d information on diet and risk factors for coronary heart disease over time to better represent long-term patterns ( 8 , 18 ) . In the Nurses ' Health Study , we used data from the 1980 , 1984 , 1986 , and 1990 question naires , and in the Health Professionals ' Follow-up Study , we used data from the 1986 and 1990 question naires . For each 2-year follow-up period in which events were reported , we computed intake for each composite item as a cumulative average of intake from all available food-frequency question naires up to the start of the follow-up period . For participants who experienced angina , coronary artery bypass graft surgery or Background —Some studies have suggested that tea consumption may be associated with lower mortality among individuals with cardiovascular disease , but the effects of tea consumption on mortality after acute myocardial infa rct ion are unknown . Methods and Results —As part of the Determinants of Myocardial Infa rct ion Onset Study , we performed a prospect i ve cohort study of 1900 patients hospitalized with a confirmed acute myocardial infa rct ion between 1989 and 1994 , with a median follow-up of 3.8 years . Trained interviewers assessed self-reported usual weekly caffeinated tea consumption during the year before infa rct ion with a st and ardized question naire . We compared long-term mortality according to tea consumption using Cox proportional hazards regression . Of the 1900 patients , 1019 consumed no tea ( nondrinkers ) , 615 consumed < 14 cups per week ( moderate tea drinkers ) , and 266 consumed 14 or more cups per week ( heavy tea drinkers ) . Compared with nondrinkers , age- and sex-adjusted mortality was lower among moderate tea drinkers ( hazard ratio , 0.69 ; 95 % CI , 0.53 to 0.89 ) and heavy tea drinkers ( hazard ratio , 0.61 ; 95 % CI , 0.42 to 0.86 ) . Additional adjustment for clinical and sociodemographic characteristics did not appreciably alter this association ( hazard ratio , 0.72 ; 95 % CI , 0.55 to 0.94 for moderate tea drinkers ; hazard ratio , 0.56 ; 95 % CI , 0.37 to 0.84 for heavy tea drinkers ) . The association of tea and mortality was similar for total and cardiovascular mortality . Conclusions —Self-reported tea consumption in the year before acute myocardial infa rct ion is associated with lower mortality after infa rct ion AIMS To examine the acute effect of red wine and de-alcoholized red wine on endothelial function . METHODS AND RESULTS High frequency ultrasound was used to measure blood flow and percentage brachial artery dilatation after reactive hyperaemia induced by forearm cuff occlusion in 12 healthy subjects , less than 40 years of age , without known cardiovascular risk factors . The subjects drank 250 ml of red wine with or without alcohol over 10 min according to a r and omized procedure . Brachial artery dilatation was measured again 30 and 60 min after the subjects had finished drinking . The subjects were studied a second time within a week of the first study in a cross-over design . After the red wine with alcohol the resting brachial artery diameter , resting blood flow , heart rate and plasma-ethanol increased significantly . After the de-alcoholized red wine these parameters were unchanged . Flow-mediated dilatation of the brachial artery was significantly higher ( P<0.05 ) after drinking de-alcoholized red wine ( 5.6+/-3.2 % ) than after drinking red wine with alcohol ( 3.6+/-2.2 % ) and before drinking ( 3.9+/-2.5 % ) . CONCLUSION After ingestion of red wine with alcohol the brachial artery dilated and the blood flow increased . These changes were not observed following the de-alcoholized red wine and were thus attributable to ethanol . These haemodynamic changes may have concealed an effect on flow-mediated brachial artery dilatation which did not increase after drinking red wine with alcohol . Flow-mediated dilatation of the brachial artery increased significantly after de-alcoholized red wine and this finding may support the hypothesis that antioxidant qualities of red wine , rather than ethanol in itself , may protect against cardiovascular disease Background — Moderate drinkers have a lower risk of mortality after myocardial infa rct ion ( MI ) . Although binge drinking has been associated with a higher risk of MI in some studies , its relation to prognosis after MI is uncertain . Methods and Results — In a prospect i ve , inception cohort study conducted at 45 US hospitals , 1935 patients hospitalized with a confirmed MI between 1989 and 1994 underwent detailed personal interviews . Patients reported their usual frequency of binge drinking of beer , wine , and liquor , defined as intake of 3 or more drinks within 1 to 2 hours , and were followed up for mortality for a median of 3.8 years . Of 1919 eligible patients , 250 ( 94 % men ) reported binge drinking during the prior year , and a total of 318 patients died during follow-up . Binge drinkers had a 2-fold higher risk of mortality than drinkers who did not binge ( hazard ratio , 2.0 ; 95 % confidence interval , 1.3 to 3.0 ) . A comparison of 192 binge drinkers and 192 other patients matched on propensity scores yielded a similar result . The association between binge drinking and total mortality tended to be similar among patients whose usual alcohol intake was light or heavier and for binge drinkers who consumed beer , wine , or liquor . Usual alcohol intake was inversely associated with mortality , but binge drinking completely attenuated this relation . Conclusions — Our results suggest that alcohol consumption may be linked to potential hazards among patients who survive acute MI . Although moderate intake has been associated with lower mortality , binge drinking , even among light drinkers , appears to be associated with 2-fold higher mortality OBJECTIVE To examine the effects of alcohol on risk of mortality from coronary heart disease ( CHD ) , cardiovascular disease , and all causes in men with established CHD . METHODS AND RESULTS In a population based prospect i ve study of 7169 men aged 45–64 years followed for a mean of 12.8 years , 655 men ( 9.1 % ) had a physician diagnosis of CHD ( myocardial infa rct ion 455 , angina only 200 ) . In these 655 men , there were 294 deaths from all causes including 175 CHD deaths . Ex-drinkers had the highest risk of CHD , cardiovascular mortality , and all cause mortality even after adjustment for lifestyle characteristics and pre-existing disease . Using occasional drinkers as the reference group , lifelong teetotallers , occasional drinkers , and light drinkers all showed similar risks of mortality from CHD , cardiovascular disease , and all causes . Moderate/heavy drinkers showed increased risk of mortality from CHD , cardiovascular disease , and all causes compared to occasional drinkers . The adverse effect of moderate/heavy drinking was confined to the 455 men with previous myocardial infa rct ion ( adjusted relative risk for all cause mortality 1.50 , 95 % confidence interval 1.01 to 2.23 ) . In contrast to lighter drinking , giving up smoking within five years of the start of follow up was associated with a considerable reduction in risk of all cause and cardiovascular mortality compared to those who continued to smoke . CONCLUSION Compared to occasional drinking , regular light alcohol consumption ( 1–14 units per week ) in men with established coronary heart disease is not associated with any significant benefit or deleterious effect for CHD , cardiovascular disease or all cause mortality . Higher levels of intake ( ⩾ 3 drinks per day ) are associated with increased mortality in men with previous myocardial infa rct ion . In contrast , smoking cessation in men with established CHD substantially reduces the risk of mortality As a result of the Seven Countries Study , the Mediterranean diet has been popularized as a healthy diet . Nevertheless , it has not replaced the prudent diet commonly prescribed to coronary patients . Recently , we completed a secondary , r and omized , prospect i ve prevention trial in 605 patients recovering from myocardial infa rct ion in which we compared an adaptation of the Cretan Mediterranean diet with the usual prescribed diet . After a mean follow-up period of 27 mo , recurrent myocardial infa rct ion , all cardiovascular events , and cardiac and total death were significantly decreased by > 70 % in the group consuming the Mediterranean diet . These protective effects were not related to serum concentrations of total , low-density-lipoprotein ( LDL ) , or high-density-lipoprotein ( HDL ) cholesterol . In contrast , protective effects were related to changes observed in plasma fatty acids : an increase in n-3 fatty acids and oleic acid and a decrease in linoleic acid that result ed from higher intakes of linolenic and oleic acids , but lower intakes of saturated fatty acids and linoleic acid . In addition , higher plasma concentrations of antioxidant vitamins C and E were observed . We conclude that a Cretan Mediterranean diet adapted to a Western population protected against coronary heart disease much more efficiently than did the prudent diet . Thus , it appears that the favorable life expectancy of the Cretans could be largely due to their diet BACKGROUND Epidemiological data suggest that the intake of antioxidants such as alpha-tocopherol ( vitamin E ) and beta-carotene has an inverse correlation with the incidence of coronary heart disease . The results from clinical trials of antioxidant supplementation in people with known coronary heart disease are inconclusive . METHODS We studied the frequency of major coronary events in 1862 men enrolled in the alpha-tocopherol beta-carotene Cancer Prevention Study ( smokers aged between 50 and 69 years ) who had a previous myocardial infa rct ion . In this r and omised , double-blind . placebo-controlled study , men had received dietary supplements of alpha-tocopherol ( 50 mg/day ) , beta-carotene ( 20 mg/day ) , both , or placebo . The median follow-up was 5.3 years . The endpoint of this sub study was the first major coronary event after r and omisation . Analyses were by intention to treat . FINDINGS 424 major coronary events ( non-fatal myocardial infa rct ion and fatal coronary heart disease ) occurred during follow-up . There were no significant differences in the number of major coronary events between any supplementation group and the placebo group ( alpha-tocopherol 94/466 ; beta-carotene 113/461 ; alpha-tocopherol and beta-carotene 123/497 ; placebo 94/438 [ log-rank test , p = 0.25 ] ) . There were significantly more deaths from fatal coronary heart disease in the beta-carotene ( 74/461 , multivariate-adjusted relative risk 1.75 [ 95 % CI 1.16 - 2.64 ] , p = 0.007 ) and combined alpha-tocopherol and beta-carotene groups ( 67/497 , relative risk 1.58 [ 1.05 - 2.40 ] , p = 0.03 ) than in the placebo group ( 39/438 ) , but there was no significant increase in the alpha-tocopherol supplementation group ( 54/466 , relative risk 1.33 [ 0.86 - 2.05 ] , p = 0.20 ) . INTERPRETATION The proportion of major coronary events in men with a previous myocardial infa rct ion who smoke was not decreased with either alpha-tocopherol or beta-carotene supplements . In fact , the risk of fatal coronary heart disease increased in the groups that received either beta-carotene or the combination of alpha-tocopherol and beta-carotene ; there was a non-significant trend of increased deaths in the alpha-tocopherol group . We do not recommend the use of alpha-tocopherol or beta-carotene supplements in this group of patients We hypothesized that n–3 polyunsaturated fatty acids ( n–3 PUFAs ) as compared to corn oil administered for 1 year following an acute myocardial infa rct ion ( MI ) may reduce plasma total homocysteine ( p-tHcy ) , ultrasensitive C-reactive protein ( µCRP ) , and the adhesive properties of the endothelium , expressed as soluble E-selectin ( sE-selectin ) and soluble intercellular adhesion molecule-1 ( sICAM-1 ) . In a prospect i ve , r and omised , double-blind study , 300 acute MI patients were allocated to highly concentrated n–3 PUFAs ( n = 150 ) or corn oil ( n = 150 ) . After 1 year on treatment there was an intergroup difference in p-tHcy in favour of the n–3 group ( n = 118 ) , p = 0.022 . However , sE-selectin , sICAM-1 and µCRP were unaffected by the treatment . In conclusion , reduction of p-tHcy by long-term n–3 PUFAs treatment was not associated with demonstrable effects on markers of endothelial adhesion properties We previously demonstrated that black tea consumption reverses endothelial dysfunction in patients with coronary artery disease . To investigate potential mechanisms of this effect , we examined plasma catechins and systemic markers of oxidation , inflammation , and antioxidant protection from 66 subjects enrolled in that study . We collected sample s at baseline , 2 h after 450 ml of black tea ( acute ) , after 4 weeks of 900 ml of black tea per day ( chronic ) , and after acute and chronic consumption of water . Total catechins increased 33 % after acute tea ( P < 0.05 ) and 29 % after chronic tea ( P < 0.05 ) . Of individual catechins , plasma epicatechin gallate ( ECG ) concentration significantly increased with acute tea consumption , and plasma epicatechin ( EC ) increased with chronic tea consumption . Tea consumption did not improve plasma antioxidant capacity and did not reduce urinary 8-hydroxy-2'-deoxyguanosine , or urinary 8-isoprostane levels . Changes in catechin levels did not correlate with changes in endothelial function , plasma markers of oxidative stress , or C-reactive protein . In contrast , endothelial function at baseline correlated with dietary flavonoid intake ( beta = 0.32 , P = 0.02 ) and with baseline plasma EC concentration after adjusting for confounding variables ( beta = 0.39 , P = 0.03 ) . These findings suggest that the benefits of black tea consumption on endothelial function may not be attributable to tea catechins or a systemic antioxidant or anti-inflammatory effect . Chronic dietary flavonoid status appears to relate to endothelial function , possibly suggesting that other flavonoids or polyphenolic components of tea favorably influence vascular health and risk for cardiovascular disease BACKGROUND There is evidence for increased formation of free radicals in patients with hypertension , raising the possibility that NO is inactivated by free radicals , which impairs coronary endothelial function . Therefore , we tested the hypothesis that the antioxidant vitamin C could improve abnormal endothelial function of coronary arteries in patients with hypertension . METHODS AND RESULTS In 22 hypertensive patients without relevant coronary artery stenoses , endothelium-dependent vascular responses of the left anterior descending coronary artery ( LAD ) to acetylcholine ( 0.01 , 0.1 , and 1.0 micromol/L ) were determined before and immediately after intravenous infusion of 3 g vitamin C ( 17 patients ) or placebo ( 5 patients ) . In a subgroup of 10 patients , papaverine-induced flow-dependent vasodilation ( FDD ) was measured before and after vitamin C ( 5 patients ) or placebo ( 5 patients ) infusion . Segmental responses of the coronary artery luminal area were analyzed with quantitative coronary angiography . Before vitamin C infusion , the mean changes of LAD luminal areas at increasing doses of acetylcholine were -6.1+/-2.2 % , -15.2+/-4.9 % , and -33.9+/-8.1 % ( negative numbers symbolize vasoconstriction ) and during FDD , 5.4+/-1.0 % . The vasoconstrictor response during acetylcholine was reduced and FDD was augmented by vitamin C. After vitamin C infusion , LAD luminal areas changed by -3.2+/-2.3 % , -5.8+/-3.6 % , and -10.2+/-5.6 % ( P<.05 , acetylcholine ) and 17.8+/-2.8 % ( P<.05 , FDD ) . Doppler flow velocity ( during baseline , acetylcholine , and FDD ) was not significantly affected by vitamin C. CONCLUSIONS Vitamin C improves the endothelium-dependent vasomotor capacity of coronary arteries in patients with hypertension and patent coronary arteries . These findings suggest that increased oxidative stress contributes to endothelial dysfunction in hypertensive patients BACKGROUND Cardioprotective effects of omega-3 polyunsaturated fatty acids ( n-3 PUFAs ) of marine origin are well recognized . Because of the shortness of marine re sources vegetable oils are increasingly used in fish farming . The effects on human health of fish fed on vegetable oils are largely unknown . METHODS In a double-blinded intervention study , 60 patients with coronary heart disease ( CHD ) were r and omly allocated to three groups consuming approximately 700 g per week for 6 weeks of differently fed Atlantic salmon : 100 % fish oil ( FO ) , 100 % rapeseed oil ( RO ) or 50 % of each ( FO/RO ) , result ing in fillets with high , intermediate and low levels of marine n-3 PUFAs . Patient analyses before and after the intervention period included serum fatty acid profile , serum lipoproteins , and markers of vascular inflammation . RESULTS The serum fatty acid profiles of the patients after the intervention mirrored those of the corresponding salmon fillets and the respective salmon feeds . Significant differences between the groups were obtained , especially for the levels of total n-3 PUFAs and the n-3/n-6 FA ratio , which were markedly increased in the FO group in contrast to the two other groups ( P < 0.02 for all ) . Additionally , significant reductions of serum triglycerides and of vascular cell adhesion molecule-1 and interleukin-6 were obtained in patients receiving the FO diet when compared with the two other groups ( P < 0.05 for all ) . CONCLUSIONS Tailor-made Atlantic salmon fillets very high in n-3 PUFAs of marine origin seem to impose favourable biochemical changes in patients with CHD when compared with ingestion of fillets with intermediate and low levels of marine n-3 PUFAs , when replaced by rapeseed oil Objective : To see whether mortality among men with angina can be reduced by dietary advice . Design : A r and omized controlled factorial trial . Setting : Male patients of general practitioners in south Wales . Subjects : A total of 3114 men under 70 y of age with angina . Interventions : Subjects were r and omly allocated to four groups : ( 1 ) advised to eat two portions of oily fish each week , or to take three fish oil capsules daily ; ( 2 ) advised to eat more fruit , vegetables and oats ; ( 3 ) given both the above types of advice ; and ( 4 ) given no specific dietary advice . Mortality was ascertained after 3–9 y. Results : Compliance was better with the fish advice than with the fruit advice . All-cause mortality was not reduced by either form of advice , and no other effects were attributable to fruit advice . Risk of cardiac death was higher among subjects advised to take oily fish than among those not so advised ; the adjusted hazard ratio was 1.26 ( 95 % confidence interval 1.00 , 1.58 ; P=0.047 ) , and even greater for sudden cardiac death ( 1.54 ; 95 % CI 1.06 , 2.23 ; P=0.025 ) . The excess risk was largely located among the subgroup given fish oil capsules . There was no evidence that it was due to interactions with medication . Conclusion : Advice to eat more fruit was poorly complied with and had no detectable effect on mortality . Men advised to eat oily fish , and particularly those supplied with fish oil capsules , had a higher risk of cardiac death . This result is unexplained ; it may arise from risk compensation or some other effect on patients ' or doctors ' behaviour . Sponsorship : British Heart Foundation , Seven Seas Limited , Novex Pharma Limited , The Fish Foundation There is evidence that moderate consumption of red wine with its high content of polyphenolic antioxidants may be more protective than white wine against development of coronary artery disease ( CAD ) . The aim of this study was to compare the acute effects of ingestion of red wine and white wine on markers of inflammation in men with CAD . Thirteen men with angiographically-proven CAD were studied in a cross-over trial . The men consumed 4 mL/kg ( 2 to 3 glasses ) red wine and white wine in r and om order during a light meal and with at least a week between interventions . Later , the men also consumed an isoenergetic nonalcoholic beverage ( control ) in the same study protocol . Venous blood was taken at baseline , 1 hour , and 6 hours after the drinks . Plasma interleukin-6 ( IL-6 ) , vascular cell adhesion molecule-1 ( VCAM-1 ) , intercellular adhesion molecule-1 ( ICAM-1 ) , blood alcohol , plasma lipids , and plasma polyphenols were measured . Mean + /- SD blood alcohol was 6.5 + /- 2.2 mmol/L and 6.9 + /- 1.1 mmol/L at 1 hour and returned to baseline at 6 hours after intake of red wine and white wine , respectively . Plasma IL-6 concentration increased significantly ( P = .01 ) during 6 hours after ingestion of red wine ( 56 % ) and white wine ( 63 % ) . The increase in plasma IL-6 concentration after ingestion of wine was significantly higher ( P = .045 ) compared with the corresponding increase ( 11 % ) following intake of the nonalcoholic beverage . Plasma IL-6 levels at 6 hours ( r = .631 , P = .02 ) were correlated significantly with plasma alcohol levels at 1 hour after ingestion of red wine . These data suggest that moderate wine intake may acutely increase plasma levels of IL-6 in men with CAD . It is possible that this increase in plasma IL-6 is a response to alcohol-induced oxidative stress in the liver The influence of a moderate dietary supplementation with omega-3 polyunsaturated fatty acids ( omega-3 PUFAs ) ( 3.4 g eicosapentaenoic and docosahexaenoic acids per day ) for six months on lipopolysaccharide ( LPS ) stimulated monocyte procoagulant activity ( PCA ) was studied in two series of experiments , evaluating the plasma and cellular phases , respectively . In the first series , st and ard cryopreserved monocyte cultures were examined in heparin plasma of atherosclerotic patients ( n = 24 , 12 given omega-3 PUFAs , 12 controls ) . In the second series , monocytes from patients ( n = 32 , 16 given omega-3 PUFAs , 16 controls ) were investigated in a st and ard plasma milieu . Plasma and monocytes were obtained from the test subjects before as well as after six months of omega-3 PUFA supplementation . Monocyte PCA , measured by the formation of fibrinopeptide A , was not significantly different when comparing plasma and monocytes from the subjects supplemented with omega-3 PUFAs with plasma and monocytes , respectively , from the control subjects . In the second series of experiments we also determined the LPS induced release of interleukin-6 ( IL-6 ) , which was not significantly different in the two groups . However , a strong correlation between the stimulated monocyte IL-6 release and PCA was demonstrated ( r = 0.70 , p = 0.00001 ) , probably reflecting an individual inflammatory response pattern BACKGROUND C-reactive protein is an inflammatory marker believed to be of value in the prediction of coronary events . We report data from a large study of C-reactive protein and other circulating inflammatory markers , as well as up date d meta-analyses , to evaluate their relevance to the prediction of coronary heart disease . METHODS Measurements were made in sample s obtained at base line from up to 2459 patients who had a nonfatal myocardial infa rct ion or died of coronary heart disease during the study and from up to 3969 controls without a coronary heart disease event in the Reykjavik prospect i ve study of 18,569 participants . Measurements were made in paired sample s obtained an average of 12 years apart from 379 of these participants in order to quantify within-person fluctuations in inflammatory marker levels . RESULTS The long-term stability of C-reactive protein values ( within-person correlation coefficient , 0.59 ; 95 percent confidence interval , 0.52 to 0.66 ) was similar to that of both blood pressure and total serum cholesterol . After adjustment for base-line values for established risk factors , the odds ratio for coronary heart disease was 1.45 ( 95 percent confidence interval , 1.25 to 1.68 ) in a comparison of participants in the top third of the group with respect to base-line C-reactive protein values with those in the bottom third , and similar overall findings were observed in an up date d meta- analysis involving a total of 7068 patients with coronary heart disease . By comparison , the odds ratios in the Reykjavik Study for coronary heart disease were somewhat weaker for the erythrocyte sedimentation rate ( 1.30 ; 95 percent confidence interval , 1.13 to 1.51 ) and the von Willebr and factor concentration ( 1.11 ; 95 percent confidence interval , 0.97 to 1.27 ) but generally stronger for established risk factors , such as an increased total cholesterol concentration ( 2.35 ; 95 percent confidence interval , 2.03 to 2.74 ) and cigarette smoking ( 1.87 ; 95 percent confidence interval , 1.62 to 2.16 ) . CONCLUSIONS C-reactive protein is a relatively moderate predictor of coronary heart disease . Recommendations regarding its use in predicting the likelihood of coronary heart disease may need to be review ed Background Effects of regular exposure to polyphenolic compounds found in tea , leading to improved endothelial function and blood pressure , may reduce cardiovascular disease risk . Controlled trials in humans have found that ingestion of tea can improve endothelial function , but also cause a rapid onset acute increase in blood pressure . Objective To examine the acute effects of tea consumption on fasting and postpr and ial vascular function and blood pressure . Methods Endothelium-dependent dilatation of the brachial artery , assessed using ultrasound and blood pressure were measured in 20 participants with a history of coronary artery disease . Measurements were performed at baseline and at 3.5 h ( blood pressure ) and 4 h ( endothelial function ) after drinking three cups of black tea or hot water ( consumed at time = 0 , 1.5 and 3 h ) with and without a high-fat ( 50 g ) meal : a total of four treatments administered in r and om order . Results The high-fat meal did not impair endothelial function . In comparison to water alone , endothelium-dependent dilatation was increased by the meal with tea ( 1.7 ( 0.4 , 3.0)% , P = 0.02 ) , but was not significantly altered by the tea alone ( 0.7 ( −0.6 , 2.0)% , P = 0.32 ) . Systolic blood pressure was significantly increased by tea alone in comparison to each of the other three groups : water alone ( 9.3 ( 4.5 , 14.1 ) mmHg , P = 0.0003 ) , meal with water ( 9.8 ( 5.0 , 14.6 ) mmHg , P = 0.0001 ) and meal with tea ( 7.2 ( 2.4,12.0 ) mmHg , P = 0.004 ) . Consumption of a meal negated the acute increase in systolic blood pressure found with tea in the fasting state . Conclusion Consumption of food may alter the acute effects of tea on vascular function and blood pressure OBJECTIVES We sought to conduct a r and omized trial with folic acid 0.5 mg/day in a patient population with stable coronary artery disease ( CAD ) . BACKGROUND Folic acid has favorable effects on vascular endothelium and lowers plasma homocysteine levels . In addition , homocysteine appears to be an independent risk factor for atherosclerotic disease . However , the value of folic acid in secondary prevention had seldom been tested . METHODS In this open-label study , 593 patients were included ; 300 were r and omized to folic acid and 293 served as controls . Mean follow-up time was 24 months . At baseline all patients had been on statin therapy for a mean of 3.2 years . RESULTS In patients treated with folic acid , plasma homocysteine levels decreased by 18 % , from 12.0 + /- 4.8 to 9.4 + /- 3.5 micromol/l , whereas these levels remained unaffected in the control group ( p < 0.001 between groups ) . The primary end point ( all-cause mortality and a composite of vascular events ) was encountered in 31 ( 10.3 % ) patients in the folic acid group and in 28 ( 9.6 % ) patients in the control group ( relative risk 1.05 ; 95 % confidence interval : 0.63 to 1.75 ) . In a multifactorial survival model with adjustments for clinical factors , the most predictive laboratory parameters were , in order of significance , levels of creatinine clearance , plasma fibrinogen , and homocysteine . CONCLUSIONS Within two years , folic acid does not seem to reduce clinical end points in patients with stable coronary artery disease ( CAD ) while on statin treatment . Homocysteine might therefore merely be a modifiable marker of disease . Thus , low-dose folic acid supplementation should be treated with reservation , until more trial outcomes become available CONTEXT Studies have found that individuals who consume 1 alcoholic drink every 1 to 2 days have a lower risk of a first acute myocardial infa rct ion ( AMI ) than abstainers or heavy drinkers , but the effect of prior drinking on mortality after AMI is uncertain . OBJECTIVE To determine the effect of prior alcohol consumption on long-term mortality among early survivors of AMI . DESIGN AND SETTING Prospect i ve inception cohort study conducted at 45 US community and tertiary care hospitals between August 1989 and September 1994 , with a median follow-up of 3.8 years . PATIENTS A total of 1913 adults hospitalized with AMI between 1989 and 1994 . MAIN OUTCOME MEASURE All-cause mortality , compared by self-reported average weekly consumption of beer , wine , and liquor during the year prior to AMI . RESULTS Of the 1913 patients , 896 ( 47 % ) abstained from alcohol , 696 ( 36 % ) consumed less than 7 alcoholic drinks/wk , and 321 ( 17 % ) consumed 7 or more alcoholic drinks/wk . Compared with abstainers , patients who consumed less than 7 drinks/wk had a lower all-cause mortality rate ( 3.4 vs 6.3 deaths per 100 person-years ; hazard ratio [ HR ] , 0.55 ; 95 % confidence interval [ CI ] , 0.43 - 0.71 ) as did those who consumed 7 or more drinks/wk ( 2.4 vs 6.3 deaths per 100 person-years ; HR , 0.38 ; 95 % CI , 0.25 - 0.55 ; P<.001 for trend ) . After adjusting for propensity to drink and other potential confounders , increasing alcohol consumption remained predictive of lower mortality for less than 7 drinks/wk , with an adjusted HR of 0.79 ( 95 % CI , 0.60 - 1.03 ) , and for 7 or more drinks/wk , with an adjusted HR of 0.68 ( 95 % CI , 0.45 - 1.05 ; P = .01 for trend ) . The association was similar for total and cardiovascular mortality , among both men and women , and among different types of alcoholic beverages . CONCLUSION Self-reported moderate alcohol consumption in the year prior to AMI is associated with reduced mortality following infa rct ion We have investigated the effect of fish oil supplementation on the association between serum non-esterified fatty acid ( NEFA ) pattern and atherosclerotic activity . We studied correlations between serum non-esterified very long-chain eicosapentaenoic ( EPA ) , docosahexaenoic acid ( DHA ) and arachidonic acid ( AA ) and biochemical markers of endothelial activation before and after 18-months intervention with fish oil supplementation . The fish oil supplementation consisted of 2.4 g of EPA and DHA per day , with corn oil as placebo . Elderly men ( n = 171 ) with high risk for coronary heart disease were divided into four intervention groups in a factorial design : fish oil supplementation ( n = 44 ) , dietary intervention ( n = 42 ) , fish oil supplementation+dietary intervention ( n = 47 ) or placebo ( n = 38 ) . The composition of fasting NEFA was analysed before and after intervention by GLC . Circulating endothelial markers were analysed by ELISA . A statistically significant positive correlation between the change in serum non-esterified DHA and soluble vascular cell adhesion molecule-1 ( sVCAM-1 ) was found in the pooled group that received fish oil supplementation ( n = 91 ; Spearman 's correlation coefficient r = 0.24 , P = 0.02 ) . No such correlation was found in the pooled group without fish oil supplementation ( n = 80 ) . Furthermore , there was a significant negative correlation between the change in serum non-esterified EPA and the relative change in sVCAM-1 in the group that did not receive fish oil supplementation ( r = -0.34 , P = 0.002 ) . No such correlation was found in the group with fish oil supplementation . We conclude that large increase in serum non-esterified EPA and DHA , which can only be attained by supplementation , might increase inflammation in vascular endothelium . A moderate dietary increase in fish oil intake may , however , have an effect on decreasing inflammatory markers OBJECTIVE Omega-3 polyunsaturated fatty acids ( omega-3 PUFA ) from fish oil slow atherosclerosis progression in coronary arteries , as we showed in a r and omized double-blind placebo-controlled clinical trial . Embedded in this trial , the present study examined the influence of 2 years of dietary supplementation with 1.65 g omega-3 PUFA per day on progression of carotid atherosclerosis in 223 patients with coronary artery disease . METHODS Coronary angiography , a comprehensive clinical examination , and intima-media thickness measurement by B-mode ultrasound of the carotid arteries ( common , internal and bifurcation ) , were performed at the study start and study end . An expert panel visually evaluated the global change of carotid atherosclerosis on a semiquantitative scale . A second outcome measure was the change of overall mean maximum intima-media thickness . RESULTS One hundred and seventy-one patients completed the study . In the global change score , 38 % of the patients in the fish oil group and 35 % in the placebo group showed progression . Global change was not different between intervention groups . Mean maximum intima-media thickness increased by 0.07+/-0.13 mm and 0.05+/-0.11 mm in the fish oil and placebo group , respectively ( mean+/-S.D. , P=0.24 ) . No correlation was found between the change in carotid and coronary arteries . CONCLUSIONS In this group of selected patients with documented coronary artery disease omega-3 PUFA given for 2 years did not demonstrate an effect on slowing progression of atherosclerosis in carotid arteries as measured by ultrasound Omega-3 fatty acids ( n-3 FA ) may reduce atherogenesis and thrombosis . We investigated the effects of n-3 FAs on procoagulant activity and cytokine expression in whole blood cultures from patients with atherosclerosis . Eleven of the 23 included patients had received 5.1 g n-3 FA daily for 6 months ( group I ) whereas 12 patients had been on placebo ( group II ) . All patients were then given 5 . g n-3 FA daily for another 4 weeks . At baseline significantly lower levels of LPS-induced prothrombin fragment1 + 2 were found in group I ( p = 0.010 ) , this difference being eliminated after 4 weeks . Il-6 and TNFalpha were significantly higher at baseline in group I and the differences in changes from baseline between the groups were statistically highly significant with increasing values in group II(Il-6 p = 0.001 , TNF alpha p = 0.002 ) . The present results indicate a reduction in pro-thrombotic potential in patients receiving highly concentrated n-3 FA , whereas some proinflammatory responses might be adverse A r and omised controlled trial with a factorial design was done to examine the effects of dietary intervention in the secondary prevention of myocardial infa rct ion ( MI ) . 2033 men who had recovered from MI were allocated to receive or not to receive advice on each of three dietary factors : a reduction in fat intake and an increase in the ratio of polyunsaturated to saturated fat , an increase in fatty fish intake , and an increase in cereal fibre intake . The advice on fat was not associated with any difference in mortality , perhaps because it produced only a small reduction ( 3 - 4 % ) in serum cholesterol . The subjects advised to eat fatty fish had a 29 % reduction in 2 year all-cause mortality compared with those not so advised . This effect , which was significant , was not altered by adjusting for ten potential confounding factors . Subjects given fibre advice had a slightly higher mortality than other subjects ( not significant ) . The 2 year incidence of reinfa rct ion plus death from ischaemic heart disease was not significantly affected by any of the dietary regimens . A modest intake of fatty fish ( two or three portions per week ) may reduce mortality in men who have recovered from MI BACKGROUND N-3 polyunsaturated fatty acids ( PUFAs ) from oily fish protect against death from cardiovascular disease . We aim ed to assess the hypothesis that incorporation of n-3 and n-6 PUFAs into advanced atherosclerotic plaques increases and decreases plaque stability , respectively . METHODS We did a r and omised controlled trial of patients awaiting carotid endarterectomy . We r and omly allocated patients control , sunflower oil ( n-6 ) , or fish-oil ( n-3 ) capsules until surgery . Primary outcome was plaque morphology indicative of stability or instability , and outcome measures were concentrations of EPA , DHA , and linoleic acid in carotid plaques ; plaque morphology ; and presence of macrophages in plaques . Analysis was per protocol . FINDINGS 188 patients were enrolled and r and omised ; 18 withdrew and eight were excluded . Duration of oil treatment was 7 - 189 days ( median 42 ) and did not differ between groups . The proportions of EPA and DHA were higher in carotid plaque fractions in patients receiving fish oil compared with those receiving control ( absolute difference 0.5 [ 95 % CI 0.3 - 0.7 ] , 0.4 [ 0.1 - 0.6 ] , and 0.2 [ 0.1 - 0.4 ] g/100 g total fatty acids for EPA ; and 0.3 [ 0.0 - 0.8 ] , 0.4 [ 0.1 - 0.7 ] , and 0.3 [ 0.1 - 0.6 ] g/100 g total fatty acids for DHA ; in plaque phospholipids , cholesteryl esters , and triacylglycerols , respectively ) . Sunflower oil had little effect on the fatty acid composition of lipid fractions . Fewer plaques from patients being treated with fish oil had thin fibrous caps and signs of inflammation and more plaques had thick fibrous caps and no signs of inflammation , compared with plaques in patients in the control and sunflower oil groups ( odds ratio 0.52 [ 95 % CI 0.24 - 0.89 ] and 1.19 [ 1.02 - 1.57 ] vs control ; 0.49 [ 0.23 - 0.90 ] and 1.16 [ 1.01 - 1.53 ] vs sunflower oil ) . The number of macrophages in plaques from patients receiving fish oil was lower than in the other two groups . Carotid plaque morphology and infiltration by macrophages did not differ between control and sunflower oil groups . INTERPRETATION Atherosclerotic plaques readily incorporate n-3 PUFAs from fish-oil supplementation , inducing changes that can enhance stability of atherosclerotic plaques . By contrast , increased consumption of n-6 PUFAs does not affect carotid plaque fatty-acid composition or stability over the time course studied here . Stability of plaques could explain reductions in non-fatal and fatal cardiovascular events associated with increased n-3 PUFA intake BACKGROUND It has been suggested that increased intake of various antioxidant vitamins reduces the incidence rates of vascular disease , cancer , and other adverse outcomes . METHODS 20,536 UK adults ( aged 40 - 80 ) with coronary disease , other occlusive arterial disease , or diabetes were r and omly allocated to receive antioxidant vitamin supplementation ( 600 mg vitamin E , 250 mg vitamin C , and 20 mg beta-carotene daily ) or matching placebo . Intention-to-treat comparisons of outcome were conducted between all vitamin-allocated and all placebo-allocated participants . An average of 83 % of participants in each treatment group remained compliant during the scheduled 5-year treatment period . Allocation to this vitamin regimen approximately doubled the plasma concentration of alpha-tocopherol , increased that of vitamin C by one-third , and quadrupled that of beta-carotene . Primary outcomes were major coronary events ( for overall analyses ) and fatal or non-fatal vascular events ( for subcategory analyses ) , with subsidiary assessment s of cancer and of other major morbidity . FINDINGS There were no significant differences in all-cause mortality ( 1446 [ 14.1 % ] vitamin-allocated vs 1389 [ 13.5 % ] placebo-allocated ) , or in deaths due to vascular ( 878 [ 8.6 % ] vs 840 [ 8.2 % ] ) or non-vascular ( 568 [ 5.5 % ] vs 549 [ 5.3 % ] ) causes . Nor were there any significant differences in the numbers of participants having non-fatal myocardial infa rct ion or coronary death ( 1063 [ 10.4 % ] vs 1047 [ 10.2 % ] ) , non-fatal or fatal stroke ( 511 [ 5.0 % ] vs 518 [ 5.0 % ] ) , or coronary or non-coronary revascularisation ( 1058 [ 10.3 % ] vs 1086 [ 10.6 % ] ) . For the first occurrence of any of these " major vascular events " , there were no material differences either overall ( 2306 [ 22.5 % ] vs 2312 [ 22.5 % ] ; event rate ratio 1.00 [ 95 % CI 0.94 - 1.06 ] ) or in any of the various subcategories considered . There were no significant effects on cancer incidence or on hospitalisation for any other non-vascular cause . INTERPRETATION Among the high-risk individuals that were studied , these antioxidant vitamins appeared to be safe . But , although this regimen increased blood vitamin concentrations substantially , it did not produce any significant reductions in the 5-year mortality from , or incidence of , any type of vascular disease , cancer , or other major outcome Long-term dietary omega-3 fatty acids improve coronary endothelial function in CAD patients , heart transplant recipients and diabetics . This study assessed whether short term omega-3 fatty acids affect radial artery function in CAD patients . A high resolution A-mode echotracking device ( NIUS 02 ) was used to measure continuously , radial artery internal diameter at rest , during flow mediated vasodilation ( FMD ) , during cold pressure test ( CPT ) , and after sublingual glyceryl trinitrate ( GTN ) . We studied 18 male CAD patients in a r and omized , double blind , placebo controlled design . Between pre- and post-intervention measurements 24 h apart , nine subjects received 18 g fish oil concentrate ( 6.4 g eicosapentaenoic acid and 3.9 g docosahexaenoic acid ) and nine subjects 18 g placebo . In the placebo group correlation between both baseline diameters was 0.98 ; P < 0.001 . Pre-intervention FMD was 7.5+/-5.6 % , CPT mediated vasoconstriction was 3.8+/-2.5 % , and GTN induced vasodilation was 15.7+/-9.8 % . Vascular responses post-intervention showed no significant difference to pre intervention , there was no significant difference between both treatment groups . The radial artery does not seem to be an immediate target for vasodilatory actions of omega-3 fatty acids OBJECTIVES We assessed the influence of alcohol intake on the development of symptomatic heart failure ( HF ) in patients with left ventricular ( LV ) dysfunction after a myocardial infa rct ion ( MI ) . BACKGROUND In contrast to protection from coronary heart disease , alcohol consumption has been linked to cardiodepressant effects and has been considered contraindicated in patients with HF . METHODS The Survival And Ventricular Enlargement ( SAVE ) trial r and omized 2231 patients with a LV ejection fraction ( EF ) < 40 % following MI to an angiotensin-converting enzyme inhibitor or placebo . Patients were classified as nondrinkers , light-to-moderate drinkers ( 1 to 10 drinks/week ) , or heavy drinkers ( > 10 drinks/week ) based on alcohol consumption reported at baseline . The primary outcome was hospitalization for HF or need for an open-label angiotensin-converting enzyme inhibitor . Analyses were repeated using alcohol consumption reported three months after MI . RESULTS Nondrinkers were older and had more comorbidities than light-to-moderate and heavy drinkers . In univariate analyses , baseline light-to-moderate alcohol intake was associated with a lower incidence of HF compared with nondrinkers ( hazard ratio [ HR ] 0.71 ; 95 % confidence interval [ CI ] 0.57 to 0.87 ) , whereas heavy drinking was not ( HR 0.91 ; 95 % CI 0.67 to 1.23 ) . After adjustment for baseline differences , light-to-moderate baseline alcohol consumption no longer significantly influenced the development of HF ( light-to-moderate drinkers HR 0.93 ; 95 % CI 0.75 to 1.17 ; heavy drinkers HR 1.25 ; 95 % CI 0.91 to 1.72 ) . Alcohol consumption reported three months after the MI similarly did not modify the risk of adverse outcome . CONCLUSIONS In patients with LV dysfunction after an MI , light-to-moderate alcohol intake either at baseline or following MI did not alter the risk for the development of HF requiring hospitalization or an open-label angiotensin-converting enzyme inhibitor BACKGROUND In the setting of atherosclerosis , endothelial vasomotor function is abnormal . Increased oxidative stress has been implicated as one potential mechanism for this observation . We therefore hypothesized that an antioxidant , ascorbic acid , would improve endothelium-dependent arterial dilation in patients with coronary artery disease . METHODS AND RESULTS Brachial artery endothelium-dependent dilation in response to hyperemia was assessed by high-resolution vascular ultrasound before and 2 hours after oral administration of either 2 g ascorbic acid or placebo in a total of 46 patients with documented coronary artery disease . Plasma ascorbic acid concentration increased 2.5-fold 2 hours after treatment ( 46+/-8 to 114+/-11 micromol/L , P=.001 ) . In the prospect ively defined group of patients with an abnormal baseline response ( < 5 % dilation ) , ascorbic acid produced marked improvement in dilation ( 2.0+/-0.6 % to 9.7+/-2.0 % ) , whereas placebo had no effect ( 1.1+/-1.5 % to 1.7+/-1.5 % , P=.003 for ascorbic acid versus placebo ) . Ascorbic acid had no effect on hyperemic flow or arterial dilation to sublingual nitroglycerin . CONCLUSIONS Ascorbic acid reverses endothelial vasomotor dysfunction in the brachial circulation of patients with coronary artery disease . These findings suggest that increased oxidative stress contributes to endothelial dysfunction in patients with atherosclerosis and that endothelial dysfunction may respond to antioxidant therapy BACKGROUND Alcohol consumption has both adverse and beneficial effects on survival . We examined the balance of these in a large prospect i ve study of mortality among U.S. adults . METHODS Of 490,000 men and women ( mean age , 56 years ; range , 30 to 104 ) who reported their alcohol and tobacco use in 1982 , 46,000 died during nine years of follow-up . We compared cause-specific and rates of death from all causes across categories of base-line alcohol consumption , adjusting for other risk factors , and related drinking and smoking habits to the cumulative probability of dying between the ages of 35 and 69 years . RESULTS Causes of death associated with drinking were cirrhosis and alcoholism ; cancers of the mouth , esophagus , pharynx , larynx , and liver combined ; breast cancer in women ; and injuries and other external causes in men . The mortality from breast cancer was 30 percent higher among women reporting at least one drink daily than among nondrinkers ( relative risk , 1.3 ; 95 percent confidence interval , 1.1 to 1.6 ) . The rates of death from all cardiovascular diseases were 30 to 40 percent lower among men ( relative risk , 0.7 ; 95 percent confidence interval , 0.7 to 0.8 ) and women ( relative risk , 0.6 ; 95 percent confidence interval , 0.6 to 0.7 ) reporting at least one drink daily than among nondrinkers , with little relation to the level of consumption . The overall death rates were lowest among men and women reporting about one drink daily . Mortality from all causes increased with heavier drinking , particularly among adults under age 60 with lower risk of cardiovascular disease . Alcohol consumption was associated with a small reduction in the overall risk of death in middle age ( ages 35 to 69 ) , whereas smoking approximately doubled this risk . CONCLUSIONS In this middle-aged and elderly population , moderate alcohol consumption slightly reduced overall mortality . The benefit depended in part on age and background cardiovascular risk and was far smaller than the large increase in risk produced by tobacco Since the first AHA Science Advisory “ Fish Consumption , Fish Oil , Lipids , and Coronary Heart Disease,”1 important new findings , including evidence from r and omized controlled trials ( RCTs ) , have been reported about the beneficial effects of omega-3 ( or n-3 ) fatty acids on cardiovascular disease ( CVD ) in patients with preexisting CVD as well as in healthy individuals.2 New information about how omega-3 fatty acids affect cardiac function ( including antiarrhythmic effects ) , hemodynamics ( cardiac mechanics ) , and arterial endothelial function have helped clarify potential mechanisms of action . The present Statement will address distinctions between plant-derived ( α-linolenic acid , C18:3n-3 ) and marine-derived ( eicosapentaenoic acid , C20:5n-3 [ EPA ] and docosahexaenoic acid , C22:6n-3 [ DHA ] ) omega-3 fatty acids . ( Unless otherwise noted , the term omega-3 fatty acids will refer to the latter . ) Evidence from epidemiological studies and RCTs will be review ed , and recommendations reflecting the current state of knowledge will be made with regard to both fish consumption and omega-3 fatty acid ( plant- and marine-derived ) supplementation . This will be done in the context of recent guidance issued by the US Environmental Protection Agency and the Food and Drug Administration ( FDA ) about the presence of environmental contaminants in certain species of fish . # # # Coronary Heart Disease As review ed by Stone,1 three prospect i ve epidemiological studies within population s reported that men who ate at least some fish weekly had a lower coronary heart disease ( CHD ) mortality rate than that of men who ate none.3–6 ⇓ ⇓ ⇓ More recent evidence that fish consumption favorably affects CHD mortality , especially nonsudden death from myocardial infa rct ion ( MI ) , has been reported in a 30-year follow-up of the Chicago Western Electric Study .7 Men who consumed 35 g or more of fish daily compared with those who consumed none had a relative risk of death from CHD of 0.62 and a relative risk of nonsudden death from MI of 0.33 . In an |
373 | 26,541,320 | Older agents such as 5-fluorouracil , irinotecan , and oxaliplatin provide high-value treatments .
More modern agents targeting the EGFR or VEGF pathways , such as bevacizumab , cetuximab , and panitumumab , do not appear to be cost-effective treatments at their current costs .
Drugs recently approved by the US Food and Drug Administration for mCRC are not cost-effective , and this is primarily driven by high drug costs | To evaluate , from a US payer perspective , the cost-effectiveness of treatment strategies for metastatic colorectal cancer ( mCRC ) , we performed a systematic review of published cost-effectiveness analyses . | BACKGROUND Current estimates of the costs of cancer care in the United States are based on data from 2003 and earlier . However , incidence , survival , and practice patterns have been changing for the majority of cancers . METHODS Cancer prevalence was estimated and projected by phase of care ( initial year following diagnosis , continuing , and last year of life ) and tumor site for 13 cancers in men and 16 cancers in women through 2020 . Cancer prevalence was calculated from cancer incidence and survival models estimated from Surveillance , Epidemiology , and End Results ( SEER ) Program data . Annualized net costs were estimated from recent SEER-Medicare linkage data , which included cl aims through 2006 among beneficiaries aged 65 years and older with a cancer diagnosis . Control subjects without cancer were identified from a 5 % r and om sample of all Medicare beneficiaries residing in the SEER areas to adjust for expenditures not related to cancer . All cost estimates were adjusted to 2010 dollars . Different scenarios for assumptions about future trends in incidence , survival , and cost were assessed with sensitivity analysis . RESULTS Assuming constant incidence , survival , and cost , we projected 13.8 and 18.1 million cancer survivors in 2010 and 2020 , respectively , with associated costs of cancer care of 124.57 and 157.77 billion 2010 US dollars . This 27 % increase in medical costs reflects US population changes only . The largest increases were in the continuing phase of care for prostate cancer ( 42 % ) and female breast cancer ( 32 % ) . Projections of current trends in incidence ( declining ) and survival ( increasing ) had small effects on 2020 estimates . However , if costs of care increase annually by 2 % in the initial and last year of life phases of care , the total cost in 2020 is projected to be $ 173 billion , which represents a 39 % increase from 2010 . CONCLUSIONS The national cost of cancer care is substantial and expected to increase because of population changes alone . Our findings have implication s for policy makers in planning and allocation of re sources Summary Background Therapeutic antibodies targeting EGFR have activity in advanced colorectal cancer , but results from clinical trials are inconsistent and the population in which most benefit is derived is uncertain . Our aim was to assess the addition of panitumumab to irinotecan in pretreated advanced colorectal cancer . Methods In this open-label , r and omised trial , we enrolled patients who had advanced colorectal cancer progressing after fluoropyrimidine treatment with or without oxaliplatin from 60 centres in the UK . From December , 2006 until June , 2008 , molecularly unselected patients were recruited to a three-arm design including irinotecan ( control ) , irinotecan plus ciclosporin , and irinotecan plus panitumumab ( IrPan ) groups . From June 10 , 2008 , in response to new data , the trial was amended to a prospect ively stratified design , restricting panitumumab r and omisation to patients with KRAS wild-type tumours ; the results of the comparison between the irinotcan and IrPan groups are reported here . We used a computer-generated r and omisation sequence ( stratified by previous EGFR targeted therapy and then minimised by centre , WHO performance status , previous oxaliplatin , previous bevacizumab , previous dose modifications , and best previous response ) to r and omly allocate patients to either irinotecan or IrPan . Patients in both groups received 350 mg/m2 intravenous irinotecan every 3 weeks ( 300 mg/m2 if aged ≥70 years or a performance status of 2 ) ; patients in the IrPan group also received intravenous panitumumab 9 mg/kg every 3 weeks . The primary endpoint was overall survival in KRAS wild-type patients who had not received previous EGFR targeted therapy , analysed by intention to treat . Tumour DNA was pyrosequenced for KRASc.146 , BRAF , NRAS , and PIK3CA mutations , and predefined molecular subgroups were analysed for interaction with the effect of panitumumab . This study is registered , number IS RCT N93248876 . Results Between Dec 4 , 2006 , and Aug 31 , 2010 , 1198 patients were enrolled , of whom 460 were included in the primary population of patients with KRASc.12–13,61 wild-type tumours and no previous EGFR targeted therapy . 230 patients were r and omly allocated to irinotecan and 230 to IrPan . There was no difference in overall survival between groups ( HR 1·01 , 95 % CI 0·83–1·23 ; p=0·91 ) , but individuals in the IrPan group had longer progression-free survival ( 0·78 , 0·64–0·95 ; p=0·015 ) and a greater number of responses ( 79 [ 34 % ] patients vs 27 [ 12 % ] ; p<0·0001 ) than did individuals in the irinotecan group . Grade 3 or worse diarrhoea ( 64 [ 29 % ] of 219 patients vs 39 [ 18 % ] of 218 patients ) , skin toxicity ( 41 [ 19 % ] vs none ) , lethargy ( 45 [21]% vs 24 [ 11 % ] ) , infection ( 42 [ 19 % ] vs 22 [ 10 % ] ) and haematological toxicity ( 48 [ 22 % ] vs 27 [ 12 % ] ) were reported more commonly in the IrPan group than in the irinotecan group . We recorded five treatment-related deaths , two in the IrPan group and three in the irinotecan group . Interpretation Adding panitumumab to irinotecan did not improve the overall survival of patients with wild-type KRAS tumours . Further refinement of molecular selection is needed for substantial benefits to be derived from EGFR targeting agents . Funding Cancer Research UK , Amgen PURPOSE We performed this phase III study to compare the irinotecan , leucovorin ( LV ) , and fluorouracil ( FU ) regimen ( FOLFIRI ) versus the oxaliplatin , LV , and FU regimen ( FOLFOX4 ) in previously untreated patients with advanced colorectal cancer . PATIENTS AND METHODS A total of 360 chemotherapy-naive patients were r and omly assigned to receive , every 2 weeks , either arm A ( FOLFIRI : irinotecan 180 mg/m(2 ) on day 1 with LV 100 mg/m(2 ) administered as a 2-hour infusion before FU 400 mg/m(2 ) administered as an intravenous bolus injection , and FU 600 mg/m(2 ) as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [ LV5FU2 ] ) or arm B ( FOLFOX4 : oxaliplatin 85 mg/m(2 ) on day 1 with LV5FU2 regimen ) . RESULTS One hundred sixty-four and 172 patients were assessable in arm A and B , respectively . Overall response rates ( ORR ) were 31 % in arm A ( 95 % CI , 24.6 % to 38.3 % ) and 34 % in arm B ( 95 % CI , 27.2 % to 41.5 % ; P = .60 ) . In both arms A and B , median time to progression ( TTP ; 7 v 7 months , respectively ) , duration of response ( 9 v 10 months , respectively ) , and overall survival ( OS ; 14 v 15 months , respectively ) were similar , without any statistically significant difference . Toxicity was mild in both groups : alopecia and gastrointestinal disturbances were the most common toxicities in arm A ; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms , and no statistical significant difference was observed . CONCLUSION There is no difference in ORR , TTP , and OS for patients treated with the FOLFIRI or FOLFOX4 regimen . Both therapies seemed effective as first-line treatment in these patients . The difference between these two combination therapies is mainly in the toxicity profile This study compared the costs and effects of insecticide (permethrin)-treated bed net ( ITN ) use in children less than five years of age in an area of intense , perennial malaria transmission in western Kenya . The data were derived from a group-r and omized controlled trial of ITNs conducted between 1996 and 1999 . The annual net cost per life-year gained was 34 U.S. dollars and the net annual cost per all-cause sick child clinic visit averted was 49 U.S. dollars . After taking into account a community effect ( protection from malaria afforded to non-ITN users who lived within 300 meters from users ) these estimates decreased to 25 U.S. dollars and 38 U.S. dollars , respectively . This study provides further evidence that ITNs are a highly cost-effective use of scarce health care re sources BACKGROUND To compare the efficacy and safety of pharmacokinetically ( PK ) guided fluorouracil ( 5-FU ) dose adjustment vs. st and ard body-surface-area ( BSA ) dosing in a FOLFOX ( folinic acid , fluorouracil , oxaliplatin ) regimen in metastatic colorectal cancer ( mCRC ) . PATIENTS AND METHODS A total of 118 patients with mCRC were administered individually determined PK-adjusted 5-FU in first-line FOLFOX chemotherapy . The comparison arm consisted of 39 patients , and these patients were also treated with FOLFOX with 5-FU by BSA . For the PK-adjusted arm 5-FU was monitored during infusion , and the dose for the next cycle was based on a dose-adjustment chart to achieve a therapeutic area under curve range ( 5-FU(ODPM Protocol ) ) . RESULTS The objective response rate was 69.7 % in the PK-adjusted arm , and median overall survival and median progression-free survival were 28 and 16 months , respectively . In the traditional patients who received BSA dosage , objective response rate was 46 % , and overall survival and progression-free survival were 22 and 10 months , respectively . Grade 3/4 toxicity was 1.7 % for diarrhea , 0.8 % for mucositis , and 18 % for neutropenia in the dose-monitored group ; they were 12 % , 15 % , and 25 % , respectively , in the BSA group . CONCLUSIONS Efficacy and tolerability of PK-adjusted FOLFOX dosing was much higher than traditional BSA dosing in agreement with previous reports for 5-FU monotherapy PK-adjusted dosing . Analysis of these results suggests that PK-guided 5-FU therapy offers added value to combination therapy for mCRC PURPOSE Severe toxicity is commonly observed in cancer patients receiving irinotecan . UDP-glucuronosyltransferase 1A1 ( UGT1A1 ) catalyzes the glucuronidation of the active metabolite SN-38 . This study prospect ively evaluated the association between the prevalence of severe toxicity and UGT1A1 genetic variation . PATIENTS AND METHODS Sixty-six cancer patients with advanced disease refractory to other treatments received irinotecan 350 mg/m(2 ) every 3 weeks . Toxicity and pharmacokinetic data were measured during cycle 1 . UGT1A1 variants ( -3279G > T , -3156G > A , promoter TA indel , 211G > A , 686C > A ) were genotyped . RESULTS The prevalence of grade 4 neutropenia was 9.5 % . Grade 4 neutropenia was much more common in patients with the TA indel 7/7 genotype ( 3 of 6 patients ; 50 % ) compared with 6/7 ( 3 of 24 patients ; 12.5 % ) and 6/6 ( 0 of 29 patients ; 0 % ) ( P = .001 ) . The TA indel genotype was significantly associated with the absolute neutrophil count nadir ( 7/7 < 6/7 < 6/6 , P = .02 ) . The relative risk of grade 4 neutropenia was 9.3 ( 95 % CI , 2.4 to 36.4 ) for the 7/7 patients versus the rest of the patients . Pretreatment total bilirubin levels ( mean + /- st and ard deviation ) were significantly higher in patients with grade 4 neutropenia ( 0.83 + /- 0.08 mg/dL ) compared to those without grade 4 neutropenia ( 0.47 + /- 0.03 mg/dL ; P < .001 ) . The -3156G > A variant seemed to distinguish different phenotypes of total bilirubin within the TA indel genotypes . The -3156 genotype and the SN-38 area under the concentration versus time curve were significant predictors of ln(absolute neutrophil count nadir ; r(2 ) = 0.51 ) . CONCLUSION UGT1A1 genotype and total bilirubin levels are strongly associated with severe neutropenia , and could be used to identify cancer patients predisposed to the severe toxicity of irinotecan . The hypothesis that the -3156G > A variant is a better predictor of UGT1A1 status than the previously reported TA indel requires further testing |
374 | 26,686,467 | Overall , the evidence supports the idea that children with CU traits do show reductions in both their CU traits and their antisocial behavior , but typically begin treatment with poorer premorbid functioning and can still end with higher levels of antisocial behavior . | BACKGROUND Children and adolescents with callous unemotional ( CU ) traits are at risk of severe and persistent antisocial behavior .
It is commonly assumed that these children are difficult to treat but it has been proposed that they may benefit from being involved in interventions that go beyond typical parent training programs .
This systematic review sought to answer two previously unanswered questions : do interventions involving young people reduce levels of CU traits ?
Do CU traits predict the effectiveness of interventions for antisocial behavior involving young people ? | BACKGROUND Early-starting child conduct problems ( CP ) are linked to the development of persistent antisocial behavior . Research ers have theorized multiple pathways to CP and that CP comprise separable domains , marked by callous-unemotional ( CU ) behavior , oppositional behavior , or ADHD symptoms . However , a lack of empirical evidence exists from studies that have examined whether there are unique correlates of these domains . METHODS We examined differential correlates of CU , oppositional , and ADHD behaviors during the preschool years to test their potentially distinct nomological networks . Multi method data , including parent and teacher reports and observations of child behavior , were drawn from a prospect i ve , longitudinal study of children assessed at age 3 and age 6 ( N = 240 ; 48 % female ) . RESULTS Dimensions of CU , oppositional , and ADHD behaviors were separable within Confirmatory Factor Analyses across mother and father reports . There were differential associations between CU , oppositional , and ADHD behaviors and socioemotional , cognitive , and behavioral outcomes : CU behavior was uniquely related to lower moral regulation , guilt , and empathy . ADHD was uniquely related to lower attentional focusing and observed effortful control . Finally , CU behavior uniquely predicted increases in teacher-reported externalizing from ages 3 - 6 over and above covariates , and ADHD and oppositional behavior . CONCLUSIONS Consistent with theory , dimensions of CU , ADHD , and oppositional behavior demonstrated separable nomological networks representing separable facets within early-starting CP This study examined whether Project Support , a parenting intervention shown to reduce child conduct problems , also exerts positive effects on features of psychopathy in children . Participants were 66 families ( mothers and children ) recruited from domestic violence shelters who participated in a r and omized controlled trial evaluating Project Support . Each family included at least one child between the ages of 4 and 9 who was exhibiting clinical levels of conduct problems . Families were r and omly assigned to the Project Support intervention condition or to an existing services comparison condition , and they were assessed on 6 occasions over 20 months , following their departure from the shelter . Children in families in the Project Support condition , compared with those in the comparison condition , exhibited greater reductions in features of psychopathy . Moreover , the changes in features of psychopathy remained after accounting for changes in conduct problems . Project Support ’s effects on features of psychopathy were mediated by improvements in mothers ’ harsh and inconsistent parenting . These findings on the effects of an intervention on features of psychopathy are the first from a r and omized controlled trial . They inform the debate about whether features of psychopathy in children are responsive to intervention , and hold important implication s for clinical practice The reliability and predictive validity of two experimental self-report versions of two measures of psychopathic features in youth , the Antisocial Process Screening Device ( APSD : Frick & Hare , 2001 ) and a modified version of the Child Psychopathy Scale ( CPS : Lynam , 1997 ) were examined in a sample of 69 arrested youth ( M age = 14.4 years ) referred to a juvenile diversion program . Parents or legal guardians completed parent-rating versions of the same measures . Reliability indicators for the APSD total measure were satisfactory although internal consistency indices ( coefficient alpha ) for the Callous/Unemotional and Impulsive/Conduct Problems scales were slightly lower than desirable . Reliability indicators for the CPS were excellent after deleting items that had poor corrected item-to-CPS total score correlations . Positive and statistically significant correlations for all measures were obtained with prospect i ve measures of program failure ( range 0.22 - 0.36 ) and rearrest at 1 year follow-up ( range 0.33 - 0.56 ) . Although further research is needed prior to the clinical use of these measures , these results signal the potential of such measures to inform clinical judgments regarding treatment compliance and risk with justice-involved youth OBJECTIVE To evaluate the effectiveness and mechanisms of Hitkashrut , a " common elements " co-parent training ( PT ) program for early intervention with preschoolers ( 3 - 5 years of age ) at risk for conduct problems ( CP ) . METHOD A r and omized controlled trial with 140 participants in PT and 69 in a minimal intervention control group . The primary outcome ( presence of CP ) was assessed at pre-intervention , post-intervention , and 1-year follow-up . Callous-unemotional traits , effortful control , parental distress , negative/inconsistent parenting , and couple relationship quality were assessed at pre- and post-intervention , whereas callous-unemotional traits and effortful control were also assessed in the PT group at follow-up . Retention was 87.1 % at post-intervention and 60 % at follow-up . Hitkashrut incorporated evidence -based components of established PT programs into a culturally adapted protocol . The facilitators were trained and supervised psychologists working in Israel 's Educational Psychology Services . RESULTS Intervention effect ( Cohen 's d ) was large at post-intervention ( ES = .76 , p < .001 ) , and an additional medium effect was found at follow-up ( ES = 0.63 , p < .001 ) . Parallel post-intervention and follow-up intervention effects were also found in the degree of clinical ly significant improvements . Effects of the intervention on callous-unemotional traits ( ES = 0.85 , p < .001 ) and effortful control ( ES = 0.47 , p < .001 ) were maintained at follow-up . Follow-up improvement in CP was mediated by improvements in parental practice s and distress . CONCLUSIONS Hitkashrut 's implementation and subsequent dissemination in real-world setting s demonstrates the potential effectiveness of common elements programs to promote innovations within service-delivery systems . Improvements in dispositional variables and the mediated follow-up effect support theoretical cascade models that emphasize early developmental malleability and the growing preventive effects of PT 's facilitated parental changes on disruptive developmental trajectories . Clinical trial registration information - The effect of a " common elements " co-parent training program ( called ' Hitkashrut ' ) on conduct in preschoolers at risk for conduct problems ; http://www.anzctr.org.au ; ACTRN12612000148875 This study examines the treatment outcomes of 139 , 6–11 year-old , clinical ly referred boys and girls diagnosed with Oppositional Defiant Disorder ( ODD ) or Conduct Disorder ( CD ) who were r and omly assigned to a modular-based treatment protocol that was applied by research study clinicians either in the community ( COMM ) or a clinic office ( CLINIC ) . To examine normative comparisons , a matched sample of 69 healthy control children was included . Multiple informants completed diagnostic interviews and self-reports at six assessment timepoints ( pretreatment to 3-year follow-up ) to evaluate changes in the child ’s behavioral and emotional problems , psychopathic features , functional impairment , diagnostic status , and service involvement . Using HLM and logistic regression models , COMM and CLINIC showed significant and comparable improvements on all outcomes . By 3-year follow-up , 36 % of COMM and 47 % of CLINIC patients no longer met criteria for either ODD or CD , and 48 % and 57 % of the children in these two respective conditions had levels of parent-rated externalizing behavior problems in the normal range . We discuss the nature and implication s of these novel findings regarding the role of treatment context or setting for the treatment and long-term outcome of behavior disorders Booster interventions have been presumed to be important methods for maintaining the effects of evidence -based programs for children with behavioral problems , but there has been remarkably little empirical attention to this assumption . The present study examines the effect of a child-oriented booster preventive intervention with children who had previously received an abbreviated version ( 24 child sessions , 10 parent sessions ) of the Coping Power targeted prevention program . Two hundred and forty-one children ( 152 boys , 89 girls ) were screened as having moderate to high levels of aggressive behavior in 4th grade , then half were r and omly assigned to receive the abbreviated Coping Power program in 5th grade , and half of the preventive intervention children were then r and omly assigned to a Booster condition in 6th grade . The Booster sessions consisted of brief monthly individual contacts , and were primarily with the children . Five assessment s across 4 years were collected from teachers , providing a three-year follow-up for all children who participated in the project . Results indicated that the abbreviated Coping Power program ( one-third shorter than the full intervention ) had long-term effects in reducing children ’s externalizing problem behaviors , proactive and reactive aggression , impulsivity traits and callous-unemotional traits . The Booster intervention did not augment these prevention effects . These findings indicate that a briefer and more readily disseminated form of an evidence -based targeted preventive intervention was effective . The findings have potential implication s for policy and guidelines about possible intervention length and booster interventions This study examined dimensions of callous behaviors in early childhood and the role of these behaviors in the development of conduct problems , as well as responsiveness to a family-centered preventative intervention . Caregiver reports of callous behaviors were examined using exploratory and confirmatory factor analysis . Problem behavior was examined using within- and cross-informant reports of these behaviors . Parenting was measured using observational methods within the context of a r and omized control trial of the Family Check-Up with a sample of 731 ethnically diverse boys and girls ( followed from ages 2 to 4 ) at high risk for later conduct problems . Results demonstrated that a measure of deceitful-callous ( DC ) behaviors had acceptable factor loadings and internal consistency at ages 3 and 4 . DC behaviors at age 3 predicted problem behavior concurrently and longitudinally within and across informant . However , DC behaviors did not reduce the effectiveness of the family preventative intervention . These findings have implication s for our underst and ing of behaviors that may precede later callous-unemotional traits and for our underst and ing of the development and prevention of early starting conduct problems Objective The aim of the present study was to determine whether psychopathic traits act as a predictor and /or moderator of the effectiveness of Multisystemic Therapy ( MST ) . Method The sample included N = 256 adolescents ( 188 boys and 68 girls ) referred for conduct problems , r and omized to MST or Treatment As Usual ( TAU ) . The mean age was 16 years ( SD = 1.31 ) . Assessment s were carried out before and immediately after treatment ( 6 months later ) . Three psychopathic traits ( callous/unemotional traits , narcissism , and impulsiveness ) were assessed with parent reports . Adolescents and parents were informants on externalizing problems . Results MST was more effective than TAU in decreasing externalizing problems for the “ lower callous/unemotional ” and “ lower narcissism ” group , but not for the “ high callous/unemotional ” and “ high narcissism ” group ( moderators ) . Impulsiveness was found to predict more post-treatment externalizing problems rated by adolescents ( predictor ) , but not more post-treatment externalizing problems rated by parents . Conclusions These findings point out the clinical relevance of adequately assessing psychopathic traits in adolescents referred for treatment of antisocial behaviour , and identifying those adolescents who show high levels of these traits . It is important to tailor MST specifically to meet the needs of juveniles with high levels of callous/unemotional traits and high levels of narcissism to obtain the same level of effectiveness as with juveniles scoring lower on these traits Impairments in emotion recognition skills are a trans-diagnostic indicator of early mental health problems and may be responsive to intervention . We report on a r and omized controlled trial of " Emotion-recognition-training " ( ERT ) versus treatment-as-usual ( TAU ) with N=195 mixed diagnostic children ( mean age 10.52 years ) referred for behavioral/emotional problems measured at pre- and 6 months post-treatment . We tested overall outcomes plus moderation and mediation models , whereby diagnostic profile was tested as a moderator of change . ERT had no impact on the group as a whole . Diagnostic status of the child did not moderate outcomes ; however , levels of callous-unemotional ( CU ) traits moderated outcomes such that children with high CU traits responded less well to TAU , while ERT produced significant improvements in affective empathy and conduct problems in these children . Emotion recognition training has potential as an adjunctive intervention specifically for clinical ly referred children with high CU traits , regardless of their diagnostic status |
375 | 27,109,087 | The first week of life accounts for most of asphyxia- , prematurity- and malformation-related mortality and one-half of sepsis-related deaths | About 99 % of neonatal deaths occur in low- and middle-income countries . | OBJECTIVE : To determine the primary causes of death in home-cared rural neonates by using prospect ively kept health records of neonates and a neonatologist 's clinical judgment . STUDY DESIGN : In the first year ( 1995 to 1996 ) of the field trial in Gadchiroli , India , trained village health workers observed neonates in 39 villages by attending home deliveries and making eight home visits during days 0 to 28 . The recorded data were vali date d in the field by a physician . An independent neonatologist assigned the most probable single primary cause of death based on these recorded data . FINDINGS : A total of 763 neonates were observed , of whom 40 died ( NMR 52.4/1000 ) . The primary causes of death were sepsis/pneumonia 21 ( 52.5 % ) , asphyxia 8 ( 20 % ) , prematurity < 32 weeks 6 ( 15 % ) , hypothermia 1 ( 2.5 % ) , and other/not known 4 ( 10 % ) . Most of the prematurity or asphyxia deaths occurred during the first 3 days of life . All 21 sepsis/pneumonia deaths occurred during days 4 to 28 . A similar picture existed in Engl and before the antibiotic era . CONCLUSION : Sepsis/pneumonia is the primary cause in half the deaths in rural neonates cared for at home in Gadchiroli , followed by asphyxia and prematurity . Infections cause a larger proportion of deaths in neonates in the community compared to the reported proportion in hospital-based studies Verbal autopsy ( VA ) is used to ascertain cause-specific neonatal mortality using parental/familial recall . We sought to compare agreement between causes of death obtained from the VA by physician review vs. computer-based algorithms . Data were drawn from a cluster-r and omised trial involving 4130 live-born infants and 167 neonatal deaths in the rural Sarlahi District of Nepal . We examined the agreement between causes ascertained by physician review and algorithm assignment by the kappa ( kappa ) statistic . We also compared responses to identical questions posed posthumously during neonatal VA interviews with those obtained during maternal interviews and clinical examinations regarding condition of newborns soon after birth . Physician review ers assigned prematurity or acute lower respiratory infection ( ALRI ) as causes of 48 % of neonatal deaths ; 41 % were assigned as uncertain . The algorithm approach assigned sepsis ( 52 % ) , ALRI ( 31 % ) , birth asphyxia ( 29 % ) , and prematurity ( 24 % ) as the most common causes of neonatal death . Physician review and algorithm assignment of causes of death showed high kappa for prematurity ( 0.73 ) , diarrhoea ( 0.81 ) and ALRI ( 0.68 ) , but was low for congenital malformation ( 0.44 ) , birth asphyxia ( 0.17 ) and sepsis ( 0.00 ) . Sensitivity and specificity of VA interview questions varied by symptom , with positive predictive values ranging from 50 % to 100 % , when compared with maternal interviews and examinations of neonates soon after birth . Analysis of the VA data by physician review and computer-based algorithms yielded disparate results for some causes but not for others . We recommend an analysis technique that combines both methods , and further validation studies to improve performance of the VA for assigning causes of neonatal death Background Three million babies are stillborn each year and 3.6 million die in the first month of life . In India , early neonatal deaths make up four-fifths of neonatal deaths and infant mortality three-quarters of under-five mortality . Information is scarce on cause-specific perinatal and neonatal mortality in urban setting s in low-income countries . We conducted verbal autopsies for stillbirths and neonatal deaths in Mumbai slum settlements . Our objectives were to classify deaths according to international cause-specific criteria and to identify major causes of delay in seeking and receiving health care for maternal and newborn health problems . Methods Over two years , 2005–2007 , births and newborn deaths in 48 slum areas were identified prospect ively by local informants . Verbal autopsies were collected by trained field research ers , cause of death was classified by clinicians , and family narratives were analysed to investigate delays on the pathway to mortality . Results Of 105 stillbirths , 65 were fresh ( 62 % ) and obstetric complications dominated the cause classification . Of 116 neonatal deaths , 87 were early and the major causes were intrapartum-related ( 28 % ) , prematurity ( 23 % ) , and severe infection ( 22 % ) . Bereavement was associated with socioeconomic quintile , previous stillbirth , and number of antenatal care visits . We identified 201 individual delays in 121/187 birth narratives ( 65 % ) . Overall , delays in receiving care after arrival at a health facility dominated and were mostly the result of referral from one institution to another . Most delays in seeking care were attributed to a failure to recognise symptoms of complications or their severity . Conclusions In Mumbai ’s slum settlements , early neonatal deaths made up 75 % of neonatal deaths and intrapartum-related complications were the greatest cause of mortality . Delays were identified in two-thirds of narratives , were predominantly related to the provision of care , and were often attributable to referrals between health providers . There is a need for clear protocol s for care and transfer at each level of the health system , and an emphasis on rapid identification of problems and communication between health facilities . Trial registration IS RCT OBJECTIVE To evaluate the prevalence , sex distribution and causes of neonatal mortality , as well as its risk factors , in an urban Pakistani population with access to obstetric and neonatal care . METHODS Study area women were enrolled at 20 - 26 weeks ' gestation in a prospect i ve population -based cohort study that was conducted from 2003 to 2005 . Physical examinations , antenatal laboratory tests and anthropometric measures were performed , and gestational age was determined by ultrasound to confirm eligibility . Demographic and health data were also collected on pretested study forms by trained female research staff . The women and neonates were seen again within 48 hours postpartum and at day 28 after the birth . All neonatal deaths were review ed using the Pattinson et al. system to assign obstetric and final causes of death ; the circumstances of the death were determined by asking the mother or family and by review ing hospital records . Frequencies and rates were calculated , and 95 % confidence intervals were determined for mortality rates . Relative risks were calculated to evaluate the associations between potential risk factors and neonatal death . Logistic regression models were used to compute adjusted odds ratios . FINDINGS Birth outcomes were ascertained for 1280 ( 94 % ) of the 1369 women enrolled . The 28-day neonatal mortality rate was 47.3 per 1000 live births . Preterm birth , Caesarean section and intrapartum complications were associated with neonatal death . Some 45 % of the deaths occurred within 48 hours and 73 % within the first week . The primary obstetric causes of death were preterm labour ( 34 % ) and intrapartum asphyxia ( 21 % ) . Final causes were classified as immaturity-related ( 26 % ) , birth asphyxia or hypoxia ( 26 % ) and infection ( 23 % ) . Neither delivery in a health facility nor by health professionals was associated with fewer neonatal deaths . The Caesarean section rate was 19 % . Almost all ( 88 % ) neonates who died received treatment and 75 % died in the hospital . CONCLUSION In an urban population with good access to professional care , we found a high neonatal mortality rate , often due to preventable conditions . These results suggest that , to decrease neonatal mortality , improved health service quality is crucial Objective To determine whether training traditional birth attendants to manage several common perinatal conditions could reduce neonatal mortality in the setting of a re source poor country with limited access to healthcare . Design Prospect i ve , cluster r and omised and controlled effectiveness study . Setting Lufwanyama , an agrarian , poorly developed district located in the Copperbelt province , Zambia . All births carried out by study birth attendants occurred at mothers ’ homes , in rural village setting s. Participants 127 traditional birth attendants and mothers and their newborns ( 3559 infants delivered regardless of vital status ) from Lufwanyama district . Interventions Using an unblinded design , birth attendants were cluster r and omised to intervention or control groups . The intervention had two components : training in a modified version of the neonatal resuscitation protocol , and single dose amoxicillin coupled with facilitated referral of infants to a health centre . Control birth attendants continued their existing st and ard of care ( basic obstetric skills and use of clean delivery kits ) . Main outcome measures The primary outcome was the proportion of liveborn infants who died by day 28 after birth , with rate ratios statistically adjusted for clustering . Secondary outcomes were mortality at different time points ; and comparison of causes of death based on verbal autopsy data . Results Among 3497 deliveries with reliable information , mortality at day 28 after birth was 45 % lower among liveborn infants delivered by intervention birth attendants than control birth attendants ( rate ratio 0.55 , 95 % confidence interval 0.33 to 0.90 ) . The greatest reductions in mortality were in the first 24 hours after birth : 7.8 deaths per 1000 live births for infants delivered by intervention birth attendants compared with 19.9 per 1000 for infants delivered by control birth attendants ( 0.40 , 0.19 to 0.83 ) . Deaths due to birth asphyxia were reduced by 63 % among infants delivered by intervention birth attendants ( 0.37 , 0.17 to 0.81 ) and by 81 % within the first two days after birth ( 0.19 , 0.07 to 0.52 ) . Stillbirths and deaths from serious infection occurred at similar rates in both groups . Conclusions Training traditional birth attendants to manage common perinatal conditions significantly reduced neonatal mortality in a rural African setting . This approach has high potential to be applied to similar setting s with dispersed rural population s. Trial registration Clinical trials.gov NCT00518856 Obstetric complications and newborn illnesses amenable to basic medical interventions underlie most perinatal deaths . Yet , despite good access to maternal and newborn care in many transitional countries , perinatal mortality is often not monitored in these setting s. The present study identified risk factors for perinatal death and the level and causes of stillbirths and neonatal deaths in the West Bank and Gaza Strip . Baseline and follow-up censuses with prospect i ve monitoring of pregnant women and newborns from September 2001 to August 2002 were conducted in 83 r and omly selected clusters of 300 households each . A total of 113 of 116 married women 15 - 49 years old with a stillbirth or neonatal death and 813 r and omly selected women with a surviving neonate were interviewed , and obstetric and newborn care records of women with a stillbirth or neonatal death were abstract ed . The perinatal and neonatal mortality rates , respectively , were 21.2 [ 95 % confidence interval ( CI ) 16.5 , 25.9 ] and 14.7 [ 95 % CI 10.2 , 19.2 ] per 1000 livebirths . The most common cause ( 27 % ) of 96 perinatal deaths was asphyxia alone ( 21 ) or with neonatal sepsis ( 5 ) , while 18/49 ( 37 % ) early and 9/19 ( 47 % ) late neonatal deaths were from respiratory distress syndrome ( 12 ) or sepsis ( 9 ) alone or together ( 6 ) . Constraint in care seeking , mainly by an Israeli checkpoint , occurred in 8 % and 10 % , respectively , of 112 pregnancies and labours and 31 % of 16 neonates prior to perinatal or late neonatal death . Poor quality care for a complication associated with the death was identified among 40 % and 20 % , respectively , of 112 pregnancies and labour/deliveries and 43 % of 68 neonates . ( Correction added after online publication 5 June 2008 : The denominators 112 pregnancies , labours , and labour/deliveries , and 16 and 68 neonates were included ; and 9 % of labours was corrected to 10 % . ) Risk factors for perinatal death as assessed by multivariable logistic regression included preterm delivery ( odds ratio [ OR ] = 11.9 , [ 95 % CI 6.7 , 21.2 ] ) , antepartum haemorrhage ( OR = 5.6 , [ 95 % CI 1.5 , 20.9 ] ) , any severe pregnancy complication ( OR = 3.4 , [ 95 % CI 1.8 , 6.6 ] ) , term delivery in a government hospital and having a labour and delivery complication ( OR = 3.8 , [ 95 % CI 1.2 , 12.0 ] ) , more than one delivery complication ( OR = 4.4 , [ 95 % CI 1.8 , 10.5 ] ) , mother 's age > 35 years ( OR = 2.9 , [ 95 % CI 1.3 , 6.8 ] ) and primiparity in a full-term pregnancy ( OR = 2.6 , [ 1.1 , 6.3 ] ) . Stillbirths are not officially reportable in the West Bank and Gaza Strip and this is the first time that perinatal mortality has been examined . Interventions to lower stillbirths and neonatal deaths should focus on improving the quality of medical care for important obstetric complications and newborn illnesses . Other transitional countries can draw lessons for their health care systems from these findings OBJECTIVE To determine population -based neonatal mortality rates in low- and middle-income countries and to examine gestational age , birth weight , and timing of death to assess the potentially preventable neonatal deaths . METHODS A prospect i ve observational study was conducted in communities in five low-income countries ( Kenya , Zambia , Guatemala , India , and Pakistan ) and one middle-income country ( Argentina ) . Over a 2-year period , all pregnant women in the study communities were enrolled by trained study staff and their infants followed to 28 days of age . RESULTS Between October 2009 and March 2011 , 153,728 babies were delivered and followed through day 28 . Neonatal death rates ranged from 41 per 1000 births in Pakistan to 8 per 1000 in Argentina ; 54 % of the neonatal deaths were > 37 weeks and 46 % weighed 2500 g or more . Half the deaths occurred within 24 hours of delivery . CONCLUSION In our population -based low- and middle-income country registries , the majority of neonatal deaths occurred in babies > 37 weeks ' gestation and almost half weighed at least 2500 g. Most deaths occurred shortly after birth . With access to better medical care and hospitalization , especially in the intrapartum and early neonatal period , many of these neonatal deaths might be prevented |
376 | 29,164,754 | Interventions including ANC/ART integration , family-centred approaches , and the use of lay healthcare providers are demonstrably effective in increasing service uptake and retention of HIV-positive mothers and their infants in PMTCT programmes . | OBJECTIVES Despite the success of Prevention of Mother-to-Child Transmission of HIV ( PMTCT ) programmes , low uptake of services and poor retention pose a formidable challenge to achieving the elimination of vertical HIV transmission in low- and middle-income countries .
This systematic review summarises interventions that demonstrate statistically significant improvements in service uptake and retention of HIV-positive pregnant and breastfeeding women and their infants along the PMTCT cascade . | Background Interventions are needed to reduce poor perinatal health . We trained community health workers ( CHWs ) as home visitors to address maternal/infant risks . Methods In a cluster r and omised controlled trial in Cape Town townships , neighbourhoods were r and omised within matched pairs to 1 ) the control , healthcare at clinics ( n = 12 neighbourhoods ; n = 594 women ) , or 2 ) a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks ( by the Philani Maternal , Child Health and Nutrition Programme ) , in addition to clinic care ( n = 12 neighbourhoods ; n = 644 women ) . Participants were assessed during pregnancy ( 2 % refusal ) and 92 % were reassessed at two weeks post-birth , 88 % at six months and 84 % at 18 months later . We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal r and om effects regressions . A binomial test for correlated outcomes evaluated overall effectiveness over time . The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received . Results Benefits were found on 7 of 32 measures of outcomes , result ing in significant overall benefits for the intervention compared to the control when using the binomial test ( p = 0.008 ) ; nevertheless , no effects were observed when only the 18 month outcomes were analyzed . Benefits on individual outcomes were related to the number of home visits received . Among women living with HIV , intervention mothers were more likely to implement the PMTCT regimens , use condoms during all sexual episodes ( OR = 1.25 ; p = 0.014 ) , have infants with healthy weight-for-age measurements ( OR = 1.42 ; p = 0.045 ) , height-for-age measurements ( OR = 1.13 , p<0.001 ) , breastfeed exclusively for six months ( OR = 3.59 ; p<0.001 ) , and breastfeed longer ( OR = 3.08 ; p<0.001 ) . Number of visits was positively associated with infant birth weight ≥2500 grams ( OR = 1.07 ; p = 0.012 ) , healthy head-circumference-for-age measurements at 6 months ( OR = 1.09 , p = 0.017 ) , and improved cognitive development at 18 months ( OR = 1.02 , p = 0.048 ) . Conclusions Home visits to neighbourhood mothers by CHWs may be a feasible strategy for enhancing maternal/child outcomes . However , visits likely must extend over several years for persistent benefits . Trial Registration Clinical Trials.gov Background Clinical evolution of HIV-infected children who have not yet initiated antiretroviral treatment ( ART ) is poorly understood in Africa . We describe severe morbidity and mortality of untreated HIV-infected children . Methods All HIV-infected children enrolled from 2004 - 2009 in a prospect i ve HIV programme in two health facilities in Abidjan , Côte d'Ivoire , were eligible from their time of inclusion . Risks of severe morbidity ( the first clinical event leading to death or hospitalisation ) and mortality were documented retrospectively and estimated using cumulative incidence functions . Associations with baseline characteristics were assessed by competing risk regression models between outcomes and antiretroviral initiation . Results 405 children were included at a median age of 4.5 years ; at baseline , 66.9 % were receiving cotrimoxazole prophylaxis , and 27.7 % met the 2006 WHO criteria for immunodeficiency by age . The risk of developing a severe morbid event was 14 % ( 95%CI : 10.7 - 17.8 ) at 18 months ; this risk was lower in children previously exposed to any prevention of mother-to-child-transmission ( PMTCT ) intervention ( adjusted subdistribution hazard ratio [ sHR ] : 0.16 , 95 % CI : 0.04 - 0.71 ) versus those without known exposure . Cumulative mortality reached 5.5 % ( 95%CI : 3.5 - 8.1 ) at 18 months . Mortality was associated with immunodeficiency ( sHR : 6.02 , 95 % CI : 1.28 - 28.42 ) . Conclusions Having benefited from early access to care minimizes the severe morbidity risk for children who acquire HIV . Despite the receipt of cotrimoxazole prophylaxis , the risk of severe morbidity and mortality remains high in untreated HIV-infected children . Such evidence adds arguments to promote earlier access to ART in HIV-infected children in Africa and improve care interventions in a context where treatment is still not available to all Background The aim of this study was to describe barriers to accessing and accepting highly active antiretroviral therapy ( HAART ) by HIV-positive mothers in the Ug and an Kabarole District 's Programme for the Prevention of Mother to Child Transmission-Plus ( PMTCT-Plus ) . Methods Our study was a qualitative descriptive exploratory study using thematic analysis . Individual in-depth interviews ( n = 45 ) were conducted with r and omly selected HIV-positive mothers who attended this programme , and who : ( a ) never enrolled in HAART ( n = 17 ) ; ( b ) enrolled but did not come back to receive HAART ( n = 2 ) ; ( c ) defaulted/interrupted HAART ( n = 14 ) ; and ( d ) are currently adhering to HAART ( n = 12 ) . A focus group was also conducted to verify the results from the interviews . Results Results indicated that economic concerns , particularly transport costs from residences to the clinics , represented the greatest barrier to accessing treatment . In addition , HIV-related stigma and non-disclosure of HIV status to clients ' sexual partners , long waiting times at the clinic and suboptimal provider-patient interactions at the hospital emerged as significant barriers . Conclusions These barriers to antiretroviral treatment of pregnant and post-natal women need to be addressed in order to improve HAART uptake and adherence for this group of the population . This would improve their survival and , at the same time , drastically reduce HIV transmission from mother to child BACKGROUND The most effective highly active antiretroviral therapy ( HAART ) to prevent mother-to-child transmission of human immunodeficiency virus type 1 ( HIV-1 ) in pregnancy and its efficacy during breast-feeding are unknown . METHODS We r and omly assigned 560 HIV-1-infected pregnant women ( CD4 + count , > or = 200 cells per cubic millimeter ) to receive coformulated abacavir , zidovudine , and lamivudine ( the nucleoside reverse-transcriptase inhibitor [ NRTI ] group ) or lopinavir-ritonavir plus zidovudine-lamivudine ( the protease-inhibitor group ) from 26 to 34 weeks ' gestation through planned weaning by 6 months post partum . A total of 170 women with CD4 + counts of less than 200 cells per cubic millimeter received nevirapine plus zidovudine-lamivudine ( the observational group ) . Infants received single-dose nevirapine and 4 weeks of zidovudine . RESULTS The rate of virologic suppression to less than 400 copies per milliliter was high and did not differ significantly among the three groups at delivery ( 96 % in the NRTI group , 93 % in the protease-inhibitor group , and 94 % in the observational group ) or throughout the breast-feeding period ( 92 % in the NRTI group , 93 % in the protease-inhibitor group , and 95 % in the observational group ) . By 6 months of age , 8 of 709 live-born infants ( 1.1 % ) were infected ( 95 % confidence interval [ CI ] , 0.5 to 2.2 ) : 6 were infected in utero ( 4 in the NRTI group , 1 in the protease-inhibitor group , and 1 in the observational group ) , and 2 were infected during the breast-feeding period ( in the NRTI group ) . Treatment-limiting adverse events occurred in 2 % of women in the NRTI group , 2 % of women in the protease-inhibitor group , and 11 % of women in the observational group . CONCLUSIONS All regimens of HAART from pregnancy through 6 months post partum result ed in high rates of virologic suppression , with an overall rate of mother-to-child transmission of 1.1 % . ( Clinical Trials.gov number , NCT00270296 . Background : Retention in care is critical for improving HIV-infected maternal outcomes and reducing vertical transmission . Health systems ' interventions such as continuous quality improvement ( CQI ) may support health services to address factors that affect the delivery of HIV-related care and thereby influence rates of retention-in-care . Methodology : We evaluated the effect of a CQI intervention on retention-in-care at 6 months postpartum of pregnant women and mothers living with HIV who had been started on lifelong antiretroviral treatment . Thirty-two health care facilities were r and omized to either implement the intervention or not . We considered women fully retained in care when they attended the 6-month postpartum visit and did not miss any previous scheduled visit by more than 30 days . Results : Five hundred eleven women living with HIV attending antenatal clinics at 26 facilities were included in the analysis . Median age at enrolment was 27 years and gestational age was 20 weeks . Seventy-one percent of women were seen at 6-month postpartum irrespective of missing any scheduled visit . However , 43 % of women were fully retained at 6-month postpartum and did not miss any scheduled visit based on our stringent study definition of retention . There was no significant difference in retention at 6 months between the intervention and control arms [ 44 % vs. 41 % , relative risk : 1.08 ; 95 % confidence interval ( CI ) : 0.78 to 1.49 ] . Initiation of ARV prophylaxis among infants within 72 hours was not different by study arm ( 66.0 % vs. 74.7 % , relative risk = 0.95 ; 95 % CI : 0.84 to 1.07 ) but rates of early infant testing at 4–6 weeks were higher in intervention sites ( 48.8 % vs. 25.3 % , adjusted relative risk : 1.76 ; 95 % CI : 1.27 to 2.42 ) . Conclusions : CQI as implemented in this study did not differ across study arms in the rates of retention . Several intervention design or implementation issues or other context ual constraints may explain the absence of effect Causes for loss-to-follow-up , including early refusals of and stopping antiretroviral therapy ( ART ) , in Malawi ’s Option B+ program are poorly understood . This study examines the main barriers and facilitators to uptake and adherence to ART under Option B+ . In depth interviews were conducted with HIV-infected women who were pregnant or postpartum in Lilongwe , Malawi ( N = 65 ) . Study participants included women who refused ART initiation ( N = 10 ) , initiated ART and then stopped ( N = 26 ) , and those who initiated ART and remained on treatment ( N = 29 ) . The barriers to ART initiation were varied and included concerns about partner support , feeling healthy , and needing time to think . The main reasons for stopping ART included side effects and lack of partner support . A substantial number of women started ART after initially refusing or stopping ART . There were several facilitators for re-starting ART , including encouragement from community health workers , side effects subsiding , decline in health , change in partner , and fear of future sickness . Amongst those who remained on ART , desire to prevent transmission and improve health were the most influential facilitators . Reasons for refusing and stopping ART were varied . ART-related side effects and feeling healthy were common barriers to ART initiation and adherence . Providing consistent pre-ART counseling , early support for patients experiencing side effects , and targeted efforts to bring women who stop treatment back into care may improve long term health outcomes Background In rural South Africa , only two-thirds of HIV-positive pregnant women seeking antenatal care at community health centers took full advantage of ‘ prevention of mother-to-child transmission ’ ( PMTCT ) services in 2010 . Studies generally support male involvement to promote PMTCT , but the nature and impact of that involvement is unclear and untested . Additionally , stigma , disclosure and intimate partner violence pose significant barriers to PMTCT uptake and retention in care , suggesting that male involvement may be ‘ necessary , but not sufficient ’ to reduce infant HIV incidence . This study exp and s on a successful United States President 's Emergency Plan for AIDS Relief (PEPFAR)-supported PMTCT couples intervention pilot study conducted in the Mpumalanga province , targeting HIV-positive pregnant women and their partners , the primary objective being to determine whether male partner involvement plus a behavioral intervention will significantly reduce infant HIV incidence . Methods / design The study follows a cluster r and omized controlled design enrolling two cohorts of HIV-positive pregnant women recruited from 12 r and omly assigned Community Health Centers ( CHC ) ( six experimental , six control ) . The two cohorts will consist of women attending without their male partners ( n = 720 ) and women attending with their male partners ( n = 720 couples ) , in order to determine whether the influence of male participation itself , or combined with a behavioral PMTCT intervention , can significantly reduce infant HIV infection ante- , peri- and postnatally . Discussion It is our intention to significantly increase PMTCT participation from current levels ( 69 % ) in the Mpumalanga province to between 90 and 95 % through engaging women and couples in a controlled , six session ante- and postnatal risk-reducing and PMTCT promotion intervention addressing barriers to PMTCT ( such as stigma , disclosure , intimate partner violence , communication , infant feeding practice s and safer conception ) that prevent women and men from utilizing treatment opportunities available to them and their infants . Based upon the encouraging preliminary results from our pilot study , successful CHC adoption of the program could have major public health policy implication s for containing the epidemic among the most vulnerable population s in rural South Africa : HIV-positive pregnant women and their infants . Trial registration Clinical Trials.gov NCT02085356 ( registration date : 10 March 2014 ) The objective of this study was to assess the acceptability and feasibility of a cell phone based case manager intervention targeting HIV-infected pregnant women on highly-active antiretroviral therapy ( HAART ) . Pregnant women ≥36 weeks gestation attending antenatal care and receiving HAART through the Option B+ program at a primary care clinic in South Africa were enrolled into a prospect i ve pilot intervention to receive text messages and telephone calls from a case manager through 6 weeks postpartum . Acceptability and feasibility of the intervention were assessed along with infant HIV testing rates and 10-week and 12-month postpartum maternal retention in care . Retention outcomes were compared to women of similar eligibility receiving care prior to the intervention . Fifty women were enrolled into the pilot from May to July 2013 . Most ( 70 % ) were HAART-naive at time of conception and started HAART during antenatal care . During the intervention , the case manager sent 482 text messages and completed 202 telephone calls , for a median of 10 text messages and 4 calls/woman . Ninety-six percent completed the postpartum interview and 47/48 ( 98 % ) endorsed the utility of the intervention . Engagement in 10-week postpartum maternal HIV care was > 90 % in the pre-intervention ( n = 50 ) and intervention ( n = 50 ) periods ; by 12-months retention fell to 72 % and was the same across periods . More infants received HIV-testing by 10-weeks in the intervention period as compared to pre-intervention ( 90.0 vs. 63.3 % , p < 0.01 ) . Maternal support through a cell phone based case manager approach was highly acceptable among South African HIV infected women on HAART and feasible , warranting further assessment of effectiveness Background : Many HIV-infected pregnant women identified during antenatal care ( ANC ) do not enroll in long-term HIV care , result ing in deterioration of maternal health and continued risk of HIV transmission to infants . Methods : We performed a cluster r and omized trial to evaluate the effect of integrating HIV care into ANC clinics in rural Kenya . Twelve facilities were r and omized to provide either integrated services ( ANC , prevention of mother-to-child transmission , and HIV care delivered in the ANC clinic ; n = 6 intervention facilities ) or st and ard ANC services ( including prevention of mother-to-child transmission and referral to a separate clinic for HIV care ; n = 6 control facilities ) . Results : There were high patient attrition rates over the course of this study . Among study participants who enrolled in HIV care , there was 12-month follow-up data for 256 of 611 ( 41.8 % ) women and postpartum data for only 325 of 1172 ( 28 % ) women . By 9 months of age , 382 of 568 ( 67.3 % ) infants at intervention sites and 338 of 594 ( 57.0 % ) at control sites had tested for HIV [ odds ratio ( OR ) 1.45 , 95 % confidence interval ( CI ) : 0.71 to 2.82 ] ; 7.3 % of infants tested HIV positive at intervention sites compared with 8.0 % of infants at control sites ( OR 0.89 , 95 % CI : 0.56 to 1.43 ) . The composite clinical /immunologic progression into AIDS was similar in both arms ( 4.9 % vs. 5.1 % , OR 0.83 , 95 % CI : 0.41 to 1.68 ) . Conclusions : Despite the provision of integrated services , patient attrition was substantial in both arms , suggesting barriers beyond lack of service integration . Integration of HIV services into the ANC clinic was not associated with a reduced risk of HIV transmission to infants and did not appear to affect short-term maternal health outcomes Objective : To determine the effect of maternal viral load at delivery on the risk of perinatal transmission of HIV-1 . Design : A nested case – control study within a prospect ively followed cohort of HIV- 1-infected pregnant women and their infants . Setting : The multicenter New York City Perinatal HIV Transmission Collaborative Study . Participants : Fifty-one women who gave birth to HIV-1-infected infants were frequency-matched within CD4 + cell count quintiles with 54 non-transmitting mothers . Main outcome measures : Maternal quantity of HIV-1 viral RNA was assayed in plasma obtained near delivery using the nucleic acid sequence-based amplification assay system . Results : Viral RNA was detected in 73 ( 70 % ) out of 105 women and the median viral load was 16 000 RNA copies/ml in transmitters and 6600 in non-transmitters ( P < 0.01 ) . When adjusted for maternal CD4 + count near delivery , women with measurable viral load were nearly sixfold more likely to transmit HIV-1 than women with viral load below detection [ adjusted odds ratio ( AOR ) , 5.8 ; 95 % confidence interval ( CI ) , 2.2–15.5 ] . The odds ratio for perinatal transmission of log10 viral load , adjusted for CD4 count was 2.7 ( 95 % CI , 1.5–5.1 ) . When stratified by the stage of HIV-1 disease , the only group with significant association between log10 viral load and transmission were AIDS-free women with CD4 + count > 500 x 106/l ( AOR , 9.1 ; 95 % CI , 2.6–31.5 ) . Conclusions : High maternal viral load increases the likelihood of perinatal transmission of HIV-1 in women without AIDS and advanced immunosuppression . HIV-1-infected pregnant women without advanced disease , shown by others to have the lowest risk of perinatal transmission , may benefit the most from efforts to identify and decrease viral load at delivery Abstract : In July 2011 , Malawi introduced an ambitious public health program known as “ Option B+ , ” which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy , regardless of clinical stage or CD4 count . Option B+ is expected to have benefits for HIV-infected women , their HIV-exposed infants , and their HIV-uninfected male sex partners . However , these benefits hinge on early uptake of prevention of mother-to-child transmission , good adherence , and long-term retention in care . The Prevention of mother-to-child transmission Uptake and REtention ( PURE ) study is a 3-arm cluster r and omized controlled trial to evaluate whether clinic- or community-based peer support will improve care-seeking and retention in care by HIV-infected pregnant and breastfeeding women , their HIV-exposed infants , and their male sex partners , and ultimately improve health outcomes in all 3 population s. We describe the PURE Malawi Consortium , the initial work conducted to inform the trial and interventions , the trial design , and the analysis plan . We then discuss concerns and expected contributions to Malawi and the region Introduction : Despite the widespread availability of prevention of mother-to-child transmission ( PMTCT ) programs , many women in sub-Saharan Africa do not participate in PMTCT . This pilot study aim ed to utilize partner participation in an intervention to support PMTCT uptake . Methods : Couples ( n = 239 ) were r and omized to receive either a comprehensive couples-based PMTCT intervention or the st and ard of care . Results : Compared to the st and ard of care , participants receiving the intervention increased HIV- and PMTCT-related knowledge ( F 1,474 = 13.94 , p = .004 ) and uptake of PMTCT , as defined by infant medication dosing ( 74 % vs. 46 % , χ2 = 4.69 , p = .03 ) . Discussion : Results indicate that increasing male attendance at antenatal clinic visits may be “ necessary but not sufficient ” to increase PMTCT uptake . Increasing HIV knowledge of both partners and encouraging active male participation in the PMTCT process through psychoeducational interventions may be a strategy to increase the uptake of PMTCT in South Africa Background : Integrating antenatal care ( ANC ) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission ( PMTCT ) cascade . This study aim ed to determine whether integration of HIV services into ANC setting s improves PMTCT service utilization outcomes . Methods : ANC clinics in rural Kenya were r and omized to integrated ( 6 clinics , 569 women ) or nonintegrated ( 6 clinics , 603 women ) services . Intervention clinics provided all HIV services , including highly active antiretroviral therapy ( HAART ) , whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility . PMTCT utilization outcomes among HIV-infected women ( maternal HIV care enrollment , HAART initiation , and 3-month infant HIV testing uptake ) were compared using generalized estimating equations and Cox regression . Results : HIV care enrollment was higher in intervention compared with control clinics [ 69 % versus 36 % ; odds ratio = 3.94 , 95 % confidence interval ( CI ) : 1.14 to 13.63 ] . Median time to enrollment was significantly shorter among intervention arm women ( 0 versus 8 days , hazard ratio = 2.20 , 95 % CI : 1.62 to 3.01 ) . Eligible women in the intervention arm were more likely to initiate HAART ( 40 % versus 17 % ; odds ratio = 3.22 , 95 % CI : 1.81 to 5.72 ) . Infant testing was more common in the intervention arm ( 25 % versus 18 % ) , however , not statistically different . No significant differences were detected in postnatal service uptake or maternal retention . Conclusions : Service integration increased maternal HIV care enrollment and HAART uptake . However , PMTCT utilization outcomes were still suboptimal , and postnatal service utilization remained poor in both study arms . Further improvements in the PMTCT cascade will require additional research and interventions Background : Lifelong antiretroviral therapy ( ART ) is recommended for all HIV-infected pregnant women , but early studies suggest that women often drop out of care postpartum and data are limited on virologic outcomes . Methods : We evaluated viral suppression ( primary outcome ) and retention in care up to 5 years after ART initiation among HIV-infected women who started lifelong ART during pregnancy , irrespective of CD4 count , in a study in rural Ug and a ( NCT00993031 ) . Participants were followed in the study for up to 1 year postpartum , then referred to clinics in surrounding communities . A r and om sample ( N = 200 ) was invited to participate in a cross-sectional follow-up study after completing the trial , involving one visit for a question naire and pregnancy and HIV-1 RNA testing . Retention in care was defined as having attended an HIV clinic in the last 90 days . Logistic regression models were used to examine factors associated with viral suppression ( HIV-1 RNA < 400 copies/ml ) at follow-up . Results : One hundred fifty women ( 75 % ) were successfully contacted for follow-up at a median of 4.2 years after starting ART ; 135 were retained in care [ 90 % , 95 % confidence interval ( CI ) : 84.0 % to 94.3 % ] and 121 demonstrated viral suppression ( 80.7 % , 95 % CI : 73.4 % to 86.7 % ) . Women who had disclosed their HIV status to their primary partner had greater odds of viral suppression ( adjusted odds ratio : 4.51 , 95 % CI : 1.02 to 19.8 ) . Conclusions : High rates of viral suppression can be achieved up to 5 years after initiating ART during pregnancy among women retained in care . Interventions to facilitate disclosure may improve long-term outcomes among women who initiate ART during pregnancy under universal treatment |
377 | 26,075,449 | The available data for the second-line suggest that sunitinib is the best option while in the third line , regorafenib is the best option | ABSTRACT This systematic review aims at assessment of the available evidence for systemic therapy options for patients with advanced gastrointestinal stromal tumors beyond first-line imatinib . | BACKGROUND Imatinib is st and ard therapy for advanced gastrointestinal stromal tumors ( GIST ) , but most patients develop resistance . This phase I-II study assessed the safety and efficacy of co-administering everolimus with imatinib in imatinib-resistant GIST . PATIENTS AND METHODS In phase I , patients received imatinib ( 600/800 mg/day ) combined with weekly ( 20 mg ) or daily ( 2.5/5.0 mg ) everolimus to determine the optimal dose . In phase II , patients were divided into two strata ( progression on imatinib only ; progression after imatinib and sunitinib/other tyrosine kinase inhibitor ) and received everolimus 2.5 mg plus imatinib 600 mg/day . Primary end point was 4-month progression-free survival ( PFS ) . RESULTS Combination treatment was well tolerated . Common adverse events were diarrhea , nausea , fatigue , and anemia . In phase II strata 1 and 2 , 4 of 23 ( 17 % ) and 13 of 35 ( 37 % ) assessable patients , respectively , were progression free at 4 months ; median PFS was 1.9 and 3.5 months , and median overall survival was 14.9 and 10.7 months , respectively . In stratum 1 , 36 % had stable disease ( SD ) and 54 % progressive disease ( PD ) , while in stratum 2 , 2 % had partial response , 43 % SD , and 32 % PD . CONCLUSION Predetermined efficacy criteria were met in both strata . The combination of everolimus and imatinib after failure on imatinib and sunitinib merits further investigation in GIST These findings may potentially influence future clinical practice , with encouraging long-term survival data and better safety of masitinib with respect to sunitinib indicating a positive benefit – risk ratio . Considered in the setting of effective subsequent therapies , data show that adding masitinib to the armaterium of drugs used to treat GIST generates a clinical ly relevant survival benefit Purpose Patients with advanced GIST following st and ard imatinib and sunitinib often have good performance status and need additional therapy . This study tested nilotinib , a second-generation tyrosine kinase inhibitor , in patients with advanced GIST refractory to st and ard therapies . Methods This single-center open-label phase II study has a primary objective to determine progression-free survival at 6 months . Using a novel statistical design , 17 patients were to be enrolled ; if ≥10 were progression free ( PF ) at 2 months , 19 additional patients would be enrolled . The therapy was considered of benefit if ≥13 of 36 patients were PF at 6 months . All patients signed informed consent and entry criteria included normal cardiac function . Exploratory analyses correlating genotype with response were also performed . Results Thirteen patients were treated ; 2 had received agents after imatinib and sunitinib . Treatment was well tolerated with one grade 4 anemia attributed to nilotinib . No measurable responses were observed ; median time to progression was 2 months . One patient remained on study with stable disease for 12 months . Mutation testing is available from 10 primary tumors with 7 exon 11 mutations , 1 exon 9 mutation , and 2 without KIT/PDGFR mutations . Two sample s from recurrent disease had 2 mutations , both primary exon 11 mutations with an additional exon 17 mutation , including the patient with prolonged stable disease . Conclusions Nilotinib was well tolerated in these patients with advanced GIST . Accrual was halted due to insufficient clinical benefit . However , nilotinib may provide benefit to specific subsets of advanced GIST with exon 17 mutations PURPOSE Most gastrointestinal stromal tumors ( GISTs ) harbor mutant KIT or platelet-derived growth factor receptor alpha ( PDGFRA ) kinases , which are imatinib targets . Sunitinib , which targets KIT , PDGFRs , and several other kinases , has demonstrated efficacy in patients with GIST after they experience imatinib failure . We evaluated the impact of primary and secondary kinase genotype on sunitinib activity . PATIENTS AND METHODS Tumor responses were assessed radiologically in a phase I/II trial of sunitinib in 97 patients with metastatic , imatinib-resistant/intolerant GIST . KIT/PDGFRA mutational status was determined for 78 patients by using tumor specimens obtained before and after prior imatinib therapy . Kinase mutants were biochemically profiled for sunitinib and imatinib sensitivity . RESULTS Clinical benefit ( partial response or stable disease for > or = 6 months ) with sunitinib was observed for the three most common primary GIST genotypes : KIT exon 9 ( 58 % ) , KIT exon 11 ( 34 % ) , and wild-type KIT/PDGFRA ( 56 % ) . Progression-free survival ( PFS ) was significantly longer for patients with primary KIT exon 9 mutations ( P = .0005 ) or with a wild-type genotype ( P = .0356 ) than for those with KIT exon 11 mutations . The same pattern was observed for overall survival ( OS ) . PFS and OS were longer for patients with secondary KIT exon 13 or 14 mutations ( which involve the KIT-adenosine triphosphate binding pocket ) than for those with exon 17 or 18 mutations ( which involve the KIT activation loop ) . Biochemical profiling studies confirmed the clinical results . CONCLUSION The clinical activity of sunitinib after imatinib failure is significantly influenced by both primary and secondary mutations in the predominant pathogenic kinases , which has implication s for optimization of the treatment of patients with GIST Purpose This multicenter phase 2 study assessed the tolerability and efficacy of motesanib , an oral inhibitor of Kit , platelet-derived growth factor receptor ( PDGFR ) , and vascular endothelial growth factor receptors ( VEGFR ) , in patients with imatinib-resistant gastrointestinal stromal tumors ( GIST ) . Methods Patients with advanced GIST who failed imatinib mesylate after ≥8 weeks of treatment with ≥600 mg daily received motesanib 125 mg orally once daily continuously for 48 weeks or until unacceptable toxicity or disease progression occurred . The primary endpoint was confirmed objective tumor response per RECIST and independent review . Secondary endpoints included progression-free survival ( PFS ) , time to progression ( TTP ) ; objective response by 18FDG-PET and by changes in tumor size and /or density ( Choi criteria ) ; pharmacokinetics and safety . Results In the patients evaluable for response ( N = 102 ) , the objective response rate was 3 % ; 59 % of patients achieved stable disease , with 14 % achieving durable stable disease ≥24 weeks ; 38 % had disease progression . Higher objective response rates were observed per 18FDG-PET ( N = 91 ) ( 30 % ) and Choi criteria ( 41 % ) . The median PFS was 16 weeks ( 95 % CI = 14–24 weeks ) ; the median TTP was 17 weeks ( 95 % CI = 15–24 weeks ) . The most common motesanib treatment-related grade 3 adverse events included hypertension ( 23 % ) , fatigue ( 9 % ) , and diarrhea ( 5 % ) . Motesanib did not accumulate with daily dosing . Conclusions In this study of patients with imatinib-resistant GIST , motesanib treatment result ed in acceptable tolerability and modest tumor control as evident in the proportion of patients who achieved stable disease and durable stable disease AIMS To assess the antitumour activity , safety , pharmacokinetics and pharmacodynamics of continuous daily sunitinib dosing in patients with imatinib-resistant/intolerant gastrointestinal stromal tumour ( GIST ) and to assess morning dosing versus evening dosing . PATIENTS AND METHODS In this open-label phase II study , patients were r and omised to receive morning or evening dosing of sunitinib 37.5mg/day . The primary end-point was clinical benefit rate ( CBR ; percent complete responses+partial responses [PRs]+stable disease [ SD ] 24 weeks ) . Secondary end-points included progression-free survival ( PFS ) , overall survival ( OS ) , safety , pharmacokinetic parameters and plasma biomarker levels . RESULTS Sixty of 61 planned patients received treatment ( 30 per dosing group ) ; 26 completed the study . Overall , the CBR was 53 % ( 95 % exact CI , 40 - 66 ) : eight patients ( 13 % ) achieved objective PRs ; 24 ( 40 % ) achieved SD 24 weeks . Median PFS was 34 weeks ( 95 % CI , 24 - 49 ) ; median OS was 107 weeks ( 95 % CI , 72 - not yet calculable ) . Most adverse events ( AEs ) were of grade 1 or 2 in severity , and were manageable through dose modification or st and ard interventions . No new AEs were apparent compared with the approved intermittent dosing schedule . Antitumour activity and safety were generally similar with morning and evening dosing . Continuous daily sunitinib dosing achieved and sustained effective drug concentrations without additional accumulation across cycles . Decreases from baseline in plasma levels of soluble KIT after 20 and 24 weeks of dosing correlated with longer OS . CONCLUSION For patients with imatinib-resistant/intolerant GIST , continuous daily sunitinib dosing appears to be an active alternative dosing strategy with acceptable safety BACKGROUND HSP90 inhibition leads to proteosomal degradation of activated KIT and has in vitro activity against gastrointestinal stromal tumors ( GIST ) . BIIB021 is an oral non-ansamycin HSP90 inhibitor . We carried out a phase II study of BIIB021 in patients with GIST refractory to imatinib and sunitinib . PATIENTS AND METHODS The primary end-point was metabolic partial response ( mPR ) as assessed by fluorodeoxyglucose positron emission tomography ( FDG-PET ) . The secondary end-points were pharmacokinetic assessment s of BIIB021 and pharmacodynamic assessment s of HSP70 . Twenty-three patients were treated on two schedules : 12 pts received 600 mg twice a week ( BIW ) and 11 patients received 400 mg three times a week ( TIW ) . All had prior imatinib and sunitinib but stopped>14 days before starting BIIB021 . RESULTS The median age was 59 years ( 33 - 88 years ) , 61 % male , 44 % Eastern Cooperative Oncology Group 1 ( ECOG1 ) . The best response was PR by FDG-PET for five patients ( 3/12 at 600 mg BIW and 2/9 at 400 TIW ) for an overall response rate of 22 % . The response duration was 25 - 138 days . Adverse events ( AEs ) were mild to moderate . The mean Cmax was 1.5 µmol and the mean AUC was 2.9 µmol h. Cmax>1.5 µmol was associated with a decrease in st and ardized uptake value ( SUVmax ) . HSP70 increased substantially following treatment . CONCLUSIONS This study met its primary end-point . BIIB021 leads to objective responses in refractory GIST patients . Pharmacodynamic studies confirmed HSP90 inhibition . Further evaluation of BIIB021 in GIST is warranted BACKGROUND Advanced GISTs are incurable , but often treatable for years with tyrosine kinase inhibitors ( TKIs ) . The majority of GISTs harbor an oncogenic activating mutation in KIT or PDGFRA . Inhibition of this activating mutation with TKIs most often leads to durable disease control for many patients . However , almost all patients develop resistance to these TKIs , typically due to the development of secondary mutations , heralding the need for new therapeutic options . We conducted a phase II study evaluating the efficacy and toxicity of pazopanib , a broad spectrum TKI inhibiting KIT , VEGFRs ( -1 , -2 , and -3 ) , and PDGFR ( -α and -β ) in patients with advanced GIST following failure of at least imatinib and sunitinib . METHODS Patients received pazopanib 800 mg orally once daily . All patients were assessed for efficacy with CT scans every 8 weeks ( two cycles ) . Patients continued pazopanib until progression or unacceptable toxicity . The primary end point was the 24-week nonprogression [ complete response+partial response+stable disease ( SD ) ] rate ( NPR ) per RECIST 1.1 . Secondary end points included PFS , OS , and toxicity . RESULTS Between August 2011 and September 2012 , a total of 25 patients were treated at two institutions . Median number of prior therapy was 3 ( range 2 - 7 ) . A total of 90 cycles of pazopanib were administered , with a median of two cycles ( range 1 to 17 + ) per patient . Best response of SD at any time was observed in 12 ( 48 % ) patients . The NPR was 17 % [ 95 % confidence interval ( CI ) 4.5 - 37 ] . All but one patient discontinued protocol either due to PD ( n = 19 ) or intolerance ( n = 4 ) . One patient with succinate dehydrogenase (SDH)-deficient GIST exhibited continuing disease control after 17 cycles . The median PFS for the entire cohort was 1.9 months ( 95 % CI 1.6 - 5.2 ) , and the median OS was 10.7 months ( 95 % CI 3.9-NR ) . CONCLUSIONS Pazopanib was reasonably well tolerated with no unexpected toxicities . Pazopanib as a single agent has marginal activity in unselected heavily pretreated patients with advanced GIST BACKGROUND This phase III open-label trial investigated the efficacy of nilotinib in patients with advanced gastrointestinal stromal tumors following prior imatinib and sunitinib failure . PATIENTS AND METHODS Patients were r and omized 2:1 to nilotinib 400 mg b.i.d . or best supportive care ( BSC ; BSC without tyrosine kinase inhibitor , BSC+imatinib , or BSC+sunitinib ) . Primary efficacy end point was progression-free survival ( PFS ) based on blinded central radiology review ( CRR ) . Patients progressing on BSC could cross over to nilotinib . RESULTS Two hundred and forty-eight patients enrolled . Median PFS was similar between arms ( nilotinib 109 days , BSC 111 days ; P=0.56 ) . Local investigator-based intent-to-treat ( ITT ) analysis showed a significantly longer median PFS with nilotinib ( 119 versus 70 days ; P=0.0007 ) . A trend in longer median overall survival ( OS ) was noted with nilotinib ( 332 versus 280 days ; P=0.29 ) . Post hoc subset analyses in patients with progression and only one prior regimen each of imatinib and sunitinib revealed a significant difference in median OS of > 4 months in favor of nilotinib ( 405 versus 280 days ; P=0.02 ) . Nilotinib was well tolerated . CONCLUSION In the ITT analysis , no significant difference in PFS was observed between treatment arms based on CRR . In the post hoc subset analyses , nilotinib provided significantly longer median OS Purpose : Cediranib is a potent VEGF signaling inhibitor with activity against all three VEGF receptors and KIT . This phase II study evaluated the antitumor activity of cediranib in patients with metastatic gastrointestinal stromal tumor ( GIST ) resistant/intolerant to imatinib , or metastatic soft-tissue sarcomas ( STS ; Clinical Trials.gov , NCT00385203 ) . Experimental Design : Patients received cediranib 45 mg/day . Primary objective was to determine the antitumor activity of cediranib according to changes in 2[18F]fluoro-2-deoxy-D-glucose positron emission tomography ( 18FDG-PET ) tumor uptake in patients with GIST using maximum st and ardized uptake values ( SUVmax ) . Secondary objectives included objective tumor response and tolerability in patients with GIST/STS . Results : Thirty-four of 36 enrolled patients were treated ( GIST n = 24 ; STS n = 10 ) . At day 29 , five patients had confirmed decreases in SUVmax ( ≥10 % from day 8) and two had confirmed partial metabolic responses ( ≥25 % decrease ) , but arithmetic mean percentage changes in SUVmax , averaged across the cohort , were not significant at day 8 [ 6.8 % ; 95 % confidence interval ( CI ) , 19.95–33.54 ) or day 29 ( 4.6 % ; 95 % CI , 8.05–17.34 ) . Eleven patients with GIST achieved a best objective tumor response of stable disease ; eight achieved stable disease ≥16 weeks . In patients with STS , four of six with alveolar soft-part sarcoma ( ASPS ) achieved confirmed and durable partial responses . The commonest adverse events were diarrhea ( 85 % ) , fatigue ( 74 % ) , and hypertension ( 68 % ) . Conclusions : In patients progressing on imatinib/sunitinib , cediranib 45 mg/day demonstrated evidence of activity by 18FDG-PET , but did not reduce average SUVmax . Evidence of antitumor activity was seen in ASPS . Clin Cancer Res ; 20(13 ) ; 3603–12 . © 2014 AACR Patients with gastrointestinal stromal tumors ( GISTs ) resistant to both imatinib and sunitinib have a poor prognosis and few therapeutic options . In this study , the efficacy and safety of nilotinib ( AMN107 ) as a third‐line therapy for patients with GISTs was evaluated BACKGROUND No effective therapeutic options for patients with unresectable imatinib-resistant gastrointestinal stromal tumour are available . We did a r and omised , double-blind , placebo-controlled , multicentre , international trial to assess tolerability and anticancer efficacy of sunitinib , a multitargeted tyrosine kinase inhibitor , in patients with advanced gastrointestinal stromal tumour who were resistant to or intolerant of previous treatment with imatinib . METHODS Blinded sunitinib or placebo was given orally once daily at a 50-mg starting dose in 6-week cycles with 4 weeks on and 2 weeks off treatment . The primary endpoint was time to tumour progression . Intention-to-treat , modified intention-to-treat , and per- protocol analyses were done . This study is registered at Clinical Trials.gov , number NCT00075218 . FINDINGS 312 patients were r and omised in a 2:1 ratio to receive sunitinib ( n=207 ) or placebo ( n=105 ) ; the trial was unblinded early when a planned interim analysis showed significantly longer time to tumour progression with sunitinib . Median time to tumour progression was 27.3 weeks ( 95 % CI 16.0 - 32.1 ) in patients receiving sunitinib and 6.4 weeks ( 4.4 - 10.0 ) in those on placebo ( hazard ratio 0.33 ; p<0.0001 ) . Therapy was reasonably well tolerated ; the most common treatment-related adverse events were fatigue , diarrhoea , skin discolouration , and nausea . INTERPRETATION We noted significant clinical benefit , including disease control and superior survival , with sunitinib compared with placebo in patients with advanced gastrointestinal stromal tumour after failure and discontinuation of imatinab . Tolerability was acceptable Purpose : Heat shock protein 90 ( HSP90 ) is required for the proper folding , function , and stability of various client proteins , two of which ( KIT and PDGFRα ) are critical in the pathogenesis and progression of gastrointestinal stromal tumors ( GIST ) . This phase I study investigated the safety and maximum tolerated dose ( MTD ) of retaspimycin hydrochloride ( IPI-504 ) , a novel potent and selective HSP90 inhibitor , in patients with metastatic and /or unresectable GIST or other soft-tissue sarcomas ( STS ) . Experimental Design : IPI-504 was administered intravenously at doses ranging from 90 to 500 mg/m2 twice weekly for 2 weeks on/1 week off . Safety , pharmacokinetic , and pharmacodynamic profiles were determined . Response was assessed by Response Evaluation Criteria for Solid Tumors ( RECIST ) 1.0 and optionally via 18-fluorodeoxyglucose positron emission tomography ( 18-FDG-PET ) imaging . Results : Fifty-four patients received IPI-504 ; 37 with GIST and 17 with other STS . The MTD was 400 mg/m2 twice weekly for 2 weeks on/1 week off . Common related adverse events were fatigue ( 59 % ) , headache ( 44 % ) , and nausea ( 43 % ) . Exposure to IPI-504 , 17-AAG , and 17-AG increased with IPI-504 dose . Stable disease ( SD ) was observed in 70 % ( 26 of 37 ) of patients with GIST and 59 % ( 10 of 17 ) of patients with STS . There was one confirmed partial response ( PR ) in a patient with GIST and one PR in a patient with liposarcoma . Metabolic partial responses occurred in 11 of 29 ( 38 % ) patients with GIST . Conclusions : In this study of advanced GIST or other STS , IPI-504 was generally well-tolerated with some evidence of antitumor activity , serving as a clinical proof-of-concept that HSP90 inhibition remains a promising strategy . Clin Cancer Res ; 19(21 ) ; 6020–9 . © 2013 AACR BACKGROUND Until now , only imatinib and sunitinib have proven clinical benefit in patients with gastrointestinal stromal tumours ( GIST ) , but almost all metastatic GIST eventually develop resistance to these agents , result ing in fatal disease progression . We aim ed to assess efficacy and safety of regorafenib in patients with metastatic or unresectable GIST progressing after failure of at least imatinib and sunitinib . METHODS We did this phase 3 trial at 57 hospitals in 17 countries . Patients with histologically confirmed , metastatic or unresectable GIST , with failure of at least previous imatinib and sunitinib were r and omised in a 2:1 ratio ( by computer-generated r and omisation list and interactive voice response system ; preallocated block design ( block size 12 ) ; stratified by treatment line and geographical region ) to receive either oral regorafenib 160 mg daily or placebo , plus best supportive care in both groups , for the first 3 weeks of each 4 week cycle . The study sponsor , participants , and investigators were masked to treatment assignment . The primary endpoint was progression-free survival ( PFS ) . At disease progression , patients assigned placebo could crossover to open-label regorafenib . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT01271712 . RESULTS From Jan 4 , to Aug 18 , 2011 , 240 patients were screened and 199 were r and omised to receive regorafenib ( n=133 ) or matching placebo ( n=66 ) . Data cutoff was Jan 26 , 2012 . Median PFS per independent blinded central review was 4·8 months ( IQR 1·4 - 9·2 ) for regorafenib and 0·9 months ( 0·9 - 1·8 ) for placebo ( hazard ratio [ HR ] 0·27 , 95 % CI 0·19 - 0·39 ; p<0·0001 ) . After progression , 56 patients ( 85 % ) assigned placebo crossed over to regorafenib . Drug-related adverse events were reported in 130 ( 98 % ) patients assigned regorafenib and 45 ( 68 % ) patients assigned placebo . The most common regorafenib-related adverse events of grade 3 or higher were hypertension ( 31 of 132 , 23 % ) , h and -foot skin reaction ( 26 of 132 , 20 % ) , and diarrhoea ( seven of 132 , 5 % ) . INTERPRETATION The results of this study show that oral regorafenib can provide a significant improvement in progression-free survival compared with placebo in patients with metastatic GIST after progression on st and ard treatments . As far as we are aware , this is the first clinical trial to show benefit from a kinase inhibitor in this highly refractory population of patients . FUNDING Bayer HealthCare Pharmaceuticals In the EORTC-ISG-AGITG trial 946 patients with advanced gastro-intestinal stromal tumours ( GIST ) were r and omised to receive 400 or 800 mg of imatinib daily . An increase in progression free survival ( PFS ) was demonstrated for patients r and omised to the high-dose arm . Patients r and omised to low-dose could cross-over to high-dose upon progression . We evaluated the feasibility , safety and efficacy of this policy . Of the 241 patients available for follow-up , 133 patients ( 55 % ) crossed over to high-dose imatinib according to the protocol . Of these patients , 92 % had not had a prior dose reduction . The cumulative incidence of subsequent dose reductions after cross-over was 17 % after six months with 51 % discontinuing therapy without requiring a dose reduction . The extent of anaemia and fatigue increased significantly after cross-over , whilst neutropenia was less severe than during low-dose treatment . Objective responses after cross-over included three patients ( 2 % ) with a partial response and 36 ( 27 % ) with stable disease . The median PFS after cross-over was 81 days , although 18.1 % of patients were still alive and progression free one year after cross-over . We conclude that a cross-over to high-dose imatinib is feasible and safe in GIST patients who progress on low-dose therapy BACKGROUND Constitutive activation of KIT receptor tyrosine kinase is critical in the pathogenesis of gastrointestinal stromal tumors . Imatinib mesylate , a selective tyrosine kinase inhibitor , has been shown in pre clinical models and preliminary clinical studies to have activity against such tumors . METHODS We conducted an open-label , r and omized , multicenter trial to evaluate the activity of imatinib in patients with advanced gastrointestinal stromal tumor . We assessed antitumor response and the safety and tolerability of the drug . Pharmacokinetics were assessed in a subgroup of patients . RESULTS A total of 147 patients were r and omly assigned to receive 400 mg or 600 mg of imatinib daily . Overall , 79 patients ( 53.7 percent ) had a partial response , 41 patients ( 27.9 percent ) had stable disease , and for technical reasons , response could not be evaluated in 7 patients ( 4.8 percent ) . No patient had a complete response to the treatment . The median duration of response had not been reached after a median follow-up of 24 weeks after the onset of response . Early resistance to imatinib was noted in 20 patients ( 13.6 percent ) . Therapy was well tolerated , although mild-to-moderate edema , diarrhea , and fatigue were common . Gastrointestinal or intraabdominal hemorrhage occurred in approximately 5 percent of patients . There were no significant differences in toxic effects or response between the two doses . Imatinib was well absorbed , with pharmacokinetics similar to those reported in patients with chronic myeloid leukemia . CONCLUSIONS Imatinib induced a sustained objective response in more than half of patients with an advanced unresectable or metastatic gastrointestinal stromal tumor . Inhibition of the KIT signal-transduction pathway is a promising treatment for advanced gastrointestinal stromal tumors , which resist conventional chemotherapy |
378 | 30,066,361 | Liraglutide alone , liraglutide/metformin and metformin alone significantly reduced waist circumference , but no change was found with orlistat .
Liraglutide appears superior to the other drugs in reducing weight and waist circumference | BACKGROUND Women with polycystic ovary syndrome ( PCOS ) are almost three times more likely to be obese than those without PCOS .
However , we have no specific interventions to induce weight loss so far and rely on drugs used to treat other symptoms of the syndrome or obesity in the general population .
OBJECTIVE The objective of this study is to compare the effectiveness of metformin , inositol , liraglutide and orlistat to induce weight loss in women with PCOS and overweight/obesity . | Objective : The aim of this study was to determine the cardiometabolic risk factors in different polycystic ovary syndrome ( PCOS ) phenotypes . Subjects and Methods : This cross-sectional study was performed between 2010 and 2011 . Eighty-nine patients with PCOS and 25 age- and weight-matched healthy controls were included in the study . Patients were grouped using the Rotterdam 2003 criteria as : group 1 , oligomenorrhea and /or anovulation ( ANOV ) and hyper and rogenemia ( HA ) and /or hyper and rogenism ( n = 23 ) ; group 2 , ANOV and polycystic ovaries ( PCO ; n = 22 ) ; group 3 , HA and PCO ( n = 22 ) ; group 4 , ANOV , HA and PCO ( n = 22 ) ; group 5 , controls ( n = 25 ) . Laboratory blood tests for diagnosis and cardiometabolic risk assessment s were performed . Insulin resistance ( IR ) was calculated in all patients with the homeostasis model assessment of IR ( HOMA-IR ) formula . An euglycemic hyperinsulinemic clamp test was performed on 5 r and omly selected cases in each subgroup , making 25 cases in total , and indicated as the ‘ M ' value ( mg/kg/min ) , which is the total body glucose disposal rate . Results : The mean BMl values of the groups were : group 1 , 26.1 ± 5.3 ; group 2 , 27.9 ± 5.2 ; group 3 , 24.3 ± 4.2 ; group 4 , 27.9 ± 7.5 ; group 5 , 24.7 ± 5.2 ( p > 0.05 ) . There were no differences in the lipid profile , plasma glucose , HOMA-IR , insulin and M values between the groups ( p > 0.05 ) . Phenotypes with oligomenorrhea/anovulation ( groups 1 , 2 and 4 ) were more obese than group 3 ( p = 0.039 ) . Conclusions : The cardiometabolic risk profile was similar among the PCOS subgroups . This finding could be attributed to the mean BMl values , which , being below 30 , were not within the obesity range . Obesity appeared to be an important determinant of high cardiovascular risk in PCOS Abstract Aim : Glucagon-like peptide 1 receptor agonists ( GLP-1 RA ) stimulate satiety leading to reductions in food intake and body weight . The effects of long- acting GLP-1 RA liraglutide on eating behavior of women with PCOS have not been investigated yet . Methods : Thirty-six obese women with PCOS ( mean ± SD , aged 31.2 ± 7.8 years , with BMI 38.7 ± 0.1 kg/m2 ) , pretreated with metformin ( 1000 mg BID ) were switched to liraglutide 1.2 mg QD sc for 12 weeks . Adiposity parameters and eating behavior as assessed by Three-Factor Eating Question naire ( TFEQ-R18 ) were examined at baseline and after 12 weeks . Results : Subjects treated with liraglutide lost on average 3.8 ± 0.1 kg ( p < 0.001 ) . Significant reductions of waist circumference and visceral adipose tissue ( VAT ) mass , volume and area were demonstrated from liraglutide induction to the end of the study . TFEQ-R18 scores were significantly different pre- and post-liraglutide intervention . After treatment with liraglutide the uncontrolled eating ( UE ) score decreased from 36.8 ± 24.5 to 19.6 ± 18.4 ( p < 0.001 ) and emotional eating ( EE ) score decreased from 49.9 ± 33.3 to 28.5 ± 26.9 ( p < 0.001 ) . Scores for cognitive restraint ( CR ) were not changed . Conclusions : Short-term liraglutide treatment was associated with weight loss and significantly improved eating behavior in obese women with PCOS Background This study was design ed to investigate the effect of metformin and flutamide alone or in combination with anthropometric indices and laboratory tests of obese/overweight PCOS women under hypocaloric diet . Methods This single blind clinical trial was performed on 120 PCOS women . At the beginning , hypocaloric diet was recommended for the patients . After one month while they were on the diet , the patients were r and omly divided in 4 groups ; metformin ( 500 mg , 3/day ) , flutamide ( 250 mg , 2/day ) , combined , metformin ( 500 mg , 3/day ) with flutamide ( 250 mg , 2/day ) and finally placebo group . The patients were treated for 6 months . Anthropometric indices and laboratory tests ( fasting and glucose-stimulated insulin levels , lipid profile and and rogens ) were measured . A one-way ANOVA ( Post Hoc ) and paired t-test were performed to analyze data . A p ≤ 0.05 was considered statistically significant . Results After treatment , reduction in weight , BMI , hip circumference was significantly greater in the metformin group in comparison to other groups ( p<0.05 ) . In addition , the fasting insulin was significantly greater in metformin group and flutamide group in comparison to metformin+flutamide and placebo groups after treatment ( p<0.05 ) . Within groups , insulin level showed significant changes ( before and after treatment ) in metformin+flutamide group and LDL reduction was significant in flutamide group before and after treatment . Post hoc tukey and two-tailed with p≤0.05 were used to define statistical significance . Conclusion Using combination of metformin and flutamide improves anthropometric indices and laboratory tests in obese/overweight PCOS women under hypocaloric diet OBJECTIVE Development of these guidelines is m and ated by the American Association of Clinical Endocrinologists ( AACE ) Board of Directors and the American College of Endocrinology ( ACE ) Board of Trustees and adheres to published AACE protocol s for the st and ardized production of clinical practice guidelines ( CPGs ) . METHODS Recommendations are based on diligent review of clinical evidence with transparent incorporation of subjective factors . RESULTS There are 9 broad clinical questions with 123 recommendation numbers that include 160 specific statements ( 85 [ 53.1 % ] strong [ Grade A ] ; 48 [ 30.0 % ] intermediate [ Grade B ] , and 11 [ 6.9 % ] weak [ Grade C ] , with 16 [ 10.0 % ] based on expert opinion [ Grade D ] ) that build a comprehensive medical care plan for obesity . There were 133 ( 83.1 % ) statements based on strong ( best evidence level [ BEL ] 1 = 79 [ 49.4 % ] ) or intermediate ( BEL 2 = 54 [ 33.7 % ] ) levels of scientific substantiation . There were 34 ( 23.6 % ) evidence -based recommendation grade s ( Grade s A-C = 144 ) that were adjusted based on subjective factors . Among the 1,790 reference citations used in this CPG , 524 ( 29.3 % ) were based on strong ( evidence level [ EL ] 1 ) , 605 ( 33.8 % ) were based on intermediate ( EL 2 ) , and 308 ( 17.2 % ) were based on weak ( EL 3 ) scientific studies , with 353 ( 19.7 % ) based on review s and opinions ( EL 4 ) . CONCLUSION The final recommendations recognize that obesity is a complex , adiposity-based chronic disease , where management targets both weight-related complications and adiposity to improve overall health and quality of life . The detailed evidence -based recommendations allow for nuanced clinical decision-making that addresses real-world medical care of patients with obesity , including screening , diagnosis , evaluation , selection of therapy , treatment goals , and individualization of care . The goal is to facilitate high- quality care of patients with obesity and provide a rational , scientific approach to management that optimizes health outcomes and safety . ABBREVIATIONS A1C = hemoglobin A1c AACE = American Association of Clinical Endocrinologists ACE = American College of Endocrinology ACSM = American College of Sports Medicine ADA = American Diabetes Association ADAPT = Arthritis , Diet , and Activity Promotion Trial ADHD = attention-deficit hyperactivity disorder AHA = American Heart Association AHEAD = Action for Health in Diabetes AHI = apnea-hypopnea index ALT = alanine aminotransferase AMA = American Medical Association ARB = angiotensin receptor blocker ART = assisted reproductive technology AUC = area under the curve BDI = Beck Depression Inventory BED = binge eating disorder BEL = best evidence level BLOOM = Behavioral Modification and Lorcaserin for Overweight and Obesity Management BLOSSOM = Behavioral Modification and Lorcaserin Second Study for Obesity Management BMI = body mass index BP = blood pressure C-SSRS = Columbia Suicidality Severity Rating Scale CAD = coronary artery disease CARDIA = Coronary Artery Risk Development in Young Adults CBT = cognitive behavioral therapy CCO = Consensus Conference on Obesity CHF = congestive heart failure CHO = carbohydrate CI = confidence interval COR-I = Contrave Obesity Research I CPG = clinical practice guideline CV = cardiovascular CVD = cardiovascular disease DASH = Dietary Approaches to Stop Hypertension DBP = diastolic blood pressure DEXA = dual-energy X-ray absorptiometry DPP = Diabetes Prevention Program DSE = diabetes support and education EL = evidence level ED = erectile dysfunction ER = extended release EWL = excess weight loss FDA = Food and Drug Administration FDG = 18F-fluorodeoxyglucose GABA = gamma-aminobutyric acid GERD = gastroesophageal reflux disease GI = gastrointestinal GLP-1 = glucagon-like peptide 1 HADS = Hospital Anxiety and Depression Scale HDL-c = high-density lipoprotein cholesterol HR = hazard ratio HTN = hypertension HUNT = Nord-Trøndelag Health Study ICSI = intracytoplasmic sperm injection IFG = impaired fasting glucose IGT = impaired glucose tolerance ILI = intensive lifestyle intervention IVF = in vitro fertilization LAGB = laparoscopic adjustable gastric b and ing LDL-c = low-density lipoprotein cholesterol LES = lower esophageal sphincter LSG = laparoscopic sleeve gastrectomy LV = left ventricle LVH = left ventricular hypertrophy LVBG = laparoscopic vertical b and ed gastroplasty MACE = major adverse cardiovascular events MAOI = monoamine oxidase inhibitor MI = myocardial infa rct ion MN RCT = meta- analysis of non-r and omized prospect i ve or case-controlled trials MRI = magnetic resonance imaging MUFA = monounsaturated fatty acid NAFLD = nonalcoholic fatty liver disease NASH = nonalcoholic steatohepatitis NES = night eating syndrome NHANES = National Health and Nutrition Examination Surveys NHLBI = National Heart , Lung , and Blood Institute NHS = Nurses ' Health Study NICE = National Institute for Health and Care Excellence OA = osteoarthritis OGTT = oral glucose tolerance test OR = odds ratio OSA = obstructive sleep apnea PHQ-9 = Patient Health Question naire PCOS = polycystic ovary syndrome PCP = primary care physician POMC = pro-opiomelanocortin POWER = Practice -Based Opportunities for Weight Reduction PPI = proton pump inhibitor PRIDE = Program to Reduce Incontinence by Diet and Exercise PSA = prostate specific antigen QOL = quality of life RA = receptor agonist RCT = r and omized controlled trial ROC = receiver operator characteristic RR = relative risk RYGB = Roux-en-Y gastric bypass SAD = sagittal abdominal diameter SBP = systolic blood pressure SCOUT = Sibutramine Cardiovascular Outcome Trial SG = sleeve gastrectomy SHBG = sex hormonebinding globulin SIEDY = Structured Interview on Erectile Dysfunction SNRI = serotonin-norepinephrine reuptake inhibitors SOS = Swedish Obese Subjects SS = surveillance study SSRI = selective serotonin reuptake inhibitors STORM = Sibutramine Trial on Obesity Reduction and Maintenance TCA = tricyclic antidepressant TONE = Trial of Nonpharmacologic Intervention in the Elderly TOS = The Obesity Society T2DM = type 2 diabetes mellitus UKPDS = United Kingdom Prospect i ve Diabetes Study U.S = United States VAT = visceral adipose tissue VLDL = very low-density lipoprotein WC = waist circumference WHO = World Health Organization WHR = waist-hip ratio WHtR = waist-to-height ratio WMD = weighted mean difference WOMAC = Western Ontario and McMaster Universities osteoarthritis index XENDOS = XEnical in the Prevention of Diabetes in Obese Subjects OBJECTIVE The long-acting glucagon-like peptide 1 receptor agonist liraglutide is linked to progressive and sustained weight loss in obese people with diabetes . However , its efficacy and safety in women with polycystic ovary syndrome ( PCOS ) has not yet been addressed . DESIGN Thirty-two obese women ( aged 27.6±7.2 years , BMI 39.5±6.2 kg/m2 ) with newly diagnosed PCOS were r and omized to receive either liraglutide 1.2 mg QD sc ( n=17 ) or metformin 1000 mg BID po ( n=15 ) for 12 weeks ; 28 patients completed the study ( 14 on liraglutide and 14 on metformin ) . The main outcome was change in body weight . RESULTS Intention-to-treat analysis showed significant BMI ( −0.98 kg/m2 ; p<0.001 ) , body weight ( −2.52 kg ; p<0.001 ) , waist circumference ( −3.38 cm ; p<0.001 ) and whole-body fat mass ( −1.26 % ; p<0.001 ) reduction in both treatment arms without significant differences between therapeutic groups . However , in a subgroup of patients ( n=9 ) with insulin resistance ( HOMAIR > 2 ) , severe obesity and higher odds ratio for the metabolic syndrome ( OR=3.9 ) , the patients fared much better with liraglutide than with metformin ( mean BMI decreased 2.13 kg/m2 vs. 0.62 kg/m2 , respectively ) . CONCLUSIONS Short-term liraglutide treatment was associated with significant weight loss in a subset of obese patients with newly diagnosed PCOS and a higher metabolic risk profile CONTEXT Polycystic ovary syndrome ( PCOS ) presents in adolescence , and obesity is a common finding . The benefits and risks of alternate approaches to the management of PCOS in obese adolescent women are not clear . OBJECTIVE We investigated the effects of metformin , oral contraceptives ( OCs ) , and /or lifestyle modification in obese adolescent women with PCOS . DESIGN Two small , r and omized , placebo-controlled clinical trials were performed . PATIENTS AND PARTICIPANTS A total of 79 obese adolescent women with PCOS participated . INTERVENTIONS In the single treatment trial , subjects were r and omized to metformin , placebo , a lifestyle modification program , or OC . In the combined treatment trial , all subjects received lifestyle modification and OC and were r and omized to metformin or placebo . MAIN OUTCOME MEASURES Serum concentrations of and rogens and lipids were measured . RESULTS Lifestyle modification alone result ed in a 59 % reduction in free and rogen index with a 122 % increase in SHBG . OC result ed in a significant decrease in total testosterone ( 44 % ) and free and rogen index ( 86 % ) but also result ed in an increase in C-reactive protein ( 39.7 % ) and cholesterol ( 14 % ) . The combination of lifestyle modification , OC , and metformin result ed in a 55 % decrease in total testosterone , as compared to 33 % with combined treatment and placebo , a 4 % reduction in waist circumference , and a significant increase in HDL ( 46 % ) . CONCLUSIONS In these preliminary trials , both lifestyle modification and OCs significantly reduce and rogens and increase SHBG in obese adolescents with PCOS . Metformin , in combination with lifestyle modification and OC , reduces central adiposity , reduces total testosterone , and increases HDL , but does not enhance overall weight reduction background Hyper and rogenism , hyperinsulinaemia and obesity play a key and coordinating roles in the pathogenesis of polycystic ovary syndrome ( PCOS ) , contributing in different ways to the clinical expression of the syndrome . Weight loss is beneficial , but the additional administration of insulin‐lowering drugs , such as metformin , and anti and rogens may produce further benefits , due to their different spectrum of action . The effects of long‐term metformin and flutamide , an anti and rogen drug , added alone or in combination with a low‐calorie diet , on body weight and fat distribution , and rogens , metabolic parameters and clinical status in obese women with PCOS were investigated Abdominal obesity and hyperinsulinemia play a key role in the development of the polycystic ovary syndrome ( PCOS ) . Dietary-induced weight loss and the administration of insulin-lowering drugs , such as metformin , are usually followed by improved hyper and rogenism and related clinical abnormalities . This study was carried out to evaluate the effects of combined hypocaloric diet and metformin on body weight , fat distribution , the glucose-insulin system , and hormones in a group of 20 obese PCOS women [ body mass index ( BMI ) > 28 kg/m2 ] with the abdominal phenotype ( waist to hip ratio > 0.80 ) , and an appropriate control group of 20 obese women who were comparable for age and pattern of body fat distribution but without PCOS . At baseline , we measured sex hormone , sex hormone-binding globulin ( SHBG ) , and leptin blood concentrations and performed an oral glucose tolerance test and computerized tomography ( CT ) at the L4-L5 level , to measure sc adipose tissue area ( SAT ) and visceral adipose tissue area . All women were then given a low-calorie diet ( 1,200 - 1,400 kcal/day ) alone for one month , after which anthropometric parameters and CT scan were newly measured . While continuing dietary treatment , PCOS women and obese controls were subsequently placed , in a r and om order , on metformin ( 850 mg/os , twice daily ) ( 12 and 8 , respectively ) or placebo ( 8 and 12 , respectively ) , according to a double-blind design , for the following 6 months . Blood tests and the CT scan were performed in each woman at the end of the study while they were still on treatment . During the treatment period , 3 women of the control group ( all treated with placebo ) were excluded because of noncompliance ; and 2 PCOS women , both treated with metformin , were also excluded because they became pregnant . Therefore , the women cohort available for final statistical analysis included 18 PCOS ( 10 treated with metformin and 8 with placebo ) and 17 control women ( 8 treated with metformin and 9 with placebo ) . The treatment was well tolerated . In the PCOS group , metformin therapy improved hirsutism and menstrual cycles significantly more than placebo . Baseline anthropometric and CT parameters were similar in all groups . Hypocaloric dieting for 1 month similarly reduced BMI values and the waist circumference in both PCOS and control groups , without any significant effect on CT scan parameters . In both PCOS and control women , however , metformin treatment reduced body weight and BMI significantly more than placebo . Changes in the waist-to-hip ratio values were similar in PCOS women and controls , regardless of pharmacological treatment . Metformin treatment significantly decreased SAT values in both PCOS and control groups , although only in the latter group were SAT changes significantly greater than those observed during the placebo treatment . On the contrary , visceral adipose tissue area values significantly decreased during metformin treatment in both PCOS and control groups , but only in the former was the effect of metformin treatment significantly higher than that of placebo . Fasting insulin significantly decreased in both PCOS women and controls , regardless of treatment , whereas glucose-stimulated insulin significantly decreased only in PCOS women and controls treated with metformin . Neither metformin or placebo significantly modified the levels of LH , FSH , dehydroepi and rosterone sulphate , and progesterone in any group , whereas testosterone concentrations decreased only in PCOS women treated with metformin . SHBG concentrations remained unchanged in all PCOS women ; whereas in the control group , they significantly increased after both metformin and placebo . Leptin levels decreased only during metformin treatment in both PCOS and control groups . ( ABSTRACT TRUNCATED OBJECTIVE To investigate the combined effect of diet and orlistat , for 24 weeks , on anthropometric features , hormonal parameters , and indices of insulin resistance in obese women with polycystic ovary syndrome ( PCOS ) and in obese women without the syndrome . DESIGN Prospect i ve clinical study . SETTING Department of obstetrics and gynecology in a major university in Greece . PATIENT(S ) Eighteen selected women with PCOS were matched for age and body mass index with 14 obese control women . INTERVENTION(S ) Subjects were prescribed an energy-restricted diet , and orlistat ( 120 mg , 3 times per d ) was administered to all subjects for 24 weeks . MAIN OUTCOME MEASURE(S ) At baseline , week 12 , and week 24 , after an overnight fast , blood sample s were collected , and serum levels of FSH , LH , PRL , T , Delta(4)A , DHEAS , 17 alpha-hydroxyprogesterone , sex hormone-binding globulin , glucose , and insulin were measured . RESULT ( S ) Testosterone levels were significantly decreased with treatment in women with PCOS ; this decrease was attributed to the first trimester , whereas T levels did not change during the second 12-week period . In women with PCOS , insulin levels and HOMA-IR values were decreased during the first 12 weeks , whereas no significant change was observed during the second trimester . CONCLUSION ( S ) Orlistat administration , combined with diet , for 24 weeks , result ed in significant weight loss and improvement of insulin resistance in obese women , with or without PCOS . Moreover , T levels were significantly decreased in women with PCOS . There appears to be a trend during the first 12-week period for greater improvement of metabolic and hormonal parameters in women with PCOS The present study investigates the combined effect of diet , physical exercise and Orlistat for 24 weeks , on serum Anti-Müllerian Hormone ( AMH ) levels in overweight and obese women with polycystic ovary syndrome ( PCOS ) and in overweight and obese controls . Sixty-one ( 61 ) selected women with PCOS and 20 overweight and obese controls followed an energy-restricted diet , physical exercise plus Orlistat administration ( 120 mg , 3 times per day ) for 24 weeks . At baseline , week 12 and week 24 , serum levels of AMH , FSH , LH , PRL , and rogens , sex hormone – binding globulin ( SHBG ) , glucose , and insulin were measured and Free And rogen Index ( FAI ) and Insulin Resistance ( IR ) indices were calculated . In PCOS women , serum AMH levels increased after 12 and 24 weeks of treatment . After 12 weeks LH and SHBG were increased , while Testosterone decreased . After 12 and 24 weeks , FAI was decreased and all indices of IR were significantly improved . We concluded that in overweight and obese women with PCOS Orlistat administration , combined with diet and physical exercise , for 24 weeks , result ed in significant weight loss , improvement of hyper and rogenism and insulin sensitivity , and increased serum AMH levels OBJECTIVE To determine the clinical , hormonal , and biochemical effects of metformin therapy in obese and nonobese patients with polycystic ovary syndrome ( PCOS ) . DESIGN Controlled clinical study . SETTING Department of Gynecology of Federal University of São Paulo , São Paulo , Brazil . PATIENT(S ) Twenty-nine patients with PCOS . INTERVENTION(S ) Patients were treated with 500 mg of p.o . metformin t.i.d . for 6 months . MAIN OUTCOME MEASURE(S ) Clinical data as well as serum concentrations of sex steroids , sex hormone-binding globulin ( SHBG ) , gonadotropins , leptin , GH , lipids , insulin , and glucose levels were assessed before and after treatment . RESULT ( S ) In the metformin group of nonobese patients , the mean fasting serum insulin concentration decreased from a pretreatment value of 12.1 + /- 2.4 to 6.3 + /- 0.6 microU/mL after treatment , and the area under the curve of insulin decreased from 5,189.1 + /- 517.4 to 3,035.6 + /- 208.9 microU/mL per minute . Also in the metformin group of nonobese patients , the mean basal serum total testosterone , free testosterone , and and rostenedione concentrations decreased by 38 % , 58 % , and 30 % , respectively . In the obese patients treated with metformin , only free testosterone showed a statistically significant decrease ( 1.7 + /- 0.2 ) . CONCLUSION ( S ) Our data suggest that nonobese patients respond better than obese patients to a 1.5 g/day metformin regimen Liraglutide ( LIRA ) treatment is associated with the dose-dependent reduction of weight . Higher doses are more effective than lower doses , although higher doses are also more poorly tolerated . Metformin may enhance the weight-lowering potential of LIRA via the stimulatory modulation of incretin in addition to its direct beneficial effects in PCOS . The aim of the present study was to evaluate whether metformin as an adjunct to low-dose LIRA affects body weight with increased efficacy compared with low-dose LIRA alone in obese patients with PCOS . In a 12-week study , 44 obese women with PCOS were r and omly offered either combined treatment ( COMBO ) with 1,000 mg metformin twice a day and 1.2 mg LIRA once a day , or treatment with 1.2 mg LIRA alone . The primary outcome of treatment was an alteration in the levels of obesity . A total of 43 patients [ aged 30.3±4.4 years ; body mass index ( BMI ) 37.2±4.5 kg/m2 ; mean ± st and ard deviation ] completed the study . The subjects treated with COMBO lost on average 6.2±2.4 kg compared with a 3.8±3.5 kg weight loss in the patients treated with LIRA alone ( P=0.024 ) . The BMI decreased by 2.2±0.8 kg/m2 in patients treated with COMBO and by 1.4±1.2 kg/m2 in patients treated with LIRA alone ( P=0.024 ) . A clinical ly significant ≥5 % weight reduction was achieved in 59.1 % of patients treated with COMBO and 42.9 % of patients treated with LIRA alone . Reductions in glucose levels following oral glucose tolerance testing , as well as in and rostenedione levels in the COMBO group were significantly greater compared with those in the LIRA group . The side effects were mild and transient in the two treatment groups . A combination of metformin and low-dose LIRA was more effective than low-dose LIRA alone in reducing body weight in obese patients with PCOS Background Liraglutide 3 mg was recently approved as an anti-obesity drug . Metformin is weight neutral , yet it could enhance the therapeutic index of GLP-1 agonist . We compared weight-lowering potential of liraglutide 1.2 mg in combination with metformin to liraglutide 3 mg monotherapy in obese PCOS . Methods Thirty obese women with PCOS ( aged 33.1 ± 6.1 years , BMI 38.3 ± 5.4 kg/m2 ) were r and omized to combination ( COMBO ) of metformin ( MET ) 1000 mg BID and liraglutide 1.2 mg QD ( N = 15 ) or liraglutide 3 mg ( LIRA3 ) QD alone ( N = 15 ) for 12 weeks . The primary outcome was change in anthropometric measures of obesity . Results Both treatments led to significant weight loss ( −3.6 ± 2.5 kg , p = 0.002 in COMBO vs −6.3 ± 3.7 kg , p = 0.001 in LIRA3 ) . BMI and waist circumference reduction in LIRA3 was greater than in COMBO ( −2.2 ± 1.3 vs −1.3 ± 0.9 kg/m2,p = 0.05 and −4.2 ± 3.4 vs −2.2 ± 6.2 cm , p = 0.014 , respectively ) . Both interventions result ed in a significant decrease of post-OGTT glucose levels . COMBO significantly reduced total testosterone and was associated with less nausea . Conclusions Short-term interventions with COMBO and LIRA3 both led to significant improvement of measures of obesity in obese PCOS , LIRA3 being superior to COMBO . However , COMBO further improved and rogen profile beyond weight reduction and was associated with better tolerability . Trial registration The study was retrospectively registered with Clinical Trials.gov ( NCT02909933 ) on 16th of September 2016 Objective To evaluate whether liraglutide or roflumilast significantly affects body weight when compared to metformin in obese women with PCOS . Design /main outcome measureA 12-week prospect i ve r and omized open-label study was conducted with 45 obese women with PCOS diagnosed by the ASRM-ESHRE Rotterdam criteria . They were r and omized to metformin ( MET ) 1000 mg BID or liraglutide ( LIRA ) 1.2 mg QD s.c . or roflumilast ( ROF ) 500 mcg QD . The primary outcome was change in measures of obesity . Results Forty-one patients ( aged 30.7 ± 7.9 years , BMI 38.6 ± 6.0 kg/m2 , mean ± SD ) completed the study . Subjects treated with LIRA lost on average 3.1 ± 3.5 kg ( p = 0.006 ) , on ROF 2.1 ± 2.0 kg ( p = 0.002 ) vs. 0.2 ± 1.83 kg in MET group . BMI decreased for 1.1 ± 1.26 kg/m2 in LIRA ( p = 0.006 ) , for 0.8 ± 0.99 kg/m2 in ROF ( p = 0.001 ) vs. 0.1 ± 0.67 kg/m2 in MET . LIRA was superior to MET in reducing weight ( p = 0.022 ) , BMI ( p = 0.020 ) , waist circumference ( p = 0.007 ) . LIRA also result ed in decrease in VAT area ( p = 0.015 ) and more favorable dynamics in glucose homeostasis during OGTT . ROF result ed in reduction of waist circumference ( p = 0.023 ) . In addition , ROF led to testosterone reduction ( p = 0.05 ) and increase in menstrual frequencies ( p = 0.009 ) when compared to baseline . ConclusionS hort-term monotherapy with liraglutide or roflumilast was associated with significant weight loss in obese PCOS . Liraglutide was superior to metformin , whereas roflumilast result ed in greater , yet not statistically significant , mean weight loss when compared to metformin . Reduction of body weight with liraglutide result ed in improvement of body composition . Trial registration Clinical Trials.gov NCT02187250 Objective The effect of metformin on weight reduction in polycystic ovary syndrome ( PCOS ) is often unsatisfactory . In this study , we investigated the potential add-on effect of treatment with the glucagon-like peptide-1 receptor agonist liraglutide on weight loss in obese nondiabetic women with PCOS who had lost < 5 % body weight during pretreatment with metformin . Methods A total of 40 obese women with PCOS , who had been pretreated with metformin for at least 6 months , participated in a 12-week open-label , prospect i ve study . They were r and omized to one of three treatment arms : metformin ( MET ) arm 1000 mg BID , liraglutide ( LIRA ) arm 1.2 mg QD s.c . , or combined MET 1000 mg BID and LIRA ( COMBI ) 1.2 mg QD s.c . Lifestyle intervention was not actively promoted . The primary outcome was change in body weight . Results Thirty six patients ( aged 31.3±7.1 years , BMI 37.1±4.6 kg/m2 ) completed the study : 14 on MET , 11 on LIRA , and 11 on combined treatment . COMBI therapy was superior to LIRA and MET monotherapy in reducing weight , BMI , and waist circumference . Subjects treated with COMBI lost on average 6.5±2.8 kg compared with a 3.8±3.7 kg loss in the LIRA group and a 1.2±1.4 kg loss in the MET group ( P<0.001 ) . The extent of weight loss was stratified : a total of 38 % of subjects were high responders who lost ≥5 % body weight , 22 % of them in the COMBI arm compared with 16 and 0 % in the LIRA and MET arm respectively . BMI decreased by 2.4±1.0 in the COMBI arm compared with 1.3±1.3 in LIRA and 0.5±0.5 in the MET arm ( P<0.001 ) . Waist circumference also decreased by 5.5±3.8 cm in the COMBI arm compared with 3.2±2.9 cm in LIRA and 1.6±2.9 cm in the MET arm ( P=0.029 ) . Subjects treated with liraglutide experienced more nausea than those treated with metformin , but severity of nausea decreased over time and did not correlate with weight loss . Conclusions Short-term combined treatment with liraglutide and metformin was associated with significant weight loss and decrease in waist circumference in obese women with PCOS who had previously been poor responders regarding weight reduction on metformin monotherapy Purpose Comparing the effects of metformin or orlistat on hormone , lipid profile and ovulation status in obese women with polycystic ovary syndrome . Methods A total of 80 women were prospect ively recruited to receive either metformin ( n = 40 ) or orlistat ( n = 40 ) . Weight , BMI , waist , serum LH , total serum testosterone and lipid profile were assessed at baseline and after 3 months . The subjects ’ ovulatory status was assessed after 3 months . Results There was no significant difference in ovulation between the two treatment groups ( 30 % vs 15 % ) . Treatment with either drug showed a significant decline in body weight , BMI ( Body Mass Index ) , and waist circumference , but the degree of decline in both groups was the same . Patients who were treated with orlistat , showed a significant reduction in total testosterone and serum lipid . Women in metformin group showed a significant reduction in serum LH . Conclusions Both metformin and orlistat showed a similar effect on weight loss and ovulation rates CONTEXT The few controlled trials performed so far indicate that the addition of metformin and /or flutamide to a hypocaloric diet in obese women with polycystic ovary syndrome ( PCOS ) effectively influences different phenotypic aspects of the syndrome . All these studies are , however , characterized by a short to medium period of treatment . OBJECTIVE Our objective was to investigate the long-term effects of these therapies . DESIGN AND SETTING We conducted a prospect i ve , r and omized , placebo-controlled trial at a medical center . PATIENTS Of 80 overweight-obese women with PCOS , 76 completed the study . INTERVENTIONS Patients were placed on a hypocaloric diet for the first month and then on a hypocaloric diet plus placebo , metformin ( 850 mg , orally , twice a day ) , flutamide ( 250 mg , orally , twice a day ) , or metformin plus flutamide for the subsequent 12 months ( 20 subjects in each group ) . MAIN OUTCOME MEASURES We assessed clinical features , computerized tomography measurement of fat distribution , and rogens , lipids , and fasting and glucose-stimulated glucose and insulin levels at baseline and after 6 and 12 months of treatment . RESULTS After 6 months , compared with placebo , flutamide further decreased visceral/sc fat mass ( P = 0.044 ) , and rostenedione ( P < 0.001 ) , dehydroepi and rosterone sulfate ( P < 0.001 ) , and hirsutism score ( P < 0.001 ) , whereas metformin further increased frequency of menstruation ( P = 0.039 ) . After 12 months , flutamide maintained the effects observed after 6 months on visceral/sc fat mass ( P = 0.033 ) and and rostenedione ( P < 0.001 ) , whereas it produced an additional decrease in dehydroepi and rosterone sulfate ( P = 0.020 ) and hirsutism score ( P = 0.019 ) ; metformin further improved the menstrual pattern ( P = 0.013 ) . Moreover , after 12 months , flutamide improved more than placebo the menstrual pattern ( P = 0.008 ) , glucose-stimulated glucose levels ( P = 0.041 ) , insulin sensitivity ( P < 0.001 ) , and low-density lipoprotein cholesterol levels ( P = 0.003 ) , whereas metformin decreased glucose-stimulated insulin levels ( P = 0.014 ) . The combination of the two drugs maintained the specific effect of each of the compounds , without any additive or synergistic effect . CONCLUSIONS These findings add relevance to the usefulness of metformin and flutamide in the treatment of dieting overweight-obese PCOS women and provide a rationale for targeting different therapeutic options according to the required outcomes in the long term Polycystic ovary syndrome ( PCOS ) is associated with increased risk of venous thromboembolism ( VTE ) and cardiovascular disease ( CVD ) in later life . We aim ed to study the effect of liraglutide intervention on markers of VTE and CVD risk , in PCOS . In a double-blind , placebo-controlled , r and omized trial , 72 overweight and /or insulin-resistant women with PCOS were r and omized , in a 2:1 ratio , to liraglutide or placebo 1.8 mg/day . Endpoints included between-group difference in change ( baseline to follow-up ) in plasminogen activator inhibitor-1 levels and in thrombin generation test parameters : endogenous thrombin potential , peak thrombin concentration , lag time and time to peak . Mean weight loss was 5.2 kg ( 95 % CI 3.0–7.5 kg , P < 0.001 ) in the liraglutide group compared with placebo . We detected no effect on endogenous thrombin potential in either group . In the liraglutide group , peak thrombin concentration decreased by 16.71 nmol/L ( 95 % CI 2.32–31.11 , P < 0.05 ) and lag time and time to peak increased by 0.13 min ( 95 % CI 0.01–0.25 , P < 0.05 ) and 0.38 min ( 95 % CI 0.09–0.68 , P < 0.05 ) , respectively , but there were no between-group differences . There was a trend toward 12 % ( 95 % CI 0–23 , P = 0.05 ) decreased plasminogen activator inhibitor-1 in the liraglutide group , and there was a trend toward 16 % ( 95 % CI −4 to 32 , P = 0.10 ) reduction , compared with placebo . In overweight women with PCOS , liraglutide intervention caused an approximate 5 % weight loss . In addition , liraglutide affected thrombin generation , although not significantly differently from placebo . A concomitant trend toward improved fibrinolysis indicates a possible reduction of the baseline thrombogenic potential . The findings point toward beneficial effects of liraglutide on markers of VTE and CVD risk , which should be further pursued in larger studies OBJECTIVE The aim of the present study is to evaluate sub-groups of PCOS patients who will benefit from metformin therapy and to find out any predictors of ovulation in PCOS sub-groups . METHOD In the current prospect ive-r and omized , placebo-controlled , double-blind study , PCOS patients ( n = 116 ) were divided into six main groups according to glucose to insulin ratio ( G-I ratio mg/10(-4 ) U ) and body mass index ( BMI kg/m2 ) as : Group 1 : normoinsulinemic ( G-I ratio > or = 4.5 mg/10(-4 ) U ) , lean ( BMI < 25 ) ( n = 37 ) ; Group 2 : normoinsulinemic , overweight ( BMI : 25 - 29.9 ) ( n = 19 ) ; Group 3 : normoinsulinemic , obese ( BMI > or = 30 ) ( n = 18 ) ; Group 4 : hyperinsulinemic ( G-I ratio < 4.5 mg/10(-4 ) U ) , lean ( n = 28 ) ; Group 5 : hyperinsulinemic , overweight ( n = 17 ) ; Group 6 : hyperinsulinemic , obese ( n = 20 ) . Patients in each group were r and omized onto placebo or metformin treatments ( 850 mg two to three times per day according to BMI ) . The rate of ovulation , biochemical profile , hormonal profile and clinical symptoms of hyper and rogenism were evaluated before and after 6 months of metformin and placebo treatments . RESULT ( S ) We observed a significant decrease in WHR following metformin therapy in the normoinsulinemic overweight sub-group ( P < 0.05 ) . The duration of the menstrual cycle significantly decreased in the normoinsulinemic obese sub-group on metformin therapy ( P < 0.05 ) . Metformin had a significant effect on hirsutism scores in hyperinsulinemic lean women ( P < 0.05 ) and decreased DHEAS levels significantly in the lean hyperinsulinemic and normoinsulinemic groups ( P < 0.05 ) . Metformin had significant effects on ovulation in only lean hyperinsulinemic women ( P < 0.05 ) . CONCLUSIONS Clinical outcomes of metformin therapy may be categorized on the basis of basal BMI and insulin levels in PCOS patients OBJECTIVE To learn whether metformin treatment affects oxidative stress as measured by serum concentrations of 8-hydroxy-2'-deoxyguanosine ( 8-OHdG ) . DESIGN Double-blind , r and omized , placebo-controlled trial . SETTING University outpatient clinic . PATIENT(S ) The study cohort consisted of 50 obese women ( body mass index [ BMI ] ≥ 27 kg/m(2 ) ) and 60 nonobese patients ( BMI < 27 kg/m(2 ) ) , mean age was 27.7 ± 4.0 SD years . INTERVENTION(S ) R and omization to receive metformin or placebo for 3 months . MAIN OUTCOME MEASURE(S ) Serum levels of 8-OHdG before and after medical treatment . RESULT ( S ) The levels of 8-OHdG were equal at baseline in the placebo and metformin groups . Obese women had higher baseline serum concentrations of 8-OHdG. Levels of 8-OHdG were statistically significantly reduced with metformin treatment , especially in obese patients with polycystic ovary syndrome . This study was a secondary sub analysis of a previously conducted prospect i ve multicenter , r and omized , placebo-controlled study on the effects of metformin on miscarriage , pregnancy , and miscarriage rates . CONCLUSION ( S ) Metformin treatment , compared with placebo , statistically significantly decreased 8-OHdG levels in women with polycystic ovary syndrome . CLINICAL TRIAL REGISTRATION NUMBER NCT00994812 |
379 | 30,590,067 | Animal and human studies were generally consistent in their findings ; however , the limited number of human studies makes it difficult to generalize and translate the results of animal research to humans . | In contrast to classical conditioning of physiological responses such as immune responses and drug effects , only a limited number of studies investigated classical conditioning of endocrine responses .
The present paper is the first systematic review that integrates evidence from animal and human trials regarding the possibility to condition the endocrine responses . | We examined whether the effects of intravenously injected insulin and glucose ( the physiological endogenous insulin production stimulus ) could be classically conditioned in healthy humans . We expected a conditioned blood glucose decrease to a conditioned stimulus ( CS ) previously paired with insulin and an , albeit lower , blood glucose decrease to a CS paired with glucose injection . In addition , we analyzed glucoregulatory hormone and symptom conditionability . Thirty healthy males were divided into three groups and were given the CS and an intravenous injection of either insulin ( 0.05 IU/kg ) in Group 1 , glucose ( 15 % , 0.5 g/kg ) in Group 2 , or placebo [ physiological saline ( 0.9 % ) ] in Group 3 during the acquisition phase on 4 days . All participants were given the olfactory CS ( rosewood-peppermint smell ) and placebo injection on Day 5 ( test ) . On Day 5 , the total blood glucose decrease tended to be higher in Group 1 than in Group 3 ( P<.10 ) , especially at CS presentation ( P<.10 ) and previous unconditioned hypoglycemia time-point ( P<.05 ) . The conditioned blood glucose decrease was statistically nonsignificant in Group 2 , but shortly after CS presentation , insulin level and blood glucose changes were negatively correlated in Groups 1 and 2 in contrast to positive correlation in Group 3 . Furthermore , Group 1 showed an increase in noradrenaline ( P<.05 ) , a temporarily delayed increase in growth hormone ( GH ; P<.05 ) , and an increase of autonomic and neuroglycopenic symptoms , reaching a medium and small effect size , respectively . Group 2 responded with an increase in cortisol ( P<.01 ) and neuroglycopenic symptoms ( P<.05 ) at the time-point of the previous unconditioned blood glucose minimum . To conclude , the effects of exogenously applied insulin can be conditioned in a reliable way . In correspondence with the lower intensity of the unconditioned stimulus ( US ) , conditioning effects with glucose- and , thus , endogenously produced insulin-are weaker but also reflect the actions of central insulin . Future studies will examine the diverse actions of insulin within the brain further The infusion of cytotoxic drugs in cancer patients is often accompanied by posttreatment nausea ( PN ) . In addition , patients complain about nausea prior to an infusion [ i.e. , anticipatory nausea ( AN ) ] . AN is mainly explained by classical conditioning , with the infusion as the unconditioned stimulus ( US ) and with the stimuli signaling the infusion as conditioned stimuli ( CS ) . Despite this conditioning etiology , a specifically derived therapy to attenuate the CS-US contingency is missing . The purpose of this study is to develop and to test an overshadowing procedure for prevention of AN , and also for the modification of PN intensity . Sixteen cancer patients were assigned to one of two groups : Overshadowing+ ( OV+ ) and Overshadowing- ( OV- ) . At the start of all infusions of two consecutive chemotherapy cycles A and B ( acquisition ) , OV+ subjects drank a saliently tasting beverage ( the overshadowing CS ) , whereas group OV- drank water . All patients received water in cycle C ( test ) . Self-reported symptoms and heart rates were recorded . As expected , in cycle C ( test ) , no patient of group OV+ showed AN , whereas two patients of group OV- developed AN . There was a tendency for a reduction of the intensity of PN , in terms of duration and latency after overshadowing , in cycle C : OV+ patients tended to show a shorter duration and a longer latency between end of infusion and PN onset . In OV- , there was a significantly larger heart rate deceleration in both measurement periods , in the anticipatory and the posttreatment measurement period . Data suggest to apply overshadowing for prevention of AN and modification of PN . Physiological markers of conditioned nausea are revealed . After its procedural implementation , the technique can be used in larger sample s now The placebo and nocebo effect is believed to be mediated by both cognitive and conditioning mechanisms , although little is known about their role in different circumstances . In this study , we first analyzed the effects of opposing verbal suggestions on experimental ischemic arm pain in healthy volunteers and on motor performance in Parkinsonian patients and found that verbally induced expectations of analgesia/hyperalgesia and motor improvement/worsening antagonized completely the effects of a conditioning procedure . We also measured the effects of opposing verbal suggestions on hormonal secretion and found that verbally induced expectations of increase/decrease of growth hormone ( GH ) and cortisol did not have any effect on the secretion of these hormones . However , if a preconditioning was performed with sumatriptan , a 5-HT1B/1D agonist that stimulates GH and inhibits cortisol secretion , a significant increase of GH and decrease of cortisol plasma concentrations were found after placebo administration , although opposite verbal suggestions were given . These findings indicate that verbally induced expectations have no effect on hormonal secretion , whereas they affect pain and motor performance . This suggests that placebo responses are mediated by conditioning when unconscious physiological functions such as hormonal secretion are involved , whereas they are mediated by expectation when conscious physiological processes such as pain and motor performance come into play , even though a conditioning procedure is performed Flaws in the design , conduct , analysis , and reporting of r and omised trials can cause the effect of an intervention to be underestimated or overestimated . The Cochrane Collaboration ’s tool for assessing risk of bias aims to make the process clearer and more Objective : To test the hypothesize that psoriasis patients treated under a partial schedule of pharmacologic ( corticosteroid ) reinforcement would show less severe symptoms and relapse than those given the same amount of drug under st and ard conditions . Behavioral conditioning as an inherent component of many pharmacotherapeutic protocol s has never been examined . Methods : A double-blind , simple r and omization intervention was conducted with 46 patients from California and New York . Initially , lesions were treated with 0.1 % acetonide triamcinolone under st and ard treatment conditions . Thereafter , a St and ard Therapy group continued on continuous reinforcement ( active drug every treatment ) with 100 % of the initial dose ; Partial Reinforcement patients received a full dose 25 % to 50 % of the time and placebo medication other times ; Dose Control patients received continuous reinforcement with 25 % to 50 % of the initial dose . Results : Severity of disease scores in California neither supported nor refuted the hypothesis . In New York , where there was no difference between Partial Reinforcement and Dose Control groups at baseline , partial reinforcement effected a greater reduction in lesion severity than Dose Control conditions and did not differ from St and ard Therapy patients receiving two to four times more drug . For the entire population , the frequency of relapse under partial reinforcement ( 26.7 % ) was lower than in Dose Control patients ( 61.5 % ) and did not differ from full-dose treatment ( 22.2 % ) . Conclusions : A partial schedule of pharmacotherapeutic reinforcement could maintain psoriasis patients with a cumulative amount of corticosteroid that was relatively ineffective when administered under st and ard treatment conditions . Conceivably , corticosteroid administration only one quarter or half as frequently as currently prescribed is sufficient to treat psoriasis . We posit , however , that these preliminary observations implicate conditioning processes in— and for the design of — regimens of pharmacotherapy . PSS = Psoriasis Severity Scale ; CS = conditioned stimulus ; UCS = unconditioned stimulus OBJECTIVE Classical conditioning of insulin effects was examined in healthy humans using a placebo-controlled design . This study examined whether subjects who experienced a conditioned stimulus ( CS ) paired with insulin in the acquisition phase of a conditioning protocol would show a conditioned decrease of blood glucose when receiving the CS with a placebo injection in the test phase . METHODS Twenty healthy male students were assigned either to group 1 , which received insulin ( 0.035 IU/kg i.v . ) , or to group 2 , which received i.v . saline on 4 consecutive days ( acquisition ) . On day 5 ( test ) , both groups were injected with saline . The CS was an olfactory stimulus . Blood glucose , serum insulin , plasma glucagon , plasma catecholamines , serum cortisol , and symptoms were repeatedly measured during each session . RESULTS In the test phase , group 1 reacted with a significantly larger decrease of blood glucose after presentation of the CS than group 2 . Within group 1 , a larger conditioned blood glucose decrease was associated with features that enhance classical conditioning ( ie , intensity of the unconditioned response and intensity of the CS ) . Furthermore , in group 1 , there was an increase of baseline insulin from day 1 to day 5 and a tendency for insulin reduction after CS presentation . Groups also tended to differ in cortisol and neuroglycopenic symptoms after CS presentation . CONCLUSIONS Conditioned effects in blood glucose are in accordance with the predictions . As a result of the exploratory analyses , our data also provide hints about conditioned changes in insulin , counterregulatory hormones , and symptoms Objectives : Pre-exposure to an environment in which a nausea-inducing body rotation will subsequently be given constitutes a latent inhibition procedure that might act to reduce anticipatory and postrotation nausea . Methods : This was tested in 24 healthy subjects r and omly assigned to receive no pre-exposure ( group 0 ) , a single pre-exposure ( group 1 ) , or three pre-exposures ( group 3 ) . Rotation was st and ardized as 5 × 1 minute rotation , but the subjects could terminate it on request . Nausea was determined on a 7-item symptom rating scale before , during , and after rotation on days 3 and 4 , whereas anticipatory nausea was measured before presumed rotation on day 5 . Saliva cortisol and tumor necrosis factor & agr ; ( TNF-&agr ; ) levels were determined at baseline before , directly , and 15 and 30 minutes after rotation every day , and before presumed rotation on day 5 . Results : Pre-exposure significantly reduced the degree of anticipatory nausea on day 5 . Cortisol levels increased with rotation and were higher at baseline on days 4 and 5 , but subjects habituated from day 3 to day 4 ; levels were lower in women than in men . In contrast , TNF-&agr ; decreased with rotation but showed no habituation . For both cortisol and TNF-&agr ; , no effects on postrotational nausea were found . Conclusion : It is concluded that repetitive pre-exposure ( latent inhibition ) reduces anticipatory but not postrotation nausea ; behavioral measures ( rotation time ) and measures of acute stress ( cortisol , TNF-&agr ; ) do not respond to latent inhibition . Thus , Pavlovian conditioning rules are effective in healthy humans with anticipatory nausea but not with postrotation nausea . Hormonal responses — TNF-&agr ; decrease with stress , compensatory cortisol increase— and gender-related effects on learning and habituation are discussed with regard to psychophysiological and psychoimmunological processes . AN = anticipatory nausea ; CS = conditioned stimulus ; US = unconditioned stimulus ; CR = conditioned response ; PN = posttreatment nausea ; UR = unconditioned response ; TNF-&agr ; = tumor necrosis factor & agr ; ; RT = rotation tolerance ; MSSQ = motion sickness susceptibility question naire ; SR = symptom rating ; ANOVA = analysis of variance A classical Pavlovian paradigm pairing an olfactory cue with allergen challenge for a single training trial was used to produce conditioned histamine release and conditioned nasal airflow decrease in seasonal allergic rhinitis sufferers . There was no conditioned increase in subjective symptoms . Histamine release and airflow decrease showed evidence of extinction by a second test trial . A second study comparing the effects of the number of training trials showed that three training trials produced greater histamine release and airflow decrease than a single training trial , suggesting stronger effects with additional training Aims /hypothesisIn humans , the intranasal route allows insulin to reach the brain while maintaining peripheral euglycaemia . Our aims were to examine acute ( unconditioned ) effects of central insulin on normal-range blood glucose and hormones in men , and to find out whether the effects of intranasal insulin can be learnt via classical conditioning . Methods In a r and omised controlled trial , 32 healthy normal-weight men ( mean age 24.2 [ SEM 0.5 ] , mean BMI 22.4 [ 0.3 ] ) received a conditioned stimulus ( CS ) and six administrations of either soluble H-insulin 100 ( 20 U [ 0.2 ml ] ; group 1 ; n = 16 ) or vehicle ( 0.2 ml ; group 2 ; n = 16 ) on day 1 . The CS was the tarry smell of meta-cresol ( used as a stabilising vehicle in many insulin preparations and placebos ) . On day 2 , all participants received the CS and six administrations of placebo . Participants and experimenters were blinded to group assignment . Sixteen individuals were r and omised to and analysed in each group . Participants were sequentially numbered for group allocation . The main outcome measures were blood glucose and insulin , expressed as cumulative difference-from-baseline changes . Results While maintaining euglycaemia , intranasal insulin induced an increase of peripheral insulin on day 1 ( group 1 , 17.78 [ 21.88 ] pmol/l vs group 2 , −10.24 [ 9.42 ] pmol/l ) , and also on day 2 when the CS was given with placebo ( group 1 , 12.53 [ 5.57 ] pmol/l vs group 2 , −5.51 [ 6.16 ] pmol/l ) . Moreover , a moderate reduction of blood glucose on day 1 ( group 1 , −0.54 [ 0.36 ] mmol/l vs group 2 , 0.58 [ 0.48 ] mmol/l ) was obtained ( all p values < 0.05 ) . There were no adverse side effects . Conclusions /interpretationThe unconditioned blood glucose decrease on day 1 and the unconditioned and conditioned increases of peripheral insulin are indicative of brain – pancreas cross-talk . The conditionability of the hormonal responses reveals new applications for intranasal insulin . Trial registration : DRKS00000537 http://apps.who.int/trial search / Funding : Deutsche Forschungsgemeinschaft DFG STO 323/1 - 1 and 1 - 2 Rationale Peripheral immune responses can be modified by associative learning procedures . Less is known , however , whether and to what extent neuroendocrine parameters can be classically conditioned . Objectives In this r and omized double-blind study , we modified an established paradigm to behaviorally condition endocrine responses in humans . Methods Thirty-one healthy male participants received a distinctively flavored green drink as the conditioned stimulus ( CS ) and intravenous injections of corticotropin-releasing hormone ( CRH ) ( CRH group , N = 17 ) or NaCl ( placebo group , N = 14 ) as the unconditioned stimulus ( US ) during two subsequent acquisition trials . Plasma levels of cortisol and noradrenaline , heart rate , and psychological parameters were analyzed before and 15 , 30 , 60 , 120 , and 180 min after injection . The two acquisition trials were followed by two evocation trials , during which participants underwent the same procedure but now receiving NaCl injections . Results CRH administration induced pronounced increases in cortisol and noradrenaline plasma concentrations , heart rate , and anxiety levels . However , re-exposure to the CS during evocations trials did not provoke conditioned increases in neuroendocrine parameters . Median split of the CRH group based on the cortisol baseline level into “ cort-high ” and “ cort-low ” subgroups showed that the “ cort-high ” subgroup displayed a significantly increased cortisol production on evocation days compared to the “ cort-low ” subgroup and the placebo group . Conclusion This taste-endocrine paradigm employing CRH injection as the US in healthy male volunteers failed to induce a behaviorally conditioned cortisol release as a learned endocrine response . Future studies should clarify a possible role of higher baseline cortisol levels in perhaps facilitating a conditioned cortisol response Objective Pavlovian conditioning of taste aversion has rarely been investigated in healthy humans using motion sickness as the unconditioned stimulus ( US ) . Methods Ninety subjects were pretested for susceptibility to illusory motion ( vection ) in a rotating drum . Thirty-two subjects susceptible to pseudomotion were assigned r and omly to two groups and received either water 1 hour before rotation and a novel taste ( elderberry juice , conditioned stimulus , [ CS ] ) immediately before rotation in a rotating chair ( conditioning group ) , or the sequence of water and juice was reversed ( control group ) . During the test session 1 week later , all subjects were exposed to water 1 hour before and juice immediately before rotation . The amount of liquids ingested , nausea ratings , rotation tolerance , and blood levels of hormones ( ACTH , ADH , PP ) were evaluated . Results Subjects in the conditioning group developed taste aversion toward the novel taste , but not subjects in the control group . Postrotation nausea rating was affected marginally by conditioning , but rotation tolerance was not changed by conditioning . ACTH and ADH but not PP levels increased with rotation , but were unaffected by conditioning . Conclusions Pavlovian conditioning of behavioral , but not of endocrine , indicators was effective in susceptible subjects using a rotating chair as US and a single CS-US pairing Animal research has indicated that the activity of the hypothalamic-pituitary-adrenal axis can be influenced by classical ( Pavlovian ) conditioning procedures . To test the hypothesis that alterations in plasma cortisol levels can be conditioned in humans , the present study used a prospect i ve , r and omized , double-blind , placebo-controlled design in which a distinctively flavored beverage was paired with p.o . administration of dexamethasone . Twenty-five healthy men were r and omly assigned to one of two groups . During the conditioning phase of the study , subjects in the experimental group received three conditioning trials ( pairings of a distinctively flavored beverage with a capsule containing 5 mg dexamethasone ) separated by 1 wk recovery periods . Subjects in the control group were treated identically , except that the capsule contained a placebo . During the test phase , all subjects underwent a test day ( reexposure to the distinctively flavored beverage before receiving a placebo capsule ) and a comparison day ( no exposure to the beverage or the capsule ) . Plasma cortisol was assessed repetitively before and after administration of the beverage and capsule , as were possible confounding factors , including : behavioral variables , psychological distress , aversive reactions to the beverage , and expectations of treatment . After reexposure to the beverage and administration of a placebo capsule ( conditioned stimuli ) , the experimental group had significantly higher levels of plasma cortisol than the control group , after controlling for variability in baseline levels of cortisol ( F(5,60)=3.09 ; P=0.015 ) that could not be explained by differences in other study variables . No differences in cortisol levels were found on the comparison day . These results support the study hypothesis that changes in plasma cortisol levels can be classically conditioned in humans by pairing a distinctive beverage with p.o . administration of dexamethasone Background Systematic Review s ( SRs ) of experimental animal studies are not yet common practice , but awareness of the merits of conducting such SRs is steadily increasing . As animal intervention studies differ from r and omized clinical trials ( RCT ) in many aspects , the methodology for SRs of clinical trials needs to be adapted and optimized for animal intervention studies . The Cochrane Collaboration developed a Risk of Bias ( RoB ) tool to establish consistency and avoid discrepancies in assessing the method ological quality of RCTs . A similar initiative is warranted in the field of animal experimentation . Methods We provide an RoB tool for animal intervention studies ( SYRCLE ’s RoB tool ) . This tool is based on the Cochrane RoB tool and has been adjusted for aspects of bias that play a specific role in animal intervention studies . To enhance transparency and applicability , we formulated signalling questions to facilitate judgment . Results The result ing RoB tool for animal studies contains 10 entries . These entries are related to selection bias , performance bias , detection bias , attrition bias , reporting bias and other biases . Half these items are in agreement with the items in the Cochrane RoB tool . Most of the variations between the two tools are due to differences in design between RCTs and animal studies . Shortcomings in , or unfamiliarity with , specific aspects of experimental design of animal studies compared to clinical studies also play a role . Conclusions SYRCLE ’s RoB tool is an adapted version of the Cochrane RoB tool . Widespread adoption and implementation of this tool will facilitate and improve critical appraisal of evidence from animal studies . This may subsequently enhance the efficiency of translating animal research into clinical practice and increase awareness of the necessity of improving the method ological quality of animal studies |
380 | 30,661,482 | According to pooled results , romiplostim appears to be the most suitable treatment in terms of OR , followed by avatrombopag , eltrombopag , fostamatinib , and rituximab .
Avatrombopag produced more satisfactory outcomes than romiplostim , eltrombopag , and rituximab in terms of ER ; severe AEs profiles were similar across all treatment arms .
Conclusion : Romiplostim appears to be the best option for patients who fail to respond to prior treatment or relapse thereafter , while avatrombopag and eltrombopag are reasonable alternatives .
Rituximab monotherapy is not recommended , as it produces the lowest OR and ER rates | ABSTRACT Objectives : The great majority of adult patients with immune thrombocytopenia ( ITP ) who fail to respond to first-line medication or who relapse following response require additional treatment .
Although broad guidelines currently exist for second-line and subsequent therapies , none to date have been prescriptive .
The purpose of this systematic review and network meta- analysis was to establish a clinical ly relevant ranking of the efficacy and safety of medications for adults ( ≥18 years old ) with previously treated ITP . | Objective : To investigate the safety and efficacy of eltrombopag for adult patients with chronic immune thrombocytopenia ( cITP ) . Methods : It was a r and omised , single-centre , 6 weeks , placebo-controlled study . Beginning in January 29(th ) , 2013 , 35 patients were enrolled , and the trial was completed on May 16(th ) , 2014 . 17 patients were assigned to receive eltrombopag ( starting dose 25 mg/d ) and 18 were assigned to receive placebo . Results : A total of 35 cases of adult cITP , 6 males and 29 females with a median age of 42(22 - 66 ) years were enrolled . One patient withdrew from eltrombopag treatment group for the adverse event ( AE ) and discontinued treatment . In first two weeks , 27.78 % ( 5/18 ) of placebo-treated compared with 64.71%(11/17 ) of eltrombopag-treated patients achieved platelet counts ≥ 30 × 10(9)/L(P=0.031 ) ; Treatment 6 weeks , the proportion of platelet counts reached ≥50 × 10(9)/L and ≥ 30 × 10(9)/L in eltrombopag-treated were higher than placebo-treated ones with statistically significant differences in both groups [ 64.71%(11/17 ) vs 11.11 % ( 2/18 ) , P=0.001 ; 76.47 % ( 13/17 ) vs 38.89 % ( 7/18 ) , P=0.028 ] ; The study also indicated a statistically significant difference in favour of eltrombopag compared with placebo in the odds of achieving the outcome of a platelet count ≥ 50 × 10(9)/L at least once during 6-week treatment ( 94.11 % vs 33.33 % , P<0.001 ) , and 70.59%(12/17 ) of patients with the platelet count continuously ≥ 50 × 10(9)/L in 50 % of treatment time in eltrombopag-treated group was more than placebo-treated one [ 11.11%(2/18 ) , P<0.001 ] . Proportions of patients who required rescue treatment were 44.44 % in placebo group and none in eltrombopag-treated one , respectively ( P=0.002 ) ; The odds of bleeding symptoms with the WHO bleeding scale had no difference in both groups after 6 weeks ( P=0.066 ) . Adverse events that occurred more frequently due to eltrombopag than placebo included increased transaminase ( 3/17 ) and blood bilirubin ( 5/17 ) , cerebral infa rct ion(1/17 ) . Conclusions : The thrombopoietin receptor agonist eltrombopag was a suitable therapeutic option for Chinese adults with cITP BACKGROUND Immune thrombocytopenia is characterised by immune-mediated destruction and suboptimum production of platelets . Despite the absence of supporting evidence , rituximab is frequently used off-label in patients with immune thrombocytopenia . We aim ed to assess the efficacy of rituximab as compared with placebo as a splenectomy-sparing treatment in patients who were previously treated with corticosteroids . METHODS In this multicentre , r and omised , double-masked , placebo-controlled trial , we enrolled corticosteroid unresponsive adult patients ( aged ≥18 years ) with primary immune thrombocytopenia and a platelet count of less than 30 × 10(9 ) platelets per L. Patients were r and omly assigned ( 1:1 ) to four weekly infusions of 375 mg/m(2 ) rituximab or placebo . Concurrent treatment with corticosteroids only was allowed during the study . The primary endpoint was rate of treatment failure within 78 weeks -- a composite of splenectomy or meeting criteria for splenectomy after week 12 if splenectomy was not done , assessed in all patients who received at least one dose of study treatment . Secondary endpoints were response rates , relapse rates , and duration of response . Efficacy endpoints were assessed with the Kaplan-Meier method . Safety endpoints were assessed in all patients who received at least one dose . This trial is registered with Clinical Trials.gov , number NCT00344149 . FINDINGS Between Aug 17 , 2006 , and June 30 , 2011 , we enrolled 112 patients . 32 ( 58 % ) of 55 patients in the rituximab group and 37 ( 69 % ) of 54 patients in the placebo group had treatment failure within 78 weeks ( Kaplan-Meier cumulative incidence 46 % for rituximab vs 52 % for placebo ( hazard ratio [ HR ] 0·89 , 95 % CI 0·55 - 1·45 ; p=0·65 ) . The cumulative incidence of overall response was 81 % in the rituximab group versus 73 % in the placebo group ( p=0·15 ) and complete response was 58 % in the rituximab group versus 50 % in the placebo group ( p=0·12 ) . Of those achieving an overall response , 68 % relapsed in the rituximab group and 78 % relapsed in the placebo group , and of those achieving complete response , 50 % relapsed in the rituximab group and 62 % relapsed in the placebo group . Time to relapse in the rituximab group was longer in patients who achieved overall response ( 36 vs 7 weeks ; p=0·01 ) but not complete response ( 76 vs 49 weeks ; p=0·19 ) . Rates of bleeding were similar in the two groups ( 21 [ 38 % ] in the rituximab group vs 27 [ 50 % ] in the placebo group ; p=0·08 ) as were rates of infection ( 22 [ 40 % ] vs 13 [ 24 % ] ; p=0·09 ) . INTERPRETATION Despite no reduction in the rate of long-term treatment failure with rituximab , a small benefit can not be ruled out , as suggested by an apparently longer duration of response and numerically higher response rates with rituximab . FUNDING South-East Regional Health Authority and Østfold Hospital , Norway ; Roche , France ; and Roche , Norway This r and omized trial was performed to investigate the efficacy of low-dose rituximab in combination with glucocorticoids for treatment of patients with immune thrombocytopenia ( ITP ) . Sixty-two patients were r and omly separated into the glucocorticoids ( control ) and the experimental ( glucocorticoids + rituximab ) groups . Patients in both groups received dexamethasone 40 mg/day on days 1–4 , followed by decrements of prednisone 60 , 30 , 15 , 10 mg/day on days 5–7 , 8–14 , 15–21 , 22–28 , respectively . Patients in the experimental group also received rituximab 100 mg on days 7 , 14 , 21 , 28 . The overall response ( OR ) was similar in both groups at day 28 ( experimental group vs. glucocorticoids group : 80.6 vs. 74.2 % , P = .938 ) ; however , sustained response ( SR ) was more pronounced in the experimental group as compared to that in the glucocorticoids group ( 77.4 vs. 38.7 % , P < .001 ) . Both groups showed similar incidence of adverse events ( experimental group vs. glucocorticoids group : 9.7 vs. 6.5 % , P = .325 ) . As expected , B cell depletion was seen in the experimental group . In addition , both groups experienced a significant up-regulation in Treg cell levels , but the up-regulation in the experimental group was maintained at an even higher level and persisted a longer time than those in the glucocorticoids group . Thus , low-dose rituximab combined with short-term glucocorticoids provides an alternative treatment for ITP prior to splenectomy To determine whether inhibition of Syk would be useful in FcgammaR-dependent cytopenias such as immune thrombocytopenic purpura ( ITP ) or autoimmune hemolytic anemia , mouse models were used to evaluate efficacy of R406 , an inhibitor of Syk function , in treating cytopenia . Both disease models responded favorably to treatment , with amelioration of ITP being more dramatic . Thus , phase 2 clinical trial was initiated to study the effects of Syk inhibition in humans with ITP . Sixteen adults with chronic ITP were entered into an open-label , single-arm cohort dose-escalation trial beginning with 75 mg and escalating as high as 175 mg twice daily . Doses were increased until a persistent response was seen , toxicity occurred , or 175 mg twice daily was reached . Eight patients achieved persistent responses with platelet counts greater than 50 x 10(9)/L ( 50 000 mm(3 ) ) on more than 67 % ( actually 95 % ) of their study visits , including 3 who had not persistently responded to thrombopoietic agents . Four others had nonsustained responses . Mean peak platelet count exceeded 100 x 10(9)/L ( 100 000 mm(3 ) ) in these 12 patients . Toxicity was primarily GI-related with diarrhea ( urgency ) and vomiting ; 2 patients had transaminitis . In conclusion , inhibition of Syk was an efficacious means of increasing and maintaining the platelet count in half the patients with chronic refractory ITP . ( Clinical Trials.gov , no. NCT00706342 ) The benefit of adding rituximab to st and ard treatment in nonsplenectomized patients with primary immune thrombocytopenia ( ITP ) is uncertain . We performed a pilot r and omized trial to determine the feasibility of recruitment , protocol adherence , and blinding of a larger trial of rituximab versus placebo ; and to evaluate the potential efficacy of adjuvant rituximab in ITP . Nonsplenectomized adults with newly diagnosed or relapsed ITP who were receiving st and ard ITP therapy for a platelet count below 30 × 10(9)/L were r and omly allocated to receive 4 weekly infusions of 375 mg/m(2 ) rituximab or saline placebo . Sixty patients were recruited over 46 months , which was slower than anticipated . Protocol adherence and follow-up targets were achieved , and blinding was successful for research staff but not for patients . After 6 months , there was no difference between rituximab and placebo groups for the composite outcome of any platelet count below 50 × 10(9)/L , significant bleeding or rescue treatment once st and ard treatment was stopped ( 21/32 [ 65.6 % ] vs 21/26 [ 80.8 % ] ; relative risk = 0.81 , 95 % confidence intervals , 0.59%-1.11 % ) . Timely accrual poses a challenge to the conduct of a large r and omized trial of rituximab for presplenectomy ITP . No difference in the frequency of the composite outcome was observed in this pilot trial ( registered at www . clinical trials.gov NCT00372892 ) Spleen tyrosine kinase ( Syk ) signaling is central to phagocytosis‐based , antibody‐mediated platelet destruction in adults with immune thrombocytopenia ( ITP ) . Fostamatinib , an oral Syk inhibitor , produced sustained on‐treatment responses in a phase 2 ITP study . In two parallel , phase 3 , multicenter , r and omized , double‐blind , placebo‐controlled trials ( FIT1 and FIT2 ) , patients with persistent/chronic ITP were r and omized 2:1 to fostamatinib ( n = 101 ) or placebo ( n = 49 ) at 100 mg BID for 24 weeks with a dose increase in nonresponders to 150 mg BID after 4 weeks . The primary endpoint was stable response ( platelets ≥50 000/μL at ≥4 of 6 biweekly visits , weeks 14‐24 , without rescue therapy ) . Baseline median platelet count was 16 000/μL ; median duration of ITP was 8.5 years . Stable responses occurred in 18 % of patients on fostamatinib vs. 2 % on placebo ( P = .0003 ) . Overall responses ( defined retrospectively as ≥1 platelet count ≥50 000/μL within the first 12 weeks on treatment ) occurred in 43 % of patients on fostamatinib vs. 14 % on placebo ( P = .0006 ) . Median time to response was 15 days ( on 100 mg bid ) , and 83 % responded within 8 weeks . The most common adverse events were diarrhea ( 31 % on fostamatinib vs. 15 % on placebo ) , hypertension ( 28 % vs. 13 % ) , nausea ( 19 % vs. 8 % ) , dizziness ( 11 % vs. 8 % ) , and ALT increase ( 11 % vs. 0 % ) . Most events were mild or moderate and resolved spontaneously or with medical management ( antihypertensive , anti‐motility agents ) . Fostamatinib produced clinical ly‐meaningful responses in ITP patients including those who failed splenectomy , thrombopoietic agents , and /or rituximab . Fostamatinib is a novel ITP treatment option that targets an important mechanism of ITP pathogenesis This study aim ed to compare the efficacy and safety of rituximab ( RTX ) plus recombinant human thrombopoietin ( rhTPO ) with RTX alone in patients with immune thrombocytopenia ( ITP ) who had failed to respond to corticosteroids or relapsed . Recruited patients were r and omized at a ratio of 2:1 into 2 groups : the combination group ( RTX + rhTPO , n = 77 ) and the monotherapy group ( RTX , n = 38 ) . Overall response was achieved in 79.2 % of patients in the combination group vs 71.1 % in the monotherapy group ( P = .36 ) , and the complete response ( CR ) rate was 45.4 % in the combination group compared with 23.7 % in the monotherapy group ( P = .026 ) . The combination group had significantly shorter time to response ( TTR ; median and range , 7 and 4 - 28 days ) compared with the monotherapy group ( 28 and 4 - 90 days ) ( P < .01 ) . There was no difference between these 2 groups in terms of the long-term response ( P = .12 ) . Our findings demonstrated that the combination of RTX and rhTPO significantly increased the CR rate and shortened TTR compared with RTX monotherapy in the treatment of corticosteroid-resistant or relapsed ITP but failed to show a beneficial effect on the long-lasting response . This study is registered at www . clinical trials.gov as # NCT01525836 Idiopathic thrombocytopenic purpura ( ITP ) is an autoimmune disorder characterized by persistent thrombocytopenia ( peripheral blood platelet count < 150 · 10 ⁄ l ) due to autoantibody binding to platelet antigen(s ) causing their premature destruction by the reticuloendothelial system , and in particular the spleen ( Woods et al , 1984a , b ) . Although the basic underlying pathophysiology of ITP has been known for 50 years ( Harrington et al , 1951 ) , the literature shows that the investigation and management of patients with thrombocytopenia vary widely , and is not evidence -based , due to a lack of clinical trials and quality research . Despite major advances in our underst and ing of the molecular basis of many blood disorders , the diagnosis of ITP remains one of exclusion ; there are currently no robust clinical or laboratory parameters that are able to establish the diagnosis of ITP with accuracy . This guideline aims to assess available diagnostic tests and therapies , and attempts to provide a rational approach to the diagnosis and treatment in adults , children and in pregnancy . Although natural history data are becoming available ( Cohen et al , 2000 ; Djulbegovic & Cohen , 2001 ; Portielje et al , 2001 ) , there are few r and omized trials in ITP and many of the recommendations , like those of the American Society of Hematology ( ASH ) Panel ( George et al , 1996 ) , are based on expert opinion BACKGROUND No firm data are available on the natural history of idiopathic thrombocytopenic purpura ( ITP ) or on mortality rates or frequency of major bleeding episodes associated with this condition . The disease is thought to have a relatively benign course , despite the frequent occurrence of very low platelet counts . This prevailing conception often guides therapeutic decisions . OBJECTIVE To estimate the bleeding risk of ITP involving persistent low platelet counts ( < 30 x 10(9)/L ) and its impact on prognosis . DESIGN Age-adjusted bleeding risk was derived from a pooled analysis of ITP clinical series based on a systematic literature search . The risk estimate was incorporated into a Markov model to determine its impact on prognosis . RESULTS Seventeen case series complied with inclusion criteria , including 1,817 patients with ITP . There were 49 cases of fatal hemorrhage over an estimated 1,258 to 3,023 patient-years at risk . The rate of fatal hemorrhage before age adjustment was estimated at between 0.0162 and 0.0389 cases per patient-year . Age-adjusted rates were 0.004 , 0.012 , and 0.130 cases per patient-year for age groups younger than 40 , 40 to 60 , and older than 60 years , respectively . Predicted 5-year mortality rates ranged from 2.2 % for patients younger than 40 years to 47.8 % for those older than 60 years . A 30-year-old woman remaining thrombocytopenic due to ITP was predicted to lose 20.4 years ( 14.9 quality -adjusted life years ) of her potential life expectancy . At age 70 , predicted loss was 9.4 years ( 5.0 quality -adjusted life years ) . CONCLUSIONS Idiopathic thrombocytopenic purpura with persistent low platelet counts carries a grave prognosis . Therefore , an active therapeutic approach in the clinical management of affected patients should be considered . In view of the significant potential implication s of the model results , we call for initiating a well- design ed prospect i ve inception cohort study of patients with ITP The efficacy and safety of romiplostim , a thrombopoietin-mimetic peptibody , were evaluated in a double-blind , placebo-controlled , r and omized trial of Japanese patients with chronic immune thrombocytopenia ( ITP ) . Thirty-four ITP patients received romiplostim ( n = 22 ) or placebo ( n = 12 ) for 12 weeks , with a starting romiplostim dose of 3 μg/kg weekly . The primary end point was the number of weeks with platelet response , defined as a platelet count ≥50 × 109/L ( not including the 4 weeks after rescue medication administration ) . Patients received a median of 4 ( range 1–19 ) prior ITP therapies including splenectomy in 44 % . On study , 68 % also received concomitant ITP therapy . Weekly responses occurred for a median of 11 weeks with romiplostim as compared to 0 weeks with placebo ( p < 0.0001 ) . Most romiplostim-treated patients ( 95 % ) achieved platelet responses ; two showed extended responses after the treatment period . The use of rescue medication was required in 9 % of romiplostim-treated patients as compared with 17 % of placebo-treated patients . Both treatment groups had similar incidences of adverse events ( 91 % romiplostim , 92 % placebo ) . Adverse events that occurred more frequently ( > 10 % ) in romiplostim-treated patients included nasopharyngitis , headache , peripheral edema , back pain , and extremity pain . In conclusion , romiplostim significantly increased and maintained platelet counts and was well tolerated in Japanese patients with ITP BACKGROUND Eltrombopag is an oral thrombopoietin receptor agonist for the treatment of thrombocytopenia . We aim ed to compare the response to once daily eltrombopag versus placebo in patients with chronic immune thrombocytopenia during a 6-month period . METHODS We undertook a phase 3 , double-blind , placebo-controlled study in adults with previously treated immune thrombocytopenia of more than 6 months ' duration who had baseline platelet counts lower than 30,000 per μL. Patients were r and omly allocated ( in a 2:1 ratio ) treatment with local st and ard of care plus 50 mg eltrombopag or matching placebo once daily for 6 months . R and omisation was done central ly with a computer-generated r and omisation schedule and was stratified by baseline platelet count ( ≤ 15,000 per μL ) , use of treatment for immune thrombocytopenia , and splenectomy status . Patients , investigators , and those assessing data were masked to allocation . Dose modifications were made on the basis of platelet response . Patients were assessed for response to treatment ( defined as a platelet count of 50,000 - 400,000 per μL ) weekly during the first 6 weeks and at least once every 4 weeks thereafter ; the primary endpoint was the odds of response to eltrombopag versus placebo . Analysis was by intention to treat . This study is registered at Clinical Trials.gov , number NCT00370331 . FINDINGS Between Nov 22 , 2006 , and July 31 , 2007 , 197 patients were r and omly allocated to treatment groups and were included in the intention-to-treat analysis ( 135 eltrombopag , 62 placebo ) . 106 ( 79 % ) patients in the eltrombopag group responded to treatment at least once during the study , compared with 17 ( 28 % ) patients in the placebo group . The odds of responding were greater in patients in the eltrombopag group compared with those in the placebo group throughout the 6-month treatment period ( odds ratio 8·2 , 99 % CI 3·59 - 18·73 ; p<0·0001 ) . 37 ( 59 % ) patients receiving eltrombopag reduced concomitant treatment versus ten ( 32 % ) patients receiving placebo ( p=0·016 ) . 24 ( 18 % ) patients receiving eltrombopag needed rescue treatment compared with 25 ( 40 % ) patients receiving placebo ( p=0·001 ) . Three ( 2 % ) patients receiving eltrombopag had thromboembolic events compared with none in patients on placebo . Nine ( 7 % ) eltrombopag-treated patients and two ( 3 % ) in the placebo group had mild increases in alanine aminotransferase concentration , and five ( 4 % ) eltrombopag-treated patients ( vs none allocated to placebo ) had increases in total bilirubin . Four ( 7 % ) patients taking placebo had serious bleeding events , compared with one ( < 1 % ) patient treated with eltrombopag . INTERPRETATION Eltrombopag is effective for management of chronic immune thrombocytopenia , and could be particularly beneficial for patients who have not responded to splenectomy or previous treatment . These benefits should be balanced with the potential risks associated with eltrombopag treatment . FUNDING GlaxoSmithKline BACKGROUND Most current treatments for chronic immune thrombocytopenic purpura ( ITP ) act by decreasing platelet destruction . In a phase 1 - 2 study , we administered a thrombopoiesis-stimulating protein , AMG 531 , to patients with ITP . METHODS In phase 1 , 24 patients who had received at least one treatment for ITP were assigned to escalating-dose cohorts of 4 patients each and given two identical doses of AMG 531 ( 0.2 to 10 microg per kilogram of body weight ) . In phase 2 , 21 patients were r and omly assigned to receive six weekly subcutaneous injections of AMG 531 ( 1 , 3 , or 6 microg per kilogram ) or placebo . The primary objective was to assess the safety of AMG 531 ; the secondary objective was to evaluate platelet counts during and after treatment . RESULTS No major adverse events that could be attributed directly to AMG 531 occurred during the treatment period ; 4 of 41 patients had transient post-treatment worsening of thrombocytopenia . In phase 1 , a platelet count that was within the targeted range ( 50,000 to 450,000 per cubic millimeter ) and at least twice the baseline count was achieved in 4 of 12 patients given 3 , 6 , or 10 mug of AMG 531 per kilogram . Overall , a platelet count of at least 50,000 per cubic millimeter was achieved in 7 of 12 patients , including 3 with counts exceeding 450,000 per cubic millimeter . Increases in the platelet count were dose-dependent ; mean peak counts were 163,000 , 309,000 , and 746,000 per cubic millimeter with 3 , 6 , and 10 microg of AMG 531 per kilogram [ corrected ] , respectively . In phase 2 , the targeted platelet range was achieved in 10 of 16 patients treated with 1 or 3 mug of AMG 531 per kilogram per week for 6 weeks . Mean peak counts were 135,000 , 241,000 , and 81,000 per cubic millimeter in the groups that received the 1-mug dose , the 3-mug dose , and placebo , respectively . CONCLUSIONS AMG 531 caused no major adverse events and increased platelet counts in patients with ITP . ( Clinical Trials.gov number , NCT00111475 [ Clinical Trials.gov ] . ) BACKGROUND Chronic immune thrombocytopenic purpura ( ITP ) is characterised by accelerated platelet destruction and decreased platelet production . Short-term administration of the thrombopoiesis-stimulating protein , romiplostim , has been shown to increase platelet counts in most patients with chronic ITP . We assessed the long-term administration of romiplostim in splenectomised and non-splenectomised patients with ITP . METHODS In two parallel trials , 63 splenectomised and 62 non-splenectomised patients with ITP and a mean of three platelet counts 30x10(9)/L or less were r and omly assigned 2:1 to subcutaneous injections of romiplostim ( n=42 in splenectomised study and n=41 in non-splenectomised study ) or placebo ( n=21 in both studies ) every week for 24 weeks . Doses of study drug were adjusted to maintain platelet counts of 50x10(9)/L to 200x10(9)/L. The primary objectives were to assess the efficacy of romiplostim as measured by a durable platelet response ( platelet count > or = 50x10(9)/L during 6 or more of the last 8 weeks of treatment ) and treatment safety . Analysis was per protocol . These studies are registered with Clinical Trials.gov , numbers NCT00102323 and NCT00102336 . FINDINGS A durable platelet response was achieved by 16 of 42 splenectomised patients given romplostim versus none of 21 given placebo ( difference in proportion of patients responding 38 % [ 95 % CI 23.4 - 52.8 ] , p=0.0013 ) , and by 25 of 41 non-splenectomised patients given romplostim versus one of 21 given placebo ( 56 % [ 38.7 - 73.7 ] , p<0.0001 ) . The overall platelet response rate ( either durable or transient platelet response ) was noted in 88 % ( 36/41 ) of non-splenectomised and 79 % ( 33/42 ) of splenectomised patients given romiplostim compared with 14 % ( three of 21 ) of non-splenectomised and no splenectomised patients given placebo ( p<0.0001 ) . Patients given romiplostim achieved platelet counts of 50x10(9)/L or more on a mean of 13.8 ( SE 0.9 ) weeks ( mean 12.3 [ 1.2 ] weeks in splenectomised group vs 15.2 [ 1.2 ] weeks in non-splenectomised group ) compared with 0.8 ( 0.4 ) weeks for those given placebo ( 0.2 [ 0.1 ] weeks vs 1.3 [ 0.8 ] weeks ) . 87 % ( 20/23 ) of patients given romiplostim ( 12/12 splenectomised and eight of 11 non-splenectomised patients ) reduced or discontinued concurrent therapy compared with 38 % ( six of 16 ) of those given placebo ( one of six splenectomised and five of ten non-splenectomised patients ) . Adverse events were much the same in patients given romiplostim and placebo . No antibodies against romiplostim or thrombopoietin were detected . INTERPRETATION Romiplostim was well tolerated , and increased and maintained platelet counts in splenectomised and non-splenectomised patients with ITP . Many patients were able to reduce or discontinue other ITP medications . Stimulation of platelet production by romiplostim may provide a new therapeutic option for patients with ITP BACKGROUND The pathogenesis of chronic idiopathic thrombocytopenic purpura ( ITP ) involves antibody-mediated platelet destruction and reduced platelet production . Stimulation of platelet production may be an effective treatment for this disorder . METHODS We conducted a trial in which 118 adults with chronic ITP and platelet counts of less than 30,000 per cubic millimeter who had had relapses or whose platelet count was refractory to at least one st and ard treatment for ITP were r and omly assigned to receive the oral thrombopoietin-receptor agonist eltrombopag ( 30 , 50 , or 75 mg daily ) or placebo . The primary end point was a platelet count of 50,000 or more per cubic millimeter on day 43 . RESULTS In the eltrombopag groups receiving 30 , 50 , and 75 mg per day , the primary end point was achieved in 28 % , 70 % , and 81 % of patients , respectively . In the placebo group , the end point was achieved in 11 % of patients . The median platelet counts on day 43 for the groups receiving 30 , 50 , and 75 mg of eltrombopag were 26,000 , 128,000 , and 183,000 per cubic millimeter , respectively ; for the placebo group the count was 16,000 per cubic millimeter . By day 15 , more than 80 % of patients receiving 50 or 75 mg of eltrombopag daily had an increased platelet count . Bleeding also decreased during treatment in these two groups . The incidence and severity of adverse events were similar in the placebo and eltrombopag groups . CONCLUSIONS Eltrombopag increased platelet counts in a dose-dependent manner in patients with relapsed or refractory ITP . ( Clinical Trials.gov number , NCT00102739 . BACKGROUND Eltrombopag is an oral , non-peptide , thrombopoietin-receptor agonist that stimulates thrombopoiesis , leading to increased platelet production . This study assessed the efficacy , safety , and tolerability of once daily eltrombopag 50 mg , and explored the efficacy of a dose increase to 75 mg . METHODS In this phase III , r and omised , double-blind , placebo-controlled study , adults from 63 sites in 23 countries with chronic idiopathic thrombocytopenic purpura ( ITP ) , platelet counts less than 30 000 per muL of blood , and one or more previous ITP treatment received st and ard care plus once-daily eltrombopag 50 mg ( n=76 ) or placebo ( n=38 ) for up to 6 weeks . Patients were r and omly assigned in a 2:1 ratio of eltrombopag : placebo by a vali date d r and omisation system . After 3 weeks , patients with platelet counts less than 50 000 per microL could increase study drug to 75 mg . The primary endpoint was the proportion of patients achieving platelet counts 50 000 per microL or more at day 43 . All participants who received at least one dose of their allocated treatment were included in the analysis . This study is registered with Clinical Trials.gov , number NCT00102739 . FINDINGS 73 patients in the eltrombopag group and 37 in the placebo group were included in the efficacy population and were evaluable for day-43 analyses . 43 ( 59 % ) eltrombopag patients and six ( 16 % ) placebo patients responded ( ie , achieved platelet counts > /=50 000 per microL ; odds ratio [ OR ] 9.61 [ 95 % CI 3.31 - 27.86 ] ; p<0.0001 ) . Response to eltrombopag compared with placebo was not affected by predefined study stratification variables ( baseline platelet counts , concomitant ITP drugs , and splenectomy status ) or by the number of previous ITP treatments . Of the 34 patients in the efficacy analysis who increased their dose of eltrombopag , ten ( 29 % ) responded . Platelet counts generally returned to baseline values within 2 weeks after the end of treatment . Patients receiving eltrombopag had less bleeding at any time during the study than did those receiving placebo ( OR 0.49 [ 95 % CI 0.26 - 0.89 ] ; p=0.021 ) . The frequency of grade 3 - 4 adverse events during treatment ( eltrombopag , two [ 3 % ] ; placebo , one [ 3 % ] ) and adverse events leading to study discontinuation ( eltrombopag , three [ 4 % ] ; placebo , two [ 5 % ] ) , were similar in both groups . INTERPRETATION Eltrombopag is an effective treatment for managment of thrombocytopenia in chronic ITP Eltrombopag , a thrombopoietin receptor agonist , raises platelet counts and reduces bleeding in patients with immune thrombocytopenia ( ITP ) . In Chinese patients , eltrombopag was evaluated at an initial dose of 25 mg , vs. 50 mg for non‐Asians , because the plasma exposure of eltrombopag is higher in East Asians . A multicentre , double‐blind , r and omised , placebo‐controlled , 8‐week , phase III study enrolled 155 patients with chronic , previously treated ITP . Dosage could be adjusted ( 25–75 mg/day ) to maintain platelet counts 50–250 × 109/l . The primary efficacy endpoint was the proportion of patients with a platelet count ≥50 × 109/l after Day 42 . Pharmacokinetics and pharmacodynamics of eltrombopag were analysed in an open‐label extension . After Day 42 , 57·7 % of eltrombopag‐treated and 6·0 % of placebo‐treated patients achieved platelet counts ≥50 × 109/l . Odds of achieving a platelet count ≥50 × 109/l were 26·08 times greater with eltrombopag than placebo ( P < 0·001 ) . Compared with placebo , time to response and duration of response were better with eltrombopag ( P < 0·001 ) and the odds of any bleeding were reduced by 72 % ( P = 0·001 ) . Tolerability , pharmacokinetics , and pharmacokinetics/pharmacodynamics were similar to previous findings in East Asian patients . In conclusion , in Chinese patients with chronic ITP , eltrombopag 25 mg once daily , elevated platelet counts to a safe range and reduced bleeding This multicenter , r and omized trial assessed the efficacy and safety of a recombinant human thrombopoietin ( rhTPO ) in patients with persistent primary immune thrombocytopenia ( ITP ) who had failed glucocorticosteroid treatment . A total of 140 eligible patients were r and omized to receive rhTPO + danazol ( rhTPO group , 73 patients ) or danazol ( control group , 67 patients ) alone . During the first phase , the increase in the mean maximal platelet counts ( 101.2 × 109/L ) and the area under curve ( 749.6 ) in the rhTPO group were significantly higher compared to control ( 33.3 × 109/L and 316.2 ; P = 0.0060 and 0.0000 , respectively ) . The major response rate ( MRR ) and total response rate ( TRR ) in the rhTPO group were 38.4 and 60.3 % , respectively , significantly higher than in control ( MRR 7.9 % , P = 0.0003 ; TRR 36.5 % , P = 0.0104 ) . In the control group , 45 patients with platelet counts < 20 × 109/L were given rhTPO during the second phase and achieved MRR 31.1 % and TRR 66.7 % . The mean platelet counts in the rhTPO group were still approximately 50 × 109/L on day 28 of the study . The overall incidence of rhTPO-related adverse events was 13.6 % . All the adverse events were generally mild . This study demonstrated that rhTPO was well tolerated , and it markedly increased platelet counts in chronic ITP patients . Stimulation of platelet production by rhTPO may provide a new therapeutic option for patients with ITP BACKGROUND Eltrombopag is an oral , non-peptide thrombopoietin receptor agonist that has shown efficacy and safety in chronic immune thrombocytopenia ( ITP ) . However , ethnic differences in eltrombopag exposure have been reported : area under the curve exposure to eltrombopag was 87 % greater among ITP patients of East Asian descent than among ITP patients of non-East Asian ITP descent . OBJECTIVES To evaluate the efficacy and safety of eltrombopag by using , in Japanese ITP patients , lower starting ( 12.5 mg ) and maximum ( 50 mg ) doses of eltrombopag than the st and ard starting ( 50 mg ) and maximum ( 75 mg ) doses approved in the USA and Europe . PATIENTS We examined 23 Japanese patients with previously treated chronic ITP with a platelet count of < 30,000 μL(-1 ) in a multicenter study comprising a r and omized , double-blind , placebo-controlled phase for 6-week evaluation ( 15 eltrombopag , and eight placebo ) and an open-label phase for 6-month evaluation ( 23 eltrombopag ) . RESULTS AND CONCLUSIONS The response rate ( platelet count of ≥ 50,000 μL(-1 ) ) at week 6 of the 6-week double-blind phase was 60 % in eltrombopag-treated patients and 0 % in placebo-treated patients . Ten of 23 patients ( 43.5 % ) responded for ≥ 75 % of predefined assessment visits during the 6-month open-label phase . Notably , 22 % ( 5/23 ) of patients responded to 12.5 mg of eltrombopag , which was administered within the first 3 weeks of eltrombopag treatment . Bleeding decreased with eltrombopag treatment as compared with baseline . Eltrombopag was generally well tolerated ; one patient experienced a transient ischemic attack on day 9 . Eltrombopag ( 12.5 - 50 mg ) is effective for the management of Japanese patients with chronic ITP ( NCT00540423 ) Stimulation of platelet production by thrombopoietin-receptor agonists ( TPO-RAs ) is an effective second-line treatment in immune thrombocytopenia ( ITP ) . This 28-day phase 2 study assigned subjects with ITP of ≥3 months to once-daily oral avatrombopag ( 2.5 , 5 , 10 , or 20 mg ) , an investigational nonpeptide TPO-RA active in humans , or placebo ; subjects completing r and omized treatment could enroll in a 24-week extension study . Of 64 r and omized subjects , 13 % ( avatrombopag 2.5 mg ) , 53 % ( 5 mg ) , 50 % ( 10 mg ) , and 80 % ( 20 mg ) , vs 0 % for placebo , achieved a platelet count ( PC ) response of ≥50 × 10(9)/L with ≥20 × 10(9)/L increase above baseline at day 28 . Fifty-three subjects ( 83 % ) entered the extension : 52 % and 76 % had a durable ( PC response at ≥75 % of their platelet assessment s over the last 14 weeks ) and overall ( stable response or response at any ≥2 consecutive visits ) response , respectively . All subjects experienced ≥1 adverse event ( AE ) ( most commonly fatigue , headache , and epistaxis ) ; 19 % ( n = 12 ) reported ≥1 serious AE ; 10 ( 16 % ) withdrew due to an AE ( 5 due to increased PC ) . Avatrombopag was active and generally well tolerated , with PC response rates and AE incidence comparable with other TPO-RAs . These studies were registered at www . clinical trials.gov as # NCT00441090 and # NCT00625443 Elevated expression of the activating Fcγ receptor ( FcγR ) I and FcγRIIa together with decreased expression of the inhibitory FcγRIIb are involved in the pathogenesis of primary immune thrombocytopenia ( ITP ) . Thrombopoietin receptor agonists ( TPO-RAs ) have been used clinical ly for the management of ITP ; however , little is known about the effect of TPO-RAs on FcγR modulation in ITP . In this prospect i ve study , we measured the alteration in monocyte FcγR expression from 21 corticosteroid-resistant/relapsed patients with chronic ITP receiving eltrombopag therapy . Results showed that the mRNA and protein levels of FcγRIIb were significantly elevated after 6-week eltrombopag treatment . Concurrently , FcγRI and IIa levels decreased remarkably , whereas FcγRIII expression did not change . In vitro phagocytosis assays indicated that a shift in the balance of FcγR toward inhibitory FcγRIIb on monocytes was accompanied with a considerable decrease in monocyte/macrophage phagocytic capacity . The response to eltrombopag therapy in patients with ITP was associated with FcγR phenotype and functional changes of monocytes/macrophages . Moreover , the plasma transforming growth factor-β1 ( TGF-β1 ) concentrations increased significantly in eltrombopag responders . Modulation of monocyte FcγR balance by TPO-RAs was also found in a murine model of ITP established by transferring splenocytes from immunized CD61 knockout mice into CD61(+ ) severe combined immunodeficient mice . Romiplostim administration in ITP mice significantly upregulated inhibitory FcγRII expression and downregulated activating FcγRI expression . These findings showed that recovery of platelet counts after TPO-RA treatment in ITP is associated with the restoration of FcγR balance toward the inhibitory FcγRIIb on monocytes , and suggested that thrombopoietic agents have a profound effect on immune modulation in ITP . This study is registered at Clinical Trials.gov as # NCT01864512 |
381 | 26,902,843 | The incidence of recurrence after achieving CRIM through endoscopic therapy was substantial .
A small minority of recurrences were dysplastic BE and HGD/EAC . | BACKGROUND AND AIMS Previous estimates of incidence of intestinal metaplasia ( IM ) recurrence after achieving complete remission of IM ( CRIM ) through endoscopic therapy of Barrett 's esophagus ( BE ) have varied widely .
We performed a systematic review and meta- analysis of studies to estimate an accurate recurrence risk after CRIM . | BACKGROUND Radiofrequency ablation ( RFA ) is safe and effective for eradicating Barrett 's esophagus ( BE ) and BE-associated early neoplasia . Most RFA studies have limited the baseline length of BE ( < 10 cm ) , and therefore little is known about RFA for longer BE . OBJECTIVE To assess the safety and efficacy of RFA with or without prior endoscopic resection ( ER ) for BE ≥ 10 cm containing neoplasia . DESIGN Prospect i ve trial . SETTING Two tertiary-care centers . PATIENTS This study involved consecutive patients with BE ≥ 10 cm with early neoplasia . INTERVENTION Focal ER for visible abnormalities , followed by a maximum of 2 circumferential and 3 focal RFA procedures every 2 to 3 months until complete remission . MAIN OUTCOME MEASUREMENTS Complete remission , defined as endoscopic resolution of BE and no intestinal metaplasia ( CR-IM ) or neoplasia ( CR-neoplasia ) in biopsy specimens . RESULTS Of the 26 patients included , 18 underwent ER for visible abnormalities before RFA . The ER specimens showed early cancer in 11 , high- grade intraepithelial neoplasia ( HGIN ) in 6 , and low- grade intraepithelial neoplasia ( LGIN ) in 1 . The worst residual histology , before RFA and after any ER , was HGIN in 16 patients and LGIN in 10 patients . CR-neoplasia and CR-IM were achieved in 83 % ( 95 % confidence interval [ CI ] , 63%-95 % ) and 79 % ( 95 % CI , 58%-93 % ) , respectively . None of the patients had fatal or severe complications and 15 % ( 95 % CI , 4%-35 % ) had moderate complications . During a mean ( ± st and ard deviation ) follow-up of 29 ( ± 9.1 ) months , no neoplasia recurred . LIMITATIONS Tertiary-care center , short follow-up . CONCLUSION ER for visible abnormalities , followed by RFA of residual BE is a safe and effective treatment for BE ≥ 10 cm containing neoplasia , with a low chance of recurrence of neoplasia or BE during follow-up STUDY AIMS The aim of the current study was to evaluate the efficacy and safety of stepwise circumferential and focal ablation using the HALO system for Barrett 's esophagus containing flat , high- grade dysplasia ( HGD ) or residual dysplasia after endoscopic resection for HGD or intramucosal cancer ( IMC ) . METHODS Visible abnormalities were removed with endoscopic resection prior to ablation . Persistence of dysplasia and absence of IMC were confirmed with biopsy after endoscopic resection . A balloon-based electrode was used for primary circumferential ablation and an endoscope-mounted electrode was used for secondary focal ablation . RESULTS Twelve patients ( nine men ; median age 70 years ) were treated ( median Barrett 's length 7 cm ) . Visible abnormalities were removed by endoscopic resection in seven patients . The worst pathological grade of residual Barrett 's esophagus after resection and prior to ablation was low- grade dysplasia ( LGD ) ( n = 1 ) and HGD ( n = 11 ) . Patients underwent a median of one circumferential and two focal ablation sessions . Complete remission of dysplasia was achieved in 12/12 patients ( 100 % ) . Complete endoscopic and histological removal of Barrett 's esophagus was achieved in 12/12 patients ( 100 % ) . There were no ablation-related stenoses , and no subsquamous Barrett 's esophagus was observed in 363 biopsies obtained from post-ablation neo-squamous mucosa . Protocol ized cleaning of the ablation zone and electrode in between ablations result ed in superior regression of Barrett 's esophagus compared with previous studies . During a median follow-up of 14 months no recurrence of dysplasia or Barrett 's esophagus was observed . CONCLUSIONS Stepwise circumferential and focal ablation for Barrett 's esophagus with flat HGD or for Barrett 's with residual dysplasia after endoscopic resection for HGD/IMC is a safe and effective treatment modality . Its success rate and safety profile compare favorably with alternatives such as esophagectomy , widespread endoscopic resection or photodynamic therapy BACKGROUND Barrett 's esophagus ( BE ) may lead to high- grade dysplasia ( HGD ) and adenocarcinoma . The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium ( POR ) and photodynamic therapy ( PDT ) for ablating HGD and reducing the incidence of esophageal adenocarcinoma . METHODS The design was a multicenter , partially blinded ( pathology ) , r and omized clinical trial conducted in patients with BE who have HGD . There were 30 contributing centers . A total of 485 patients were screened , with 208 in the intent-to-treat population and 202 in the safety population . Patients were r and omized on a 2:1 basis to compare PDT with POR plus omeprazole ( PORPDT ) with omeprazole only ( OM ) . The main outcome measurement was complete HGD ablation occurring at any time during the study period . RESULTS There was a significant difference ( p < 0.0001 ) in favor of PORPDT ( 106/138 [ 77 % ] ) compared with OM ( 27/70 [ 39 % ] ) in complete ablation of HGD at any time during the study period . The occurrence of adenocarcinoma in the PORPDT group ( 13 % ) ( n=18 ) was significantly lower ( p < 0.006 ) compared with the OM group ( 28 % ) [ corrected ] ( n=20 ) . The safety profile showed 94 % of patients in the PORPDT group and 13 % of patients in the OM group had treatment-related adverse effects . The limitations of the study were that PDT therapy may have had to be applied more than once and that patients spent more time in treatment . The patients and the physicians were not blinded to the treatment . CONCLUSIONS PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma BACKGROUND Ablation of Barrett 's esophagus ( BE ) has been advocated as a method to eliminate the risk of malignant transformation of BE . OBJECTIVE To provide longer follow-up and determine safety and efficacy of multipolar ablation for nondysplastic BE . DESIGN Prospect i ve cohort study . SETTING Gastroenterology Unit at the Policlinica Metropolitana , a tertiary care center in Caracas , Venezuela . PATIENTS One hundred sixty-six patients with nondysplastic BE and histologic evidence of intestinal metaplasia . INTERVENTIONS Patients underwent multipolar electrocoagulation ablation therapy to areas of BE identified with magnification chromoendoscopy . The identified areas were treated with a 50-W energy source and a 7F " gold " probe . After complete ablation , patients were followed on an annual basis with magnification chromoendoscopy . At annual visits , biopsy specimens were taken in areas identified at baseline as BE . Targeted biopsy specimens were taken in areas of recurrent BE identified by using magnification chromoendoscopy . MAIN OUTCOME MEASUREMENTS Mortality , incidence of recurrent BE , incidence of adenocarcinoma in ablated BE , and morbidity associated with multipolar electrocoagulation . RESULTS One hundred sixty-six patients were recruited for the study ; 139 completed at least 10 years of follow-up . Complications developed in less than 5 % of patients , all of which were minor . Recurrent BE occurred in less than 5 % of patients . No adenocarcinoma or high- grade dysplasia of the esophagus developed in any of the patients . LIMITATION Uncontrolled clinical trial . CONCLUSIONS Long-term follow-up of ablation of BE with multipolar electrocoagulation ablation therapy indicates that this is a safe , effective method to ablate BE over the long term BACKGROUND Barrett 's esophagus is a premalignant condition induced by gastroesophageal reflux . The aim of this prospect i ve study was to assess the efficacy of argon plasma coagulation in combination with high-dose omeprazole therapy to ablate nondysplastic Barrett 's epithelium . METHODS In 73 patients with histologically confirmed Barrett 's epithelium , argon plasma coagulation was used in combination with maximal acid suppression ( omeprazole 40 mg three times a day ) . Histologic and endoscopic changes were evaluated at 6- and 12-month intervals . RESULTS In 69 of 70 patients ( 98.6 % ) complete squamous regeneration was achieved after a median of 2 argon plasma coagulation sessions ( range 1 to 5 ) . During a median follow-up of 12 months ( range 2 to 51 months ) there has been no relapse or evidence of the development of dysplasia under continuous acid suppression . Three patients ( 4.3 % ) developed a mild stricture of the distal esophagus that resolved after a single session of bougie dilation . CONCLUSIONS In our experience , argon plasma coagulation in combination with high-dose omeprazole treatment is an effective and safe technique for complete ablation of nondysplastic Barrett 's epithelium . Restoration of squamous mucosa after argon plasma coagulation appears to be long-lasting AIM To report the long-term outcome of patients after complete ablation of non-neoplastic Barrett 's esophagus ( BE ) with respect to BE relapse and development of intraepithelial neoplasia or esophageal adenocarcinoma . METHODS In 70 patients with histologically proven non-neoplastic BE , complete BE ablation was achieved by argon plasma coagulation ( APC ) and high-dose proton pump inhibitor therapy ( 120 mg omeprazole daily ) . Sixty-six patients ( 94.4 % ) underwent further surveillance endoscopy . At each surveillance endoscopy four-quadrant biopsies were taken from the neo-squamous epithelium at 2 cm intervals depending on the pre-treatment length of BE mucosa beginning at the neo-Z-line , and from any endoscopically suspicious lesion . RESULTS The median follow-up of 66 patients was 51 mo ( range 9 - 85 mo ) giving a total of 280.5 patient years . A mean of 6 biopsies were taken during surveillance endoscopies . In 13 patients ( 19.7 % ) tongues or isl and s suspicious for BE were found during endoscopy . In 8 of these patients ( 12.1 % ) non-neoplastic BE relapse was confirmed histologically giving a histological relapse rate of 3 % per year . In none of the patients , intraepithelial neoplasia nor an esophageal adenocarcinoma was detected . Logistic regression analysis identified endoscopic detection of isl and s or tongues as the only positive predictor of BE relapse ( P = 0.0004 ) . CONCLUSION The long-term relapse rate of non-neoplastic BE following complete ablation with high-power APC is low ( 3 % per year ) i ( n d m e This is one of a series of statements discussing the use of GI endoscopy in common clinical situations . The St and ards of Practice Committee of the American Society for Gastrointestinal Endoscopy prepared this text . In preparing this guideline , a search of the medical literature was performed using PubMed . Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants . When limited or no data exist from well- design ed prospect i ve trials , emphasis is given to results of large series and reports from recognized experts . Guidelines for appropriate use of endoscopy are based on a critical review of the available data and expert consensus at the time the guidelines are drafted . Further controlled clinical studies may be needed to clarify aspects of this guideline . This guideline may be revised as necessary to account for changes in technology , new data , or other aspects of clinical practice . The recommendations were based on review ed studies and were grade d on the strength of the supporting evidence ( Table 1).1 The strength of individual recommendations is based on both the aggregate evidence quality and an assessment of the anticipated benefits and harms . Weaker recommendations are indicated by phrases such as “ we suggest , ” whereas stronger recommendations are typically stated as “ we recommend . ” This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients . This guideline is not a rule and should not be construed as establishing a legal st and ard of care or as encouraging , advocating , requiring , or discouraging any particular treatment . Clinical decisions in any particular case involve a complex analysis of the patient ’s condition and available courses of action . Therefore , clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines AIM This prospect i ve study evaluated the effectiveness of 90 W argon plasma coagulation ( APC ) for the ablation of Barrett 's esophagus ( BE ) that is considered to be the main risk factor for the development of esophageal adenocarcinoma . METHODS The results from 25 patients , observed at the First Department of General Surgery , University of Verona , Italy , from October 2000 to October 2003 , who underwent APC for histologically proven BE were prospect ively analyzed . RESULTS The ablation treatment was completed in all the patients but one ( 96 % ) . The mean number of APC sessions needed to complete ablation was 1.6 ( total number : 40 ) . The eradication was obtained in the majority of cases by one session only ( 60 % ) , two sessions were required in 24 % of the cases and three or more in 16 % . About 43 % of the sessions were complicated . Retrosternal pain ( 22.5 % ) and fever ( 17.5 % ) were the most frequent symptoms . Only one major complication occurred , it was an hemorrhage due to ulcer formation on the treated esophagus that required urgent endoscopic sclerosis and admission . The follow-up was accomplished in all the patients with a mean period of 26.3 mo and 20 patients ( 84 % ) with a follow-up period longer than 24 mo . Only one patient showed a relapse of metaplastic mucosa 12 mo after the completion of ablation . The patient was hence re-treated and now is free from recurrence 33 mo later . CONCLUSION High power setting ( 90 W ) APC showed to be safe and effective . The effects persist at a mean follow-up period of two years with a comparable cost in term of complications with respect to st and ard power setting s. Further studies with greater number of patients are required to confirm these results and to assess if ablation reduces the incidence of malignant progression IMPORTANCE Barrett esophagus containing low- grade dysplasia is associated with an increased risk of developing esophageal adenocarcinoma , a cancer with a rapidly increasing incidence in the western world . OBJECTIVE To investigate whether endoscopic radiofrequency ablation could decrease the rate of neoplastic progression . DESIGN , SETTING , AND PARTICIPANTS Multicenter r and omized clinical trial that enrolled 136 patients with a confirmed diagnosis of Barrett esophagus containing low- grade dysplasia at 9 European sites between June 2007 and June 2011 . Patient follow-up ended May 2013 . INTERVENTIONS Eligible patients were r and omly assigned in a 1:1 ratio to either endoscopic treatment with radiofrequency ablation ( ablation ) or endoscopic surveillance ( control ) . Ablation was performed with the balloon device for circumferential ablation of the esophagus or the focal device for targeted ablation , with a maximum of 5 sessions allowed . MAIN OUTCOMES AND MEASURES The primary outcome was neoplastic progression to high- grade dysplasia or adenocarcinoma during a 3-year follow-up since r and omization . Secondary outcomes were complete eradication of dysplasia and intestinal metaplasia and adverse events . RESULTS Sixty-eight patients were r and omized to receive ablation and 68 to receive control . Ablation reduced the risk of progression to high- grade dysplasia or adenocarcinoma by 25.0 % ( 1.5 % for ablation vs 26.5 % for control ; 95 % CI , 14.1%-35.9 % ; P < .001 ) and the risk of progression to adenocarcinoma by 7.4 % ( 1.5 % for ablation vs 8.8 % for control ; 95 % CI , 0%-14.7 % ; P = .03 ) . Among patients in the ablation group , complete eradication occurred in 92.6 % for dysplasia and 88.2 % for intestinal metaplasia compared with 27.9 % for dysplasia and 0.0 % for intestinal metaplasia among patients in the control group ( P < .001 ) . Treatment-related adverse events occurred in 19.1 % of patients receiving ablation ( P < .001 ) . The most common adverse event was stricture , occurring in 8 patients receiving ablation ( 11.8 % ) , all resolved by endoscopic dilation ( median , 1 session ) . The data and safety monitoring board recommended early termination of the trial due to superiority of ablation for the primary outcome and the potential for patient safety issues if the trial continued . CONCLUSIONS AND RELEVANCE In this r and omized trial of patients with Barrett esophagus and a confirmed diagnosis of low- grade dysplasia , radiofrequency ablation result ed in a reduced risk of neoplastic progression over 3 years of follow-up . TRIAL REGISTRATION trialregister.nl Identifier : NTR1198 BACKGROUND AND STUDY AIMS Stepwise circumferential and focal ablation of nondysplastic Barrett 's esophagus has proven safe and effective . This study assessed the efficacy and safety of ablation for Barrett 's esophagus with high- grade dysplasia ( HGD ) , and residual Barrett 's esophagus with dysplasia after prior endoscopic resection for visible lesions . PATIENTS AND METHODS This was a prospect i ve cohort study . All visible abnormalities were resected prior to ablation . Persistence of dysplasia and absence of invasive cancer was confirmed with biopsies after endoscopic resection . A balloon-based electrode was used for primary circumferential ablation and an endoscope-mounted electrode was used for secondary focal ablation . Eradication of dysplasia and Barrett 's esophagus was the main outcome measure . RESULTS Eleven patients ( eight men ; median age 60 years ) were treated ( median Barrett 's length 5 cm ) . Visible abnormalities were removed with endoscopic resection in six patients . The worst pathological grade of residual Barrett 's esophagus after endoscopic resection and prior to ablation was LGD ( n = 2 ) and HGD ( n = 9 ) . Patients underwent a median of two circumferential and two focal ablation sessions . Complete remission of dysplasia and complete endoscopic and histological removal of Barrett 's esophagus was achieved in 11/11 patients ( 100 % ) . There were no adverse events or strictures , and in none of the 473 biopsies of neo-squamous mucosa was subsquamous Barrett 's esophagus ( " buried Barrett 's " ) observed . During a median follow-up period of 14 months after the last treatment session and a median number of two follow-up endoscopies , none of the patients showed recurrence of dysplasia or endoscopic signs of recurrent Barrett 's mucosa . CONCLUSIONS Stepwise circumferential and focal ablation appears to be a safe and effective treatment for complete removal of Barrett 's esophagus containing HGD , and can be safely performed after prior endoscopic resection for endoscopically visible abnormalities OBJECTIVE : The term Barrett 's esophagus refers to a premalignant condition that is characterized by the replacement of the esophageal squamous mucosa by a columnar-lined one . Preliminary studies have demonstrated reversal of Barrett 's mucosa after endoscopic coagulation with different techniques associated with acid inhibition . However , most of these studies have shown that residual Barrett 's gl and s are found underneath the new squamous epithelium in up to 40 % of patients . The goal of our study is to verify whether complete restoration of Barrett 's mucosa can be achieved by the combination of high power setting argon plasma coagulation and omeprazole . METHODS : A total of 33 patients ( mean age : 55.2 yr , range : 21–84 yr ; 21 men and 12 women ) with histologically demonstrated Barrett 's esophagus ( mean length : 4.05 cm , range : 0.5–7 cm ) were treated . Fourteen cases presented with low- grade dysplasia and one with high- grade dysplasia . All of the extent , or until a maximum of 4 cm , of the Barrett 's mucosa was cauterized in each session using argon beam coagulation at a power setting of 65–70 W. All patients received 60 mg omeprazole during the treatment period . RESULTS : Complete restoration of squamous mucosa was obtained in all 33 cases after a mean of 1.96 sessions ( range , 1–4 ) . Endoscopic results were histologically confirmed . Nineteen ( 57.5 % ) patients experienced moderate to severe chest pain and odyno-dysphagia lasting for 3–10 days after the procedure . Five of these cases experienced high fever and a small volume of pleural effusion , and three patients developed esophageal strictures that needed to be dilated . Another patient developed pneumomediastinum and subcutaneous emphysema without evidence s of perforation . After a mean follow-up of 10.6 months there was one endoscopic , as well as histological , recurrence of Barrett 's mucosa in a patient with an ineffective laparoscopic fundoplication . CONCLUSIONS : High power setting argon plasma coagulation combined with intensive acid suppression is an effective treatment for the total endoscopic ablation of Barrett 's esophagus , at least in the short term . Long-term follow-up of treated patients in whom gastroesophageal reflux is surgically or medically alleviated seems m and atory before drawing definitive conclusions about this therapy The treatment of Barrett 's esophagus is still controversial . Actually , the only method to prevent the development to cancer is endoscopic surveillance , which ensures good results in terms of long-term survival . An ideal treatment capable of destroying columnar metaplasia , followed by squamous epithelium regeneration could potentially result in a decrease of the incidence of adenocarcinoma . Recently most ablative techniques were used , such as photodynamic therapy , ablation therapy with Nd-YAG laser or argon plasma coagulation and endoscopic mucosal resection . We started a prospect i ve study in January 1998 , enrolling 94 patients affected by Barrett 's esophagus and c and i date s for antireflux repair in order to assess the effectiveness and the results of endoscopic coagulation with argon plasma combined with surgery in the treatment of uncomplicated Barrett 's esophagus . All patients underwent endoscopic treatment with argon plasma ; we observed complete response in 68 patients ( 72.34 % ) , 27 of them ( 39.7 % ) underwent antireflux surgery and the other 41 continued medical therapy . Post-operatively 19 patients ( 70 % ) underwent regular surveillance endoscopies and in two cases metaplasia recurred . The final objective of these combined treatments should be the complete eradication of metaplastic mucosa . Our experience was that argon plasma coagulation combined with antireflux surgery or proton pump inhibitor therapy gave satisfactory results , even if follow-up is too short to evaluate the potential evolution of metaplasia to cancer . For this reason , we recommend that this technique should be done only in specialized centres and that these patients continue their endoscopic surveillance program BACKGROUND & AIMS Radiofrequency ablation ( RFA ) , with or without endoscopic resection effectively eradicates Barrett 's esophagus ( BE ) containing high- grade intraepithelial neoplasia and /or early-stage cancer . We followed patients who received RFA for BE containing high- grade intraepithelial neoplasia and /or early-stage cancer for 5 years to determine the durability of treatment response . METHODS We followed 54 patients with BE ( 2 - 12 cm ) , previously enrolled in 4 consecutive cohort studies in which they underwent focal endoscopic resection in case of visible lesions ( n = 40 [ 72 % ] ) , followed by serial RFA every 3 months . Patients underwent high-resolution endoscopy with narrow-b and imaging at 6 and 12 months after treatment and then annually for 5 years ( median , 61 months ; interquartile range , 53 - 65 months ) ; r and om biopsy sample s were collected from neosquamous epithelium and gastric cardia . After 5 years , endoscopic ultrasound and endoscopic resection of neosquamous epithelium were performed . Outcomes included sustained complete remission of neoplasia or intestinal metaplasia ( IM ) , IM in gastric cardia , or buried gl and s in neosquamous epithelium . RESULTS After 5 years , Kaplan-Meier analysis showed sustained complete remission of neoplasia and intestinal metaplasia in 90 % of patients ; neoplasia recurred in 3 patients and was managed endoscopically . Focal IM in the cardia was found in 19 of 54 patients ( 35 % ) , in 53 of 1143 gastric cardia biopsies ( 4.6 % ) . The incidence of IM of the cardia did not increase over time ; and IM was diagnosed based on only a single biopsy in 89 % of patients . Buried gl and s were detected in 3 of 3543 neosquamous epithelium biopsies ( 0.08 % , from 3 patients ) . No endoscopic resection sample s had buried gl and s. CONCLUSIONS Among patients who have undergone RFA with or without endoscopic resection for neoplastic BE , 90 % remain in remission at 5-year follow-up , with all recurrences managed endoscopically . This treatment approach is therefore an effective and durable alternative to esophagectomy ; www.trialregister.nl number , NTR2938 Background Radical oesophageal resection has until now been regarded as the gold st and ard for treatment in intraepithelial high- grade neoplasia or early adenocarcinoma of the oesophagus . However , the mortality and morbidity rates are substantial . Design A new therapeutic approach involving low-risk endoscopic therapy modalities was examined in the framework of a prospect i ve study . Patients A total of 115 patients with intraepithelial high- grade neoplasia ( 19 ) and early adenocarcinoma ( 96 ) in Barrett 's oesophagus . Methods Endoscopic mucosal resection ( EMR ) was used in 70 patients , and photodynamic therapy ( PDT ) was used in 32 patients . The two procedures were combined in ten patients . Three patients underwent primary treatment with argon plasma coagulation ( APC ) . The average follow-up was 34 ± 10 months ( range 24–60 months ) . Results Complete local remission was achieved in 98 % . The overall complication rate was 9.5 % . Major complications , such as perforation and severe bleeding , did not occur . Minor complications included not haemoglobin relevant bleeding ( drop of haemoglobin less than 2 g/dl ) ( 5 ) and stenosis ( 3 ) after EMR , and long-lasting odynophagia ( 1 ) and sunburn ( 2 ) after PDT . In all , 13 patients have died so far , but in only one case due to the underlying disease . The calculated overall 3-year survival rate is 88 % . During the follow-up period , a 30 % rate of metachronous lesions was observed ; endoscopic therapy was performed successfully in all but one of these patients . Conclusions These good acute-phase and intermediate results , along with low morbidity rates and no mortality , suggest that the organ-preserving local endoscopic procedure including EMR and PDT is an attractive alternative to oesophageal resection . Therefore , endoscopic therapy might replace radical oesophageal resection in future in cases of intraepithelial high- grade neoplasia and early mucosal adenocarcinoma in Barrett 's oesophagus The clinical value of endoscopic ablation of nondysplastic Barrett ’s epithelium is controversial . It has been stated that ablation , combined with acid suppression or antireflux surgery , may reduce the risk of adenocarcinoma , thereby obviating the need for endoscopic surveillance in these patients . Eighteen symptomatic patients were enrolled in a prospect i ve study of Nd : YAG laser ablation of Barrett ’s esophagus followed by treatment with proton pump inhibitors or antireflux surgery . All patients had intestinal metaplasia and no associated dysplasia or carcinoma . Laser treatment was performed with noncontact fibers and a power output of 60 watts . The mean number of treament sessions was three ( range 1 to 5 ) , and the mean energy delivered during each session was 2800 joules ( range 600 to 4800 joules ) . All patients were given a st and ard dose of omeprazole ( 40 mg/day ) throughout the study period . In two patients a mild distal esophageal stricture occurred and required a single dilatation . Macroscopic and histologic eradication of the specialized columnar epithelium was documented in 8 of 12 patients with tongues of Barrett ’s metaplasia , in one of four patients with circumferential Barrett ’s metaplasia , and in two of two patients with short-segment Barrett ’s esophagus . In five patients ( 28 % ) only a partial ablation could be achieved despite repeated laser treatment . Two patients ( 11 % ) , one with tongues and the other with circumferential Barrett ’s metaplasia , were considered nonresponders . Adenocarcinoma undermining regenerated squamous epithelium was found , 6 months after eradication , in one patient who underwent esophagogastric resection . Twelve patients agreed to undergo antireflux surgery . Over a mean follow-up period of 14 months ( range 4 to 32 months ) , two patients presented with recurrent Barrett ’s metaplasia : one at 8 months after successful Nissen fundoplication and the other after 1 year of continuous omeprazole treatment . Progression of Barrett ’s metaplasia was found in two other patients receiving pharmacologic therapy in whom a partial response to laser treatment had been obtained . In conclusion , Nd : YAG laser therapy of nondysplastic Barrett ’s esophagus , performed in conjunction with omeprazole treatment and followed by antireflux surgery , allows a partial regression of specialized columnar epithelium in most patients . However , this is a time-consuming procedure that produced only temporary eradication , did not prove effective in reducing cancer risk , and did not obviate the need for endoscopic surveillance BACKGROUND The safety , efficacy , and durability of radiofrequency ablation ( RFA ) , with or without EMR , have been established for long-segment Barrett 's esophagus ( LSBE ) . Ablating ultralong-segment Barrett 's esophagus ( ULSBE ) may be associated with increased stricture formation , eradication failure , and treatment session requirements . OBJECTIVES Our primary objective was to compare eradication and stricture rates between LSBE ( ≥3 to < 8 cm ) and ULSBE ( ≥8 cm ) . Our secondary objective was to evaluate treatment durability and session requirements . DESIGN Retrospective review of prospect ively collected data . SETTING Tertiary care facility . PATIENTS A total of 72 patients ( 34 ULSBE , 38 LSBE ; mean Barrett 's segment length of 10.8 and 4.7 cm ) underwent RFA between August 2005 and September 2010 . Mean follow-up was 45 and 34 months , respectively . MAIN OUTCOME MEASUREMENTS Eradication and complication rates for ULSBE and LSBE . RESULTS Eradication rates for dysplasia ( 90 % vs 88 % , P = 1.0 ) and intestinal metaplasia ( IM ) ( 77 % vs 82 % , P = .77 ) were similar . ULSBE patients required more overall ( P < .01 ) and circumferential ( P < .01 ) RFA ; however , stricture rates were identical ( 14 % ) . There was no dysplasia recurrence , and IM recurrence was similar ( ULSBE , 23 % ; LSBE , 16 % ; P = .52 ) . At 3 years , IM remained eradicated in 65 % of ULSBE and 82 % of LSBE , without maintenance RFA . On multivariate regression analysis , increasing Barrett 's length was associated with a reduced likelihood for eradicating IM ( odds ratio 0.87 ; 95 % CI , 0.75 - 1.00 ) , but not dysplasia ( odds ratio 1.13 ; 95 % CI , 0.95 - 1.35 ) . LIMITATIONS Single center . CONCLUSION ULSBE can be treated in its entirety at each session with efficacy and safety comparable to LSBE . ULSBE requires more effort to achieve IM eradication , and RFA is less durable in maintaining this eradication at 3-year follow-up The aim of the prospect i ve clinical study presented here is to test the effectiveness of a multimode approach consisting of argon plasma coagulation combined with laparoscopic fundoplication in the management of Barrett 's esophagus . Argon plasma coagulation was performed in 19 patients with Barrett 's esophagus who had previously undergone surgical antireflux treatment . The mean follow-up time was 17 months , ranging between 6 and 27 months . Squamous epithelium was completely restored in all patients . In 68.4 % of cases two sessions were required . The most frequent complications were chest discomfort and retrosternal pain . In 11 patients the symptoms lasted 3 days and in six cases persisted for a longer period , requiring analgesic medication . Short-term dysphagia and odynophagia were observed in four patients BACKGROUND & AIMS Radiofrequency ablation ( RFA ) can eradicate dysplasia and intestinal metaplasia in patients with dysplastic Barrett 's esophagus ( BE ) , and reduce rates of esophageal adenocarcinoma . We assessed long-term rates of eradication , durability of neosquamous epithelium , disease progression , and safety of RFA in patients with dysplastic BE . METHODS We performed a r and omized trial of 127 subjects with dysplastic BE ; after cross-over subjects were included , 119 received RFA . Subjects were followed for a mean time of 3.05 years ; the study was extended to 5 years for patients with eradication of intestinal metaplasia at 2 years . Outcomes included eradication of dysplasia or intestinal metaplasia after 2 and 3 years , durability of response , disease progression , and adverse events . RESULTS After 2 years , 101 of 106 patients had complete eradication of all dysplasia ( 95 % ) and 99 of 106 had eradication of intestinal metaplasia ( 93 % ) . After 2 years , among subjects with initial low- grade dysplasia , all dysplasia was eradicated in 51 of 52 ( 98 % ) and intestinal metaplasia was eradicated in 51 of 52 ( 98 % ) ; among subjects with initial high- grade dysplasia , all dysplasia was eradicated in 50 of 54 ( 93 % ) and intestinal metaplasia was eradicated in 48 of 54 ( 89 % ) . After 3 years , dysplasia was eradicated in 55 of 56 of subjects ( 98 % ) and intestinal metaplasia was eradicated in 51 of 56 ( 91 % ) . Kaplan-Meier analysis showed that dysplasia remained eradicated in > 85 % of patients and intestinal metaplasia in > 75 % , without maintenance RFA . Serious adverse events occurred in 4 of 119 subjects ( 3.4 % ) ; the rate of stricture was 7.6 % . The rate of esophageal adenocarcinoma was 1 per 181 patient-years ( 0.55%/patient-years ) ; there was no cancer-related morbidity or mortality . The annual rate of any neoplastic progression was 1 per 73 patient-years ( 1.37%/patient-years ) . CONCLUSIONS In subjects with dysplastic BE , RFA therapy has an acceptable safety profile , is durable , and is associated with a low rate of disease progression , for up to 3 years Objective . Several studies have shown that argon plasma coagulation ( APC ) combined with proton-pump inhibitor ( PPI ) therapy is a suitable procedure to eradicate Barrett 's epithelium for a short-term follow-up . The real impact of this kind of management with respect to cancer risk and durability of squamous regeneration remains unclear . We present the follow-up data for up to 51 months after eradication of Barrett 's mucosa . Material and methods . In 1998–2001 , 25 patients with Barrett 's esophagus were included in a prospect i ve study . After baseline documentation , Barrett 's epithelium was treated with repeated APC until complete squamous restoration was reached . Thereafter , all patients were continuously treated with high-dose PPIs . Results . Each patient underwent a median of four APC sessions . Twenty-one ( 84 % ) of the patients had complete squamous regeneration at the end of treatment . During a follow-up of up to 51 months , Barrett 's epithelium was found to have recurred in 14/21 ( 66 % ) patients . Including the patients with initially incomplete squamous restoration , a long-lasting and complete effect was achieved in only 7 patients ( 28 % ) after a mean follow-up period of 30 months . Conclusions . So far , it is still not proven whether coagulation-induced squamous regeneration reduces the risk of Barrett 's carcinoma . Furthermore , the high relapse rate , the procedure-related risk , and the high costs incurred preclude the routine use of APC for the treatment of non-dysplastic Barrett 's esophagus . The different recurrence rates between published studies may be due to technical differences and PPI schedule . We suggest that optimal conditions for the procedure must be defined before further studies are undertaken In a retrospective survey , 487 research projects approved by the Central Oxford Research Ethics Committee between 1984 and 1987 , were studied for evidence of publication bias . As of May , 1990 , 285 of the studies had been analysed by the investigators , and 52 % of these had been published . Studies with statistically significant results were more likely to be published than those finding no difference between the study groups ( adjusted odds ratio [ OR ] 2.32 ; 95 % confidence interval [ Cl ] 1.25 - 4.28 ) . Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor . An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results , and with increasing sample size . The tendency towards publication bias was greater with observational and laboratory-based experimental studies ( OR = 3.79 ; 95 % Cl = 1.47 - 9.76 ) than with r and omised clinical trials ( OR = 0.84 ; 95 % Cl = 0.34 - 2.09 ) . We have confirmed the presence of publication bias in a cohort of clinical research studies . These findings suggest that conclusions based only on a review of published data should be interpreted cautiously , especially for observational studies . Improved strategies are needed to identify the results of unpublished as well as published studies Objective After focal endoscopic resection ( ER ) of high- grade dysplasia ( HGD ) or early cancer ( EC ) in Barrett 's oesophagus ( BO ) , eradication of all remaining BO reduces the recurrence risk . The aim of this study was to compare the safety of stepwise radical ER ( SRER ) versus focal ER followed by radiofrequency ablation ( RFA ) for complete eradication of BO containing HGD/EC . Methods A multicentre r and omised clinical trial was carried out in three tertiary centres . Patients with BO ≤5 cm containing HGD/EC were r and omised to SRER or ER/RFA . Patients in the SRER group underwent piecemeal ER of 50 % of BO followed by serial ER . Patients in the ER/RFA group underwent focal ER for visible lesions followed by serial RFA . Follow-up endoscopy with biopsies ( four-quadrant/2 cm BO ) was performed at 6 and 12 months and then annually . The main outcome measures were : stenosis rate ; complications ; complete histological response for neoplasia ( CR-neoplasia ) ; and complete histological response for intestinal metaplasia ( CR-IM ) . Results CR-neoplasia was achieved in 25/25 ( 100 % ) SRER and in 21/22 ( 96 % ) ER/RFA patients . CR-IM was achieved in 23 ( 92 % ) SRER and 21 ( 96 % ) ER/RFA patients . The stenosis rate was significantly higher in SRER ( 88 % ) versus ER/RFA ( 14 % ; p<0.001 ) , result ing in more therapeutic sessions in SRER ( 6 vs 3 ; p<0.001 ) due to dilations . After median 24 months follow-up , one SRER patient had recurrence of EC , requiring ER . Conclusions In patients with BO ≤5 cm containing HGD/EC , SRER and ER/RFA achieved comparably high rates of CR-IM and CR-neoplasia . However , SRER was associated with a higher number of complications and therapeutic sessions . For these patients , a combined endoscopic approach of focal ER followed by RFA may thus be preferred over SRER . Clinical trial number NTR1337 BACKGROUND & AIMS Radiofrequency ablation ( RFA ) is safe and effective for eradicating intestinal metaplasia and neoplasia in patients with Barrett 's esophagus . We sought to assess the safety and efficacy of RFA in conjunction with baseline endoscopic resection for high- grade intraepithelial neoplasia ( HGIN ) and early cancer . METHODS This multicenter , prospect i ve cohort study included 24 patients ( mean age , 65 years ; median Barrett 's esophagus , 8 cm ) , with Barrett 's esophagus of < or = 12 cm containing HGIN or early cancer , from 3 European tertiary-care medical centers . Visible lesions were endoscopically resected , followed by serial RFA . Focal escape endoscopic resection was used if Barrett tissue persisted despite RFA . Complete response , defined as all biopsies negative for intestinal metaplasia and neoplasia , was assessed during endoscopy with 4-quadrant biopsies taken every 1 cm of the original Barrett 's segment 2 months after the patient was last treated . RESULTS Twenty-three patients underwent pre-RFA endoscopic resection for visible lesions ; 16 patients had early cancer and 7 patients had HGIN . The worst residual histology results , pre-RFA ( after any endoscopic resection ) were : HGIN ( 10 patients ) , low- grade intraepithelial neoplasia ( 11 patients ) , and intestinal metaplasia ( 3 patients ) . Neoplasia and intestinal metaplasia were eradicated in 95 % and 88 % of patients , respectively ; after escape endoscopic resection in 2 patients , rates improved to 100 % and 96 % , respectively . Complications after RFA included melena ( n = 1 ) and dysphagia ( n = 1 ) . After additional follow-up ( median , 22 months ; interquartile range , 17.2 - 23.8 months ) no neoplasia recurred . CONCLUSIONS This European multicenter study to show that early neoplasia in Barrett 's esophagus can be effectively and safely treated with RFA , in combination with prior endoscopic resection of visible lesions |
382 | 31,929,888 | The meta-analyses were conducted using Review Manager version 5.3 software , which is design ed for conducting Cochrane review s. As regards perioperative parameters , NSRH was found to be associated with a lower intraoperative blood loss and a shorter length of hospital stay in comparison with CRH .
Patients undergoing NSRH experienced lower incidence of urinary , colorectal and sexual dysfunction compared with patients undergoing CRH .
However , the resected parametrial width was favorable in patients with CRH , suggesting that NSRH was inferior to CRH in terms of radicality .
The 5-year disease-free and overall survival rates were similar between the two groups .
In this systematic review and meta- analysis , the collected data to date demonstrated that the nerve-sparing approach guarantees minimized surgical-related pelvic dysfunction , with similar oncological outcomes as CRH .
However , further RCTs should be conducted to confirm the superiority and safety of NSRH | The aim of the present study was to compare the oncological outcome of nerve-sparing radical hysterectomy ( NSRH ) and conventional radical hysterectomy ( CRH ) for early-stage cervical cancer using a meta- analysis . | OBJECTIVES The objectives of this study were to describe our laparoscopic nerve-sparing radical hysterectomy ( LNSRH ) technique and to assess the feasibility and safety of the procedure , as well as its impact on voiding function . We introduce a fascia space dissection technique in order to preserve the pelvic splanchnic nerve , the hypogastric nerve and the bladder branch of the inferior hypogastric plexus under magnification ( ×10.5 ) during laparoscopic radical hysterectomy ( LRH ) with pelvic lymphadenectomy . METHODS From October 2006 to November 2009 , 163 consecutive patients with cervical cancer underwent laparoscopic radical hysterectomy ( LRH ) and pelvic lymphadenectomy , with 82 women undergoing LNSRH with fascia space dissection technique ( LNSRH group ) and 81 undergoing LRH ( LRH group ) . Data from 163 patients were prospect ively collected and compared . Post-operative assessment of bladder function included the following : the time to recover the ability to void spontaneously and to achieve a post-void residual urine ( PVR ) volume of less than 50 ml , with urination function grade d. RESULTS The laparoscopic nerve-sparing radical hysterectomy procedure was completed successfully and was conducted safely in all of the patients . There were no conversions to open surgery in the two groups . The median operative duration in the LNSRH and the LRH groups were 163.52±34.47 min and 132.13±31.42 min , respectively . Blood loss was 142.12±62.38 ml and 187.69±68.63 ml , respectively . The time taken to obtain a post-void residual urine volume of less than 50 ml after removal of the urethral catheter was 7.42±2.35 d ( 5 - 18 d ) in LNSRH group and was 16.75±7.73 d ( 5 - 35 d ) in LRH group ( P<0.05 ) . The bladder void function recovery to Grade s 0-I was 76 ( 92.7 % ) for the LNSRH group and 59 ( 72.8 % ) for the LRH group . A mean follow-up of 22.3 ( 5 - 42 ) months was adhered to , and no patient had a recurrence or metastasis . CONCLUSIONS The technique described in this preliminary study appears to be safe , feasible , and easy in our population , with satisfactory recovery of voiding function OBJECTIVE To investigate bladder and intestinal function recovery and quality of sexual life after laparoscopic nerve-sparing radical hysterectomy ( LNRH ) for treatment of early invasive cervical carcinoma . METHODS Subjects included patients who underwent radical hysterectomy by laparotomy who were r and omly assigned to 2 groups : 30 patients who underwent LNRH and 35 classical laparoscopic radical hysterectomy ( LRH ) . We assessed the patients general clinical information , surgical characteristics , pathological findings , and adjuvant therapies . A urodynamic study was used to assess bladder function . Intestinal function recovery and quality of sexual life were evaluated by question naire . RESULTS No significant differences were found in age , surgery characteristics , pathological findings , adjuvant therapies , and main adverse effects between the 2 groups . The mean duration of the postoperative catheterization ( DPC ) in group LNRH was shorter than that in group LRH ( P < 0.001 ) . The maximum flow rate , maximum cystometric capacity , maximum detrusor pressure and urinary complications in group LNRH were better than those in group LRH . The quality of sexual life evaluated according to the female sexual function index ( FSFI ) was better in group LNRH than in those who underwent LRH . The intestinal function of patients in group LNRH also recovered better compared with patients in group LRH OBJECTIVES . The aim of this study was to compare 4 versus 6 courses of adjuvant chemotherapy after neoadjuvant chemotherapy plus radical surgery in terms of overall survival ( OS ) , disease-free survival ( DFS ) , recurrence rate and toxicity profile . METHODS . We r and omly assigned 200 patients with IB2-IIB cervical cancer to receive 4 ( Group A ) or 6 ( Group B ) courses of cisplatin 100 mg/mq and paclitaxel 175 mg/mq every 21 days . RESULTS . At 4-years follow-up , the comparison of recurrence rate ( p = 1 ; RR = 1.005 ; 95 % CI = 0.87 to 1.161 ) , OS ( p = 0.906 ) and DFS ( p = 0.825 ) did not show statistically significant differences between the two groups . Data analysis showed statistically significant differences between the two groups in term of episodes of leukopenia ( p = 0.0072 ; RR = 1.513 ; 95 % CI = 1.127 - 2.03 ) , anemia ( p = 0.048 ; RR = 1.188 ; CI = 1.012 - 1.395 ) and febrile neutropenia ( p = 0.042 ; RR = 1.119 ; 95 % CI = 1.014 - 1.235 ) , in favor of Group A. As regards non-hematological toxicities , there were no statistically significant differences in terms of gastrointestinal symptoms ( p = 0.49 ; RR = 1.046 ; CI = 0.948 - 1.153 . On the contrary , there was a statistically significant difference regarding neurological symptoms ( p=0.014 ; RR=1.208 ; CI=1.046 - 1.395 ) , that were less frequent in Group A ( 13 % ) than in Group B ( 28 % ) . CONCLUSIONS . Adjuvant treatment with 4 or 6 courses of platinum-based chemotherapy showed similar results in terms of OS and DSF , with a favorable toxicity profile in favor of the first regimen The objective of this study is to describe a technique for preserving the autonomic nerve systematic ally , including the hypogastric nerves , pelvic splanchnic nerves , and pelvic plexus and its vesical branches , based on anatomic considerations for the autonomic nerves innervating the urinary bladder , in radical hysterectomies and to assess postsurgical bladder function . A nerve-sparing radical hysterectomy was carried out on 27 consecutive patients with uterine cervical cancer treated between 2000 and 2002 . The FIGO stages of the disease consisted of 10 stage Ib1 , 6 stage Ib2 , 3 stage IIa , and 8 stage IIb . The nerve-sparing procedure was successfully completed in 22 of the 27 patients ( 81.5 % ) in the study . At 1 year after the operation , bladder symptoms were significantly improved in the nerve-sparing group compared to the non – nerve-sparing group . Urinary incontinence and abnormal ( diminished ) bladder sensation were observed in three of the five patients ( two patients had both symptoms ) , for whom the nerve-sparing procedure could not be performed , but none of the 22 patients for whom the nerve-sparing procedure was performed had incontinence , and only two patients had abnormal ( increased ) bladder sensation ( P = 0.0034 for incontinence and P = 0.030 for abnormal bladder sensation ) . The patients ' survival was not adversely affected by the nerve-sparing procedure . Although it is still preliminary , the surgical technique described in this report is thought to be effective for preserving bladder function , and thus , the quality of life could be improved for patients with cervical cancer who are treated with a radical hysterectomy . For further evaluation of the efficacy of nerve-sparing radical hysterectomy , a prospect i ve r and omized trial needs to be performed OBJECTIVE The study aim ed to evaluate the clinical outcomes of laparoscopic nerve-sparing radical hysterectomy ( LNRH ) for bulky-stage cervical cancer ( lesion ≥ 6 cm ) after neoadjuvant chemotherapy ( NAC ) . METHODS This study prospect i ve recruited patients with pathology-confirmed cervical cancer presenting as a bulky mass ( lesion ≥ 6 cm ) . Subjects included patients who underwent laparoscopic radical surgery . They were assigned to one of two groups by surgical method : patients who underwent LNRH after NAC and patients who underwent classical laparoscopic radical hysterectomy ( LRH ) after NAC . We compared the patients ' general clinical characteristics , surgical profiles , pathological findings and adjuvant therapies between the two groups . Recovery of bladder and intestinal function was evaluated by question naire . Patients were followed for up to 1 year to determine the maintenance of effect . RESULTS Compared with patients treated with LRH , patients who underwent LNRH presented no significant differences in age , surgery characteristics , pathological findings , adjuvant therapies or main adverse effects . The mean duration of residual urine < 50 mL in the LNRH group was 11 days , much shorter than that in the LRH group ( 18 days ; P < 0.001 ) . The period of passage of gas by anus was shorter ( 38.9 ± 4.1 h ) in LNRH patients than that in LRH patients ( 56.5 ± 4.0 h ; P < 0.001 ) . The urinary and intestinal symptoms were evaluated 1 year after surgery . The recovery of urinary and intestinal function of patients was better in the LNRH group than in the LRH group . CONCLUSION LNRH is a safe and feasible surgical management for bulky-stage cervical cancer patients ( lesion ≥ 6 cm ) , and after NAC , the urinary and intestinal function of patients in LNRH group showed better recovery compared with functions in the LRH group . The technique is relatively new , and its oncologic efficiency has not yet been fully established . Prospect i ve r and omised controlled studies with an increased number of patients and long-term postoperative follow-up should be carried out to investigate the effect of this therapeutic strategy for bulky-stage cervical cancer OBJECTIVE Surgical therapy for cervical carcinoma carries a significant risk of functional impairment to the bladder . This study evaluates the feasibility and complications of nerve-sparing radical hysterectomy ( NRH ) in Taiwan . METHODS Between March 2010 and March 2011 , consecutive patients diagnosed with early stage cervical cancer ( FIGO stage Ia2 to Ib1 ) and tumor size < 3 cm were recruited prospect ively to undergo NRH or conventional radical hysterectomy ( RH ) . Patients with histories of urinary stress incontinence or bladder dysfunction disease were excluded . A modified Tokyo nerve-sparing radical hysterectomy was performed . RESULTS A total of 30 patients were enrolled . Among these , 18 patients underwent NRH with successful bilaterally nerve-sparing procedures in 15 cases ( 83 % ) , unilaterally nerve-sparing procedures in 2 cases ( 11 % ) , and a failure in 1 case ( 6 % ) . The indwelling catheter was removed on postoperative day 6 . The mean±SD duration from operation to spontaneous voiding was 6.8 ± 1.5 days for women who underwent NRH ; the corresponding duration for women who underwent RH or failed NRH was 20.6 ± 3 days . None of the patients who underwent NRH required intermittent catheterization . All 12 patients who underwent RH needed self-catheterization after discharge . There was a significant reduction in the incidence of postoperative self-catheterization ( p<0.01 ) and bladder dysfunction ( p<0.006 ) . Average satisfaction score analyzed by the Likert-scale question naire was 4.5 for the NRH group and 1.9 for RH group ( p<0.0001 ) . CONCLUSIONS We concluded that the new technique of NRH can reduce postoperative bladder dysfunctions OBJECTIVE To assess the nerve-sparing radical hysterectomy ( NSRH ) technique and its impact on postoperative voiding function . METHODS Forty-four patients with International Federation of Gynecology and Obstetrics ( FIGO ) stage I b1-IIa cervical cancer were enrolled and r and omized into NSRH group ( study group , n = 22 ) and conventional radical hysterectomy ( CRH ) group ( control group , n = 22 ) . The pelvic autonomic nerve pathway ( including hypogastric nerve , pelvic splanchnic nerve , inferior hypogastric plexus and bladder branch ) was completely preserved in the NSRH group . Related parameters were compared between the two groups . RESULTS The estimated blood loss in NSRH group and CRH group were ( 550 + /- 241 ) ml and ( 475 + /- 284 ) ml , respectively , with no significant difference ( P > 0.05 ) . The mean operation time in NSRH group and CRH group were ( 329 + /- 43 ) min and ( 272 + /- 56 ) min , respectively , with a significant difference ( P < 0.01 ) . More patients in NSRH group had post-void residual urine volume ( PVR ) < 100 ml than that in CRH group on day 8 after surgery ( 68 % vs. 18 % , P < 0.01 ) . The median duration of postoperative catheterization was significantly shorter in NRSH group ( 8 - 23 days , median 8 days ) than that in CRH group ( 8 - 32 days , median 20 days ; P < 0.01 ) . Neither surgery-related injury nor pathologically positive margin was reported in either of the groups . CONCLUSIONS NSRH is a feasible and safe technique for preserving bladder function . Larger prospect i ve studies are needed to confirm the efficacy of this technique OBJECTIVE To decrease postoperative morbidity associated with radical hysterectomy Rutledge type III , we identified the parasympathetic innervation of the bladder in the cardinal ligament . METHODS During laparoscopic dissection of the cardinal ligament , we used 7x magnification on 38 consecutive patients with cervical cancer stages IB1 to IIIA with high risk for parametrial involvement when we performed laparoscopy-assisted radical vaginal hysterectomy type III between August 1997 and January 1999 . RESULTS The middle rectal artery was identified as a l and mark separating the vascular from the neural part of the cardinal ligament . The neural part was shown to contain the splanchnic pelvic nerves which anastomose with the pelvic plexus . Following preservation of these neural structures all patients were able to void their bladder spontaneously . Following nerve-sparing technique , patients regained bladder function significantly quicker compared with a control group ( n = 28 ) in which the neural part of the cardinal ligament had not been preserved : suprapubic drainage 11.2 days versus 21.4 days ( P = 0.0007 ) . CONCLUSION Using the middle rectal artery as a l and mark the neural part of the cardinal ligament can be preserved , result ing in preservation of the motor function of the bladder Objective : To investigate the bladder function recovery and quality of life ( QOL ) using nerve-sparing radical hysterectomy ( NSRH ) in treating early invasive cervical carcinoma . Methods : Subjects included patients who underwent radical hysterectomy by laparotomy for early-stage cervical carcinoma . Thirty-one patients were r and omly assigned to 2 groups : group A , 15 patients who underwent NSRH ; and group B , 16 patients who underwent classical radical hysterectomy . We observed the patients ' general clinical information , surgical characteristics , postoperative vital signs , pathological findings , adjuvant therapies , and adverse effects . A urodynamic study was used to assess the bladder function . The patients ' QOL was evaluated by Functional Assessment of Cervical Cancer Therapy ( FACT-Cx ) . Results : Twenty-nine patients completed the study . No significant differences were found in age , body mass index , surgery characteristics , pathological findings , adjuvant therapies , and main adverse effects between the 2 groups ( P > 0.05 ) . The postoperative time of bladder function recovery in group A was obviously earlier than that in group B ( P < 0.05 ) . The urodynamic study showed that the extent of bladder function recovery in group A was better than that in group B ( P < 0.05 ) . The QOL in group A evaluated 1 year after operation was improved compared with that in group B ( P < 0.05 ) . The QOL analysis showed that group A did much better than group B in social and family life , emotional well-being , working status , and the symptom correlated with the operation ( P < 0.05 ) . No significant differences were found in basic bodily functions ( P > 0.05 ) . Conclusions : Nerve-sparing radical hysterectomy is a safe and reliable technique for early invasive cervical carcinoma . The postoperative bladder function recovery and the patients ' QOL were improved after NSRH compared with the control group . Therefore , NSRH could be an alternative management to modify the classical surgery for cervical carcinoma with International Federation of Gynecology and Obstetrics stages IB1 to IIA Objectives Nerve-sparing radical hysterectomy for early stage cervical cancer was introduced to improve quality of life after treatment . Sparing the pelvic autonomic nerves reduces bladder , bowel , and sexual dysfunction . The Leiden nerve-sparing radical hysterectomy ( LNSRH ) was modified to the Swift procedure , the latter being more radical regarding the sacrouterine and parametrial resection . We investigate whether nerve-sparing surgery has comparable oncological outcomes as the conventional radical hysterectomy ( CRH ) . Concurrently , we investigate whether there is a difference regarding the oncological outcomes of the 2 nerve-sparing techniques . Methods This is a single-center , observational prospect i ve cohort study analyzing oncological outcomes in women undergoing CRH ( 1994–1999 ) , LNSRH ( 2001–2005 ) , or Swift procedure ( 2006–2010 ) for early stage cervical cancer ( International Federation of Gynecology and Obstetrics IA2–IIA ) . Results Three hundred sixty-three patients ( 124 CRH , 122 LNSRH , and 117 Swift ) were included . International Federation of Gynecology and Obstetrics stage IB2 or higher ( P = 0.005 ) was significantly more prevalent in the CRH cohort . The 5-year pelvic relapse – free survival and overall survival were not significantly different between the 3 cohorts ( P = 0.116 ) . Regarding the nerve-sparing cohorts , the Swift cohort showed a significant better 5-year overall survival ( 87.2 % ) compared with the LNSRH cohort ( 78.8 % ) ( P = 0.04 ) . In the LNSRH cohort , resection planes less than 5 mm free and need for adjuvant therapy were significantly higher than in the Swift cohort ( P = 0.026 and 0.046 , respectively ) . Conclusions The nerve-sparing radical hysterectomy shows a similar oncological outcome compared with the CRH . The more radical Swift version of nerve-sparing techniques is preferable to the former LNSRH procedure |
383 | 29,254,256 | Therefore , the treatment effect of MTAs on OS might be different in younger and older HCC patients undergoing first-line or second-line treatment , but not for PFS benefit | Currently , whether the impact of age on efficacy of molecular targeted agents ( MTAs ) in the treatment of hepatocellular carcinoma ( HCC ) patients remains undetermined . | BACKGROUND VEGF and VEGF receptor-2-mediated angiogenesis contribute to hepatocellular carcinoma pathogenesis . Ramucirumab is a recombinant IgG1 monoclonal antibody and VEGF receptor-2 antagonist . We aim ed to assess the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma following first-line therapy with sorafenib . METHODS In this r and omised , placebo-controlled , double-blind , multicentre , phase 3 trial ( REACH ) , patients were enrolled from 154 centres in 27 countries . Eligible patients were aged 18 years or older , had hepatocellular carcinoma with Barcelona Clinic Liver Cancer stage C disease or stage B disease that was refractory or not amenable to locoregional therapy , had Child-Pugh A liver disease , an Eastern Cooperative Oncology Group performance status of 0 or 1 , had previously received sorafenib ( stopped because of progression or intolerance ) , and had adequate haematological and biochemical parameters . Patients were r and omly assigned ( 1:1 ) to receive intravenous ramucirumab ( 8 mg/kg ) or placebo every 2 weeks , plus best supportive care , until disease progression , unacceptable toxicity , or death . R and omisation was stratified by geographic region and cause of liver disease with a stratified permuted block method . Patients , medical staff , investigators , and the funder were masked to treatment assignment . The primary endpoint was overall survival in the intention-to-treat population . This study is registered with Clinical Trials.gov , number NCT01140347 . FINDINGS Between Nov 4 , 2010 , and April 18 , 2013 , 565 patients were enrolled , of whom 283 were assigned to ramucirumab and 282 were assigned to placebo . Median overall survival for the ramucirumab group was 9·2 months ( 95 % CI 8·0 - 10·6 ) versus 7·6 months ( 6·0 - 9·3 ) for the placebo group ( HR 0·87 [ 95 % CI 0·72 - 1·05 ] ; p=0·14 ) . Grade 3 or greater adverse events occurring in 5 % or more of patients in either treatment group were ascites ( 13 [ 5 % ] of 277 patients treated with ramucirumab vs 11 [ 4 % ] of 276 patients treated with placebo ) , hypertension ( 34 [ 12 % ] vs ten [ 4 % ] ) , asthenia ( 14 [ 5 % ] vs five [ 2 % ] ) , malignant neoplasm progression ( 18 [ 6 % ] vs 11 [ 4 % ] ) , increased aspartate aminotransferase concentration ( 15 [ 5 % ] vs 23 [ 8 % ] ) , thrombocytopenia ( 13 [ 5 % ] vs one [ < 1 % ] ) , hyperbilirubinaemia ( three [ 1 % ] vs 13 [ 5 % ] ) , and increased blood bilirubin ( five [ 2 % ] vs 14 [ 5 % ] ) . The most frequently reported ( ≥1 % ) treatment-emergent serious adverse event of any grade or grade 3 or more was malignant neoplasm progression . INTERPRETATION Second-line treatment with ramucirumab did not significantly improve survival over placebo in patients with advanced hepatocellular carcinoma . No new safety signals were noted in eligible patients and the safety profile is manageable . FUNDING Eli Lilly and PURPOSE This phase II study of sorafenib , an oral multikinase inhibitor that targets Raf kinase and receptor tyrosine kinases , assessed efficacy , toxicity , pharmacokinetics , and biomarkers in advanced hepatocellular carcinoma ( HCC ) patients . METHODS Patients with inoperable HCC , no prior systemic treatment , and Child-Pugh ( CP ) A or B , received continuous , oral sorafenib 400 mg bid in 4-week cycles . Tumor response was assessed every two cycles using modified WHO criteria . Sorafenib pharmacokinetics were measured in plasma sample s. Biomarker analysis included phosphorylated extracellular signal regulated kinase ( pERK ) in pretreatment biopsies ( immunohistochemistry ) and blood-cell RNA expression patterns in selected patients . RESULTS Of 137 patients treated ( male , 71 % ; median age , 69 years ) , 72 % had CP A , and 28 % had CP B. On the basis of independent assessment , three ( 2.2 % ) patients achieved a partial response , eight ( 5.8 % ) had a minor response , and 46 ( 33.6 % ) had stable disease for at least 16 weeks . Investigator-assessed median time to progression ( TTP ) was 4.2 months , and median overall survival was 9.2 months . Grade 3/4 drug-related toxicities included fatigue ( 9.5 % ) , diarrhea ( 8.0 % ) , and h and -foot skin reaction ( 5.1 % ) . There were no significant pharmacokinetic differences between CP A and B patients . Pretreatment tumor pERK levels correlated with TTP . A panel of 18 expressed genes was identified that distinguished " nonprogressors " from " progressors " with an estimated 100 % accuracy . CONCLUSION Although single-agent sorafenib has modest efficacy in HCC , the manageable toxicity and mechanisms of action support a role for combination regimens with other anticancer agents PURPOSE Open-label , phase III trial evaluating whether sunitinib was superior or equivalent to sorafenib in hepatocellular cancer . PATIENTS AND METHODS Patients were stratified and r and omly assigned to receive sunitinib 37.5 mg once per day or sorafenib 400 mg twice per day . Primary end point was overall survival ( OS ) . RESULTS Early trial termination occurred for futility and safety reasons . A total of 1,074 patients were r and omly assigned to the study ( sunitinib arm , n = 530 ; sorafenib arm , n = 544 ) . For sunitinib and sorafenib , respectively , median OS was 7.9 versus 10.2 months ( hazard ratio [ HR ] , 1.30 ; one-sided P = .9990 ; two-sided P = .0014 ) ; median progression-free survival ( PFS ; 3.6 v 3.0 months ; HR , 1.13 ; one-sided P = .8785 ; two-sided P = .2286 ) and time to progression ( TTP ; 4.1 v 3.8 months ; HR , 1.13 ; one-sided P = .8312 ; two-sided P = .3082 ) were comparable . Median OS was similar among Asian ( 7.7 v 8.8 months ; HR , 1.21 ; one-sided P = .9829 ) and hepatitis B-infected patients ( 7.6 v 8.0 months ; HR , 1.10 ; one-sided P = .8286 ) , but was shorter with sunitinib in hepatitis C-infected patients ( 9.2 v 17.6 months ; HR , 1.52 ; one-sided P = .9835 ) . Sunitinib was associated with more frequent and severe adverse events ( AEs ) than sorafenib . Common grade 3/4 AEs were thrombocytopenia ( 29.7 % ) and neutropenia ( 25.7 % ) for sunitinib ; h and -foot syndrome ( 21.2 % ) for sorafenib . Discontinuations owing to AEs were similar ( sunitinib , 13.3 % ; sorafenib , 12.7 % ) . CONCLUSION OS with sunitinib was not superior or equivalent but was significantly inferior to sorafenib . OS was comparable in Asian and hepatitis B-infected patients . OS was superior in hepatitis C-infected patients who received sorafenib . Sunitinib-treated patients reported more frequent and severe toxicity BACKGROUND The efficacy and safety of axitinib , a potent and selective vascular endothelial growth factor receptors 1 - 3 inhibitor , combined with best supportive care ( BSC ) was evaluated in a global , r and omized , placebo-controlled phase II trial in patients with locally advanced or metastatic hepatocellular carcinoma ( HCC ) . PATIENTS AND METHODS Patients with HCC and Child-Pugh Class A who progressed on or were intolerant to one prior antiangiogenic therapy were stratified by tumour invasion ( presence/absence of extrahepatic spread and /or vascular invasion ) and region ( Asian/non-Asian ) and r and omized ( 2:1 ) to axitinib/BSC ( starting dose 5 mg twice-daily ) or placebo/BSC . The primary end point was overall survival ( OS ) . RESULTS The estimated hazard ratio for OS was 0.907 [ 95 % confidence interval ( CI ) 0.646 - 1.274 ; one-sided stratified P = 0.287 ] for axitinib/BSC ( n = 134 ) versus placebo/BSC ( n = 68 ) , with the median ( 95 % CI ) of 12.7 ( 10.2 - 14.9 ) versus 9.7 ( 5.9 - 11.8 ) months , respectively . Results of prespecified subgroup analyses in Asian versus non-Asian patients or presence versus absence of tumour invasion were consistent with the overall population . Improvements favouring axitinib/BSC ( P < 0.01 ) were observed in secondary efficacy end point analyses [ progression-free survival ( PFS ) , time to tumour progression ( TTP ) , and clinical benefit rate ( CBR ) ] , and were retained among Asian patients in the prespecified subgroup analyses . Overall response rate did not differ significantly between treatments and patient-reported outcomes favoured placebo/BSC . Most common all-causality adverse events with axitinib/BSC were diarrhoea ( 54 % ) , hypertension ( 54 % ) , and decreased appetite ( 47 % ) . Baseline serum analyses identified potential new prognostic ( interleukin-6 , E-selectin , interleukin-8 , angiopoietin-2 , migration inhibitory factor , and c-MET ) or predictive ( E-selectin and stromal-derived factor-1 ) factors for survival . CONCLUSIONS Axitinib/BSC did not improve OS over placebo/BSC in the overall population or in stratification subgroups . However , axitinib/BSC result ed in significantly longer PFS and TTP and higher CBR , with acceptable toxicity in patients with advanced HCC . TRIAL REGISTRATION Clinical Trials.gov , NCT01210495 BACKGROUND In Japan and South Korea , transarterial chemoembolisation ( TACE ) is an important locoregional treatment for patients with unresectable hepatocellular carcinoma ( HCC ) . Sorafenib , a multikinase inhibitor , has been shown effective and safe in patients with advanced HCC . This phase III trial assessed the efficacy and safety of sorafenib in Japanese and Korean patients with unresectable HCC who responded to TACE . METHODS Patients ( n=458 ) with unresectable HCC , Child-Pugh class A cirrhosis and ≥25 % tumour necrosis/shrinkage 1 - 3 months after 1 or 2 TACE sessions were r and omised 1:1 to sorafenib 400 mg bid or placebo and treated until progression/recurrence or unacceptable toxicity . Primary end-point was time to progression/recurrence ( TTP ) . Secondary end-point was overall survival ( OS ) . FINDINGS Baseline characteristics in the two groups were similar ; > 50 % of patients started sorafenib>9 weeks after TACE . Median TTP in the sorafenib and placebo groups was 5.4 and 3.7 months , respectively ( hazard ratio ( HR ) , 0.87 ; 95 % confidence interval ( CI ) , 0.70 - 1.09 ; P=0.252 ) . HR ( sorafenib/placebo ) for OS was 1.06 ( 95 % CI , 0.69 - 1.64 ; P=0.790 ) . Median daily dose of sorafenib was 386 mg , with 73 % of patients having dose reductions and 91 % having dose interruptions . Median administration of sorafenib and placebo was 17.1 and 20.1 weeks , respectively . No unexpected adverse events were observed . INTERPRETATION This trial , conducted prior to the reporting of registration al phase III trials , found that sorafenib did not significantly prolong TTP in patients who responded to TACE . This may have been due to delays in starting sorafenib after TACE and /or low daily sorafenib doses PURPOSE This open-label phase III trial evaluated efficacy and tolerability of linifanib versus sorafenib in patients with advanced hepatocellular carcinoma ( HCC ) without prior systemic therapy . PATIENTS AND METHODS Patients were r and omly assigned in a 1:1 ratio to linifanib 17.5 mg once daily or sorafenib 400 mg twice daily . Patients were stratified by region ( Outside Asia , Japan , and rest of Asia ) , Eastern Cooperative Oncology Group performance score ( ECOG PS ; 0 or 1 ) , vascular invasion or extrahepatic spread ( yes or no ) , and hepatitis B virus ( HBV ) infection ( yes or no ) . The primary end point of the study was overall survival ( OS ) . Secondary end points were time to progression ( TTP ) and objective response rate ( ORR ) per RECIST v1.1 . RESULTS We r and omly assigned 1,035 patients ( median age , 60 years ; Asian , 66.6 % ; ECOG PS 0 , 65.2 % ; HBV , 49.1 % ; vascular invasion or extrahepatic spread , 70.1 % ) . Median OS was 9.1 months on the linifanib arm ( 95 % CI , 8.1 to 10.2 ) and 9.8 months on the sorafenib arm ( 95 % CI , 8.3 to 11.0 ; hazard ratio [ HR ] , 1.046 ; 95 % CI , 0.896 to 1.221 ) . For prespecified stratification subgroups , OS HRs ranged from 0.793 to 1.119 and the 95 % CI contained 1.0 . Median TTP was 5.4 months on the linifanib arm ( 95 % CI , 4.2 to 5.6 ) and 4.0 months on the sorafenib arm ( 95 % CI , 2.8 to 4.2 ; HR , 0.759 ; 95 % CI , 0.643 to 0.895 ; P = .001 ) . Best response rate was 13.0 % on the linifanib arm versus 6.9 % on the sorafenib arm . Grade 3/4 adverse events ( AEs ) ; serious AEs ; and AEs leading to discontinuation , dose interruption , and reduction were more frequent with linifanib ( all P < .001 ) . CONCLUSION Linifanib and sorafenib had similar OS in advanced HCC . Predefined superiority and noninferiority OS boundaries were not met for linifanib and the study failed to meet the primary end point . TTP and ORR favored linifanib ; safety results favored sorafenib PURPOSE Brivanib is a dual inhibitor of vascular-endothelial growth factor and fibroblast growth factor receptors that are implicated in the pathogenesis of hepatocellular carcinoma ( HCC ) . Our multinational , r and omized , double-blind , phase III trial compared brivanib with sorafenib as first-line treatment for HCC . PATIENTS AND METHODS Advanced HCC patients who had no prior systemic therapy were r and omly assigned ( ratio , 1:1 ) to receive sorafenib 400 mg twice daily orally ( n = 578 ) or brivanib 800 mg once daily orally ( n = 577 ) . Primary end point was overall survival ( OS ) . Secondary end points included time to progression ( TTP ) , objective response rate ( ORR ) , disease control rate ( DCR ) based on modified Response Evaluation Criteria in Solid Tumors ( mRECIST ) , and safety . RESULTS The primary end point of OS noninferiority for brivanib versus sorafenib in the per- protocol population ( n = 1,150 ) was not met ( hazard ratio [ HR ] , 1.06 ; 95.8 % CI , 0.93 to 1.22 ) , based on the prespecified margin ( upper CI limit for HR ≤ 1.08 ) . Median OS was 9.9 months for sorafenib and 9.5 months for brivanib . TTP , ORR , and DCR were similar between the study arms . Most frequent grade 3/4 adverse events for sorafenib and brivanib were hyponatremia ( 9 % and 23 % , respectively ) , AST elevation ( 17 % and 14 % ) , fatigue ( 7 % and 15 % ) , h and -foot-skin reaction ( 15 % and 2 % ) , and hypertension ( 5 % and 13 % ) . Discontinuation as a result of adverse events was 33 % for sorafenib and 43 % for brivanib ; rates for dose reduction were 50 % and 49 % , respectively . CONCLUSION Our study did not meet its primary end point of OS noninferiority for brivanib versus sorafenib . However , both agents had similar antitumor activity , based on secondary efficacy end points . Brivanib had an acceptable safety profile , but was less well-tolerated than sorafenib BACKGROUND Hepatocellular carcinoma ( HCC ) tumour spread is partly dependent on neoangiogenesis . In this open-label , multicentre , phase II trial done in Europe and Asia , sunitinib , a multitargeted tyrosine-kinase inhibitor with anti-angiogenic properties , was assessed in patients with advanced unresectable HCC . METHODS Between February and July , 2006 , eligible patients were enrolled and treated with repeated cycles of oral sunitinib ( 50 mg/day for 4 weeks , followed by 2 weeks off treatment ) . The primary endpoint of this Simon two-stage phase II trial was objective response rate according to Response Evaluation Criteria in Solid Tumours ( RECIST ) criteria , with an expected response rate of 15 % . This trial is registered with Clinical Trials.gov , number NCT00247676 . FINDINGS Of 37 patients enrolled , one ( 2.7 % ) patient experienced a confirmed partial response , giving an overall objective response rate of 2.7 % ( 95 % CI 0.1 - 14.2 ) ; on the basis of this , the trial did not proceed to the second stage . 13 ( 35 % ) of 37 patients achieved stable disease for over 3 months . Commonly observed grade 3 and 4 adverse events included thrombocytopenia ( 14 of 37 ; 37.8 % ) , neutropenia ( nine of 37 ; 24.3 % ) , asthenia ( five of 37 ; 13.5 % ) , h and -foot syndrome ( four of 37 ; 10.8 % ) , and anaemia ( four of 37 ; 10.8 % ) . There were four deaths among the 37 patients ( 10.8 % ) that were possibly related to treatment . INTERPRETATION Sunitinib showed pronounced toxicities at a dose of 50 mg/day in patients with unresectable HCC . The response rate was low , and the study did not meet the primary endpoint based on RECIST criteria . FUNDING Pfizer Oncology BACKGROUND Tivantinib ( ARQ 197 ) , a selective oral inhibitor of MET , has shown promising antitumour activity in hepatocellular carcinoma as monotherapy and in combination with sorafenib . We aim ed to assess efficacy and safety of tivantinib for second-line treatment of advanced hepatocellular carcinoma . METHODS In this completed , multicentre , r and omised , placebo-controlled , double-blind , phase 2 study , we enrolled patients with advanced hepatocellular carcinoma and Child-Pugh A cirrhosis who had progressed on or were unable to tolerate first-line systemic therapy . We r and omly allocated patients 2:1 to receive tivantinib ( 360 mg twice-daily ) or placebo until disease progression . The tivantinib dose was amended to 240 mg twice-daily because of high incidence of treatment-emergent grade 3 or worse neutropenia . R and omisation was done central ly by an interactive voice-response system , stratified by Eastern Cooperative Oncology Group performance status and vascular invasion . The primary endpoint was time to progression , according to independent radiological review in the intention-to-treat population . We assessed tumour sample s for MET expression with immunohistochemistry ( high expression was regarded as ≥2 + in ≥50 % of tumour cells ) . This study is registered with Clinical Trials.gov , number NCT00988741 . FINDINGS 71 patients were r and omly assigned to receive tivantinib ( 38 at 360 mg twice-daily and 33 at 240 mg twice-daily ) ; 36 patients were r and omly assigned to receive placebo . At the time of analysis , 46 ( 65 % ) patients in the tivantinib group and 26 ( 72 % ) of those in the placebo group had progressive disease . Time to progression was longer for patients treated with tivantinib ( 1·6 months [ 95 % CI 1·4 - 2·8 ] ) than placebo ( 1·4 months [ 1·4 - 1·5 ] ; hazard ratio [ HR ] 0·64 , 90 % CI 0·43 - 0·94 ; p=0·04 ) . For patients with MET-high tumours , median time to progression was longer with tivantinib than for those on placebo ( 2·7 months [ 95 % CI 1·4 - 8·5 ] for 22 MET-high patients on tivantinib vs 1·4 months [ 1·4 - 1·6 ] for 15 MET-high patients on placebo ; HR 0·43 , 95 % CI 0·19 - 0·97 ; p=0·03 ) . The most common grade 3 or worse adverse events in the tivantinib group were neutropenia ( ten patients [ 14 % ] vs none in the placebo group ) and anaemia ( eight [ 11 % ] vs none in the placebo group ) . Eight patients ( 21 % ) in the tivantinib 360 mg group had grade 3 or worse neutropenia compared with two ( 6 % ) patients in the 240 mg group . Four deaths related to tivantinib occurred from severe neutropenia . 24 ( 34 % ) patients in the tivantinib group and 14 ( 39 % ) patients in the placebo group had serious adverse events . INTERPRETATION Tivantinib could provide an option for second-line treatment of patients with advanced hepatocellular carcinoma and well-compensated liver cirrhosis , particularly for patients with MET-high tumours . Confirmation in a phase 3 trial is needed , with a starting dose of tivantinib 240 mg twice-daily . FUNDING ArQule , Daiichi Sankyo ( Daiichi Sankyo Group ) BACKGROUND There is no st and ard of care for adjuvant therapy for patients with hepatocellular carcinoma . This trial was design ed to assess the efficacy and safety of sorafenib versus placebo as adjuvant therapy in patients with hepatocellular carcinoma after surgical resection or local ablation . METHODS We undertook this phase 3 , double-blind , placebo-controlled study of patients with hepatocellular carcinoma with a complete radiological response after surgical resection ( n=900 ) or local ablation ( n=214 ) in 202 sites ( hospitals and research centres ) in 28 countries . Patients were r and omly assigned ( 1:1 ) to receive 400 mg oral sorafenib or placebo twice a day , for a maximum of 4 years , according to a block r and omisation scheme ( block size of four ) using an interactive voice-response system . Patients were stratified by curative treatment , geography , Child-Pugh status , and recurrence risk . The primary outcome was recurrence-free survival assessed after data base cut-off on Nov 29 , 2013 . We analysed efficacy in the intention-to-treat population and safety in r and omly assigned patients receiving at least one study dose . The final analysis is reported . This study is registered with Clinical Trials.gov , number NCT00692770 . FINDINGS We screened 1602 patients between Aug 15 , 2008 , and Nov 17 , 2010 , and r and omly assigned 1114 patients . Of 556 patients in the sorafenib group , 553 ( > 99 % ) received the study treatment and 471 ( 85 % ) terminated treatment . Of 558 patients in the placebo group , 554 ( 99 % ) received the study treatment and 447 ( 80 % ) terminated treatment . Median duration of treatment and mean daily dose were 12·5 months ( IQR 2·6 - 35·8 ) and 577 mg per day ( SD 212·8 ) for sorafenib , compared with 22·2 months ( 8·1 - 38·8 ) and 778·0 mg per day ( 79·8 ) for placebo . Dose modification was reported for 497 ( 89 % ) of 559 patients in the sorafenib group and 206 ( 38 % ) of 548 patients in the placebo group . At final analysis , 464 recurrence-free survival events had occurred ( 270 in the placebo group and 194 in the sorafenib group ) . Median follow-up for recurrence-free survival was 8·5 months ( IQR 2·9 - 19·5 ) in the sorafenib group and 8·4 months ( 2·9 - 19·8 ) in the placebo group . We noted no difference in median recurrence-free survival between the two groups ( 33·3 months in the sorafenib group vs 33·7 months in the placebo group ; hazard ratio [ HR ] 0·940 ; 95 % CI 0·780 - 1·134 ; one-sided p=0·26 ) . The most common grade 3 or 4 adverse events were h and -foot skin reaction ( 154 [ 28 % ] of 559 patients in the sorafenib group vs four [ < 1 % ] of 548 patients in the placebo group ) and diarrhoea ( 36 [ 6 % ] vs five [ < 1 % ] in the placebo group ) . Sorafenib-related serious adverse events included h and -foot skin reaction ( ten [ 2 % ] ) , abnormal hepatic function ( four [ < 1 % ] ) , and fatigue ( three [ < 1 % ] ) . There were four ( < 1 % ) drug-related deaths in the sorafenib group and two ( < 1 % ) in the placebo group . INTERPRETATION Our data indicate that sorafenib is not an effective intervention in the adjuvant setting for hepatocellular carcinoma following resection or ablation IMPORTANCE Aside from the multikinase inhibitor sorafenib , there are no effective systemic therapies for the treatment of advanced hepatocellular carcinoma . OBJECTIVE To assess the efficacy of everolimus in patients with advanced hepatocellular carcinoma for whom sorafenib treatment failed . DESIGN , SETTING , AND PARTICIPANTS EVOLVE-1 was a r and omized , double-blind , phase 3 study conducted among 546 adults with Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma and Child-Pugh A liver function whose disease progressed during or after sorafenib or who were intolerant of sorafenib . Patients were enrolled from 17 countries between May 2010 and March 2012 . R and omization was stratified by region ( Asia vs rest of world ) and macrovascular invasion ( present vs absent ) . INTERVENTIONS Everolimus , 7.5 mg/d , or matching placebo , both given in combination with best supportive care and continued until disease progression or intolerable toxicity . Per the 2:1 r and omization scheme , 362 patients were r and omized to the everolimus group and 184 patients to the placebo group . MAIN OUTCOMES AND MEASURES The primary end point was overall survival . Secondary end points included time to progression and the disease control rate ( the percentage of patients with a best overall response of complete or partial response or stable disease ) . RESULTS No significant difference in overall survival was seen between treatment groups , with 303 deaths ( 83.7 % ) in the everolimus group and 151 deaths ( 82.1 % ) in the placebo group ( hazard ratio [ HR ] , 1.05 ; 95 % CI , 0.86 - 1.27 ; P = .68 ; median overall survival , 7.6 months with everolimus , 7.3 months with placebo ) . Median time to progression with everolimus and placebo was 3.0 months and 2.6 months , respectively ( HR , 0.93 ; 95 % CI , 0.75 - 1.15 ) , and disease control rate was 56.1 % and 45.1 % , respectively ( P = .01 ) . The most common grade 3/4 adverse events for everolimus vs placebo were anemia ( 7.8 % vs 3.3 % , respectively ) , asthenia ( 7.8 % vs 5.5 % , respectively ) , and decreased appetite ( 6.1 % vs 0.5 % , respectively ) . No patients experienced hepatitis C viral flare . Based on central laboratory results , hepatitis B viral reactivation was experienced by 39 patients ( 29 everolimus , 10 placebo ) ; all cases were asymptomatic , but 3 everolimus recipients discontinued therapy . CONCLUSIONS AND RELEVANCE Everolimus did not improve overall survival in patients with advanced hepatocellular carcinoma whose disease progressed during or after receiving sorafenib or who were intolerant of sorafenib . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01035229 UNLABELLED Transarterial chemoembolization ( TACE ) is the current st and ard of treatment for unresectable intermediate-stage hepatocellular carcinoma ( HCC ) . Brivanib , a selective dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling , may improve the effectiveness of TACE when given as an adjuvant to TACE . In this multinational , r and omized , double-blind , placebo-controlled , phase III study , 870 patients with TACE-eligible HCC were planned to be r and omly assigned ( 1:1 ) after the first TACE to receive either brivanib 800 mg or placebo orally once-daily . The primary endpoint was overall survival ( OS ) . Secondary endpoints included time to disease progression ( TTDP ; a composite endpoint based on development of extrahepatic spread or vascular invasion , deterioration of liver function or performance status , or death ) , time to extrahepatic spread or vascular invasion ( TTES/VI ) , rate of TACE , and safety . Time to radiographic progression ( TTP ) and objective response rate were exploratory endpoints . The trial was terminated after r and omization of 502 patients ( brivanib , 249 ; placebo , 253 ) when two other phase III studies of brivanib in advanced HCC patients failed to meet OS objectives . At termination , median follow-up was approximately 16 months . Intention-to-treat analysis showed no improvement in OS with brivanib versus placebo ( median , 26.4 [ 95 % confidence interval { CI } : 19.1 to not reached ] vs. 26.1 months [ 19.0 - 30.9 ] ; hazard ratio [ HR ] : 0.90 [ 95 % CI : 0.66 - 1.23 ] ; log-rank P=0.5280 ) . Brivanib improved TTES/VI ( HR , 0.64 [ 95 % CI : 0.45 - 0.90 ] ) , TTP ( 0.61 [ 0.48 - 0.77 ] ) , and rate of TACE ( 0.72 [ 0.61 - 0.86 ] ) , but not TTDP ( 0.94 [ 0.72 - 1.22 ] ) versus placebo . Most frequent grade 3 - 4 adverse events included hyponatremia ( brivanib , 18 % vs. placebo , 5 % ) and hypertension ( 13 % vs. 3 % ) . CONCLUSIONS In this study , brivanib as adjuvant therapy to TACE did not improve OS BACKGROUND There are no systemic treatments for patients with hepatocellular carcinoma ( HCC ) whose disease progresses during sorafenib treatment . We aim ed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment . METHODS In this r and omised , double-blind , parallel-group , phase 3 trial done at 152 sites in 21 countries , adults with HCC who tolerated sorafenib ( ≥400 mg/day for ≥20 of last 28 days of treatment ) , progressed on sorafenib , and had Child-Pugh A liver function were enrolled . Participants were r and omly assigned ( 2:1 ) by a computer-generated r and omisation list and interactive voice response system and stratified by geographical region , Eastern Cooperative Oncology Group performance status , macrovascular invasion , extrahepatic disease , and α-fetoprotein level to best supportive care plus oral regorafenib 160 mg or placebo once daily during weeks 1 - 3 of each 4-week cycle . Investigators , patients , and the funder were masked to treatment assignment . The primary endpoint was overall survival ( defined as time from r and omisation to death due to any cause ) and analysed by intention to treat . This trial is registered with Clinical Trials.gov , number NCT01774344 . FINDINGS Between May 14 , 2013 , and Dec 31 , 2015 , 843 patients were screened , of whom 573 were enrolled and r and omised ( 379 to regorafenib and 194 to placebo ; population for efficacy analyses ) , and 567 initiated treatment ( 374 received regorafenib and 193 received placebo ; population for safety analyses ) . Regorafenib improved overall survival with a hazard ratio of 0·63 ( 95 % CI 0·50 - 0·79 ; one-sided p<0·0001 ) ; median survival was 10·6 months ( 95 % CI 9·1 - 12·1 ) for regorafenib versus 7·8 months ( 6·3 - 8·8 ) for placebo . Adverse events were reported in all regorafenib recipients ( 374 [ 100 % ] of 374 ) and 179 ( 93 % ) of 193 placebo recipients . The most common clinical ly relevant grade 3 or 4 treatment-emergent events were hypertension ( 57 patients [ 15 % ] in the regorafenib group vs nine patients [ 5 % ] in the placebo group ) , h and -foot skin reaction ( 47 patients [ 13 % ] vs one [ 1 % ] ) , fatigue ( 34 patients [ 9 % ] vs nine patients [ 5 % ] ) , and diarrhoea ( 12 patients [ 3 % ] vs no patients ) . Of the 88 deaths ( grade 5 adverse events ) reported during the study ( 50 patients [ 13 % ] assigned to regorafenib and 38 [ 20 % ] assigned to placebo ) , seven ( 2 % ) were considered by the investigator to be related to study drug in the regorafenib group and two ( 1 % ) in the placebo group , including two patients ( 1 % ) with hepatic failure in the placebo group . INTERPRETATION Regorafenib is the only systemic treatment shown to provide survival benefit in HCC patients progressing on sorafenib treatment . Future trials should explore combinations of regorafenib with other systemic agents and third-line treatments for patients who fail or who do not tolerate the sequence of sorafenib and regorafenib . FUNDING Bayer |
384 | 19,160,158 | This study showed that NBI did not reduce the miss rate .
Given these results , it seems unlikely that NBI will be the whole solution to adenoma miss rates , at least in routine patients | This single−center study from the USA examined the ability of narrow b and imaging ( NBI ) , a novel “ blue light ” advanced endoscopic imaging tech− nique , to reduce adenoma miss rates and thereby increase detection .
With the advent of national bowel cancer screening programs and competing tech− nologies such as computed tomography ( CT ) co− lonography , the issue of colonoscopic miss rates has been recently highlighted .
This has led to a focus on colonoscopic quality , as assessed by adenoma detection rates [ 2 ] . | Context How often does colonoscopy miss adenomas ? Contribution During a multicenter screening trial , experienced colonoscopists performed same-day optical ( OC ) and virtual colonoscopy ( VC ) on 1233 asymptomatic adults . Optical colonoscopy performed without knowledge of the VC findings missed 55 of 511 polyps ; 21 of these polyps were adenomas measuring 6 mm or greater . Adenomas missed by OC were usually on the proximal side of a fold or near the anal verge . Virtual colonoscopy missed 14 % of the adenomas that measured 6 mm or greater that were de-tected by OC . Implication s Neither OC nor VC is a perfect test : Each misses 10 % to 14 % of adenomas that measure 6 mm or greater . The Editors Optical colonoscopy ( OC ) is widely accepted as the gold st and ard for detecting colorectal neoplasia ( 1 , 2 ) . However , even in the most experienced h and s , this skilled examination is underst and ably not infallible . Retrospective analysis has suggested that the OC miss rate for adenomas 10 mm or greater is approximately 10 % ( 3 ) . More recently , prospect i ve back-to-back or t and em colonoscopy studies have reported miss rates for 10-mm adenomas ranging from 0 % to 6 % ( 4 , 5 ) . However , in addition to evaluating relatively small population s of patients with a high prevalence of polyps , a notable weakness common to these studies was that they used OC as its own reference st and ard . In a large , prospect i ve , multicenter trial that was primarily intended to evaluate the performance of virtual colonoscopy ( VC ) in asymptomatic adults ( 6 ) , we also had a unique opportunity to evaluate the adenoma miss rate on OC by segmentally unblinding the results from same-day VC . By using a reference st and ard other than OC itself for comparison , we could uncover lesions that may be systematic ally missed on repeated colonoscopies . These data not only provide novel insight into OC miss rates but also indicate the relative blind spots where more attention could be focused . Methods Study Design The institutional review boards at all 3 participating medical centers approved the study protocol for same-day VC and OC , and all patients provided written informed consent . We recruited asymptomatic adults who were referred for colorectal cancer screening . Exclusion criteria were a positive stool guiaic test result or iron deficiency anemia within the past 6 months ; rectal bleeding , hematochezia , or unintentional weight loss of more than 10 pounds within the past 12 months ; OC within the past 10 years or barium enema within the past 5 years ; personal history of adenomatous polyps , colorectal cancer , or inflammatory bowel disease ; and family history of familial adenomatous polyposis or nonpolyposis cancer syndromes . Between May 2002 and June 2003 , 1253 asymptomatic adults enrolled in the study . Eight patients were excluded because of failure to reach the cecum at OC , 6 patients were excluded because of inadequate colonic preparation , and another 6 patients were excluded because of computed tomography ( CT ) system failure . The final study group comprised 1233 asymptomatic adults ( 728 men and 505 women ; mean age , 57.8 years ) who successfully completed same-day VC and OC . Study participants underwent colonic preparation with oral intake of 90 mL of phospho-soda and 10 mg of bisacodyl . To opacify residual colonic fluid and stool for VC examination , patients also consumed dilute oral contrast as previously described ( 7 ) . Our CT protocol and VC technique have also been detailed previously ( 6 ) . To briefly summarize , we obtained supine and prone CT acquisitions on multidetector scanners after patient-controlled rectal insufflation of room air . One of 6 trained radiologists interpreted VC studies by using a commercially available CT colonography system ( Viatronix V3D-Colon , version 1.2 , Viatronix , Inc. , Stony Brook , New York ) . We used the 3-dimensional endoluminal fly-through view primarily for detecting polyps and 2-dimensional images for confirmation and problem solving . We measured polyps on the 3-dimensional view and recorded them by segment ( cecum , ascending colon , hepatic flexure , transverse colon , splenic flexure , descending colon , sigmoid colon , or rectum ) . We defined the proximal colon as including the cecum to the splenic flexure . We prospect ively rated diagnostic confidence for each detected lesion on a 3-point scale ( most certain , intermediate , and least certain ) . One of 17 experienced colonoscopists performed OC immediately after VC interpretation by using st and ard commercial video colonoscopes ( Olympus , Inc. , Melville , New York ) . The colonoscope was advanced to the cecum and then sequentially withdrawn into more distal segments for polyp detection . The colonoscopist measured polyps by using a calibrated linear probe , which is more accurate than either visual or biopsy forceps estimation ( 8) . Our polyp-matching algorithm requires VC and OC agreement according to size ( within a 50 % margin of error ) and location ( within the same or adjacent segment ) . After the colonoscopist evaluated a given segment , a study nurse unblinded the VC results for the previous segment . For any suspected polyp seen on VC that measured 5 mm or greater but was not seen on the initial blinded OC , the colonoscopist closely reexamined that segment and could review the VC images for guidance . We sent all retrieved polyps for histologic examination . For all cases in which a colorectal neoplasm measuring 6 mm or greater was found on second-look OC , we retrospectively review ed both the VC and OC images . We recorded polyp characteristics , such as size , morphologic characteristic ( sessile , pedunculated , or flat ) , and location on VC . If the polyp was situated on a colonic fold on VC , we further subcategorized it as being located on the back ( proximal ) side , front ( distal ) side , or edge of the fold . We analyzed both supine and prone VC sets for all cases . The primary reason that diminutive polyps measuring 5 mm at VC were included for potential unblinding at OC was that , given the relative error in polyp measurement , such polyps found on second-look OC might , in fact , measure 6 mm or greater . This allows for more accurate assessment of the OC miss rate at the 6-mm threshold . We did not include unblinded polyps that measured 5 mm or less on both VC and OC examinations in the final analysis . All study participants completed a detailed question naire on their personal and family medical history . For the purpose s of this study , particular attention was given to the question about previous abdominal or pelvic surgery , since adhesions could conceivably result in a more difficult colonoscopic examination . Statistical Analysis Prospect i ve OC performance was compared against the enhanced reference st and ard of second-look OC after segmental unblinding of VC results . We estimated exact binomial 95 % CIs for OC miss rates . We used the chi-square test to compare the frequency of previous abdominal surgery among patients with and without polyps missed at OC and also to compare the OC miss rates among the 3 medical centers . We calculated the 95 % CIs by using Stata software , version 7.0 for Windows ( Stata Corp. , College Station , Texas ) , and performed the chi-square tests by using SAS software , version 8.0 for Windows ( SAS Institute , Inc. , Cary , North Carolina ) . Role of the Funding Source The funding source had no role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results The performance characteristics of VC from this prospect i ve , multicenter screening trial , using OC as the reference st and ard , have been previously reported ( 6 ) . Our technique of segmental unblinding also allows for a separate assessment of OC by using the blinded VC results for comparison , which is the focus of this study . We identified 1310 polyps at OC in the 1233 asymptomatic adults ; 511 ( 39.0 % ) of these polyps measured 5 mm or greater ( Figure 1).Of these 511 polyps , 55 ( 10.8 % ) were found only on second-look OC after segmental unblinding of VC results . Twenty-four ( 43.6 % ) of the 55 unblinded lesions were nonadenomatous , including 16 hyperplastic polyps . Of the 31 missed neoplasms , 10 adenomas that measured only 5 mm were excluded from further analysis because of their diminutive size ( 9 ) . Including unblinded lesions , 554 adenomas were detected on OC in this screening sample ; 210 of these measured 6 mm or greater and 51 measured 10 mm or greater . Figure 1 . Polyp flowchart . In 20 patients ( 17 men and 3 women ; mean age , 58.2 years ) , 21 adenomas measuring 6 mm or greater ( range , 6 mm to 17 mm ; mean , 8.1 mm ) were found on OC only after the VC results were unblinded , which represent the lesions of primary interest for this study ( Table ) . The corresponding adenoma miss rate on prospect i ve OC examination was 10.0 % ( 95 % CI , 6.3 % to 14.9 % ) ( 21 of 210 adenomas ) at a 6-mm cutoff . The 20 patients with missed adenomas that measured 6 mm or greater represented only 1.6 % of the study sample ( 20 of 1233 patients ) but 11.9 % of patients with adenomas 6 mm or greater ( 20 of 168 patients ) . At 8-mm and 10-mm thresholds , the OC adenoma miss rates by polyp were 10.5 % ( CI , 5.2 % to 18.5 % ) ( 10 of 95 adenomas ) and 11.8 % ( CI , 4.4 % to 23.9 % ) ( 6 of 51 adenomas ) , respectively . The 10 patients with missed adenomas 8 mm or greater represented 12.2 % ( 10 of 82 patients ) of all patients with neoplasms of this size or greater ; the 6 patients with missed adenomas 8 mm or greater represented 12.5 % of all patients with neoplasms 10 mm or greater . Table . Characteristics of Neoplasms Missed at Prospect i ve Colonoscopic Evaluation Seventeen ( 81.0 % ) of the 21 unblinded neoplasms 6 mm or greater were tubular adenomas , 3 ( 14.3 % ) were tubulovillous adenomas , and 1 ( 4.8 % ) was an adenocarcinoma . Seven ( 33.3 % ) of the 21 unblinded polyps were classified as advanced lesions ( that is , size 10 mm or high- grade dysplasia , prominent villous component , or focus of malignancy ) . There were 15 sessile lesions , 4 pedunculated lesions , and 2 flat Background and aims : Colonoscopy is an established method of colorectal cancer screening , but has an adenoma miss rate of 10–20 % . Detection rates are expected to improve with optimised visualisation methods . This prospect i ve r and omised study evaluated narrow-b and imaging ( NBI ) , a new technique that may enhance image contrast in colon adenoma detection . Methods : Eligible patients presenting for diagnostic colonoscopy were r and omly assigned to undergo wide-angle colonoscopy using either conventional high-resolution imaging or NBI during instrument withdrawal . The primary outcome parameter was the difference in the adenoma detection rate between the two techniques . Results : A total of 401 patients were included ( mean age 59.4 years , 52.6 % men ) . Adenomas were detected more frequently in the NBI group ( 23 % ) than in the control group ( 17 % ) with a number of 17 colonoscopies needed to find one additional adenoma patient ; however , the difference was not statistically significant ( p = 0.129 ) . When the two techniques were compared in consecutive subgroups of 100 study patients , adenoma rates in the NBI group remained fairly stable , whereas these rates steadily increased in the control group ( 8 % , 15 % , 17 % , and 26.5 % , respectively ) . Significant differences in the first 100 cases ( 26.5 % versus 8 % ; p = 0.02 ) could not be maintained in the last 100 cases ( 25.5 % versus 26.5 % , p = 0.91 ) . Conclusions : The increased adenoma detection rate means of NBI colonoscopy were statistically not significant . It remains speculative as to whether the increasing adenoma rate in the conventional group may have been caused by a training effect of better polyp recognition on NBI BACKGROUND AND STUDY AIM Patients with longst and ing ulcerative colitis are at increased risk of developing colorectal cancer . Colonoscopic surveillance is advised , but the detection of neoplasia by conventional colonoscopy is difficult . The aim of this study was to compare the accuracy of narrow-b and imaging ( NBI ) , a new imaging technique , with st and ard colonoscopy for the detection of neoplasia in patients with longst and ing ulcerative colitis . PATIENTS AND METHODS This was a prospect i ve , r and omized , crossover study of 42 patients with longst and ing ulcerative colitis . All participants underwent NBI and conventional colonoscopy with at least 3 weeks between the procedures . R and omization determined the order of the examinations . Targeted biopsies were taken during both procedures ; additional r and om biopsies were taken at conventional colonoscopy only . The number of patients with neoplasia detected by targeted biopsies was used to assess the sensitivity for each technique . RESULTS With NBI , 52 suspicious lesions were detected in 17 patients , compared with 28 suspicious lesions in 13 patients detected during conventional colonoscopy . Histopathological evaluation of targeted biopsies revealed 11 patients with neoplasia : in four patients the neoplasia was detected by both techniques , in four patients neoplasia was detected only by NBI , and in three patients neoplasia was detected only by conventional colonoscopy ( P = 0.705 ) . Aside from targeted biopsies , 1522 r and om biopsies were taken . These revealed one additional patient with dysplasia that was not detected by either technique . CONCLUSIONS The sensitivity of the studied first-generation NBI system for the detection of patients with neoplasia seems to be comparable to conventional colonoscopy , although more suspicious lesions were found during NBI . We believe that it is still too early to stop taking additional r and om biopsies at surveillance colonoscopy in patients with ulcerative colitis BACKGROUND Narrow-b and imaging ( NBI ) is a novel illumination technology for endoscopy that enhances vasculature of the GI tract . OBJECTIVE The aim was to eluci date whether NBI colonoscopy can identify dysplasia in patients with ulcerative colitis ( UC ) . DESIGN Cross-sectional study of eligible patients . SETTING Single center . PATIENTS 46 patients with UC . INTERVENTIONS Apparently flat mucosa at each segment and visible protruding lesions were observed by magnifying NBI colonoscopy . The surface structure was classified into honeycomb-like , villous , or tortuous pattern . The grade of dysplasia was determined in the specimens obtained from protrusions and from flat mucosa . MAIN OUTCOME MEASUREMENTS The positive predictive value of conventional and NBI colonoscopy for the diagnosis of dysplasia . RESULTS A total of 296 sites ( 20 protruding lesions and 276 flat areas ) were examined by NBI colonoscopy . The surface pattern was determined to be honeycomb like in 161 sites , villous in 85 sites , and tortuous in 50 sites . Five dysplastic lesions were detected in 3 patients . A patient had 3 dysplastic lesions and the other 2 had a dysplastic lesion each . The positive rate of dysplasia was higher in protrusions ( 2/20 sites , 10 % ) than in flat mucosa ( 3/276 sites , 1.1 % , P = .038 ; however , correction for the multiple testing of data removes this significance ) . When the surface pattern was taken into account , the rate of positive dysplasia was higher in the tortuous pattern ( 4/50 sites , 8 % ) than in the honeycomb-like or villous patterns ( 1/246 sites , 0.4 % , P = .003 ) . LIMITATIONS Uncontrolled study . CONCLUSIONS The tortuous pattern determined by NBI colonoscopy may be a clue for the identification of dysplasia during surveillance for UC BACKGROUND & AIMS Outcomes of colon surveillance after colorectal cancer screening with colonoscopy are uncertain . We conducted a prospect i ve study to measure incidence of advanced neoplasia in patients within 5.5 years of screening colonoscopy . METHODS Three thous and one hundred twenty-one asymptomatic subjects , age 50 to 75 years , had screening colonoscopy between 1994 and 1997 in the Department of Veterans Affairs . One thous and one hundred seventy-one subjects with neoplasia and 501 neoplasia-free controls were assigned to colonoscopic surveillance over 5 years . Cohorts were defined by baseline findings . Relative risks for advanced neoplasia within 5.5 years were calculated . Advanced neoplasia was defined as tubular adenoma greater than > or = 10 mm , adenoma with villous histology , adenoma with high- grade dysplasia , or invasive cancer . RESULTS Eight hundred ninety-five ( 76.4 % ) patients with neoplasia and 298 subjects ( 59.5 % ) without neoplasia at baseline had colonoscopy within 5.5 years ; 2.4 % of patients with no neoplasia had interval advanced neoplasia . The relative risk in patients with baseline neoplasia was 1.92 ( 95 % CI : 0.83 - 4.42 ) with 1 or 2 tubular adenomas < 10 mm , 5.01 ( 95 % CI : 2.10 - 11.96 ) with 3 or more tubular adenomas < 10 mm , 6.40 ( 95 % CI : 2.74 - 14.94 ) with tubular adenoma > or = 10 mm , 6.05 ( 95 % CI : 2.48 - 14.71 ) for villous adenoma , and 6.87 ( 95 % CI : 2.61 - 18.07 ) for adenoma with high- grade dysplasia . CONCLUSIONS There is a strong association between results of baseline screening colonoscopy and rate of serious incident lesions during 5.5 years of surveillance . Patients with 1 or 2 tubular adenomas less than 10 mm represent a low-risk group compared with other patients with colon neoplasia Objective : Colonoscopy , the “ gold st and ard ” screening test for colorectal cancer ( CRC ) , has known diagnostic limitations . Advances in endoscope technology have focused on improving mucosal visualisation . In addition to increased angle of view and resolution features , recent colonoscopes have non-white-light optics , such as narrow b and imaging ( NBI ) , to enhance image contrast . We aim ed to study the neoplasia diagnostic characteristics of NBI , by comparing the neoplasm miss rate when the colonoscopy was performed under NBI versus white light ( WL ) . Design : R and omised controlled trial . Setting : US Veterans hospital . Patients : Elective colonoscopy adults . Intervention : We r and omly assigned patients to undergo a colonoscopic examination using NBI or WL . All patients underwent a second examination using WL , as the reference st and ard . Main outcome measures : The primary end point was the difference in the neoplasm miss rate , and secondary outcome was the neoplasm detection rate . Results : In 276 t and em colonoscopy patients , there was no significant difference of miss or detection rates between NBI or WL colonoscopy techniques . Of the 135 patients in the NBI group , 17 patients ( 12.6 % ; 95 % confidence interval ( CI ) 7.5 to 19.4 % ) had a missed neoplasm , as compared with 17 of the 141 patients ( 12.1 % ; 95 % CI 7.2 to 18.6 % ) in the WL group , with a miss rate risk difference of 0.5 % ( 95 % CI −7.2 to 8.3 ) . 130 patients ( 47 % ) had at least one neoplasm . Missed lesions with NBI showed similar characteristics to those missed with WL . All missed neoplasms were tubular adenomas , the majority ( 78 % ) was ⩽5 mm and none were larger than 1 cm ( one-sided 95 % CI up to 1 % ) . Nonpolypoid lesions represented 35 % ( 13/37 ) of missed neoplasms . Interpretation : NBI did not improve the colorectal neoplasm miss rate compared to WL ; the miss rate for advanced adenomas was less than 1 % and for all adenomas was 12 % . The neoplasm detection rates were similar high using NBI or WL ; almost a half the study patients had at least one adenoma . Clinical trials.gov identifier : BACKGROUND & AIMS Timely diagnosis of intraepithelial neoplasias ( IN ) and colitis-associated colon carcinomas ( CRC ) is crucially important for the treatment of ulcerative colitis ( UC ) . We performed a r and omized , controlled trial to test whether chromoendoscopy ( CE ) might facilitate early detection of IN and CRC in UC . METHODS A total of 263 patients with long-st and ing UC ( > or=8 years ) were screened for potential inclusion in the study , 165 of whom were r and omized at a 1:1 ratio to undergo conventional colonoscopy or colonoscopy with CE using 0.1 % methylene blue . Five mucosal biopsy specimens were taken every 10 cm between the rectum and cecum . Circumscript lesions in the colon were evaluated according to a modified pit pattern classification . RESULTS In the CE group , there was a significantly better correlation between the endoscopic assessment of degree ( P = 0.0002 ) and extent ( 89 % vs. 52 % ; P < 0.0001 ) of colonic inflammation and the histopathologic findings compared with the conventional colonoscopy group . More targeted biopsies were possible , and significantly more IN were detected in the CE group ( 32 vs. 10 ; P = 0.003 ) . Using the modified pit pattern classification , both the sensitivity and specificity for differentiation between non-neoplastic and neoplastic lesions were 93 % . CONCLUSIONS Based on our prospect i ve r and omized trial , CE permits more accurate diagnosis of the extent and severity of the inflammatory activity in UC compared with conventional colonoscopy . In addition , CE with methylene blue is a novel tool for the early detection of IN and CRC in patients with UC . These findings have important implication s for medical and surgical interventions BACKGROUND AND STUDY AIM Polyp miss rates during colonoscopy have been calculated in a few t and em or back-to-back colonoscopy studies . Our objective was to assess the adenoma miss rate while limiting technique or operator expertise biases , i. e. by performing a large multicenter study , with same-day back-to-back video colonoscopy , done by two different operators in r and omized order and blinded to the other examination . PATIENTS AND METHODS 294 patients at 11 centers were included . Among the 286 analyzable t and em colonoscopies , miss rates were calculated in both a lesion- and patient-based analysis . Each of these rates was determined for polyps overall , for adenomas , and then for lesions larger than 5 mm , and for advanced adenomas . Univariate and logistic regression analysis were performed to define independent variables associated with missed polyps or adenomas . RESULTS The miss rates for polyps , adenomas , polyps > or = 5 mm , adenomas > or = 5 mm , and advanced adenomas were , respectively , 28 % , 20 % , 12 % , 9 % and 11 % . None of the masses with a carcinomatous ( n = 3 ) or carcinoid component ( n = 1 ) was missed . The specific lesion miss rates for patients with polyps and adenomas were respectively 36 % and 26 % but the corresponding rates were 23 % and 9.4 % when calculated for all 286 patients . The diameter ( 1-mm increments ) and number of polyps ( > or = 3 ) were independently associated with a lower polyp miss rate , whereas sessile or flat shape and left location were significantly associated with a higher miss rate . Adequacy of cleansing , presence of diverticula , and duration of withdrawal for the first procedure were not associated with adenoma miss rate . CONCLUSIONS We confirm a significant miss rate for polyps or adenoma during colonoscopy . Detection of flat polyps is an issue that must be focused on to improve the quality of colonoscopy OBJECTIVES : Unse date d colonoscopy is an uncomfortable procedure for most patients . Discomfort during colonoscopy is largely related to looping of the colonoscope , which displaces the colon from its native configuration and stretches attachments to the mesentery . A novel computer-assisted colonoscope utilizes a fully articulated , computer-controlled insertion tube . On manual insertion of the colonoscope , the position and angle of the scope 's tip are encoded into a computer algorithm . As the colonoscope is advanced , the computer directs each successive segment to take the same shape that the tip had at a given insertion depth . The insertion tube thus changes its shape at different insertion depths in a “ follow-the-leader ” manner . METHODS : This initial clinical trial with this novel colonoscopy system was design ed as a prospect i ve , nonr and omized , unblinded , feasibility study . Three physicians of varying levels of experience participated in the study . RESULTS : Eleven consecutive patients ( seven men , four women , age range 19–80 ) meeting inclusion criteria for screening or diagnostic colonoscopy were enrolled in the study . The cecum was reached in 10 consecutive patients ( 100 % ) . Findings included diverticular disease in two cases and multiple colonic polyps in two cases . Postprocedure assessment at discharge , 48 h , and 30 days revealed no complications or adverse effects . Physician satisfaction and patient acceptance of this new technique were high . CONCLUSIONS : In this limited , first of its kind feasibility study , the computer-assisted colonoscope was shown to perform colonoscopy safely and effectively . The colonoscope 's unique design limited loop formation during colonoscopy . Large-scale clinical trials are indicated BACKGROUND AND AIMS Because of the large number of biopsy specimens , surveillance colonoscopy in ulcerative colitis ( UC ) is currently time consuming and significant flat lesions still may be missed . In this study we assessed the value of combined chromoscopy and endomicroscopy for the diagnosis of intraepithelial neoplasias in a r and omized controlled trial . METHODS A total of 161 patients with long-term UC in clinical remission were r and omized at a 1:1 ratio to undergo conventional colonoscopy or chromoscopy with endomicroscopy . Eight patients were excluded because of insufficient bowel preparation . In the conventional colonoscopic group ( n = 73 ) , r and om biopsy examinations and targeted biopsy examinations were performed . In the endomicroscopy group ( n = 80 ) , circumscribed mucosal lesions were identified by chromoscopy and evaluated for targeted biopsy examination by endomicroscopy . The primary outcome analysis was based on the detection of neoplasias . RESULTS By using chromoscopy with endomicroscopy , 4.75-fold more neoplasias could be detected ( P = .005 ) than with conventional colonoscopy , although 50 % fewer biopsy specimens ( P = .008 ) were required . If only circumscribed lesions would have been biopsied in the first group , the total number of biopsy specimens could have been reduced by more than 90 % . A total of 5580 confocal endomicroscopic images from 134 circumscribed lesions were compared with histologic results . The presence of neoplastic changes could be predicted by endomicroscopy with high accuracy ( sensitivity , 94.7 % ; specificity , 98.3 % ; accuracy , 97.8 % ) . CONCLUSIONS Endomicroscopy based on in vivo histology can determine if UC lesions identified by chromoscopy should undergo biopsy examination , thereby increasing the diagnostic yield and reducing the need for biopsy examinations . Thus , chromoscopy-guided endomicroscopy may lead to significant improvements in the clinical management of UC BACKGROUND AND STUDY AIMS The limited angle of view of st and ard colonoscopes means that lesions can be missed . A multidirectional viewing system ( OmniVision ) has been developed recently and has been incorporated into the Aer-O-Scope ( GI View Ltd. , Ramat Gan , Israel ) , a disposable , self-propelling , and self-navigating colonoscope . The objectives of this study were to qualitatively assess the sensitivity of this viewing system in an ex vivo porcine polyp induction model , and to demonstrate its feasibility and safety in live pigs . MATERIAL S AND METHODS For the ex vivo part of the study , six red metal beads of various sizes were r and omly sewn into the mucosa of an unfolded , 2-meter-long porcine colonic segment . Seven passages of the Aer-O-Scope were video-recorded separately and blindly review ed by six experienced gastroenterologists . The sensitivity of the Aer-O-Scope to detect beads of various sizes was calculated . For the in vivo experiment , in a repeated-measure study , nine female domestic pigs were examined with the Aer-O-Scope with the OmniView optics , followed immediately by examination with st and ard optical colonoscopy in order to assess the integrity of the colonic mucosa . RESULTS In the ex vivo study the sensitivity of the Aer-O-Scope was 97.6 % ( CI 94.0%-100 % ) for any bead ( i. e. any " polyp " ) . The rate of polyp detection was similar for the six endoscopists , and was consistent for all bead sizes . The average false-positive rate was 0.3 % polyps per run ( SD 0.61 % ) . The mean time taken for the video assessment was 8.0 minutes ( SD 4.0 minutes ) . In the in vivo experiments with the Aer-O-Scope , both the front-viewing and omnidirectional-viewing systems were functional in all cases . The colon in front of the optical capsule was well distended and a complete and meticulous inspection of the entire colonic mucosa was performed in all the pigs . There were no adverse events . CONCLUSIONS The OmniVision system allows for a highly sensitive inspection of the colonic mucosa without the need for tip manipulation . Clinical studies are warranted in order to vali date these results in humans BACKGROUND Several new instruments have been developed in the effort to improve the acceptance of colonoscopy for colorectal cancer screening . A new colonoscope , the Invendoscope , is presented here . It consists of an endoscopic sheath with an inverted sleeve , instrument channel , and an electrohydraulic deflecting tip . The instrument is steered by a h and -held device and propelled by a motorized drive unit . OBJECTIVE Our purpose was to evaluate the feasibility of the new Invendoscope SC40 . DESIGN Prospect i ve single-arm pilot study over 2 time periods using 2 different instrument prototypes ( 170 and 180/200 cm ) . PATIENTS Thirty-four healthy volunteers ( 19 men , mean age 49.7 years ) . Technical instrument defects led to premature termination in 5 additional volunteers during the 2 study periods ( 4 in phase 1 , 1 in phase 2 ) , who were excluded from further analysis . INTERVENTIONS Total colonoscopy was attempted , with all procedures being performed without sedation . MAIN OUTCOME MEASUREMENTS Cecal intubation rate . RESULTS The cecum was reached in 82 % of the 34 cases ( 95 % CI , 66%-92 % ) , with better results in period 2 than in period 1 ( 90 % vs 79 % ) ; of the 6 incomplete examinations , 4 reached the mid transverse colon or beyond and 2 were stopped in the sigmoid colon because of pain . The volunteer rating showed a mean score of 1.96 ( range 1 - 6 ; 1 = no discomfort ) . No complications were encountered . LIMITATIONS No data regarding diagnostic accuracy and no data comparing the instrument with conventional colonoscopy are available as yet . CONCLUSIONS This pilot proof-of-principle study of a new motor-driven colonoscope showed promising cecal intubation rates and an absence of pain in 92 % of cases . Further clinical and comparative studies are warranted BACKGROUND & AIMS Detection of adenomas is an important goal of colonoscopy . Narrow b and imaging ( NBI ) might highlight adenomas and lead to higher rates of adenoma detection . METHODS This was a r and omized controlled trial of colonoscopy withdrawal in white light versus NBI in 434 patients aged 50 years or older with intact colons . All examinations were performed by a single experienced endoscopist with a known high detection rate of adenomas using high-definition , wide-angle ( 170 degrees field of view ) colonoscopes . RESULTS There was no difference in the percent of patients with > or=1 adenoma for the entire cohort in white light ( 67 % ) versus NBI ( 65 % ) ( P = .61 ) or in the subset of 257 patients with indication screening ( 58 % vs 57 % ; P = .91 ) . Both the prevalences of adenomas and the numbers of adenomas per colonoscopy are the highest ever reported in colonoscopy studies . The high prevalence rates of adenomas were accounted for by detection of large numbers of adenomas , including flat adenomas , which were < or=5 mm . CONCLUSIONS NBI did not result in better detection of adenomas by an endoscopist with a known high detection rate using white light . This result does not exclude a possible benefit of NBI in reducing variation between endoscopists in detection of adenomas . The very high adenoma detection rate in this study suggests that high definition should be directly tested for its effect on detection of adenomas |
385 | 20,573,267 | Azathioprine has equivalent efficacy as a maintenance agent to cyclophosphamide with fewer episodes of leukopenia .
Mycophenolate mofetil may be equivalent to cyclophosphamide as an induction agent but result ed in a higher relapse rate when tested against Azathioprine in remission maintenance .
Rituximab is an effective remission induction agent .
Methotrexate or Leflunomide are potential choices in remission maintenance therapy .
Oral co-trimoxazole did not reduce relapses significantly in Wegener 's granulomatosis .
Conclusions Plasma exchange is effective in patients with severe ARF secondary to vasculitis .
Pulse cyclophosphamide results in an increased risk of relapse when compared to continuous oral use but a reduced total dose .
Whilst cyclophosphamide is st and ard induction treatment , rituximab and mycophenolate mofetil are also effective .
Azathioprine , methotrexate and leflunomide are effective as maintenance therapy . | Background Renal vasculitis presents as rapidly progressive glomerulonephritis and comprises of a group of conditions characterised by acute kidney failure , haematuria and proteinuria .
Treatment of these conditions involves the use of steroid and non-steroid agents with or without adjunctive plasma exchange .
Although immunosuppression has been successful , many questions remain unanswered in terms of dose and duration of therapy , the use of plasma exchange and the role of new therapies .
This systematic review was conducted to determine the benefits and harms of any intervention for the treatment of renal vasculitis in adults . | Systemic vasculitis associated with autoantibodies to neutrophil cytoplasmic antigens ( ANCA ) is the most frequent cause of rapidly progressive glomerulonephritis . Renal failure at presentation carries an increased risk for ESRD and death despite immunosuppressive therapy . This study investigated whether the addition of plasma exchange was more effective than intravenous methylprednisolone in the achievement of renal recovery in those who presented with a serum creatinine > 500 micromol/L ( 5.8 mg/dl ) . A total of 137 patients with a new diagnosis of ANCA-associated systemic vasculitis confirmed by renal biopsy and serum creatinine > 500 micromol/L ( 5.8 mg/dl ) were r and omly assigned to receive seven plasma exchanges ( n = 70 ) or 3000 mg of intravenous methylprednisolone ( n = 67 ) . Both groups received oral cyclophosphamide and oral prednisolone . The primary end point was dialysis independence at 3 mo . Secondary end points included renal and patient survival at 1 yr and severe adverse event rates . At 3 mo , 33 ( 49 % ) of 67 after intravenous methylprednisolone compared with 48 ( 69 % ) or 70 after plasma exchange were alive and independent of dialysis ( 95 % confidence interval for the difference 18 to 35 % ; P = 0.02 ) . As compared with intravenous methylprednisolone , plasma exchange was associated with a reduction in risk for progression to ESRD of 24 % ( 95 % confidence interval 6.1 to 41 % ) , from 43 to 19 % , at 12 mo . Patient survival and severe adverse event rates at 1 yr were 51 ( 76 % ) of 67 and 32 of 67 ( 48 % ) in the intravenous methylprednisolone group and 51 ( 73 % ) of 70 and 35 of ( 50 % ) 70 in the plasma exchange group , respectively . Plasma exchange increased the rate of renal recovery in ANCA-associated systemic vasculitis that presented with renal failure when compared with intravenous methylprednisolone . Patient survival and severe adverse event rates were similar in both groups In a r and omized study of 26 patients with histologically confirmed rapidly progressive crescentic glomerulonephritis , 12 patients were treated with immunosuppressants alone ( corticosteroids , cyclophosphamide and azathioprine ) while the other 14 patients received not only the identical immunosuppressive treatment but also plasma exchange therapy for four weeks . No statistically significant difference was found between the two groups . After 8 weeks , 73 % and 69 % of the patients in each respective group showed recompensation of renal function ; serum creatinine fell from initially 7.0 and 6.2 mg/dl mean to 2.7 and 2.3 mg/dl mean , and under continued immunosuppression did not rise in the following months . Thus , in non-autoantibody induced rapidly progressive glomerulonephritis , kidney function could be improved substantially by immunosuppressive therapy , but an advantage of supplementary plasma exchange could not be shown BACKGROUND The majority of patients with Wegener 's granulomatosis have disease flares after conventional medications are tapered . There is no consistently safe , effective treatment for the maintenance of remission . METHODS We conducted a r and omized , placebo-controlled trial at eight centers to evaluate etanercept for the maintenance of remission in 180 patients with Wegener 's granulomatosis . The primary outcome was sustained remission , defined as a Birmingham Vasculitis Activity Score for Wegener 's Granulomatosis of 0 for at least six months ( scores can range from 0 to 67 , with higher scores indicating more active disease ) . In addition to etanercept or placebo , patients received st and ard therapy ( glucocorticoids plus cyclophosphamide or methotrexate ) . After remission , st and ard medications were tapered according to the protocol . RESULTS The mean follow-up for the overall cohort was 27 months . Of the 174 patients who could be evaluated , 126 ( 72.4 percent ) had a sustained remission , but only 86 ( 49.4 percent ) remained in remission for the remainder of the trial . There were no significant differences between the etanercept and control groups in the rates of sustained remission ( 69.7 percent vs. 75.3 percent , P=0.39 ) , sustained periods of low-level disease activity ( 86.5 percent vs. 90.6 percent , P=0.32 ) , or the time required to achieve those measures . Disease flares were common in both groups , with 118 flares in the etanercept group ( 23 severe and 95 limited ) and 134 in the control group ( 25 severe and 109 limited ) . There was no significant difference between the etanercept and control groups in the relative risk of disease flares per 100 person-years of follow-up ( 0.89 , P=0.54 ) . During the study , 56.2 percent of patients in the etanercept group and 57.1 percent of those in the control group had at least one severe or life-threatening adverse event or died ( P=0.90 ) . Solid cancers developed in six patients in the etanercept group , as compared with none in the control group ( P=0.01 ) . CONCLUSIONS Etanercept is not effective for the maintenance of remission in patients with Wegener 's granulomatosis . Durable remissions were achieved in only a minority of the patients , and there was a high rate of treatment-related complications BACKGROUND Current st and ard therapy for Wegener 's granulomatosis and microscopic polyangiitis combines corticosteroids and cyclophosphamide to induce remission , followed by a less toxic immunosuppressant such as azathioprine or methotrexate for maintenance therapy . However , azathioprine and methotrexate have not been compared with regard to safety and efficacy . METHODS In this prospect i ve , open-label , multicenter trial , we r and omly assigned patients with Wegener 's granulomatosis or microscopic polyangiitis who entered remission with intravenous cyclophosphamide and corticosteroids to receive oral azathioprine ( at a dose of 2.0 mg per kilogram of body weight per day ) or methotrexate ( at a dose of 0.3 mg per kilogram per week , progressively increased to 25 mg per week ) for 12 months . The primary end point was an adverse event requiring discontinuation of the study drug or causing death ; the sample size was calculated on the basis of the primary hypothesis that methotrexate would be less toxic than azathioprine . The secondary end points were severe adverse events and relapse . RESULTS Among 159 eligible patients , 126 ( 79 % ) had a remission , were r and omly assigned to receive a study drug in two groups of 63 patients each , and were followed for a mean ( + /-SD ) period of 29+/-13 months . Adverse events occurred in 29 azathioprine recipients and 35 methotrexate recipients ( P=0.29 ) ; grade 3 or 4 events occurred in 5 patients in the azathioprine group and 11 patients in the methotrexate group ( P=0.11 ) . The primary end point was reached in 7 patients who received azathioprine as compared with 12 patients who received methotrexate ( P=0.21 ) , with a corresponding hazard ratio for methotrexate of 1.65 ( 95 % confidence interval , 0.65 to 4.18 ; P=0.29 ) . There was one death in the methotrexate group . Twenty-three patients who received azathioprine and 21 patients who received methotrexate had a relapse ( P=0.71 ) ; 73 % of these patients had a relapse after discontinuation of the study drug . CONCLUSIONS These results do not support the primary hypothesis that methotrexate is safer than azathioprine . The two agents appear to be similar alternatives for maintenance therapy in patients with Wegener 's granulomatosis and microscopic polyangiitis after initial remission . ( Clinical Trials.gov number , NCT00349674 . OBJECTIVE We performed a single-centre non-blinded clinical trial to compare the clinical efficacies of mycophenolate mofetil ( MMF ) and intermittent cyclophosphamide ( CTX ) pulse therapy as induction treatments in patients with antineutrophil cytoplasmic antibody ( ANCA ) vasculitis ( AAV ) and moderate renal involvement . METHODS Patients with active AAV and serum creatinine < 500 micromol/L received either MMF treatment ( MMF group ) or monthly CTX pulse therapy ( CTX group ) for 6 months . Disease activity was assessed using the Birmingham Vasculitis Activity Score ( BVAS ) . The disease activity , remission rate , renal function and adverse reactions were compared between the two groups . RESULTS A total of 35 patients ( 15 male , 20 female : aged 49.1 + /- 12.2 years ) were enrolled , with 18 in the MMF group and 17 in the CTX group . Of the 35 patients , 28 were MPO-ANCA positive and 2 were PR3-ANCA positive . Four patients were lost to follow-up in the CTX group . At Month 6 , BVAS scores were much lower in the MMF group than in the CTX group ( 0.2 + /- 0.89 versus 2.6 + /- 1.7 , P < 0.05 ) . In the intent-to-treatment analysis , 14 of 18 patients ( 77.8 % ) treated with MMF and 8 of 17 patients receiving CTX ( 47.1 % ) had complete remission with an absolute difference of 30.7 % . Eight of 18 patients ( 44.4 % ) in the MMF group and 2 of 17 patients ( 15.4 % ) in the CTX group recovered renal function . Serum ANCA decreased to normal in 41.7 % of patients in the MMF group and in 16.7 % in the CTX group . Side effects in the MMF group were pneumonia ( 1 ) , herpes zoster ( 1 ) and gastrointestinal symptoms ( 2 ) , and in the CTX group were leukocytopenia ( 1 ) , gastrointestinal distress ( 4 ) and pneumonia ( 1 ) . CONCLUSION Our study suggests that MMF effectively ameliorates disease activity and considerably improves renal function in patients with AAV . Further large-scale multicentre prospect i ve r and omized controlled trials will be needed to confirm these findings OBJECTIVES Results from open-label trials suggest that methotrexate ( MTX ) and leflunomide ( LEF ) are effective for maintenance of remission in Wegener 's granulomatosis ( WG ) , but data from r and omized controlled clinical trails are not yet available . METHODS In this multicentre , prospect i ve r and omized controlled clinical trial , patients with generalized WG were treated either with oral LEF 30 mg/day or oral MTX ( starting with 7.5 mg/week reaching 20 mg/week after 8 weeks ) for 2 yrs following induction of remission with cyclophosphamide . The primary endpoint was the incidence of relapses . Secondary outcome parameters were DEI , BVAS , SF-36 , cANCA-titre , ESR and CRP . RESULTS Fifty-four patients were included in the study , 26 in the LEF-limb , 28 in the MTX-limb . In the LEF-group , six patients relapsed after a median time of 7 months , thereof one major relapse with a new pulmonary manifestation . In the MTX-group , 13 relapses occurred in 6 months , of which seven were major : rapidly progressive glomerulonephritis ( n = 4 ) , pulmonary haemorrhage ( n = 2 ) and one cerebral granuloma . The significantly higher incidence of major relapses in the MTX-limb ( P = 0.037 ) led to premature termination of the study . In the LEF-limb , four patients were withdrawn due to hypertension ( n = 2 ) , peripheral neuropathy ( n = 1 ) and leucopenia ( n = 1 ) . CONCLUSION LEF at a dosage of 30 mg/day appears to be effective in the prevention of major relapses in WG , however , this is associated with an increased frequency of adverse events . Further studies testing other dosing regimens of lower doses of LEF are needed to confirm these promising results in larger patients cohorts Although cyclophosphamide and prednisolone are effective in treating systemic vasculitis , the optimum treatment regimes and duration of treatment are unknown . We r and omized 54 patients aged 15 - 70 years ( median 57.5 years ) with systemic vasculitis ( classical polyarteritis n = 8 , microscopic polyarteritis n = 17 , Wegener 's granulomatosis n = 29 ) to treatment with either pulse cyclophosphamide and prednisolone ( PCYP ) ( n = 24 ) or continuous oral and prednisolone and cyclophosphamide , with the latter followed after a median of 3 months ( range 1.5 - 10 months ) by azathioprine ( CCAZP ) ( n = 30 ) . Patients on CCAZP were more likely to develop leucopenia ( 13/30 ) than patients on PCYP , ( 7/24 ) although the difference was not significant . The numbers of infective episodes during follow up were comparable in the two groups at 1.7/patient for PCYP and 1.66/patient for CCAZP . Overall , 26/30 patients ( 87 % ) treated with CCAZP developed treatment-related toxicity , as did 17/24 patients ( 71 % ) treated with PCYP . After a median follow-up of 40.4 months ( range 0.7 - 64.8 ) , there was no difference in the frequency of deaths ( PCYP 5 , CCAZP 4 ) , relapses ( PCCYP 7 , CCAZP 8) , treatment failures ( PCYP 4 , CCAZP 4 ) , improvement in disease activity scores or renal function . Survival at three years was 77 % in patients treated with PCYP , and 90 % in patients on CCAZP ( p = 0.38 ) . There was a tendency towards increased toxicity in patients treated with the continuous regimen To determine whether plasma exchange was of additional benefit in patients treated with oral immunosuppressive drugs for focal necrotizing glomerulonephritis ( without anti-GBM antibodies ) , we performed a r and omized controlled trial with stratification for renal function on entry . Forty-eight cases were analyzed , 25 in the treatment group ( plasma exchange , prednisolone , cyclophosphamide and azathioprine ) and 23 in the control group ( drug therapy only ) . There was no difference in outcome in patients presenting with serum creatinine less than 500 mumol/liter ( N = 17 ) , or greater than 500 mumol/liter but not on dialysis ( N = 12 ) , all but one of whom had improved by four weeks . However , patients who were initially dialysis-dependent ( N = 19 ) were more likely to have recovered renal function ( P = 0.041 ) if treated with plasma exchange as well as drugs ( 10 of 11 ) rather than with drugs alone ( 3 of 8) . Long-term follow-up showed that improvement in renal function was generally maintained . The results of this trial confirm that focal necrotizing glomerulonephritis related to systemic vasculitis responds well to immunosuppressive drugs when treatment is started early , and suggest that plasma exchange is of additional benefit in dialysis-dependent cases OBJECTIVE To investigate the effectiveness and side effects of oral versus pulse cyclophosphamide ( CYC ) in combination with corticosteroids ( CS ) in the treatment of systemic Wegener 's granulomatosis ( WG ) . METHODS Patients with newly diagnosed systemic WG were enrolled in a prospect i ve , r and omized trial . At the time of diagnosis , prior to r and omization , every patient received a daily injection of methylprednisolone for 3 days , followed by daily oral prednisone ( 1 mg/kg/day ) and a 0.7-gm/m2 pulse of CYC . Patients were then r and omly assigned to receive either prednisone plus intravenous pulse CYC ( group A ) or prednisone plus oral CYC ( group B ) as first-line treatment . CYC was given for at least 1 year and was then progressively tapered and discontinued . RESULTS Fifty patients were included in the study : 27 in group A and 23 in group B. At 6 months , 24 group A patients ( 88.9 % ) were in remission , versus 18 group B patients ( 78.3 % ) . At the end of the trial , 18 group A patients ( 66.7 % ) and 13 group B patients ( 56.5 % ) were in remission . In group A , 66.7 % of the patients experienced side effects , versus 69.6 % in group B. Infectious side effects were significantly more frequent in group B ( 69.6 % ) than in group A ( 40.7 % ) ( P < 0.05 ) . The incidence of Pneumocystis carinii pneumonia was higher in oral CYC-treated patients ( 30.4 % ) than in pulse CYC-treated patients ( 11.1 % ) . Nine group A patients ( 33.3 % ) and 10 group B patients ( 43.5 % ) died . Actuarial curves showed that relapses were significantly more frequent in group A ( 59.2 % ) than in group B ( 13 % ) ( P = 0.02 ) . CONCLUSION Our results indicate that pulse CYC is as effective as oral CYC in achieving initial remission of WG and is associated with fewer side effects and lower mortality . However , in the long term , treatment with pulse CYC does not maintain remission or prevent relapses as well as oral CYC A therapeutic removal of antibodies may be achieved by immunoadsorption ( IA ) or by plasma exchange ( PE ) . The aim of this prospect i ve r and omised study was to compare the efficacy of these different techniques with regard to treatment of patients with rapidly progressive glomerulonephritis ( RPG ) having at least 50 % crescents . Forty-four patients with a RPG were included for treatment either by IA or PE ( with albumin as substitution for removed plasma ) . All patients were additionally treated with immunosuppression . A median of 6 sessions of PEs were performed in 23 patients compared with 6 IAs in 21 patients . Goodpasture 's syndrome ( GP ) was present in 6 patients ( PE 3 , IA 3 ) . All of them started and ended in dialysis , two died . Among the remaining 38 patients ( 26 men , 12 women ) 87 % had antibodies to ANCA . Creatinine clearance for PE versus IA were at a median at start 17.1 and 19.8 ml/min , and at 6 months 49 and 49 ml/min , respectively . At 6 months 7 of 10 patients did not need dialysis ( remaining : IA 0/5 and PE 2/5 , n.s . ) . The extent of improvement did not differ between the groups . Three patients died during the observation period of 6 months ( IA 2 ; PE 1 , on HD ) . Although no difference was found between the IA or the PE group this study shows that the protocol used was associated with an improved renal function in most patients ( except for Goodpasture 's syndrome ) whereas 70 % of them could leave the dialysis program BACKGROUND The primary systemic vasculitides usually associated with autoantibodies to neutrophil cytoplasmic antigens include Wegener 's granulomatosis and microscopic polyangiitis . We investigated whether exposure to cyclophosphamide in patients with generalized vasculitis could be reduced by substitution of azathioprine at remission . METHODS We studied patients with a new diagnosis of generalized vasculitis and a serum creatinine concentration of 5.7 mg per deciliter ( 500 micromol per liter ) or less . All patients received at least three months of therapy with oral cyclophosphamide and prednisolone . After remission , patients were r and omly assigned to continued cyclophosphamide therapy ( 1.5 mg per kilogram of body weight per day ) or a substitute regimen of azathioprine ( 2 mg per kilogram per day ) . Both groups continued to receive prednisolone and were followed for 18 months from study entry . Relapse was the primary end point . RESULTS Of 155 patients studied , 144 ( 93 percent ) entered remission and were r and omly assigned to azathioprine ( 71 patients ) or continued cyclophosphamide ( 73 patients ) . There were eight deaths ( 5 percent ) , seven of them during the first three months . Eleven relapses occurred in the azathioprine group ( 15.5 percent ) , and 10 occurred in the cyclophosphamide group ( 13.7 percent , P=0.65 ) . Severe adverse events occurred in 15 patients during the induction phase ( 10 percent ) , in 8 patients in the azathioprine group during the remission phase ( 11 percent ) , and in 7 patients in the cyclophosphamide group during the remission phase ( 10 percent , P=0.94 for the comparison between groups during the remission phase ) . The relapse rate was lower among the patients with microscopic polyangiitis than among those with Wegener 's granulomatosis ( P=0.03 ) . CONCLUSIONS In patients with generalized vasculitis , the withdrawal of cyclophosphamide and the substitution of azathioprine after remission did not increase the rate of relapse . Thus , the duration of exposure to cyclophosphamide may be safely reduced BACKGROUND Respiratory tract infections may trigger relapses in patients with Wegener 's granulomatosis in remission . Uncontrolled data have suggested that treatment with trimethoprim-sulfamethoxazole ( co-trimoxazole ) may be beneficial . METHODS We conducted a prospect i ve , r and omized , placebo-controlled study of the efficacy of co-trimoxazole ( 800 mg of sulfamethoxazole and 160 mg of trimethoprim ) given twice daily for 24 months in preventing relapses in patients with Wegener 's granulomatosis in remission during or after treatment with cyclophosphamide and prednisolone . Relapses and infections were assessed with predefined criteria based on clinical , laboratory , and histopathological findings . Patients were evaluated at least once every three months for signs of disease activity , compliance with the treatment regimen , side effects of the therapy , and evidence of infections . Titers of serum antineutrophil cytoplasmic antibodies were measured serially . RESULTS Forty-one patients were assigned to receive co-trimoxazole , and 40 to receive placebo . In 8 of the 41 patients in the co-trimoxazole group ( 20 percent ) , the drug had to be stopped because of side effects . According to life-table analysis , 82 percent of the patients remained in remission at 24 months , as compared with 60 percent of the patients in the placebo group ( relative risk of relapse , 0.40 ; 95 percent confidence interval , 0.17 to 0.98 ) . There were fewer respiratory tract infections ( P = 0.005 ) and non-respiratory tract infections ( P = 0.05 ) in the co-trimoxazole group than in the placebo group . There were no significant differences in antineutrophil cytoplasmic antibody titers at any time . Proportional-hazards regression analysis identified treatment with co-trimoxazole as an independent factor associated with prolonged disease-free survival and a positive antineutrophil cytoplasmic antibody test at the start of treatment as a risk factor for relapse . CONCLUSIONS Treatment with co-trimoxazole reduces the incidence of relapses in patients with Wegener 's granulomatosis in remission Context Because cyclophosphamide has many adverse effects , dosing regimens that maintain efficacy but improve safety would be welcome . Contribution In this r and omized comparison of pulse and daily oral cyclophosphamide regimens for treatment of ANCA-associated vasculitis , equal proportions of patients had remissions , but the pulse regimen seemed safer , mainly because it caused less leukopenia . Caution Patients and providers were not blinded to the intervention , and the study was not powered to detect differences in relapse rate . Implication The efficacy of pulse cyclophosphamide for treatment of ANCA-associated vasculitis seems no different from that of daily oral treatment and may be safer . The Editors Wegener granulomatosis , microscopic polyangiitis , and the renal-limited variant of microscopic polyangiitis are all associated with antineutrophil cytoplasmic antibodies ( ANCAs ) and are therefore referred to collectively as ANCA-associated vasculitis . The justification for grouping these diseases together as a single clinical entity goes beyond ANCA seropositivity ; they cause similar histologic changes in the kidney , are associated with similar pathogenic autoantibodies , and respond similarly to induction immunosuppressive treatment . However , they also differ in important respects ; for example , granuloma formation and relapse after treatment are more common in Wegener granulomatosis ( 1 , 2 ) . Outcomes for these previously fatal diseases improved dramatically with the introduction of daily oral cyclophosphamide therapy ( 3 , 4 ) . However , cyclophosphamide has significant adverse effects that influence long-term morbidity and mortality ( 5 , 6 ) . Strategies to reduce these adverse effects include reducing the duration of cyclophosphamide use to 3 to 6 months ( maximum , 9 months ) ( 2 ) and switching to an alternative immunosuppressive regimen after induction of remission and using methotrexate instead of cyclophosphamide in patients without generalized disease and significantly impaired renal function ( 7 ) . For many patients , however , cyclophosphamide remains the mainstay of therapy for inducing remission and treating relapse , so regimens that maintain efficacy while minimizing cyclophosphamide dose and maximizing safety would be welcome . Previous studies ( 8) suggest that pulse cyclophosphamide regimens are safe and provide less cumulative cyclophosphamide exposure than daily oral cyclophosphamide regimens . However , small study sizes and variations in treatment regimens , including the use of treatments alongside cyclophosphamide , make the findings preliminary . We design ed this trial to test the hypothesis that a regimen of pulsed intermittent cyclophosphamide would be as effective but less toxic than daily oral cyclophosphamide for inducing remission in patients with generalized ANCA-associated vasculitis with active glomerulonephritis . Methods Trial Design and Participants Our trial was an open-label , multicenter , r and omized , controlled trial conducted over 18 months . Patients , providers , and the investigators who assessed trial outcomes were not blinded to treatment assignment . Our inclusion criteria were newly diagnosed Wegener granulomatosis , microscopic polyangiitis , or renal-limited microscopic polyangiitis ( diagnostic criteria adapted from the 1992 Chapel Hill consensus conference [ 9 ] and our group 's previous studies [ 2 , 7 , 1012 ] ) ; renal involvement attributable to active vasculitis ( as defined by at least 1 of the following : serum creatinine level > 150 mol/L [ > 1.7 mg/dL ] and 500 mol/L [ 5.7 mg/dL ] , biopsy demonstrating necrotizing glomerulonephritis , erythrocyte casts , or hematuria [ > 30 erythrocytes per high-power field ] and proteinuria [ > 1 g/d ] ) ; and confirmatory histology or ANCA positivity . Our exclusion criteria were coexistence of other multisystem autoimmune disease ; hepatitis B or C virus or HIV infection ; serum creatinine level greater than 500 mol/L ( > 5.7 mg/dL ) ; previous cancer ; pregnancy ; or age younger than 18 or older than 80 years . We conducted our study according to the Declaration of Helsinki . Informed consent was obtained from each participant , and each participating center review ed the trial protocol and granted ethical approval . R and om Assignment R and om assignments were computer-generated and performed central ly by permuted blocks of 4 , stratified by country and disease . Patients were enrolled by their treating physician and registered with the central trial coordinating office by fax su bmi ssion of a form that contained information on center , date of birth , sex , disease , and creatinine level . We r and omly assigned patients on a 1:1 basis to receive pulse or daily oral cyclophosphamide . Data were collected in record books , entered into a central computerized data base , and vali date d against the record books before analysis . Eleven patients withdrew before r and om assignment ; we r and omly assigned 149 patients . Interventions We design ed the pulse cyclophosphamide regimen by investigator consensus , on the basis of published experience with pulse cyclophosphamide in ANCA-associated vasculitis . Patients received 3 intravenous pulses of cyclophosphamide , 15 mg/kg , given 2 weeks apart , followed by pulses at 3-week intervals ( 15 mg/kg intravenously or 5 mg/kg orally on 3 consecutive days , at the physician 's discretion ) until remission , and then for another 3 months . The maximum dose per pulse was 1.2 g. We reduced the cyclophosphamide dose by 2.5 mg/kg per pulse for persons age 60 to 70 years , 5 mg/kg per pulse for persons older than 70 years , and 2.5 mg/kg per pulse for persons with a serum creatinine level of 300 to 500 mol/L ( 3.4 to 5.7 mg/dL ) . At minimum , blood counts were checked on day 10 and 14 after each pulse and immediately before the next pulse . We reduced the dose of the subsequent pulse by 20 % for patients with a leukocyte nadir of 2 to 3109/L and 40 % for those with a nadir of 1 to 2109/L. The daily oral cyclophosphamide group received cyclophosphamide , 2 mg/kg per day , until remission , followed by 1.5 mg/kg per day for another 3 months . The maximum oral dose was 200 mg , and we reduced the dose by 25 % for persons older than 60 years and 50 % for those older than 70 years . At minimum , blood counts were checked weekly for the first month , twice-weekly for the second month , and monthly thereafter . We withheld cyclophosphamide for persons with a leukocyte count less than 4109/L , then resumed therapy at a dose reduced by 25 mg/d when their count increased to greater than 4109/L. Both groups continued the cyclophosphamide regimens for 3 months after remission , after which all patients received azathioprine , 2 mg/kg per day orally , until month 18 for remission maintenance . The maximum daily oral dose of azathioprine was 200 mg . Both groups also received prednisolone , 1 mg/kg orally , tapered to 12.5 mg at the end of month 3 and to 5 mg at the end of the study ( month 18 ) . 2-Mercaptoethanesulfonate sodium was optional in both groups . No patients received plasmapheresis . We recommended prophylaxis for Pneumocystis jiroveci for all patients . Treatment was allowed to follow local practice for patients who did not achieve remission at 9 months . We collected data on these patients but censored them for purpose s of this analysis . For more details on the protocol , see Appendix 1 . Outcomes and Follow-up We defined outcomes by using the Birmingham Vasculitis Activity Score ( BVAS ) index , which measures manifestations of active vasculitis during the 28 days before the date of assessment ( 13 ) . Our primary outcome was time to remission , defined as the absence of new or worse signs of disease activity on the BVAS and no more than 1 item indicating persistent disease activity ( BVAS 1 ) . Secondary outcomes included the proportion of patients who achieved remission at 6 and 9 months and the proportion with major and minor relapses . We defined major relapse as the recurrence or first appearance of at least 1 BVAS item indicating threatened vital organ function attributable to active vasculitis . We defined minor relapse as the recurrence or first appearance of at least 3 other BVAS items related to nonvital organs . An investigator classified patients as achieving remission or having relapse , and an independent observer vali date d these classifications retrospectively . Additional secondary outcomes were death ; change in renal function ; adverse events , including leukopenia and infection ; and the cumulative dose of cyclophosphamide and prednisolone , which we calculated as the total cumulative drug dose at each time point in the study ( 3 , 6 , 9 , 12 , 15 , and 18 months ) divided by the number of patients in the study at that point . For each time point , we considered only the dose of drug for those patients still in the study . Unless otherwise noted , we assessed these outcomes at baseline ; at 1.5 , 3 , 4.5 , 6 , 7.5 , 9 , 12 , 15 , and 18 months after baseline ; and at relapse , on the basis of st and ard recommendations . Clinical assessment s included BVAS measures at every visit and measures of cumulative damage from any cause since disease onset , as scored by the Vasculitis Damage Index ( 14 ) , at baseline and every 3 months . Laboratory assessment s included measures of full blood count , C-reactive protein , alanine transaminase , serum creatinine , and glucose , as well as dipstick urine analysis . We calculated glomerular filtration rate at entry , remission , and study end by using the Modification of Diet in Renal Disease method ( 15 ) . Statistical Analysis We determined the sample size for the trial by clinical rather than statistical considerations . We set a recruitment goal of 160 patients ; we considered that number ambitious , given the rarity of these conditions ( 12 per 1 million persons ) and the need to recruit patients and conduct the trial within a period ( 5 years ) that was reasonable for our re sources . We performed analyses by intention to treat . To account for censoring , we compared remission and survival by using survival methods instead of A prospect i ve r and omised trial was carried out in 14 patients with severe ' idiopathic ' acute crescentic glomerulonephritis . The mean percentage of crescents was 78 per cent and 11 patients were anuric at presentation . Eight patients received pulses of methylprednisolone , immunosuppressive drugs and anticoagulants and six the same therapeutic regimen plus plasma exchanges for one to two months . Mean follow-up was 22 months . Recovery was statistically better in the PE+ group ( p less than 0.02 ) , but for discontinuation of dialysis , the difference is significant only at two months ( p less than 0.02 ) , perhaps because of the small number of patients . For this reason and because all pathological subgroups can not be analysed separately , this study is continuing OBJECTIVE There is growing concern about the toxic side effects of daily oral cyclophosphamide ( CYC ) treatment . Intravenous ( i.v . ) pulse administration of CYC has been shown to be effective in patients with systemic lupus erythematosus , but contradictory results have been reported in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis . METHODS The efficacy and toxicity of i.v . pulse administration of CYC ( 0.75 gm/m2 ) versus daily oral CYC treatment ( 2 mg/kg body weight ) were investigated in a prospect i ve , r and omized , multicenter study in patients with ANCA-associated vasculitis and renal involvement . RESULTS The cumulative CYC dose was reduced by 57 % in patients with i.v . pulse treatment ( n = 22 ) compared with patients treated with daily oral therapy ( n = 25 ) . Patient survival , remission rate , time of remission , relapse rate , and outcome of renal function were not different between the 2 treatment groups . However , the rate of leukopenia ( P < 0.01 ) and severe infections ( P < 0.05 by 1-tailed test ) was significantly reduced in the i.v . pulse group compared with the group receiving daily oral treatment . Moreover , gonadal toxicity was reduced in the i.v . pulse group , as indicated by significantly lower levels of follicle-stimulating hormone . CONCLUSION This r and omized study shows that i.v . CYC administration is an effective therapeutic tool with low toxicity in patients with ANCA-associated vasculitis and renal involvement Sixty-three patients with crescentic glomerulonephritis ( cellular crescents in greater than 50 % of glomeruli ) were considered for a prospect i ve r and omized trial comparing intravenous methylprednisolone , prednisone , and azathioprine with and without plasma exchange . Of 32 patients who fulfilled the inclusion criteria for this study , 16 were r and omly assigned to receive drug therapy ( control ) and 16 to receive plasma exchange as well . The r and omization was stratified for initial need of dialysis , and the presence of oliguria and sclerosis . Renal pathology was similar in the two groups of patients . There was no significant difference in the number of patients initially on dialysis who were able to discontinue it during the study ( 2/7 control v 3/4 plasma exchange ) , whereas no control but two plasma exchange-treated patients started dialysis during the study . Serum creatinine at r and omization was similar in the two groups : 769 + /- 486 mumol/L ( 8.7 + /- 5.5 mg/dL ) in the control group versus 643 + /- 275 mumol/L ( 7.3 + /- 3.1 mg/dL ) in the plasma exchange group . There was no significant difference between the two groups in mean serum creatinine , change in serum creatinine , change in reciprocal , or change in logarithm of serum creatinine at 1 , 3 , 6 , or 12 months following r and omization . Power calculation , assuming a 20 % difference would be clinical ly relevant , was 0.94 at 12 months . There was significant morbidity in both groups ; there were two deaths within 1 year of r and omization , both of pulmonary infection and both in the plasma exchange group . We conclude that plasma exchange offers no additional therapeutic benefit to patients with idiopathic rapidly progressive glomerulonephritis ( RPGN ) who are not dialysis-dependent at presentation Intravenous immunoglobulin ( IVIg ) is a potential alternative treatment for anti-neutrophil cytoplasm antibody (ANCA)-associated systemic vasculitis ( AASV ) with less toxicity than conventional immunosuppressive agents . This r and omized , placebo-controlled trial aim ed to investigate the efficacy of a single course of IVIg ( total dose 2 g/kg ) in previously-treated AASV with persistent disease activity in whom there was an intention to escalate therapy . Vasculitic activity was monitored by the Birmingham vasculitis activity score ( BVAS ) , C-reactive protein ( CRP ) and ANCA levels . Treatment response was defined as a reduction in BVAS of more than 50 % after 3 months , and there was an intention to keep doses of concurrent immunosuppressive drugs unchanged during this period ; follow-up continued to 12 months . Seventeen patients were r and omized to receive IVIg and 17 to receive placebo . Treatment responses were found in 14/17 and 6/17 of the IVIg and placebo groups , respectively ( p=0.015 , OR 8.56 , 95%CI 1.74 - 42.2 ) . Following infusion of trial medication , greater falls in CRP were seen at 2 weeks ( p=0.02 ) and 1 month ( p=0.04 ) in the IVIg group . No differences were observed between ANCA levels or cumulative exposure to immunosuppressive drugs , and after 3 months there were no differences in CRP levels or disease activity between the IVIg and placebo groups . Seventeen adverse effects occurred after IVIg and six after placebo : they were mostly mild , although reversible rises in serum creatinine occurred in four from the IVIg group . A single course of IVIg reduced disease activity in persistent AASV , but this effect was not maintained beyond 3 months ; mild , reversible side-effects following IVIg were frequent . IVIg is an alternative treatment for AASV with persistent disease activity after st and ard therapy |
386 | 23,319,855 | One person-centered intervention , ie , the Eden Alternative , was associated with significant improvements in residents ' levels of boredom and helplessness .
In contrast , facility-specific person-centered interventions were found to impact nurses ' sense of job satisfaction and their capacity to meet the individual needs of residents in a positive way .
The complexity of the interventions and range of outcomes examined makes it difficult to form accurate conclusions about the impact of person-centered care interventions adopted and implemented in aged-care facilities .
The few negative consequences of the introduction of person-centered care models suggest that the introduction of person-centered care is not always incorporated within a wider " hierarchy of needs " structure , where safety and physiological need are met before moving onto higher level needs . | BACKGROUND Several residential aged-care facilities have replaced the institutional model of care to one that accepts person-centered care as the guiding st and ard of practice .
This culture change is impacting the provision of aged-care services around the world .
This systematic review evaluates the evidence for an impact of person-centered interventions on aged-care residents and nursing staff . | BACKGROUND Evidence for improved outcomes for people with dementia through provision of person-centred care and dementia-care mapping is largely observational . We aim ed to do a large , r and omised comparison of person-centred care , dementia-care mapping , and usual care . METHODS In a cluster r and omised controlled trial , urban residential sites were r and omly assigned to person-centred care , dementia-care mapping , or usual care . Carers received training and support in either intervention or continued usual care . Treatment allocation was masked to assessors . The primary outcome was agitation measured with the Cohen-Mansfield agitation inventory ( CMAI ) . Secondary outcomes included psychiatric symptoms including hallucinations , neuropsychological status , quality of life , falls , and cost of treatment . Outcome measures were assessed before and directly after 4 months of intervention , and at 4 months of follow-up . Hierarchical linear models were used to test treatment and time effects . Analysis was by intention to treat . This trial is registered with the Australia and New Zeal and Clinical Trials Registry , number ACTRN12608000084381 . FINDINGS 15 care sites with 289 residents were r and omly assigned . Pairwise contrasts revealed that at follow-up , and relative to usual care , CMAI score was lower in sites providing mapping ( mean difference 10.9 , 95 % CI 0.7 - 21.1 ; p=0.04 ) and person-centred care ( 13.6 , 3.3 - 23.9 ; p=0.01 ) . Compared with usual care , fewer falls were recorded in sites that used mapping ( 0.24 , 0.08 - 0.40 ; p=0.02 ) but there were more falls with person-centred care ( 0.15 , 0.02 - 0.28 ; p=0.03 ) . There were no other significant effects . INTERPRETATION Person-centred care and dementia-care mapping both seem to reduce agitation in people with dementia in residential care In a resident-oriented care model applied in nursing homes , the residents are assigned to primary nurses . These primary nurses are responsible for the total care of the residents assigned to them . The purpose of the present study , using a pretest , post-test and control group quasi-experimental design , was to evaluate the effects of the implementation of resident-oriented care on the following aspects of quality of care : coordination of care , instrumental aspects , expressive aspects , resident wellbeing and satisfaction with care , and family satisfaction with care . The study was carried out on somatic and psycho-geriatric wards in three nursing homes in the Netherl and s. Data were collected by question naires , interviews and observations . The results of the study showed that the intervention was partly successful in the experimental group . Some aspects of the resident-oriented care model were not clearly evident . Moreover , the effects on quality -of-care aspects were limited . The results revealed that the ' coordination of care ' increased on half of the experimental wards . Furthermore , there was an indication that ' expressive aspects ' changed in favour of the experimental wards . The implementation of resident-oriented care had no effect on resident wellbeing and satisfaction or on family satisfaction . Finally , the results are discussed in the light of some method ological limitations that often go together with intervention studies in the real world OBJECTIVES To determine the effects of a small-house nursing home model , THE GREEN HOUSE ( GH ) , on residents ' reported outcomes and quality of care . DESIGN Two-year longitudinal quasi-experimental study comparing GH residents with residents at two comparison sites using data collected at baseline and three follow-up intervals . SETTING Four 10-person GHs , the sponsoring nursing home for those GHs , and a traditional nursing home with the same owner . PARTICIPANTS All residents in the GHs ( 40 at any time ) at baseline and three 6-month follow-up intervals , and 40 r and omly selected residents in each of the two comparison groups . INTERVENTION The GH alters the physical scale environment ( small-scale , private rooms and bathrooms , residential kitchen , dining room , and hearth ) , the staffing model for professional and certified nursing assistants , and the philosophy of care . MEASUREMENTS Scales for 11 domains of resident quality of life , emotional well-being , satisfaction , self-reported health , and functional status were derived from interviews at four points in time . Quality of care was measured using indicators derived from Minimum Data Set assessment s. RESULTS Controlling for baseline characteristics ( age , sex , activities of daily living , date of admission , and proxy interview status ) , statistically significant differences in self-reported dimensions of quality of life favored the GHs over one or both comparison groups . The quality of care in the GHs at least equaled , and for change in functional status exceeded , the comparison nursing homes . CONCLUSION The GH is a promising model to improve quality of life for nursing home residents , with implication s for staff development and medical director roles The authors compared the effects of the staff 's perceptions of the culture in a LTC facility pre and post-intervention(s ) . One unit had significant architectural modification ( physical intervention ) . On the second unit , efforts were directed toward culture change through management modification ( social intervention through goal setting and role modeling ) . Lastly , both were compared to a third control unit where there was no planned change . On the unit with the social intervention model there was an attempt to support a " neighborhood " sense for residents and staff that would encourage residents to become more self-directed and self-sufficient rather than remain in the passive " good patient " role . Significant staff training re sources and time were devoted to this effort . On the second unit , the architectural renovation sought to provide a distinctly home-like open , and relaxed atmosphere with a large , well-equipped day room . This encouraged closer resident and staff interactions and included a staff workstation that was part of the day room . On a third control unit , no changes were made |
387 | 18,927,072 | There was some indication of greater effect with high-dose metformin ( > 1500 mg/day ) and longer duration of therapy ( > 8 weeks ) .
A structured lifestyle modification programme to achieve weight loss should still be the first line treatment in obese women with or without PCOS .
Adequately powered RCTs are required to confirm the findings of this review and to assess whether the addition of high-dose metformin therapy to a structured lifestyle modification programme might contribute to more weight loss | BACKGROUND Women of reproductive age , who are overweight or obese , are prone to infertility .
Weight loss in these women leads to increased fecundity , higher chances of conception after infertility treatment and improved pregnancy outcome .
In spite of the advantages , most patients have difficulty in losing weight and often regain lost weight over time .
This review assesses whether treatment with insulin sensitizing drugs contributes to weight loss , compared with diet or a lifestyle modification programme . | OBJECTIVE To evaluate whether morbidly obese women have an increased risk of pregnancy complications and adverse perinatal outcomes . METHODS In a prospect i ve population -based cohort study , 3,480 women with morbid obesity , defined as a body mass index ( BMI ) more than 40 , and 12,698 women with a BMI between 35.1 and 40 were compared with normal-weight women ( BMI 19.8 - 26 ) . The perinatal outcome of singletons born to women without insulin-dependent diabetes mellitus was evaluated after suitable adjustments . RESULTS In the group of morbidly obese mothers ( BMI greater than 40 ) as compared with the normal-weight mothers , there was an increased risk of the following outcomes ( adjusted odds ratio ; 95 % confidence interval ) : preeclampsia ( 4.82 ; 4.04 , 5.74 ) , antepartum stillbirth ( 2.79 ; 1.94 , 4.02 ) , cesarean delivery ( 2.69 ; 2.49 , 2.90 ) , instrumental delivery ( 1.34 ; 1.16 , 1.56 ) , shoulder dystocia ( 3.14 ; 1.86 , 5.31 ) , meconium aspiration ( 2.85 ; 1.60 , 5.07 ) , fetal distress ( 2.52 ; 2.12 , 2.99 ) , early neonatal death ( 3.41 ; 2.07 , 5.63 ) , and large-for-gestational age ( 3.82 ; 3.50 , 4.16 ) . The associations were similar for women with BMI s between 35.1 and 40 but to a lesser degree . CONCLUSION Maternal morbid obesity in early pregnancy is strongly associated with a number of pregnancy complications and perinatal conditions . LEVEL OF EVIDENCE BACKGROUND / AIMS Non-Alcoholic Steatohepatitis ( NASH ) is a chronic liver disease frequently associated with insulin resistance and type 2 diabetes mellitus ( T2DM ) . Pioglitazone reverses the metabolic and histological abnormalities of patients with impaired glucose tolerance or T2DM and NASH , but also leads to weight gain . To underst and the nature of weight gain associated with pioglitazone treatment in NASH we analyzed 35 patients who completed tests for determination of whole body fat ( WBF ) and total body water ( TBW ) . METHODS Twenty-one patients received pioglitazone and 14 placebo in a double-blind , r and omized fashion for a period of 6 months . WBF and TBW were measured before and after treatment using DXA , a water dilution technique and bioimpedance . RESULTS Pioglitazone increased body weight ( from 93.6+/-4.2 to 96.1+/-4.5 kg , p<0.003 ) and WBF measured with DXA ( from 32.9+/-2.1 to 35.4+/-2.5 kg , p<0.002 ) while no changes were seen with placebo . Total body water was not altered significantly either after pioglitazone ( from 45.4+/-2.3 to 45.6+/-2.7 l , p = NS ) or placebo . Muscle hydration and extracellular water were unchanged both by pioglitazone and placebo treatments . CONCLUSIONS Six months of pioglitazone treatment in patients with NASH is associated with weight gain that is attributable to an increase in adipose tissue mass and not to water retention background Hyper and rogenism , hyperinsulinaemia and obesity play a key and coordinating roles in the pathogenesis of polycystic ovary syndrome ( PCOS ) , contributing in different ways to the clinical expression of the syndrome . Weight loss is beneficial , but the additional administration of insulin‐lowering drugs , such as metformin , and anti and rogens may produce further benefits , due to their different spectrum of action . The effects of long‐term metformin and flutamide , an anti and rogen drug , added alone or in combination with a low‐calorie diet , on body weight and fat distribution , and rogens , metabolic parameters and clinical status in obese women with PCOS were investigated Abdominal obesity and hyperinsulinemia play a key role in the development of the polycystic ovary syndrome ( PCOS ) . Dietary-induced weight loss and the administration of insulin-lowering drugs , such as metformin , are usually followed by improved hyper and rogenism and related clinical abnormalities . This study was carried out to evaluate the effects of combined hypocaloric diet and metformin on body weight , fat distribution , the glucose-insulin system , and hormones in a group of 20 obese PCOS women [ body mass index ( BMI ) > 28 kg/m2 ] with the abdominal phenotype ( waist to hip ratio > 0.80 ) , and an appropriate control group of 20 obese women who were comparable for age and pattern of body fat distribution but without PCOS . At baseline , we measured sex hormone , sex hormone-binding globulin ( SHBG ) , and leptin blood concentrations and performed an oral glucose tolerance test and computerized tomography ( CT ) at the L4-L5 level , to measure sc adipose tissue area ( SAT ) and visceral adipose tissue area . All women were then given a low-calorie diet ( 1,200 - 1,400 kcal/day ) alone for one month , after which anthropometric parameters and CT scan were newly measured . While continuing dietary treatment , PCOS women and obese controls were subsequently placed , in a r and om order , on metformin ( 850 mg/os , twice daily ) ( 12 and 8 , respectively ) or placebo ( 8 and 12 , respectively ) , according to a double-blind design , for the following 6 months . Blood tests and the CT scan were performed in each woman at the end of the study while they were still on treatment . During the treatment period , 3 women of the control group ( all treated with placebo ) were excluded because of noncompliance ; and 2 PCOS women , both treated with metformin , were also excluded because they became pregnant . Therefore , the women cohort available for final statistical analysis included 18 PCOS ( 10 treated with metformin and 8 with placebo ) and 17 control women ( 8 treated with metformin and 9 with placebo ) . The treatment was well tolerated . In the PCOS group , metformin therapy improved hirsutism and menstrual cycles significantly more than placebo . Baseline anthropometric and CT parameters were similar in all groups . Hypocaloric dieting for 1 month similarly reduced BMI values and the waist circumference in both PCOS and control groups , without any significant effect on CT scan parameters . In both PCOS and control women , however , metformin treatment reduced body weight and BMI significantly more than placebo . Changes in the waist-to-hip ratio values were similar in PCOS women and controls , regardless of pharmacological treatment . Metformin treatment significantly decreased SAT values in both PCOS and control groups , although only in the latter group were SAT changes significantly greater than those observed during the placebo treatment . On the contrary , visceral adipose tissue area values significantly decreased during metformin treatment in both PCOS and control groups , but only in the former was the effect of metformin treatment significantly higher than that of placebo . Fasting insulin significantly decreased in both PCOS women and controls , regardless of treatment , whereas glucose-stimulated insulin significantly decreased only in PCOS women and controls treated with metformin . Neither metformin or placebo significantly modified the levels of LH , FSH , dehydroepi and rosterone sulphate , and progesterone in any group , whereas testosterone concentrations decreased only in PCOS women treated with metformin . SHBG concentrations remained unchanged in all PCOS women ; whereas in the control group , they significantly increased after both metformin and placebo . Leptin levels decreased only during metformin treatment in both PCOS and control groups . ( ABSTRACT TRUNCATED BACKGROUND Insulin resistance and increased ovarian cytochrome P450c17 alpha activity are both features of the polycystic ovary syndrome . P450c17 alpha , which is involved in and rogen bio synthesis , has both 17 alpha-hydroxylase and 17,20-lyase activities . Increased activity of this enzyme results in exaggerated conversion of progesterone to 17 alpha-hydroxyprogesterone in response to stimulation by gonadotrophin . We hypothesized that hyperinsulinemia stimulates ovarian P450c17 alpha activity . METHODS We measured fasting serum steroid concentrations and the response of serum 17 alpha-hydroxyprogesterone to leuprolide , a gonadotrophin-releasing hormone agonist , and performed oral glucose-tolerance tests before and after oral administration of either metformin ( 500 mg three times daily ) or placebo for four to eight weeks in 24 obese women with the polycystic ovary syndrome . RESULTS In the 11 women given metformin , the mean ( + /- SE ) area under the serum insulin curve after oral glucose administration decreased from 9303 + /- 1603 to 4982 + /- 911 microU per milliliter per minute ( 56 + /- 10 to 30 + /- 6 nmol per liter per minute ) ( P = 0.004 ) . This decrease was associated with a reduction in the basal serum 17 alpha-hydroxyprogesterone concentration from 135 + /- 21 to 66 + /- 7 ng per deciliter ( 4.1 + /- 0.6 to 2.0 + /- 0.2 nmol per liter ) ( P = 0.01 ) and a reduction in the leuprolide-stimulated peak serum 17 alpha-hydroxyprogesterone concentration from 455 + /- 54 to 281 + /- 52 ng per deciliter ( 13.7 + /- 1.6 to 8.5 + /- 1.6 nmol per liter ) ( P = 0.01 ) . The serum 17 alpha-hydroxyprogesterone values increased slightly in the placebo group . In the metformin group , the basal serum luteinizing hormone concentration decreased from 8.5 + /- 2.2 to 2.8 + /- 0.5 mlU per milliliter ( P = 0.01 ) , the serum free testosterone concentration decreased from 0.34 + /- 0.07 to 0.19 + /- 0.05 ng per deciliter ( 12 + /- 3 to 7 + /- 2 pmol per liter ) ( P = 0.009 ) , and the serum sex hormone-binding globulin concentration increased from 0.8 + /- 0.2 to 2.3 + /- 0.6 microgram per deciliter ( 29 + /- 7 to 80 + /- 21 nmol per liter ) ( P < 0.001 ) . None of these values changed significantly in the placebo group . CONCLUSIONS In obese women with the polycystic ovary syndrome , decreasing serum insulin concentrations with metformin reduces ovarian cytochrome P450c17 alpha activity and ameliorates hyper and rogenism Severe insulin resistance is a key abnormality in obese women with polycystic ovary syndrome ( PCOS ) . The purpose of this study was to evaluate whether pioglitazone decreases insulin resistance ( IR ) and hyper and rogenism to the same extent as metformin in obese women with PCOS who have not received any previous treatment . Fifty-two women with PCOS were r and omly allocated to receive either pioglitazone ( 30 mg/d , n = 25 ) or metformin ( 850 mg three times daily , n = 27 ) and were assessed before and after 6 months . Body weight , body mass index , and waist to hip ratio increased significantly ( P < /= 0.05 ) after pioglitazone treatment but not after metformin treatment . Fasting serum insulin concentration ( P < 0.001 for both drugs ) and the area under the insulin curve during a 2-h oral glucose tolerance test decreased after pioglitazone ( P < 0.002 ) or metformin ( P < 0.05 ) treatment . IR ( homeostasis model of assessment -IR index ) decreased and insulin sensitivity ( elevation of the quantitative insulin sensitivity check index and the fasting glucose to insulin ratio ) increased ( P < /= 0.008 ) after treatment with either drug . Hirsutism ( P < 0.05 ) and serum concentrations of free testosterone ( P < 0.02 ) and and rostenedione ( P < 0.01 ) declined to a similar extent after treatment with the drugs . Treatment with pioglitazone or metformin was associated with the occurrence of pregnancy ( n = 5 and n = 3 , respectively ) . These results suggest that pioglitazone is as effective as metformin in improving insulin sensitivity and hyper and rogenism , despite an increase in body weight , body mass index , and the waist to hip ratio associated with pioglitazone BACKGROUND Our aim was to investigate the effect of pre-treatment with metformin in women with polycystic ovary syndrome ( PCOS ) scheduled for IVF stimulation . METHODS Seventy-three oligo/amenorrhoeic women with polycystic ovaries and at least one of the following criteria : hyper and rogenaemia , elevated LH/FSH ratio , hyperinsulinism , decreased SHBG levels or hirsutism , were studied . Normal weight and overweight patients were r and omized separately in a prospect i ve , r and omized , double blind study . All patients were treated for at least 16 weeks with metformin ( 1000 mg bid ) or placebo ending on the day of HCG injection . RESULTS No differences were found in the primary end-points : duration of FSH stimulation 14.4 ( 13.1 - 15.7 ) versus 14.2 ( 12.6 - 15.7 ) days or estradiol on the day of HCG injection 6.8 ( 5.3 - 8.2 ) versus 7.6 ( 5.6 - 9.6 ) nmol/l in the metformin and placebo groups , respectively . The secondary end-points number of oocytes , fertilization rates , embryo quality , pregnancy rates and clinical pregnancy rates were equal . However , in the normal weight subgroup ( BMI < 28 kg/m(2 ) , n = 27 ) , pregnancy rates following IVF were 0.71 ( 0.63 - 0.79 ) versus 0.23 ( 0.15 - 0.31 ) in the metformin and placebo groups , respectively ( P = 0.04 ) . Overall clinical pregnancy rates were equal : 0.51 ( 0.34 - 0.68 ) versus 0.44 ( 0.27 - 0.62 ) in the metformin and placebo groups , respectively . However , in the normal weight subgroup , clinical pregnancy rates were 0.67 ( 0.43 - 0.91 ) and 0.33 ( 0.06 - 0.60 ) , respectively ( P = 0.06 ) . CONCLUSIONS Pre-treatment with metformin prior to conventional IVF/ICSI in women with PCOS does not improve stimulation or clinical outcome . However , among normal weight PCOS women , pre-treatment with metformin tends to improve pregnancy rates . Further studies in subgroups of PCOS women are required BACKGROUND Obesity is increasing rapidly among women all over the world . Obesity is a known risk factor for subfertility due to anovulation , but it is unknown whether obesity also affects spontaneous pregnancy chances in subfertile , ovulatory women . METHODS We evaluated whether obesity affected the chance of a spontaneous pregnancy in a prospect ively assembled cohort of 3029 consecutive subfertile couples . Women had to be ovulatory and had to have at least one patent tube , whereas men had to have a normal semen analysis . Time to spontaneous ongoing pregnancy within 12 months was the primary endpoint . RESULTS The probability of a spontaneous pregnancy declined linearly with a body mass index ( BMI ) over 29 kg/m(2 ) . Corrected for possible related factors , women with a high BMI had a 4 % lower pregnancy rate per kg/m(2 ) increase [ hazard ratio : 0.96 ( 95 % CI 0.91 - 0.99 ) ] . CONCLUSIONS These results indicate that obesity is associated with lower pregnancy rates in subfertile ovulatory women OBJECTIVE To evaluate the effect of metformin therapy on hyper and rogenism , insulin resistance , cervical scores , ovulation , and pregnancy rates in clomiphene citrate-resistant women with polycystic ovary syndrome ( PCOS ) . DESIGN Prospect i ve , r and omized , double-blind , placebo-controlled study . SETTING Infertility clinic of a tertiary referral center . PATIENT(S ) Fifty-six women with clomiphene citrate-resistant PCOS . INTERVENTION(S ) Two cycles of oral metformin therapy ( 850 mg , twice daily ) in group I and placebo therapy ( twice daily ) in group II . Clomiphene citrate ( 100 mg/day ) on cycle days 3 - 7 of the second cycle in both groups . MAIN OUTCOME MEASURE(S ) Insulin , T , DHEAS , FSH , LH , body mass index ( BMI ) , waist-to-hip ratio , endometrial thickness , cervical score , ovulation , and pregnancy rates in clomiphene-induced cycles after metformin therapy . RESULT ( S ) Metformin therapy result ed in a significant decrease in total T , LH level , LH/FSH ratio , insulin resistance , and mean BMI . No difference in waist-to-hip ratio , DHEAS level , and fasting insulin level was observed . Clomiphene citrate induction result ed in higher ovulation rates and thicker endometrium in the metformin group than in the placebo group . There was higher cumulative pregnancy rate in the metformin group ; however , there was no significant difference in the pregnancy rate between the two groups . CONCLUSION ( S ) Metformin therapy not only decreases hyper and rogenism and insulin resistance but also improves ovulation rates , cervical scores , and pregnancy rates in clomiphene citrate-resistant women with PCOS Evidence suggests that hyperinsulinemic insulin resistance may increase serum levels of ovarian and rogens and reduce sex hormone-binding globulin ( SHBG ) levels in humans . The present study was conducted to assess the effect of administration of the biguanide metformin , a drug commonly used in the treatment of diabetes mellitus , on and rogen and insulin levels in 24 hirsute patients . The patients selected for the study were obese , with a body mass index higher than 25 kg/m2 and high fasting insulin ( > 90 pmol/L ) and low SHBG levels ( < 30 nmol/L ) . All patients were given a low calorie diet ( 1500 Cal/day ) and r and omized for either metformin administration at a dose of 850 mg or a placebo , twice daily for 4 months , in a double blind study . In the placebo group , diet result ed in a significant decrease in body mass index ( 30.8 + /- 1.0 vs. 32.7 + /- 1.5 kg/m2 ; P < 0.0001 ) , fasting insulin ( 127 + /- 11 vs. 156 + /- 14 pmol/L ; P < 0.01 ) , non-SHBG-bound testosterone ( 0.19 + /- 0.02 vs. 0.28 + /- 0.03 nmol/L ; P < 0.02 ) , and rostenedione ( 5.8 + /- 0.5 vs. 9.0 + /- 1.1 nmol/L ; P < 0.03 ) , and 3 alpha-diolglucuronide ( 8.6 + /- 1.1 vs. 11.7 + /- 1.9 ; P < 0.005 ) plasma concentrations and a significant increase in the glucose/insulin ratio ( 0.047 + /- 0.005 vs. 0.035 + /- 0.003 ; P < 0.001 ) and plasma concentrations of SHBG ( 26.0 + /- 3.3 vs. 19.1 + /- 1.9 nmol/L ; P < 0.001 ) and dehydroepi and rosterone sulfate ( 8.7 + /- 1.5 vs. 8.4 + /- 1.3 ; P < 0.05 ) . Beneficial effects of diet were not significantly different in the patients who were given metformin instead of placebo . These results confirm that weight loss induced by a low calorie diet is effective in improving hyperinsulinemia and hyper and rogenism in obese and hirsute women . With our study design , metformin administration had no additional benefit over the effect of diet Obesity can affect ovulation and the chances of pregnancy . In this prospect i ve study , a weight loss programme was assessed to determine whether it could help infertile overweight anovulatory women to establish ovulation and assist in achieving pregnancy , ideally without further medical intervention . The subjects acted as their own historical controls . They underwent a weekly programme of behavioural change in relation to exercise and diet over 6 months ; those who did not complete the 6 months were treated as the comparison group . Women in the study group lost an average of 6.3 kg , with 12 of the 13 subjects resuming ovulation and 11 becoming pregnant , five of these spontaneously . Fitness , diet and psychometric measurements all improved . Fasting insulin and testosterone concentrations dropped significantly , while sex hormone binding globulin concentrations rose . None of these changes occurred in the comparison group . Thus , weight loss with a result ant improvement in ovulation , pregnancy outcome , self-esteem and endocrine parameters is the first therapeutic option for women who are infertile and overweight We hypothesized that hyperinsulinemia contributes to early pregnancy loss in the polycystic ovary syndrome by adversely affecting endometrial function and environment . Serum glycodelin , a putative biomarker of endometrial function , is decreased in women with early pregnancy loss . Insulin-like growth factor-binding protein-1 may also play an important role in pregnancy by facilitating adhesion processes at the feto-maternal interface . We studied 48 women with polycystic ovary syndrome before and after 4 weeks of administration of 500 mg metformin ( n = 26 ) or placebo ( n = 22 ) 3 times daily . Oral glucose tolerance tests were performed , and serum glycodelin and insulin-like growth factor-binding protein-1 were measured during the follicular and clomiphene-induced luteal phases of menses . In the metformin group , the mean ( + /-SE ) area under the serum insulin curve after glucose administration decreased from 62 + /- 6 to 19 + /- 2 nmol/L.min ( P < 0.001 ) . Follicular phase serum glycodelin concentrations increased 20-fold from 150 + /- 46 to 2813 + /- 1192 pmol/L ( P < 0.001 ) , and serum insulin-like-growth factor-binding protein-1 concentrations increased from 936 + /- 152 to 2396 + /- 300 pmol/L ( P < 0.001 ) . Similarly , luteal phase serum glycodelin concentrations increased 3-fold from 3434 + /- 1299 to 10624 + /- 1803 pmol/L ( P < 0.001 ) , and serum insulin-like growth factor-binding protein-1 concentrations increased from 1220 + /- 136 to 4916 + /- 596 pmol/L ( P < 0.001 ) . Uterine vascular penetration also increased in the metformin group , as did blood flow of spiral arteries , as demonstrated by a 20 % decrease in the resistance index from 0.71 + /- 0.02 to 0.57 + /- 0.03 ( P < 0.001 ) . These variables did not change in the placebo group . We conclude that insulin reduction with metformin increases follicular and luteal phase serum glycodelin and insulin-like growth factor-binding protein-1 concentrations and enhances luteal phase uterine vascularity and blood flow in the polycystic ovary syndrome . These changes may reflect an improved endometrial milieu for the establishment and maintenance of pregnancy BACKGROUND Elevated levels of plasma homocysteine ( Hcy ) have been implicated as a significant risk factor for cardiovascular disease . Although long-term treatment with metformin can increase Hcy levels in patients with type II diabetes mellitus or coronary heart disease , it is becoming an increasingly accepted and widespread medication in polycystic ovary syndrome ( PCOS ) . In the literature , only one study has demonstrated that metformin increases Hcy levels in PCOS patients , but the effect of other insulin sensitizers on Hcy levels have not been reported previously in women with PCOS . We aim ed to assess the effects of metformin and rosiglitazone on plasma Hcy levels in patients with PCOS . METHODS Thirty women were r and omized to two groups : 15 women in group 1 received 850 mg of metformin twice daily for 3 months . In group 2 , 15 women received 4 mg of rosiglitazone for 3 months . In both groups , body mass index , menstrual pattern , and plasma total Hcy , insulin , glucose and lipid metabolism parameters were recorded at baseline and at 3 months . RESULTS Hcy levels increased from 8.93+/-0.49 to 11.26+/-0.86 micromol/l ( P = 0.002 ) and from 10.70+/-0.86 to 12.36+/-0.81 micromol/l ( P = 0.01 ) in the metformin and rosiglitazone groups , respectively . Apolipoprotein ( Apo ) A1 levels increased from 127.10+/-6.85 to 145.7+/-7.18 mg/dl ( P = 0.018 ) in the metformin group . Total cholesterol ( total-C ) , high-density lipoprotein cholesterol ( HDL-C ) , low-density lipoprotein cholesterol ( LDL-C ) , lipoprotein ( a ) and Apo B levels decreased in the metformin group , but the change was not significant . Total-C levels decreased from 161.15+/-8.94 to 150.23+/-8.73 mg/dl ( P = 0.026 ) , HDL-C decreased from 43.13+/-2.65 to 39.15+/-2.52 mg/dl ( P = 0.005 ) and LDL-C levels decreased from 93.83+/-6.06 to 80.7+/-2.30 mg/dl ( P = 0.021 ) in the rosiglitazone group . CONCLUSION Treatment with insulin sensitizers in women with PCOS may lead to increases in Hcy levels CONTEXT Metformin treatment of women with polycystic ovary syndrome ( PCOS ) is widespread , as determined by studies with diverse patient population s. No comparative examination of weight changes or metabolite responses to different doses has been reported . OBJECTIVE The aim of this study was to determine whether different doses of metformin ( 1500 or 2550 mg/d ) would have different effects on body weight , circulating hormones , markers of inflammation , and lipid profiles . DESIGN The study included prospect i ve cohorts r and omized to two doses of metformin . SETTING The study was performed at a university teaching hospital with patients from gynecology/endocrinology clinics . PATIENTS The patients studied were obese ( body mass index , 30 to < 37 kg/m2 ; n = 42 ) and morbidly obese ( body mass index , > or = 37 kg/m2 ; n = 41 ) women with PCOS . INTERVENTION Patients were r and omized to two doses of metformin , and parameters were assessed after 4 and 8 months . MAIN OUTCOME MEASURES The main outcome measures were changes in body mass , circulating hormones , markers of inflammation , and lipid profiles . RESULTS Intention to treat analyses showed significant weight loss in both dose groups . Only the obese subgroup showed a dose relationship ( 1.5 and 3.6 kg in 1500- and 2550-mg groups , respectively ; P = 0.04 ) . The morbidly obese group showed similar reductions ( 3.9 and 3.8 kg ) in both groups . Suppression of and rostenedione was significant with both metformin doses , but there was no clear dose relationship . Generally , beneficial changes in lipid profiles were not related to dose . CONCLUSION Weight loss is a feature of protracted metformin therapy in obese women with PCOS , with greater weight reduction potentially achievable with higher doses . Additional studies are required to determine whether other aspects of the disorder may benefit from the higher dose of metformin OBJECTIVE To determine whether weight loss in obese , hyper and rogenic , anovulatory women is associated with resumption of ovulation and /or with changes in insulin , and rogen , and gonadotropin concentrations . DESIGN Prospect i ve , r and omized , controlled study . SETTING University research center . PATIENTS Twelve obese , hyper and rogenic , anovulatory women . INTERVENTIONS Twelve-week weight loss program in treatment ( n = 6 ) ; 12-week " waiting list " in control group ( n = 6 ) . MAIN OUTCOME MEASURES [ 1 ] Ovulation ; [ 2 ] fasting insulin and glucose measurements ; [ 3 ] sex hormone-binding globulin ( SHBG ) , total and non-SHBG T concentrations ; [ 4 ] LH pulse frequency , amplitude , and concentration ; and [ 5 ] FSH concentration . RESULTS In contrast with the control group who showed no change in weight , ovulation status , or hormone levels , women in the treatment group lost an average of 16.2 kg and showed a significant increase in SHBG , a significant decline in non-SHBG T , and a decline ( though nonsignificant ) in fasting insulin . Four of six subjects resumed ovulation . However , no changes were evident in LH pulse frequency or amplitude or in mean LH and FSH concentrations . CONCLUSIONS Weight loss in obese , hyper and rogenic , anovulatory women appears to reduce insulin and non-SHBG T concentrations despite the absence of a change in gonadotropin secretion and may lead to resumption of ovulation OBJECTIVE The aim of our study is to investigate and compare the clinical , biochemical and hormonal changes during application of insulin-sensitizers from two different groups . STUDY DESIGN This prospect i ve , open clinical study lasted 3 months and included 30 women with PCOS , divided in two groups of 15 women each . Group 1 received 850 mg metformin twice a day and group 2 was treated with rosiglitazone 4 mg a day . Serum levels of testosterone , immune reactive insulin ( IRI ) , sex hormone binding globulin ( SHBG ) , dehydroepi and rosterone sulfate ( DHEAS ) and lipid metabolism parameters were measured before the treatment , and on the 3rd month . Free and rogen index ( FAI ) and homeostasis model assessment of insulin resistance ( HOMA-IR ) were calculated . Body mass index ( BMI ) and waist-to-hip ratio ( WHR ) were assessed at baseline and at the end of therapy . RESULTS Two parameters change significantly in the 3rd month in our study --testosterone and insulin . Much better decrease in the level of testosterone and free and rogen index was established in group treated with metformin , while the indices of insulin resistance were better influenced in the group treated with rosiglitazone . CONCLUSION Application of insulin sensitizers from both groups has a favorable influence on the basic hormonal deviations in PCOS -- the hyper and rogenemia and the insulin resistance . In cases with PCOS metformin treatment influences better hyper and rogenemia , while rosiglitazone affects more pronouncedly insulin resistance and hyperinsulinemia Obesity affects ovulation , response to fertility treatment , pregnancy rates and outcome . In this prospect i ve study , a weight loss programme was assessed to determine whether it could help obese infertile women , irrespective of their infertility diagnosis , to achieve a viable pregnancy , ideally without further medical intervention . The subjects underwent a weekly programme aim ed at lifestyle changes in relation to exercise and diet for 6 months ; those that did not complete the 6 months were treated as a comparison group . Women in the study lost an average of 10.2 kg/m2 , with 60 of the 67 anovulatory subjects resuming spontaneous ovulation , 52 achieving a pregnancy ( 18 spontaneously ) and 45 a live birth . The miscarriage rate was 18 % , compared to 75 % for the same women prior to the programme . Psychometric measurements also improved . None of these changes occurred in the comparison group . The cost savings of the programme were considerable . Prior to the programme , the 67 women had had treatment costing a total of A$ 550,000 for two live births , a cost of A$ 275,000 per baby . After the programme , the same women had treatment costing a total of A$ 210,000 for 45 babies , a cost of A$ 4600 per baby . Thus weight loss should be considered as a first option for women who are infertile and overweight BACKGROUND The efficacy of thiazolidinediones , as compared with other oral glucose-lowering medications , in maintaining long-term glycemic control in type 2 diabetes is not known . METHODS We evaluated rosiglitazone , metformin , and glyburide as initial treatment for recently diagnosed type 2 diabetes in a double-blind , r and omized , controlled clinical trial involving 4360 patients . The patients were treated for a median of 4.0 years . The primary outcome was the time to monotherapy failure , which was defined as a confirmed level of fasting plasma glucose of more than 180 mg per deciliter ( 10.0 mmol per liter ) , for rosiglitazone , as compared with metformin or glyburide . Prespecified secondary outcomes were levels of fasting plasma glucose and glycated hemoglobin , insulin sensitivity , and beta-cell function . RESULTS Kaplan-Meier analysis showed a cumulative incidence of monotherapy failure at 5 years of 15 % with rosiglitazone , 21 % with metformin , and 34 % with glyburide . This represents a risk reduction of 32 % for rosiglitazone , as compared with metformin , and 63 % , as compared with glyburide ( P<0.001 for both comparisons ) . The difference in the durability of the treatment effect was greater between rosiglitazone and glyburide than between rosiglitazone and metformin . Glyburide was associated with a lower risk of cardiovascular events ( including congestive heart failure ) than was rosiglitazone ( P<0.05 ) , and the risk associated with metformin was similar to that with rosiglitazone . Rosiglitazone was associated with more weight gain and edema than either metformin or glyburide but with fewer gastrointestinal events than metformin and with less hypoglycemia than glyburide ( P<0.001 for all comparisons ) . CONCLUSIONS The potential risks and benefits , the profile of adverse events , and the costs of these three drugs should all be considered to help inform the choice of pharmacotherapy for patients with type 2 diabetes . ( Clinical Trials.gov number , NCT00279045 [ Clinical Trials.gov ] . ) OBJECTIVE This study was undertaken to determine whether obesity is associated with obstetric complications and cesarean delivery . METHODS A large prospect i ve multicenter data base was studied . Subjects were divided into 3 groups : body mass index ( BMI ) less than 30 ( control ) , 30 to 34.9 ( obese ) , and 35 or greater ( morbidly obese ) . Groups were compared by using univariate and multivariable logistic regression analyses . RESULTS The study included 16,102 patients : 3,752 control , 1,473 obese , and 877 morbidly obese patients . Obesity and morbid obesity had a statistically significant association with gestational hypertension ( odds ratios [ ORs ] 2.5 and 3.2 ) , preeclampsia ( ORs 1.6 and 3.3 ) , gestational diabetes ( ORs 2.6 and 4.0 ) , and fetal birth weight greater than 4000 g ( ORs 1.7 and 1.9 ) and greater than 4500 g ( ORs 2.0 and 2.4 ) . For nulliparous patients , the cesarean delivery rate was 20.7 % for the control group , 33.8 % for obese , and 47.4 % for morbidly obese patients . CONCLUSION Obesity is an independent risk factor for adverse obstetric outcome and is significantly associated with an increased cesarean delivery rate OBJECTIVE To determine whether metformin treatment increases the ovulation and pregnancy rates in response to clomiphene citrate ( CC ) in women who are resistant to CC alone . DESIGN R and omized , double-blind , placebo-controlled trial . SETTING Multicenter environment . PATIENT(S ) Anovulatory women with the polycystic ovary syndrome ( PCOS ) who were resistant to CC . INTERVENTION(S ) Participants received placebo or metformin , 500 mg three times daily , for 7 weeks . Information on reproductive steroids , gonadotropins , and oral glucose tolerance testing was obtained at baseline and after treatment . Metformin or placebo was continued and CC treatment was begun at 50 mg daily for 5 days . Serum P level > or = 4 ng/mL was considered to indicate ovulation . With ovulation , the daily CC dose was not changed , but with anovulation it was increased by 50 mg for the next cycle . Patients completed the study when they had had six ovulatory cycles , became pregnant , or experienced anovulation while receiving 150 mg of CC . MAIN OUTCOME MEASURE(S ) Ovulation and pregnancy rates . RESULT ( S ) In the metformin and placebo groups , 9 of 12 participants ( 75 % ) and 4 of 15 participants ( 27 % ) ovulated , and 6 of 11 participants ( 55 % ) and 1 of 14 participants ( 7 % ) conceived , respectively . Comparisons between the groups were significant . CONCLUSION ( S ) In anovulatory women with PCOS who are resistant to CC , metformin use significantly increased the ovulation rate and pregnancy rate from CC treatment BACKGROUND Weight-loss medications are recommended as an adjunct to a comprehensive program of diet , exercise , and behavior therapy but are typically prescribed with minimal or no lifestyle modification . This practice is likely to limit therapeutic benefits . METHODS In this one-year trial , we r and omly assigned 224 obese adults to receive 15 mg of sibutramine per day alone , delivered by a primary care provider in eight visits of 10 to 15 minutes each ; lifestyle-modification counseling alone , delivered in 30 group sessions ; sibutramine plus 30 group sessions of lifestyle-modification counseling ( i.e. , combined therapy ) ; or sibutramine plus brief lifestyle-modification counseling delivered by a primary care provider in eight visits of 10 to 15 minutes each . All subjects were prescribed a diet of 1200 to 1500 kcal per day and the same exercise regimen . RESULTS At one year , subjects who received combined therapy lost a mean ( + /-SD ) of 12.1+/-9.8 kg , whereas those receiving sibutramine alone lost 5.0+/-7.4 kg , those treated by lifestyle modification alone lost 6.7+/-7.9 kg , and those receiving sibutramine plus brief therapy lost 7.5+/-8.0 kg ( P<0.001 ) . Those in the combined-therapy group who frequently recorded their food intake lost more weight than those who did so infrequently ( 18.1+/-9.8 kg vs. 7.7+/-7.5 kg , P=0.04 ) . CONCLUSIONS The combination of medication and group lifestyle modification result ed in more weight loss than either medication or lifestyle modification alone . The results underscore the importance of prescribing weight-loss medications in combination with , rather than in lieu of , lifestyle modification |
388 | 25,834,456 | Conclusion The ERCC1 rs11615 polymorphism was closely associated with the clinical outcomes of GC and CRC patients treated with oxaliplatin-based chemotherapy | Purpose The relationship between the excision repair cross-complementing 1 ( ERCC1 ) rs11615 polymorphism ( C/T ) and responses to oxaliplatin-based chemotherapy for gastric cancer ( GC ) and colorectal cancer ( CRC ) patients is controversial .
Therefore , we performed a meta- analysis to assess this relationship . | Purpose ERCC1 and ERCC2 play critical roles in the nucleotide excision repair pathway that effectively repairs DNA damage induced by chemotherapeutic agents . Therefore , functional single nucleotide polymorphisms ( SNPs ) in these genes could have an impact on clinical outcomes in cancer patients who received chemotherapy . However , few studies have simultaneously investigated the roles of ERCC1 and ERCC2 SNPs in clinical outcomes in gastric cancer patients . Experimental Design We genotyped by the TaqMan assay three common , potentially functional ERCC1 ( rs3212986 ) and ERCC2 SNPs ( rs13181 and rs1799793 ) in 360 gastric cancer patients . We used both Kaplan-Meier tests and Cox proportional hazards models to evaluate the effects of ERCC1 and ERCC2 genotypes and haplotypes on clinical outcomes . Results We found that , compared with ERCC2 rs1799793 GG+AG genotypes , the homozygous variant AA genotype was associated with significantly poorer overall survival ( OS ) ( AA vs. GG+AG , log-rank P = 0.012 ) and significantly higher risk of death ( AA vs. GG+AG , Adjusted hazards ratio [ HR ] 2.13 ; 95 % CI , 1.28 to 3.56 ; P = 0.004 ) . In combined analyses , patients with any one of the three unfavorable genotypes ( i.e. ERCC1 rs3212986 TT , ERCC2 rs13181 GG and rs1799793 AA ) had statistically significant hazards of poor prognosis ( Adjusted HR , 1.54 ; 95 % CI , 1.06 to 2.25 ; P = 0.025 ) , compared with those without any unfavorable genotypes . Furthermore , the haplotype A-G-G ( rs1799793/rs13181/rs3212986 ) had a significant impact on OS ( Adjusted HR , 1.57 ; 95 % CI , 1.11 to 2.21 ; P = 0.011 ) , compared with the common haplotype G-T-G. Conclusion ERCC1 and ERCC2 functional SNPs may jointly affect OS in Caucasian gastric cancer patients . Additional large prospect i ve studies are essential to confirm our findings Background The objective of this study was to evaluate the efficacy and toxicity of infusional 5-fluorouracil ( 5-FU ) , folinic acid and oxaliplatin ( modified FOLFOX-6 ) in patients with advanced gastric cancer ( AGC ) , as first-line palliative combination chemotherapy . We also analyzed the predictive or prognostic value of germline polymorphisms of c and i date genes associated with 5-FU and oxaliplatin . Methods Seventy-three patients were administered a 2 hour infusion of oxaliplatin ( 100 mg/m2 ) and folinic acid ( 100 mg/m2 ) followed by a 46 hour continuous infusion of 5-FU ( 2,400 mg/m2 ) . Genomic DNA from the patients ' peripheral blood mononuclear cells was extracted . Ten polymorphisms within five genes were investigated including TS , GSTP , ERCC , XPD and XRCC . Results The overall response rate ( RR ) was 43.8 % . Median time to progression ( TTP ) and overall survival ( OS ) were 6.0 months and 12.6 months , respectively . Toxicities were generally tolerable and manageable . The RR was significantly higher in patients with a 6-bp deletion homozygote ( -6 bp/-6 bp ) in TS-3'UTR ( 55.0 % vs. 30.3 % in + 6 bp/+6 bp or + 6 bp/-6 bp , p = 0.034 ) , and C/A or A/A in XPD156 ( 52.0 % vs. 26.1 % in C/C , p = 0.038 ) . The -6 bp/-6 bp in TS-3'UTR was significantly associated with a prolonged TTP and OS . In a multivariate analysis , the 6-bp deletion in TS-3'UTR was identified as an independent prognostic marker of TTP ( hazard ratio = 0.561 , p = 0.032 ) . Conclusion Modified FOLFOX-6 chemotherapy appears to be active and well tolerated as first line chemotherapy in AGC patients . The 6-bp deletion in TS-3'UTR might be a c and i date to select patients who are likely to benefit from 5-FU based modified FOLFOX-6 in future large scale trial CONTEXT AND OBJECTIVE Oxaliplatin is one of the chemotherapy regimens most used for treating colorectal cancer . One of the main limitations to its use is induction of peripheral neuropathy . Previous studies have shown that vitamin E can reduce the incidence of peripheral neuropathy by 50 % . This study aim ed to assess the effectiveness of vitamin E for prevention of oxaliplatin-induced peripheral neuropathy . DESIGN AND SETTING Prospect i ve , phase II , r and omized pilot study developed at a university hospital in the Greater ABC region . METHODS Patients were r and omized five days before starting oxaliplatin treatment , to receive either vitamin E or placebo until the end of the chemotherapy regimen . The outcome was evaluated using the Common Terminology Criteria for Adverse Events ( CTCAE ) , version 3 , and specific gradation scales for oxaliplatin-induced peripheral neuropathy . Patients with colorectal and gastric cancer who had been scheduled to receive oxaliplatin-based chemotherapy were included . Both groups received calcium and magnesium supplementation before and after oxaliplatin infusions . RESULTS Eighteen patients were r and omized to the vitamin E group and 16 to the placebo group . Cumulative incidence of 83 % with peripheral neuropathy grade s 1/2 was observed in the vitamin E group , versus 68 % in the placebo group ( P = 0.45 ) . A trend towards more diarrhea was observed among patients who received vitamin E ( 55.6 % vs. 18.8 % ; P = 0.06 ) . There were no other significant differences in toxicity between the groups . CONCLUSIONS No significant decrease in the incidence of acute oxaliplatin-induced peripheral neuropathy was demonstrated through vitamin E use In this marker evaluation study , we tested whether distinct patterns of functional genomic polymorphisms in genes involved in drug metabolic pathways and DNA repair that predict clinical outcome to 5-fluorouracil (5-FU)/oxaliplatin chemotherapy in patients with advanced colorectal cancer could be identified . Functional polymorphisms in DNA-repair genes XPD , ERCC1 , XRCC1 , XPA , and metabolising genes glutathione S-transferase GSTP1 , GSTT1 , GSTM1 , and thymidylate synthase ( TS ) were assessed retrospectively in 106 patients with refractory stage IV disease who received 5-FU/oxaliplatin combination chemotherapy , using a polymerase chain reaction-based RFLP technique . Favourable genotypes from polymorphisms in XPD-751 , ERCC1 - 118 , GSTP1 - 105 , and TS-3′-untranslated region ( 3′UTR ) that are associated with overall survival were identified . After adjustment for performance status , the relative risks of dying for patients who possessed the unfavourable genotype were : 3.33 for XPD-751 ( P=0.037 ) , 3.25 for GSTP1 - 105 ( P=0.072 ) , 2.05 for ERCC1 - 118 ( P=0.037 ) , and 1.65 for TS-3′UTR ( P=0.091 ) when compared to their respective beneficial genomic variants . Combination analysis with all four polymorphisms revealed that patients possessing ⩾2 favourable genotypes survived a median of 17.4 months ( 95 % confidence interval ( CI ) : 9.4 , 26.5 ) compared to 5.4 months ( 95 % CI : 4.3 , 6.0 ) in patients with no favourable genotype . Patients who carried one favourable genotype demonstrated intermediate survival of 10.2 months ( 95 % CI : 6.8 , 15.3 ; P<0.001 ) . Polymorphisms in the TS-3′UTR and GSTP1 - 105 gene were also associated with time to progression . After adjustment for performance status , patients with an unfavourable TS-3′UTR genotype had a relative risk of disease progression of 1.76 ( P=0.020 ) and those with the unfavourable GSTP1 - 105 genotype showed a relative risk of progression of 2.00 ( P=0.018 ) . The genomic polymorphisms XPD-751 , ERCC1 - 118 , GSTP1 - 105 , and TS-3′UTR may be useful in predicting overall survival and time to progression of colorectal cancer in patients who receive 5-FU/oxaliplatin chemotherapy . These findings require independent prospect i ve confirmation Background : While single nucleotide polymorphisms ( SNP ) in genes involved in DNA repair or drug metabolism have been shown to influence survival of metastatic colon cancer patients treated with FOLFOX , data on adjuvant setting are scarce . Methods : This study evaluated the correlation between disease-free survival ( DFS ) of 210 unselected stage III colon cancer patients receiving FOLFOX chemotherapy , and ERCC1 - 118 ( rs11615 , c.354T > C ) , XRCC1 - 399 ( rs25487 , c.1196G > A ) and GSTP1 - 105 ( rs1695 , c.313A > G ) polymorphisms . SNP were determined on tumor DNA using a PCR-based RFLP technique . Results : In univariate analysis , a trend towards longer DFS was observed for ERCC1 ( C/T + T/T ) versus ( C/C ) ( HR=2.29 ; p=0.06 ) , and XRCC1 ( A/A ) versus ( G/G + G/A ) ( HR=1.61 ; p=0.16 ) , but not for GSTP1 genotypes ; a statistically significant p value was obtained when combining ERCC1 and XRCC1 favorable genotypes ( 0 versus ≥ 1 favorable genotypes , HR=2.42 ; p=0.02 ) . After adjustment on tumor stage , lymph node ratio and differentiation grade , multivariate analysis showed that combining ERCC1 and XRCC1 genotypes gave a p value slightly above the threshold for statistical significance ( HR=2.03 ; p=0.06 ) , which was lower than for tumor stage , lymph node ratio or differentiation grade . Conclusion : The association of ERCC1 and XRCC1 polymorphisms may influence the prognosis of stage III colon cancer patients treated with FOLFOX adjuvant chemotherapy . Yet , these findings need to be confirmed in independent prospect i ve studies Background : The FAST was a factorial trial in first-line treatment of advanced non-small-cell lung cancer ( NSCLC ) , addressing the role of replacing cisplatin with a non-platinum agent . The prognostic and predictive effect of ERCC1/BRCA1 expression and ERCC1/XPD/XRCC1–3 gene polymorphisms on outcomes of patients was examined . Methods : Patients were r and omised to receive treatment with or without cisplatin . ERCC1/BRCA1 expression was determined by immunohistochemistry . ERCC1 ( C8092A , C118 T ) , XPD ( Lys751Gln ) , XRCC1 ( Arg399Gln ) and XRCC3 ( Thr241Met ) gene polymorphisms were evaluated on tumour DNA by TaqMan allelic discrimination assay . Results : Tumour sample s were available from 110 of 433 patients enrolled : 54.7 % were ERCC1 positive and 51.4 % were BRCA1 positive . Overall , ERCC1-negative patients had better response rate ( P=0.004 ) , progression-free survival ( P=0.023 ) and overall survival ( P=0.012 ) compared with positive ones , with no statistically significant treatment interaction . The BRCA1-positive patients showed numerically better outcomes , although not statistically significant , with no treatment interaction . Among DNA repair gene polymorphisms , only XRCC1 Gln/Gln genotype evidence d a potential prognostic role ( P=0.036 ) . Conclusion : This study confirms the prognostic role of ERCC1 expression and XRCC1 ( Arg399Gln ) polymorphism in advanced NSCLC treated with first-line chemotherapy . None of these biomarkers was shown to be a specific predictive factor of cisplatin efficacy Purpose The aim of this study was to assess whether genetic polymorphisms in p53 , glutathione S-transferase P1 ( GSTP1 ) , GSTM1 , excision repair cross complementing group 1 ( ERCC1 ) and X-ray repair cross-complementing group 1 ( XRCC1 ) genes are associated with clinical outcome of gastric cancer patients treated with oxaliplatin-based adjuvant chemotherapy . Methods The genetic polymorphisms in p53 , GSTP1,GSTM1 ( null ) , ERCC1 and XRCC1 were determined in 102 gastric cancer patients treated with oxaliplatin-based adjuvant chemotherapy using polymerase chain reaction-ligation detection reaction method . Results Among the five studied polymorphisms , p53 codon 72 Pro/Pro , GSTP1 codon 105 Ile/Ile , and XRCC1 codon 399 Gln/Gln + Arg/Gln were associated with poor relapse-free survival and overall survival ( P < 0.05 ) ; and the prognostic effect was retained in the Cox multivariate analysis . Combination analysis with the three polymorphisms using the Kaplan – Meier method and Cox multivariate analysis revealed that the relapse-free and overall survivals significantly increase with the number of favorable genotypes ( P < 0.05 ) . No significant association was found between the GSTM1 ( null ) or the ERCC1 codon 118 genotypes and the clinical outcome ( P > 0.05 ) . Conclusion Testing for p53 Arg72Pro , GSTP1 Ile105Val , and XRCC1 Arg399Gln polymorphisms may allow identification of gastric cancer patients who will benefit from oxaliplatin-based adjuvant chemotherapy . Selecting specific adjuvant treatments according to the individual genetic background may represent an innovative strategy that warrants prospect i ve studies WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT * Numerous clinical studies , including a few prospect i ve ones , have reported conflicting results on the impact of gene polymorphisms related to fluorouracil ( FU ) and oxaliplatin pharmacodynamics . WHAT THIS STUDY ADDS * This prospect i ve study is the first to report that clinical response to FOLFOX is significantly related to methylenetetrahydrofolate reductase ( MTHFR ) gene polymorphisms ( 677C-->T and 1298A-->C ) , with a response rate of 37 , 53 , 63 and 80 % in patients harbouring no , one , two or three favourable MTHFR alleles , respectively . * Only polymorphisms of genes related to oxaliplatin pharmacodynamics ( GSTpi 105Ile-->Val and XPD 751Ly-->Gln ) influenced progression-free survival . * These results corroborate the observation that response was related to the cumulative FU dose , whereas progression-free survival was related to the cumulative oxaliplatin dose . AIMS To test prospect ively the predictive value of germinal gene polymorphisms related to fluorouracil ( FU ) and oxaliplatin ( Oxa ) pharmacodynamics on toxicity and responsiveness of colorectal cancer ( CRC ) patients receiving FOLFOX therapy . METHODS Advanced CRC patients ( n= 117 ) receiving FOLFOX 7 therapy were enrolled . Gene polymorphisms relevant for FU [ thymidylate synthase ( TYMS , 28 bp repeats including the G-->C mutation + 6 bp deletion in 3'UTR ) , methylenetetrahydrofolate reductase ( MTHFR , 677C-->T , 1298A-->C ) , dihydropyrimidine deshydrogenase ( IVS14 + 1G-->A ) and Oxa : glutathione S-transferase ( GST ) pi ( 105Ile-->Val , 114Ala-->Val ) , excision repair cross-complementing group 1 ( ERCC1 ) ( 118AAT-->AAC ) , ERCC2 ( XPD , 751Lys-->Gln ) and XRCC1 ( 399Arg-->Gln ) ] were determined ( blood mononuclear cells ) . RESULTS None of the genotypes was predictive of toxicity . Response rate ( 54.7 % complete response + partial response ) was related to FU pharmacogenetics , with both 677C-->T ( P= 0.042 ) and 1298A-->C ( P= 0.004 ) MTHFR genotypes linked to clinical response . Importantly , the score of favourable MTHFR alleles ( 677 T and 1298C ) was positively linked to response , with response rates of 37.1 , 53.3 , 62.5 and 80.0 % in patients bearing no , one , two or three favourable alleles , respectively ( P= 0.040 ) . Polymorphisms of genes related to Oxa pharmacodynamics showed an influence on progression-free survival , with a better outcome in patients bearing GSTpi 105 Val/Val genotype or XPD 751Lys-containing genotype ( P= 0.054 ) . CONCLUSIONS These results show that response to FOLFOX therapy in CRC patients may be driven by MTHFR germinal polymorphisms e15580 Background : Pharmacogenetic advances in cancer chemotherapy have the potential to predict clinical benefit to particular regimens . Oxaliplatin and irinotecan have shown to be effective in the treatment of gastric cancer . We assessed whether single nucleotide polymorphisms ( SNPs ) in ERCC1 , GST , TS , and UGT1A1predicted overall survival in gastric cancer patients receiving FOLFOX and /or FOLFIRI chemotherapy . METHODS Total genomic DNA was extracted from whole blood of patient . The PCR- restriction fragment length polymorphism ( RFLP ) method was applied to detect the known variant sites of ERCC1 , GST , TS , and UGT1A1 . RESULTS Response rate of FOLFOX ( N=75 ) was 24 % . Grade 3 - 4 neutropenia and neurotoxicity were observed 34.7 % and 16 % , respectively . TTP and OS of 1st line administration of FOLFOX ( N=35 ) was 3.1 months ( 95 % CI , 0.1 - 6.1 months ) and 13.9 months ( 95 % CI , 12.2 - 15.6 months ) . Only the GSTM1 positive genotype showed a significantly better time to progression ( P=0.023 ) . But significant genotype variation of TS , GST and ERCC1,which assumed to affect to activity of oxaliplatin was not observed to RR , toxicity , and overall survival . Response rate of FOLFIRI ( N=74 ) was 23 % . Grade 3 - 4 neutropenia and diarrhea were observed 55.4 % and 9.5 % , respectively . TTP and OS of 1st line administration of FOLFIRI ( N=33 ) was 4.9 months ( 95 % CI , 3.5 - 6.4 months ) and 19.0 months ( 95 % CI , 8.5 - 29.5months ) . Low expression type ( 2R/2R , 2R/3C , and 3C/3C ) of TS was associated with high incidence of grade ≥3 neutropenia . But significant genotype variation of UGT1A1,which assumed to affect to toxicity of irinotecan was not observed to RR , toxicity , and survival . CONCLUSIONS In this study , GSTM1 positive genotype showed a significantly better time to progression in the advanced gastric cancer treated with FOLFOX . Low expression type ( 2R/2R , 2R/3C , and 3C/3C ) of TS was associated with high incidence of grade ≥3 neutropenia in the advanced gastric cancer treated with FOLFIRI . Well design ed prospect i ve trial will be clearly identifying relations between chemotherapy and genetic variations . No significant financial relationships to disclose We studied the role of TS ( 5'VNTR , 5'SNP and 3'UTR ) , XRCC1 - 399 , XPD-751 , ERCC1 - 118 and XRCC3 - 241 genetic polymorphisms in tailoring fluroropyrimidine/oxaliplatin treatment . For this purpose , 110 XELOX (capecitabine/oxaliplatin)- or FUOX (fluorouracil/oxaliplatin)-treated metastatic colorectal cancer patients were selected prospect ively for genotyping . In the FUOX group , TS-3'UTR + 6bp/+6bp ( hazards ratio , HR=2.62 , p=0.007 ) and ERCC1 - 118C/T or C/C ( HR=1.96 , p=0.050 ) genotypes correlated with a shorter progression-free survival ( PFS ) . When analysed jointly , the higher the number of favourable genotypes ( FG ) the longer the PFS ( 6.8 m , 9.6 m and 25.8 m for 0 , 1 or 2 FG ; p=0.005 ) . Disease-control rate was 100 % in patients with 2 FG ( 87 % and 38.5 % for 1 or 0 FG ; p=0.001 ) . In the multivariate analysis , ERCC1 - 118 ( HR=2.12 , p=0.0037 ) and TS-3'UTR ( HR=2.68 , p=0.006 ) were strong independent prognostic factors . According to this , patients harbouring TS-3'UTR + 6bp/+6bp and ERCC1 - 118C/T or C/C genotypes may better receive capecitabine instead of 5FU in an oxaliplatin-based first-line treatment PURPOSE The objective is to investigate whether polymorphisms with putative influence on fluorouracil/oxaliplatin activity are associated with clinical outcomes of patients with advanced colorectal cancer treated with first-line oxaliplatin , folinic acid , and fluorouracil palliative chemotherapy . MATERIAL S AND METHODS Consecutive patients were prospect ively enrolled onto medical oncology units in Central Italy . Patients were required to have cytologically/histologically confirmed metastatic disease with at least one measurable lesion . Peripheral blood sample s were used for genotyping 12 polymorphisms in thymidylate synthase , methylenetetrahydrofolate reductase , xeroderma pigmentosum group D ( XPD ) , excision repair cross complementing group 1 ( ERCC1 ) , x-ray cross complementing group 1 , x-ray cross complementing protein 3 , glutathione S-transferases ( GSTs ) genes . The primary end point of the study was to investigate the association between genotypes and progression-free survival ( PFS ) . RESULTS In 166 patients , ERCC1 - 118 T/T , XPD-751 A/C , and XPD-751 C/C genotypes were independently associated with adverse PFS . The presence of two risk genotypes ( ERCC1 - 118 T/T combined with either XPD-751 A/C or XPD-751 C/C ) occurred in 50 patients ( 31 % ) . This profiling showed an independent role for unfavorable PFS with a hazard ratio of 2.84 % and 95 % CI of 1.47 to 5.45 ( P = .002 ) . Neurotoxicity was significantly associated with GSTP1 - 105 A/G. Carriers of the GSTP1 - 105 G/G genotype were more prone to suffer from grade 3 neurotoxicity than carriers of GSTP1 - 105 A/G and GSTP1 - 105 A/A genotypes . CONCLUSION A pharmacogenetic approach may be an innovative strategy for optimizing palliative chemotherapy in patients with advanced colorectal cancer . These findings deserve confirmation in additional prospect i ve studies |
389 | 26,802,174 | Marked ethnic differences in age-specific prevalence of myopia exist . | The aim of this review was to quantify the global variation in childhood myopia prevalence over time taking account of demographic and study design factors . | PURPOSE To determine the prevalence of refractive error types in Singaporean Chinese children aged 6 to 72 months . METHODS The Strabismus , Amblyopia and Refractive Error in Singaporean Children ( STARS ) is a population -based study in southwest Singapore . Door-to-door recruitment of participants was used , with disproportionate r and om sampling in 6-month increments . Parental question naires were administered . Participant eye examinations included logMAR visual acuity , cycloplegic autorefraction , and ocular biometry . Overall and age-specific prevalences of myopia ( spherical equivalence [ SE ] < or= -0.50 D ) , high myopia ( SE < or= -6.00 D ) , hyperopia ( SE > or= + 3.00 D ) , astigmatism ( cylinder > or= + 1.50 D ) , and anisometropia ( SE difference between each eye > or=2.00 D ) were calculated . RESULTS A total of 3009 children were examined ( participation rate , 72.3 % ) . Right eye ( OD ) cycloplegia data were available for 1375 boys and 1264 girls ( mean age , 41 months ) . Mean OD SE was + 0.69 D ( SD 1.15 ) . Overall myopia prevalence was 11.0 % with no variance between the sexes ( P = 0.91 ) . The prevalence of high myopia ( at least -6.00 D ) was 0.2 % . The prevalences of hyperopia , astigmatism , and anisometropia were 1.4 % , 8.6 % , and 0.6 % , respectively . Most astigmatism ( > 95 % ) was with-the-rule ( cylinder axes between 1 degrees and 15 degrees or 165 degrees and 180 degrees ) . Myopia was present in 15.8 % , 14.9 % , 20.2 % , 8.6 % , 7.6 % , and 6.4 % of children aged 6 to 11 , 12 to 23 , 24 to 35 , 36 to 47 , 48 to 59 , and 60 to 72 months , respectively . Prevalence increased with age for astigmatism ( P < 0.001 ) , but not for hyperopia or anisometropia ( P = 0.55 and P = 0.37 ) , respectively . CONCLUSIONS The prevalences of myopia and astigmatism in young Singaporean Chinese children are high , but that of hyperopia is low . Age effects were observed for each refractive error category , but differences between the sexes were not significant . Age-related variation in myopia prevalence may be influenced by ocular development , environment , and /or testability PURPOSE To describe the methodology , sampling strategy and preliminary results for the Aston Eye Study ( AES ) , a cross-sectional study to determine the prevalence of refractive error and its associated ocular biometry in a large multi-racial sample of school children from the metropolitan area of Birmingham , Engl and . METHODS A target sample of 1700 children aged 6 - 7 years and 1200 aged 12 - 13 years is being selected from Birmingham schools selected r and omly with stratification by area deprivation index ( a measure of socio-economic status ) . Schools with pupils predominantly ( > 70 % ) from a single race are excluded . Sample size calculations account for the likely participation rate and the clustering of individuals within schools . Procedures involve st and ardised protocol s to allow for comparison with international population -based data . Visual acuity , non-contact ocular biometry ( axial length , corneal radius of curvature and anterior chamber depth ) and cycloplegic autorefraction are measured in both eyes . Distance and near oculomotor balance , height and weight are also assessed . Question naires for parents and older children will allow the influence of environmental factors on refractive error to be examined . RESULTS Recruitment and data collection are ongoing ( currently N=655 ) . Preliminary cross-sectional data on 213 South Asian , 44 black African Caribbean and 70 white European children aged 6 - 7 years and 114 South Asian , 40 black African Caribbean and 115 white European children aged 12 - 13 years found myopia prevalence of 9.4 % and 29.4 % for the two age groups respectively . A more negative mean spherical equivalent refraction ( SER ) was observed in older children ( -0.21 D vs + 0.87 D ) . Ethnic differences in myopia prevalence are emerging with South Asian children having higher levels than white European children 36.8 % vs 18.6 % ( for the older children ) . Axial length , corneal radius of curvature and anterior chamber depth were normally distributed , while SER was leptokurtic ( p<0.001 ) with a slight negative skew . CONCLUSIONS The AES will allow ethnic differences in the ocular characteristics of children from a large metropolitan area of the UK to be examined . The findings to date indicate the emergence of higher levels of myopia by early adolescence in second and third generation British South Asians , compared to white European children . The continuation of the AES will allow the early determinants of these ethnic differences to be studied PURPOSE To determine the risk factors of incident myopia in a school-based cohort study in Singaporean children . METHODS A 3-year prospect i ve cohort study was conducted in Singaporean school children aged 7 to 9 years in three schools at entry . Chinese children without myopia at baseline ( n = 994 ) were included in the analysis . The main outcome was incident myopia , defined as spherical equivalent ( SE ) at least -0.75 D based on cycloplegic autorefraction . Other definitions of incident myopia , at least -0.5 D and at least -1.0 D , were also assessed . RESULTS After controlling for school , age , gender , income , reading in books per week and intelligence quotient ( IQ ) test scores , we found the relative risk ( RR ) of incident myopia defined as -0.75 D to be 1.55 ( 95 % confidence interval [ CI ] 1.18 - 2.04 ) for two versus no myopic parents . The multivariate RR of myopia for IQ in the third versus first tertile was 1.50 ( 95 % CI , 1.19 - 1.89 ) . However , the RR of incident myopia was 1.01 ( 95 % CI , 0.97 - 1.05 ) for every unit increase in books read per week . Similar results were obtained with definitions of -0.5 and -1.0 D for incident myopia . CONCLUSIONS These data provide new prospect i ve evidence of essential links between parental myopia , IQ scores and subsequent myopia development . However , reading in books per week was not associated with incident myopia PURPOSE To investigate the hypothesis that the excessive growth of the eye in myopia is associated with general growth and thus influenced by early life biological and social factors , and that these associations underlie recent secular trends of increasing prevalence and severity of myopia . DESIGN Cohort study . PARTICIPANTS A total of 2487 r and omly selected 44-year-old members of the 1958 British birth cohort ( 27 % sub sample ) . METHODS Diverse and detailed biological , social , and lifestyle data have been collected by following members since birth through a series of clinical examinations or face-to-face interviews carried out by trained examiners . At 44 years , cohort members underwent autorefraction using the Nikon Retinomax 2 ( Nikon Corp. , Tokyo , Japan ) under non-cycloplegic conditions . A lifecourse epidemiologic approach , based on 4 sequential multivariable " life stage " models ( preconceptional ; prenatal , perinatal , and postnatal ; childhood ; and adult ) , was used to examine the influence of early life biological , social and lifestyle factors , growth patterns , and " eye-specific " factors on myopia . MAIN OUTCOME MEASURES Myopia severity ( all , mild/moderate : spherical equivalent -0.75 to -5.99 diopters [ D ] ; severe : ≥-6.00 D extreme vs. emmetropia -0.74 to + 0.99 D ) and myopia onset ( early [ < 16 years ] vs. later ) . RESULTS A total of 1214 individuals ( 49 % ; 95 % confidence interval , 48.8 - 50.8 ) were myopic ( late onset in 979 [ 80.6 % ] ) . Myopia was positively associated with low birthweight for gestational age , gender , greater maternal age , higher paternal occupational social class , and maternal smoking in early pregnancy . Myopia was independently associated with proxy markers of near work and educational performance , with some differences by onset and severity . In adults , greater height and higher educational attainment and socioeconomic status were associated with myopia . CONCLUSIONS Trends in the key influences on child health and growth identified as novel putative risk factors in this study are consistent with global trends of increasing myopia : increasing births to older mothers , increasing rates of intrauterine growth retardation and survival of affected children , increasing persistence of smoking in pregnancy , and changing socioeconomic status . Prospect s for prevention of myopia would be improved by a paradigm shift in myopia research , with lifecourse and genetic epidemiologic approaches applied in t and em in large unselected population We aim ed to identify the prevalence and risk factors of myopia among secondary -school students in Amman . Thus 1777 ( 1081 males and 696 females ) students aged 12 - 17 years old were recruited from 8 schools r and omly selected from 8 different geographic locations in Amman . Data were collected by question naire , and self-reported myopia was checked against school medical records . The prevalence of myopia was 17.6 % , with no significant difference between males and females after adjusting for other possible variables . Myopia was significantly associated with age , family history of myopia , computer use , and reading and writing outside school . Playing sports was inversely associated with myopia but there was no association with watching television OBJECTIVE To assess the relationship of near , midworking distance , and outdoor activities with prevalence of myopia in school-aged children . DESIGN Cross-sectional study of 2 age sample s from 51 Sydney schools , selected using a r and om cluster design . PARTICIPANTS One thous and seven hundred sixty-five 6-year-olds ( year 1 ) and 2367 12-year-olds ( year 7 ) participated in the Sydney Myopia Study from 2003 to 2005 . METHODS Children had a comprehensive eye examination , including cycloplegic refraction . Parents and children completed detailed question naires on activity . MAIN OUTCOME MEASURES Myopia prevalence and mean spherical equivalent ( SE ) in relation to patterns of near , midworking distance , and outdoor activities . Myopia was defined as SE refraction < or = -0.5 diopters ( D ) . RESULTS Higher levels of outdoor activity ( sport and leisure activities ) were associated with more hyperopic refractions and lower myopia prevalence in the 12-year-old students . Students who combined high levels of near work with low levels of outdoor activity had the least hyperopic mean refraction ( + 0.27 D ; 95 % confidence interval [ CI ] , 0.02 - 0.52 ) , whereas students who combined low levels of near work with high levels of outdoor activity had the most hyperopic mean refraction ( + 0.56 D ; 95 % CI , 0.38 - 0.75 ) . Significant protective associations with increased outdoor activity were seen for the lowest ( P = 0.04 ) and middle ( P = 0.02 ) tertiles of near-work activity . The lowest odds ratios for myopia , after adjusting for confounders , were found in groups reporting the highest levels of outdoor activity . There were no associations between indoor sport and myopia . No consistent associations between refraction and measures of activity were seen in the 6-year-old sample . CONCLUSIONS Higher levels of total time spent outdoors , rather than sport per se , were associated with less myopia and a more hyperopic mean refraction , after adjusting for near work , parental myopia , and ethnicity BACKGROUND Refractive error is an important cause of preventable visual impairment and blindness worldwide . Population -based studies will continue to be a key part in identification ofthe magnitude and the importance of this common eye disease . OBJECTIVE To assess the prevalence of the refractive error in primary school-aged children in Bangkok and Nakhonpathom together with the provision of the appropriately free of charge spectacles . MATERIAL AND METHOD A Population -based cross-sectional analytic study was conducted between October 2008 and September 2009 . R and om selection of geographically defined clusters was used to identify the study sample . The examination included visual acuity ( VA ) by Snellen chart and pinhole correction , autorefraction under cycloplegic refraction , ocular motility evaluation , examination of the external eye , anterior segment , media , and fundus . Ophthalmologists screened for ocular abnormalities . RESULTS Among 2340 children , 1100 in Bangkok and 1240 in Nakhonpathom were examined The prevalence of refractive error in Bangkok and Nakhornpathom were 12.7 % and 5.7 % respectively . Refractive error was the cause in 97.6 % of eyes with reduced vision , amblyopia in 0.5 % , other causes in 0.8 % , and unexplained causes in 1.1 % . CONCLUSION The present study showed a relative high prevalence of uncorrected refractive error in the central part of Thail and especially in Bangkok . Eye health education and screening is recommended to evaluate the need for refractive correction with appropriate prescription of spectacles PURPOSE To assess the prevalence of refractive error and visual impairment in school-age children in Gombak District , a suburban area near Kuala Lumpur city . DESIGN Population -based , cross-sectional survey . PARTICIPANTS Four thous and six hundred thirty-four children 7 to 15 years of age living in 3004 households . METHODS R and om selection of geographically defined clusters was used to identify the study sample . Children in 34 clusters were enumerated through a door-to-door survey and examined in 140 schools between March and July 2003 . The examination included visual acuity measurements ; ocular motility evaluation ; retinoscopy and autorefraction under cycloplegia ; and examination of the external eye , anterior segment , media , and fundus . MAIN OUTCOME MEASURES Distance visual acuity and cycloplegic refraction . RESULTS The examined population was 70.3 % Malay , 16.5 % Chinese , 8.9 % Indian , and 4.3 % of other ethnicity . The prevalence of uncorrected ( unaided ) , presenting , and best-corrected visual impairment ( visual acuity < or = 20/40 in the better eye ) was 17.1 % , 10.1 % , and 1.4 % , respectively . More than half of those in need of corrective spectacles were without them . In eyes with reduced vision , refractive error was the cause in 87.0 % , amblyopia in 2.0 % , other causes in 0.6 % , and unexplained causes in 10.4 % , mainly suspected amblyopia . Myopia ( spherical equivalent of at least -0.50 diopter [ D ] in either eye ) measured with retinoscopy was present in 9.8 % of children 7 years of age , increasing to 34.4 % in 15-year-olds ; and in 10.0 % and 32.5 % , respectively , with autorefraction . Myopia was associated with older age , female gender , higher parental education , and Chinese ethnicity . Hyperopia ( > or = 2.00 D ) with retinoscopy varied from 3.8 % in 7-year-olds , 5.0 % with autorefraction , to less than 1 % by age 15 , with either measurement method . Hyperopia was associated with younger age and " other " ethnicity . Astigmatism ( > or = 0.75 D ) was present in 15.7 % of children with retinoscopy and in 21.3 % with autorefraction . CONCLUSIONS Visual impairment in school-age children in urban Gombak District is overwhelmingly caused by myopia , with a particularly high prevalence among children of Chinese ethnicity . Eye health education and screening may help address the unmet need for refractive correction PURPOSE To assess the prevalence of refractive error and related visual impairment in school-aged children in the rural population of the Mahabubnagar district in the southern Indian state of And hra Pradesh . METHODS R and om selection of village-based clusters was used to identify a sample of children 7 to 15 years of age . From April 2000 through February 2001 , children in the 25 selected clusters were enumerated in a door-to-door survey and examined at a rural eye center in the district . The examination included visual acuity measurements , ocular motility evaluation , retinoscopy and autorefraction under cycloplegia , and examination of the anterior segment , media , and fundus . Myopia was defined as spherical equivalent refractive error of at least -0.50 D and hyperopia as + 2.00 D or more . Children with reduced vision and a sample of those with normal vision underwent independent replicate examinations for quality assurance in seven clusters . RESULTS A total of 4414 children from 4876 households was enumerated , and 4074 ( 92.3 % ) were examined . The prevalence of uncorrected , baseline ( presenting ) , and best corrected visual acuity of 20/40 or worse in the better eye was 2.7 % , 2.6 % , and 0.78 % , respectively . Refractive error was the cause in 61 % of eyes with vision impairment , amblyopia in 12 % , other causes in 15 % , and unexplained causes in the remaining 13 % . A gradual shift toward less-positive values of refractive error occurred with increasing age in both boys and girls . Myopia in one or both eyes was present in 4.1 % of the children . Myopia risk was associated with female gender and having a father with a higher level of schooling . Higher risk of myopia in children of older age was of borderline statistical significance ( P = 0.069 ) . Hyperopia in at least one eye was present in 0.8 % of children , with no significant predictors . CONCLUSIONS Refractive error was the main cause of visual impairment in children aged between 7 and 15 years in rural India . There was a benefit of spectacles in 70 % of those who had visual acuity of 20/40 or worse in the better eye at baseline examination . Because visual impairment can have a significant impact on a child 's life in terms of education and development , it is important that effective strategies be developed to eliminate this easily treated cause of visual impairment Purpose To examine the prevalence of refractive errors and prevalence and causes of vision loss among preschool and school children in East China . Methods Using a r and om cluster sampling in a cross-sectional school-based study design , children with an age of 4–18 years were selected from kindergartens , primary schools , and junior and senior high schools in the rural Guanxian County and the city of Weihai . All children underwent a complete ocular examination including measurement of uncorrected ( UCVA ) and best corrected visual acuity ( BCVA ) and auto-refractometry under cycloplegia . Myopia was defined as refractive error of ≤−0.5 diopters ( D ) , high myopia as ≤−6.0D , and amblyopia as BCVA ≤20/32 without any obvious reason for vision reduction and with strabismus or refractive errors as potential reasons . Results Out of 6364 eligible children , 6026 ( 94.7 % ) children participated . Prevalence of myopia ( overall : 36.9±0.6%;95 % confidence interval (CI):36.0,38.0 ) increased ( P<0.001 ) from 1.7±1.2 % ( 95%CI:0.0,4.0 ) in the 4-years olds to 84.6±3.2 % ( 95%CI:78.0,91.0 ) in 17-years olds . Myopia was associated with older age ( OR:1.56;95%CI:1.52,1.60;P<0.001 ) , female gender ( OR:1.22;95%CI:1.08,1.39;P = 0.002 ) and urban region ( OR:2.88;95%CI:2.53,3.29;P<0.001 ) . Prevalence of high myopia ( 2.0±0.2 % ) increased from 0.7±0.3 % ( 95%CI:0.1,1.3 ) in 10-years olds to 13.9±3.0 ( 95%CI:7.8,19.9 ) in 17-years olds . It was associated with older age ( OR:1.50;95%CI:1.41,1.60;P<0.001 ) and urban region (OR:3.11;95%CI:2.08,4.66);P<0.001 ) . Astigmatism ( ≥0.75D ) ( 36.3±0.6%;95%CI:35.0,38.0 ) was associated with older age ( P<0.001;OR:1.06;95%CI:1.04,1.09 ) , more myopic refractive error ( P<0.001;OR:0.94;95%CI:0.91,0.97 ) and urban region ( P<0.001;OR:1.47;95%CI:1.31,1.64 ) . BCVA was ≤20/40 in the better eye in 19 ( 0.32 % ) children . UCVA ≤20/40 in at least one eye was found in 2046 ( 34.05 % ) children , with undercorrected refractive error as cause in 1975 ( 32.9 % ) children . Amblyopia ( BCVA ≤20/32 ) was detected in 44 ( 0.7 % ) children ( 11 children with bilateral amblyopia ) . Conclusions In coastal East China , about 14 % of the 17-years olds were highly myopic , and 80 % were myopic . Prevalence of myopia increased with older age , female gender and urban region . About 0.7 % of pre-school children and school children were amblyopic OBJECTIVE To study the associations between near work , outdoor activity , and myopia among children attending secondary school in rural China . METHODS Among a r and om cluster sample of 1892 children in Xichang , China , subjects with an uncorrected acuity of 6/12 or less in either eye ( n = 984 ) and a 25 % sample of children with normal vision ( n = 248 ) underwent measurement of refractive error . Subjects were administered a question naire on parental education , time spent outdoors , and weekly time spent engaged in and preferred working distance for a variety of near-work activities . RESULTS Among 1232 children with refraction data , 998 ( 81.0 % ) completed the near-work survey . Their mean age was 14.6 years ( SD , 0.8 years ) , 55.6 % were girls , and 83.1 % had myopia of -0.5 diopters or less ( more myopia ) in both eyes . Time and diopter-hours spent on near activities did not differ between children with and without myopia . In regression models , time spent on near activities and time outdoors were unassociated with myopia , adjusting for age , sex , and parental education . CONCLUSIONS These and other recent results raise some doubts about the association between near work and myopia . Additional efforts to identify other environmental factors associated with myopia risk and that may be amenable to intervention are warranted PURPOSE To assess the prevalence of refractive error and related visual impairment in school-aged children in an urban population in New Delhi , India . METHODS R and om selection of geographically defined clusters was used to identify a sample of children 5 to 15 years of age . From December 2000 through March 2001 , children in 22 selected clusters were enumerated through a door-to-door survey and examined at a local facility . The examination included visual acuity measurements , ocular motility evaluation , retinoscopy and autorefraction under cycloplegia , and examination of the anterior segment , media , and fundus . Myopia was defined as spherical equivalent refractive error of at least -0.50 D and hyperopia as + 2.00 D or more . Children with reduced vision and a sample of those with normal vision underwent independent replicate examinations for quality assurance in four of the clusters . RESULTS A total of 7008 children from 3426 households were enumerated , and 6447 ( 92.0 % ) examined . The prevalence of uncorrected , baseline ( presenting ) , and best corrected visual acuity of 20/40 or worse in the better eye was 6.4 % , 4.9 % , and 0.81 % , respectively . Refractive error was the cause in 81.7 % of eyes with vision impairment , amblyopia in 4.4 % , retinal disorders in 4.7 % , other causes in 3.3 % , and unexplained causes in the remaining 5.9 % . There was an age-related shift in refractive error from hyperopia in young children ( 15.6 % in 5-year-olds ) toward myopia in older children ( 10.8 % in 15-year-olds ) . Overall , hyperopia was present in 7.7 % of children and myopia in 7.4 % . Hyperopia was associated with female gender . Myopia was more common in children of fathers with higher levels of education . CONCLUSIONS Reduced vision because of uncorrected refractive error is a major public health problem in urban school-aged children in India . Cost-effective strategies are needed to eliminate this easily treated cause of vision impairment Purpose To examine the prevalence of refractive error and distribution of ocular biometric parameters among major ethnic groups in a population -based sample of 11–15-year-old Australian children . Methods The Sydney Myopia Study examined 2353 students ( 75.3 % response ) from a r and om cluster- sample of 21 secondary schools across Sydney . Examinations included cycloplegic autorefraction , and measures of corneal radius of curvature , anterior chamber depth , and axial length . Results Participants mean age was 12.7 years ( range 11.1–14.4 ) ; 49.4 % were female . Overall , 60.0 % of children had European Caucasian ethnicity , 15.0 % East Asian , 7.1 % Middle Eastern , and 5.5 % South Asian . The most frequent refractive error was mild hyperopia ( 59.4 % , 95 % confidence interval ( CI ) , 53.2–65.6 ) , defined as spherical equivalent ( SE ) + 0.50 to + 1.99 D. Myopia ( SE−0.50 D or less ) was found in 11.9 % , 95 % ( CI 6.6–17.2 ) , and moderate hyperopia ( SE⩾+2.00 D ) in 3.5 % , 95 % ( CI 2.8–4.1 ) . Myopia prevalence was lower among European Caucasian children ( 4.6 % , 95 % CI 3.1–6.1 ) and Middle Eastern children ( 6.1 % , 95 % CI 1.3–11.0 ) than among East Asian ( 39.5 % , 95 % , CI 25.6–53.5 ) and South Asian ( 31.5 % , 95 % , CI 21.6–41.4 ) children . European Caucasian children had the most hyperopic mean SE ( + 0.82 D ) and shortest mean axial length ( 23.23 mm ) . East Asian children had the most myopic mean SE ( −0.69 D ) and greatest mean axial length ( 23.86 mm ) . Conclusion The overall myopia prevalence in this sample was lower than in recent similar-aged European Caucasian population sample s. East Asian children in our sample had both a higher prevalence of myopia and longer mean axial length PURPOSE To assess the prevalence of refractive error and vision impairment in school age children in the terai area of the Mechi zone in Eastern Nepal . METHODS R and om selection of village-based clusters was used to identify a sample of children 5 to 15 years of age . Children in the 25 selected clusters were enumerated through a door-to-door household survey and invited to village sites for examination . Visual acuity measurements , cycloplegic retinoscopy , cycloplegic autorefraction , ocular motility evaluation , and anterior segment , media , and fundus examinations were done from May 1998 through July 1998 . Independent replicate examinations for quality assurance monitoring took place in all children with reduced vision and in a sample of those with normal vision in seven villages . RESULTS A total of 5,526 children from 3,724 households were enumerated , and 5,067 children ( 91.7 % ) were examined . The prevalence of uncorrected , presenting , and best visual acuity 0.5 ( 20/40 ) or worse in at least one eye was 2.9 % , 2.8 % , and 1.4 % , respectively ; 0.4 % had best visual acuity 0.5 or worse in both eyes . Refractive error was the cause in 56 % of the 200 eyes with reduced uncorrected vision , amblyopia in 9 % , other causes in 19 % , with unexplained causes in the remaining 16 % . Myopia -0.5 diopter or less in either eye or hyperopia 2 diopters or greater was observed in less than 3 % of children . Hyperopia risk was associated with female gender and myopia risk with older age . CONCLUSIONS The prevalence of reduced vision is very low in school-age children in Nepal , most of it because of correctable refractive error . Further studies are needed to determine whether the prevalence of myopia will be higher for more recent birth cohorts PURPOSE In order to underst and and up date the prevalence of myopia in Taiwan , a nationwide survey was performed in 1995 . METHODS We stratified the cluster sampling by developmental grading of the city , using a size proportional to the population . Two cities were r and omly selected from each city grading . The total number of students enrolled was 11,178 , including 5,676 boys and 5,502 girls . The refractive status and corneal radius of each student were measured with an autorefractometer under cycloplegia and checked with retinoscopy . Axial length was measured with biometric ultrasound . RESULTS The myopic rate was from 12 % at the age of 6 , it increased to 56 % at the age of 12 , and then to 76 % at the age of 15 . A myopic rate of 84 % was found for the age range of 16 to 18 . The prevalence of high myopia ( over -6.0 D ) at the age of 18 was 20 % in girls and 12 % in boys . The mean refractive status became myopic at the age of 9 , then increased to -3.92 D in girls and -2.71 D in boys at the age of 18 . The increase of axial length is correspondent with the progression of myopia . The anterior chamber depth ( ACD ) was deeper with age and the severity of myopia , whereas the corneal curvature remained unchanged . The lens thickness became thinner from age 7 to 13 , then it became thicker with age and the severity of myopia after age 15 . The prevalence and degree of myopia in girls was more severe than in boys . CONCLUSIONS The prevalence of myopia in Taiwan increased year by year . The increase in severity and prevalence of high myopia may be due to earlier onset PURPOSE To assess the prevalence of refractive error and visual impairment in school-aged African children in South Africa . METHODS R and om selection of geographically defined clusters was used to identify a sample of children 5 to 15 years of age in the Durban area . From January to August 2002 , children in 35 clusters were enumerated through a door-to-door survey and examined in temporary facilities . The examination included visual acuity measurements , ocular motility evaluation , retinoscopy and autorefraction under cycloplegia , and examination of the anterior segment , media , and fundus . In nine clusters , children with reduced vision and a sample of those with normal vision underwent independent replicate examinations for quality assurance . RESULTS A total of 5599 children living in 2712 households were enumerated , and 4890 ( 87.3 % ) were examined . The prevalence of uncorrected , presenting , and best-corrected visual acuity of 20/40 or worse in the better eye was 1.4 % , 1.2 % , and 0.32 % , respectively . Refractive error was the cause in 63.6 % of the 191 eyes with reduced vision , amblyopia in 7.3 % , retinal disorders in 9.9 % , corneal opacity in 3.7 % , other causes in 3.1 % , and unexplained causes in the remaining 12.0 % . Exterior and anterior segment abnormalities were observed in 528 ( 10.8 % ) children , mainly corneal and conjunctival . Myopia ( at least -0.50 D ) in one or both eyes was present in 2.9 % of children when measured with retinoscopy and in 4.0 % measured with autorefraction . Beginning with an upward trend at age 14 , myopia prevalence with autorefraction reached 9.6 % at age 15 . Myopia was also associated with increased parental education . Hyperopia ( + 2.00 D or more ) in at least one eye was present in 1.8 % of children when measured with retinoscopy and in 2.6 % measured with autorefraction , with no significant predictors of hyperopia risk . CONCLUSIONS The prevalence of reduced vision is low in school-age African children , most of it because of uncorrected refractive error . The high prevalence of corneal and other anterior segment abnormalities is a reflection of the inadequacy of primary eye care services in this area PURPOSE To assess the prevalence of refractive errors and vision impairment in school-age children in a suburban area ( La Florida ) of Santiago , Chile . METHODS R and om selection of geographically defined clusters was used to identify a representative sample of children 5 to 15 years of age . Children in the 26 selected clusters were enumerated through a door-to-door survey and invited to report to a community health clinic for examination . Visual acuity measurements , cycloplegic retinoscopy , cycloplegic autorefraction , ocular motility evaluation , and examination of the external eye , anterior segment , media , and fundus were done from April through August 1998 . Independent replicate examinations of all children with reduced vision and a sample of those with normal vision were done for quality assurance monitoring in six clusters . RESULTS A total of 6,998 children from 3,830 households were enumerated , and 5,303 children ( 75.8 % ) were examined . The prevalence of uncorrected , presenting , and best visual acuity 0.50 ( 20/40 ) or worse in at least one eye was 15.8 % , 14.7 % , and 7.4 % , respectively ; 3.3 % had best visual acuity 0.50 or worse in both eyes . Refractive error was the cause in 56.3 % of the 1,285 eyes with reduced vision , amblyopia in 6.5 % , other causes in 4.3 % , with unexplained causes in the remaining 32.9 % . Myopia -0.50 diopter or less in either eye was present in 3.4 % of 5-year-old children , increasing to 19.4 % in males and 14.7 % in females by age 15 . Over this same age range , hyperopia 2.00 diopters or greater decreased from 22.7 % to 7.1 % in males and from 26.3 % to 8.9 % in females . Females had a significantly higher risk of hyperopia than males . CONCLUSIONS Refractive error , associated primarily with myopia , is a major cause of reduced vision in school-age children in La Florida . More than 7 % of children could benefit from the provision of proper spectacles . Efforts are needed to make existing programs that provide free spectacles for school children more effective . Further studies are needed to determine whether the upward trend in myopia continues far beyond 15 years of age PURPOSE China is urbanizing rapidly , and the prevalence of myopia is high . This study was conducted to identify the reasons for observed differences in the prevalence of myopia among urban versus rural Chinese children . METHODS All children with uncorrected acuity of 6/12 or worse and a 50 % r and om sample of children with vision better than 6/12 at all secondary schools in mixed rural-urban Liangying Township , Guangdong , underwent cycloplegic refraction , and provided data on age , gender , parental education , weekly near work and time outdoors , and urban development level of respondents ' neighborhoods ( 12-item question naire ) . Population density of 32 villages and urban zones in Liangying was calculated from census figures ( mean population density , 217 persons/km(2 ) ; range , 94 - 957 ; mean for Guangdong , 486 ) . RESULTS Among 5844 eligible children , 4612 ( 78.9 % ) had parental consent and completed examinations ; 2957 were refracted per protocol , and 2480 ( 83.9 % ) of these had question naire data . Those with completed examinations were more likely to be girls ( P < 0.001 ) , and question naire respondents were more myopic ( P = 0.02 ) , but otherwise did not differ significantly from nonrespondents . In multivariate models , older age ( P < 0.001 ) , more near work ( P = 0.02 ) , and higher population density ( P = 0.003 ) , but not development index , parental education , or time outdoors were significantly associated with more myopic refractive error . CONCLUSIONS Higher population density appears to be associated with myopia risk , independent of academic activity , time spent outdoors , familial educational level , or economic development , factors that have been thought to explain higher myopia prevalence among urban children . Mechanisms for this apparent association should be sought Aim : To determine the prevalence of refractive errors among schoolchildren in urban and rural areas of Dezful County , Iran . Methods : In a cross-sectional study , using r and om cluster sampling , 5721 Dezful schoolchildren were selected from 39 clusters . The participants in the study totalled 5544 ; 3673 elementary and middle school students and 1871 high school students . For the former group , cycloplegic refraction and for the latter , non-cycloplegic refraction was tested . In all participants , uncorrected visual acuity and best corrected visual acuity were determined , and those with a visual acuity of 20/40 or worse , underwent a complete ophthalmic examination to determine the cause of visual impairment . A spherical equivalent of −0.5 diopter ( D ) or worse was defined as myopia , + 2.0 D or more was defined as hyperopia , and a cylinder refraction greater than 0.75 D was considered astigmatism . Results : The uncorrected visual acuity was 20/40 or worse in the better eye of 224 schoolchildren ( 3.8 % of participants ) . This figure ( percentage ) was 14 ( 0.03 % ) based on their best corrected visual acuity and 96 ( 1.7 % ) with their presenting vision . According to results of cycloplegic refraction , 3.4 % ( 95 % confidence interval ( CI ) , 2.5 to 4.4 ) of the primary and middle school students were myopic and 16.6 % ( 95 % CI , 13.6 to 19.7 ) were hyperopic . For high school students , these rates were 2.1 % ( 95 % CI , 0.7 to 3.5 ) and 33.0 % ( 95 % CI , 24.9 to 41.1 ) , respectively , with non-cycloplegic refraction . In the multivariate logistic regression for primary and middle school students , myopia was correlated with age ( p = 0.030 ) , and hyperopia was correlated with age ( p<0.001 ) and area of residence ( p = 0.007 ) . In high school students , hyperopia again showed a correlation with their area of residence ( p = 0.029 ) . Conclusion : The present study reveals the considerable prevalence rates of refractive errors among schoolchildren in Dezful County and the high rate of an unmet need for their correction . Although myopia is not very prevalent , the high rate of hyperopia in the studied population emphasises its need for attention PURPOSE To determine the epidemiology of refractive errors in an adult Chinese population in Singapore . METHODS A disproportionate , stratified , clustered , r and om-sampling procedure was used to select names of 2000 Chinese people aged 40 to 79 years from the 1996 Singapore electoral register in the Tanjong Pagar district in Singapore . These people were invited to a central ized clinic for a comprehensive eye examination , including refraction . Refraction was also performed on nonrespondents in their homes . Myopia , high myopia , and hyperopia were defined as a spherical equivalent ( SE ) in the right eye of less than -0.5 D , less than -5.0 D , and more than + 0.5 D , respectively . Astigmatism was defined as less than -0.5 D of cylinder . Anisometropia was defined as a difference in SE of more than 1.0 D between the two eyes . Only phakic eyes were analyzed . RESULTS From 1717 eligible people , 1232 ( 71.8 % ) were examined . Adjusted to the 1997 Singapore population , the overall prevalence of myopia , hyperopia , astigmatism , and anisometropia was 38.7 % ( 95 % confidence interval [ CI ] : 35.5 , 42.1 ) , 28.4 % ( 95 % CI : 25.3 , 31.3 ) , 37.8 % ( 95 % CI : 34.6 , 41.1 ) , and 15.9 % ( 95 % CI : 13.5 , 18.4 ) , respectively . The prevalence of high myopia was 9.1 % ( 95 % CI : 7.2 , 11.2 ) , with women having significantly higher rates than men . The age pattern of myopia was bimodal , with higher prevalence in the 40 to 49 and 70 to 81 age groups and lower prevalence between those age ranges . Prevalence was reversed in hyperopia , with a higher prevalence in subjects aged 50 to 69 . There was a monotonic increase in prevalence with age for both astigmatism and anisometropia . Increasing educational levels , higher individual income , professional or office-related occupations , better housing , and greater severity of nuclear opacity were all significantly associated with higher rates of myopia , after adjustment for age and sex . CONCLUSIONS The results indicate that whereas myopia is 1.5 to 2.5 times more prevalent in adult Chinese residing in Singapore than in similarly aged European-derived population s in the United States and Australia , the sociodemographic associations are similar Purpose . To assess epidemiological aspects of refractive errors in school-age children in Burkina Faso ( west- central Africa ) . Methods . A total of 315 school children ( ranging from 6 to 16 years of age and belonging to different ethnic groups ) taken at r and om from two urban schools in eastern Burkina Faso were examined to assess their refractive error , which was determined by non-cycloplegic retinoscopy with optical fogging . The st and ard Refractive Error Study in Children ( RESC ) definitions of refractive errors were used : myopia ≤−0.5 D spherical equivalent ( SE ) in at least one eye , hyperopia ≥2 D SE in at least one eye , astigmatism ≤−0.75 D cylinder in at least one eye , and anisometropia ≥1 D SE difference between the two eyes . Results . Unilateral myopia and bilateral myopia were found in 2.5 and 1 % , respectively ; unilateral hyperopia in 17.1 % , bilateral hyperopia in 8.6 % ; astigmatism in at least one eye in 11.7 % . The highest prevalence value ( 18.4 % ) of astigmatism ( ≤−0.75 D ) in at least one eye was found in the Gourmantché ethnic group . The low prevalence of large refractive errors makes visual acuity in these children very good ( visual acuity logarithm of the minimum angle of resolution −0.073 ± 0.123 SD ) . Conclusions . There was a low prevalence of myopia in these African school children . Clinical ly significant high hyperopia ( ≥+2 D SE ) was also uncommon . There were no significant differences between the distributions of refractive errors according to gender or ethnicity . With respect to age groups , the prevalences of hyperopia and astigmatism were significantly higher in the younger age groups Aim : To compare the prevalences of refractive errors in Malay , Chinese and Indian children in Malaysia and Singapore . Methods : Children aged 7–9 years from three schools in the Singapore Cohort study of the Risk factors for Myopia ( n = 1962 ) and similarly aged children from a r and om cluster sample in the metropolitan Kuala Lumpur area in the Malaysia Refractive Error Study in Children ( n = 1752 ) were compared . Cycloplegic autorefraction was conducted in both countries . Results : The prevalence of myopia ( spherical equivalent of at least −0.5 diopters ( D ) in either eye ) was higher in Singapore Malays ( 22.1 % ) than in Malays in Malaysia ( 9.2 % ; 95 % confidence interval ( CI ) 11.2 to 14.7 ; p<0.001 ) . Similarly , Singapore Chinese ( 40.1 % ) had higher prevalences than Malaysian Chinese ( 30.9 % ; 95 % CI 1.5 to 16.9 ) . Singapore Indians had a higher prevalence ( 34.1 % ) than Malaysian Indians ( 12.5 % ; 95 % CI 17.4 to 25.9 ) . The multivariate odds ratio of astigmatism ( cylinder at least 0.75 D in either eye ) in Singapore Malays compared with Malaysian Malays was 3.47 ( 95 % CI 2.79 to 4.32 ) . Ethnicity-specific hyperopia rates did not differ in Singapore and Malaysia . Conclusion : The ethnicity-specific prevalences of myopia in Singapore Malays , Chinese and Indians are higher than those in Malaysian Malays , Chinese and Indians . As Malays , Chinese and Indians in Malaysia have genetic make-up similar to that of Malays , Chinese and Indians in Singapore , environmental factors may contribute to the higher myopia rates Purpose : To assess the prevalence of refractive error in schoolchildren aged 12–14 years in urban and rural setting s in Cambodia ’s Phnom Penh and K and al provinces . Methods : Ten schools from Phnom Penh Province and 26 schools from K and al Province were r and omly selected and surveyed in October 2010 . Children were examined by teams of Australian and Cambodian optometrists , ophthalmic nurses and ophthalmologists who performed visual acuity ( VA ) testing and cycloplegic refraction . Results : A total of 5527 children were included in the study . The prevalence of uncorrected , presenting and best-corrected VA ≤ 6/12 in the better eye were 2.48 % ( 95 % confidence interval [ CI ] 2.02–2.83 % ) , 1.90 % ( 95 % CI 1.52–2.24 % ) and 0.36 % ( 95 % CI 0.20–0.52 % ) , respectively ; 43 children presented with glasses whilst a total of 315 glasses were dispensed . The total prevalence of refractive error was 6.57 % ( 95 % CI 5.91–7.22 % ) , but there was a significant difference between urban ( 13.7 % , 95 % CI 12.2–15.2 % ) and rural ( 2.5 % , 95 % CI 2.03–3.07 % ) schools ( P < 0.0001 ) . Refractive error accounted for 91.2 % of visually impaired eyes , cataract for 1.7 % , and other causes for 7.1 % . Myopia ( spherical equivalent ≤ −0.50 diopters [ D ] in either eye ) was associated with increased age , female gender and urban schooling . Conclusions : The prevalence of refractive error was significantly higher in urban Phnom Penh schools than rural schools in K and al Province . The prevalence of refractive error , particularly myopia was relatively low compared to previous reports in Asia . The majority of children did not have appropriate correction with spectacles , highlighting the need for more effective screening and optical intervention PURPOSE To assess the prevalence of refractive error and visual impairment in school children in a rural area of southern China . DESIGN Prospect i ve cross-sectional survey . PARTICIPANTS Two thous and four hundred children from junior high schools in Yangxi County . METHODS R and om selection of classes from the 3 junior high school grade levels was used to identify the study sample . Children from 36 classes in 13 schools were examined in April 2005 . The examination included visual acuity ( VA ) testing ; ocular motility evaluation ; cycloplegic autorefraction ; and examination of the external eye , anterior segment , media , and fundus . MAIN OUTCOME MEASURES Distance VA and cycloplegic refraction . RESULTS Among 2515 enumerated children , 2454 ( 97.6 % ) were examined . The study population consisted of the 2400 children between 13 and 17 years old . Prevalences of uncorrected , presenting , and best-corrected VA < or = 20/40 in the better eye were 27.0 % , 16.6 % , and 0.46 % , respectively . Sixty percent of those who could achieve acuity > or = 20/32 in at least one eye with best correction were without the necessary spectacles . Refractive error was the cause in 97.1 % of eyes with reduced vision ; amblyopia , 0.81 % ; other causes , 0.67 % ; and unexplained causes , 1.4 % . Myopia ( spherical equivalent , -0.50 diopters [ D ] or more in either eye ) affected 36.8 % of 13-year-olds , increasing to 53.9 % of 17-year-olds . Myopia was associated with higher grade level , female gender , schooling in the county urban center , and higher parental education . Hyperopia ( + 2.00 D or more ) affected approximately 1.0 % in all age groups . Astigmatism ( > or = 0.75 D ) was present in 25.3 % of all children . CONCLUSIONS Reduced vision because of uncorrected myopia is a public health problem among school-age children in rural China . Effective VA screening strategies are needed to eliminate this easily treated cause of visual impairment PURPOSE To assess the prevalence of refractive error and visual impairment in school-age children in a metropolitan area of southern China . METHODS R and om selection of geographically defined clusters was used to identify children 5 to 15 years of age in Guangzhou . Children in 22 clusters were enumerated through a door-to-door survey and examined in 71 schools and 19 community facilities from October 2002 to January 2003 . The examination included visual acuity measurements , ocular motility evaluation , retinoscopy , and autorefraction under cycloplegia and examination of the external eye , anterior segment , media , and fundus . RESULTS A total of 5053 children living in 4814 households were enumerated , and 4364 ( 86.4 % ) were examined . The prevalence of uncorrected , presenting , and best-corrected visual acuity 20/40 or worse in the better eye was 22.3 % , 10.3 % , and 0.62 % , respectively . Refractive error was the cause in 94.9 % of the 2335 eyes with reduced vision , amblyopia in 1.9 % , other causes in 0.4 % , and unexplained causes in the remaining 2.8 % . External and anterior segment abnormalities were seen in 1496 ( 34.3 % ) children , mainly minor conjunctival abnormalities . Media and fundus abnormalities were observed in 32 ( 0.73 % ) children . Myopia ( spherical equivalent of at least -0.50 D in either eye ) measured with retinoscopy affected 73.1 % of children 15 years of age , 78.4 % with autorefraction . The prevalence of myopia was 3.3 % in 5-year-olds with retinoscopy and 5.7 % with autorefraction . Females had a significantly higher risk of myopia . Hyperopia ( + 2.00 D or more ) measured with retinoscopy was present in 16.7 % of 5-year-olds , 17.0 % with autorefraction . The prevalence of hyperopia was below 1 % in 15-year-olds , with both methods . Astigmatism ( cylinder of > or = 0.75 D ) was present in 33.6 % of children with retinoscopy and in 42.7 % with autorefraction . CONCLUSIONS The prevalence of reduced vision because of myopia is high in school-age children living in metropolitan Guangzhou , representing an important public health problem . One third of these children do not have the necessary corrective spectacles . Effective strategies are needed to eliminate this easily treated cause of significant visual impairment |
390 | 24,126,647 | Overall , strength of evidence was low for ulcer healing and low or insufficient for time to complete healing .
Compared with st and ard care , some advanced wound care therapies may improve the proportion of ulcers healed and reduce time to healing , although evidence is limited . | BACKGROUND Nonhealing ulcers affect patient quality of life and impose a substantial financial burden on the health care system .
PURPOSE To systematic ally evaluate benefits and harms of advanced wound care therapies for nonhealing diabetic , venous , and arterial ulcers . | OBJECTIVE The aim was to establish the potential efficacy , tolerability and side-effect profile of electromagnetic therapy as an adjunct to conventional dressings in the treatment of venous leg ulcers . METHOD A prospect i ve , r and omized , double blind controlled clinical trial was carried out in a dedicated leg ulcer clinic based in one urban general practice . Nineteen patients with leg ulcers of confirmed venous aetiology were assessed . The main outcome measures were rate and scale of venous leg ulcer healing , changes in patient-reported pain levels , quality of life , degree of mobility , side effect profile and acceptability to patients and staff . RESULTS Sixty-eight per cent of patients attending this dedicated clinic achieved improvements in the size of their ulcer ( 4 , 21 % , healed fully ) and in reduced pain levels ( P < 0.05 ) during the trial , despite the chronicity of ulcer histories . Patients treated with electromagnetic therapy at 800 Hz were found at day 50 to have significantly greater healing ( P < 0.05 ) and pain control ( P < 0.05 ) than placebo therapy or treatment with 600 Hz . All patients reported improved mobility at the end of the study . The electromagnetic therapy was well tolerated by patients , with no differences between groups in reporting adverse events , and proved acceptable to staff . CONCLUSIONS Despite the small numbers in this pilot study , electromagnetic therapy provided significant gains in the healing of venous leg ulcers and reduction in pain BACKGROUND Diabetic foot ulcers are associated with significant morbidity . Conventional treatment modalities are often of limited success in promoting complete wound closure . The aim of the present study was to examine the efficacy of noninvasive ozone-oxygen therapy in the treatment of diabetic foot ulcers . METHODS Diabetes patients with a Wagner classification stage 2 or 3 ulcer or a stage 4 ulcer after debridement of at least 8 weeks in duration were included in this double-blind , r and omized , placebo-controlled clinical trial . Patients received conventional treatment in combination with either ozone-oxygen treatment or sham treatments for 12 weeks , and after an additional 12 weeks , wound status was re-examined . RESULTS In total , 61 patients ( 62 % male , 62.6±9.8 years old ) participated in the study ; 32 were r and omized to ozone treatment , and 29 to placebo . The proportion of subjects with full wound closure did not differ significantly by treatment assignment ( 41 % vs. 33 % , P=0.34 ) . Among the 34 subjects who completed the study per protocol ( PP ) ( 16 in the ozone group , 18 in the placebo group ) , a significantly higher rate of complete wound closure was observed in the ozone group ( 81 % vs. 44 % , P=0.03 ) . Among PP patients with wound size ≤5 cm(2 ) , the rate of total wound closure was 100 % versus 50 % in the sham treatment group ( P=0.006 ) . A nonsignificant , 55.5 % relative increase in healed wound area was detected in the ozone group versus the placebo group ( 4.2±4.9 cm(2 ) vs. 2.7±1.5 cm(2 ) , P=0.23 ) . CONCLUSIONS Among PP patients , ozone treatment in addition to conventional treatment was superior to conventional treatment alone in promoting the complete healing of diabetic foot ulcers Nonhealing diabetic foot ulcers are a common cause of amputation . Emerging cellular therapies such as platelet-rich plasma gel provide ulcer management options to avoid loss of limb . The purpose of this prospect i ve , r and omized , controlled , blinded , multicenter clinical study was to evaluate the safety and efficacy of autologous platelet-rich plasma gel for the treatment of nonhealing diabetic foot ulcers . One hundred , twenty-nine ( 129 ) patients were screened ; 72 completed a 7-day screening period and met the study inclusion criteria . Patients were r and omized into two groups - the st and ard care with platelet-rich plasma gel or control ( saline gel ) dressing group - and evaluated biweekly for 12 weeks or until healing . Healing was confirmed 1 week following closure and monitored for another 11 weeks . An independent audit led to the exclusion of 32 patients from the final per- protocol analysis because of protocol violations and failure to complete treatment . In this group , 13 out of 19 ( 68.4 % ) of the platelet-rich plasma gel and nine out of 21 ( 42.9 % ) of the control wounds healed . After adjusting for wound size outliers ( n = 5 ) , significantly more platelet-rich plasma gel ( 13 out of 16 , 81.3 % ) than control gel ( eight out of 19 , 42.1 % ) treated wounds healed ( P = 0.036 , Fisher 's exact test ) . Kaplan-Meier time-to-healing also was significantly different between groups ( log-rank , P = 0.0177 ) . No treatment-related serious adverse events were reported and bovine thrombin used in the preparation of PRP did not cause Factor V inhibition . When used with good st and ards of care , the majority of nonhealing diabetic foot ulcers treated with autologous platelet-rich plasma gel can be expected to heal OBJECTIVE Chronic diabetic foot ulcers are a source of major concern for both patients and health care systems . The aim of this study was to evaluate the effect of hyperbaric oxygen therapy ( HBOT ) in the management of chronic diabetic foot ulcers . RESEARCH DESIGN AND METHODS The Hyperbaric Oxygen Therapy in Diabetics with Chronic Foot Ulcers ( HODFU ) study was a r and omized , single-center , double-blinded , placebo-controlled clinical trial . The outcomes for the group receiving HBOT were compared with those of the group receiving treatment with hyperbaric air . Treatments were given in a multi-place hyperbaric chamber for 85-min daily ( session duration 95 min ) , five days a week for eight weeks ( 40 treatment sessions ) . The study was performed in an ambulatory setting . RESULTS Ninety-four patients with Wagner grade 2 , 3 , or 4 ulcers , which had been present for > 3 months , were studied . In the intention-to-treat analysis , complete healing of the index ulcer was achieved in 37 patients at 1-year of follow-up : 25/48 ( 52 % ) in the HBOT group and 12/42 ( 29 % ) in the placebo group ( P = 0.03 ) . In a sub- analysis of those patients completing > 35 HBOT sessions , healing of the index ulcer occurred in 23/38 ( 61 % ) in the HBOT group and 10/37 ( 27 % ) in the placebo group ( P = 0.009 ) . The frequency of adverse events was low . CONCLUSIONS The HODFU study showed that adjunctive treatment with HBOT facilitates healing of chronic foot ulcers in selected patients with diabetes OBJECTIVE To test the safety , efficacy , and immunological impact of a cultured allogeneic human skin equivalent ( HSE ) in the treatment of venous ulcers . DESIGN Prospect i ve , r and omized study . SETTING Multicenter study in the outpatient setting . INTERVENTION Each patient with a venous ulcer received either compression therapy alone or compression therapy and treatment with HSE . The patients were evaluated for HSE safety , complete ( 100 % ) ulcer healing , time to wound closure , wound recurrence , and immune response to the HSE . OUTCOME The study was completed as planned in 293 r and omized patients . RESULTS Treatment with HSE was more effective than compression therapy in the percentage of patients healed by 6 months ( 63 % vs 49 % ; P=.02 , Fisher exact test , 2-tailed ) and the median time to complete wound closure ( 61 days vs 181 days ; P=.003 , log-rank test ) . Treatment with HSE was superior to compression therapy in healing larger ( > 1000 mm2 ; P=.02 ) and deeper ulcers ( P=.003 ) and ulcers of more than 6 months ' duration ( P=.001 ) . Occurrence of adverse events was similar in both groups . No symptoms or signs of rejection occurred in response to treatment with HSE , and no HSE-specific immune responses were detected in vitro to bovine collagen or to alloantigens expressed on keratinocytes or fibroblasts . CONCLUSIONS Treatment with HSE healed venous ulcers more rapidly and in more patients than compression therapy alone . There was no clinical or laboratory evidence of rejection or sensitization in response to HSE application . These data suggest that HSE represents a significant advance in the treatment of venous ulcers , particularly those that are difficult to heal PURPOSE The purpose of this study was to investigate the efficacy and safety of recombinant human platelet-derived growth factor ( rhPDGF-BB ) in a double-blind , placebo-controlled , multicenter study of patients with chronic diabetic ulcers . METHODS Patients with chronic , full-thickness , lower-extremity diabetic neurotrophic ulcers of at least 8 weeks ' duration , free of necrotic and infected tissue after debridement , and with transcutaneous oxygen tensions of 30 mm Hg or greater were studied . A total of 118 patients were r and omized to receive either topical rhPDGF-BB ( 2.2 micrograms/cm2 of ulcer area ) or placebo until the ulcer was completely resurfaced or for a maximum of 20 weeks , whichever occurred first . RESULTS Twenty-nine ( 48 % ) of 61 patients r and omized to the rhPDGF-BB group achieved complete wound healing during the study compared with only 14 ( 25 % ) of 57 patients r and omized to the placebo group ( p = 0.01 ) . The median reduction in wound area in the group given rhPDGF-BB was 98.8 % compared with 82.1 % in the group given placebo ( p = 0.09 ) . There were no significant differences in the incidence or severity of adverse events between the rhPDGF-BB and placebo groups . CONCLUSIONS Once-daily topical application of rhPDGF-BB is safe and effective in stimulating the healing of chronic , full-thickness , lower-extremity diabetic neurotrophic ulcers OBJECTIVE To evaluate the healing rate of venous leg ulcers treated with Promogran . METHOD Patients with stagnating venous leg ulcers were recruited . Target wounds were > or = 2 cm but < or = 10 cm in any one dimension . Subjects were r and omly allocated to receive either Promogran or a non-adherent dressing ( Adaptic ) with a secondary dressing of gauze followed by short-stress compression ( Biflex ) . Weekly wound assessment s occurred over 12 weeks and dressings were changed twice weekly by the investigator and /or nurse team . Planimetry tracings and photographs were blindly review ed and assessed by two independent investigators . An intent-to-treat analysis was performed . RESULTS Seventy-three patients were included . Thirty-seven were r and omly allocated Promogran and 36 Adaptic . Twenty-nine patients completed the 12-week follow-up visit , 25 healed before week 12 and 19 stopped follow-up before week 12 for reasons unrelated to healing . Significantly more patients in the Adaptic group than in the Promogran group switched to another dressing ( 22.2 % versus 5.4 % ; p = 0.035 ) . Eleven venous leg ulcers healed in the control group ( 31 % ) and 15 in the Promogran group ( 41 % ) ( p = 0.373 ) . Overall , 15 venous leg ulcers healed or improved in the control group ( 42 % ) and 23 in the Promogran group ( 62 % ) ( p = 0.079 ) . Surface area decreased , on average , by 36.5 + /- 11.4 % ( median decrease : 44.6 % ) in the Adaptic group and by 54.4 + /- 10.9 % ( median decrease : 82.4 % ) in the Promogran group ( p < 0.001 ) . A < or = 20 % surface area reduction was observed in 15 patients in the Adaptic group and in seven in the Promogran group ( 42 % versus 19 % ; p = 0.034 ) . No severe local adverse events were noted in either group , although poor tolerability caused a dressing switch in five patients in the control group and three in the Promogran group . Dressing acceptability was good or excellent in more than 60 % of subjects in both groups . CONCLUSION The results suggest that Promogran may accelerate healing in venous leg ulcers and was well tolerated compared with the current st and ard of care Diabetic foot wounds present a great challenge to wound care practitioners . The objective of this pilot study was to determine whether vacuum-assisted closure ( V.A.C. ) therapy would afford quicker wound resolution as compared to saline-moistened gauze in the treatment of postoperative diabetic foot wounds . Ten patients were r and omized into either the experimental V.A.C. group or control saline gauze group . Included in the study were diabetic patients 18 to 75 years of age who had a nonhealing foot ulceration . Excluded were those patients with venous disease , coagulopathy , or those who had active infections not resolved by initial surgical debridement . All foot ulcers were surgically debrided prior to initiation of V.A.C. or gauze treatment . In the experimental group , V.A.C. dressings were applied in accordance with manufacturer 's protocol for chronic wounds and changed every 48 hours . In the control group , saline gauze dressings were applied at the time of surgical debridement and changed twice a day thereafter . Measurements and photos were obtained to document wound progress . Main outcome measures included : 1 ) time to satisfactory healing ( calculated from date of initial debridement to date of definitive closure , and 2 ) change in wound surface area ( calculated from initial wound tracing to final tracing ) . Satisfactory healing in the V.A.C. group was achieved in 22.8 ( + /- 17.4 ) days , compared to 42.8 ( + /- 32.5 ) days in the control group . Surface area changes of 28.4 % ( + /- 24.3 ) average decrease in wound size in the V.A.C. group , compared to a 9.5 % ( + /- 16.9 ) average increase in the control group during measurement period BACKGROUND : The extract of oak bark ( QRB7 ) has been used for years as a topical medication with success . QRB7 is the proprietary oak bark extract in Bensal HP . It is indicated as an external treatment for the inflammation and irritation associated with many common forms of dermatitis , including certain eczematoid conditions . These conditions include complications associated with pyodermas , and in the treatment of insect bites , burns , and fungal infections . OBJECTIVE : To quantitatively measure the difference in diabetic ulcer size reduction when using Bensal HP versus silver sulfadiazine cream ( SSC ) for topical treatment as an adjunct to conventional treatment . SETTING : Private office of the primary author . METHODS : Forty diabetic patients with noncellulitic plantar Wagner grade 1 or 2 ulcers and a minimal ankle brachial index of 0.75 were r and omly assigned to either the Bensal HP ( QRB7 ) treatment group or SSC control group for 6 weeks of treatment . In addition to either Bensal HP or SSC , all wounds were cultured and treated with debridement at time 0 , 2 , 4 , and 6 weeks and with off-loading . RESULTS : The combined wound diameter of the Bensal HP group decreased 72.5 % compared to 54.7 % for the SSC group . There was a statistical significance between the decreases in wound sizes after 6 weeks of treatment ( P = .016 ) . The Cohen effect size for the Bensal HP group was 2.06 compared with 1.03 for the SSC group . CONCLUSION : In this tightly controlled 6-week study in which no patients were lost to follow-up , Bensal HP seems to be an effective treatment for properly treated diabetic ulcers , outperforming an identical control group whose only difference was SSC as a medication OBJECTIVES to assess the effect of topical autologous platelet lysate on the healing of chronic venous ulcers . DESIGN a r and omised placebo controlled double-blind trial . MATERIAL S all patients had blood taken for preparation of autologous platelet lysate . METHODS patients with proven chronic venous ulceration were r and omised to the trial . Autologous platelet lysate or placebo buffer solution were applied twice per week for up to 9 months in combination with st and ardised compression b and aging . RESULTS a total of 86 patients ( 36 males and 50 females , median age 70 years ) were entered into the study . The patient and treatment groups were equivalent for ulcer size , ulcer duration and other characteristics . Cox regression analysis of the time to ulcer healing did not show any difference in healing between platelet lysate and placebo application . CONCLUSIONS platelet lysate prepared and delivered by the method used in this study had no influence on the healing of chronic venous ulceration Twenty‐seven patients with chronic venous leg ulcers were assigned to two treatment groups . Fifteen were treated with cryopreserved cultured allogeneic keratinocyte sheets and compression b and ages and 12 with compression only . The observation time was 8 weeks and the keratinocyte grafting procedure was performed once weekly . The mean reduction of the initial wound area was 35 % in the treatment group and 14 % in the control group . This difference was not significant . The poor effect on wound healing given by the cryopreserved allogeneic keratinocyte sheets contrasts with our earlier experience using fresh keratinocyte sheets . We believe that this is due to a weakened condition of the cryostored cells , as we have shown a loss in protein synthesis capacity of at least 50 % OBJECTIVE To study the effect of systemic hyperbaric oxygenation ( HBO ) therapy on the healing course of nonischemic chronic diabetic foot ulcers . RESEARCH DESIGN AND METHODS From 1999 to 2000 , 28 patients ( average age 60.2 + /- 9.7 years , diabetes duration 18.2 + /- 6.6 years ) , of whom 87 % had type 2 diabetes , demonstrating chronic Wagner grade s I-III foot ulcers without clinical symptoms of arteriopathy , were studied . They were r and omized to undergo HBO because their ulcers did not improve over 3 months of full st and ard treatment . All the patients demonstrated signs of neuropathy . HBO was applied twice a day , 5 days a week for 2 weeks ; each session lasted 90 min at 2.5 ATA ( absolute temperature air ) . The main parameter studied was the size of the foot ulcer measured on tracing graphs with a computer . It was evaluated before HBO and at day 15 and 30 after the baseline . RESULTS HBO was well tolerated in all but one patient ( barotraumatic otitis ) . The transcutaneous oxygen pressure ( TcPO(2 ) ) measured on the dorsum of the feet of the patients was 45.6 + /- 18.1 mmHg ( room air ) . During HBO , the TcPO(2 ) measured around the ulcer increased significantly from 21.9 + /- 12.1 to 454.2 + /- 128.1 mmHg ( P < 0.001 ) . At day 15 ( i.e. , after completion of HBO ) , the size of ulcers decreased significantly in the HBO group ( 41.8 + /- 25.5 vs. 21.7 + /- 16.9 % in the control group [ P = 0.037 ] ) . Such a difference could no longer be observed at day 30 ( 48.1 + /- 30.3 vs. 41.7 + /- 27.3 % ) . Four weeks later , complete healing was observed in two patients having undergone HBO and none in the control group . CONCLUSIONS In addition to st and ard multidisciplinary management , HBO doubles the mean healing rate of nonischemic chronic foot ulcers in selected diabetic patients . The time dependence of the effect of HBO warrants further investigations OBJECTIVE ischaemic lower-extremity ulcers in the diabetic population are a source of major concern because of the associated high risk of limb-threatening complications . The aim of this study was to evaluate the role of hyperbaric oxygen in the management of these ulcers . METHOD eighteen diabetic patients with ischaemic , non-healing lower-extremity ulcers were recruited in a double-blind study . Patients were r and omly assigned either to receive 100 % oxygen ( treatment group ) or air ( control group ) , at 2.4 atmospheres of absolute pressure for 90 min daily ( total of 30 treatments ) . RESULTS healing with complete epithelialisation was achieved in five out of eight ulcers in the treatment group compared to one out of eight ulcers in the control group . The median decrease of the wound areas in the treatment group was 100 % and in the control group was 52 % ( p=0.027 ) . Cost-effectiveness analysis has shown that despite the extra cost involved in using hyperbaric oxygen , there was a potential saving in the total cost of treatment for each patient during the study . CONCLUSION hyperbaric oxygen enhanced the healing of ischaemic , non-healing diabetic leg ulcers and may be used as a valuable adjunct to conventional therapy when reconstructive surgery is not possible OBJECTIVE We assessed in a r and omized prospect i ve trial the effectiveness of Graftskin , a living skin equivalent , in treating noninfected nonischemic chronic plantar diabetic foot ulcers . RESEARCH DESIGN AND METHODS In 24 centers in the U.S. , 208 patients were r and omly assigned to ulcer treatment either with Graftskin ( 112 patients ) or saline-moistened gauze ( 96 patients , control group ) . St and ard state-of-the-art adjunctive therapy , which included extensive surgical debridement and adequate foot off-loading , was provided in both groups . Graftskin was applied at the beginning of the study and weekly thereafter for a maximum of 4 weeks ( maximum of five applications ) or earlier if complete healing occurred . The major outcome of complete wound healing was assessed by intention to treat at the 12-week follow-up visit . RESULTS At the 12-week follow-up visit , 63 ( 56 % ) Graftskin-treated patients achieved complete wound healing compared with 36 ( 38 % ) in the control group ( P = 0.0042 ) . The Kaplan-Meier median time to complete closure was 65 days for Graftskin , significantly lower than the 90 days observed in the control group ( P = 0.0026 ) . The odds ratio for complete healing for a Graftskin-treated ulcer compared with a control-treated ulcer was 2.14 ( 95 % CI 1.23 - 3.74 ) . The rate of adverse reactions was similar between the two groups with the exception of osteomyelitis and lower-limb amputations , both of which were less frequent in the Graftskin group . CONCLUSIONS Application of Graftskin for a maximum of 4 weeks results in a higher healing rate when compared with state-of-the-art currently available treatment and is not associated with any significant side effects . Graftskin may be a very useful adjunct for the management of diabetic foot ulcers that are resistant to the currently available st and ard of care The effect of an electromagnetic field on the healing of skin ulcers of venous origin in humans has been investigated in a double-blind study . Forty-four patients have been admitted to the study ; one-half were exposed to active stimulators ( experimental group ) and the remaining to dummy stimulators ( control group ) . The stimulation was scheduled to last a maximum of 90 days . The success rate was significantly higher in the experimental group both at day 90 ( p less than 0.02 ) and in the follow-up period ( p less than 0.005 ) . The data suggest that the effect of the electromagnetic field lasts even when the stimulation is over . No ulcers worsened in the experimental group , while four worsened in the control group . Twenty-five percent of the patients in the experimental group and 50 % in the control group experienced recurrence of the ulcer . It is concluded that stimulation with an electromagnetic field is a useful adjunctive therapy in the management of these patients OBJECTIVE To assess the effect of a tissue-engineered human dermis ( Dermagraft ) in healing diabetic foot ulcers . RESEARCH DESIGN AND METHODS This controlled prospect i ve multicenter r and omized single-blinded pilot study evaluated healing over a 12-week period in 50 patients with diabetic foot ulcers . These patients were r and omized into four groups ( three different dosage regimens of Dermagraft and one control group ) . All patients received identical care except for the use of Dermagraft tissue . Ulcer healing was assessed by percentage of wounds achieving complete or 50 % closure , time to complete or 50 % closure , and volume and area measurements . RESULTS Ulcers treated with the highest dosage of Dermagraft , one piece applied weekly for 8 weeks ( group A ) , healed significantly more often than those treated with conventional wound closure methods ; 50 % ( 6 of 12 ) of the Dermagraft-treated and 8 % ( 1 of 13 ) of the control ulcers healed completely ( P = 0.03 ) . The percentage of wounds achieving 50 % closure was also significantly higher ( 75 vs. 23 % ; P = 0.018 ) , and the time to complete or 50 % closure was faster ( P = 0.056 ) . The group A regimen was more effective than other treatment regimens . All three were better than the control , however , and a dose-response was observed . There were no safety concerns . After a mean of 14 months of follow-up ( range 11 - 22 months ) , there were no recurrences in the Dermagraft-healed ulcers . CONCLUSIONS Dermagraft was associated with more complete and rapid healing in diabetic foot ulcers . The recurrence data may indicate an improved quality of wound healing OBJECTIVE To compare the efficacy and safety of topically applied recombinant human platelet-derived growth factor-BB ( rhPDGF-BB ) ( becaplermin ) with placebo gel in patients with chronic diabetic neuropathic ulcers of the lower extremities . RESEARCH DESIGN AND METHODS This multicenter double-blind placebo-controlled phase 111 trial included 382 patients with type 1 or type 2 diabetes and chronic ulcers of at least 8 weeks ' duration . After sharp debridement of the ulcer , patients were r and omized to receive becaplermin gel 30 μg/g , becaplermin gel 100 μg/g , or placebo gel , in conjunction with a st and ardized regimen of good wound care until complete wound closure was achieved or for a maximum of 20 weeks . Moist saline-soaked gauze dressings were changed twice daily with study medication applied by patients or caregivers at the evening dressing change . Safety was assessed by monitoring adverse events ( AEs ) and by clinical laboratory evaluations . RESULTS Compared with placebo gel , becaplermin gel 100 μg/g significantly increased the incidence of complete wound closure by 43 % ( 50 vs. 35 % , P = 0.007 ) and decreased the time to achieve complete wound closure by 32 % ( 86 vs. 127 days ; estimated 35th percentile , P = 0.013 ) . AEs reported during treatment or during a 3-month follow-up period were similar in nature and incidence across all treatment groups . CONCLUSIONS Becaplermin gel 100 μg/g , in conjunction with good wound care , significantly increased the incidence of complete wound closure and significantly reduced the time to complete closure of chronic diabetic neuropathic ulcers . The safety profile of becaplermin gel was similar to that of placebo gel LyphoDerm ( XCELLentis , Belgium ) is an end-sterilized , freeze-dried lysate from cultured allogeneic epidermal keratinocytes , formulated into a hydrophilic gel . Its efficacy and safety were evaluated , in combination with st and ard care ( hydrocolloid dressing and compression therapy ) , in 194 patients suffering from hard-to-heal ( lasting more than 6 weeks and not responding to conventional therapy ) venous leg ulcers . Two control groups received st and ard care , with or without vehicle , respectively . Patients had a median age of 67.5 years and the majority were females ( 61 % ) . The median duration of the ulcer was 43 weeks and in 39 % of the subjects it had been present for more than 1 year . Thirty-eight percent of the patients in the st and ard care + LyphoDerm group had complete ulcer healing within 24 weeks ( primary end point ) compared to 27 % of patients in the st and ard care + vehicle pooled groups ( P = 0.114 ) in the " as treated " intent-to-treat cohort ( 37 % vs. 27 % in the " as r and omized intent-to-treat cohort ; p = 0.137 ) . In the subgroup of patients with enlarging ulcers , the difference between the two groups was significant ( 30 % vs. 11 % ; p = 0.024 in the " as treated " intent-to-treat cohort and 31 % vs. 9 % ; p = 0.005 in the " as r and omized " intent-to-treat cohort ) . LyphoDerm was well tolerated and safe , and no differences in the frequency of adverse events were noted between the treatment groups . Although the primary objective of the study was not achieved , the exploratory analysis carried out in patients with enlarging ulcers suggests that LyphoDerm could offer a new prospect for the treatment of patients with venous ulcers that may prove to be a significant adjunct to the overall provision of care This study compared wound healing efficacy of two silver dressings , AQUACEL ( ® ) Ag and Urgotul ( ® ) Silver , against venous ulcers at risk of infection , over 8 weeks of treatment . The primary objective was to show non inferiority of AQUACEL ( ® ) Ag to Urgotul ( ® ) Silver . Patients ( 281 ) were r and omised into two groups . The AQUACEL ( ® ) Ag group had 145 patients treated with AQUACEL ( ® ) Ag for 4 weeks followed by AQUACEL for another 4 weeks . TheUrgotul ( ® ) Silver group had 136 patients treated with Urgotul ( ® ) Silver for 4 weeks followed by Urgotul ( ® ) for another 4 weeks . In both groups , ulcer size and depth , safety events and ulcer healing were compared . After 8 weeks of treatment , the AQUACEL ( ® ) Ag group had a relative wound size reduction ( 49·65 % ± 52·53 % ) compared with the Urgotul ( ® ) Silver group ( 42·81 % ± 60·0 % ) . The non inferiority of the AQUACEL ( ® ) Ag group to the Urgotul ( ® ) Silver group was established based on the difference between them ( 6·84 % ± 56·3 % , 95 % confidence interval -6·56 to 20·2 ) and the pre-defined non inferiority margin ( -15 % ) . Composite wound healing analysis showed that the AQUACEL ( ® ) Ag group had statistically higher percentage of subjects with better wound progression ( 66·9 % versus 51·9 % , P = 0·0108 ) . In general , both dressings were effective at promoting healing of venous ulcers AIMS Diabetic foot ulcers ( DFUs ) are at risk of infection and impaired healing , placing patients at risk of lower extremity amputation . DFU care requires debridement and dressings . A prospect i ve , multicentre study compared clinical efficacy and safety of AQUACEL Hydrofiber dressings containing ionic silver ( AQAg ) with those of Algosteril calcium alginate ( CA ) dressings in managing out- patients with Type 1 or 2 diabetes mellitus and non-ischaemic Wagner Grade 1 or 2 DFUs . METHODS Patients stratified by antibiotic use on enrolment were r and omly assigned to similar protocol s including off-loading , AQAg ( n = 67 ) or CA ( n = 67 ) primary dressings and secondary foam dressings for 8 weeks or until healing . Clinical efficacy measures were healing outcomes and primarily healing speed . Adverse events were recorded . RESULTS AQAg and CA groups were comparable at baseline . All ulcer healing outcomes improved in both groups . The mean time to healing was 53 days for AQAg ulcers and 58 days for CA ulcers ( P = 0.34 ) . AQAg-treated ulcers reduced in depth nearly twice as much as CA-treated ulcers ( 0.25 cm vs. 0.13 cm ; P = 0.04 ) . There was more overall ulcer improvement and less deterioration in AQAg subjects ( P = 0.058 ) , particularly in the subset initially using antibiotics ( P = 0.02 ) . Safety profiles of both groups were similar . CONCLUSION When added to st and ard care with appropriate off-loading , AQAg silver dressings were associated with favourable clinical outcomes compared with CA dressings , specifically in ulcer depth reduction and in infected ulcers requiring antibiotic treatment . This study reports the first significant clinical effects of a primary wound dressing containing silver on DFU healing To evaluate the effect of hyperbaric oxygen therapy on chronic wound healing , 16 otherwise healthy patients who had nondiabetic , chronic leg ulcers with no large vessel disease were included in a double-blind study . Patients were grouped according to age and then r and omly assigned to two groups breathing either air or oxygen at 2.5 atmospheres of absolute pressure for 90 minutes 5 days per week for a total of 30 treatments . The wound area was copied onto transparent film covering the wound and then measured using only one matching wound from each patient . The mean decrease of the wound areas at weeks 2 , 4 , and 6 in the oxygen group were 6 percent ( SD + /- 14 ) , 22 percent ( SD + /- 13 ) , and 35.7 percent ( SD + /- 17 ) , respectively , and in the air group , 2.8 percent ( SD + /- 11 ) , 3.7 percent ( SD + /- 11 ) , and 2.7 percent ( SD + /- 11 ) , respectively , giving a p value less than 0.05 at week 4 , and a p value less than 0.001 at week 6 between the groups using the Mann-Whitney U test . These data indicate that hyperbaric oxygen therapy may be used as a valuable adjunct to conventional therapies when nondiabetic wounds do not heal Non healing diabetic foot ulcers and the result ing potential amputations present significant costs to the health care system and reduce patient quality of life . The goal of diabetic foot ulcer treatment is to obtain wound closure as expeditiously as possible . The use of platelet-rich plasma ( PRP ) to enhance wound healing has increased dramatically over the last decade . However , controversies exist in the literature regarding the added benefit of this procedure . The aim of this study is to investigate the efficiency of platelet releasate on the healing of chronic diabetic ulcers in comparison with platelet-poor plasma ( PPP ) . This study included 24 patients with chronic diabetic ulcers . They were systematic ally r and omised into two groups : PRP group ( n = 12 ) and PPP group ( n = 12 ) . The results showed that healing in PRP group was significantly faster ( P < 0·005 ) . PRP enhances healing of chronic diabetic foot ulcers The efficacy of a bilayered , living skin construct ( APLIGRAF(R ) [ Graftskin ] ) was evaluated in patients ( n = 120 ) with hard- to-heal venous leg ulcers of greater than 1 year 's duration . The study was prospect i ve , r and omized , and controlled . Patients received Graftskin plus compression therapy , or st and ard compression therapy ( active control ) . Patients were evaluated for frequency and time to complete ( 100 % ) wound closure . Treatment with Graftskin was significantly more effective than active control in the percentage of patients healed by 6 months ( 47 % vs. 19 % ; p < 0.005 ) and the median time to complete wound closure ( p < 0.005 ) . Analysis with multivariate regression methods , adjusting for factors generally thought to influence wound healing ( duration , baseline area , depth , location , fibrinous wound bed , and infection ) , showed that patients treated with Graftskin were twice as likely to achieve complete wound closure by 6 months ( p < 0.005 ) , and over 60 % more effective in achieving wound closure than active control ( p < 0.01 ) . These data indicate that Graftskin is an effective treatment for venous ulcers of greater than 1 year 's duration Abstract Background : Diabetes Mellitus ( DM ) is the most common endocrine disease worldwide . One of the most important chronic complications of this disease is the development of diabetic foot . The management of diabetic foot wounds is quite important with respect to public health . Aims : To determine the effect of Vacuum Assisted Closure ( VAC ) therapy on the quality of life in the treatment of diabetic foot ulcers and compare it with st and art wound care . Methods : Between May 2007 to December 2008 , 67 consecutive patients with diabetic foot ulcers were r and omly assigned to VAC therapy ( Group1 , n : 30 ) or st and art wound care ( Group 2 , n : 37 ) . The SF-36 question naire was administered the day before and in the month following wound healing . Global analyses of the 8 domains and 2 comprehensive indexes of SF-36 , Physical Component Summary ( PCS ) and Mental Component Summary ( MCS ) were performed . Clinical measures included st and ard antidiabetic treatment , daily wound care including antiseptic bath , debridement , toe removal for gangrene when necessary , and wound care with conventional methods or VAC . Healing time was calculated as the time from hospital admission to the time of re-epithelization . Results : There were no differences in the mean age , ulcer size and pulse status of the patients in both groups . Healing time in the VAC group was significantly reduced ( p < 0.05 ) . All 8 domains of SF-36 and MCS and PCS scores improved remarkably after VAC therapy . Conclusion : Vacuum Assited Closure therapy was found to be effective in the treatment of chronic diabetic ulcers . The improvement of quality of life demonstrates a clear-cut indication in this particular group of patients HYPOTHESIS Promogran , a wound dressing consisting of collagen and oxidized regenerated cellulose , is more effective that st and ard care in treating chronic diabetic plantar ulcers . DESIGN R and omized , prospect i ve , controlled multicenter trial . SETTING University teaching hospitals and primary care centers . PATIENTS A total of 276 patients from 11 centers were enrolled in the study . The mean age of the patients was 58.3 years ( range , 23 - 85 years ) . All patients had at least 1 diabetic foot ulcer . INTERVENTIONS Patients were r and omized to receive Promogran ( n = 138 ) or moistened gauze ( control group ; n = 138 ) and a secondary dressing . Dressings were changed when clinical ly required . The maximum follow-up for each patient was 12 weeks . MAIN OUTCOME MEASURE Complete healing of the study ulcer ( wound ) . RESULTS After 12 weeks of treatment , 51 ( 37.0 % ) Promogran-treated patients had complete wound closure compared with 39 ( 28.3 % ) control patients s , but this difference was not statistically significant ( P = .12 ) . The difference in healing between treatment groups achieved borderline significance in the subgroup of patients with wounds of less than 6 months ' duration . In patients with ulcers of less than 6 months ' duration , 43 ( 45 % ) of 95 Promogran-treated patients healed compared with 29 ( 33 % ) of 89 controls ( P = .056 ) . In the group with wounds of at least 6 months ' duration , similar numbers of patients healed in the control ( 10/49 [ 20 % ] ) and the Promogran ( 8/43 [ 19 % ] ; P = .83 ) groups . No differences were seen in the safety measurements between groups . Patients and investigators expressed a strong preference for Promogran compared with moistened gauze . CONCLUSIONS Promogran was comparable to moistened gauze in promoting wound healing in diabetic foot ulcers . It showed an additional efficacy for ulcers of less than 6 months ' duration that was of marginal statistical significance . Furthermore , Promogran had a safety profile that was similar to that of moistened gauze , with greater user satisfaction . Therefore , Promogran may be a useful adjunct in the management of diabetic foot ulceration , especially in ulcers of less than 6 months ' duration BACKGROUND Venous leg ulcers are a major cause of morbidity , economic loss , and decreased quality of life in affected patients . Recently , bio material s derived from natural tissue sources have been used to stimulate wound closure . One such bio material obtained from porcine small-intestine submucosa ( SIS ) has shown promise as an effective treatment to manage full-thickness wounds . Our objective was to compare the effectiveness of SIS wound matrix with compression vs compression alone in healing chronic leg ulcers within 12 weeks . METHODS This was a prospect i ve , r and omized , controlled multicenter trial . Patients were 120 patients with at least 1 chronic leg ulcer . Patients were r and omly assigned to receive either weekly topical treatment of SIS plus compression therapy ( n = 62 ) or compression therapy alone ( n = 58 ) . Ulcer size was determined at enrollment and weekly throughout the treatment . Healing was assessed weekly for up to 12 weeks . Recurrence after 6 months was recorded . The primary outcome measure was the proportion of ulcers healed in each group at 12 weeks . RESULTS After 12 weeks of treatment , 55 % of the wounds in the SIS group were healed , as compared with 34 % in the st and ard-care group ( P = .0196 ) . None of the healed patients treated with SIS wound matrix and seen for the 6-month follow-up experienced ulcer recurrence . CONCLUSIONS The SIS wound matrix , as an adjunct therapy , significantly improves healing of chronic leg ulcers over compression therapy alone OBJECTIVE To compare healing rates at 12 weeks for full-thickness diabetic foot ulcers treated with OASIS Wound Matrix , an acellular wound care product , versus Regranex Gel . DESIGN R and omized , prospect i ve , controlled multicenter trial at 9 outpatient wound care clinics . SUBJECTSA total of 73 patients with at least 1 diabetic foot ulcer were entered into the trial and completed the protocol . INTERVENTION Patients were r and omized to receive either OASIS Wound Matrix ( n = 37 ) or Regranex Gel ( n = 36 ) and a secondary dressing . Wounds were cleansed and debrided , if needed , at a weekly clinic visit . Dressings were changed as needed . The maximum treatment period for each patient was 12 weeks . PRIMARY OUTCOME MEASUREIncidence of healing in each group at 12 weeks . RESULTS After 12 weeks of treatment , 18 ( 49 % ) OASIS-treated patients had complete wound closure compared with 10 ( 28 % ) Regranex-treated patients . CONCLUSION Although the sample size was not large enough to demonstrate that the incidence of healing in the OASIS group was statistically superior ( P = .055 ) , the study results showed that treatment with OASIS is as effective as Regranex in healing full-thickness diabetic foot ulcers by 12 weeks In a r and omized multicenter study , 26 subjects with diabetes , neuropathy , and foot ulceration were treated with st and ard local wound care and application of either a living skin equivalent [ LSE ] ( Dermagraft ® , Advanced BioHealing , La Jolla , Calif ) or extracellular matrix [ ECM ] collagen wound dressing ( OASIS ® Wound Matrix , Healthpoint , Fort Worth , Tex ) . Subjects were analyzed to confirm that the wounds , demographics , and health characteristics of subjects in each group were equivalent . Depending on the r and omization , subjects received up to 3 applications of LSE or 8 applications of ECM . Subjects received this treatment in conjunction with st and ard saline dressings for a maximum of 12 weeks , and were observed for 20 weeks . No statistically significant difference was found in the size , distribution , or characteristics of the wounds evaluated in each group . There was no statistically significant difference in the time to closure or the rate of closure between the two groups . Similarly , no significant adverse events were reported in either group . The results of this study show comparable healing rates with use of either material . Further , it was hypothesized that both collagen and cellular components are necessary , and it is suggested that various conditions may make one or the other material more desirable p < 0.01 ) and the median time to complete wound closure ( 7 vs. 15 weeks , p= 0.0021 , rank-sum test ) . There was no difference in the wound closure rate of meshed and unmeshed graft at 4 , 8 , 12 , or 24 weeks ( p > 0.05 ) . Three indolent localized wound infections in the tissue-engineered skin graft group were the only complication . Tissue-engineered skin grafting can be used safely in previously ischemic wounds after lower extremity revascularization . Treatment with this graft promotes healing more rapidly and in more patients than st and ard moist dressings . It obviates the risk , inconvenience , and expense of donor skin harvesting , anesthesia , and hospitalization associated with autologous skin grafting . This graft may represent an advance in the treatment of previously ischemic lower extremity foot wounds AIM In addition to contemporary compression therapy , one of the therapeutic approaches is the use of a topical wound care agent . The goal of this pilot registry study is to evaluate the efficacy and safety of a uniquely design ed ointment containing multivalent silver oxide ( Ag4O4 ) in the healing of difficult diabetic or venous ulcerations . METHODS Patients who had ulcers result ing from chronic venous insufficiency or diabetes participated in this open-label , r and omized registry study . All patients were evaluated by measuring both the area of the ulceration and microcirculatory parameters . 148 patients were included in the study and categorized into two main groups : venous ulcers and diabetic ulcers . Each main group was then r and omized into two sub-groups : topical treatment with silver oxide ointment and the control group ( st and ard cleaning and compression management methods , without silver ointment ) . All patients were treated with accepted cleaning and compression management . RESULTS . In subjects with venous ulcers : After 4 weeks , the silver treatment was more effective than the control group treatment : Skin PO2 was increased 2.1 times more than the control group ( 17.4 % to 8.2 % ) and skin flux ( RF ) was improved 1.6 times more than the control group ( -38.7 % to -24.2 % ) . The total surface area of the ulcer was significantly reduced in the silver treatment group by 1.9 times the control group ( -88.7 % to -46.9 % ) . In addition , in the silver treatment group we observed complete closure of the ulceration in 42 % of subjects compared to 22 % in the control group ( P=<0.05 ) . In subjects with diabetic ulcers : after 4 weeks , the silver treatment was more effective than the control group treatment : Skin PO2 increased 2.6 times more than the control group ( 23.3 % to 9.1 % ) and skin flux ( RF ) was significantly improved 4.3 times more than the control group(-26.7 % to -6.2 % ) . The total surface area of the ulcer was significantly reduced in the silver treatment group by 3.7 times the control group ( -89.0 % to -23.9 % ) . In addition , in the silver treatment group we observed complete closure of the ulceration in 39 % of subjects compared to 16 % in the control group ( P</=0.05 ) . CONCLUSION This pilot study provides observational data on the efficacy of local treatment of ulcers with a multivalent silver oxide containing ointment . The silver ointment improved microcirculation and the healing rate of all 78 patients that were treated with multivalent silver ointment and closed twice as many ulcers in 4 weeks compared to the control groups ( 40.7 % silver treatment compared to 19.4 % for the control ) . This study demonstrates the feasibility of this type of treatment and provides evidence of efficacy to plan larger r and omized controlled studies . The large number of patients that were helped in this study demonstrates the efficacy of multivalent silver oxide topical ointment and its important role in ulcer therapy Background Lower extremity ulcers are a serious complication of diabetes mellitus ( DM ) . These ulcers show decreased angiogenic response and production of growth factors . Recombinant human platelet derived growth factor ( rhPDGF ) has been found to decrease the time to healing . This study was conducted to evaluate its efficacy in the treatment of diabetic foot ulcers . Methods A total of 50 patients with type 1 or type 2 DM and chronic ulcers , of at least 4 weeks duration , were studied . They were r and omised into two groups , of 25 patients each . The patients in group ‘ A ’ ( test group ) received treatment with topical application of rhPDGF gel and those in group ‘ B ’ ( control group ) were treated with local application of KY Jelly as a placebo . A st and ardised regimen of good wound care was provided to both groups . Healing or reduction in size of the wound , over a period of 10 weeks after commencement of treatment was recorded . Results The mean age of the patients was 49.9 years in the control group and 56.2 years in test group . The median duration of ulcer at time of enrolment in the study was 6 weeks in control and 5 weeks in test group . Fifteen ulcers in control group belonged to IAET ( International Association of Enterostomal Therapy ) class III and 10 ulcers to class IV where as 16 ulcers were in IAET class III and 9 ulcers in IAET class IV in the test group . The mean size of the wounds was 26.5 ± 2.5 cm2 in control group and 29.9 ± 3.4 cm2 in test group . All patients tolerated the test medication well . At the end of 10 weeks , 18 ( 72 % ) ulcers had healed in control group and 15 ( 60 % ) in test group ( p > 0.05 ) . Three ulcers in control group showed > 75 % reduction in size compared to 2 in the test group ( p > 0.05 ) . Conclusion This study did not show any statistically significant improvement in ulcer healing rates after the use of topically applied rhPDGF Antimicrobial silver dressings are used beneath graduated compression in the treatment of venous ulceration . There is little information on whether their use is effective . This was a prospect i ve r and omized trial and cost‐effectiveness analysis of silver‐donating versus non‐silver low‐adherence dressings in the treatment of venous leg ulcers Efficacy and safety of a collagen-alginate topical wound dressing ( FIBRACOL Collagen-Alginate Wound Dressing ) in the treatment of diabetic foot ulcers was compared with that of regular gauze moistened with normal saline . Seventy-five patients with foot ulcers were assigned r and omly in a 2:1 ratio to the collagen-alginate test dressing or the gauze dressing . At the end of the study , the mean percent reduction of the wound area was 80.6 % + /- 6 % in the collagen-alginate dressing group and 61.1 % + /- 26 % in the gauze dressing group ( p = .4692 ) . Thirty-nine ( 78 % ) patients treated with the collagen-alginate dressing achieved > or = 75 % wound area reduction , compared with 15 ( 60 % ) of gauze-treated patients . Complete healing was achieved in 24 ( 48 % ) of the collagen-alginate dressing group and 9 ( 36 % ) of the gauze dressing group . Wound size , when averaged over the 8-week period and with the duration of the ulcer taken into account , was reduced significantly in the collagen-alginate dressing group , as compared with the gauze dressing group ( df = 1 , p = .0049 ) . It is concluded that the collagen-alginate test dressing is as or more effective and safe as the currently used treatment Background & objectives : Diabetic foot ulcers are the most common cause of non-traumatic lower extremity amputations in developing countries . The aim of this pilot study was to evaluate the safety of using a polyherbal formulation in healing diabetic foot ulcers in comparison with st and ard silver sulphadiazine cream among patients with type 2 diabetes . Methods : A total of 40 ( M : F=29:14 ) consecutive type 2 diabetes patients with foot ulcers were enrolled in this study . They were r and omly assigned to two groups of 20 each ; Group 1 was treated with polyherbal formulation and group 2 with silver sulphadiazine cream . All the patients were followed up for a period of 5 months . The baseline ulcer size was noted and photograph of the wound was taken at the baseline and at each follow up visit . Number of days taken for healing of the wound was recorded . Results : The mean age of patients , duration of diabetes and HbA1c% were similar in both the study groups . The mean length and width of the ulcers was also similar in both the groups at baseline visit . There was a significant decrease in the size of the wound ( length and width ) in both the study groups ( P<0.001 ) . The mean time taken for the healing of the ulcer was around 43 days in both groups . Interpretation & conclusions : Diabetic wound cream prepared by using polyherbal formulation was found to be effective as well as safe in healing diabetic foot ulcers like the st and ard silver sulphadiazine cream BACKGROUND A number of different treatment approaches have been recommended for the treatment of venous ulceration , including local ulcer treatment , compression and drug therapy . Recent advances in tissue engineering have result ed in living tissues being developed for cutaneous wound repair and skin replacement . The aim of this pilot study was to compare the rate of healing of venous ulcers in patients treated with Dermagraft ( a human fibroblast-derived dermal replacement ) and compression therapy or compression therapy alone . METHODS A total of 18 patients with venous ulceration of the leg were recruited into the pilot study . Ten patients were treated with Dermagraft and compression therapy , and eight patients were treated with compression therapy alone . Healing was assessed by ulcer tracing and computerised planimetry . Skin perfusion was measured by laser Doppler . RESULTS Five ( 50 % ) of the patients treated with Dermagraft and one ( 12.5 % ) control patient had healed by the end of the 12-week study period ( NS ) . The total ulcer area rate of healing and linear rate of healing was significantly improved in patients treated with Dermagraft ( P=0.001 and P=0.006 , respectively , Mann-Whitney U-test ) . The number of capillaries increased in both the treatment and control group . Peri-ulcer skin perfusion increased by 20 % in patients treated with Dermagraft , compared with 4.9 % in the control group . CONCLUSION The data from this small pilot study suggests that Dermagraft is associated with improved healing of venous ulceration . Following this pilot study , further clinical studies are needed to confirm the validity of these results in ' hard to heal ' venous leg ulcers UNLABELLED Background . It was hypothesized that the rate of wound closure and the number of grafts required will be the same when treating diabetic foot ulcers with TheraSkin ® , a cryopreserved split-thickness skin allograft ( SSA ) , as compared to Apligraft ® , a bioengineered skin substitute ( BSS ) . METHODS A prospect i ve study using sequentially enrolled patients seen in a large podiatric practice encompassing multiple locations was conducted . Patients were sequentially enrolled and treated with either BSS or SSA . All other factors of treatment were st and ardized across the patient population . Data analysis included an analysis of co-factors in each group in order to determine if anything else may have influenced the outcomes . RESULTS Data from 17 wounds ( 16 patients ) treated with BSS and 12 wounds treated with SSA were analyzed . The average wound sizes were comparable , as was the average number of applications utilized . These data revealed that 41.3 % of the wounds treated with BSS closed within 12 weeks , as compared to 66.7 % of the wounds treated with SSA . At 20 weeks , 47.1 % of the wounds in the BSS group closed , while 66.7 % of the SSA wounds closed . There were a comparable number of adverse events in each group , with none that were a direct result of the biologic material being used . CONCLUSION SSA result ed in a higher percentage of wounds closing after 12 and 20 weeks , as compared to wounds treated with BSS . There were no adverse events noted that were directly related to either graft material Chronic wounds such as venous stasis ulcers have become a socioeconomic problem . Even with successful initial management , the recurrence rate approaches 70 % . With the advent of new wound healing agents , nonoperative attempts to heal these wounds appear indicated . This study reports a prospect i ve r and omized evaluator-blinded trial comparing two potential wound healing agents to an inert vehicle placebo . Eighty-six evaluable patients completed the trial . Silver sulfadiazine 1 % in a cream proved to statistically reduce the ulcer size compared with a biologically active tripeptide copper complex 0.4 % cream formulation or the placebo . There was no difference between the latter two treatments . Silver sulfadiazine has been shown to allow keratinocyte replication and to have antiinflammatory properties . In this trial its antibacterial action was not used since all ulcers had comparable bacterial levels ( less than or equal to 10(5)/gm of tissue ) before treatment . These results suggest that the silver sulfadiazine cream used in this study may facilitate healing in wounds healing largely by the process of epithelialization This 12-week , prospect i ve , r and omised , controlled multi-centre study compared the proportion of healed diabetic foot ulcers and mean healing time between patients receiving acellular matrix ( AM ) ( study group ) and st and ard of care ( control group ) therapies . Eighty-six patients were r and omised into study ( 47 patients ) and control ( 39 patients ) groups . No significant differences in demographics or pre-treatment ulcer data were calculated . Complete healing and mean healing time were 69.6 % and 5.7 weeks , respectively , for the study group and 46.2 % and 6.8 weeks , respectively , for the control group . The proportion of healed ulcers between the groups was statistically significant ( P = 0.0289 ) , with odds of healing in the study group 2.7 times higher than in the control group . Kaplan-Meier survivorship analysis for time to complete healing at 12 weeks showed a significantly higher non healing rate ( P = 0.015 ) for the control group ( 53.9 % ) compared with the study group ( 30.4 % ) . After adjusting for ulcer size at presentation , which was a statistically significant covariate ( P = 0.0194 ) , a statistically significant difference in non healing rate between groups was calculated ( P = 0.0233 ) , with odds of healing 2.0 times higher in the study versus control group . This study supports the use of single-application AM therapy as an effective treatment of diabetic , neuropathic ulcers The aim of this work was to study the safety and effectiveness of silver foam dressing ( Contreet ® Ag , Coloplast , Humlebaek , Denmark ) in promoting the healing of infected venous ulcers over 9 weeks of treatment . Forty-two patients with infected venous ulcers were included and r and omized into two groups . Group A had 21 patients ( 12 women and 9 men , mean age 61.2 years ) who were treated with the silver foam for 9 weeks . Group B also had 21 patients ( 14 women and 7 men , mean age 58.7 years ) who were treated with a nonadhesive foam ( Biatain ® , Coloplast , Humlebaek , Denmark ) for 9 weeks . In both groups , ulcer size and depth , intensity of pain , wound exudation , bacterial load , side effects of both material s , and ulcer healing were documented and compared . There was no significant difference at the initial assessment in both groups regarding ulcer size , ulcer depth , grade of exudation , pain intensity , or bacterial load . However , group A ulcers had a significantly greater healing ( P = 0.02 ) compared to group B. Pain intensity was significantly less in group A patients at several time points . After 9 weeks of treatment , the silver foam dressing was found to be a safe material that promotes rapid healing of venous ulcers and relieves pain . OBJECTIVE To examine the effectiveness and cost-effectiveness of antimicrobial silver-donating dressings for venous leg ulcers compared with simple non-adherent ( also known as low-adherent ) dressings . DESIGN A pragmatic , prospect i ve r and omised controlled trial ( RCT ) and cost-effectiveness analysis of silver-donating versus low-adherent dressings in the treatment of venous leg ulcers . A non-r and omised observational group was also recruited . SETTING Primary and secondary care services in the north and south of Engl and ( Sheffield and Exeter ) . PARTICIPANTS Consenting patients with active ulceration of the lower leg that had been present for a period of greater than 6 weeks . INTERVENTIONS Patients were r and omised to receive either a silver-donating or non-silver low-adherent dressing applied beneath compression b and ages or hosiery . The choice of dressing within these groups was left to clinician preference . Evaluation was by clinical assessment , supplemented by evaluation of quality of life and cost-effectiveness . MAIN OUTCOME MEASURES The primary outcome measure was complete ulcer healing at 12 weeks in the index limb . Secondary measures were costs and quality -adjusted life-years ( QALYs ) , cost-effectiveness , time to healing , and recurrence rate at 6 months and 1 year . RESULTS In total , 304 participants were recruited to the clinical trial : 213 to the RCT and 91 to the observational arm . Within the RCT 107 were r and omised to antimicrobial dressings and 106 to the control dressings . There were no significant differences ( p > 0.05 ) between the two groups for the primary outcome measure of proportion of ulcers healed at 12 weeks ( 59.6 % for silver and 56.7 % for control dressings ) . The overall median time to healing was also not significantly different between the two groups ( p = 0.408 ) . A total of 24 patients had recurrent ulcers within 1 year ; the recurrence rates of 11.6 % ( n = 11 ) for the antimicrobial and 14.4 % ( n = 13 ) for the control dressings were not significant . Mean utility valuations for both the EuroQol 5 dimensions ( EQ-5D ) quality of life question naire and Short Form 6 dimensions ( SF-6D ) utility index showed no differences for either group at 1 , 3 , 6 or 12 months . Compared with the control group , the antimicrobial group had an incremental cost of 97.85 pounds and an incremental QALY gain of 0.0002 , giving an incremental cost-effectiveness ratio for the antimicrobial dressings of 489,250 pounds . Cost-effectiveness modelling of the results of the RCT showed that antimicrobial dressings were not cost-effective . CONCLUSIONS No significant differences in either primary or secondary end points were found between the use of antimicrobial silver-donating dressings and the control group of low-adherent dressings . Modelling showed that antimicrobial silver dressings were not cost-effective . TRIAL REGISTRATION Current Controlled Trials IS RCT N72485131 OBJECTIVE To determine if a human fibroblast-derived dermal substitute could promote the healing of diabetic foot ulcers . RESEARCH DESIGN AND METHODS A r and omized , controlled , multicenter study was undertaken at 35 centers throughout the U.S. and enrolled 314 patients to evaluate complete wound closure by 12 weeks . Patients were r and omized to either the Dermagraft treatment group or control ( conventional therapy ) . Except for the application of Dermagraft , treatment of study ulcers was identical for patients in both groups . All patients received pressure-reducing footwear and were allowed to be ambulatory during the study . RESULTS The results demonstrated that patients with chronic diabetic foot ulcers of > 6 weeks duration experienced a significant clinical benefit when treated with Dermagraft versus patients treated with conventional therapy alone . With regard to complete wound closure by week 12 , 30.0 % ( 39 of 130 ) of Dermagraft patients healed compared with 18.3 % ( 21 of 115 ) of control patients ( P = 0.023 ) . The overall incidence of adverse events was similar for both the Dermagraft and control groups , but the Dermagraft group experienced significantly fewer ulcer-related adverse events . CONCLUSIONS The data from this study show that Dermagraft is a safe and effective treatment for chronic diabetic foot ulcers |
391 | 21,757,243 | A number of patient characteristics , hospital characteristics , physician characteristics , care processes and " other " factors were associated with door to balloon time .
Prognostic factors for longer times include : pre-hospital delay in presentation , cerebrovascular disease , absence of chest pain , lower PCI volume and specialization hospital , lower sum ST elevation , absence of Q waves and left bundle branch block .
Underst and ing prognostic factors for door to balloon time can likely lead to improved quality of care for STEMI | BACKGROUND Door to balloon time is important in the outcome of ST-elevation myocardial infa rct ion treated with primary percutaneous intervention .
This review summarizes prognostic factors for door to balloon time in STEMI patients presenting to a PCI capable hospital . | Prognosis studies are investigations of future events or the evaluation of associations between risk factors and health outcomes in population s of patients ( 1 ) . The results of such studies improve our underst and ing of the clinical course of a disease and assist clinicians in making informed decisions about how best to manage patients . Prognostic research also informs the design of intervention studies by helping define subgroups of patients who may benefit from a new treatment and by providing necessary information about the natural history of a disorder ( 2 ) . There has recently been a rapid increase in the use of systematic review methods to synthesize the evidence on research questions related to prognosis . It is essential that investigators conducting systematic review s thoroughly appraise the method ologic quality of included studies to be confident that a study 's design , conduct , analysis , and interpretation have adequately reduced the opportunity for bias ( 3 , 4 ) . Caution is warranted , however , because inclusion of method ologically weak studies can threaten the internal validity of a systematic review ( 4 ) . This follows abundant empirical evidence that inadequate attention to biases can cause invalid results and inferences ( 5 - 9 ) . However , there is limited consensus on how to appraise the quality of prognosis studies ( 1 ) . A useful framework to assess bias in such studies follows the basic principles of epidemiologic research ( 10 , 11 ) . We focus on 6 areas of potential bias : study participation , study attrition , prognostic factor measurement , confounding measurement and account , outcome measurement , and analysis . The main objectives of our review of review s are to describe methods used to assess the quality of prognosis studies and to describe how well current practice s assess potential biases . Our secondary objective is to develop recommendations to guide future quality appraisal , both within single studies of prognostic factors and within systematic review s of the evidence . We hope this work facilitates future discussion and research on biases in prognosis studies and systematic review s. Methods Literature Search and Study Selection We identified systematic review s of prognosis studies by search ing MEDLINE ( 1966 to October 2005 ) using the search strategy recommended by McKibbon and colleagues ( 12 ) . This strategy combines broad search terms for systematic review s ( systematic review .mp ; meta- analysis .mp ) and a sensitive search strategy for prognosis studies ( cohort , incidence , mortality , follow-up studies , prognos * , predict * , or course ) . We also search ed the reference lists of included review s and method ologic papers to identify other relevant publications . We restricted our search to English- language publications . One review er conducted the search and selected the studies . Systematic review s , defined as review s of published studies with a comprehensive search and systematic selection , were included if they assessed the method ologic quality of the included studies by using 1 or more explicit criteria . We excluded studies if they were meta-analyses of independent patient data only , if their primary goal was to investigate the effectiveness of an intervention or specific diagnostic or screening tests , or if they included studies that were not done on humans . Data Extraction and Synthesis Individual items included in the quality assessment of the systematic review s were recorded as they were reported in the publication ( that is , the information that would be available to readers and future review ers ) . We review ed journal Web sites and contacted the authors of the systematic review s for additional information when authors made such an offer in their original papers . When review s assessed different study design s by using different sets of quality items , we extracted only those items used to assess cohort studies . We constructed a comprehensive list of distinct items that the review s used to assess the quality of their included studies . The full text of each review was screened . All items used by the review authors to assess the quality of studies were extracted into a computerized spreadsheet by 1 review er . Two experienced review ers , a clinical epidemiologist and an epidemiologist , independently synthesized the quality items extracted from the prognosis review s to determine how well the systematic review s assessed potential biases . We did this in 3 steps : 1 ) identified distinct concepts or domains addressed by the quality items ; 2 ) grouped each extracted quality item into the appropriate domain or domains ; and 3 ) identified the domains necessary to assess potential biases in prognosis studies . We then used this information to assess how well the review s ' quality assessment included items from the domains necessary to assess potential biases . After completing each of the first 3 steps , the review ers met to attempt to reach a consensus . The consensus process involved each review er presenting his or her observations and results , followed by discussion and debate . A third review er was available in cases of persistent disagreement or uncertainty . In the first step , all domains addressed by the quality items were identified . The first review er iteratively and progressively defined the domains as items were extracted from the included review s. The second review er defined domains from a r and om list of all extracted quality items . Limited guidance was provided to the review ers so that their assessment s and definitions of domains would be independent . The review ers agreed on a final set of domains that adequately and completely defined all of the extracted items . In the second step , review ers independently grouped each extracted item into the appropriate domains . Review ers considered each extracted item by asking , What is each particular quality item addressing ? or What are the review 's authors getting at with the particular quality assessment item ? . Items were grouped into the domain or domains that best represented the concepts being addressed . For example , the extracted items at least 80 % of the group originally identified was located for follow-up and follow-up was sufficiently complete or does n't jeopardize validity were each independently classified by both review ers as assessing the domain completeness of follow-up adequate , whereas the extracted item quantification and description of all subjects lost to follow-up was classified as assessing the domain completeness of follow-up described . In the third step , we identified the domains necessary to assess potential biases . Each review er considered the ability of the identified domains to adequately address , at least in part , 1 of the following 6 potential biases : 1 ) study participation , 2 ) study attrition , 3 ) prognostic factor measurement , 4 ) confounding measurement and account , 5 ) outcome measurement , and 6 ) analysis . Domains were considered to adequately address part of the framework if information garnered from that domain would inform the assessment of potential bias . For example , both review ers judged that the identified domain study population represents source population or population of interest assessed potential bias in a prognosis study , whereas the domain research question definition did not , although the latter is an important consideration in assessing the inclusion of studies in a systematic review . Finally , on the basis of our previous ratings , we looked at whether each review included items from the domains necessary to assess the 6 potential biases . We calculated the frequency of systematic review s by assessing each potential bias and the number of review s that adequately assessed bias overall . From this systematic synthesis , we developed recommendations for improving quality appraisal in future systematic review s of prognosis studies . We used Microsoft Access and Excel 2002 ( Microsoft Corp. , Redmond , Washington ) for data management and SAS for Windows , version 9.1 ( SAS Institute , Inc. , Cary , North Carolina ) for descriptive statistics . Role of the Funding Sources The funding sources , the Canadian Institutes of Health Research , the Canadian Chiropractic Research Foundation , the Ontario Chiropractic Association , and the Ontario Ministry of Health and Long Term Care , did not have a role in the collection , analysis , or interpretation of the data or in the decision to su bmi t the manuscript for publication . Results We identified 1384 potentially relevant articles . Figure 1 shows a flow chart of studies that were included and excluded . Figure 2 shows the number of review s identified by year of publication . We excluded 131 systematic review s of prognosis studies that did not seem to include any quality assessment of the included studies ; this represented 44 % of prognosis review s. We included 163 review s of prognosis studies in our analysis ( 13 - 175 ) . The most common topics were cancer ( 15 % ) , musculoskeletal disorders and rheumatology ( 13 % ) , cardiovascular ( 10 % ) , neurology ( 10 % ) , and obstetrics ( 10 % ) . Other review s included a wide range of health and health care topics . Sixty-three percent of the review s investigated the association between a specific prognostic factor and a particular outcome ; the remainder investigated multiple prognostic factors or models . The number of primary studies included in each systematic review ranged from 3 to 167 ( median , 18 [ interquartile range , 12 to 31 ] ) . A complete description of the included review s is available from the authors on request . Figure 1 . Flow diagram of inclusion and exclusion criteria of systematic review s. Figure 2 . Number of systematic review s of prognosis studies identified over time . Quality Items One hundred fifty-three review s provided adequate detail to allow extraction of quality items . Eight hundred eighty-two distinct quality items were extracted from the review s. Most review s developed their own set of quality items , with only a few applying criteria from previous review s. Most quality items Background Studies about the influence of various factors on clinical therapy and course in acute coronary syndromes have shown that the outcome is related to admission time to the hospital , with an impaired prognosis in patients admitted out of regular working hours . However little is known about the impact of admission on weekend in hospitals with catheterisation laboratories . Methods We analyzed data of the prospect i ve MITRA-PLUS registry of 11,516 patients with ST-elevation myocardial infa rct ion ( STEMI ) admitted to hospitals with catheterization facilities for differences of in-hospital mortality between patients admitted during regular working hours , at night and on weekends . Results The prehospital delay and “ door-to-balloon”-time were significantly longer on weekends and at nights than at regular working hours ( median 196 Vs . 240 Vs . 155 min ; P < 0.0001 ; 60 Vs . 84 min at weekends , resp . 75 min at nights ; P < 0.0001 ) . Reperfusion therapy was performed in 72.8 % ( 8,248/11,332 ) patients , and there were less patients treated on weekend versus “ on”-hours ( 69.7 Vs . 77 % , P < 0.0001 ) . On weekends we found a significant higher in-hospital mortality ( 11.1 Vs . 9.4 % , P = 0.01 ) and at night there was a trend to higher in-hospital mortality when compared with regular working hours ( 10.6 Vs . 9.4 % , P = 0.07 ) . Conclusion In patients with STEMI admitted to hospitals with catheterization facilities , admission during the “ off”-hours is associated with higher in-hospital mortality . This may be due to lower rates of revascularization therapy and longer prehospital and in-hospital delays as compared to “ on”-hours Objective To evaluate the association between door-to-balloon time and mortality in hospital in patients undergoing primary percutaneous coronary intervention for ST elevation myocardial infa rct ion to assess the incremental mortality benefit of reductions in door-to-balloon times of less than 90 minutes . Design Prospect i ve cohort study of patients enrolled in the American College of Cardiology National Cardiovascular Data Registry , 2005 - 6 . Setting Acute care hospitals . Participants 43 801 patients with ST elevation myocardial infa rct ion undergoing primary percutaneous coronary intervention . Main outcome measure Mortality in hospital . Results Median door-to-balloon time was 83 minutes ( interquartile range 6 - 109 , 57.9 % treated within 90 minutes ) . Overall mortality in hospital was 4.6 % . Multivariable logistic regression models with fractional polynomial models indicated that longer door-to-balloon times were associated with a higher adjusted risk of mortality in hospital in a continuous non-linear fashion ( 30 minutes=3.0 % , 60 minutes=3.5 % , 90 minutes=4.3 % , 120 minutes=5.6 % , 150 minutes=7.0 % , 180 minutes=8.4 % , P<0.001 ) . A reduction in door-to-balloon time from 90 minutes to 60 minutes was associated with 0.8 % lower mortality , and a reduction from 60 minutes to 30 minutes with a 0.5 % lower mortality . Conclusion Any delay in primary percutaneous coronary intervention after a patient arrives at hospital is associated with higher mortality in hospital in those admitted with ST elevation myocardial infa rct ion . Time to treatment should be as short as possible , even in centres currently providing primary percutaneous coronary intervention within 90 minutes Background : The use of the prehospital electrocardiogram ( ECG ) to identify patients with ST-segment elevation myocardial infa rct ion ( STEMI ) , coupled with a central ised system to alert the cardiac catheterisation team in preparation for prompt intervention , has been shown to reduce door-to-balloon times ( DBT ) effectively . A confounding variable in prolonging the recommended 90 min DBT is the time of day or day of the week of patient presentation . We postulated that use of the prehospital ECG , coupled with an emergency department initiated “ Cath Alert ” system , could neutralise DBT delays related to time of day or day of week . Methods : A prospect i ve study was conducted on 167 consecutive patients presenting to our emergency department with acute STEMI . All patients were treated with primary percutaneous coronary intervention . Patients were grouped according to time of presentation : during regular hours ( Monday to Friday 08:00 to 17:00 ) vs off hours ( after 17:00 on weekdays and all hours on weekends ) . Baseline recorded variables included mode of presentation , transmission of prehospital ECG , and activation of Cath Alert system . Results : Overall , the mean ( SD ) DBT was 69 ( 35 ) mins , with the majority of patients ( n = 131 , 78 % ) achieving the recommended DBT of 90 mins . The shortest DBT occurred in patients who arrived by emergency medical services with use of the prehospital ECG and Cath Alert system ( 53 ( 21 ) min ) , while those who arrived as a walk-in without use of emergency medical services had the longest DBT ( 105 ( 38 ) min ; p<0.001 ) . Compared to regular hours , presentation during off hours prolonged DBT in patients presenting via emergency medical services ( 75 ( 16 ) vs 53 ( 18 ) min , p = 0.03 ) . With transmission of the prehospital ECG , the delay in DBT was improved among those presenting off hours , nullifying the adverse effect of off hour presentation ( 54 ( 21 ) vs 49 ( 22 ) min ; p = 0.26 ) . Conclusion : Variables such as time of day and mode of presentation have an impact on achieving currently recommended DBT in patients with STEMI . With the addition of each prehospital variable in succession — that is , arrival by emergency medical services , Cath Alert system , and the prehospital ECG — the DBT can be progressively shortened and the adverse “ off hour effect ” nullified Hypothesis : In this prospect i ve study , we sought to evaluate the effect of a logistic modification in this treatment process INTRODUCTION In recent decades pre-hospital emergency plans have been developed in Portugal , in order to improve the quality and efficiency of medical care in acute situations . However , the real impact of these measures in the treatment of acute coronary patients has not been thoroughly studied . OBJECTIVE To evaluate the impact of pre-hospital emergency care ( PHE ) in the management and prognosis of patients admitted to hospital with acute myocardial infa rct ion ( AMI ) . POPULATION Three hundred and eighty-one consecutive patients admitted to our hospital with AMI between 7/1/2001 and 12/31/2002 . METHODS The patients referred to the Emergency Department ( ED ) after PHE care were prospect ively compared with other patients admitted with AMI ( controls ) , in terms of clinical and demographic characteristics , initial ECG , time of symptoms-to-ED , symptoms-to-ECG , and door-to-needle/balloon , Killip class , in-hospital morbidity and mortality , ejection fraction ( EF ) at discharge , morbidity and mortality during the first year and EF after one year . RESULTS Of the 51 patients ( mean age 66 , 57 % male ) of the PHE group , 55 % ( mean age 66 , 64 % male ) presented ST elevation on admission ECG . Of the 330 patients ( mean age 63 years , 70 % male ) of the control group , ST elevation was present in 41 % ( p = 0.05 ) , mean age 59 years ( p < 0.02 ) , 77 % male ( NS ) . There were no significant differences between the groups when cardiovascular risk factors , cardiac event history and comorbidity were studied . Time of symptoms-to-ED ( 124 vs. 256 min ) and symptoms-to-ECG ( 138 vs. 292 min ) were shorter in the PHE group ( p < 0.005 and < 0.003 , respectively ) . Door-to-ECG time was 14 min vs. 36 min in the control group ( p < 0.02 ) . In patients with ST elevation , door-to-needle ( 77 vs. 105 min ) and door-to-balloon ( 79 vs. 132 min ) times were shorter after PHE ( NS , p = 0.08 ) . Overall , the time of symptoms-to-reperfusion was shorter in the PHE group . There were no differences in Killip class , in-hospital mortality or one-year mortality/morbidity . The prevalence of EF < 45 % was lower in the PHE group , both at discharge ( 39 vs. 58 % , p = 0.08 ) and on the first year echocardiogram ( 8.3 vs. 46 % , p < 0.04 ) . CONCLUSIONS Compared to other patients with AMI , those admitted to the ED after PHE are older and more frequently present ST elevation . PHE has a significant impact in reducing the time between first symptoms and admission to the ED , first ECG and reperfusion therapy . In patients with ST elevation at admission , the prevalence of heart failure after one year was found to be significantly lower in the PHE group , revealing the positive impact of PHE care in AMI that persists after one-year follow-up Background — Quality improvement efforts have focused on strategies to improve the timeliness of reperfusion therapy in ST-elevation myocardial infa rct ion patients who present to hospitals with and without percutaneous coronary intervention ( PCI ) capability . We implemented and evaluated a protocol to optimize the timeliness of reperfusion therapy and to coordinate systems of care for a PCI center and 28 regional hospitals located up to 150 miles away across 3 states . Methods and Results — The present study focused on a prospect i ve , observational cohort of 597 patients who presented with ST-segment elevation and within 12 hours of symptom onset to Saint Marys Hospital and 28 regional hospitals up to 150 miles away between May 2004 and December 2006 . The Mayo Clinic ST-elevation myocardial infa rct ion protocol implemented strategies to improve timeliness of reperfusion therapy and to coordinate systems of care for transfer between hospitals . The study sample consisted of 258 patients who presented to Saint Marys Hospital and were treated with primary PCI ( group A ) , 105 patients who presented to a regional hospital with symptom onset > 3 hours and then were transferred for primary PCI ( group B ) , and 131 patients who presented to a regional hospital with symptom onset <3 hours and were treated with full-dose fibrinolytic therapy ( group C ) . For groups A and B , median door-to-balloon times were 71 and 116 minutes , respectively . Door-to-balloon time < 90 minutes was achieved in 75 % of group A and 12 % of group B. Median door-to-needle time was 25 minutes for group C , and 70 % had door-to-needle time < 30 minutes . Conclusions — The Mayo Clinic ST-elevation myocardial infa rct ion protocol demonstrates the feasibility of implementing strategies to optimize the timeliness of reperfusion therapy and the times that can be achieved through coordinated systems of care for ST-elevation myocardial infa rct ion patients presenting to a PCI center ( Saint Marys Hospital ) and 28 regional hospitals without PCI capability located up to 150 miles away across 3 states Background — Consensus guidelines and hospital quality -of-care programs recommend that ST-elevation myocardial infa rct ion patients achieve a door-to-balloon time of ≤90 minutes . However , there are limited prospect i ve data on specific measures to significantly reduce door-to-balloon time . Methods and Results — We prospect ively determined the impact on median door-to-balloon time of a protocol m and ating ( 1 ) emergency department physician activation of the catheterization laboratory and ( 2 ) immediate transfer of the patient to an immediately available catheterization laboratory by an in-house transfer team consisting of an emergency department nurse , a critical care unit nurse , and a chest pain unit nurse . We collected door-to-balloon time for 60 consecutive ST-elevation myocardial infa rct ion patients undergoing emergency percutaneous intervention within 24 hours of presentation from October 1 , 2004 , through August 31 , 2005 , and compared this group with 86 consecutive ST-elevation myocardial infa rct ion patients from September 1 , 2005 , through June 26 , 2006 , after protocol implementation . Median door-to-balloon time decreased overall ( 113.5 versus 75.5 minutes ; P<0.0001 ) , during regular hours ( 83.5 versus 64.5 minutes ; P=0.005 ) , during off-hours ( 123.5 versus 77.5 minutes ; P<0.0001 ) , and with transfer from an outside affiliated emergency department ( 147 versus 85 minutes ; P=0.0006 ) . Treatment within 90 minutes increased from 28 % to 71 % ( P<0.0001 ) . Mean infa rct size decreased ( peak creatinine kinase , 2623±3329 versus 1517±1556 IU/L ; P=0.0089 ) , as did hospital length of stay ( 5±7 versus 3±2 days ; P=0.0097 ) and total hospital costs per admission ( $ 26 826±29 497 versus $ 18 280±8943 ; P=0.0125 ) . Conclusions — Emergency department physician activation of the catheterization laboratory and immediate transfer of the patient to an immediately available catheterization laboratory reduce door-to-balloon time , leading to a reduction in myocardial infa rct size , hospital length of stay , and total hospital costs OBJECTIVES Our goal was to examine the effects of implementing a fully automated wireless network to reduce door-to-intervention times ( D2I ) in ST-segment elevation myocardial infa rct ion ( STEMI ) . BACKGROUND Wireless technologies used to transmit prehospital electrocardiograms ( ECGs ) have helped to decrease D2I times but have unrealized potential . METHODS A fully automated wireless network that facilitates simultaneous 12-lead ECG transmission from emergency medical services ( EMS ) personnel in the field to the emergency department ( ED ) and offsite cardiologists via smartphones was developed . The system is composed of preconfigured Bluetooth devices , preprogrammed receiving/transmitting stations , dedicated e-mail servers , and smartphones . The network facilitates direct communication between offsite cardiologists and EMS personnel , allowing for patient triage directly to the cardiac catheterization laboratory from the field . Demographic , laboratory , and time interval data were prospect ively collected and compared with calendar year 2005 data . RESULTS From June to December 2006 , 80 ECGs with suspected STEMI were transmitted via the network . Twenty patients with ECGs consistent with STEMI were triaged to the catheterization laboratory . Improvement was seen in mean door-to-cardiologist notification ( -14.6 vs. 61.4 min , p < 0.001 ) , door-to-arterial access ( 47.6 vs. 108.1 min , p < 0.001 ) , time-to-first angiographic injection ( 52.8 vs. 119.2 min , p < 0.001 ) , and D2I times ( 80.1 vs. 145.6 min , p < 0.001 ) compared with 2005 data . CONCLUSIONS A fully automated wireless network that transmits ECGs simultaneously to the ED and offsite cardiologists for the early evaluation and triage of patients with suspected STEMI can decrease D2I times to < 90 min and has the potential to be broadly applied in clinical practice BACKGROUND Percutaneous coronary intervention ( PCI ) is now a favorable treatment for acute ST elevation myocardial infa rct ion ( STEMI ) . However , in non-official hours ( non-OH ) , this modality of treatment has a question able outcome because of the treatment delay . OBJECTIVE To compare the outcomes of PCI during official hours ( OH ) with non-OH in acute STEMI patients . MATERIAL AND METHOD A prospect i ve consecutive registry of PCI in acute ST-elevation MI patients at King Chulalongkorn Memorial Hospital from May 1999 to December 2003 were analyzed . Kaplan Meier survival analysis was used to determine the in-hospital mortality . Multivariate analysis was used to determine the prognostic factors for in-hospital mortality . RESULTS Two hundred and fifty six consecutive patients ( OH-107 , non-OH-149 ) who underwent PCI for acute STEMI were enrolled . Their mean age ( 61.9 + /- 12.2 vs 60.6 + /- 12.8 y , p = ns ) , male gender ( 73.8 % vs 73.2 % , p = ns ) , history of diabetes ( 30.2 % vs 33.8 % , p = ns ) , severity of the patients ( percent of patients in Killip IV--22.4 vs 21.5 , p = ns ) , ejection fraction ( 48.7 + /- 15.1 vs 45.9 + /- 14.7 , p = ns ) , cardiopulmonary resuscitation prior PCI ( 15.0 % vs 14.2 % , p = ns ) , anterior MI ( 55.1 % vs 51.0 % , p = ns ) were similar in both groups . Hypertension was slightly less common ( 39.6 % vs 52.7 % , p = 0.04 ) but smoking was more common ( 62.6 % vs 49.0 % , p = 0.03 ) in OH group . Door to balloon time and decision to balloon time were significantly shorter in the OH group than the non-OH group ( 67.9 + /- 47 vs 119.6 + /- 83 min , p < 0.001 and 60.8 + /- 35 vs 98.3 min , p < 0.001 ) . However , the total delayed time was not statistically significantly different ( 402 + /- 316 vs 424 + /- 215 , p = 0.55 ) . Angiographic success rate was achieved in 98.1 % for the OH group and 94.7 % in the non-OH group ( p = ns ) . In-hospital mortality rate was 10.3 % and 10.7 % respectively . CONCLUSION The door to balloon time for PCI in acute STEMI patients in the non-OH group was longer than the OH group ; however , the total delayed time was not different . The in-hospital mortality rate was similar BACKGROUND Many reports have shown that female gender carries a worse prognosis when developing acute myocardial infa rct ion ( MI ) , whether or not reperfusion therapy is used . The primary percutaneous coronary intervention ( 1-PCI ) is currently a preferable treatment for acute ST-elevation MI . However , the data concerning the difference between the outcomes in the treatment of the disease in men and women in Thail and is still insufficient . MATERIAL AND METHOD A prospect i ve registry of acute ST-elevation MI patients who underwent 1-PCI at King Chulalongkorn Memorial Hospital from June 1999 to December 2002 were analyzed . Kaplan Meier survival analysis is used to determine the in-hospital mortality . RESULTS The consecutive 184 ( F-52 , M-131 ) patients who underwent 1-PCI were recruited . Female subjects were older ( 66.6 + /- 12 y versus 59.0 + /- 11.6 y , p < 0.01 ) ; they also had higher percentage of diabetes ( 45.1 versus 27.1 , p < 0.01 ) , but a fewer number of smoker ( 17.7 versus 66.2 , p < 0.001 ) . The percentage of patients who had cardiogenic shock tended to be higher in women ( 34.6 versus 19.9 , p = 0.08 ) ; however , the number of anterior wall MI and ejection fraction were not different . The mean door to balloon time ( 109 + /- 95 versus 99 + /- 68 minutes ) and pain to balloon time ( 454 + /- 271 versus 372 + /- 298 minutes ) were not different in both groups . The angiographic success with TIMI 3 flow was achieved in 92.3 % for females and 86.9 % for the males . The in-hospital mortality was significantly higher in females ( 23.1 versus 6.1 , p = 0.002 ) . Univariate analyses demonstrated that the feminine gender , cardiogenic shock , smoking , ejection fraction less than 40 , cardiac arrest prior PCI and angiographic were the predictors for in-hospital mortality . When using multivariate analyses by Cox proportional model , only cardiogenic shock , history of hypertension and angiographic success were the significant predictors . Women had 2.15 times of in-hospital mortality higher than males ; however , the confidence interval cross-over 1 ( 0.74 - 6.42 ) and p value was 0.16 . CONCLUSION Females tend to have a poor prognosis when they develop acute ST-elevation MI which requires treatment with 1-PCI BACKGROUND / PURPOSE We tested the hypothesis that paramedic recognition of ST-elevation myocardial infa rct ion ( STEMI ) and cardiologist activation of the cardiac catheterization laboratory without transmission of the electrocardiogram reduces door-to-balloon times . METHODS We studied a consecutive series of patients suspected to have STEMI who were taken to the cardiac catheterization laboratory in the 6-month period before hotline implementation ( historical controls ) and during the first year of hotline use ( intervention group , hotline ; emergency medical service patients without hotline , concurrent controls ) . RESULTS Emergency medical services activated the hotline 47 times , and 25 patients were subsequently taken to the catheterization laboratory . Patients who received PCI involving hotline use ( n = 20 ) had significantly shorter door-to-balloon times ( 58 minutes ; 25th-75th percentile , 52 - 73 minutes ) than historical controls ( n = 15 ) ( 112 minutes ; 25th-75th percentile , 81 - 137 ; P < .0001 ) and concurrent controls ( n = 15 ) ( 92 minutes ; 25th-75th percentile , 76 - 112 ; P = .019 ) . CONCLUSIONS Paramedic transtelephonic communication to cardiologist of clinical and electrocardiogram assessment result ed in a 54-minute reduction in door-to-balloon time for patients with STEMI OBJECTIVES The objectives were to compare the proportion of false-positive activations and intervention times between emergency department ( ED ) and field-based activation of the coronary catheterization laboratory ( cath ) team for emergency medical services ( EMS ) patients identified by out-of-hospital ( OOH ) 12-lead electrocardiogram ( ECG ) with ST-segment elevation myocardial infa rct ion ( STEMI ) . METHODS This was a retrospective review of prospect ively collected continuous quality improvement data at a single , urban , academic medical center . By protocol , weekday activation of the cath team occurred based on OOH notification of a computer-interpreted OOH ECG indicating potential STEMI . Night and weekend activation occurred at the discretion of the attending emergency physician ( EP ) after advanced ED notification and after patient arrival and assessment . Basic demographic information and cardiac risk factors were recorded , as well as door-to-balloon ( DTB ) and ultimate diagnosis . RESULTS From May 2007 through March 2008 , there were 23 field activations and 33 ED activations . There was no difference in demographic or clinical characteristics between the two groups . In the field activation group , 9/23 ( 39 % ) were false-positives , while 3/33 ( 9 % ) were false-positives in the ED activation group ( 30 % higher absolute difference in the field activation group , 95 % confidence interval [ CI ] = 8 % to 52 % , p = 0.02 ) . OOH times and time spent in the ED were similar between the two groups . DTB times were 77 minutes for field activation and 68 minutes for ED activation , respectively ( difference 9 minutes , 95 % CI = -9 to 27 ) . CONCLUSIONS Emergency physician activation of the cath team results in a lower proportion of false-positive activations without clearly sacrificing DTB time when compared to field activation based solely on the results of the OOH ECG Primary angioplasty is superior to thrombolysis in acute myocardial infa rct ion when performed in a timely manner but the benefits are unknown when inter-hospital transfer is required for angioplasty . On the 20th March 2002 at the American College of Cardiology 51st Annual Scientific Session , the results of the Danish Multicentre R and omized Trial on Thrombolytic Therapy versus Acute Coronary Angioplasty in Acute Myocardial Infa rct ion ( DANAMI-2 ) were presented . 1,572 patients were r and omized to front loaded tPA or angioplasty on presentation within 12 h of acute myocardial infa rct ion ; 1,129 from hospitals requiring transfer for up to 3 h for angioplasty . The trial was stopped early since there was a 40 % relative reduction in the composite primary end-point of death , disabling stroke or reinfa rct ion within 30 days ( absolute reduction 13.7 to 8 % , p=0.0003 ) with primary angioplasty . This appeared to be driven by a significant reduction of reinfa rct ion from 6.3 to 1.6 % . Ambulance transfer was shown to be safe but time to angioplasty was approximately 60 min longer than time to thrombolysis . No data are as yet available on the relative infa rct sizes or left ventricular function in the two groups . The management of acute myocardial infa rct ion is an area of missed opportunities . Patients present late to hospital , up to 30 % of eligible patients do not receive reperfusion therapy and door to needle time is longer than is ideal . Whilst we await the full details of the trial and long term follow-up , we should not forget the challenges of conventional management of acute myocardial infa rct ion Objectives : We investigated the impact of an emergency medical services call on the management of acute myocardial infa rct ion , considering time intervals for intervention and revascularization procedures . Methods : Data were prospect ively collected from January 2001 to October 2002 from 531 patients hospitalized for myocardial infa rct ion with ST segment elevation and a pre-hospital delay of less than 24 h. Results : Only 26 % of patients called the emergency medical services at the onset of symptoms ( n=140 ) . Other patients ( n=391 , 74 % ) called another medical contact . Baseline characteristics and cardiovascular history were similar in the two groups , except for the percutaneous coronary intervention history ( 10 % in the emergency medical services group versus 4 % in the other medical contact group , P<0.05 ) . Time intervals from the onset of symptoms of myocardial infa rct ion to call or to medical intervention , as well as the time interval from medical intervention to hospital admission were significantly shorter in the emergency medical services group . The early reperfusion rate was also significantly greater in the emergency medical services group ( 77 % ) compared with the other medical contact group ( 64 % ) , mainly because of a greater incidence of primary percutaneous coronary intervention ( 36 versus 26 % , P<0.03 , respectively ) . Multivariate analysis adjusted for sex and age showed that less than three medical care providers [ odds ratio ( OR ) 5.042 , P<0.001 ] , percutaneous coronary intervention history ( OR 2.462 , P<0.05 ) , as well as rhythmic disorders ( OR 2.105 , P<0.05 ) and complete atrioventricular block ( OR 2.757 , P<0.05 ) were independent predictors of emergency medical services care . Conclusion : This study demonstrated that a call to the emergency medical services is underutilized by patients with symptoms of myocardial infa rct ion , and documented the beneficial effects of an emergency medical services call by reducing pre-hospital delays and increasing early revascularization therapies AIM This paper reports the in-hospital findings of a study identifying gender specific care pathway delays or treatment opportunities amongst Irish women and men hospitalized with myocardial infa rct ion . BACKGROUND Reperfusion therapy is of optimum benefit when administered early , yet research shows that women continue to experience greater in-hospital delays to treatment than men . METHOD A 1-year prospect i ve census was carried out from December 2001 to November 2002 with 277 ( 31 % ) female and 613 ( 69 % ) male patients with myocardial infa rct ion who were consecutively admitted to the six major teaching hospitals in Dublin , Irel and . RESULTS Women experienced greater ' Triage to first medical assessment ' delays than men ( P=0.001 ) , and waited a median of 30 minutes for their first medical contact , compared with 20 minutes for men ( P<0.0001 ) . The median ' door to needle ' time for women was 70 minutes in comparison with 52 minutes for men ( P=0.02 ) . Women waited longer than men for aspirin ( P=0.02 ) , whilst men received a bed in the coronary care unit almost 1 hour sooner than women ( P<0.0001 ) . Despite these delays to treatment , women and men experienced similar rates of reperfusion treatment . CONCLUSIONS In-hospital treatment delays experienced by women may limit their potential to achieve the maximum benefits from reperfusion therapies . Triage nursing provides the first entry point to hospital care for the majority of female patients with myocardial infa rct ion , and therefore Accident and Emergency Department nurses are in an optimum position to influence positively the pathway of care for this group Background Primary percutaneous coronary intervention ( PCI ) for ST elevation myocardial infa rct ion ( STEMI ) improves outcome in comparison to fibrinolysis . However , it is unclear whether patients treated in interventional facilities with 24-h primary PCI service have lower rates of adverse events . Methods We analyzed data of consecutive patients with STEMI prospect ively enrolled in the German Acute Coronary Syndromes registry between July 2000 and November 2002 who were admitted to hospitals with catheterisation laboratory . Results Overall 6,350 patients were divided into two groups : 2,779 ( 43.8 % ) were treated in hospitals with and 3,571 ( 56.2 % ) without 24-h on-call cardiac catheter laboratories . 83.0 % of the patients at facilities with and only 69.9 % of the patients at facilities without 24-h PCI service received early reperfusion therapy ( P < 0.001 ) . Hospital death ( 7.4 % vs. 9.9 % , P < 0.001 ) , non-fatal myocardial reinfa rct ion ( 2.5 % vs. 6.4 % , P < 0.0001 ) and stroke ( 0.3 vs. 1.0 % , P < 0.01 ) occurred significantly less often in patients treated in hospitals with 24-h primary PCI service . After adjustment for the confounding factors in the propensity score analysis the 24-h on-call strategy remained superior for the combined endpoint of death , reinfa rct ion and stroke ( OR 0.63 , 95 % CI 0.54–0.75 ) . Conclusions In clinical practice the rate of patients receiving reperfusion therapy was significantly higher in hospitals with 24-h primary PCI service which was associated with an improved in-hospital outcome . Though the data was collected at a time that does not completely represent current clinical practice , these results could have an impact on planning efficient infa rct networks in the future Primary percutaneous coronary intervention proved to be superior to thrombolysis in reducing ST-segment elevation acute myocardial infa rct ion ( STEAMI ) mortality . However , whether such benefit is similar in women and men remains unclear . The aim of the present analysis was to assess the independent effect of female gender on management and on early and 1-year mortality in Florence , Italy , where primary percutaneous coronary intervention is the preferred reperfusion strategy for STEAMI . The study included a cohort of 920 unselected patients with STEAMI ( men = 627 , women = 293 ) prospect ively enrolled in the AMI-Florence , population -based registry over 12 months . Women were older ( 76 vs 68 years , p < 0.001 ) and more frequently had Killip class > I heart failure than men . The median delay to hospital admission was marginally longer in women ( 160 vs 130 minutes , p = 0.09 ) . Coronary reperfusion treatment was performed less often in women ( 49 % vs 58 % , p < 0.013 ) ; primary percutaneous coronary intervention was performed more often in both genders ( 90 % vs 91 % ) and with similar median door-to-balloon time ( 50 vs 45 minutes , p = 0.44 ) . Both in-hospital ( 16 % vs 8 % , p < 0.001 ) and 1-year mortality ( 25 % vs 18 % , p = 0.016 ) were higher in women . However , after adjusting for age and other baseline characteristics , reperfusion treatment ( odds ratio 1.27 , 95 % confidence interval [ CI ] 0.78 to 2.08 ) and 1-year mortality ( hazard ratio [ HR ] 0.91 , 95 % CI 0.67 to 1.24 ) were independent of female gender . Compared with conservative therapy , reperfusion treatment was associated with a similar reduction in 1-year mortality in women ( HR 0.59 , 95 % CI 0.34 to 1.02 ) and men ( HR 0.58 , 95 % CI 0.37 to 0.92 ) . Our data suggest that older age and several age-related factors may largely account for the higher mortality of women after STEAMI . Even in the general population , improvement in prognosis associated with reperfusion treatment is independent of gender Background Ambulance use expedites the definitive treatment of acute myocardial infa rct ion ( AMI ) . The aim of this study was to evaluate the effect of ambulance use on the administration of early reperfusion therapies for patients with AMI in Beijing , China . Methods Data were prospect ively collected from 498 patients with ST‐elevation myocardial infa rct ion ( STEMI ) who were admitted within 12 hours of symptom onset to 19 hospitals in Beijing between November 1 , 2005 and December 31 , 2006 . The baseline characteristics of and the initial management of the ambulance users and the non‐ambulance users were compared . Results Only 186 ( 37.3 % ) patients used an ambulance as transportation to the hospital . Ambulance users were , on average , older and at relatively higher risk on presentation than the non‐ambulance users . After adjustment for patient and hospital characteristics , ambulance use was associated with a greater early reperfusion rate , mainly because of a greater incidence of primary percutaneous coronary intervention . In addition , ambulance users had a significantly shorter median door‐to‐balloon ( 120 compared with 145 minutes , P < 0.001 ) and symptom onset‐to‐balloon ( 223 compared with 300 minutes , P<0.001 ) time than non‐ambulance users . Conclusions Ambulances are underused by AMI patients in Beijing . Ambulance use may lead to more frequent and faster receipt of early reperfusion therapies . New public health strategies should be developed to facilitate an increased use of ambulances by AMI patients In the treatment of acute myocardial infa rct ion , delayed reperfusion therapy is associated with increased mortality . Predictors of delay have been described for fibrinolysis but not for primary percutaneous transluminal coronary angioplasty ( pPTCA ) . Therefore , we studied 40,017 consecutive patients with acute myocardial infa rct ion who underwent pPTCA in the National Registry of Myocardial Infa rct ion between June 1994 and April 2000 . Median door-to-balloon times were calculated , and factors independently associated with a delay of > 120 minutes were determined by logistic regression . The median door-to-balloon time among all patients was 111 minutes ( interquartile range 84 to 152 ) . The proportion of patients with a delay of > 2 hours was greater among those aged > or = 65 years ( 49 % vs 41 % ) , women ( 50 % vs 42 % ) , patients with contraindications to fibrinolysis ( 60 % vs 41 % ) , and those without chest pain on admission ( 61 % vs 43 % , all p < 0.0001 ) . Delay was also more common with transfer from another hospital ( 87 % vs 38 % ) , with presentation outside the hours of 8 A.M. to 4 P.M. ( 51 % vs 38 % ) , and in hospitals performing < 49 pPTCAs/year ( 47 % vs 41 % , all p < 0.0001 ) . The strongest independent predictor of delay was hospital transfer , along with non-daytime presentation and low-volume centers . Older age , female sex , and non-white race were weaker predictors . Both patient and hospital factors are associated with delay in pPTCA after presentation . These findings may help design treatment algorithms to minimize delay , thus improving the survival benefit of pPTCA . These results may also help design trials of combination reperfusion strategies |
392 | 22,318,100 | These effects were especially obvious in term infants and infants without hemolytic diseases .
Conclusions Clofibrate may have short-term benefits for the infants with hyperbilirubinaemia , especially for population of term infants and infants without hemolytic diseases . | Objective To evaluate the effect of clofibrate for unconjugated hyperbilirubinemia in neonates . | Objective This study was design ed to determine the effect of clofibrate on neonatal uncomplicated jaundice treated with home phototherapy . Methods This clinical trial study was performed on 60 newborns with jaundice that received home phototherapy . Inclusion criteria were body weight between 2500 to 4000 gr , breastfed , total serum bilirubin ( TSB ) between 14 to 20 mg/dl , aged over 72 hours . The neonates were r and omly divided into two groups . All received home phototherapy . Group I received a single dose of 50 mg/kg clofibrate and the other group served as control group . Total serum bilirubin level was measured every 24 hours . Findings Two groups were matched regarding weight , sex , age and first TSB . At 24 and 48 hours of treatment , the mean values of TSB in the clofibrate group were 13.72 ( 1.56 ) , 9.5 ( 0.56 ) and in the control group 15.30 ( 1.44 ) , 12.6 ( 1.44 ) . The results show that TSB was significantly decreased after 24 and 48 hours in clofibrate group ( P<0.001 ) . The mean duration of phototherapy in group I was 72(0.0 ) hours and in the control group 76.80 ( ±9.76 ) hours . The duration of phototherapy was significantly shorter in clofibrate group ( P<0.001 ) . Conclusion Clofibrate is effective for out patients with neonatal hyperbilirubinemia who are under home phototherapy . Of course , further studies are needed for approved routine use of this drug in the treatment of neonatal jaundice BACKGROUND Hyperbilirubinemia is a common problem in newborn infants . It can progress to kernicterus in severe forms , unless an intervention is initiated . The objective of this study was to determine the therapeutic effect of clofibrate in full-term neonates with nonhemolytic jaundice . METHODS A r and omized clinical trial was performed on two groups of full-term jaundiced neonates : the clofibrate-treated group ( n = 30 ) and the control group ( n = 30 ) . Infants in the clofibrate group received a single oral dose of 100 mg/kg clofibrate while the neonates in the control group received distilled water ( same color and volume ) ; both groups received phototherapy . Serum total and direct bilirubin levels were measured at the beginning , 16 , 24 , 48 , and 74 hours , after the start of the trial . RESULTS The mean+/-SD total serum bilirubin level of the control and clofibrate groups at enrollment was 17.5+/-2.3 and 18.2+/-1.9 mg/dL , respectively ( P = 0.199 ) . The mean+/-SD total serum bilirubin in the control and clofibrate groups after 48 hours was 11.4+/-2.4 and 10.1+/-2.4 mg/dL , respectively ( P = 0.047 ) . After 72 hours of intervention , 25 ( 83 % ) neonates of the clofibrate group and 16 ( 53 % ) of the control group were discharged with a total serum bilirubin of < 10 mg/dL ( P = 0.026 ) . No side-effect was observed on serial examination during hospitalization , and on the first and seventh day after discharge . CONCLUSION Clofibrate results in a faster decline in TSB , shorter duration of hospitalization and had no side effects in jaundiced full-term neonates Glucose-6-phosphate dehydrogenase ( G6PD ) deficiency may cause severe hyperbilirubinemia with bilirubin encephalopathy unless intervention is initiated . The aim of this study was to assess the efficacy of clofibrate in full term G6PD deficient neonates with jaundice . A r and omized clinical trial study was performed in two groups of full-term G6PD deficient jaundiced neonates ( clofibrate treated group , n = 21 ; control group , n = 19 ) . Infants in the clofibrate group received a single oral dose of 100 mg/kg clofibrate , whereas control group received nothing . Both groups were treated with phototherapy . Serum total and direct bilirubin levels were measured at the onset of treatments , 16 , 24 and 48 hours later . On enrollment , the mean total serum bilirubin ( TSB ) level in the clofibrate treated group was 18.40 + /- 2.41 and in the control group was 17.49 + /- 1.03 ( p = 0.401 ) . At 16 , 24 and 48 hours of treatment , the mean TSB in the clofibrate group were 15.2 + /- 1.9 , 12.6 + /- 2.4 , and 10.1 + /- 2.4 and in the control group were 16.5 + /- 1.2 , 13.3 + /- 2.2 and 11.4 + /- 2.4 , respectively ( p = 0.047 ) . At 48 hours , 7 ( 33 % ) cases in the clofibrate group and one ( 5 % ) case in the control group were discharged with a TSB < 10 mg/dl ( p = 0.031 ) . No side effects were observed on serial examinations during hospitalization , or on the 1st and 7th days after discharge . The results show that clofibrate induces a faster decline in serum total bilirubin level , a shorter duration of phototherapy , and hospitalization with no side effects in full-term G6PD deficient neonates with jaundice A double blind therapeutic trial of ethyl clofibrate as a preventive treatment of hyperbilirubinemia in preterm neonates was performed in neonates of gestational ages ranging between 31 and 36 weeks . Forty-six children were given the treatment and 43 a placebo . A single 100 mg/kg dose of ethyl clofibrate was administered orally , between the 24th and the 48th hour of life . Significant results in the treated neonates are as follows : a lesser intensity of jaundice from the 48th hour of treatment ; a lesser need for repeated bilirubinemia assay for the control of evolution and a lesser use of phototherapy if the serum concentration of clofibric acid is above or equal to the 140 micrograms therapeutic level before the 24th hour of treatment . The analysis of results also shows that the therapeutic clofibric acid serum level is reduced in 66 % of neonates of relatively high gestational ages ( 34 - 36 weeks ) and in 33 % only of neonates of lower gestational ages ( 31 - 33 weeks ) . This study , added to the previous therapeutic trial performed in at term neonates , shows the efficacy of clofibrate in the preventive treatment of hyperbilirubinemia in preterm neonates . Further studies will allow to define the exact dosage according to gestational age BACKGROUND Despite an underst and ing of the enzymatic pathways leading to bilirubin production and degradation , very few pharmacologic interventions are utilized and the mainstay of treatment remains phototherapy . AIMS To evaluate the efficacy of clofibrate in reducing total serum bilirubin levels in late pre-term neonates with non-hemolytic jaundice . DESIGN AND SETTING Double-blind , placebo-controlled , r and omized trial ; tertiary level neonatal unit . MATERIAL S AND METHODS A r and omized controlled study was carried out in the neonatal ward of Children 's Hospital , Tabriz , Iran , over a 1-year period . Sixty-eight healthy late pre-term infants readmitted with non-hemolytic hyperbilirubinemia were r and omized to receive phototherapy and clofibrate ( n= 35 ) or phototherapy and placebo ( n= 33 ) . STATISTICAL ANALYSIS USED Chi-square test and independent sample ' t ' test . RESULTS There were no significant differences in the weight , gender , modes of delivery and age of neonates between the two groups . Similarly the mean total serum bilirubin ( TSB ) level at the time of admission was not significantly different between the two groups [ mean+/- SD : 19.72 + /- 1.79 ( 95 % confidence interval : 19.12 - 20.54 mg/dL ) vs. 20.05 + /- 2.82 ( 95 % confidence interval , 19.54 - 22.04 mg/dL ) , P= 0.57 ] . The mean TSB 48 hours after phototherapy [ mean+/- SD : 8.06+/- 1.34 ( 95 % confidence interval : 7.94 - 10.18 mg/dL ) vs.10.94 + /- 2.87 ( 95 % confidence interval : 9.92 - 12.16 mg/dL ) , P= 0.02 ] and the mean duration of phototherapy [ mean+/- SD : 64.32 + /- 12.48 ( 95 % confidence interval : 60 - 81.6 hours ) vs. 87.84 + /- 29.76 ( 95 % confidence interval : 79.2 - 108 hours ) , P < 0.001 ] were significantly lower in the clofibrate-treated group . CONCLUSIONS Clofibrate is an effective adjunctive drug in neonatal hyperbilirubinemia , which results in decreased TSB level and reduced duration of phototherapy in late pre-term newborns A double blind controlled study of the therapeutic effect of clofibrate , an inductor of bilirubin glucuronyl transferase , was performed in neonates born at term and presenting with physiologic jaundice . 47 children were treated with a single oral dose of clofibrate . 46 control children were given corn oil alone . Results show that mean plasma bilirubin levels are significantly lower in the treated group as compared with the control group , from the 16th hour of treatment , if there is no ABO incompatibility . Clofibrate treatment also result ed in a shorter duration of jaundice and a restricted use of phototherapy . No undesirable side-effect was observed |
393 | 28,291,553 | Conclusions Isotretinoin treatment for acne does not appear to be associated with an increased risk for depression .
Moreover , the treatment of acne appears to ameliorate depressive symptoms | Background The relationship between isotretinoin treatment for acne and depression is controversial .
Quantitative analysis has not yet been conducted .
Objective To conduct a meta‐ analysis , evidence ‐based examination of the relationship between isotretinoin and depression . | BACKGROUND According to some animal data , impairments in learning and memory are seen with isotretinoin . Isotretinoin has been shown to affect human brain metabolism , but the data on human neural functions is lacking . OBJECTIVES To evaluate whether isotretinoin treatment affects cognitive functions , causes depression and anxiety or alters anger level and anger expression . METHODS Neuropsychological tests of attention and executive functions , behavioural tests measuring anger and depression and measures assessing acne severity were applied to 63 severe and /or resistant acne patients from four medical centres including one primary care institute and three university hospitals at the beginning , at the end of first month , third month and at end of treatment with isotretinoin . RESULTS From a total of 63 patients , 15 missed the final visit and 48 were evaluated . Overall , 11 ( six women , five men ) and five ( all women ) patients reported anger and depression , respectively , during treatment . Eleven of these 16 patients improved spontaneously . No detrimental effects of isotretinoin treatment on either executive functions or mood were found . Several executive functions and control of anger trait were found to be improved . Clearing of acne was obtained in 94.6 % of patients . LIMITATIONS Improvement of several measures may be related to learning effect of repeated testing . Investigating brain functions is a complex process and various methods can be used . CONCLUSION The test battery used in this study , which is commonly used to evaluate mental status both in adults and children , did not show any negative effect of isotretinoin on executive functional parameters in acne patients We evaluated the psychiatric morbidity and mood characteristics of a group ( n = 72 ) of patients with cystic acne before and after treatment with one of three dosage schedules of isotretinoin . Although no excess psychiatric morbidity was observed , substantial evidence of psychologic distress was noted before treatment . Significant reductions in anxiety were observed on several measures of anxiety after treatment , with mitigation of anxiety and depression most robust in those patients with the greatest dermatologic improvement with isotretinoin BACKGROUND Patients with cystic acne ( CA ) frequently report feeling self conscious , anxiety and social isolation . METHODS Mood characteristics as well as self-esteem scores of 38 patients with CA were evaluated before and after 30 days treatment with isotretinoin . A high pressure , liquid chromatography method was used for the evaluation of catecholamines ( epinephrine ( E ) and nor-epinephrine ( NE ) ) in the blood of the patients at the time of the study and in controls ( n = 30 ) after their psychological testing . Moreover , E and NE were measured in the blood of eight healthy volunteers before and after 1 month ' treatment ' with the drug . RESULTS The CA subjects evidence d anxiety and high catecholamine plasma levels ( E = 98.0+/-0.8 pg/ml , NE = 250.8+/-56.6 pg/ml ) before treatment compared to controls ( E = 71.8+/-23.0 pg/ml , NE = 190.0+/-52 pg/ml , P < 0.006 ) , and these levels were lower ( E = 75.4+/-21.4 pg/ml , NE = 202.0+/-49.9 pg/ml , P < 0.001 ) when their psychological status returned to normal after treatment . No differences were observed in E and NE levels in the eight healthy volunteers who received the same dose of the drug at the same time of study . CONCLUSIONS It is suggested that not only the psychological status is influenced in subjects with CA but also their sympathoadrenal system BACKGROUND : Isotretinoin therapy and its alleged adverse psychiatric effects have received considerable media attention during the past years . The aim of this pilot study was to investigate whether there was any association between isotretinoin therapy and anxiety , depression or suicidal ideation . METHODS : Forty‐five patients with severe recalcitrant acne were enrolled in this study . Isotretinoin was administered at a dose of 0.5–1 mg/kg per day in two divided doses with food for 16 weeks . All patients received a complete dermatological examination and the severity levels of their acne were scored according to the Leeds Revised Acne Grading system at baseline ( before isotretinoin treatment ) and follow‐up assessment s at weeks 4 , 8 and 16 of the treatment . Severity of anxiety and depressive symptoms were assessed with the Clinical Anxiety Scale and Montgomery‐Asberg Depression Rating Scale before and upon completion of the 16‐week isotretinoin treatment . RESULTS : Twenty‐three patients completed the final assessment . There was a statistically significant decrease in anxiety scores . Depression scores also decreased but were not statistically significant . No patient committed or attempted suicide . CONCLUSIONS : This pilot study was unable to detect an association between the use of isotretinoin and an increased risk for anxiety , depression , or suicidal thoughts Rationale The acne drug isotretinoin has 13-cis retinoic acid as its active agent . Adverse effects that have been described include severe depression . Animal studies indicate that the hippocampus is particularly sensitive to retinoic acid . Changes induced by isotretinoin to hippocampal function could contribute to depression but may be more evident in altered visuospatial learning and memory , the primary function of the hippocampus . Objectives We aim ed to test the hypothesis that a course of oral isotretinoin therapy would result in declining visuospatial learning and memory . Methods CANTAB tasks design ed to assess visuospatial memory were performed repeatedly on 14 males and 3 females in an open prospect i ve observational study of patients with severe acne undergoing isotretinoin therapy . Beck ’s Depression Inventory and Global Acne Grade were also administered . Results Performance stayed unchanged for DMS , SRM and PRM tasks , while surprisingly participants improved their speed on the PRM task . Performance improved across sessions on the PAL task , and moreover the dose of isotretinoin correlated with improvement in the total trial score , reduction in total error rate and stage completed at the first trial . Conclusion Isotretinoin does not reduce learning and memory and our study suggests that it may instead lead to a dose-related improvement in specific aspects of hippocampal learning and memory . Retinoic acid functions in the hippocampus as the active metabolite of vitamin A , suggesting that this may be a limiting factor in the human hippocampus and addition of exogenous retinoic acid brings levels closer to an optimal state Background : Isotretinoin is an effective treatment for severe acne . Although the spectrum of side effects has been well documented , the changing incidence of such side effects over the course of treatment has not been studied in detail . Objectives : The purpose of our study was to examine a group of patients monthly over their course of treatment and prospect ively document the side effects experienced . Methods : Over the period between January 1991 and July 1996 , 124 courses of treatment with isotretinoin for severe acne were followed . The patients were treated for 4 months at a dose of 1 mg per kg body weight . A question naire was administered monthly , inquiring specifically about side effects known to be associated with isotretinoin . Any additional side effects were also noted . Results : The majority of patients experienced persistent dryness of lips . Dry eyes affected 40 % of patients ; this continued throughout treatment in 25 % . Contact lens wearers were more likely to develop conjunctivitis . Lower back pain was reported early in about 30 % of patients and fewer than 10 % of patients would develop it later in the course of treatment . Arthralgia was noted in 16.5 % of patients at the first visit and there was little change with ongoing treatment . Hair loss was experienced in a small percentage but was rarely noted on more than one occasion . Headaches occurred in less than 10 % and were occasionally severe , but most often intermittent and recorded at a single visit . Depression occurred in 4 % of patients and tended to persist throughout the treatment . All these patients completed the full course of treatment . Conclusion : This prospect i ve analysis has shown that patients treated with isotretinoin experienced a predictable series of side effects . Some occurred fleetingly , but several persisted for the duration of treatment BACKGROUND Depression and mood changes appear as potentional side effects of isotretinoin in the Summary of Product Characteristics . There have been many studies treating this topic but in most cases not identifying any significant depression or suicide risk . To further investigate this issue , we conducted a prospect i ve , uncontrolled study to evaluate mood changes and suicidal ideations in patients receiving isotretinoin therapy . METHODS One-hundred patients were included in our single center , no-blind , and no controlled prospect i ve study . All patients completed the Beck 's Depression Inventory , Version II ( BDI-II ) before the treatment , following the first month of the treatment and then every third month until finishing the isotretinoin therapy . All question naires were checked by a psychiatrist . Suicidal ideations were monitored . Statistical analysis of BDI-II scores was performed . RESULTS All patients completed the study . Before the treatment , six percent of the patients had suffered from depressive symptoms . During the isotretinoin treatment , we did not find any deterioration of depression problems in any of these patients . On the contrary , in most patients the depressive symptoms disappeared . Symptoms of depression occurred in two patients , in which case coexisting situational factors were found to be the cause . No occurrence of suicidal ideations was found . CONCLUSIONS We did not find any depressive symptoms or suicide risk caused by isotretinoin . On the contrary , a statistically significant improvement of BDI-II scores was found . In our opinion , patients have to be informed about the risk of depression but emphasizing the fact that it is very rare Background : There have been concerns about the association between isotretinoin therapy and depressive symptoms . Objective : The objective of this study is to evaluate whether there is an association between isotretinoin therapy and the onset of depression . Methods : A total of 50 patients with moderate to severe recalcitrant acne and 30 healthy volunteer people were enrolled in the study . Depressive symptoms and anxiety status were assessed at baseline and then 1 and 4 months after the initiation of isotretinoin treatment . Results : We detected improvement in Beck Depression Inventory ( BDI ) and State and Trait Anxiety Inventory ( STAI ) scores in acne patients after isotretinoin therapy . Statistically significant improvement in depressive symptoms began at the first month . Improvement in anxiety was detected later than the improvement in depressive symptoms and a statistically significant difference was detected between the first and the second follow-up . Conclusions : Our results provide no relationship between isotretinoin use and depression in acne patients BACKGROUND Isotretinoin-Lidose , the first new formulation of isotretinoin in 30 years , differs from previously approved isotretinoin formulations in that it is less dependent on the presence of fat in the gut for absorption . OBJECTIVE Evaluate the safety profiles of isotretinoin-Lidose and food-dependent generic isotretinoin in the largest clinical study with isotretinoin-925 r and omized patients from 49 study sites . Determine if the efficacy of this new formulation is noninferior to an existing isotretinoin . METHODS Multicenter , double-blind , r and omized , parallel-group , noninferiority trial . Study medication was taken with meals twice daily for 20 weeks . Patients were followed for 4 weeks after the last dose . Safety evaluations included recordings of adverse events , assessment s for depression , anxiety , emergent psychotic symptoms , and suicidal ideation/behavior , as well as DEXA and X-ray evaluations and changes in bone age . Two co- primary efficacy outcomes were measured to assess noninferiority : a ) change in total nodular facial and truncal lesion count at from baseline to week 20 and b ) percentage of patients who experienced at least 90 % reduction in nodular facial and truncal lesion count from baseline to week 20 . LIMITATIONS Although isotretinoin-Lidose can be taken without meals , it was given with food because the absorption of both formulations in the study had to be similar to detect noninferiority . RESULTS The safety profile of the 2 formulations was comparable . Criteria for noninferiority for both co- primary efficacy outcomes were met based on predetermined margins . CONCLUSION Safety and efficacy of isotretinoin-Lidose is similar and noninferior to food-dependent generic isotretinoin , respectively There have been recent concerns about the possible association between isotretinoin therapy and depressive symptoms . We conducted a prospect i ve study to evaluate depressive symptoms and quality of life in acne patients having either isotretinoin or antibiotics/topical treatments . There were 215 patients ( mean age 20 years ) included in the study . Depression , quality of life and acne severity ratings were administered at baseline , 1 month , 3 months and end of treatment or 6 months , and compared between both treatment groups . The changes in the mean depression scores did not differ significantly between both groups ( P = 0.62 ) . The incidence of isotretinoin patients with moderate depressive symptoms remained relatively unchanged from baseline . The changes in the quality ‐of‐life measures scores between treatment groups showed no significant difference . No correlation between isotretinoin dose and depression score was found . Although five isotretinoin patients were withdrawn during the study because of worsening of mood , no definite causal relationship was established . This pilot study does not appear to support any direct link between depression and isotretinoin , apart from being a rare unpredictable idiosyncratic side‐effect . However , because of the study limitations , a larger study is needed to confirm the findings BACKGROUND There has been concern that the use of isotretinoin to treat acne may lead to depression . To date , research has not conclusively determined if this concern is warranted when contemplating the use of isotretinoin . OBJECTIVE This study investigated the impact of isotretinoin use for patients with acne on mood status . The hypothesis was that an association exists between the use of isotretinoin and the development of depression , aside from acne severity . METHODS We studied the relationship between isotretinoin and depression using a prospect i ve , controlled , cohort design . The study was conducted in a community dermatology clinic . The exposed cohort consisted of consenting patients who were initiating isotretinoin treatment for acne . Patients were either treated with isotretinoin ( Acutaneï ) therapy ( study group ) ( N=100 ) or by oral ( N=41 ) or topical acne therapy ( control group ) ( N=59 ) . The Center for Epidemiologic Studies Depression scale and the Zung Depression Status Inventory were used to assess depression both at baseline and after 2 months of prescribed use of isotretinoin or a control medication ( topical or oral antibiotics ) . RESULTS There was no correlation between isotretinoin use and the development of depression , based on either the Centre for Epidemiologic Studies Depression scale ( Fisherâs exact test , P=0.497 ) or Zung Depression Status Inventory ( ANOVA ; F=1.4 , P=0.2 ) . CONCLUSION Isotretinoin does not appear to be associated with the development of depression . Thus , denying patients with significant acne an effective medication for fear of developing depression may not be indicated at this point in time BACKGROUND Isotretinoin is a very effective drug for treating severe recalcitrant nodular acne . A new micronized formulation of isotretinoin has been shown to be clinical ly equivalent to st and ard isotretinoin with improved bioavailability and minimal food effect . The safety profile of the micronized formulation has not been described previously . OBJECTIVE The objective of this article is to report the incidence and intensity of adverse events found in a comparative , double-blind efficacy study that showed clinical equivalence of the new micronized formulation of isotretinoin and the st and ard isotretinoin formulation ( Accutane ) . METHODS Six hundred patients with severe recalcitrant nodular acne were treated with micronized isotretinoin ( n = 300 ) under fasted conditions or st and ard isotretinoin ( n = 300 ) under fed conditions . One cohort received single daily doses of 0.4 mg/kg of micronized isotretinoin without food and the other cohort received 1.0 mg/kg per day of st and ard isotretinoin in two divided doses with food . Adverse events were monitored during 20 weeks of drug therapy . RESULTS The proportion of adverse events in most body systems was generally lower in patients receiving micronized isotretinoin than in those receiving st and ard isotretinoin . CONCLUSION Micronized isotretinoin appears to have a safety profile similar to that of st and ard isotretinoin and to carry a lower risk of mucocutaneous events and hypertriglyceridemia BACKGROUND Since the introduction of isotretinoin to the market , many adverse psychiatric effects , including depression , anxiety and suicide attempts were reported . The aim of this study was to determine whether patients with acne who were treated with isotretinoin experienced significant increases in psychiatric symptoms over a 4-month period compared with patients who received topical acne therapy . METHODS Seventy-eight acne patients were allocated either to isotretinoin treatment ( study group ) ( n = 37 ) or to topical treatment ( control group ) ( n = 41 ) . Their psychological status was evaluated at the baseline , second and fourth months of the treatment . All patients were required to complete the dermatology life quality index ( DLQI ) , the Hospital anxiety and depression ( HAD ) scale , and the beck depression inventory ( BDI ) . RESULTS The two groups were not different from each other in terms of DLQI , BDI , HAD-A , HAD-D and total HAD scores at baseline . However , at the end of the second month quality of life was more impaired in the topical treatment group compared to the isotretinoin group ( P < 0.05 ) , and there were no difference between two groups in terms of BDI , HAD-A , HAD-D , and total HAD scores ( P > 0.05 ) . At the end of fourth month quality of life and all psychological test scores had improved more in the isotretinoin group compared to topical treatment group ( P < 0.05 ) . CONCLUSION Results of the present study indicate that there is no increase in depressive and anxiety symptoms in the isotretinoin treatment group compared to that in the topical group . Instead , successful treatment of acne seems to improve both depressive and anxiety symptoms and improve quality of life Acne patients are subject to different degree of psychosocial distress . The emotional impact of acne vulgaris due to disfigurement caused by the disease is undisputed . Most common reactions to the acne are depression and anxiety . The use of isotretinoin , one of the most effective options in acne treatment , increases depression symptoms . The aim of this study was to investigate the psychological status of the patients with moderate to severe acne and to compare patients treated with isotretinoin with patients treated with vitamin C. A total of 85 patients suffering from acne vulgaris were included in the study . The results of this study do not find a significant correlation between the use of isotretinoin and the psychological effects of the drug OBJECTIVE To investigate the putative association between isotretinoin treatment and depressive symptoms or suicidal ideation among Finnish male military conscripts . METHODS ; Consecutive acne patients were enrolled into an uncontrolled , prospect i ve 12-week follow-up study conducted at the Central Military Hospital , Helsinki , Finl and . Of the 135 patients prescribed isotretinoin , 126 ( 93.3 % ) completed the follow-up . Depression and suicidal ideation were investigated with the Beck Depression Inventory ( BDI ) at baseline , weeks 4 - 6 , and weeks 10 - 12 . RESULTS BDI mean score was low at baseline and declined further significantly ( p < 0.001 ) during the follow-up from 3.0 ( SD 3.948 ) to 1.8 ( SD 3.783 ) among patients on isotretinoin . Moreover , the proportion of patients with clinical ly significant depressive symptoms ( BDI > or= 10 ) declined non-significantly from 7.1 % to 3.2 % . Suicidal ideation was reported by 17 ( 13.5 % ) patients at baseline and 9 ( 7.1 % ) patients at the end of the follow-up ( NS ) . During the follow-up , one non-depressed patient attempted suicide while intoxicated by alcohol . CONCLUSION On group level , isotretinoin seems not to be typically associated with treatment-emergent depression or suicidal ideation among young men . However , the possibility that individual patients may be susceptible for mood effects of isotretinoin as a rare idiosyncratic reaction can not be excluded |
394 | 29,844,879 | Conclusions Although ARBs significantly decreased plasma low-density lipoprotein and total cholesterol levels , the current evidence is insufficient to support the efficacy of ARBs in managing fibrosis in NAFLD patients | Objective Non-alcoholic fatty liver disease ( NAFLD ) is one of the most common chronic liver diseases , ranging from simple steatosis to progressive steatohepatitis and cirrhosis .
Because of their anti-inflammatory and anti-fibrotic effects , angiotensin receptor blockers ( ARBs ) are potential therapeutic agents for NAFLD .
The present systematic review assessed the effectiveness of ARBs in NAFLD management . | Summary Background Recent data suggest that the renin-angiotensin-aldosteron system ( RAAS ) may be of importance in the pathogenesis of nonalcoholic fatty liver disease ( NAFLD ) . We were interested to investigate whether the therapy with RAAS blockers in patients with different stages of chronic kidney disease ( CKD ) has any effect on steatosis and fibrosis grade ; NAFLD documented by transient elastography ( TE ) ( Fibroscan ® -CAP ) . Methods Of 191 patients with various stages of CKD there were 61 patients with CKD grade III and IV , 62 patients with end-stage renal disease treated with chronic hemodialysis and 68 renal transplant recipients . Liver stiffness was selected as the parameter to quantify liver fibrosis . Furthermore , the Controlled Attenuation Parameter ( CAP ) was used to detect and quantify liver steatosis with the help of TE . Results CKD patients ( p = 0.005 ) and CKD-NAFLD patients ( p = 0.0005 ) with angiotensin-converting enzyme inhibitors ( ACE-I ) or angiotensin receptor blockers ( ARBs ) had statistically significant lower degree of liver stiffness in comparison to those without these medications ( p = 0.005 ) . Also , we were interested to explore is there any difference in fibrosis and steatosis grade due to use of ACE-I or ARBs . We did not find statistically significant differences between those two subgroups of patients with respect to liver steatosis/fibrosis . Conclusion Based on our results , RAAS blockers could be an attractive option for the management of NAFLD . We believe that TE provides the opportunity of noninvasive screening of NAFLD in CKD patients . In further prospect i ve analysis , we believe that by using TE as noninvasive method we could investigate are ACE-I/ARBs really effective medications for the treatment of NAFLD in CKD patients .ZusammenfassungGrundlagenKürzlich berichtete Ergebnisse deuten darauf hin , dass das Renin-Angiotensin System ( RAAS ) von Bedeutung für die Pathogenese der nicht-alkoholischen Fettleber ( NAFLD ) sein könnte . Wir untersuchten , ob bei Patienten mit verschiedenen Stadien einer chronischen Nierenerkrankung ( CKD ) eine Therapie mit Blockern des RAAS eine Wirkung auf den Steatose- beziehungsweise Fibrose-Grad ( dokumentiert mittels transienter Elastographie ( TE ) – Fibroscan ® -CAP ) der Leber ausübt . Method ikEs wurden 191 Patienten mit verschiedenen Stadien der Niereninsuffizienz untersucht : 61 Patienten waren i m Stadium III der CKD , 62 Patienten waren i m Endstadium der Niereninsuffizienz und an der chronischen Hämodialyse , 68 Patienten waren Nierentransplantatempfänger . Als Parameter zur Quantifizierung der Leberfibrose wurde die Steifheit der Leber herangezogen . Außerdem wurde mit Hilfe der TE der „ Controlled Attenuation Parameter ( CAP ) “ zur Erkennung und Quantifizierung einer Steatose der Leber verwendet . ErgebnisseDie CKD Patienten ( p = 0,05 ) und die CKD-NAFLD Patienten ( p = 0,0005 ) , die mit ACE Hemmern oder Angiotensinrezeptorblockern beh and elt worden waren , hatten i m Vergleich zu den Patienten ohne diese Medikation einen statistisch signifikant niedrigeren Grad der Lebersteifheit . In Bezug auf die Steatose beziehungsweise den Fibrosegrad der Leber war kein statistisch signifikanter Einfluss der Medikation zu erheben . SchlussfolgerungUnsere Ergebnisse lassen den Schluss zu , dass RAAS Blocker eine attraktive Option beim Management der NAFLD sein könnten . Wir glauben , dass die TE eine Möglichkeit bietet , bei CKD Patienten nicht invasiv auf NAFLD zu screenen Telmisartan , a new angiotensin II type 1 receptor blocker ( ARB ) , was recently reported to stimulate PPARgamma , and stronger effects of Telmisartan on insulin sensitivity has been expected than the class effect of ARB . In the present study , we examined the effects of Telmisartan on insulin sensitivity and adipokine levels in hypertensive and type 2 diabetic patients . Out patients with both hypertension and type 2 diabetes mellitus ( n=36 ; male 23 , female 13 ) , received 20 - 40 mg Telmisartan orally once daily for 6 months . Physical examinations and blood or urine tests were performed before and 3 or 6 months after starting Telmisartan treatment . Results were statistically compared using Wilcoxon analysis . Telmisartan treatment for 3 or 6 months reduced systolic and diastolic blood pressure and urinary albumin excretion . Fasting plasma glucose , HbA1c , total and HDL-cholesterol , triglyceride , body weight , BMI and waist length were not changed . Fasting IRI and HOMA-IR were significantly decreased after Telmisartan treatment , suggesting the improved insulin sensitivity . Total and high molecular adiponectin were not changed . Interestingly , serum leptin was significantly increased by 3 months Telmisartan treatment , suggesting a possible involvement of leptin in improved insulin sensitivity . In conclusion , Telmisartan improved insulin resistance with increased serum leptin level in hypertensive and type 2 diabetic patients Introduction Non-alcoholic fatty liver disease ( NAFLD ) is a common liver disease worldwide . Experimental and small clinical trials have demonstrated that angiotensin II blockers ( ARB ) may be anti-fibrotic in the liver . The aim of this r and omised controlled trial was to assess whether treatment with Losartan for 96 weeks slowed , halted or reversed the progression of fibrosis in patients with non-alcoholic steatohepatitis ( NASH ) . Methods Double-blind r and omised-controlled trial of Losartan 50 mg once a day versus placebo for 96 weeks in patients with histological evidence of NASH . The primary outcome for the study was change in histological fibrosis stage from pre-treatment to end-of-treatment . Results The study planned to recruit 214 patients . However , recruitment was slower than expected , and after 45 patients were r and omised ( median age 55 ; 56 % male ; 60 % diabetic ; median fibrosis stage 2 ) , enrolment was suspended . Thirty-two patients ( 15 losartan and 17 placebo ) completed follow up period : one patient ( 6.7 % ) treated with losartan and 4 patients ( 23.5 % ) in the placebo group were “ responders ” ( lower fibrosis stage at follow up compared with baseline ) . The major reason for slow recruitment was that 39 % of potentially eligible patients were already taking an ARB or angiotensin converting enzyme inhibitor ( ACEI ) , and 15 % were taking other prohibited medications . Conclusions Due to the widespread use of ACEI and ARB in patients with NASH this trial failed to recruit sufficient patients to determine whether losartan has anti-fibrotic effects in the liver . Trial registration IS RCT N Saga Telmisartan Aggressive Research ( STAR ) is a single-arm , prospect i ve multi-center trial to evaluate the effectiveness of treatment with telmisartan in patients with hypertension . A total of 197 patients with a systolic blood pressure of > or = 140 or a diastolic blood pressure of > or = 90 mmHg were enrolled in this study , and were prescribed 20 to 80 mg/day of telmisartan for 6 months . In all patients , both systolic and diastolic blood pressures decreased ( 159+/-20 to 135+/-12 mmHg , p<0.0001 , 87+/-12 to 75+/-8 mmHg , p<0.0001 , respectively ) . In addition , total cholesterol ( TC ) levels decreased from 200+/-40 to 188+/-33 mg/dl ( p<0.05 ) . In patients with TC > or = 220 mg/dl , the change was more striking ( 249+/-33 to 204+/-31 mg/dl , p<0.0001 ) . Even in patients receiving statins , TC levels still were decreased ( 216+/-51 to 190+/-31 mg/dl , p<0.02 ) . In addition , TC levels were also decreased even in patients receiving telmisartan in exchange for other ARBs with TC > or = 220 mg/d . Triglyceride ( TG ) levels were decreased ( 270+/-199 to 175+/-74 mg/dl , p<0.005 ) in patients with TG levels > or = 150 mg/dl . Fasting blood glucose ( FBG ) was decreased ( 158+/-68 to 138+/-60 mg/dl , p<0.05 ) in patients with FBG > or = 110 mg/dl . These results suggest that telmisartan may have favorable effects on lipid and glucose metabolism , in addition to lowering blood pressure . The profound effect of telmisartan to lower cholesterol suggests a potential use in hypertensive patients with dyslipidemia Fatty liver is one of the local morphological manifestations of metabolic syndrome and is frequently associated with insulin resistance . Insulin resistance is also common in patients with chronic hepatitis C. Hyperinsulinemia is an independent risk factor for hypertension and cardiovascular mortality . The aim of this study was to evaluate the therapeutic efficacy of angiotensin II receptor blockers ( ARBs ) , telmisartan and olmesartan , for patients with non-alcoholic fatty liver disease ( NAFLD ) and chronic hepatitis C ( CH-C ) . We analyzed the incidence of obesity , insulin resistance , and other disorders in patients with NAFLD ( Group A ) , CH-C ( Group B ) , or other liver diseases ( Group C ) . We evaluated whether the ARBs , telmisartan and olmesartan , improved insulin resistance and liver injury by measuring the homeostasis model assessment ratio of insulin resistance ( HOMA-IR ) and serum alanine aminotransferase ( ALT ) . The incidence of obesity ( BMI > or = 25 kg/m2 ) was significantly higher in Group A than in Groups B and C. The incidence of insulin resistance ( HOMA-IR > or = 2.5 ) in Groups A and B was significantly higher than in Group C. Regular doses of telmisartan and olmesartan significantly improved HOMA-IR and ALT levels not only in NAFLD patients but also in patients with CH-C. The effects tended to be more notable with telmisartan . In conclusion , telmisartan and olmesartan improved insulin sensitivity and may possibly be used as liver protecting agents in CH-C as well as NAFLD patients UNLABELLED Medication combinations that improve the efficacy of thiazolidinediones or ameliorate weight-gain side effects of therapy represent an attractive potential treatment for ( NASH ) . The aim of this r and omized , open-label trial was to assess the efficacy of rosiglitazone and metformin in combination versus rosiglitazone and losartan , compared to rosiglitazone alone , after 48 weeks of therapy . A total of 137 subjects with biopsy-proven NASH were enrolled and r and omly assigned to receive either 4 mg twice-daily of rosiglitazone , 4 mg of rosiglitazone and 500 mg of metformin twice-daily , or 4 mg of rosiglitazone twice-daily and 50 mg of losartan once-daily for 48 weeks . Patients were screened for other etiologies of chronic liver disease , including daily alcohol intake in excess of 20 g. Repeat liver biopsy was performed after 48 weeks of therapy and review ed in a blinded fashion by a single expert hepatopathologist . The primary aim of the study was to assess for differences between treatment groups in the improvement of steatosis , hepatocellular inflammation , and fibrosis . In total , 108 subjects completed the trial . Primary outcome revealed no significant difference between treatment groups in all histologic parameters ( steatosis , P = 0.137 ; hepatocellular inflammation , P = 0.320 ; fibrosis , P = 0.229 ) . Overall improvement in steatosis , hepatocellular inflammation , ballooning degeneration , and fibrosis was observed ( P ≤ 0.001 ) . Serum aminotransferases were reduced in all three groups ( P < 0.001 within treatment , P > 0.05 between groups ) . Metformin did not significantly mitigate weight gain ( P = 0.051 ) . CONCLUSIONS Forty-eight weeks of combination therapy with rosiglitazone and metformin or rosiglitazone and losartan confers no greater benefit than rosiglitazone alone with respect to histopathology AIM To evaluate insulin resistance , cytolysis and non-alcoholic steatohepatitis ( NASH ) score ( NAS ) using the Kleiner and Brunt criteria in 54 patients with NASH and mild-to-moderate hypertension , treated with telmisartan vs valsartan for 20 mo . METHODS All patients met the NCEP-ATP III criteria for metabolic syndrome . Histology confirmed steatohepatitis , defined as a NAS greater than five up to 3 wk prior inclusion , using the current criteria . Patients with viral hepatitis , chronic alcohol intake , drug abuse or other significant immune or metabolic hepatic pathology were excluded . Subjects were r and omly assigned either to the valsartan ( V ) group ( st and ard dose 80 mg o.d . , n = 26 ) , or to the telmisartan ( T ) group ( st and ard dose 20 mg o.d . , n = 28 ) . Treatment had to be taken daily at the same hour with no concomitant medication or alcohol consumption allowed . Neither the patient nor the medical staff was aware of treatment group allocation . Paired liver biopsies obtained at inclusion ( visit 1 ) and end of treatment ( EOT ) were assessed by a single blinded pathologist , not aware of patient or treatment group . Blood pressure , BMI , ALT , AST , HOMA-IR , plasma triglycerides ( TG ) and total cholesterol ( TC ) were evaluated at inclusion and every 4 mo until EOT ( visit 6 ) . RESULTS At EOT we noticed a significant decrease in ALT levels vs inclusion in all patients and this decrease did not differ significantly in group T vs group V. HOMA-IR significantly decreased at EOT vs inclusion in all patients but in group T , the mean HOMA-IR decrease per month was higher than in group V. NAS significantly diminished at EOT in all patients with a higher decrease in group T vs group V. CONCLUSION Angiotensin receptor blockers seem to be efficient in hypertension-associated NASH . Telmisartan showed a higher efficacy regarding insulin resistance and histology , perhaps because of its specific PPAR-gamma lig and effect Background / Aim : Telmisartan can attenuate two hit pathogenesis of non-alcoholic steatohepatitis ( NASH ) . This study aim ed to observe the effect of Telmisartan on non-alcoholic fatty liver disease ( NAFLD ) activity score ( NAS ) and fibrosis score in NASH patients . Patients and Methods : A total of 50 NASH patients were r and omized ; 35 of group 1 were treated with Telmisartan 40/80 mg once daily with life style modification ( TL ) and 15 of group 2 underwent only life style modification ( L ) for 1 year . At the end , 20 of TL group and 10 of L group were analyzed . Those who showed NAS improvement ≥ 2 or NAS improvement ≥ 1 with fibrosis improvement ≥ 1 were considered as responders . Results : Baseline alanine aminotransferase ( ALT ) , aspartate aminotransferase ( AST ) , insulin resistance index , components of metabolic syndrome , age , and sex were similar in both groups . At the end of study , NAS improvement in TL and L groups was 2.15 ± 1.66 and 1.10 ± 0.57 ( P = 0.017 ) and fibrosis improvement was 0.65 ± 0.93 and –0.30 ± 0.48 ( P = 0.001 ) , respectively . NAS improved by ≥ 2 in 13 ( 65 % ) and 2 ( 20 % ) patients and fibrosis score improved by ≥ 1 in 8 ( 40 % ) patients and none of the patients in TL group and L group , respectively . Telmisartan and life style modification could improve steatosis , ballooning , lobular inflammation , and fibrosis . Life style modification could improve ballooning only , but fibrosis deteriorated . TL group showed improvement in NAS and fibrosis score [ P value : 0.035 ; odds ratio ( OR ) = 92.07 , confidence interval ( CI ) = 1.39–6106 ] to the level of response by regression analysis . Weight reduction and improvement of metabolic syndrome did not influence the response . There were similar minor adverse events in both groups . Conclusion : Telmisartan improved NAS and fibrosis score in NASH with insignificant adverse events |
395 | 26,337,865 | Consequently it is not clear if any one systemic antibiotic treatment is better than others in resolving infection or in terms of safety . | BACKGROUND Foot infection is the most common cause of non-traumatic amputation in people with diabetes .
Most diabetic foot infections ( DFIs ) require systemic antibiotic therapy and the initial choice is usually empirical .
Although there are many antibiotics available , uncertainty exists about which is the best for treating DFIs .
OBJECTIVES To determine the effects and safety of systemic antibiotics in the treatment of DFIs compared with other systemic antibiotics , topical foot care or placebo . | A phase 3 , r and omized , double-blind trial was conducted in subjects with diabetic foot infections without osteomyelitis ( primary study ) or with osteomyelitis ( sub study ) to determine the efficacy and safety of parenteral ( intravenous [ iv ] ) tigecycline ( 150 mg once-daily ) versus 1 g once-daily iv ertapenem ± vancomycin . Among 944 subjects in the primary study who received ≥1 dose of study drug , > 85 % had type 2 diabetes ; ~90 % had Perfusion , Extent , Depth/tissue loss , Infection , and Sensation infection grade 2 or 3 ; and ~20 % reported prior antibiotic failure . For the clinical ly evaluable population at test-of-cure , 77.5 % of tigecycline- and 82.5 % of ertapenem ± vancomycin-treated subjects were cured . Corresponding rates for the clinical modified intent-to-treat population were 71.4 % and 77.9 % , respectively . Clinical cure rates in the sub study were low ( < 36 % ) for a subset of tigecycline-treated subjects with osteomyelitis . Nausea and vomiting occurred significantly more often after tigecycline treatment ( P = 0.003 and P < 0.001 , respectively ) , result ing in significantly higher discontinuation rates in the primary study ( nausea P = 0.007 , vomiting P < 0.001 ) . In the primary study , tigecycline did not meet criteria for noninferiority compared with ertapenem ± vancomycin in the treatment of subjects with diabetic foot infections Aims /hypothesisThe aim of the present study was to investigate re source utilisation and associated costs in patients with diabetic foot ulcers and to analyse differences in re source utilisation between individuals with or without peripheral arterial disease ( PAD ) and /or infection . Methods Data on re source utilisation were collected prospect ively in a European multicentre study . Data on 1,088 patients were available for the analysis of re source use , and data on 821 patients were included in the costing analysis . Costs were calculated for each patient by multiplying the country-specific direct and indirect unit costs by the number of re sources used from inclusion into the study up to a defined endpoint . Country-specific costs were converted into purchasing power st and ards . Results Re source use and costs varied between outcome groups and between disease severity groups . The highest costs per patient were for hospitalisation , antibiotics , amputations and other surgery . All types of re source utilisation and costs increased with the severity of disease . The total cost per patient was more than four times higher for patients with infection and PAD at inclusion than for patients in the least severe group , who had neither . Conclusions /interpretationImportant differences in re source use and costs were found between different patient groups . The costs are highest for individuals with both peripheral arterial disease and infection , and these are mainly related to substantial costs for hospitalisation . In view of the magnitude of the costs associated with in-hospital stay , reducing the number and duration of hospital admissions seems an attractive option to decrease costs in diabetic foot disease Daptomycin is the first available agent from a new class of antibiotics , the cyclic lipopeptides , that has activity against a broad range of gram-positive pathogens , including organisms that are resistant to methicillin , vancomycin , and other currently available agents . Daptomycin ( 4 mg/kg intravenously [ iv ] every 24 h for 7 - 14 days ) was compared with conventional antibiotics ( penicillinase-resistant penicillins [ 4 - 12 g iv per day ] or vancomycin [ 1 g iv every 12 h ] ) in 2 r and omized , international trials involving 1092 patients with complicated skin and skin-structure infections . Among 902 clinical ly evaluable patients , clinical success rates were 83.4 % and 84.2 % for the daptomycin- and comparator-treated groups , respectively ( 95 % confidence interval , -4.0 to 5.6 ) . Among patients successfully treated with iv daptomycin , 63 % required only 4 - 7 days of therapy , compared with 33 % of comparator-treated patients ( P<.0001 ) . The frequency and distribution of adverse events were similar among both treatment groups . Overall , the safety and efficacy of daptomycin were comparable with conventional therapy BACKGROUND Severe skin and soft-tissue infections ( SSTIs ) , particularly diabetic foot infections , are a source of considerable morbidity and mortality . Inappropriate antimicrobial therapy may contribute to the increasing emergence of bacterial resistance , as well as to increased health care costs . Thus , there is a continuing search for reasonably safe , well-tolerated , and effective antimicrobial agents that are less susceptible to the development of resistance than older agents . OBJECTIVE The Department of Veterans Affairs ( VA ) Medical Center in Nashville , Tennessee , was I site in a multicenter , Phase III , r and omized , investigator-blinded clinical trial comparing the safety and efficacy of clinafloxacin with those of piperacillin/tazobactam in the treatment of adult patients with SSTI . METHODS Over an 18-month period , patients aged > or = 18 years with physical findings of acute bacterial SSTI requiring hospitalization and intravenous antimicrobial therapy were r and omized in a 1:1 ratio to receive either clinafloxacin 200 mg IV every 12 hours or piperacillin/tazobactam 3.375 g IV every 6 hours . After a minimum of 3 days of intravenous therapy , a switch to oral therapy with clinafloxacin 200 mg PO every 12 hours or amoxicillin/clavulanate 500 mg PO every 8 hours could be made in the respective treatment groups . RESULTS The center enrolled 84 patients ( 42 in each group ) , all but I of whom were male , reflecting the typical VA medical center population . The mean age was 60 years ( range , 36 - 80 years ) in the clinafloxacin group and 65 years ( range , 35 - 87 ) in the piperacillin/tazobactam group ; the latter group was significantly older ( P = 0.0482 ) , which could have affected recovery rates . Sixty-six patients were white and 18 were black . The mean ( + /- SD ) duration of treatment was 10.69 + /- 5.34 days in the clinafloxacin group and 12.07 + /- 5.06 days in the piperacillin/tazobactam group ; the mean length of stay was 10.83 + /- 10.28 days and 14.95 + /- 19.20 days , respectively . Fifty-three ( 63 % ) patients were switched to oral therapy ( 21 in the clinafloxacin group , 32 in the piperacillin/tazobactam group ) . The most commonly isolated pathogens were Staphylococcus aureus , Enterococcus faecalis , Pseudomonas aeruginosa , and Enterobacter cloacae . Clinical cure rates and microbiologic eradication rates were similar between the 2 treatments . The piperacillin/ tazobactam arm experienced more all-cause adverse events than the clinafloxacin arm , although the difference was not statistically significant . The clinafloxacin arm experienced significantly more adverse events ( eg , photosensitivity ) that were judged by the investigator to be drug related ( P = 0.034 ) . CONCLUSIONS In this study population of hospitalized adults , clinafloxacin was as effective as piperacillin/tazobactam in the treatment of complicated SSTIs . Appropriate pre caution s must be taken against exposure to sunlight and ultraviolet light in patients receiving clinafloxacin , and adequate monitoring is necessary . Further investigation is necessary into how the phototoxic effects of the flu oroquinolones can be limited This study tested whether levofloxacin , at a new high dose of 750 mg , was effective for the treatment of complicated skin and skin-structure infections ( SSSIs ) . Patients with complicated SSSIs ( n=399 ) were r and omly assigned in a ratio of 1:1 to 2 treatment arms : levofloxacin ( 750 mg given once per day intravenously [ iv ] , orally , or iv/orally ) or ticarcillin-clavulanate ( TC ; 3.1 g given iv every 4 - 6 hours ) followed , at the investigator 's discretion , by amoxicillin-clavulanate ( AC ; 875 mg given orally every 12 hours ) . In the clinical ly evaluable population , therapeutic equivalence was demonstrated between the levofloxacin and TC/AC regimens ( success rates of 84.1 % and 80.3 % , respectively ) . In the microbiologically evaluable population , the overall rate of eradication was 83.7 % in the levofloxacin treatment group and 71.4 % in the TC/AC treatment group ( 95 % confidence interval , -24.3 to -0.2 ) . Both levofloxacin and TC/AC were well tolerated . These data demonstrate that levofloxacin ( 750 mg once per day ) is safe and at least as effective as TC/AC for complicated SSSIs Objectives The primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens : moxifloxacin iv/oral versus piperacillin/tazobactam ( TZP ) iv followed by oral amoxicillin/clavulanate ( AMC ) . Patients and methods The study had a prospect i ve , r and omized , double-dummy , double-blind , multicentre design . Patients ≥18 years were prospect ively stratified according to complicated skin and skin structure infection ( cSSSI ) subtype/diagnosis ( major abscess , diabetic foot infection , wound infection or infected ischaemic ulcer ) , surgical intervention and severity of illness . Diagnoses and disease severity were based on predetermined criteria , documented by repeated photographs , and confirmed by an independent data review committee . Patients were r and omized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7–21 days . The primary efficacy variable was clinical response at test of cure ( TOC ) for the per- protocol ( PP ) population . Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions . Clinical trials registry number : NCT 00402727 . Results A total of 813 patients were r and omized . Clinical success rates at TOC were similar for moxifloxacin and TZP – AMC in the PP [ 320/361 ( 88.6 % ) versus 275/307 ( 89.6 % ) , respectively ; P = 0.758 ] and intent-to-treat ( ITT ) [ 350/426 ( 82.2 % ) versus 305/377 ( 80.9 % ) , respectively ; P = 0.632 ] population s. Thus , moxifloxacin was non-inferior to TZP – AMC . Bacteriological success rates were high in both treatment arms [ moxifloxacin : 432/497 ( 86.9 % ) versus TZP – AMC : 370/429 ( 86.2 % ) , microbiologically valid ( MBV ) population ] . Moxifloxacin was non-inferior to TZP – AMC at TOC in both the MBV and the ITT population s. Both treatments were well tolerated . Conclusions Once-daily iv/oral moxifloxacin monotherapy was clinical ly and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs Background In the United Kingdom ( UK ) , there is an extensive market for the class ' A ' drug heroin . Many heroin users spend time in prison . People addicted to heroin often require prescribed medication when attempting to cease their drug use . The most commonly used detoxification agents in UK prisons are buprenorphine , dihydrocodeine and methadone . However , national guidelines do not state a detoxification drug of choice . Indeed , there is a paucity of research evaluating the most effective treatment for opiate detoxification in prisons . This study seeks to address the paucity by evaluating routinely used interventions amongst drug using prisoners within UK prisons . Methods / Design The Leeds Evaluation of Efficacy of Detoxification Study ( LEEDS ) Prisons Pilot Study will use r and omised controlled trial methodology to compare the open use of buprenorphine and dihydrocodeine for opiate detoxification , given in the context of routine care , within HMP Leeds . Prisoners who are eligible and give informed consent will be entered into the trial . The primary outcome measure will be abstinence status at five days post detoxification , as determined by a urine test . Secondary outcomes during the detoxification and then at one , three and six months post detoxification will be recorded The management of infectious diabetic foot ulcers is a major concern . Various treatment modalities are used . The efficacy and tolerability of a combination of ofloxacin and tinidazole in diabetic foot ulcer has been assessed in 60 patients in the present trial . The results are promising Linezolid , the first available member of a new antibiotic class , the oxazolidinones , is broadly active against gram-positive bacteria , including drug-resistant strains . In this r and omized , open-label trial , hospitalized adults with known or suspected methicillin-resistant Staphylococcus aureus ( MRSA ) infections were treated with linezolid ( 600 mg twice daily ; n=240 ) or vancomycin ( 1 g twice daily ; n=220 ) for 7 - 28 days . S. aureus was isolated from 53 % of patients ; 93 % of these isolates were MRSA . Skin and soft-tissue infection was the most common diagnosis , followed by pneumonia and urinary tract infection . At the test-of-cure visit ( 15 - 21 days after the end of therapy ) , among evaluable patients with MRSA , there was no statistical difference between the 2 treatment groups with respect to clinical cure rates ( 73.2 % of patients in the linezolid group and 73.1 % in the vancomycin group ) or microbiological success rates ( 58.9 % in the linezolid group and 63.2 % in the vancomycin group ) . Both regimens were well tolerated , with similar rates of adverse events BACKGROUND Diabetic foot infections are a common and serious problem , yet few r and omised trials of adequate quality have compared the efficacy of the various antibiotic regimens available for their treatment . Our aim was to assess the efficacy and safety of ertapenem versus piperacillin/tazobactam for foot infections . METHODS We did a r and omised , double-blinded , multicentre trial in adults ( n=586 ) with diabetes and a foot infection classified as moderate-to-severe and requiring intravenous antibiotics . We assigned patients intravenous ertapenem ( 1 g daily ; n=295 ) or piperacillin/tazobactam ( 3.375 g every 6 h ; n=291 ) given for a minimum of 5 days , after which oral amoxicillin/clavulanic acid ( 875/125 mg every 12 h ) could be given for up to 23 days . Investigators retained the option to administer vancomycin to patients in either group to ensure adequate coverage for potentially antibiotic resistant Enterococcus spp and meticillin-resistant Staphylococcus aureus ( MRSA ) . Our primary outcome was the proportion of patients with a favourable clinical response ( cure or improvement ) on the day that intravenous antibiotic was discontinued . Analyses were by an evaluable-patient only approach . This study is registered with , number NCT00229112 . FINDINGS Of the 576 patients treated , 445 were available for assessment at the end of intravenous therapy . Both baseline characteristics and favourable clinical response rates were similar for the 226 who received ertapenem and the 219 who received piperacillin/tazobactam ( 94%vs 92 % , respectively ; between treatment difference 1.9 % , 95 % CI -2.9 to 6.9 ) . Rates of favourable microbiological responses ( eradication rates and clinical outcomes , by pathogen ) and adverse events did not differ between groups . INTERPRETATION Clinical and microbiological outcomes for patients treated with ertapenem were equivalent to those for patients treated with piperacillin/tazobactam , suggesting that this once-daily antibiotic should be considered for parenteral therapy of diabetic foot infections , when deemed appropriate OBJECTIVES The predominant pathogens causing diabetic foot infections are Gram-positive cocci , many of which are now resistant to commonly prescribed antibiotics . Daptomycin is a new agent that is active against most Gram-positive pathogens . To compare the effectiveness of daptomycin against semi-synthetic penicillins or vancomycin , we analysed the subset of diabetic patients with an infected ulcer enrolled in two r and omized , controlled investigator-blind trials of patients with complicated skin and soft-tissue infections presumptively caused by Gram-positive organisms . PATIENTS AND METHODS Patients with a diabetic ulcer infection were prospect ively stratified to ensure they were equally represented in the treatment groups , then r and omized to either daptomycin [ 4 mg/kg every 24 h intravenously ( iv ) ] or a pre-selected comparator ( vancomycin or a semi-synthetic penicillin ) for 7 - 14 days . RESULTS Among 133 patients with a diabetic ulcer infection , 103 were clinical ly evaluable ; 47 received daptomycin and 56 received a comparator . Most infections were monomicrobial , and Staphylococcus aureus was the predominant pathogen . Success rates for patients treated with daptomycin or the comparators were not statistically different for clinical ( 66 % versus 70 % , respectively ; 95 % CI , -14.4 , 21.8 ) or microbiological ( overall or by pathogen ) outcomes . Both treatments were generally well tolerated , with most adverse events of mild to moderate severity . CONCLUSIONS The clinical and microbiological efficacy and safety of daptomycin were similar to those of commonly used comparator antibiotics for treating infected diabetic foot ulcers caused by Gram-positive pathogens . Daptomycin should be considered for treating these infections , especially those caused by resistant Gram-positive pathogens ABSTRACT To evaluate empirical therapy with trimethoprim-sulfamethoxazole or doxycycline for outpatient skin and soft tissue infections in an area of high prevalence of methicillin-resistant Staphylococcus aureus , a r and omized , prospect i ve , open-label investigation was performed . The overall clinical failure rate was 9 % , with all failures occurring in the trimethoprim-sulfamethoxazole group . However , there was no significant difference between the clinical failure rate of empirical trimethoprim-sulfamethoxazole therapy and that of doxycycline therapy A cost-effectiveness analysis was performed following a double-blind , r and omized study of ampicillin/sulbactam ( A/S ) versus imipenem/cilastatin ( I/C ) for the treatment of limb-threatening foot infections in 90 diabetic patients . There were no significant differences between the treatments in terms of clinical success rate , adverse-event frequency , duration of study antibiotic treatment , or length of hospitalization . Costs of the study antibiotics , treatment of failures and adverse events , and hospitalization were calculated . Mean per-patient treatment cost in the A/S group was $ 14,084 , compared with $ 17,008 in the I/C group ( P = .05 ) , primarily because of lower drug and hospitalization costs and less-severe adverse events in the A/S group . Sensitivity analyses varying drug prices or hospital costs demonstrated that A/S was consistently more cost-effective than I/C. Varying the clinical success rate for each drug revealed that I/C would have to be 30 % more effective than A/S to change the economic decisions BACKGROUND A r and omized , double-blind , multicenter trial involving patients with a broad range of complicated skin and skin-structure infections due to either gram-positive or gram-negative bacteria was conducted to compare ceftobiprole monotherapy with treatment with vancomycin plus ceftazidime . METHODS Patients were r and omized 2:1 to receive ceftobiprole or to receive vancomycin plus ceftazidime . Outcomes were determined at a test-of-cure visit ( 7 - 14 days after completion of therapy ) and were analyzed for all patients with complicated skin and skin-structure infections , as well as for subgroups , on the basis of major types of infections and severity of disease . RESULTS Among the clinical ly evaluable and the intent-to-treat population s , clinical cure rates at the test-of-cure visit were similar in the ceftobiprole and comparator treatment arms ( clinical cure rate , 90.5 % [ 439 of 485 patients ] and 90.2 % [ 220 of 244 patients ] in the clinical ly evaluable population , respectively ; 81.9 % [ 448 of 547 patients ] and 80.8 % [ 227 of 281 patients ] in the intent-to-treat population , respectively ) . Clinical cure rates in ceftobiprole-treated patients ranged from 86.2 % ( 125 of 145 patients ) among those with diabetes who had foot infections to 93.0 % ( 80 of 86 patients ) among those with cellulitis . Among patients treated with ceftobiprole , clinical cure rates were similar among patients from whom gram-negative bacteria were isolated ( 87.9 % [ 109 of 124 patients ] ) and among patients from whom gram-positive bacteria were isolated ( 91.8 % [ 292 of 318 patients ] ) and were not statistically different from the clinical cure rates among comparator-treated patients ( 89.7 % [ 61 of 68 patients ] and 90.3 % [ 149 of 165 patients ] , respectively ) . Rates of adverse events and serious adverse events in the 2 treatment groups were similar . CONCLUSIONS Ceftobiprole monotherapy is as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections and infections due to gram-positive and gram-negative bacteria Foot infections in diabetic patients are predominantly caused by gram-positive cocci , many of which are now antibiotic resistant . Because linezolid is active against these pathogens , we compared the efficacy and safety of intravenous and oral formulations with that of intravenous ampicillin-sulbactam and intravenous and oral amoxicillin-clavulanate given for 7 - 28 days in a r and omized , open-label , multicenter study of all types of foot infection in diabetic patients ( ratio of linezolid to comparator drug recipients , 2:1 ) . Among 371 patients , the clinical cure rates associated with linezolid and the comparators were statistically equivalent overall ( 81 % vs. 71 % , respectively ) but were significantly higher for linezolid-treated patients with infected foot ulcers ( 81 % vs. 68 % ; P=.018 ) and for patients without osteomyelitis ( 87 % vs. 72 % ; P=.003 ) . Cure rates were comparable for in patients and out patients and for both oral and intravenous formulations . Drug-related adverse events were significantly more common in the linezolid group , but they were generally mild and reversible . Linezolid was at least as effective as aminopenicillin/beta-lactamase inhibitors for treating foot infections in diabetic patients BACKGROUND Soft tissue and bone infections of the lower limb continue to be a frequent and serious complication in patients with diabetes mellitus . The best choice of antimicrobial for the empiric treatment of moderate to severe diabetic foot infections has not been established clearly . METHODS We conducted a prospect i ve , r and omized , open-label , multicenter trial comparing piperacillin/tazobactam ( P/T ) ( 4 g/0.5 g q8h ) and ampicillin/sulbactam ( A/S ) ( 2 g/1 g q6h ) as a parenteral treatment for 314 adult patients with moderate-to-severe infected diabetic foot ulcers . Patients with polymicrobial infections involving methicillin-resistant Staphylococcus aureus also received vancomycin 1 g q12h . RESULTS Clinical efficacy rates ( cure or improvement ) were statistically equivalent overall ( 81 % for P/T vs. 83.1 % for A/S ) , and median duration of treatment was similar in the clinical ly evaluable population s ( nine days for P/T , 10 days for A/S ) . Drug-related adverse events for both study drugs were comparable in frequency and type . CONCLUSIONS Although both study drugs provide safe and effective empiric treatment for moderate-to-severe infected diabetic foot ulcers , piperacillin/tazobactam has the advantage of covering Pseudomonas aeruginosa ( bacteriologic success rate of 85.7 % ) , the most commonly isolated gram-negative pathogen in this study ABSTRACT This r and omized , double-blind , multicenter trial compared the efficacy and safety of linezolid , an oxazolidinone , with those of oxacillin-dicloxacillin in patients with complicated skin and soft tissue infections . A total of 826 hospitalized adult patients were r and omized to receive linezolid ( 600 mg intravenously [ i.v . ] ) every 12 h or oxacillin ( 2 g i.v . ) every 6 h ; following sufficient clinical improvement , patients were switched to the respective oral agents ( linezolid [ 600 mg orally ] every 12 h or dicloxacillin [ 500 mg orally ] every 6 hours ) . Primary efficacy variables were clinical cure rates in both the intent-to-treat ( ITT ) population and clinical ly evaluable ( CE ) patients and microbiological success rate in microbiologically evaluable ( ME ) patients . Safety and tolerability were evaluated in the ITT population . Demographics and baseline characteristics were similar across treatment groups in the 819 ITT patients . In the ITT population , the clinical cure rates were 69.8 and 64.9 % in the linezolid and oxacillin-dicloxacillin groups , respectively ( P = 0.141 ; 95 % confidence interval −1.58 to 11.25 ) . In 298 CE linezolid-treated patients , the clinical cure rate was 88.6 % , compared with a cure rate of 85.8 % in 302 CE patients who received oxacillin-dicloxacillin . In 143 ME linezolid-treated patients , the microbiological success rate was 88.1 % , compared with a success rate of 86.1 % in 151 ME patients who received oxacillin-dicloxacillin . Both agents were well tolerated ; most adverse events were of mild-to-moderate intensity . No serious drug-related adverse events were reported in the linezolid group . These data support the use of linezolid for the treatment of adults with complicated skin and soft tissue infections The effect of different antibiotics on the outcome of surgical care in the management of diabetic foot was investigated . We r and omly allocated 100 patients with diabetic foot into one of four groups . Each patient 's infection was grade d ( Wagner classification ) . All patients were offered the same surgical care but each group was assigned a different antibiotic . Hospital stay for the four groups ranged from 7 to 14 days . Five patients experienced complications from septicaemia ; 15 patients underwent amputation ; and five patients experienced temporary renal impairment . Careful consideration to the type of antibiotic used is essential In this prospect i ve , r and omized , open-label clinical trial , we compared the efficacy and safety of two antibiotic regimens for severe diabetic foot infections ( DFI ) . Sixty-two in- patients with DFI received either piperacillin/tazobactam ( Pip-Tazo , n = 30 ) ( 4.5 g intravenously every 8h ) or imipenem/cilastatin ( IMP , n = 32 ) ( 0.5 g intravenously every 6h ) . The mean duration of treatment was 21 days for Pip-Tazo and 24 days for IMP . Twenty-two ( 73.3 % ) patients in the Pip-Tazo group and 26 ( 81.2 % ) patients in the IMP group had DFI associated with osteomyelitis . Successful clinical response was seen in 14 ( 46.7 % ) patients in the Pip-Tazo group and in nine ( 28.1 % ) patients in the IMP group [ relative risk ( RR ) 1.6 ( 95 % CI 0.84 - 3.25 ) , p 0.130 ] . Two patients in the IMP group and none in the PIP-Tazo group relapsed [ RR 2 ( 0.94 - 4.24 ) , p 0.058 ] . Eighty-nine microorganisms were isolated : 38 ( 43 % ) Gram-positive and 51(57 % ) Gram-negative . Among patients with positive culture , 47 ( 96 % ) had complete and two ( 4 % ) had partial microbiological response . Microbiological response rates were similar in both groups ( p 1.000 ) . Amputation was performed in 18 ( 60 % ) and 22 ( 69 % ) patients in the Pip-Tazo and IMP groups ( p 0.739 ) respectively . Side effects were more common in the Pip-Tazo group ( 30 % vs. 9.4 % ) , but they were generally mild and reversible . In conclusion , although the sample size was small and the results did not reach statistical significance , Pip-Tazo produced a better clinical response rate than IMP in the treatment of severe DFI . There was no significant difference between the treatment groups with respect to microbiological response , relapse and amputation rates ABSTRACT Skin and soft tissue infections ( SSTIs ) are a common cause of morbidity in both the community and the hospital . An SSTI is classified as complicated if the infection has spread to the deeper soft tissues , if surgical intervention is necessary , or if the patient has a comorbid condition hindering treatment response ( e.g. , diabetes mellitus or human immunodeficiency virus ) . The purpose of this study was to compare linezolid to vancomycin in the treatment of suspected or proven methicillin-resistant gram-positive complicated SSTIs ( CSSTIs ) requiring hospitalization . This was a r and omized , open-label , comparator-controlled , multicenter , multinational study that included patients with suspected or proven methicillin-resistant Staphylococcus aureus ( MRSA ) infections that involved substantial areas of skin or deeper soft tissues , such as cellulitis , abscesses , infected ulcers , or burns ( < 10 % of total body surface area ) . Patients were r and omized ( 1:1 ) to receive linezolid ( 600 mg ) every 12 h either intravenously ( i.v . ) or orally or vancomycin ( 1 g ) every 12 h i.v . In the intent-to-treat population , 92.2 % and 88.5 % of patients treated with linezolid and vancomycin , respectively , were clinical ly cured at the test-of-cure ( TOC ) visit ( P = 0.057 ) . Linezolid outcomes ( 124/140 patients or 88.6 % ) were superior to vancomycin outcomes ( 97/145 patients or 66.9 % ) at the TOC visit for patients with MRSA infections ( P < 0.001 ) . Drug-related adverse events were reported in similar numbers in both the linezolid and the vancomycin arms of the trial . The results of this study demonstrate that linezolid therapy is well tolerated , equivalent to vancomycin in treating CSSTIs , and superior to vancomycin in the treatment of CSSTIs due to MRSA The efficacy and safety of ceftizoxime and cefoxitin were compared in a r and omized , double-blind study of therapy for lower extremity infections in patients with diabetes mellitus or peripheral vascular disease . Overall clinical responses were satisfactory in 82 % ( 23/28 ) of patients treated with ceftizoxime and in 68 % ( 17/25 ) of patients treated with cefoxitin . The difference was not statistically significant . Ceftizoxime had superior in vitro activity against Enterobacteriaceae , especially Enterobacter cloacae , whereas cefoxitin had better activity against the Bacteroides fragilis group . Relapses of infection were common in both groups during long-term follow-up ; only about one third of patients in either group maintained satisfactory outcomes after one year . More than half of the patients in both groups responded to one or more courses of medical therapy and avoided major amputations for one year following entry into the study In a double-blind r and omized trial , imipenem/cilastatin ( I/C ; 500 mg every 6 hours ) and ampicillin/sulbactam ( A/S ; 3 g every 6 hours ) were compared in regard to their efficacy for initial empirical and definitive parenteral treatment of limb-threatening pedal infection in diabetic patients . The major endpoints of treatment were cure ( resolution of soft-tissue infection ) , failure ( inadequate improvement , necessitating a change in antibiotic therapy ) , and eradication ( clearance of all pathogens from the wound and any bone cultures ) . Patients in the two treatment groups were similar in regard to the severity of diabetes ; presence of neuropathy and peripheral vascular disease ; site and severity of infection ; pathogen isolated ; and frequency of osteomyelitis ( associated with 68 % of the 48 A/S-treated infections and 56 % of the 48 I/C-treated infections ) . After 5 days of empirical treatment , improvement was noted in 94 % of the A/S and 98 % of the I/C recipients . At the end of definitive treatment ( days ' duration [ mean + /- SD ] : 13 + /- 6.5 [ A/S ] , 14.8 + /- 8.6 [ I/C ] ) , outcomes were similar : cure , 81 % ( A/S ) vs. 85 % ( I/C ) ; failure , 17 % ( A/S ) vs. 13 % ( I/C ) ; and eradication , 67 % ( A/S ) vs. 75 % ( I/C ) . Treatment failures were associated with the presence of antibiotic-resistant pathogens and possible nosocomial acquisition of infections . The number of adverse events among patients in the two treatment groups was similar : 7 in the A/S group ( 4 had diarrhea and 3 had rash ) and 9 in the I/C group ( 5 had diarrhea , 2 had severe nausea , 1 had rash , and 1 had seizure ) . Efficacy of A/S and I/C is similar for initial empirical and definitive treatment of limb-threatening pedal infection in patients with diabetes We conducted a prospect i ve , r and omized , double-blind trial comparing ertapenem ( 1 g once daily ) with piperacillin-tazobactam ( 3.375 g every 6 h ) as parenteral treatment for 540 adults with complicated skin and skin-structure infections . The most common diagnoses were skin or soft-tissue abscesses and lower-extremity infections associated with diabetes . The mean duration ( + /- st and ard deviation ) of therapy was 9.1+/-3.1 days for ertapenem and 9.8+/-3.3 days for piperacillin-tazobactam . At the assessment of primary efficacy end point , 10 - 21 days after treatment , 82.4 % of those who received ertapenem and 84.4 % of those who received piperacillin-tazobactam were cured . The difference in response rates , adjusting for the patients ' assigned strata , was -2.0 % ( 95 % confidence interval , -10.2 % to 6.2 % ) , indicating that the response rates in the 2 treatment groups were equivalent . Cure rates for the 2 treatment groups were similar when compared by stratum , diagnosis , and severity of infection . The frequency and severity of drug-related adverse events were similar in the treatment groups We compared the efficacy and safety of two beta-lactam-beta-lactamase inhibitor combinations , namely , piperacillin-tazobactam and ticarcillin-clavulanate , in the treatment of complicated bacterial infections of skin that required hospitalization . The study was a r and omized , double-blind , comparative trial involving 20 centers . The infections were classified as ( i ) cellulitis with drainage , ( ii ) cutaneous abscess , ( iii ) diabetic or ischemic foot infection , and ( iv ) infected wounds and ulcers with drainage . The clinical response rates were comparable for the two treatment regimens ( 61 % of the patients were cured with piperacillin-tazobactam and ticarcillin-clavulanate and improvement was seen in 15 and 16 % of patients treated with piperacillin-tazobactam and ticarcillin-clavulanate , respectively ) . Both regimens were found to be safe and well tolerated . These data support the use of piperacillin-tazobactam for initial empiric therapy of hospitalized patients with complicated skin and skin structure infections In this prospect i ve , double-blind , multicentre trial , adult patients with complicated skin and skin structure infection ( cSSSI ) r and omly received sequential intravenous (i.v.)/oral ( p.o . ) moxifloxacin ( 400 mg once a day ) or a control regimen of i.v . piperacillin-tazobactam ( 3.0/0.375 g every 6 h ) followed by p.o . amoxicillin-clavulanate ( 800 mg every 12 h ) , each for 7 - 14 days . Clinical cure rates at the test-of-cure visit ( 10 - 42 days post therapy ) for the efficacy-valid population were 79 % ( 143/180 ) for the moxifloxacin-treated group and 82 % ( 153/187 ) for the control group ( 95 % confidence interval , -12.04 , 3.29 ) . Bacteriological eradication rates for Staphylococcus aureus , the most prevalent organism , were 78 % and 80 % , respectively . The incidence of drug-related adverse events was similar for both groups ( 31 % moxifloxacin , 30 % control ) . Sequential i.v./p.o . moxifloxacin was as effective and well tolerated as i.v . piperacillin-tazobactam followed by p.o . amoxicillin-clavulanate in treating patients with cSSSI Diabetic foot infections , a frequent and serious cause of morbidity in patients with diabetes mellitus , are caused by anaerobic and aerobic bacteria . Given the fact that seriously impaired host defense factors are almost always present in these patients , bactericidal agents with a broad spectrum of antimicrobial activity are required for their treatment . Seventy-four patients with diabetic foot infections were treated with parenteral sulbactam-ampicillin ( 1.5 g , q.i.d . ) . All patients were followed-up prospect ively in order to determine the efficacy and safety of sulbactam-ampicillin . The mean duration ( + /- SD ) of treatment in patients with osteomyelitis ( n = 49 ) and soft tissue infections ( n = 25 ) was 41 + /- 5 and 14 + /- 3 days , respectively . Infected limbs were amputated at various levels in 14 patients ( 19 % ) . Clinical cure rates were 86 % and 100 % in patients with osteomyelitis and with soft tissue infection , respectively . The most frequent side effect was diarrhea and observed in 10 patients ( 14 % ) . The results of the present study indicate that sulbactam-ampicillin is safe and effective in the treatment of diabetic foot infections A r and omized trial to compare the efficacy and safety of 1 g of ceftriaxone daily and 3 to 4 g of cefazolin daily was conducted in 84 hospitalized adults with skin and soft tissue infections . A variety of infections including bacteriologically proven cellulitis , suppurative diabetic foot ulcer , soft tissue abscess , and other miscellaneous infections were treated . Side effects were minimal . Colonization with various microorganisms was observed during therapy with both agents . Clinical cure with or without surgery was achieved in 81 percent ( 34 ) of 42 patients treated with ceftriaxone and 77 percent ( 32 ) of 42 patients treated with cefazolin . The major difference between antibiotics was the rate of failure in infections caused by multiple organisms : five failures among 13 patients treated with cefazolin compared with no failures among 12 patients treated with ceftriaxone . Ceftriaxone appears to be an effective agent when given once daily as therapy for many serious skin and soft tissue infections Background : Complicated skin and skin structure infections ( cSSSIs ) are an important healthcare concern worldwide , as they can be life-threatening and challenging to treat . cSSSIs are normally managed using a combination of surgical intervention and prompt antibiotic use . New therapeutic options , including novel antibiotics , are required to improve outcomes in terms of duration of illness and to reduce the consumption of healthcare re sources . Methods : This was a prospect i ve , r and omized , open-label , parallel-group , multinational clinical study comparing sequential intravenous/oral ( iv/po ) moxifloxacin , 400 mg once daily , and iv amoxicillin/clavulanate , 1,000 mg/ 200 mg three times daily followed by po amoxicillin/ clavulanate , 500 mg/125 mg three times daily , for 7–21 days in hospitalized patients . Results : A total of 804 patients were enrolled ( mean age 51.8 years ) . The most common clinical diagnosis was complicated erysipelas ( 32.1 % moxifloxacin ; 30.0 % amoxicillin/ clavulanate ) and major abscess ( 31.1 % moxifloxacin ; 29.3 % amoxicillin/clavulanate ) . Overall clinical success rates at the test-of-cure ( TOC ) visit ( 14–28 days post-treatment ) for the per- protocol population ( primary efficacy variable ) were 80.6 % ( 254/315 ) for patients in the moxifloxacin group and 84.5 % ( 268/317 ) for those receiving amoxicillin/clavulanate ( 95 % confidence interval [ CI ] –9.41 , 2.18 ) . Similar results were obtained for the intention-to-treat population ( 95 % CI –7.56 , 4.31 ) . In both treatment groups , the highest clinical success rates were recorded for patients with complicated erysipelas , major abscess , surgical wound infection , and cellulitis . The lowest clinical cure rates were reported for diabetic foot infection and necrotizing fasciitis . In the microbiologically evaluable population , the bacteriological success rate ( eradication and presumed eradication ) was 76.0 % ( 127/ 167 ) in the moxifloxacin group and 81.4 % ( 140/172 ) in the amoxicillin/clavulanate group ( 95 % CI –12.96 , 4.41 ) . Staphylococcus aureus ( 137 isolates ) and Escherichia coli ( 50 isolates ) were the most frequently isolated skin pathogens . Adverse event rates were comparable between treatment groups . Conclusions : Treatment with sequential iv/po moxifloxacin monotherapy once daily is clinical ly comparable to that with iv/po amoxicillin/clavulanate three times daily in the management of cSSSIs . Moxifloxacin ’s simple dose regimen offers an advantage over amoxicillin/clavulanate and represents a valuable addition to current antibiotic regimens used in the treatment of cSSSIs OBJECTIVES Complicated skin and skin structure infections ( cSSSIs ) , including diabetic foot infections ( DFIs ) , are often polymicrobial , requiring combination or broad-spectrum therapy . Moxifloxacin , a broad-spectrum fluoroquinolone , is approved for cSSSI and can be administered by either intravenous ( iv ) or oral routes . To assess the efficacy of moxifloxacin for treating DFIs , we analysed a subset of patients with these infections who were enrolled in a prospect i ve , double-blind study that compared the efficacy of moxifloxacin with piperacillin-tazobactam and amoxicillin-clavulanate . METHODS Patients > or=18 years of age with a DFI requiring initial iv therapy were r and omized to either moxifloxacin ( 400 mg/day ) or piperacillin-tazobactam ( 3.0/0.375 g every 6 h ) for at least 3 days followed by moxifloxacin ( 400 mg/day orally ) or amoxicillin-clavulanate ( 800 mg every 12 h orally ) , if appropriate , for 7 - 14 days . DFI was usually defined as any foot infection plus a history of diabetes . Our primary efficacy outcome was the clinical response of the infection at test-of-cure ( TOC ) , 10 - 42 days post-therapy . RESULTS Among 617 patients enrolled in the original study , 78 with DFIs were evaluable for treatment efficacy . Clinical cure rates at TOC were similar for moxifloxacin and piperacillin-tazobactam/amoxicillin-clavulanate ( 68 % versus 61 % ) for patients with investigator-defined infection ( P=0.54 ) . Overall pathogen eradication rates in the microbiologically-valid population were 69 % versus 66 % for moxifloxacin and comparator , respectively ( P=1.00 ) . CONCLUSIONS Intravenous+/-oral moxifloxacin was as effective as iv piperacillin-tazobactam+/-amoxicillin-clavulanate in treating moderate-to-severe DFIs . Moxifloxacin may have potential as a monotherapy regimen for DFIs Abstract An open trial and a multicenter , three-group , r and omized trial versus cefazolin were performed to study the use of teicoplanin in the treatment of serious skin and soft tissue infections caused by Gram-positive bacteria . A total of 418 patients were entered into the r and omized trial , 293 of whom were available for efficacy analysis , and 262 patients were entered in the open trial . The r and omized trial had three arms : intramuscular ( 125 patients ) vs intravenous ( 148 patients ) teicoplanin vs cefazolin ( 145 patients ) . In both trials teicoplanin was administered once daily , originally as 3 mg/kg per day , with the option of higher doses in the open trial . Cefazolin was given at a dose of 1.5–4 g/day , in three divided doses . In the r and omized trial , teicoplanin and cefazolin showed similar overall efficacy . The higher dose of teicoplanin ( 6 mg/kg ) was significantly more effective than the lower dose ( 3 mg/kg ) , particularly in patients with diabetes . In the open trial , teicoplanin had a clinical success rate of 93 % . There was no significant difference in the incidence of adverse events between the cefazolin and teicoplanin groups . Outpatient ambulatory therapy was shown to be a practical method of administering teicoplanin . Once-daily dosing with teicoplanin may allow physicians to treat skin and soft tissue infections on a totally outpatient basis PURPOSE Lower extremity infections in the presence vascular insufficiency are difficult and costly to treat . Few well-controlled clinical trials evaluating the management of these infections exist . We decided to investigate the ability of a new fluoroquinolone , ciprofloxacin , to reduce the morbidity associated with these infections and the amount of in-hospital time required for the administration of antibiotic therapy . PATIENTS AND METHODS Forty-eight patients with peripheral vascular disease ( 46 with diabetes mellitus ) who presented to the hospital for treatment of lower extremity infections were r and omized in a blinded fashion to receive oral ciprofloxacin at a dosage of either 750 mg or 1,000 mg twice daily . Patients with osteomyelitis received three months of therapy and those with infections limited to soft tissues , three weeks of ciprofloxacin treatment . All subjects were followed for one year . RESULTS One patient received an amputation 24 hours after enrollment , and two patients discontinued therapy after 20 and 34 days because of adverse effects and were not evaluable . At the one-year follow-up , 27 of the 45 ( 60 percent ) evaluable patients had a fully successful outcome defined as not requiring either repeat antimicrobial therapy for their initial infection or amputation of the involved extremity . In the group of 18 patients in whom therapy failed , a total of only nine amputations were required . In the 15 patients whose lesion closed during therapy , 93 % ( 14 patients ) experienced a long-term successful outcome . CONCLUSION Treatment with this new fluoroquinolone offers promise for the improved outcome of patients with the serious infectious complication of infected lower extremity ulcerations in peripheral vascular disease , diabetes mellitus , or both BACKGROUND This open-label study compared oral or intravenous linezolid with intravenous vancomycin for treatment of complicated skin and soft-tissue infections ( cSSTIs ) caused by methicillin-resistant Staphylococcus aureus ( MRSA ) . METHODS Patients with proven MRSA cSSTI were r and omized to receive linezolid or vancomycin . Clinical and microbiologic outcomes , duration of antimicrobial therapy , length of hospital stay , and safety were assessed . RESULTS In the per- protocol population , the rate of clinical success was similar in linezolid- and vancomycin-treated patients ( P = .249 ) . The rate of success was significantly higher in linezolid-treated patients in the modified intent-to-treat population ( P = .048 ) . The microbiologic success rate was higher for linezolid at the end of treatment ( P < .001 ) and was similar at the end of the study ( P = .127 ) . Patients receiving linezolid had a significantly shorter length of stay and duration of intravenous therapy than patients receiving vancomycin . Both agents were well tolerated . Adverse events were similar to each drug 's established safety profile . CONCLUSIONS Linezolid is an effective alternative to vancomycin for the treatment of cSSTI caused by MRSA ABSTRACT Ceftobiprole is the first broad-spectrum cephalosporin with activity against methicillin-resistant Staphylococcus aureus ( MRSA ) to be assessed in late-stage clinical trials . As a pivotal step in the clinical development of ceftobiprole , a multicenter , global , r and omized , double-blind trial was conducted to compare the efficacy of ceftobiprole to that of vancomycin in patients with complicated skin and skin structure infections ( cSSSIs ) caused by gram-positive bacteria . The primary objective was to assess noninferiority on the basis of the cure rates 7 to 14 days after the completion of therapy in patients administered ceftobiprole 500 mg every 12 h or vancomycin 1 g every 12 h. Of 784 patients r and omized , 282 receiving ceftobiprole and 277 receiving vancomycin were clinical ly evaluable . Of these patients , 93.3 % treated with ceftobiprole and 93.5 % treated with vancomycin were cured ( 95 % confidence interval of difference , −4.4 % , 3.9 % ) . The cure rates for patients with MRSA infections were 91.8 % ( 56/61 ) with ceftobiprole treatment and 90.0 % ( 54/60 ) with vancomycin treatment ( 95 % confidence interval of difference , −8.4 % , 12.1 % ) . At least one adverse event ( AE ) was reported by 52 % of the ceftobiprole-treated patients and 51 % of the vancomycin-treated patients . The most common AEs reported by the ceftobiprole-treated patients were nausea ( 14 % ) and taste disturbance ( 8 % ) . Discontinuation of the study drug because of treatment-emergent AEs occurred in 4 % ( n = 17 ) of the ceftobiprole-treated patients and 6 % ( n = 22 ) of the vancomycin-treated patients . The results of this trial support the use of ceftobiprole as an effective and well-tolerated treatment option for patients with cSSSIs caused by a spectrum of gram-positive bacteria Oral ciprofloxacin ( 750 mg twice daily ) was compared with intravenous cefotaxime ( 2 g three times daily ) as therapy for 61 episodes of skin and skin structure infections occurring in adult patients . A variety of infections including cellulitis , infected ulcers , abscesses , and other miscellaneous infections were treated . Clinical cure was achieved in 77 percent ( 24 patients ) of 31 patients treated with ciprofloxacin and in 76 percent ( 22 patients ) of 28 patients treated with cefotaxime . The response was slower in infected diabetic patients than in non-diabetic patients in both groups . Side effects were minimal and appeared only in the cefotaxime group . Ciprofloxacin taken twice daily was as effective as cefotaxime administered intravenously three times daily in the treatment of skin and skin structure infections A controlled , r and omized study to compare the efficacy and safety of ticarcillin plus clavulanic acid with moxalactam was carried out in 25 evaluable patients with bone , joint , and skin or skin structure infections . Of the 13 patients in the ticarcillin plus clavulanic acid-treated group , nine had osteomyelitis , two had septic arthritis , one had cellulitis , and one had a wound infection . Four of the 12 moxalactam-treated patients had osteomyelitis , one had septic arthritis , and the other seven had cellulitis and /or infected ulcers . A total of 21 causative organisms were isolated in the group treated with ticarcillin plus clavulanic acid : Enterobacteriaceae ( 10 ) , Pseudomonas aeruginosa ( five ) , obligate anaerobes ( three ) , Staphylococcus aureus ( two ) , and Acinetobacter species ( one ) . Cultures in the moxalactam-treated group yielded 23 pathogens : Enterobacteriaceae ( seven ) , S. aureus ( six ) , group B streptococci ( four ) , P. aeruginosa ( two ) , obligate anaerobes ( two ) , Streptococcus pyogenes ( one ) , and Aeromonas species ( one ) . A cure or satisfactory response was achieved in 12 of the 13 ( 92 percent ) patients who received ticarcillin plus clavulanic acid and in 10 of the 12 ( 83 percent ) patients who received moxalactam . One patient with septic arthritis who received ticarcillin plus clavulanic acid had a relapse during therapy , as did one moxalactam-treated patient with a post-surgical wound infection . The other patient in whom moxalactam treatment failed had a wound infection that became reinfected . Some abnormalities in laboratory parameters occurred in each group , but none was severe enough to warrant discontinuation of treatment ABSTRACT Patients ( n = 409 ) with severe skin and soft tissue infections ( SSTIs ) were r and omized to receive clinafloxacin or piperacillin-tazobactam ( plus optional vancomycin for methicillin-resistant cocci ) , administered intravenously , with the option to switch to oral medication . Most patients had cellulitis , wound infections , or diabetic foot infections . Staphylococcus aureus , Enterococcus faecalis , and Pseudomonas aeruginosa were the most common baseline pathogens . Fewer baseline pathogens were resistant to clinafloxacin ( 1.8 % ) than to piperacillin-tazobactam ( 6.2 % ) ( P = 0.001 ) . The clinafloxacin and piperacillin-tazobactam groups did not differ significantly in clinical cure rates ( 68.8 and 65.2 % , respectively ) or microbiologic eradication rates ( 61.5 and 57.2 % ) . Clinafloxacin yielded higher eradication rates for all three of the most common pathogenic species , although no differences were statistically significant . Within the power of this study , the overall frequency of adverse events was similar ( P = 0.577 ) in the two treatment groups . Drug-associated adverse events ( P = 0.050 ) and treatment discontinuations ( P = 0.052 ) were marginally more frequent in the clinafloxacin group , primarily due to phototoxicity in out patients receiving clinafloxacin . Although most cases of phototoxicity were mild to moderate , four cases were reported as severe . In summary , clinafloxacin monotherapy was equivalent in effectiveness to therapy with piperacillin-tazobactam plus optional vancomycin in the treatment of hospitalized patients with severe SSTIs Fluoroquinolones have been shown to be effective in the treatment of complicated skin and skin-structure infections , in part because of their broad-spectrum antibacterial activity against causative pathogens that are resistant to older antimicrobial agents . We enrolled 603 adult patients ( > 58 % male , > 85 % white ) in a double-masked , double-dummy , r and omized , multicenter trial to compare the efficacy and tolerability of sparfloxacin ( 400-mg loading dose followed by 200 mg once daily ) with those of ciprofloxacin ( 750 mg twice daily ) for 10 days in the treatment of community-acquired , complicated skin and skin-structure infections . The primary efficacy variable was clinical response , based on assessment of signs and symptoms , in the clinical ly assessable population . Patients in the sparfloxacin and ciprofloxacin groups were comparable with respect to demographic characteristics , underlying diseases , medical history , and laboratory test results . Wound infection was the most common diagnosis , and Staphylococcus aureus was the most frequently isolated pathogen . For the 475 clinical ly assessable patients , the clinical success rate ( percentage of patients cured or improved ) was 90.1 % ( 210/233 ) with sparfloxacin and 87.2 % ( 211/242 ) with ciprofloxacin . In this analysis ( 95 % confidence interval [ CI ] , -2.8 to 8.6 ) and the intent-to-treat analyses ( 95 % CI , -4.2 to 6.2 ) , results with sparfloxacin were statistically equivalent to those with ciprofloxacin ( 95 % CI , -1 to 15.3 ) . For bacteriologically assessable patients , eradication rates were 87.0 % ( 141/162 ) with sparfloxacin and 79.9 % ( 123/154 ) with ciprofloxacin ( 95 % CI , -1 to 15.3 ) . Eradication rates of S. aureus and coagulase-negative staphylococcal infections were 90.2 % ( 101/112 ) with sparfloxacin and 77.9 % ( 88/113 ) with ciprofloxacin . For patients with 2 or more pathogens at baseline ( mixed infections ) , bacteriologic success was 87.6 % for sparfloxacin and 77.9 % for ciprofloxacin . Pseudomonas aeruginosa infections were eradicated or presumed eradicated in 71.4 % ( 10/14 ) of sparfloxacin-treated patients and 87.5 % ( 7/8 ) of ciprofloxacin-treated patients . Overall success rates in the bacteriologically assessable patients for sparfloxacin ( 84.6 % [ 137/162 ] ) and ciprofloxacin ( 78.6 % [ 121/154 ] ) were statistically equivalent ( 95 % CI , -2.5 to 14.5 ) . Tolerability was assessed in all patients who received study medication . The overall frequency of treatment-related adverse events was comparable in the 2 treatment groups ( 26.5 % sparfloxacin , 23.3 % ciprofloxacin ) . Drug-related adverse events involving the digestive system occurred in 7.1 % of sparfloxacin-treated patients and 19.0 % of ciprofloxacin-treated patients ; photosensitivity reactions were reported in 11.1 % of patients in the sparfloxacin group and 0.7 % of patients in the ciprofloxacin group ( P < 0.001 ) . The mean change in QTc interval from baseline to the maximum on-treatment value was greater in the sparfloxacin group ( 9 milliseconds ) than in the ciprofloxacin group ( 3 milliseconds ) ( P = 0.005 ; 95 % CI , 0.002 to 0.010 ) . The efficacy of sparfloxacin was comparable to that of ciprofloxacin in the treatment of community-acquired , complicated skin and skin-structure infections , including those caused by staphylococci , the most common pathogens . Sparfloxacin 's once-daily regimen , high skin-tissue penetration , and improved activity against gram-positive cocci make it a therapeutic alternative to ciprofloxacin for patients who are not at risk for photosensitivity reactions or adverse events associated with prolongation of the QTc interval To investigate the effect of oral antibiotics in purely neuropathic ulcers ( Wagner grade 1 - 2 , no osteomyelitis ) , a double blind placebo-controlled study was performed . Forty-four patients were enrolled and subjected to st and ard treatment with absolute pressure relief ( half shoes ) , daily wound cleansing ( topical disinfectant ) , sterile dressings ( specialized nurse ) . Patients were r and omized to an antibiotic ( amoxicillin plus clavulanic acid ) , or placebo . The study was stopped when the antibiotic proved unsuitable according to swab result , or on clinical grounds ( no improvement within 6 days of recruitment ) . Main outcome measure was the ulcer closing rate during 20 days , as assessed by st and ardized photographs . All ulcers except one were infected . Of the placebo group ( n = 22 ) , 2 patients had to be withdrawn within 6 days , versus 3 patients of the antibiotic-group ( n = 22 ) . In the placebo group , 10 ulcers were healed versus 6 ulcers in the antibiotic group ( NS ) . Mean ( 95 % CI ) reduction in ulcer radius was 0.41 ( 0.21 - 0.61 ) mm day-1 in the placebo group versus 0.27 ( 0.15 - 0.39 ) mm day-1 in the antibiotic group ( NS ) . In conclusion , there is no benefit from antibiotic treatment with amoxicillin plus clavulanic acid as a supplement to st and ard therapy in uncomplicated neuropathic foot ulcers , provided pressure relief is complete , and wound care is performed strictly supervised . However , a Type-II statistical error can not be excluded in this small study A prospect i ve , r and omized , double-blind , multicenter study was conducted of hospitalized patients to compare the efficacy and safety of oral ciprofloxacin ( dosage , 750 mg every 12 hours ) with intravenous cefotaxime ( dosage , 2.0 g every 8 hours ) as monotherapy for difficult skin and skin structure infections requiring hospitalization . Five hundred seventy patients were assessed for an analysis of safety and 461 patients were assessed for an analysis of efficacy . The most common infections were infected ulcers and abscesses . At the end of therapy , there was a higher incidence of recurrent or persistent organisms in the cefotaxime group compared with ciprofloxacin . Adverse reactions related to either therapy were rare . By pathogens , there were no differences in activity , except the higher rate of recurrent or persistent Pseudomonas aeruginosa infection in the cefotaxime group . By diagnosis , the two drugs had comparable efficacy , except for the higher incidence of bacteriologic failure in patients with polymicrobial infected ulcers in the cefotaxime group . Larger studies are needed to evaluate emergence of resistance to ciprofloxacin . Oral ciprofloxacin therapy is as safe and effective as parenteral cefotaxime in the treatment of difficult infections of the skin and skin structure , and affords the prospect of early discharge from the hospital and significant cost savings BACKGROUND Patients with diabetes mellitus , particularly those with poor glucose control , commonly experience various medical complications related to the disease ( eg , renal impairment , decreased peripheral vascular circulation , suppressed immune function ) . Infections of the lower extremities can range from superficial cellulitis to ulcerative , deep soft-tissue infections to osteomyelitis that necessitates some degree of amputation . OBJECTIVE This study compared the efficacy , tolerability , and cost differences associated with the use of metronidazole plus ceftriaxone ( MTZ/CTX ) given once daily with those of ticarcillin/clavulanate potassium ( T/C ) given every 6 hours in hospitalized older males with diabetic lower-extremity infections . METHODS This prospect i ve , open-label study was conducted at a Veterans Affairs Medical Center . Male patients with diabetes and a lower-extremity infection were r and omized to receive MTZ/CTX 1 g once daily or T/C 3.1 g every 6 hours . Treatment success was determined at 96 hours or on discontinuation of antibiotic . Success was measured in terms of body temperature < 38.3 degrees C ( 100.6 degrees F ) , normalization of the finger-stick blood sugar concentration , improvement in wound staging , or a white blood cell count < 10,000 cells/mm3 . Medication acquisition costs per treatment arm were calculated and compared . RESULTS Seventy patients were enrolled in the study ( 36 MTZ/CTX , 34 T/C ) . The study population had a mean ( SD ) age of 63.8 ( 10.8 ) years , a duration of diabetes of 12.4 ( 9.1 ) years , 0.5 ( 0.7 ) diabetes-related comorbidities , and an initial creatinine clearance of 67.1 ( 26.0 ) mL/min . There were no significant differences between groups at r and omization . At 96 hours , treatment success was achieved in 31 ( 86 % ) patients in the MTZ/CTX group , compared with 28 ( 82 % ) patients in the T/C group ( P = NS ) . Twenty-six patients were considered successfully treated on the final day of therapy in both the MTZ/CTX group ( 72 % ) and the T/C group ( 76 % ) ( P = NS ) . There were no significant differences in primary or secondary measures of success between the 2 groups . No single or multiple baseline factors predicted treatment success or failure . No patient experienced adverse events considered related to study medication . MTZ/CTX was associated with savings of $ 61.06 per hospital admission , or $ 2198.05 for all patients who received this combination . CONCLUSION In this population of older males , once-daily MTZ/CTX was as well tolerated and effective as T/C in the treatment of diabetic lower-extremity infections and was associated with reduced institutional costs OBJECTIVE To compare the clinical outcome and bacteriological response in diabetic patients with a foot infection treated with imipenem/cilastatin or a combination of piperacillin/clindamycin . METHODS Patients hospitalised for diabetic foot lesions Wagner Stages II , III or IV were r and omly assigned to receive either imipenem/cilastatin 500 mg QID or piperacillin 3000 mg QID in combination with clindamycin 600 mg TID . Cultures were obtained and clinical observations were made . RESULTS Forty-six patients ( mean age 71.4 + /- 9.8 years ) entered the study , 22 received imipenem/cilastatin ( IC ) and 24 received piperacillin/clindamycin ( PCL ) combination therapy . In the IC group 22.2 % was considered to be clinical ly cured , 76.2 % improved . In the PCL group this was 25.0 % and 50.0 % , respectively . In the IC treatment group 45.0 % of baseline pathogens was eradicated compared to 70.0 % in the PCL group . Adverse events were more often reported in PCL treated patients ( 50.0 % vs. 19.0 % P < 0.05 ) . CONCLUSIONS Impipenem/cilastatin and piperacillin/clindamycin combination therapy were equally effective in the treatment of patients with diabetic foot lesions . The imipenem/cilastatin regimen caused less side effects This prospect i ve , r and omized , multicenter trial compared the efficacy of two antibiotic regimens for treatment of foot infections in diabetic adults . Patients with infections requiring hospitalization were r and omized to receive either intravenous ofloxacin followed by oral ofloxacin or intravenous ampicillin/sulbactam followed by oral amoxicillin/clavulanate ( the aminopenicillin regimen ) for 14 - 28 days . Patients with osteomyelitis were eligible for the study if the infected bone was to be removed . Of 108 patients enrolled in the study , 88 who were evaluable had various skin and soft-tissue infections , and 24 % had osteomyelitis . For the ofloxacin and aminopenicillin regimens , the mean duration of intravenous therapy was 7.8 and 7.1 days , respectively , the mean duration of oral therapy was 13.2 and 12.0 days , respectively , the rate of eradication of pathogens was 78 % and 88 % , respectively , and the overall rate of clinical cure or improvement was 85 % and 83 % , respectively . Thus , about 3 weeks of therapy with either regimen was well tolerated and effective in treating these diabetic foot infections In a r and omized comparative trial , 45 patients were treated with amdinocillin plus cefoxitin or cefoxitin alone for bacterial soft tissue infections . Most patients were diabetic and had polymicrobial foot infections . The combination of amdinocillin plus cefoxitin was active in vitro against 71 percent of the isolates obtained before therapy as compared with 65 percent for cefoxitin alone . The combination demonstrated synergy for 29 percent of the isolates tested . A satisfactory clinical response occurred in 90 percent and 71 percent of patients treated with the combination regimen and cefoxitin , respectively , ( p greater than 0.1 ) . An increase in serum creatinine thought to be due to interstitial nephritis occurred in one patient treated with the combination regimen . The combination of amdinocillin and cefoxitin was effective in mixed soft tissue infections including diabetic foot infections BACKGROUND In a multicenter , international , double-blind , r and omized clinical trial involving hospitalized patients with complicated skin and skin-structure infections ( cSSSIs ) , meropenem and imipenem/cilastatin ( both administered 500 mg intravenously every 8 hours ) were not significantly different in their efficacy and safety profiles . OBJECTIVE The objective of the post hoc subgroup analysis discussed in the current article was to report the efficacy and tolerability of meropenem and imipenem/cilastatin for the treatment of cSSSIs in patients with or without underlying diabetes mellitus ( DM ) . METHODS Hospitalized patients aged > or = 13 years with evidence of cSSSIs were eligible for inclusion . Patients were r and omized to receive meropenem or imipenem/cilastatin , each 500 mg intravenously every 8 hours , for at least 3 days and up to a maximum of 14 days . Patients were analyzed according to the presence or absence of DM and by the pathogen(s ) isolated from wound cultures at baseline , end of N treatment , and test-of-cure visits . The primary efficacy end point was clinical outcome at the posttreatment follow-up ( test-of-cure ) visit in the clinical ly evaluable and modified intent-to-treat ( intent-to-treat [ ITT ] subjects who met all eligibility criteria ) population s ; this was defined as 7 to 14 days after final administration of antibiotics . The secondary efficacy end points included clinical response at the test-of-cure visit in the ITT population ( ie , those who received > 1 dose of study drug ) and at the end of N treatment visit in the clinical ly evaluable and fully evaluable population s. At baseline , the end of N treatment , and the test-of-cure visits , specimens were obtained from the most extensive site of skin and skin-structure infection and were cultured for bacteria . Adverse events were monitored daily during treatment and for 30 days after the completion of all antibiotic treatment . RESULTS Of the 1076 patients enrolled in the original study , 398 had DM . The mean ages of patients with and without DM were 55 and 45 years , respectively ; 17.3 % of patients with DM and 6.1 % of patients without DM had impaired renal function at study entry . Complex abscess was the most common infection diagnosis in both groups ( patients with DM , 30.0 % ; patients without DM , 48.8 % ) . The other top infections per group ( patients with and without DM , respectively ) were as follows : cellulitis , 24.6 % and 12.4 % ; and ischemic/diabetic ulcers , 20.9 % and 1.9 % . Gram-negative aerobic and anaerobic pathogens accounted for > 40 % of bacterial isolates from both groups , with polymicrobial infections reported in 44.2 % of patients with DM and 34.0 % of patients without DM . In the clinical ly evaluable population , the satisfactory clinical response rate was 85.6 % for patients with DM receiving meropenem and 72.4 % for those receiving imipenem/cilastatin ; for patients without DM , those rates were 86.6 % and 89.0 % , respectively . Meropenem and imipenem/cilastatin were generally well tolerated . Reported adverse events were similar between groups . CONCLUSION This subgroup analysis found that 500 mg every 8 hours intravenously of meropenem or imipenem/cilastatin appeared efficacious and well tolerated for the treatment of cSSSIs among these patients with and without DM Oral fleroxacin , 400 mg once a day , and oral amoxicillin/clavulanate potassium ( AMX/CP ) , 400 mg/125 mg three times a day , administered for 4 - 21 days , were compared for efficacy and safety in the treatment of skin and soft tissue infections . A total of 113 patients were enrolled in a multicenter , r and omized , double-blind trial ; 57 were assigned to fleroxacin and 56 to AMX/CP . A total of 22 and 33 patients in the fleroxacin and AMX/CP groups , respectively , were evaluable for efficacy . The most common diagnoses were skin abscess ( 14 ; 62 % ) and wound infections ( 5 ; 23 % ) in the fleroxacin group and skin abscess ( 17 ; 52 % ) and skin ulcer ( 9 ; 27 % ) in the AMX/CP group . A total of 20 ( 91 % ) of the fleroxacin-treated patients and 29 ( 88 % ) of the AMX/CP-treated patients were bacteriologically cured ( two fleroxacin- and one AMX/CP-treated patients developed super-infection ) . The eradication rate for Staphylococcus aureus was 100 % ( 11 of 11 ) in the fleroxacin group and 89 % ( 17 of 19 ) in the AMX/CP group ; 18 ( 82 % ) of the fleroxacin group and 25 ( 76 % ) of the AMX/CP group were clinical ly cured . Adverse events were seen in 22 % ( 12 of 54 ) of the fleroxacin group and 25 % ( 13 of 53 ) of the AMX/CP group . None were serious . Bacteriologic and clinical cure rates and safety results for the two groups were similar . The small sample size precluded statistical analysis at the 95 % confidence level Most diabetic foot infections are believed to be caused by both aerobic and anaerobic bacteria and to require hospitalization and parenteral antimicrobial therapy . We prospect ively evaluated diabetic patients with non-limb-threatening lower-extremity infections not yet treated with antibiotics . The patients were r and omized to outpatient treatment with oral clindamycin hydrochloride or cephalexin for 2 weeks and evaluated every 3 to 7 days . In 56 assessable patients , curettage yielded a mean of 2.1 microorganisms . Aerobic gram-positive cocci were isolated in 50 cases ( 89 % ) , and were the sole pathogen in 21 ( 42 % ) of these . Aerobic gram-negative bacilli and anaerobes were isolated in 20 ( 36 % ) and 7 ( 13 % ) cases , respectively , and almost always in polymicrobial infections . Fifty-one infections ( 91 % ) were eradicated , 42 ( 75 % ) after 2 weeks of treatment ; only 5 ( 9 % ) were initially treatment failures , and 3 ( 5 % ) were subsequently cured with further outpatient oral antibiotic treatment . After a mean follow-up of 15 months , no further treatment was required in 43 ( 84 % ) of the cured patients . Previously untreated lower-extremity infections in diabetic patients are usually caused by aerobic gram-positive cocci , and generally respond well to outpatient management with oral antibiotic therapy OBJECTIVE To compare outcomes of treating complicated skin and skin structure infections ( cSSSI ) caused by methicillin-resistant Staphylococcus aureus ( MRSA ) with linezolid versus vancomycin in diabetic and non-diabetic patients . METHODS We pooled data from three prospect i ve clinical trials in which 1056 patients were r and omized to receive either linezolid ( intravenous ( IV ) or oral ) or vancomycin ( IV ) every 12h , for 7 - 28 days . RESULTS Diabetic ( n=349 ) and non-diabetic patients ( n=707 ) had comparable demographics and co-morbidities . Clinical success rates were lower in diabetic than in non-diabetic patients ( 72.3 % and 85.8 % , respectively ) . Overall , non-diabetic patients had a shorter adjusted mean length of stay ( LOS ) compared with diabetic patients ( 8.2 and 10.7 days , respectively ; p<0.0001 ) . Among diabetic patients , rates were comparable with linezolid and vancomycin treatment for clinical success ( 74 % and 71 % , respectively ) and microbiological success ( 60 % and 54 % , respectively ) . Among non-diabetic patients , clinical and microbiological success rates were higher in linezolid- than in vancomycin-treated patients ( 90 % and 81 % , respectively , and 78 % and 65 % , respectively ) . Rates of drug-related adverse events were comparable in diabetic and non-diabetic patients and with linezolid and vancomycin treatment . Adjusted mean LOS was shorter with linezolid than with vancomycin treatment in diabetic patients ( 9.5 and 11.7 days , respectively ; p=0.03 ) and non-diabetic patients ( 7.6 and 8.9 days , respectively ; p=0.02 ) . CONCLUSIONS Clinical success rates were lower in diabetic than non-diabetic patients with cSSSI caused by MRSA . Comparing linezolid and vancomycin , clinical and microbiological success rates were comparable in diabetic patients , but were better for linezolid than for vancomycin in non-diabetic patients |
396 | 23,930,214 | Based on higher test accuracy , our results support the use of HCII in cervical cancer screening programs . | The effectiveness of screening programs for cervical cancer has benefited from the inclusion of Human papillomavirus ( HPV ) DNA assays ; which assay to choose , however , is not clear based on previous review s. Our review addressed test accuracy of Hybrid Capture II ( HCII ) and polymerase chain reaction ( PCR ) assays based on studies with stronger design s and with more clinical ly relevant outcomes . | We prospect ively evaluated the 5-year predictive values of adding high-risk human papillomavirus ( hrHPV ) testing to cytology for the detection of ⩾cervical intraepithelial neoplasia (CIN)3 lesions in a population -based cohort of 2810 women . At baseline , nine ( 0.3 % ) women had prevalent lesions ⩾CIN3 , all being hrHPV positive . After 5 years of follow-up , four ( 6.5 % ) of the 62 hrHPV-positive women with normal cytology developed lesions ⩾CIN3 , vs only one ( 0.05 % ) of the 2175 hrHPV-negative women with normal cytology . High-risk human papillomavirus testing or combined screening revealed a much higher sensitivity , at the cost of a small decrease in specificity , and a higher negative predictive value for the detection of lesions ⩾CIN3 till the next screening round ( 5 years ) than cytology alone Cervical intraepithelial neoplasia 3 ( CIN3 ) is the precursor of mostsquamous carcinomas and serves as a surrogate end point . However , small CIN3 lesions are rarely associated with concurrent invasion . We hypothesized that aggressive follow-up for cytology of atypical squamous cells of undetermined significance ( ASCUS ) or low- grade squamous intraepithelial lesion ( LSIL ) leads predominantly to detection of smaller CIN3 lesions than those usually associated with cancer . We assessed this hypothesis in a masked histopathologic review of 330 CIN3 lesions in the ASCUS LSILTriage Study , focusing on ASCUS referrals . ASCUS referrals underwent r and omized management [ colposcopy for repeat cytology of high- grade squamous intraepithelial lesion ( HSIL ) , colposcopy for oncogenic human papillomavirus ( HPV ) detection or repeat HSIL , or immediate colposcopy ] ; then all were followed with repeat cytology for 2 years , followed by colposcopy and aggressive treatment . We assessed all CIN3 lesions qualitatively and measured 39 of them . CIN3 lesions were overwhelmingly small . Compared with enrollment , lesions found at follow-up or exit involved fewer tissue fragments ( P < 0.01 ) and showed less diffuse gl and involvement ( P = 0.03 ) . CIN3 lesions found postenrollment after HPV testing involved the fewest tissue fragments [ versus immediate colposcopy ( P = 0.04 ) or repeat cytology of HSIL ( P = 0.02 ) ] , and none showed diffuse gl and involvement . The median distal-proximal length was 6.5 mm ( median replacement of total epithelium = 5 % ) in the 39 measured cases . We conclude that CIN3 lesions underlying ASCUS or LSIL generally lack features associated with invasion , particularly if managed using HPV testing , suggesting that aggressive management leads to early detection of CIN3 but probably prevents relatively few cancers in screened population Objective To evaluate the efficiency of human papillomavirus ( HPV ) testing by Hybrid Capture II ( Digene Diagnostics Inc. , Silver Spring , MD ) with regard to detecting biopsyconfirmed cervical intraepithelial neoplasia ( CIN ) or high- grade CIN in women with mild atypia , compared with the efficiencies of polymerase chain reaction ( PCR ) , Southern blot hybridization , and cytology . Methods We prospect ively studied 378 women with atypical squamous cells of undetermined significance ( ASCUS ) ( n = 111 ) or low- grade squamous intraepithelial lesions ( SILs ) ( n = 267 ) demonstrated by referral cytology . We did repeat cytology , sampling for detection of HPV DNA by Hybrid Capture II , PCR , and Southern blot hybridization , and colposcopic evaluation with cervical biopsies . Results All participants underwent the Hybrid Capture II test and 320 underwent the three HPV tests . Sensitivities of Hybrid Capture II for detecting CIN and high- grade CIN ( 0.81 and 0.86 , respectively ) were similar to those of cytology ( 0.83 and 0.82 , respectively ) and PCR ( 0.77 and 0.95 , respectively ) , and higher than those of Southern blot hybridization ( 0.48 and 0.45 , respectively ) . Compared with cytology , combined triage with Hybrid Capture II improved sensitivities for detecting CIN ( 0.94 versus 0.83 , P < .001 ) and high- grade CIN ( 0.96 versus 0.85 ) , though the latter difference was not significant ( P = .17 ) . In women with ASCUS , sensitivities of combined triage and cytology for detecting CIN were 0.94 and 0.71 , respectively ( P = .01 ) , and sensitivities of the two methods for detecting high- grade CIN were 0.92 and 0.66 , respectively ( P = .13 ) . The increase in sensitivity was lower among women with low- grade SILs ; for these women , cytology had high sensitivity ( 0.86 for CIN and 1.00 for high- grade CIN ) . The specificity of combined triage was significantly lower than that of cytology in both groups . Conclusion Compared with repeat cytology , combined triage with HPV testing markedly improves sensitivity for detecting CIN in women with ASCUS , but at the expense of specificity We evaluated Hybrid Capture 2 ( HC2 ) and polymerase chain reaction ( PCR ) results for paired specimens collected at 19,187 visits from 5,026 of 5,060 women participating in the Atypical Squamous Cells of Undetermined Significance /Low- Grade Squamous Intraepithelial Lesion Triage Study ( ALTS ) . We examined the test agreement between HC2 and PCR detection for any of 13 carcinogenic human papillomavirus types targeted by HC2 and compared clinical performance of the 2 tests for detecting concurrent and follow-up cervical intraepithelial neoplasia ( CIN ) 3 or cancer . The k value for the 2 assays was 0.65 ( 95 % confidence interval , 0.64 - 0.66 ) , with 82.7 % crude agreement . HC2 was more sensitive ( 93.6 % vs 89.3 % ; P < .0005 ) but less specific ( 41.2 % vs 48.5 % ; P < .0005 ) than PCR for detecting 2-year cumulative CIN 3 or cancer ( n = 503 ) . The presence of multiple types as detected by PCR and /or cytologic abnormality increased the likelihood of an HC2 + result . Increased sensitivity of HC2 compared with PCR was surprising , given the theoretical advantages of PCR-based methods for analytic sensitivity . Smaller amounts of material used in PCR could have limited its sensitivity , but our results demonstrate the importance of optimization and st and ardization of PCR-based assays for clinical applications BACKGROUND Human papillomavirus ( HPV ) testing is known to be more sensitive , but less specific than cytology for detecting cervical intraepithelial neoplasia ( CIN ) . We assessed the efficacy of cervical-cancer screening policies that are based on HPV testing . METHODS Between March , 2004 , and December , 2004 , in two separate recruitment phases , women aged 25 - 60 years were r and omly assigned to conventional cytology or to HPV testing in combination with liquid-based cytology ( first phase ) or alone ( second phase ) . R and omisation was done by computer in two screening centres and by sequential opening of numbered sealed envelopes in the remaining seven centres . During phase one , women who were HPV-positive and aged 35 - 60 years were referred to colposcopy , whereas women aged 25 - 34 years were referred to colposcopy only if cytology was also abnormal or HPV testing was persistently positive . During phase two , women in the HPV group were referred for colposcopy if the HPV test was positive . Two rounds of screening occurred in each phase , and all women had cytology testing only at the second round . The primary endpoint was the detection of grade 2 and 3 CIN , and of invasive cervical cancers during the first and second screening rounds . Analysis was done by intention to screen . This trial is registered , number IS RCT N81678807 . FINDINGS In total for both phases , 47,001 women were r and omly assigned to the cytology group and 47,369 to HPV testing . 33,851 women from the cytology group and 32,998 from the HPV-testing group had a second round of screening . We also retrieved the histological diagnoses from screening done elsewhere . The detection of invasive cervical cancers was similar for the two groups in the first round of screening ( nine in the cytology group vs seven in the HPV group , p=0.62 ) ; no cases were detected in the HPV group during round two , compared with nine in the cytology group ( p=0.004 ) . Overall , in the two rounds of screening , 18 invasive cancers were detected in the cytology group versus seven in the HPV group ( p=0.028 ) . Among women aged 35 - 60 years , at round one the relative detection ( HPV vs cytology ) was 2.00 ( 95 % CI 1.44 - 2.77 ) for CIN2 , 2.08 ( 1.47 - 2.95 ) for CIN3 , and 2.03 ( 1.60 - 2.57 ) for CIN2 and 3 together . At round two the relative detection was 0.54 ( 0.23 - 1.28 ) for CIN2 , 0.48 ( 0.21 - 1.11 ) for CIN3 , and 0.51 ( 0.28 - 0.93 ) for CIN2 and 3 together . Among women aged 25 - 34 years , there was significant heterogeneity between phases in the relative detection of CIN3 . At round one the relative detection was 0.93 ( 0.52 - 1.64 ) in phase one and 3.91 ( 2.02 - 7.57 ) in phase two . At round two the relative detection was 1.34 ( 0.46 - 3.84 ) in phase one and 0.20 ( 0.04 - 0.93 ) in phase two . Pooling both phases , the detection ratio of CIN2 for women aged 25 - 34 years was 4.09 ( 2.24 - 7.48 ) at round one and 0.64 ( 0.23 - 1.27 ) at round two . INTERPRETATION HPV-based screening is more effective than cytology in preventing invasive cervical cancer , by detecting persistent high- grade lesions earlier and providing a longer low-risk period . However , in younger women , HPV screening leads to over-diagnosis of regressive CIN2 . FUNDING European Union , Italian Ministry of Health , Regional Health Administrations of Piemonte , Tuscany , Veneto and Emilia-Romagna , and Public Health Agency of Lazio ABSTRACT The use of high-risk human papillomavirus ( hrHPV ) testing as an adjunct to cervical cytology in population -based screening programs is currently based on DNA hybridization and PCR assays . The aim of this study was to prospect ively assess the diagnostic performance of the Hybrid Capture 2 test ( HC2 ; Digene Corporation ) in comparison with that of the recently developed PCR-based AMPLICOR HPV test ( Roche Molecular Systems ) for the detection of 13 hrHPV types . A reverse line blot hybridization assay ( Innogenetics ) was used as an internal reference st and ard in discordant cases . Two hundred seventy-one patients with atypical squamous cells of uncertain significance ( ASCUS ) in cervical sample s underwent hrHPV testing . The chi-square test was performed to compare respective proportions . Totals of 160/271 ( 59 % ) and 156/271 ( 58 % ) were found to be positive for hrHPV with HC2 and AMPLICOR , respectively . Concordant results were obtained for 235 ( 86.7 % ) of the 271 sample s ( kappa statistic , 0.73 ± 0.04 ) . Considering types 26 , 53 , and 66 as oncogenic types , negative predictive values ( NPVs ) of HC2 and AMPLICOR were 92.8 % and 87.8 % , respectively ( difference was not significant ) , and their respective accuracies were 94.8 % and 91.9 % ( difference was not significant ) . Considering types 26 , 53 , and 66 as not oncogenic , the respective HC2 and AMPLICOR NPVs were 92.8 % and 97.4 % ( difference was not significant ) , and accuracy was significantly higher for the AMPLICOR assay ( 95.9 % versus 90.8 % for HC2 ) ( P < 0.05 ) . For ASCUS sample s , the NPV was 92.8 % for HC2 testing and might be compromised if the copy number of HPV DNA was low . The NPV was 97.4 % for the AMPLICOR assay and might be compromised if HPV types 26 , 53 , and 66 were considered oncogenic . The accuracy of these two assays is good and is compatible with routine clinical use in the triage of ASCUS cases BACKGROUND The ATHENA study was design ed to assess the performance of carcinogenic human papillomavirus ( HPV ) testing and HPV16 or HPV18 genotyping compared with liquid-based cytology for cervical cancer screening in a large US population aged 21 years and older . We did a sub analysis of this population to compare the screening performance of the cobas HPV test versus liquid-based cytology in women aged 25 years and older , and assess management strategies for HPV-positive women . METHODS Women aged 25 years or older who were attending routine cervical screening were enrolled from 61 clinical centres in 23 US states . Cervical specimens were obtained for liquid-based cytology and HPV DNA testing with two first-generation assays ( Amplicor HPV test and Linear Array HPV genotyping test ) and the second-generation cobas HPV test ( with individual HPV16 and HPV18 detection ) . Colposcopy and diagnostic biopsies were done on women with atypical squamous cells of undetermined significance ( ASC-US ) or worse cytology , those who tested positive with either first-generation HPV test , and a r and om sample of women who tested negative for HPV and cytology . All women not selected for colposcopy received their results and exited the study . Participants and colposcopists were masked to cytology and HPV test results until the colposcopy visit was completed . The primary endpoint for this sub study was histologically confirmed cervical intraepithelial neoplasia grade 3 ( CIN3 ) or worse . This study is registered with Clinical Trials.gov , number NCT00709891 ; the study is in the follow-up phase , which is due to be completed in December , 2012 . FINDINGS From May 27 , 2008 , to Aug 27 , 2009 , 47,208 women were enrolled , of whom 41,955 met our eligibility criteria . Valid cobas HPV and liquid-based cytology test results were available for 40,901 women ( 97 % ) , who were included in this analysis . Of these , 4275 women ( 10 % ) tested cobas HPV positive and 2617 ( 6 % ) had abnormal cytology . 431 women were diagnosed with CIN2 or worse and 274 with CIN3 or worse . In women who had colposcopy , the cobas HPV test was more sensitive than liquid-based cytology for detection of CIN3 or worse ( 252/274 [ 92·0 % , 95 % CI 88·1 - 94·6 ] vs 146/274 [ 53·3 % , 95 % CI 47·4 - 59·1 ] ; difference 38·7 % , 95 % CI 31·9 - 45·5 ; p<0·0001 ) . Addition of liquid-based cytology to HPV testing increased sensitivity for CIN3 or worse to 96·7 % ( 265/274 , 95 % CI 93·9 - 98·3 ) , but increased the number of screen positives by 35·2 % ( 5783/40,901 vs 4275/40,901 ) compared with HPV testing alone . As a triage test to identify CIN3 or worse in HPV-positive women , detection of HPV16 , HPV18 , or both alone was equivalent to detection of ASC-US or worse alone in terms of sensitivity ( 150/252 [ 59·5 % ] vs 133/252 [ 52·8 % ] ; p=0·11 ) and positive predictive value ( PPV ) ( 150/966 [ 15·5 % ] vs 133/940 [ 14·1 % ] ; p=0·20 ) . Among HPV-positive women , detection of HPV16 , HPV18 , or both or low- grade squamous intraepithelial lesion or worse cytology had better sensitivity ( 182/252 [ 72·2 % ] ; p<0·0001 ) and similar PPV ( 182/1314 [ 13·9 % ] ; p=0·70 ) for detection of CIN3 or worse than ASC-US or worse cytology alone . Furthermore , detection of HPV16 , HPV18 , or both or high- grade squamous intraepithelial lesion or worse cytology had higher sensitivity ( 165/252 [ 65·5 % ] ; p=0·0011 ) and PPV ( 165/1013 [ 16·3 % ] ; p=0·031 ) for detection of CIN3 or worse than ASC-US or worse cytology alone . INTERPRETATION HPV testing with separate HPV16 and HPV18 detection could provide an alternative , more sensitive , and efficient strategy for cervical cancer screening than do methods based solely on cytology . FUNDING Roche Molecular Systems BACKGROUND Screening for cervical cancer based on testing for human papillomavirus ( HPV ) increases the sensitivity of detection of high- grade ( grade 2 or 3 ) cervical intraepithelial neoplasia , but whether this gain represents overdiagnosis or protection against future high- grade cervical epithelial neoplasia or cervical cancer is unknown . METHODS In a population -based screening program in Sweden , 12,527 women 32 to 38 years of age were r and omly assigned at a 1:1 ratio to have an HPV test plus a Papanicolaou ( Pap ) test ( intervention group ) or a Pap test alone ( control group ) . Women with a positive HPV test and a normal Pap test result were offered a second HPV test at least 1 year later , and those who were found to be persistently infected with the same high-risk type of HPV were then offered colposcopy with cervical biopsy . A similar number of double-blinded Pap smears and colposcopies with biopsy were performed in r and omly selected women in the control group . Comprehensive registry data were used to follow the women for a mean of 4.1 years . The relative rates of grade 2 or 3 cervical intraepithelial neoplasia or cancer detected at enrollment and at subsequent screening examinations were calculated . RESULTS At enrollment , the proportion of women in the intervention group who were found to have lesions of grade 2 or 3 cervical intraepithelial neoplasia or cancer was 51 % greater ( 95 % confidence interval [ CI ] , 13 to 102 ) than the proportion of women in the control group who were found to have such lesions . At subsequent screening examinations , the proportion of women in the intervention group who were found to have grade 2 or 3 lesions or cancer was 42 % less ( 95 % CI , 4 to 64 ) and the proportion with grade 3 lesions or cancer was 47 % less ( 95 % CI , 2 to 71 ) than the proportions of control women who were found to have such lesions . Women with persistent HPV infection remained at high risk for grade 2 or 3 lesions or cancer after referral for colposcopy . CONCLUSIONS The addition of an HPV test to the Pap test to screen women in their mid-30s for cervical cancer reduces the incidence of grade 2 or 3 cervical intraepithelial neoplasia or cancer detected by subsequent screening examinations . ( Clinical Trials.gov number , NCT00479375 [ Clinical Trials.gov ] . ) |
397 | 25,040,672 | With all available data included , analysis indicated a marginal effect of dishware size on food intake , with larger dishware size associated with greater intake . | It has been suggested that providing consumers with smaller dishware may prove an effective way of helping people eat less and preventing weight gain , but experimental evidence supporting this has been mixed .
The objective of the present work was to examine the current evidence base for whether experimentally manipulated differences in dishware size influence food consumption . | OBJECTIVES : Dishware size is thought to influence eating behaviors , but effects on children ’s self-served portion sizes and intakes have not been studied . We aim ed to evaluate whether larger dishware increased children ’s self-served portion sizes and intake during meals . METHODS : A within-subjects experimental design was used to test the effects of dishware size ( ie , plates and bowls ) on children 's self-served portion sizes and intakes in a naturalistic setting . Subjects were predominantly African American elementary school – aged children ( n = 42 ) observed on repeated occasions during school lunch . Children served themselves an entree and side dishes using either child- or adult-size dishware , which represented a 100 % increase in the surface area of plates and volume of bowls across conditions . Condition order was r and omly assigned and counterbalanced across 2 first- grade classrooms . Entrées of amorphous and unit form were evaluated on separate days . Fruit and vegetable side dishes were evaluated at each meal . Fixed portions of milk and bread were provided at each meal . RESULTS : Children served more energy ( mean = 90.1 kcal , SE = 29.4 kcal ) when using adult-size dishware . Adult-size dishware promoted energy intake indirectly , where every additional calorie served result ed in a 0.43-kcal increase in total energy intakes at lunch ( t = 7.72 , P = .001 ) . CONCLUSIONS : Children served themselves more with larger plates and bowls and consumed nearly 50 % of the calories that they served . This provides new evidence that children ’s self-served portion sizes are influenced by size-related facets of their eating environments , which , in turn , may influence children ’s energy intake Background The increasing prevalence of obesity is a significant health threat and a major public health challenge . A critical need exists to develop and evaluate practical methods for the treatment of obesity in the clinical setting . One of the factors contributing to the obesity epidemic is food portion sizes . Limited data are available on the efficacy of visual or tactile devices design ed to enhance patient underst and ing and control of portion sizes . A portion control plate is a commercially-available product that can provide visual cues of portion size and potentially contribute to weight loss by enhancing portion size control among obese patients . This tool holds promise as a useful adjunct to dietary counseling . Our objective was to evaluate a portion control intervention including dietary counseling and a portion control plate to facilitate weight loss among obese patients in a primary care practice . Findings We r and omized 65 obese patients [ body mass index ( BMI ) ≥ 30 and < 40 ] to an intervention including counseling by a dietitian incorporating a portion control plate or to usual care . Following initial consultation , patients in the intervention arm were contacted at 1 , 3 , and 5 months by the dietician for brief follow-up counseling . Usual care subjects received instructional h and outs on diet and exercise . Forty-two ( 65 % ) subjects returned to have weight assessed at 6 months . Subjects in the portion control intervention had a greater percentage change ( ± SD ) in weight from baseline at 3 months ( -2.4 % ± 3.7 % vs. -0.5 % ± 2.2 % ; p = 0.041 ) and a non significant trend in weight change from baseline at 6 months ( -2.1 % ± 3.8 % vs. -0.7 % ± 3.7 % ; p = 0.232 ) compared with usual care . Nearly one-half of patients assigned to the portion control intervention who completed the study reported the overall intervention was helpful and the majority would recommend it to others . Conclusions Our findings suggest that a portion control intervention incorporating dietary counseling and a portion control plate may be effective for enhancing weight loss among obese subjects . A portion control intervention deserves further evaluation as a weight control strategy in the primary care setting .Trial registration Current controlled trials The aim of the study was to determine whether plate size affects ad libitum energy intake ( EI ) at a buffet-style lunch in overweight , yet unrestrained women . Twenty overweight/obese ( BMI = 25 - 40 kg/m(2 ) ) women attended two study visits , and were r and omly assigned to small ( 19.5 cm ) or large ( 26.5 cm ) diameter plate size at a free choice lunch meal . At 9 am participants were given a small ( 0.5 MJ ) breakfast , followed at 12 noon by the lunch meal from which they ate ad lib until comfortably full . Mean ( SEM ) EI at lunch was 3975 (239)kJ and 3901 ( 249 ) kJ respectively for small and large plate size . There was no detectable difference in EI between the two plate sizes ( P>0.05 ) . When in a raised state of hunger and offered a palatable buffet meal , altering the diameter of the dining plate onto which food was self-served did not significantly alter ad lib EI . We conclude there was no evidence that a smaller plate suppressed EI in a group of unrestrained , overweight women encouraged to eat to appetite from a wide choice of items . Whether plate size is a useful cue for portion size , and hence control of EI , in individuals actively restricting intake however remains possible , and requires investigation BACKGROUND Portion size is an important determinant of energy intake . To our knowledge , no r and omized controlled trial has evaluated the efficacy of portion control tools to induce weight loss . In patients with type 2 diabetes mellitus , weight reduction improves glycemic control . METHODS We r and omly assigned 130 obese patients with type 2 diabetes mellitus ( including 55 patients taking insulin ) to the daily use of a commercially available portion control plate for 6 months ( intervention group ) vs to usual care in the form of dietary teaching ( usual care control group ) . RESULTS Follow-up was 93.8 % . Patients in the intervention group lost significantly more weight than control subjects ( mean+/-SD , 1.8%+/-3.9 % vs 0.1%+/-3.0 % , P=.006 ) . Compared with controls , more patients in the intervention group required a decrease in their diabetes medications at 6 months ( 26.2 % vs 10.8 % , P=.04 ) . CONCLUSIONS Compared with usual care , the portion control tool studied was effective in inducing weight loss . The portion control plate also enabled patients with diabetes mellitus to decrease their hypoglycemic medications without sacrificing glycemic control . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00254124 Objective : Because younger children lack the motor skills required to serve themselves without spilling , adults often ask children how much they would like to eat and then serve the requested amount onto bowls . Previous research shows that larger bowls biases adults towards serving themselves larger portions . We examine if larger bowls biases children towards requesting more food from the adults who serve them . Study Design : Study 1 was a between-subject design involving 69 pre-schoolers who were r and omized to receive either a small ( 8 oz ) or large ( 16 oz ) cereal bowl and were asked to tell research ers how much cereal they wanted for a morning snack . Study 2 was a within-subject design involving 18 elementary school age children at a summer camp who were given a small ( 8 oz ) cereal bowl on one day and a large ( 16 oz ) cereal bowl on another day and asked by a cafeteria server how much cereal and milk they wanted for breakfast . Methods : Hidden scales measured how much cereal and milk were served , consumed , and wasted . BMI levels were obtained at the end of the study . Results : Study 1 indicated that younger children requested almost twice cereal to eat when presented with a larger bowl . Study 2 shows that older children consumed 52 % more and wasted 26 % more when served with a larger bowl . Conclusion : An immediate step to reducing overeating would be for parents and adult caregivers to use smaller bowls when serving food to children BACKGROUND Because people eat most of what they serve themselves , any context ual cues that lead them to over-serve should lead them to over-eat . In building on the size-contrast illusion , this research examines whether the size of a bowl or serving spoon unknowingly biases how much a person serves and eats . METHODS The 2 x 2 between-subjects design involved 85 nutrition experts who were attending an ice cream social to celebrate the success of a colleague in 2002 . They were r and omly given either a smaller ( 17 oz ) or a larger ( 34 oz ) bowl and either a smaller ( 2 oz ) or larger ( 3 oz ) ice cream scoop . After serving themselves , they completed a brief survey as their ice cream was weighed . The analysis was conducted in 2003 . RESULTS Even when nutrition experts were given a larger bowl , they served themselves 31.0 % more ( 6.25 vs 4.77 oz , F(1 , 80 ) = 8.05 , p < 0.01 ) without being aware of it . Their servings increased by 14.5 % when they were given a larger serving spoon ( 5.77 vs 5.04 oz , F(1 , 80)=2.70 , p = 0.10 ) . CONCLUSIONS People could try using the size of their bowls and possibly serving spoons to help them better control how much they consume . Those interested in losing weight should use smaller bowls and spoons , while those needing to gain weight -- such as the undernourished or aged -- could be encouraged to use larger ones . Epidemiologic implication s are discussed BACKGROUND Smaller plates are often recommended as a strategy for controlling energy intake ; however , the effect of plate size on meal energy intake in normal weight compared to overweight or obese individuals is not known . The present study aim ed to investigate this further . METHODS Ten normal weight [ mean ( SD ) body mass index , 21.7 ( 2.0 ) kg m(-2 ) ] and 10 overweight or obese [ 31.7 ( 3.6 ) kg m(-2 ) ] women attended a metabolic laboratory on two separate days for lunch . In this cross-over study , subjects were r and omly assigned to eat lunch using either a small ( 21.6 cm ) or a large ( 27.4 cm ) plate . Each subject self-served spaghetti mixed with tomato sauce from an individual serving bowl onto the assigned plate , and ate until satisfied . The meal was consumed alone at a private table . During the second study day , each subject underwent the same procedure but used the alternate size plate . The amount eaten and energy consumed were calculated and a mixed effects analysis of variance model was used to compare energy intakes . RESULTS Energy intakes using the small and large plate were 1356 ( 515 ) and 1365 ( 393 ) kJ , respectively , in normal weight subjects and 1314 ( 632 ) and 1226 ( 431 ) kJ , respectively , in overweight/obese subjects . Neither plate size , nor plate size by weight status significantly affected meal energy intake . There was no plate size by weight status effect on ratings of palatability , hunger , satiety , fullness or prospect i ve consumption . CONCLUSIONS Plate size did not affect energy intake from a single meal in either the normal weight or overweight/obese subjects |
398 | 25,924,806 | No test was consistently useful in more than one study .Combining two tests so that an individual both missed some drinks between meals and expressed fatigue was sensitive at 0.71 ( 95 % CI 0.29 to 0.96 ) and specific at 0.92 ( 95 % CI 0.83 to 0.97).There was sufficient evidence to suggest that several st and -alone tests often used to assess dehydration in older people ( including fluid intake , urine specific gravity , urine colour , urine volume , heart rate , dry mouth , feeling thirsty and BIA assessment of intracellular water or extracellular water ) are not useful , and should not be relied on individually as ways of assessing presence or absence of dehydration in older people .
No tests were found consistently useful in diagnosing current water-loss dehydration .
AUTHORS ' CONCLUSIONS There is limited evidence of the diagnostic utility of any individual clinical symptom , sign or test or combination of tests to indicate water-loss dehydration in older people .
Individual tests should not be used in this population to indicate dehydration ; they miss a high proportion of people with dehydration , and wrongly label those who are adequately hydrated .
Combining several tests may improve diagnostic accuracy | BACKGROUND There is evidence that water-loss dehydration is common in older people and associated with many causes of morbidity and mortality .
However , it is unclear what clinical symptoms , signs and tests may be used to identify early dehydration in older people , so that support can be mobilised to improve hydration before health and well-being are compromised .
Water-loss dehydration was defined primarily as including everyone with either impending or current water-loss dehydration ( including all those with serum osmolality ≥ 295 mOsm/kg as being dehydrated ) . | A study of prognosis over the first six weeks following admission to a department of geriatric medicine compared the predictive value of a clinical assessment at admission with other more objective parameters such as profile investigations , mental test score and assessment of dehydration and constitutional upset . A total of 739 patients were studied prospect ively . The clinical assessment proved to be by far the strongest predictor of six-week mortality . In men the prediction it gave was not improved significantly by addition of the other factors . In women serum albumin , blood urea and assessment of constitutional upset added significantly to the prediction , thought the overall improvement in classification was small and mental test score made a borderline contribution only Background and Purpose Abnormal physiological parameters after acute stroke may induce early neurological deterioration . Studies of the effect of dehydration on stroke outcome are limited . We examined the association of raised plasma osmolality on stroke outcome at 3 months and the change of plasma osmolality with hydration during the first week after stroke . Methods Acute stroke patients had their plasma osmolality measured at admission and at days 1 , 3 , and 7 . Maximum plasma osmolality and the area under curve ( AUC ) were also calculated during the first week . Patients were stratified according to how they were hydrated : orally , intravenously , or both . Outcome included survival at 3 months after stroke . Logistic regression was performed to examine the association between raised plasma osmolality ( > 296 mOsm/kg ) and survival , adjusting for stroke severity . Linear regression was performed to examine the pattern of plasma osmolality across hydration groups . Results One hundred sixty-seven patients were included . Mean admission ( 300 mOsm/kg , SD 11.4 ) , maximum ( 308.1 mOsm/kg , SD 17.1 ) , and AUC ( 298.3 mOsm/kg , SD 11.7 ) plasma osmolality were significantly higher in those who died compared with survivors ( 293.1 mOsm/kg [ SD 8.2 ] , 297.7 mOsm/kg [ SD 8.7 ] , and 291.7 mOsm/kg [ SD 8.1 ] , respectively;P < 0.0001 ) . Admission plasma osmolality > 296 mOsm/kg was significantly associated with mortality ( OR 2.4 , 95 % CI 1.0 to 5.9 ) . In patients hydrated intravenously , there was no significant fall in plasma osmolality compared with patients hydrated orally ( P = 0.68 ) . Conclusions Raised plasma osmolality on admission is associated with stroke mortality , after correcting for case mix . Correction of dehydration after stroke requires a more systematic approach . Trials are required to determine whether correcting dehydration after stroke improves outcome OBJECTIVES Multi-Frequency Bioelectrical Impedance Analysis ( MFBIA ) is a quick , simple , and inexpensive method to assess body fluid compartments . This study aim ed at determining the validity of MFBIA in detecting clinical ly relevant changes of fluid balance in geriatric patients . DESIGN A prospect i ve , observational study . SETTING The 22-bed Geriatric Department of the University Hospital Nijmegen . PARTICIPANTS Hospitalized patients were eligible if they did not have a pacemaker , were not suffering from terminal illnesses , and did not have psychogeriatric diseases likely to interfere with capacity to consent or comply . During a 16-months period , 218 patients were admitted , of whom 78 patients were eligible and 53 consented to participate . MEASUREMENTS Each subject 's fluid balance was diagnosed twice a week as dehydrated , overhydrated , or euvolemic , based on st and ardized physical examination , laboratory tests , and weight evaluation . Changes in fluid balance were quantified by measuring total body water ( TBW ) and extracellular fluid ( ECF ) applying deuterium- and bromide-dilution techniques . Impedance at 1 , 5 , 50 , and 100 kHz and body weight were measured daily . Sensitivity and Guyatt 's responsiveness indexes of MFBIA in detecting dehydration and overhydration were determined . RESULTS In total , 1071 MFBIA measurements were performed , during which 14 transitions from dehydration to euvolemia and 13 transitions from overhydration to euvolemia were monitored . Rehydration of dehydrated patients caused an increase in TBW and ECF of 3.4 + /- 1.8 L and 1.9 + /- 1.9 L , respectively , which result ed in significant decreases in impedance of 133 + /- 67 omega at 1 kHz and 93 + /- 61 omega at 100 kHz ( P = .001 ) . Treatment of overhydrated patients caused a TBW and ECF loss of 3.8 + /- 4.2 L and 3.1 + /- 3.8 L , respectively , which result ed in significant increases in impedance of 104 + /- 72 omega at 1 kHz and 81 + /- 68 omega at 100 kHz ( P < .001 ) . Sensitivity of a single MFBIA in diagnosing dehydration and overhydration was 14 % and 17 % , respectively . Responsiveness indexes of weighing and MFBIA for dehydration and overhydration were similar at all frequencies and greater than one . CONCLUSION The sensitivity of a single impedance measurement in detecting dehydration and overhydration was low . However , responsiveness of serial measurements to intra-individual changes in fluid balance was good . Therefore , this noninvasive technique may be used in clinical practice to improve monitoring fluid balance in geriatric patients , especially when daily weighing is difficult Whole blood viscosity , plasma viscosity , hematocrit , and fibrinogen are considered independent risk factors for coronary heart disease and can be elevated by dehydration . The associations between fatal coronary heart disease and intake of water and fluids other than water were examined among the 8,280 male and 12,017 female participants aged 38 - 100 years who were without heart disease , stroke , or diabetes at baseline in 1976 in the Adventist Health Study , a prospect i ve cohort study . A total of 246 fatal coronary heart disease events occurred during the 6-year follow-up . High daily intakes of water ( five or more glasses ) compared with low ( two or fewer glasses ) were associated with a relative risk in men of 0.46 ( 95 % confidence interval ( CI ) : 0.28 , 0.75 ; p trend = 0.001 ) and , in women , of 0.59 ( 95 % CI : 0.36 , 0.97 ) . A high versus low intake of fluids other than water was associated with a relative risk of 2.47 ( 95 % CI : 1.04 , 5.88 ) in women and of 1.46 ( 95 % CI : 0.7 , 3.03 ) in men . All associations remained virtually unchanged in multivariate analysis adjusting for age , smoking , hypertension , body mass index , education , and ( in women only ) hormone replacement therapy . Fluid intake as a putative coronary heart disease risk factor may deserve further consideration in other population s or using other study design BACKGROUND Bedside ultrasound has been suggested as a non-invasive modality to estimate central venous pressure ( CVP ) . OBJECTIVE Evaluate a simple bedside ultrasound technique to measure the diameter of the inferior vena cava ( IVC ) and correlate to simultaneously measured CVP . Secondary comparisons include anatomic location , probe orientation , and phase of respiration . METHODS An unblinded prospect i ve observation study was performed in an emergency department and critical care unit . Subjects were a convenience sample of adult patients with a central line at the superior venocaval-atrial junction . Ultrasound measured transverse and longitudinal diameters of the IVC at the subxiphoid , suprailiac , and mid-abdomen , each measured at end-inspiration and end-expiration . Correlation and regression analysis were used to relate CVP and IVC diameters . RESULTS There were 72 subjects with a mean age of 67 years ( range 21 - 94 years ) , 37 ( 53 % ) male , enrolled over 9 months . Seven subjects were excluded for tricuspid valvulopathy . Primary diagnoses were : respiratory failure 12 ( 18 % ) , sepsis 11 ( 17 % ) , and pancreatitis 3 ( 5 % ) . There were 28 ( 43 % ) patients mechanically ventilated . Adequate measurements were obtainable in 57 ( 89 % ) using the subxiphoid , in 44 ( 68 % ) using the mid-abdomen , and in 28 ( 43 % ) using the suprailiac views . The correlation coefficients were statistically significant at 0.49 ( 95 % confidence interval [ CI ] 0.26 - 0.66 ) , 0.51 ( 95 % CI 0.23 - 0.71 ) , and 0.50 ( 95 % CI 0.14 - 0.74 ) for end-inspiratory longitudinal subxiphoid , midpoint , and suprailiac views , respectively . Transverse values were statistically significant at 0.42 ( 95 % CI 0.18 - 0.61 ) , 0.38 ( 95 % CI 0.09 - 0.61 ) , and 0.67 ( 95 % CI 0.40 - 0.84 ) , respectively . End-expiratory measurements gave similar or slightly less significant values . CONCLUSION The subxiphoid was the most reliably viewed of the three anatomic locations ; however , the suprailiac view produced superior correlations to the CVP . Longitudinal views generally outperformed transverse views . A simple ultrasound measure of the IVC yields weak correlation to the CVP AIM Investigation was done in the institutionalized elderly in order to know the value of urine osmolality in this population . METHODS Cross sectional study was done in the government institutionalized elderly that localized in South Jakarta . By using simple r and om sampling , 50 elderly people were chosen from all of the residents in this institutionalized elderly aged more than 60 years . They were excluded if they had diabetes mellitus , abnormal cortisol ( reference range of morning cortisol , 5 - 25 ug/dL ) , potassium less than 3 meq/L , chronic diarrhoe , congestive heart failure , nephrotic syndrome , and cirrhosis of the liver , and also if they were in manitol or diuretic treatment , and not cooperative . All of these data were analyzed with descriptive analysis and comparative T-test of two non-related groups . RESULTS There were 28 elderly peoples consisted of 13 males and 15 females participated in this study . The mean of the urine osmolality was 581 + /- 174 mosmol/Kg . The mean of the urine osmolality in the female group ( 657.33 + /- 126.54 mosmol/kg ) was significantly higher than in the male group ( p = 0.01 ) . CONCLUSION The urine osmolality in the elderly is high and the so-called normal value is 407 - 755 mosmol/Kg . Further study is needed to investigate the lowest urine osmolality value as the diagnostic tool of hyponatremia due to water excretion disorder in the elderly BACKGROUND Well-recognized markers for static ( one time ) or dynamic ( monitoring over time ) dehydration assessment have not been rigorously tested for their usefulness in clinical , military , and sports medicine communities . OBJECTIVE This study evaluated the components of biological variation and the accuracy of potential markers in plasma , urine , saliva , and body mass ( B(m ) ) for static and dynamic dehydration assessment . DESIGN We studied 18 healthy volunteers ( 13 men and 5 women ) while carefully controlling hydration and numerous preanalytic factors . Biological variation was determined over 3 consecutive days by using published methods . Atypical values based on statistical deviations from a homeostatic set point were examined . Measured deviations in body fluid were produced by using a separate , prospect i ve dehydration experiment and evaluated by receiver operating characteristic ( ROC ) analysis to quantify diagnostic accuracy . RESULTS All dehydration markers displayed substantial individuality and one-half of the dehydration markers displayed marked heterogeneity of intraindividual variation . Decision levels for all dehydration markers were within one SD of the ROC criterion values , and most levels were nearly identical to the prospect i ve group means after volunteers were dehydrated by 1.8 - 7.0 % of B(m ) . However , only plasma osmolality ( P(osm ) ) showed statistical promise for use in the static dehydration assessment . A diagnostic decision level of 301 plusmn 5 mmol/kg was proposed . Reference change values of 9 mmol/kg ( P(osm ) ) , 0.010 [ urine specific gravity ( U(sg ) ) ] , and 2.5 % change in B(m ) were also statistically valid for dynamic dehydration assessment at the 95 % probability level . CONCLUSIONS P(osm ) is the only useful marker for static dehydration assessment . P(osm ) , U(sg ) , and B(m ) are valid markers in the setting of dynamic dehydration assessment BACKGROUND Older adults are at increased risk of dehydration , yet water balance is understudied in this population . OBJECTIVE This controlled diet study assessed the effect of age on water input , output , and balance in healthy adults . Hydration status ( plasma osmolality and urine specific gravity ) and body composition were also measured . DESIGN Eleven men and 14 women aged 23 - 46 y and 10 men and 11 women aged 63 - 81 y were subjects . Water balance was assessed during days 7 - 10 of three 18-d controlled feeding trials with protein intakes of 0.50 , 0.75 , and 1.00 g . kg(-1 ) . d(-1 ) . Total water input included water from the provided foods and beverages , ad libitum intake , and metabolic production . Water output included the losses in urine and stool and the insensible losses from respiration and nonsweating perspiration . RESULTS Ad libitum water consumption , total water intake , water output through urine , total water output , and net water balance were not different in the older subjects than in the younger subjects . Markers of hydration status were within the range of clinical normalcy for all groups . Total body water ( TBW ) was not significantly different , fat-free mass ( FFM ) was significantly lower ( P < 0.05 ) , and FFM hydration ( TBW : FFM ) was significantly higher ( P < 0.05 ) in the older subjects than in the younger subjects . Dietary protein intake did not influence any of these results . CONCLUSIONS These results show that healthy older adults maintain water input , output , and balance comparable to those of younger adults and have no apparent changes in hydration status . The results support that the hydration of FFM is increased in older men and women OBJECTIVE Dehydration is a common condition and frequent cause of hospitalization in older people , despite the caregiver 's high attention in attempt to avoid its occurrence . In this study , various physical signs were examined as clinical signs of dehydration in elderly . METHODS A prospect i ve observational study was conducted in an acute care teaching hospital . Consecutive elderly patients who were admitted to the Department of Medicine were evaluated . Dehydration was defined as a calculated serum osmolality above 295 mOsm/L. The patients diagnosed as dehydrated or not dehydrated were observed for physical signs of dehydration . Data of blood and urine chemistry analysis were also compared between the two groups . RESULTS A total of 27 elderly patients admitted with acute medical conditions were included in this study . For the physical signs , dry axilla had moderate sensitivity ( 44 % ) and excellent specificity ( 89 % ) to detect dehydration . Sunken eyes and delayed capillary refill time also showed relatively good specificity ( 83 % ) . For laboratory data , the mean concentrations of serum sodium of the dehydrated group ( 146 mEq/L ) was significantly higher ( p<0.01 ) than those of the non-dehydrated group ( 134 mEq/L ) . CONCLUSION Physical signs of dehydration in elderly showed relatively good specificity but poor sensitivity . The evaluation of the axillary moisture could help assess dehydration as well as laboratory data analysis such as serum sodium concentration OBJECTIVES Dehydration in older adults contributes to increased morbidity and mortality during hospitalization . As such , early diagnosis of dehydration may improve patient outcome and reduce the burden on healthcare . This prospect i ve study investigated the diagnostic accuracy of routinely used physical signs , and noninvasive markers of hydration in urine and saliva . DESIGN Prospect i ve diagnostic accuracy study . SETTING Hospital acute medical care unit and emergency department . PARTICIPANTS One hundred thirty older adults [ 59 males , 71 females , mean ( st and ard deviation ) age = 78 ( 9 ) years ] . MEASUREMENTS Participants with any primary diagnosis underwent a hydration assessment within 30 minutes of admittance to hospital . Hydration assessment comprised 7 physical signs of dehydration [ tachycardia ( > 100 bpm ) , low systolic blood pressure ( < 100 mm Hg ) , dry mucous membrane , dry axilla , poor skin turgor , sunken eyes , and long capillary refill time ( > 2 seconds ) ] , urine color , urine specific gravity , saliva flow rate , and saliva osmolality . Plasma osmolality and the blood urea nitrogen to creatinine ratio were assessed as reference st and ards of hydration with 21 % of participants classified with water-loss dehydration ( plasma osmolality > 295 mOsm/kg ) , 19 % classified with water- and -solute-loss dehydration ( blood urea nitrogen to creatinine ratio > 20 ) , and 60 % classified as euhydrated . RESULTS All physical signs showed poor sensitivity ( 0%-44 % ) for detecting either form of dehydration , with only low systolic blood pressure demonstrating potential utility for aiding the diagnosis of water- and -solute-loss dehydration [ diagnostic odds ratio ( OR ) = 14.7 ] . Neither urine color , urine specific gravity , nor saliva flow rate could discriminate hydration status ( area under the receiver operating characteristic curve = 0.49 - 0.57 , P > .05 ) . In contrast , saliva osmolality demonstrated moderate diagnostic accuracy ( area under the receiver operating characteristic curve = 0.76 , P < .001 ) to distinguish both dehydration types ( 70 % sensitivity , 68 % specificity , OR = 5.0 ( 95 % confidence interval 1.7 - 15.1 ) for water-loss dehydration , and 78 % sensitivity , 72 % specificity , OR = 8.9 ( 95 % confidence interval 2.5 - 30.7 ) for water- and -solute-loss dehydration ) . CONCLUSIONS With the exception of low systolic blood pressure , which could aid in the specific diagnosis of water- and -solute-loss dehydration , physical signs and urine markers show little utility to determine if an elderly patient is dehydrated . Saliva osmolality demonstrated superior diagnostic accuracy compared with physical signs and urine markers , and may have utility for the assessment of both water-loss and water- and -solute-loss dehydration in older individuals . It is particularly noteworthy that saliva osmolality was able to detect water- and -solute-loss dehydration , for which a measurement of plasma osmolality would have no diagnostic utility Although it is generally appropriate for a healthy adult to consume 2000 to 2500 ml per day , the literature does not address evaluating any st and ard . The objective here was to develop a weight-based hydration management intervention and evaluate the impact of this on the incidence of acute confusion ( AC ) using an N = 98 . The intervention consisted of a fluid intake goal based on 100 ml per kg for the first 10 kg , 50ml/kg for the next 10 kg , and 15 ml for the remaining body weight . The treatment group received instruction and assistance on the fluid goal and the control group received routine care . Measurements included serum electrolytes , bioimpedance analysis , urinalysis , Mini-Mental State Exam , and the NEECHAM . There was no difference in the incidence of AC between treatment and controls , but those individuals with ≥ 90 % compliance demonstrated higher ECF volumes and also lower urine leukocyte counts Background : Serum osmolality is an accurate indicator of hydration status in older adults . Glucose , urea , and electrolyte concentrations are used to calculate serum osmolarity , which is an indirect estimate of serum osmolality , but which serum osmolarity equations best predict serum osmolality in the elderly is unclear . Objective : We assessed the agreement of measured serum osmolality with calculated serum osmolarity equations in older people . Design : Serum osmolality was measured by using freezing point depression in a cross-sectional study . Plasma glucose , urea , and electrolytes were analyzed and entered into 38 serum osmolarity-prediction equations . The Bl and -Altman method was used to evaluate the agreement and differential bias between measured osmolality and calculated osmolarity . The sensitivity and specificity of the most-promising equations were examined against serum osmolality ( reference st and ard ) . Results : A total of 186 people living in UK residential care took part in the Dehydration Recognition In our Elders study ( 66 % women ; mean ± SD age : 85.8 ± 7.9 y ; with a range of cognitive and physical impairments ) and were included in analyses . Forty-six percent of participants had impending or current dehydration ( serum osmolality ≥295 mmol/kg ) . Participants with diabetes ( n = 33 ; 18 % ) had higher glucose ( P < 0.001 ) and serum osmolality ( P < 0.01 ) . Of 38 predictive equations used to calculate osmolarity , 4 equations showed reasonable agreement with measured osmolality . One [ calculated osmolarity = 1.86 × ( Na+ + K+ ) + 1.15 × glucose + urea + 14 ; all in mmol/L ] was characterized by narrower limits of agreement and the capacity to predict serum osmolality within 2 % in > 80 % of participants , regardless of diabetes or hydration status . The equation 's sensitivity ( 79 % ) and specificity ( 89 % ) for impending dehydration ( ≥295 mmol/kg ) and current dehydration ( > 300 mmol/kg ) ( 69 % and 93 % , respectively ) were reasonable . Conclusions : The assessment of a panel of equations for the prediction of serum osmolarity led to identification of one formula with a greater diagnostic performance . This equation may be used to predict hydration status in frail older people ( as a first-stage screening ) or to estimate hydration status in population studies . This trial was registered at the Research Register for Social Care ( http://www . research register.org.uk ) as 122273 BACKGROUND Hyponatremia is the most common electrolyte abnormality in hospitalized individuals . METHODS To investigate the association between serum sodium concentration and mortality , we conducted a prospect i ve cohort study of 98,411 adults hospitalized between 2000 and 2003 at 2 teaching hospitals in Boston , Massachusetts . The main outcome measures were in-hospital , 1-year , and 5-year mortality . Multivariable logistic regression and Cox proportional hazards models were used to compare outcomes in patients with varying degrees of hyponatremia against those with normal serum sodium concentration . RESULTS Hyponatremia ( serum sodium concentration < 135 mEq/L ) was observed in 14.5 % of patients on initial measurement . Compared with patients with normonatremia ( 135 - 144 mEq/L ) , those with hyponatremia were older ( 67.0 vs 63.1 years , P < .001 ) and had more comorbid conditions ( mean Deyo-Charlson Index 1.9 vs 1.4 , P < .001 ) . In multivariable-adjusted models , patients with hyponatremia had an increased risk of death in hospital ( odds ratio 1.47 , 95 % confidence interval [ CI ] , 1.33 - 1.62 ) , at 1 year ( hazard ratio 1.38 , 95 % CI , 1.32 - 1.46 ) , and at 5 years ( hazard ratio 1.25 , 95 % CI , 1.21 - 1.30 ) . The increased risk of death was evident even in those with mild hyponatremia ( 130 - 134 mEq/L ; odds ratio 1.37 , 95 % CI , 1.23 - 1.52 ) . The relationship between hyponatremia and mortality was pronounced in patients admitted with cardiovascular disease , metastatic cancer , and those admitted for procedures related to the musculoskeletal system . Resolution of hyponatremia during hospitalization attenuated the increased mortality risk conferred by hyponatremia . CONCLUSION Hyponatremia , even when mild , is associated with increased mortality AIMS The primary objective was to investigate the efficacy of desmopressin orally disintegrating tablet versus placebo in patients with nocturia . Pharmacodynamics , safety and patient-reported quality of life ( QoL ) outcomes were also evaluated . One of several benefits of the new formulation is increased bioavailability . Exploring lower doses allows for a better evaluation of therapeutic effect versus tolerability . METHODS This was a 4-week , r and omized , double-blind study comparing 10 , 25 , 50 , or 100 µg desmopressin versus placebo in adults with defined nocturia . RESULTS The intent to treat population comprised 757 patients experiencing ∼3 voids/night and a high prevalence of nocturnal polyuria ( ∼90 % ) . Increasing doses of desmopressin were associated with decreasing numbers of nocturnal voids and voided volume , greater proportions of subjects with > 33 % reduction in nocturnal voids , and increased duration of first sleep period . The lowest dose reaching statistical significance ( P < 0.05 vs. placebo ) varied by endpoint . Improvements were clinical ly meaningful , meaning that patients actually had fewer nightly voids . Post hoc analyses by gender suggested a lower minimum effective dose for women . Desmopressin was generally well tolerated . Reductions in serum sodium to < 125 mmol/L in six women ( taking > 25 µg desmopressin ) and two men ( aged 67 and 82 ) taking 100 µg , support lower and gender-specific dosing to reduce the small but clinical ly significant risk of hyponatraemia . Each void reduced/hour of sleep gained was associated with significant improvements in QoL. CONCLUSIONS Desmopressin orally disintegrating tablet is an effective and well-tolerated treatment for patients with nocturia . Further exploration of the lower dose range is warranted OBJECTIVE To examine long-term mortality and its determinants in nursing home residents with dementia diagnosed with a lower respiratory tract infection ( LRI ) . SETTING AND PATIENTS US ( Missouri ) nursing home residents ( 541 ) and Dutch residents ( 403 ) with dementia who were treated with antibiotics for an LRI . METHODS Prospect i ve studies of nursing home-acquired LRI in the US ( Missouri ) and in the Netherl and s. Measurements included demographics , indicators of acute illness , general health condition , intake problems , and comorbid disease . Six-month mortality rates were calculated and Cox proportional hazards models were developed for mortality up to 2 years after diagnosis . RESULTS Six-month mortality was 48.8 % among Dutch residents and 36.4 % among US residents . After multivariable adjustment , Dutch nationality was not associated with higher long-term mortality . Variables most strongly associated with long-term mortality were activity of daily living dependency and male gender . Other variables associated with outcome were diverse : respiratory difficulty , age , dehydration , congestive heart failure , decreased alertness , decubitus ulcers , Parkinson disease , weight loss/poor nutrition , and pulse rate . CONCLUSION LRI is followed by substantial mortality in the months after diagnosis , indicating high frailty of nursing home residents with dementia who develop LRI . A variety of patient characteristics , including many not directly related to LRI , were consistently associated with long-term mortality in two cohorts with differing illness severity . The results are relevant for informing families , evaluating poor long-term survival in the context of care and treatment , and balancing the potential burdens and benefits of care Background : Colonoscopic preparations are defectively tolerated among many very old patients and the quality of preparation is often inadequate . Methods : Seventy-two patients aged 80 years or more were r and omized to receive either NaP ( 37 ) or PEG ( 35 ) preparation . Patients ' and endoscopists ' opinions of the preparation and colonoscopy were ascertained , the adverse effects were recorded , clinical indicators of dehydration such as tongue dryness , upper body muscle weakness and confusion were assessed and laboratory tests were taken before and after the preparation . Results : Patients ' evaluations showed no significant difference regarding the tolerance of preparations . Only the frequency of nausea was higher in the NaP group ( 16%/9 % , P = 0.01 ) . Assessment of the indicators of dehydration showed a difference only in tongue dryness in the NaP group ( P = 0.02 ) . The quality of preparation was evaluated by endoscopists as good or excellent in 81 % of cases in the NaP group and in 77 % of cases in the PEG group . The median values of potassium decreased from 4.0 mmol/L to 3.7 mmol/L ( P < 0.05 ) and of sodium increased from 142 mmol/L to 145 mmol/L ( P < 0.05 ) after NaP preparation . Conclusion : Sodium phosphate and PEG preparations are almost equally tolerated and effective in very old in patients . NaP preparations cause more changes in the levels of potassium and sodium . For those elderly patients who are vulnerable to complications caused by electrolyte disturbances we recommend PEG preparation BACKGROUND : Distribution and clearance of an infused bolus can be studied by repetitive sampling of invasive total hemoglobin ( tHb ) using volume kinetic equations . Pulse CO-oximetry , a recent advancement in patient monitoring that allows for the continuous and noninvasive estimation of hemoglobin concentration ( SpHb ) , would greatly facilitate the scientific and clinical use of the volume kinetic parameters . In the present study , we examined whether serial measurements of SpHb in an emergency room setting can be used to calculate distribution volume ( V ) and clearance ( Cl ) rate of an infused bolus . METHODS : This was a prospect i ve , observational study of patients in 2 age groups admitted for various reasons to the emergency room of a tertiary care center . IV catheters were placed in both arms of the subjects to induce plasma volume expansion by infusion of a buffered crystalloid glucose solution and for withdrawing venous blood sample s for analysis of tHb at 0 , 5 , 10 , 15 , 30 , 45 , 60 , 75 , and 90 minutes after start of infusion . During these interventions , subjects were simultaneously monitored by pulse CO-oximetry for measurement of SpHb ( Masimo Radical-7 , Rev E ReSposable Sensor ) . Bias , precision , and limits of agreement were calculated in Bl and -Altman plots to compare the accuracy of SpHb with invasive tHb measurements . Using volume kinetic ( pharmacokinetics for fluids ) equations , V and Cl were determined . RESULTS : Thirty patients ( 14 from the young group with a mean age of 30 years , and 16 from the geriatric group with mean age of 84 years ) were enrolled in the study . When all data were included , this yielded 242 data pairs with a bias of −0.47 ( 95 % confidence interval , −0.62 to −0.32 ) between SpHb and tHb . However , 5 patients were omitted because of low quality signals , leaving 193 hemoglobin data pairs for further analysis . Bias was then −0.24 ( 95 % confidence interval , −0.39 to −0.09 ) . The biases show that the device on average slightly underestimates tHb values . The precision of SpHb decreases when the low signal quality indicator is present . For the 27 subjects for whom the V and Cl were calculated , there were no significant differences in the estimation of the distribution volumes using either tHb or SpHb values . Clearance constants were also estimated , but with less accuracy . CONCLUSIONS : Our data show that SpHb by pulse CO-oximetry may be used to calculate volume of distribution in an emergency room setting Elderly patients with heart failure ( HF ) may be troubled by thirst , despite the fact that elderly have an impaired ability to sense thirst . The present study was undertaken to compare the intensity of thirst in patients with and without HF and to evaluate how this symptom relates to the health-related quality of life and indices of the fluid balance . Forty-eight patients ( mean age 80 years ) admitted to hospital with worsening HF ( n = 23 ) or with other acute illness ( n = 25 ) grade d their thirst and estimated their health-related quality of life ( HRQoL ) . Serum sodium was measured and urine sample s were assessed for color and electrolyte content . The HF patients reported significantly more intensive thirst ( median = 75 mm ) compared with those in the control group ( median = 25 mm ; p < 0.0001 ) . There was no statistically significant relationship between thirst and HRQoL , which was low overall . Serum sodium and urine color did not differ significantly between the groups , but the urine of the HF patients had a lower sodium concentration and osmolality . We conclude that elderly patients with worsening HF have considerably increased thirst and , hence , intense thirst should be regarded as a symptom of HF STUDY OBJECTIVE To determine which of the signs and symptoms of dehydration obtainable from patient history and physical examination in the emergency department are most useful in assessing the severity of dehydration in elderly patients . DESIGN Prospect i ve , correlational study . SETTING Two university teaching hospitals . PATIENTS Fifty-five patients aged 60 or older presenting to the emergency department with suspected dehydration were studied . MEASUREMENTS AND MAIN RESULTS In the emergency department , patients were evaluated by a st and ardized history and physical examination that included assessment of 38 signs and symptoms commonly attributed to dehydration . The relationships between the presence and intensity of these putative dehydration indicators and an independent rating of dehydration severity based on a comprehensive review of the medical record were evaluated . Also evaluated were the relationships between these dehydration indicators and patient age . Indicators that correlated best with dehydration severity but were unrelated to patient age included : tongue dryness ( P less than 0.001 ) , longitudinal tongue furrows ( P less than 0.001 ) , dryness of the mucous membranes of the mouth ( P less than 0.001 ) , upper body muscle weakness ( P less than 0.001 ) , confusion ( P less than 0.001 ) , speech difficulty ( P less than 0.01 ) , and sunkenness of eyes ( P less than 0.01 ) . Other indicators had only weak associations with dehydration severity or were also related to age . Patient thirst was unrelated to dehydration severity . CONCLUSIONS A set of signs and symptoms related to dehydration severity in elderly patients has been identified . These indicators may be more useful for evaluation of dehydration severity in the emergency department than other commonly used indicators Background Food and drink are important determinants of physical and social health in care home residents . This study explored whether a pragmatic methodology including routinely collected data was feasible in UK care homes , to describe the health , wellbeing and nutritional status of care home residents and assess effects of changed provision of food and drink at three care homes on residents ' falls ( primary outcome ) , anaemia , weight , dehydration , cognitive status , depression , lipids and satisfaction with food and drink provision . Methods We measured health , wellbeing and nutritional status of 120 of 213 residents of six care homes in Norfolk , UK . An intervention comprising improved dining atmosphere , greater food choice , extended restaurant hours , and readily available snacks and drinks machines was implemented in three care homes . Three control homes maintained their previous system . Outcomes were assessed in the year before and the year after the changes . Results Use of routinely collected data was partially successful , but loss to follow up and levels of missing data were high , limiting power to identify trends in the data .This was a frail older population ( mean age 87 , 71 % female ) with multiple varied health problems . During the first year 60 % of residents had one or more falls , 40 % a wound care visit , and 40 % a urinary tract infection . 45 % were on diuretics , 24 % antidepressants , and 43 % on psychotropic medication . There was a slight increase in falls from year 1 to year 2 in the intervention homes , and a much bigger increase in control homes , leading to a statistically non-significant 24 % relative reduction in residents ' rate of falls in intervention homes compared with control homes ( adjusted rate ratio 0.76 , 95 % CI 0.57 to 1.02 , p = 0.06 ) . Conclusions Care home residents are frail and experience multiple health risks . This intervention to improve food and drink provision was well received by residents , but effects on health indicators ( despite the relative reduction in falls rate ) were inconclusive , partly due to problems with routine data collection and loss to follow up . Further research with more homes is needed to underst and which , if any , components of the intervention may be successful . Trial registration Trial registration : IS RCT N86057119 OBJECTIVE To determine the incidence of early hypernatremic dehydration among residents of a nursing home care unit ( NHCU ) presenting with significant febrile episodes ( FE ) . DESIGN Prospect i ve cohort analytic study . FE were defined as temperature ( T ) > 100 degrees F oral ( o ) or 101 degrees F rectal ( r ) for > or = 24 hours . SETTING NHCU in a Veterans Administration hospital . PATIENTS A total of 130 residents of the NHCU were monitored for FE during a 4-month study period . MAIN OUTCOME MEASURES Blood urea nitrogen (BUN)/creatinine ( Cr ) ( abnormal > or = 25 ) and serum sodium (Na)(abnormal > or = 146 mmol/L ) were drawn within 24 - 48 hours of the onset of all FE ; documentation of impaired oral intake ( OI ) by staff ; necessity of transfer to acute medical wards and mortality were recorded . RESULTS There were 48 FE among 42 residents ( 39 M , 3 F ; mean age 75 + /- 11.3 ) . Maximum recorded T during the FE ranged from 100.1 degrees F-102.2 degrees F o and 101.2 degrees F-105.3 degrees F r. Laboratory values were available for 40/48 FE . Twenty-three percent ( 9/40 ) had elevated BUN/Cr ratios , 25 % ( 10/40 ) had elevated serum Na , and 12.5 % ( 5/40 ) had both . In patients noted to have impaired OI ( n = 11 ) as documented by staff , increased serum Na or BUN/Cr ratio was observed in 82 % ( 9/11 ) . A r and om control group of 37 nonacutely ill , nonfebrile NHCU residents ( 33 M , 4 F ; mean age 75 + /- 10.1 ) having routine annual laboratory tests revealed only 1 resident ( age 95 ) with an elevated Na of 146 and BUN/Cr ratio of 26 and 1 resident with an increased BUN/Cr ratio of 28 . None of the controls had any staff documentation of impaired OI . Of the 5 deaths in the febrile group with laboratory data ( total deaths = 6 ; 14 % ) , 100 % had either elevated serum Na and /or elevated BUN/Cr ratios , and 80 % ( 4/5 ) had both . Comparing the febrile group with controls , BUN/Cr ratios were found to be significantly elevated in the febrile group ( P < 0.05 ) . Serum sodium values were also significantly elevated in the febrile group ( P < 0.01 ) . CONCLUSIONS Staff documentation of impaired OI was highly associated with either elevated serum Na or increased BUN/Cr ratios . These data show that many older NHCU patients with significant fevers often have early impaired OI and laboratory evidence of dehydration . These data indicate that staff should institute appropriate monitoring for dehydration at the time of earliest detection of fever in this population Patients with chronic lung disease productive of sputum are generally encouraged to drink a large amount of fluid to facilitate sputum production . This clinical practice has not been tested systematic ally . Twelve out patients with chronic obstructive pulmonary disease in clinical ly stable condition who had daily sputum production were asked in r and om sequence : 1 ) to drink one glass of fluid every waking hour after supper and upon waking the next morning ( hydration ) , 2 ) to drink no fluid after supper and upon waking the next morning ( dry ) , and 3 ) to drink fluid ad lib ( ad lib ) . Each morning sputum collection was started upon waking and continued for four hours . The differences in volume , elasticity of sputum , respiratory symptoms , and ease of expectoration were not significant . We conclude that moderate hydration and dehydration have no effect on volume expectorated , the elasticity of sputum , respiratory symptoms or forced expiratory volume in one second Background : Hyperosmolar syndromes are associated with high mortality rates , yet little is known about their incidence and their prognosis . Objective : To determine the 1-year incidence of hyperosmolar states and the prognostic factors for in-hospital and 1-year mortality . Method : A 6-month prospect i ve cohort study was conducted in a 40-bed acute care geriatric unit and included all patients who developed plasma osmolarity of 320 mosm/l or greater . Age , sex and known cognitive impairment as possible risk factors of hyperosmolarity were assessed . In-hospital and 1-year mortality were calculated and risk factors for death among baseline patient characteristics were sought . Results : 48 ( 11 ) of the 436 in patients in the study were identified as hyperosmolar . Diabetic hyperosmolarity was found in 8 patients . Cognitive impairment was a risk factor for hyperosmolarity ( relative risk 2.39 , 95 % confidence interval 2.18–3.33 , p < 0.001 ) , but not age or sex . Infections were accompanied by hyperosmolarity in 30 ( 62.5 ) . Thirty-five patients ( 72.9 ) were bed- or chair-ridden . In-hospital mortality was higher in hyperosmolar patients ( 35.4 ) than in the others ( 16.7 % , p = 0.003 ) . Causes of death were infection in 5 ( 29.4 ) , terminal cachexia in 5 , thrombosis in 3 , gastric bleeding in 1 , renal failure in 2 and heart failure in 1 . Functional dependency for mobility was a risk factor for in-hospital mortality but not the degree of hyperosmolarity . One-year mortality was 68.7 % . Functional dependency and pressure ulcers were independent predictors of 1-year mortality ( p = 0.005 and p = 0.044 , respectively ) . Conclusion : Hyperosmolar states occurred in cognitively impaired and dependent patients and result ed in high mortality rates at short and at mid-term . Mortality was related to functional dependency rather than to hyperosmolarity OBJECTIVES To assess BIA data given by Analycor 3 and some bio-impedance equations to assist geriatricians with discriminative diagnosis of hypertonic dehydration , during heat waves . DESIGN Prospect i ve study : a dehydrated patients group has been compared with a r and omised control group . SETTING The study was carried out in a French geriatric department , in the Emile Roux geriatric hospital . PARTICIPANTS 36 : six men and twelve women in each group . MEASUREMENTS The most valuable clinical indicators of dehydration severity were recorded and scored . BIA measurements were performed with an Analycor 3 analyzer ; TBW was calculated from impedances at 50 and 100 kHz , ECW from impedance at 5 kHz ; Calculations were made also with formula described in the literature , vali date d in healthy or in institutionalised elderly subjects . RESULTS TBW and ECW values were always lower in dehydrated group than in control group , but without significance , whatever the applied formula ; however ICW values calculated with " manufacturers equations " significantly decreased in dehydrated group . Data given by the analyzer used in this study , as well as BIA age specific equations discriminated the severely hypertonic dehydrated patients sub-group , but not the mildly hypertonic dehydrated patients sub-group . CONCLUSION The BIA data given by the analyzer used in this study assist geriatricians at bedside with discriminative diagnosis of hypertonic dehydration , especially in severe hypertonic dehydration , but data given by the analyzer used in this study , as well as age specific equations are sometimes in poor agreement with clinical and biological parameters usually selected to assess dehydration , in mildly dehydrated patients This investigation evaluated the validity and sensitivity of urine color ( Ucol ) , specific gravity ( Usg ) , and osmolality ( Uosm ) as indices of hydration status , by comparing them to changes in body water . Nine highly trained males underwent a 42-hr protocol involving dehydration to 3.7 % of body mass ( Day 1 , -2.64 kg ) , cycling to exhaustion ( Day 2 , -5.2 % of body mass , -3.68 kg ) , and oral rehydration for 21 hr . The ranges of mean ( across time ) blood and urine values were Ucol , 1 - 7 ; Usg , 1.004 - 1.029 ; Uosm , 117 - 1,081 mOsm x kg-1 ; and plasma osmolality ( Posm ) , 280 - 298 mOsm x kg-1 . Urine color tracked changes in body water as effectively as ( or better than ) Uosm , Usg , urine volume , Posm , plasma sodium , and plasma total protein . We concluded that ( a ) Ucol , Uosm , and Usg are valid indices of hydration status , and ( b ) marked dehydration , exercise , and rehydration had little effect on the validity and sensitivity of these indices Objective To design and evaluate a simple and rapid method to predict body hydration status in critically ill patients . Design Prospect i ve , consecutive sample . Setting Medical intensive care unit of a university hospital . Patients 31 consecutive patients . Methods All patients were classified daily for hydration status by the attending physician based on clinical impression , weight changes and laboratory measurements . The hydration status was scored as ‘ dehydrated ’ , ‘ euvolemic ’ or ‘ edematous ’ . The total body impedance was measured daily by a tetrapolar impedance technique . Results Resistances > 700Ω were found in dehydrated subjects and resistances of < 400 Ω in edematous patients . Weight gain was observed in dehydrated and weight loss in edematous patients . A discriminant analysis was used to create a predictive model for hydration using the daily impedance and weight measurements . If a cutoff point of 60 % for the predicted classification was used to categorize the patient 's hydration as dehydrated , euvolemic and edematous , no false positive predictions were observed for the dehydrated or the edematous state . Conclusion Impedance measurements are in close agreement with the clinical impression of hydration of critically ill patients . Future investigations must eluci date the clinical importance BACKGROUND The study investigators conducted a vigorous screening protocol for delirium in rural long-term care ( LTC ) facilities for a period of 28 days focusing on Bioelectrical Impedance Analysis ( BIA ) and other hydration parameters as risk factors . METHODS A two-stage cluster sampling procedure was used to r and omly select participants ( n = 313 ) from 13 LTC facilities located in southeastern Iowa , stratified on facility bed size . BIA was used to estimate intracellular water ( ICW ) , extracellular water ( ECW ) , and total body water ( TBW ) on four occasions -- baseline and follow-up days 7 , 14 , and 28 . Volume estimates were calculated as a percent of body weight ( % WT ) . Serum electrolytes and hematology were also measured . Delirium was measured with four strict criteria : a NEECHAM Confusion Scale score < 25 , Vigilance " A " score > 2 , a Mini-Mental Status Examination < baseline , and a positive Confusion Assessment Method score . RESULTS There were n = 69 delirium cases ( 22.0 % ) . Blood urea nitrogen/creatinine ratios greater than 21:1 ( odds ratio = 1.76 , 95 % confidence interval 1.02 - 3.06 ) . No significant risk for delirium was associated with ICW , ECW , or TBW as a percent of body weight . CONCLUSIONS Some changes were observed with a slight decrease in ICW between day 7 and day 14 of follow-up that tended to follow an increase in delirium events , but in general the BIA measures did not predict delirium events OBJECTIVE To investigate the factors that influenced fluid intake among nursing home residents who were not eating well . DESIGN A prospect i ve , descriptive , anthropological study . SETTING Two proprietary nursing homes with 105 and 138 beds , respectively . PARTICIPANTS Forty nursing home residents . MEASUREMENTS Participant observation , event analysis , bedside dysphagia screening , mental and functional status evaluation , assessment of level of family/advocate involvement , and chart review were used to collect data . Data were gathered on the amount of liquid served and consumed over a 3- day period . Daily fluid intake was compared with three established st and ards : St and ard 1 ( 30 mL/kg body weight ) , St and ard 2 ( 1 mL/kcal/energy consumed ) , and St and ard 3 ( 100 mL/kg for the first 10 kg , 50 mL/kg for the next 10 kg , 15 mL/kg for the remaining kg ) . RESULTS The residents ' mean fluid intake was inadequate ; 39 of the 40 residents consumed less than 1500 mL/day . Using three established st and ards , we found that the fluid intake was inadequate for nearly all of the residents . The amount of fluid consumed with and between meals was low . Some residents took no fluids for extended periods of time , which result ed in their fluid intake being erratic and inadequate even when it was resumed . Clinical ( undiagnosed dysphagia , cognitive and functional impairment , lack of pain management ) , sociocultural ( lack of social support , inability to speak English , and lack of attention to individual beverage preferences ) , and institutional factors ( an inadequate number of knowledgeable staff and lack of supervision of certified nursing assistants by professional staff ) contributed to low fluid intake . During the data collection , 25 of the 40 residents had illnesses/conditions that may have been related to dehydration . CONCLUSIONS When staffing is inadequate and supervision is poor , residents with moderate to severe dysphagia , severe cognitive and functional impairment , aphasia or inability to speak English , and a lack of family or friends to assist them at mealtime are at great risk for dehydration . Adequate fluid intake can be achieved by simple interventions such as offering residents preferred liquids systematic ally and by having an adequate number of supervised staff help them to drink while properly positioned UNLABELLED It has been suggested that tear fluid is isotonic with plasma , and plasma osmolality ( P(osm ) ) is an accepted , albeit invasive , hydration marker . Our aim was to determine whether tear fluid osmolarity ( T(osm ) ) assessed using a new , portable , noninvasive , rapid collection and measurement device tracks hydration . PURPOSE This study aim ed to compare changes in T(osm ) and another widely used noninvasive marker , urine specific gravity ( USG ) , with changes in P(osm ) during hypertonic-hypovolemia . METHODS In a r and omized order , 14 healthy volunteers exercised in the heat on one occasion with fluid restriction ( FR ) until 1 % , 2 % , and 3 % body mass loss ( BML ) and with overnight fluid restriction until 08:00 h the following day , and on another occasion with fluid intake ( FI ) . Volunteers were rehydrated between 08:00 and 11:00 h. T(osm ) was assessed using the TearLab osmolarity system . RESULTS P(osm ) and USG increased with progressive dehydration on FR ( P < 0.001 ) . T(osm ) increased significantly on FR from 293 ± 9 to 305 ± 13 mOsm·L(-1 ) at 3 % BML and remained elevated overnight ( 304 ± 14 mOsm·L(-1 ) ; P < 0.001 ) . P(osm ) and T(osm ) decreased during exercise on FI and returned to preexercise values the following morning . Rehydration restored P(osm ) , USG , and T(osm ) to within preexercise values . The mean correlation between T(osm ) and P(osm ) was r = 0.93 and that between USG and P(osm ) was r = 0.72 . CONCLUSIONS T(osm ) increased with dehydration and tracked alterations in P(osm ) with comparable utility to USG . Measuring T(osm ) using the TearLab osmolarity system may offer sports medicine practitioners , clinicians , and research investigators a practical and rapid hydration assessment technique AIM In the critically ill patient the hemodynamic management is essential . Usually the hemodynamic status is estimated by the measurement of the intravascular pressure or volume and by computing the fluid balance , while the change in body weight estimates the total body water . The fluid balance is computed by subtracting the fluid output to the input . Although the input ( fluids , drugs , infusion . ) are well known , the output are difficult to correctly compute , because they depend on several factors such as the body-room temperature , amount of humidity and may change with time . Aim of this study was to prospect ively evaluate the accuracy of the fluid balance compared to the body weight measured by a dedicated mattress ( Hill-Rom ) . METHODS Fifteen critically ill patients were enrolled ( mean age of 63.2+/-19.7 years , body mass index of 24.9+/-3.5 kg/m2 ) and the measurements were computed every 8 hours . The data were analyzed by the Bl and -Altman test . RESULTS Four-hundred and seventy-two measurements for a mean intensive care stay of 12.3.+/-7.3 days were computed . The Bl and -Altamn showed a great inaccuracy , because the agreement ( the difference between the 2 methods ) was poor with a st and ard deviation of 1 840 L. CONCLUSION Although the fluid balance was not accurate , the only body weight without any intravascular measurement is not helpful for a correct clinical hemodynamic management of the patient OBJECTIVE To determine changes in st and ard laboratory measures of dehydration among residents of a nursing home care unit ( NHCU ) over a 6-month period . DESIGN A prospect i ve cohort analytic study . SETTING A 130-bed NHCU in a Department of Veterans Affairs Hospital . PATIENTS Fifteen infirm but stable male residents ( mean age 77 years ; range ( R ) 62 - 93 ) on one ward of the NHCU . MAIN OUTCOME MEASURES We studied prospect ively for 6 months the serum osmolality ( osm ) , serum sodium ( Na ) , blood urea nitrogen/creatinine ( BUN/Cr ) ratios and weight ( wt ) for 15 patients of the NHCU . None of the patients was acutely ill during the study period or exhibited clinical signs of dehydration . RESULTS Mean serum osm at baseline : 291.6 mOsm/kg ( R 278 to 300 ) ; 3 months : 291.5 mOsm/kg ( R 276 to 301 ) ; 6 months : 291.3 mOsm/kg ( R 283 - 300 ) were all similar . Forty percent ( 6/15 ) of patients had at least one high normal/elevated reading ( > or = 295 mOsm/kg ) during the study . Three patients ( 20 % ) had readings of > or = 300 mOsm/kg , but none of these patients had either concurrent increased serum Na ( > or = 146 mmole/L ) or BUN/Cr ratios ( > or = 25 ) . Mean serum Na at baseline : 143.0 mmole/L ( R 139 - 148 ) ; 3 months : 142.1 mmole/L ( R 138 - 149 ) ; 6 months : 142.9 mmole/L ( R 137 - 150 ) were all similar . Sixty percent ( 9/15 ) of the patients maintained normal ( nl ) serum Na levels throughout the study . The relationship between the change in serum Na and serum osm levels from baseline to 6 months was not significant ( r = 0.242 ) . BUN/Cr ratios ranged from 12 - 34 over the study period with 3 of 15 patients ( 20 % ) demonstrating elevated ratios consistently throughout the study without clinical evidence of dehydration . Only two patients had both high nl/elevated serum osm and elevated serum Na , although both had nl BUN/Cr ratios . Neither of these patients was thought by staff to be clinical ly dehydrated . Analysis of variance ( ANOVA ) indicated none of the laboratory measures changed significantly over time ( serum osm : F(2,28 ) < 1 ; Na : F(2,28 ) < 1 ; BUN/Cr : F(2,28 ) < 1 ) . There was no significant change in weight between the baseline and six month readings . CONCLUSIONS These data suggest that in the presence of clinical stability , long-term care residents may have a serum osm in the high normal/elevated range without overt clinical evidence of dehydration , an accompanying elevated Na , or BUN/Cr ratio . This may indicate a different central osm setting for these residents as the serum osm appeared to be stable for each resident over time . These data also suggest that measures of serum osm , Na , and BUN/Cr in the long-term care setting may accurately predict future laboratory values in an individual patient if baseline values are drawn when the patient is not acutely ill OBJECTIVES To assess early clinical signs and their prognostic value in elderly patients with hypernatremia . DESIGN Prospect i ve , case control study of 150 patients with hypernatremia matched to 300 controls . SETTING Multicenter study including seven short- and long-term geriatric care facilities . MEASUREMENTS Clinical assessment of hydration status at bedside , such as abnormal skin turgor or dry oral mucosa . SECONDARY OUTCOME MEASURES 30-day mortality rate and clinical indicators ( assessed at the peak of natremia ) associated with mortality . RESULTS Patients and controls were comparable in terms of drugs and underlying diseases , except for history of dementia , which was more frequent in patients than in controls . Patients were significantly more likely than controls to have low blood pressure , tachycardia , dry oral mucosa , abnormal skin turgor , and recent change of consciousness . Only three clinical findings were found in at least 60 % of patients with hypernatremia : orthostatic blood pressure and abnormal subclavicular and forearm skin turgor . The latter two signs were significantly more frequent in patients with hypernatremia . Four other signs ( tachycardia , abnormal subclavicular skin turgor , dry oral mucosa , and recent change of consciousness ) had a specificity of greater than 79 % . Using logistic regression , four signs were significantly and independently associated with hypernatremia : abnormal subclavicular and thigh skin turgor , dry oral mucosa , and recent change of consciousness . The mortality rate was 41.5 % and was significantly higher in patients with hypernatremia . The status of consciousness when hypernatremia was diagnosed was the single prognostic indicator associated with mortality ( odds ratio=2.3 , 95 % confidence interval=1.01 - 5.2 ) . CONCLUSION Most of the classical signs of dehydration are irregularly present in patients with hypernatremia . Caregivers should carefully screen any variations in consciousness , because they may reveal severe hypernatremia The nutritional requirements of healthy people differ from those who have chronic wounds and while it is generally suggested that the nutritional status of persons with chronic wounds must be addressed , actual data about the nutritional status of older adults with venous ulcers is limited . The nutritional status of hospitalized older adults ( n = 40 , average age 77 + /- 7.4 ) with vascular disease was compared to r and omly selected out patients with venous insufficiency ulcers ( n = 37 , average age 70.4 + /- 8.13 ) using the Mini Nutritional Assessment instrument . Among all patients assessed , 37 ( 48 % ) were at risk for malnutrition or were malnourished . No differences between nutritional status and age or gender were found . The proportion of patients at risk for malnutrition or currently malnourished was significantly higher in the venous ulcer ( 24 out of 37 ) than in the control group ( 13 of 40 , chi2 = 15.51 , P < 0.05 ) . Statistically significant differences were found between the control and venous ulcer group for all anthropometrical assessment variables ( BMI , arm circumference , calf circumference , and weight loss in past 3 months ) , use of more than three prescription drugs , dietary history/ assessment ( appetite , fluid consumption , independent feeding ) , and patient self-rated health . The results of this study confirm that a complete patient assessment must include evaluating patient nutritional status and that nutritional disorders are a serious problem among the elderly , especially those with venous ulcers . Additional studies to help optimize the nutritional assessment and management of older adults with venous ulcers are needed Observational data have suggested that increased water intake decreases the risk of CHD . A postulated mechanism is that increased water ingestion reduces blood viscosity . The aim of the present study was to assess the effect of increased fluid intake on blood viscosity . Men ( n 67 ) and postmenopausal women ( n 27 ) with one or more risk factors for CVD who reported intake of < or = 0.5 litres water daily were r and omised to a control group ( n 31 ) , an intervention group ( n 32 ) that increased their daily water intake by 1 litre/d and an intervention group ( n 31 ) that ingested 1 litre blueberry juice/d . All were encouraged to continue their usual diet and lifestyle . Whole-blood viscosity and blood and urine chemistries were measured by st and ard techniques after 2 and 4 weeks . Urine volume increased ( by a median of 872 and 725 ml in the water and blueberry juice groups , respectively , v. 10 ml in the control group ; P < or = 0.002 ) , confirming the subjects ' adherence to the protocol . Urine osmolality and urinary levels of Na , K and creatinine decreased in the water and blueberry juice groups v. the controls ( P<0.05 ) . No change was seen in whole-blood viscosity or in levels of fibrinogen , total protein , lipids , glucose , insulin , C-peptide or other chemistry and haematology variables . In conclusion , a postulated protective effect of increased water or fluid intake is not explained by a change in blood viscosity and increased fluid intake does not influence CVD risk factors in the short term OBJECTIVES To evaluate the influence of age on plasma arginine vasopressin ( AVP ) concentrations and the relationship between plasma AVP and serum osmolality in younger and older subjects , and in the elderly , to assess the effect of gender on plasma AVP concentration and to determine the impact of prostagl and in blockade on renal responsiveness to AVP . DESIGN Cross-sectional study ; r and omized , double-blind , crossover , placebo-controlled study . SETTING The Renal Laboratory , Royal North Shore Hospital ( younger adults ) and Clinical Room , St Vincents Hospital ( elderly subjects ) . PARTICIPANTS 45 younger adults ( 35 + /- 9 years ) , and 41 elderly subjects ( 29 males , 12 females ; 78 + /- 3 years ) . All subjects were healthy and non-institutionalized . The elderly subjects were screened to exclude significant pathology ( clinical assessment , multiple investigations ) . INTERVENTION Blood sample s were drawn from all younger and elderly subjects . The elderly subjects were r and omly allocated indomethacin or placebo for 1 month . Following a 1 to 2-week washout , the alternative was administered for a further 1 month . MAIN OUTCOME MEASURES Plasma AVP and serum osmolality and plasma AVP , serum , and urine osmolality at baseline were measured on indomethacin and placebo . RESULTS In the elderly subjects , baseline plasma AVP concentration was significantly higher than in the younger subjects studied ( 4.7 + /- 0.7 vs 2.1 + /- 0.2 pg/mL respectively ; P = 0.0003 ) . Plasma AVP was strongly correlated with serum osmolality in the younger subjects ( r = 0.76 , P = 0.0001 ) but not in the elderly cohort ( r = -0.18 , P = 0.26 ) . No difference was found between the sexes in plasma AVP ( P = 0.89 ) , and indomethacin treatment did not alter the plasma AVP/urine osmolality ratio ( P = 0.85 ) in the elderly subjects . In addition , changes in plasma AVP with indomethacin therapy did not correlate with changes in serum osmolality ( r = 0.16 , P = 0.09 ) . CONCLUSIONS Aging is accompanied by an increase in plasma AVP concentrations . In healthy , elderly subjects , plasma AVP is not dependent on serum osmolality and is not influenced by gender . Indomethacin has no effect on the renal responsiveness to plasma AVP Prevention of pressure ulcers is fundamental to safe care of nursing home residents yet the role of hydration in pressure ulcer prevention has not been systematic ally examined . This r and omized clinical trial was undertaken to determine whether administration of supplemental fluid to nursing home residents at risk for pressure ulcers would enhance collagen deposition , increase estimated total body water , augment subcutaneous tissue oxygenation , and was safe . After a baseline period , 64 subjects were r and omized to receive the fluid volume prescribed or additional fluid ( prescribed plus 10 mL/kg ) for 5 days . Participants ' potential to heal as measured with hydroxyproline was low at baseline and did not increase significantly during treatment when additional fluid was systematic ally provided . Fluid intake increased significantly during treatment . Estimates of total body water and subcutaneous oxygen did not increase , indicating hydration was not improved . Supplemental fluid did not result in overhydration as measured by clinical parameters . Further work is needed to examine the relationship between fluid intake and hydration in nursing home residents as well as the role of hydration in pressure ulcer prevention Critical illness affects body composition profoundly , especially body cell mass ( BCM ) . BCM loss reflects lean tissue wasting and could be a nutritional marker in critically ill patients . However , BCM assessment with usual isotopic or tracer methods is impractical in intensive care units ( ICUs ) . We aim ed to modelize the BCM of critically ill patients using variables available at bedside . Fat-free mass ( FFM ) , bone mineral ( Mo ) , and extracellular water ( ECW ) of 49 critically ill patients were measured prospect ively by dual-energy X-ray absorptiometry and multifrequency bioimpedance . BCM was estimated according to the four-compartment cellular level : BCM = FFM - ( ECW/0.98 ) - ( 0.73 × Mo ) . Variables that might influence the BCM were assessed , and multivariable analysis using fractional polynomials was conducted to determine the relations between BCM and these data . Bootstrap resampling was then used to estimate the most stable model predicting BCM . BCM was 22.7 ± 5.4 kg . The most frequent model included height ( cm ) , leg circumference ( cm ) , weight shift ( Δ ) between ICU admission and body composition assessment ( kg ) , and trunk length ( cm ) as a linear function : BCM ( kg ) = 0.266 × height + 0.287 × leg circumference + 0.305 × Δweight - 0.406 × trunk length - 13.52 . The fraction of variance explained by this model ( adjusted r(2 ) ) was 46 % . Including bioelectrical impedance analysis variables in the model did not improve BCM prediction . In summary , our results suggest that BCM can be estimated at bedside , with an error lower than ±20 % in 90 % subjects , on the basis of static ( height , trunk length ) , less stable ( leg circumference ) , and dynamic biometric variables ( Δweight ) for critically ill patients Elderly individuals are at risk for acute confusion ( AC ) during hospitalization . Using a prospect i ve design , this study assessed the relationship between admission risk factors and subsequent development of AC in 117 elderly hospitalized patients . AC was ascertained using the NEECHAM Confusion Scale . Other measures included demographic data , cognitive status , physical function , laboratory data , medications , infections , activity , pain , and nursing acuity . The cumulative incidence estimate was 14 % . Patients who developed AC were more likely to be admitted to the hospital from somewhere other than home , to have lower admission NEECHAM and MMSE scores , and to have restricted activity levels , an infection , and abnormal lab values . These patients were more cognitively and physically frail and may have been chronically undernourished and dehydrated on admission to the hospital . Nurses can be trained to routinely assess for acute confusion using easily implemented instruments incorporated into a research -based protocol OBJECTIVE : To address whether : ( 1 ) bioelectrical impedance analysis ( BIA ) can provide precise and accurate estimates of total body water ( TBW ) and extracellular water ( ECW ) in healthy elderly subjects , that display age-induced changes in body composition , ( 2 ) BIA models are improved by introducing variables related to geometrical body-shape and osmolarity . DESIGN : Cross-validation of available BIA models and models developed in the study .SUBJECTS : 58 healthy elderly subjects ( 31 women , 27 men , 66.8±4.7 y , mean±s.d . ) MEASUREMENTS : BIA at 5 , 50 and 100 kHz , 18O labelled water measurements of TBW , Br measurements of ECW , anthropometric variables , plasma osmolarity . RESULTS : Published BIA models for estimating TBW , entail various degrees of bias . Precise models ( SEE of the models 0.8 L at 100 kHz , 1.0 L at 50 kHz ) involving height2/resistance , weight , gender , circumferences and plasma osmolarity were established with data from 30 subjects chosen at r and om . Cross-validation of an independent group ( n=28 ) showed no bias ( −1.5±3.2 L at 100 kHz , −1.4±3.2 L at 50 kHz , P = NS ) . CONCLUSION : We conclude that BIA models with increased accuracy and precision for predicting ECW and TBW can be derived in healthy elderly subjects . Repeated measures had a mean difference of 0.2±1.2 The authors used a quasi-experimental treatment and control group design with 49 participants from four nursing homes to test the effectiveness of an 8-week hydration intervention in reducing hydration-linked events ( HLEs ) . A Kaplan Meier survival curve with log rank test was calculated to determine incidence and time to occurrence of a HLE . Incidence of and time to a HLE did not differ between the treatment and control groups over an 8-week period ( p > .05 ) . However , treatment group participants were found to be more frail , more cognitively impaired , and more at risk for acute confusion than the control group participants . Although there were no statistically significant differences between the groups , it is clinical ly significant that the frailer , more at-risk participants in the treatment group had a lower incidence of HLEs OBJECTIVE To evaluate a three-phase , behavioral intervention to improve fluid intake in nursing home ( NH ) residents . DESIGN Controlled clinical intervention trial . SETTING Two community NHs . PARTICIPANTS Sixty-three incontinent NH residents . INTERVENTION Participants were r and omized into intervention and control groups . The intervention consisted of three phases for a total of 32 weeks : ( 1 ) 16 weeks of four verbal prompts to drink per day , in between meals ; ( 2 ) 8 weeks of eight verbal prompts per day , in between meals ; and ( 3 ) 8 weeks of eight verbal prompts per day , in between meals , plus compliance with participant beverage preferences . MEASUREMENTS Between-meal fluid intake was measured in ounces by research staff during all three phases of the intervention . Percentage of fluids consumed during meals was also estimated by research staff for a total of nine meals per participant ( 3 consecutive days ) at baseline and at 8 and 32 weeks into the intervention . Serum osmolality , blood urea nitrogen , and creatinine values were obtained for all participants in one of the two sites at the same three time points . RESULTS The majority ( 78 % ) of participants increased their fluid intake between meals in response to the increase in verbal prompts ( phase 1 to 2 ) . A subset of residents ( 21 % ) , however , only increased their fluid intake in response to beverage preference compliance ( phase 3 ) . There was a significant reduction in the proportion of intervention participants who had laboratory values indicative of dehydration compared with the control participants . Cognitive and nutritional status were predictive of residents ' responsiveness to the intervention . CONCLUSIONS A behavioral intervention that consists of verbal prompts and beverage preference compliance was effective in increasing fluid intake among most of a sample of incontinent NH residents . Verbal prompting alone was effective in improving fluid intake in the more cognitively impaired residents , whereas preference compliance was needed to increase fluid intake among less cognitively impaired NH residents In order to test the hypothesis that urine colour can be used as an index of hydration in critically ill patients , we selected 40 intensive care and high‐dependency patients and correlated urine colour ( scored on an eight‐point scale ) with various indices of hydration : urine : plasma sodium , osmolality and urea ratios , urine output and central venous pressure . In addition , we compared the colour‐chart score with scores made by intensive care nurses ( without the benefit of a colour chart ) in order to test subjective assessment of urine colour . There were weak but statistically significant correlations between urine colour and urine output ( Spearman 's r = − 0.555 ) and between urine colour and urine : plasma sodium ratio ( Spearman 's r = − 0.459 ) . Subjective assessment of urine colour appeared to be reliable . Thus , although urine colour does vary with hydration in the critically ill , assessment of urine colour adds little to the overall assessment of hydration in this group of patients BACKGROUND The computation of fluid balances ( FBs ) by subtracting fluid outputs from inputs is a common critical care practice . Limited information exists about the accuracy and consistency of nurse-registered cumulative FBs and regarding the value of suggested corrections for non-measurable losses . METHODS From 147 ICU patients , we prospect ively evaluated the cumulative FBs and their relationship to changes in body weight ( BW ) . St and ardised measurements of BW were performed on admission and discharge . FB charts were accurately review ed and arithmetic errors corrected . Net cumulative FBs and adjusted cumulative FBs ( considering sensible or insensible fluid losses/fever/liquid faeces ) were analysed for all patients and 3 subgroups ( cardiac-cerebral , septic , and others ) . Agreement between FBs and BW changes was calculated according to the defined subgroups and confounding variables . RESULTS Cumulative FBs were inaccurate in 49 cases ( 33 % ) with errors ranging from -3606 mL to + 2020 mL. The total ( average daily ) difference between measured BW and FBs ( mean ± SD ) was 0.185±1.874 kg ( 0.101±1.020 kg ) . Correlation ( r(2 ) ) and Bl and -Altman agreement was poor between BW changes and net cumulative FBs ( 0.552 and -1.26±5.41 kg ) and slightly better between BW changes and adjusted cumulative FBs ( 0.714 and + 0.18±3.68 kg ) . St and ard deviations of the average daily differences between BW changes and FBs were always > 1 L. Correction of the net FBs as suggested in the literature were not useful . New multiple regression models only modestly improved correlation . CONCLUSION For a large portion of patients nurse-registered cumulative FBs are neither accurate nor do they agree with st and ardised BW measurements . Patient care and clinical decision-making should be based on more objective techniques OBJECTIVES To improve identification of patients at high risk for delirium , this study developed a chart abstract ion tool for delirium risk and vali date d the tool against clinical expert diagnosis of delirium . DESIGN Prospect i ve cohort study . SETTING Tertiary Veterans Affairs hospital in New Engl and . PARTICIPANTS One hundred veterans admitted to the medical service . MEASUREMENTS While admitted , each participant underwent serial assessment s for delirium by a clinical expert . Using the four criteria of a vali date d delirium prediction rule ( cognitive impairment , sensory deficit , severe illness , and dehydration ) , chart review terms were selected for each criterion , and delirium risk was the sum of criteria present ( range : 0 - 4 ; 4 = worst ) . After discharge , a nurse blinded to the expert 's diagnosis completed the chart tool . RESULTS The participants were mostly male ( 94 % ) and older ( mean age 81 ± 7 ) , and 23 % developed overall delirium ( 14 % incident ) . The rate of overall delirium was 11 % in participants with zero risk factors , 18 % in those with one or two , and 50 % in those with three or four ( P = .01 ; c-statistic 0.65 , 95 % confidence interval ( CI ) = 0.54 - 0.76 ) . For incident delirium , the rates were 11 % , 13 % , and 25 % , respectively ( P = .53 ; c-statistic 0.56 , 95 % CI = 0.42 - 0.74 ) . Discharge to a rehabilitation center or nursing home increased with increasing delirium risk ( 0 % , 18 % , 60 % , P = .02 ) . CONCLUSION A chart abstract ion tool was effective at identifying overall delirium risk but not incident delirium risk . Although the tool can not replace clinical assessment and diagnosis of delirium , the use of this tool as an educational , clinical , or quality measurement aid warrants additional study Elderly patients in long-term care have a high plasma osmolality ( pOSM ) and associated increased mortality . In these patients , we examined pOSM , thirst ( visual analogue scale , VAS ) and arginine vasopressin ( AVP ) response to 16-hour dehydration and 2-hour rehydration . Twelve patients were r and omly divided into two groups ( A & B ) . Group A had their fluid balance monitored for two weeks , group B did not . Single measurements of VAS , pOSM and AVP were conducted on days 0 , 7 and 13 . Dehydration tests were conducted in both groups at the start of the study ( DAY 1 ) , and at the end of the two-week period ( DAY 14 ) . There were no significant differences between group A and B , so the results are presented for the two groups combined . There was a significant increase in both pOSM and VAS during dehydration , and a significant fall in both variables during rehydration [ F ( 9,99 ) = 18.69 , p<0.001 , and F(9,99 ) = 11.25 , p<0.001 , respectively ] . Plasma AVP did not change significantly during either dehydration or rehydration [ F ( 9,99 ) = 0.59 , p=0.8 ] . There were no significant differences in response for any of the three variables between DAY 1 and DAY 14 . We conclude that elderly patients in long-term care exhibit changes in thirst and osmolality during dehydration and rehydration , and that these responses are reproducible . The lack of a significant AVP response requires further investigation OBJECTIVE Ultrasonography has been suggested as a useful noninvasive tool for the detection and follow-up for hypovolemia . Two possible sonographic markers as a surrogate for hypovolemia are the diameters of the inferior vena cava ( dIVC ) and the right ventricle ( dRV ) . The goal of this study was to evaluate IVC and RV diameters and diameter changes in patients treated for hypovolemia and compare these findings with healthy volunteers . METHODS Fifty healthy volunteers and 50 consecutive hypovolemic patients were enrolled in the study . The dIVC , both during inspiration ( IVCi ) and expiration ( IVCe ) , was measured in hypovolemic patients both before and after fluid resuscitation , and they were also measured in healthy volunteers during the time they participated in the study . The dIVC , in hypovolemic patients both before and after fluid resuscitation , was measured ultrasonographically by M-mode in the subxiphoid area . The dRV was measured ultrasonographically by B-mode in the third and fourth intercostals spaces . RESULTS The average diameters of the IVCe , IVCi , and dRV in hypovolemic patients upon arrival were significantly lower compared with healthy volunteers ( P = .001 ) . After fluid resuscitation , there was a significant increase in the mean diameters of the IVCe , IVCi , and RV in hypovolemic patients ( P = .001 ) . CONCLUSIONS The results indicate that the dIVC and dRV are consistently low in hypovolemic subjects when compared with euvolemic subjects . Bedside serial measurements of dIVC and dRV could be a useful noninvasive tool for the detection and follow-up of patients with hypovolemia and evaluation of the response to the treatment |
399 | 20,395,841 | Year of publication , use of preoperative radiation , use of laparoscopy , and use of protecting stoma were not significant variables , but average age , median tumor height , and method of detection ( clinical vs. radiologic ) showed significance to explain heterogeneity in anastomotic leak rates .
Year of publication , study origin , average age , and use of laparoscopy were significant , but median tumor height and preoperative radiation use were not significant in explaining heterogeneity among observed postoperative death rates .
With multivariable analysis , only average age for anastomotic leak and year of publication for postoperative death remained significant .
Benchmark complication rates for radical rectal cancer surgery were obtained for use in sample size calculations in future studies and for quality control purpose s. Postoperative death rates showed improvement in recent years | OBJECTIVE This systematic review was design ed to determine postoperative complication rates of radical surgery for rectal cancer ( abdominal perineal resection and anterior resection ) .
SUMMARY OF BACKGROUND DATA Lack of accepted complication rates for rectal cancer surgery may hinder quality improvement efforts and may impede the conception of future studies because of uncertainty regarding the expected event rates . | AIM To assess the feasibility and efficacy of laparoscopic total mesorectal excision ( LTME ) of low rectal cancer with preservation of anal sphincter . METHODS From June 2001 to June 2003 , 82 patients with low rectal cancer underwent laparoscopic total mesorectal excision with preservation of anal sphincter . The lowest edge of tumors was below peritoneal reflection and 1.5 - 7 cm from the dentate line ( 1.5 - 5 cm in 48 cases , 5 - 7 cm in 34 cases ) . RESULTS LTME with anal sphincter preservation was performed on 82 r and omized patients with low rectal cancer , and 100 % sphincter preservation rate was achieved . There were 30 patients with laparoscopic low anterior resection ( LLAR ) at the level of the anastomosis below peritoneal reflection and 2 cm above from the dentate line ; 27 patients with laparoscopic ultralow anterior resection ( LULAR ) at the level of anastomoses 2 cm below from the dentate line ; and 25 patients with laparoscopic coloanal anastomoses ( LCAA ) at the level of the anastomoses at or below the dentate line . No defunctioning ileostomy was created in any case . The mean operating time was 120 minutes ( ranged from 110 - 220 min ) , and the mean operative blood loss was 20 mL ( ranged from 5 - 120 mL ) . Bowel function was restored and diet was resumed on day 1 or 2 after operation . The mean hospital stay was 8 days ( ranged from 5 - 14 ) . Postoperative analgesics were used in 45 patients . After surgery , 2 patients had urinary retention , one had anastomotic leakage , and another 2 patients had local recurrence one year later . No interoperative complication was observed . CONCLUSION LTME with preservation of anal sphincter is a feasible , safe and minimally invasive technique with less postoperative pain and rapid recovery , and importantly , it has preserved the function of the sphincter Background The role of laparoscopic resection ( LR ) in the management of extraperitoneal rectal cancer still is unclear . This study aim ed to compare perioperative and long-term results of laparoscopic and open resection ( OR ) for low and midrectal cancer . Methods A prospect i ve nonr and omized trial comparing patients su bmi tted to OR or LR for low and midrectal cancer at a single institution was conducted . Results The study included 191 consecutive patients : 98 patients who underwent LR and 93 who underwent OR . The mean follow-up period was 46.3 months for LR and 49.7 months for OR . The conversion rate for LR was 18.4 % . With the use of LR , the mean time for complete patient mobilization was shorter ( 1.7 vs 3.3 days ; p < 0.001 ) and patients were earlier in passing flatus ( 2.6 vs 3.9 days ; p < 0.001 ) and stools ( 3.8 vs 4.7 days ; p < 0.01 ) , and in resuming oral intake ( 3.4 vs 4.8 days ; p < 0.001 ) . The mean hospital stay was shorter for LR , but the difference did not reach significance ( 11.4 vs 13 days ) . Morbidity and mortality rates were similar : LR ( 24.4 % and 1 % ) and OR ( 23.6 % and 2.2 % ) . Laparoscopic patients presented a higher rate of anastomotic fistulas ( 13.5 % vs 5.1 % ) and reoperations ( 6.1 % vs 3.2 % ) but the difference was statistically nonsignificant . Laparoscopic resection presented a significantly lower local recurrence rate ( 3.2 % vs 12.6 % ; p < 0.05 ) . The cumulative survival and disease-free rates at 5 years were , respectively , 80 % and 65.4 % after LR and 68.9 % and 58.9 % after OR ( nonsignificant difference ) . Stage-by-stage comparison showed prolonged cumulative survival for stages III and IV cancer in LR ( 82.5 % vs 40.5 % ; p = 0.006 and 15.8 % vs 0 % ; p = 0.013 , respectively ) and a reduced rate of cancer-related death for stage III in LR ( 11.4 % vs 51.9 % ; p = 0.001 ) . Conclusions As compared with conventional open surgery , LR for low and midrectal cancer is characterized by a faster recovery and similar overall morbidity ( but a higher rate of anastomotic leakages ) , and does not present any adverse oncologic effect Objective To assess the efficacy of a novel coloplasty colonic pouch design in optimizing bowel function after ultralow anterior resection . Summary Background Data A colonic J-pouch may reduce excessive stool frequency and incontinence after anterior resection , but at the risk of evacuation problems . Experimental surgery on pigs has suggested that a coloplasty pouch ( CP ) may be a useful alternative . Although CP has recently been shown to be feasible in patients , there is no r and omized controlled trial comparing bowel function with the J-pouch . Methods After anterior resection for cancer , patients were allocated to either J-pouch or CP-anal anastomoses . Continence scoring , anorectal manometry , and endoanal ultrasound assessment s were made before surgery . All complications were recorded , and these preoperative assessment s were repeated at 4 months . The assessment s were repeated again at 1 year , and a quality of life question naire was added . Results Eighty-eight patients were recruited from October 1998 to April 2000 . Both groups were well matched for age , gender , staging , adjuvant therapy , and mean follow-up . There were no differences in the intraoperative time and hospital stay . CP result ed in more anastomotic leaks . At 4 months , J-pouch patients had 10.3 % less stool fragmentation but poorer stool deferment and more nocturnal leakage . However , there were no differences in the bowel function , continence score , and quality of life at 1 year . There were no differences in the anorectal manometry and endoanal ultrasound findings . Conclusions Coloplasty pouches result ed in more anastomotic leaks and minimal differences in bowel function . At present , the J-pouch remains the benchmark for routine clinical practice , and due care ( including defunctioning stoma ) should be exercised in situations requiring CP Objectives To compare a colonic J-pouch or a side-to-end anastomosis after low-anterior resection for rectal cancer with regard to functional and surgical outcome . Summary Background Data A complication after restorative rectal surgery with a straight anastomosis is low-anterior resection syndrome with a postoperatively deteriorated anorectal function . The colonic J-reservoir is sometimes used with the purpose of reducing these symptoms . An alternative method is to use a simple side-to-end anastomosis . Methods One-hundred patients with rectal cancer undergoing total mesorectal excision and colo-anal anastomosis were r and omized to receive either a colonic pouch or a side-to-end anastomosis using the descending colon . Surgical results and complications were recorded . Patients were followed with a functional evaluation at 6 and 12 months postoperatively . Results Fifty patients were r and omized to each group . Patient characteristics in both groups were very similar regarding age , gender , tumor level , and Dukes ’ stages . A large proportion of the patients received short-term preoperative radiotherapy ( 78 % ) . There was no significant difference in surgical outcome between the 2 techniques with respect to anastomotic height ( 4 cm ) , perioperative blood loss ( 500 ml ) , hospital stay ( 11 days ) , postoperative complications , reoperations or pelvic sepsis rates . Comparing functional results in the 2 study groups , only the ability to evacuate the bowel in < 15 minutes at 6 months reached a significant difference in favor of the pouch procedure . Conclusions The data from this study show that either a colonic J-pouch or a side-to-end anastomosis performed on the descending colon in low-anterior resection with total mesorectal excision are methods that can be used with similar expected functional and surgical results PURPOSE The optimal timing of surgery after preoperative radiotherapy in rectal cancer is unknown . The aim of this trial was to evaluate the role of the interval between preoperative radiotherapy and surgery . PATIENTS AND METHODS Patients with rectal carcinoma accessible to rectal digital examination , staged T2 to T3 , NX , M0 , were r and omized before radiotherapy ( 39 Gy in 13 fractions ) into two groups : in the short interval ( SI ) group , surgery had to be performed within 2 weeks after completion of radiation therapy , compared with 6 to 8 weeks in the long interval ( LI ) group . Between 1991 and 1995 , 201 patients were enrolled onto the study . RESULTS A long interval between preoperative radiotherapy and surgery was associated with a significantly better clinical tumor response ( 53 . 1 % in the SI group v 71.7 % in the LI group , P = .007 ) and pathologic downstaging ( 10.3 % in the SI group v 26 % in the LI group , P = .005 ) . At a median follow-up of 33 months , there were no differences in morbidity , local relapse , and short-term survival between the two groups . Sphincter-preserving surgery was performed in 76 % of cases in the LI group versus 68 % in the SI group ( P = 0.27 ) . CONCLUSION A long interval between preoperative irradiation and surgery provides increased tumor downstaging with no detrimental effect on toxicity and early clinical results . When sphincter preservation is question able , a long interval may increase the chance of a successful sphincter-saving surgery Mesorectal excision for rectal cancer has result ed in local recurrence rates of 3–11 per cent compared with up to 38 per cent after conventional methods . The results of a prospect i ve Danish study with a historical control group are presented Abstract . Although increasing evidence suggests that prophylactic drainage after intra-peritoneal colorectal anastomoses is unnecessary , drains for infra-peritoneal rectal anastomoses , where the leak rate is higher , are widely employed still . The aim of this study was to assess the effect of prophylactic drainage after anastomosis below the peritoneal reflection . All patients attending one specialist unit over an 8-month period for elective rectal cancer resection with an infra-peritoneal anastomosis were r and omised to drainage or no drainage . The incidence of anastomotic leak and complications specific to the drain as well as other complications were compared . Fifty-nine patients were analysed ( 31 with drain ) . Twenty-five of the drained and 16 of the no-drain patients had a defunctioning stoma ( p = ns ) . The groups were comparable for demographic data , operation and anastomotic height from the anal verge . There were three leaks ( 10 % ) in the drain group and five leaks ( 18 % ) in the no-drain group ( p = ns ) . There were 2 ( 7 % ) patients in each group with a clinical leak . There were no specific drain complications and the incidence of other complications was similar in both groups . In conclusion , this study supports the contention that there is no difference in morbidity with or without the use of a drain for infra-peritoneal anastomoses Abstract Background : A population based prospect i ve r and omized trial on preoperative radiotherapy in operable rectal cancer was conducted in Stockholm , Sweden . Five hundred fifty-seven patients from 12 institutions were included with histologically proven , clinical ly resectable rectal adenocarcinoma . Patients planned for local excision or previously irradiated to the pelvis were excluded . Methods : A total of 272 patients were allocated to preoperative irradiation with 25 Gy in five cycles during 5–7 days to the rectum and the pararectal tissues ( RT+ group ) and 285 patients were allocated to surgery only ( RT− group ) . The median follow-up time was 50 months . No patient was lost to follow-up . Surgery was considered curative in 479 patients ( 86 % ) . Results : Locoregional recurrence occurred in 10 % of the patients in the RT+ group versus 21 % in the RT− group ( p<0.01 ) . Among the curatively operated patients , distant metastases occurred in 19 % in the RT+ group versus 26 % in the RT− group ( p=0.02 ) . The overall survival was improved in the irradiated patients ( p=0.02 ) . Postoperative complications were more common after irradiation but were usually mild . The postoperative mortality was low in both groups . Conclusion : Preoperative short-term , high-dose radiotherapy as given in this trial reduces the risk of local and distant recurrence and improves survival after curative surgery for rectal carcinoma PURPOSE : The aim of this study was to investigate the role of omentoplasty , by means of intact omentum , in preventing anastomotic leakages after rectal resection . METHODS : Between 1992 and 1997 a total of 112 patients ( 64 males ) with a mean age of 64.7 ( range , 39–83 ) years were r and omly assigned to undergo omentoplasty ( Group A ) or not ( Group B ) to reinforce the colorectal anastomosis after anterior resection for rectal cancer . The primary end point was anastomotic leakage ; the secondary end point included morbility and mortality related to omentoplasty . RESULTS : The two groups were comparable in terms of preoperative and intraoperative characteristics . Staple-ring disruption at plain abdominal radiographs was detected in seven instances in Group A and in ten in Group B patients ( P = not significant ) . Two leakages were evident clinical ly in Group A and seven in Group B ( P<0.05 ) . Three leaks were documented radiologically in Group A and eight in Group B ( P = not significant ) . No complications related to omentoplasty were observed in Group A. There were two repeat operations for anastomotic leakage in Group B. At follow-up , one stricture developed in Group A and three in Group B ( P = not significant ) CONCLUSIONS : Despite a similar incidence of staple-ring defects , a strikingly lower rate of clinical ly and radiologically detected leaks developed in patients su bmi tted to omentoplasty . Although not affecting the incidence of anastomotic disruption , omentoplasty seems to contain the severity of anastomotic leakage Purpose This study was design ed to evaluate the impact of laparoscopic rectal resection on short-term postoperative morbidity and costs . Methods A total of 168 patients with rectal cancer were r and omly assigned to laparoscopic ( n = 83 ) or open ( n = 85 ) resection . Outcome parameters were : postoperative morbidity , length of hospital stay , quality of life , long-term survival , and local recurrences . The mean follow-up period was 53.6 months . Cost-benefit analysis was based on hospital costs . Results Operative time was 53 minutes longer in the laparoscopic group ( P < 0.0001 ) . Postoperative morbidity rate was 28.9 percent in the laparoscopic vs. 40 percent in the open group ( P = 0.18 ) . The mean length of hospital stay was 10 ( 4.9 ) days in the laparoscopic group and 13.6 ( 10 ) days in the open group ( P = 0.004 ) . Local recurrence rate and five-year survival were similar in both groups ; however , the limited number of patients does not allow firm conclusions . Quality of life was better in the laparoscopic group only in the first year after surgery ( P < 0.0001 ) . The additional charge in the laparoscopic group was $ 1,748 per patient r and omized ( $ 1,194 the result of surgical instruments and $ 554 the result of longer operative time ) . The saving in the laparoscopic group was $ 1,396 per patient r and omized ( $ 647 the result of shorter length of hospital stay and $ 749 the result of the lower cost of postoperative complications ) . The net balance result ed in $ 351 extra cost per patient r and omly allocated to the laparoscopic group . Conclusions Short-term postoperative morbidity was similar in the two groups . Laparoscopic resection reduced length of hospital stay , improved first-year quality of life , and slightly increased hospital costs BACKGROUND / AIMS Laparoscopic mesorectal excision with preservation of the autonomic pelvic nerves for rectal cancer including selected advanced lower rectal cancer is now challenging . The aims of the study were to assess the surgical results and short-term outcomes of this procedure prospect ively . METHODOLOGY Seventy-four of 281 rectal cancer patients , since the introduction of laparoscopic colorectal surgery in our hospital , have undergone laparoscopic rectal surgery . The location of the tumor distributed in upper rectum ; 33 , middle ; 22 , and lower 19 . The mesorectal excision with preservation of the autonomic pelvic nerves was performed for all the patients . The laparoscopic mesorectal excision was performed under 8 to 10 cmH2O CO2 pneumoperitoneum and lymph node dissection was performed along the feeding artery depend on individuals . Ipsilateral lateral lymph node dissection was added for 5 cases of advanced lower rectal cancer . RESULTS Open conversion occurred in 4 cases , 2 of those were due to locally advanced tumors and 2 technical difficulties in transaction of the distal rectum . There were 15 postoperative complications , 7 anastomotic leakage ( 10.6 % ) , 3 transient urinary retention ( 4.1 % ) , 4 wound infection ( 5.3 % ) , and 1 small bowel obstruction ( 1.4 % ) . No mortality was recorded in this series . Time of operation was 203 + /- 54 min in mesorectal excision cases and 270 + /- 42 min mesorectal excision with lateral lymph node dissection cases . Blood loss was 92 + /- 90 g and 276 + /- 66 g respectively . The hospital length-of-stay was 11.7 days in average . CONCLUSIONS Laparoscopic mesorectal excision with preservation of autonomic pelvic nerves for rectal cancer patients including selected advanced lower rectal cancer is favorable Background Although it is now considered a st and ard treatment to irradiate an advanced mid or low rectal tumor before surgical total mesorectal excision ( TME ) , the optimal time interval between radiation therapy and surgery remains controversial . Material s and methods Between 1995 and 2005 , patients undergoing preoperative radiation therapy and TME for locally advanced mid and low rectal tumors treated in the VU Medical Center or the Zaans Medical Center were entered into this study . All patients received identical radiation treatment in the VU Medical Center and were subsequently operated on within 2 weeks in the Zaans Medical Center ( SI group ) and after 6–8 weeks in the VU Medical Center ( LI group ) . Preoperative tumor staging , operative data , postoperative complications , pathology results , and follow-up were compared . Results The SI group ( N=57 ) underwent surgery after a median delay of 4 days and the LI group ( N=51 ) after 45 days . Operative data and short-term morbidity were comparable for both groups . However , significantly higher numbers of complete remissions ( 12 vs 0 % ) , tumor downstaging ( 55 vs 26 % ) , and less lymph-node metastases ( 22 vs 44 % ) were found in the LI group . No significant differences were found regarding local control or long-term survival after a median follow-up of 34 months . ConclusionS everal advantages , such as complete remissions and downstaging in the LI group , do not appear to have expression in a better survival or less local recurrences after a median follow-up of 34 months . Although larger ( r and omized ) studies will be needed for definite conclusions , this may indicate that patients can be operated on within 2 weeks after radiation therapy The introduction of staplers in general surgery allowed to perform gastrointestinal anastomoses easier and with better results . Because many series report an important incidence of complications even using stapling instruments , the A.C.O.I. ( Italian Association of General Hospital Surgeons ) , with the support of Auto Suture Italy , promoted a collaborative trial in Italy to evaluate the real incidence of complications after stapled colorectal or esophago-jejunal anastomoses . The study has been carried out during the period April 1990-December 1991 and 58 Centres throughout Italy participated with 420 esophagojejunostomies after Total Gastrectomy and 544 Colorectal anastomoses after Anterior Resection of the Rectum . Many variables were evaluated such as patients general conditions , the pathology and the site of anastomosis , the instrument used , the technique of reconstruction , if it was an urgent or an elective procedure , the incidence of intraoperative problems and the surgical experience . The most frequent complications were bleeding , leakage and stenosis . The incidence of bleeding was low in both groups , it was an occasional event not related with any of the variables previously described . Furthermore it was never important and never required reoperation or caused death of the patient . Leakage was the most frequent and serious complication ( 12.4 % in colorectal anastomoses and 5.5 % in esophagojejunostomies ) and was mainly related to the incidence of intraoperative technical problems ( tearing of the stump or purse string failure ) , to urgent procedures , to low and ultra low colorectal anastomoses and to centres with less experience , particularly with an experience of less than 50 mechanical anastomoses . Late complications such stenoses , were particularly frequent ( 8.4 % ) after a leakage and in very low colorectal anastomoses . Perioperative Mortality was very low in birth groups ( 1.1 % for colorectal anastomoses and 2.6 % for esophagojejunostomies ) one of the lowest described in the Literature . This study seem to confirm that staplers are effective , safe and easy to use , showing a low incidence of complications and they make possible anastomoses otherwise technically impossible The merits of stapled versus h and sewn anastomosis were evaluated in a prospect i ve r and omized study of 60 patients undergoing resection for rectal cancer . The analysed factors included the time required for construction of anastomosis , post operative complications , local recurrence , disease free state and survival . H and sewn anastomosis was performed in two layers with 3/0 silk in 30 cases and the stapled anastomosis with EEA staplers in 30 cases . The anastomosis time averaged 24 minutes in the suture group and 16 minutes in the stapling group . Five post-operative complications occurred in each group . Six patients of the h and sewn group developed local recurrence as a first sign of treatment failure compared to four patients in the stapled group . The average time of study was 41 months . No significant difference was found in the overall survival pattern of the two groups To evaluate the feasibility , effectiveness , and long-term bowel function of preoperative hyperfractionated accelerated radiotherapy in primary resectable rectal cancer . A total of 184 consecutive patients ( median age 65 years , male : female=2 : 1 ) with clinical T3Nx rectal adenocarcinoma received preoperative pelvic radiation therapy with single fractions of 2.5 Gy twice daily ( interval 6 h between fractions ) to a total dose of 25 Gy within 1 week . Surgery was conducted the following week . Postoperative histology revealed UICC stage I in 33 % , stage II in 26 % , stage III in 34 % , and stage IV in 7 % of the patients . Median follow-up was 43 months ( 53 months for surviving patients ) . The actuarial 4-year-local-recurrence rate was 2.1 % , overall recurrence 23 % . Disease-specific and disease-free survivals at 4 years ( excluding stage IV ) were 82 and 69 % , respectively . Overall survival for 4 years was 68 % . Postoperative mortality was 0.5 % ( one patient ) , early anastomotic leakage occurred in 11.4 % , and anastomotic stenosis requiring treatment in 6 % , of 132 patients with primary anastomosis . Seven of 184 patients ( 3.8 % ) died of abdominal complications , all within the first year . Bowel function was satisfactory after more than 5 years . Local control in primarily resectable rectal cancer after 10 × 2.5 Gy is excellent , warranting further evaluation of this treatment BACKGROUND Postoperative chemoradiotherapy is the recommended st and ard therapy for patients with locally advanced rectal cancer . In recent years , encouraging results with preoperative radiotherapy have been reported . We compared preoperative chemoradiotherapy with postoperative chemoradiotherapy for locally advanced rectal cancer . METHODS We r and omly assigned patients with clinical stage T3 or T4 or node-positive disease to receive either preoperative or postoperative chemoradiotherapy . The preoperative treatment consisted of 5040 cGy delivered in fractions of 180 cGy per day , five days per week , and fluorouracil , given in a 120-hour continuous intravenous infusion at a dose of 1000 mg per square meter of body-surface area per day during the first and fifth weeks of radiotherapy . Surgery was performed six weeks after the completion of chemoradiotherapy . One month after surgery , four five-day cycles of fluorouracil ( 500 mg per square meter per day ) were given . Chemoradiotherapy was identical in the postoperative-treatment group , except for the delivery of a boost of 540 cGy . The primary end point was overall survival . RESULTS Four hundred twenty-one patients were r and omly assigned to receive preoperative chemoradiotherapy and 402 patients to receive postoperative chemoradiotherapy . The overall five-year survival rates were 76 percent and 74 percent , respectively ( P=0.80 ) . The five-year cumulative incidence of local relapse was 6 percent for patients assigned to preoperative chemoradiotherapy and 13 percent in the postoperative-treatment group ( P=0.006 ) . Grade 3 or 4 acute toxic effects occurred in 27 percent of the patients in the preoperative-treatment group , as compared with 40 percent of the patients in the postoperative-treatment group ( P=0.001 ) ; the corresponding rates of long-term toxic effects were 14 percent and 24 percent , respectively ( P=0.01 ) . CONCLUSIONS Preoperative chemoradiotherapy , as compared with postoperative chemoradiotherapy , improved local control and was associated with reduced toxicity but did not improve overall survival OBJECTIVE --To establish whether a single preoperative dose of cefotaxime plus metronidazole was as effective as a st and ard three dose regimen of cefuroxime plus metronidazole in preventing wound infection after colorectal surgery . DESIGN -- Prospect i ve r and omised allocation to one of two prophylactic antibiotic regimens in a parallel group trial . Group sequential analyses of each 250 patients were performed . SETTING --14 District general and teaching hospitals . PATIENTS --1018 Adults having colorectal operations were r and omised , of whom 943 were evaluated . Demographic features , conditions requiring surgery , and operative procedures were similar in the two groups . Most patients had surgery for carcinoma of the colon or rectum . INTERVENTIONS --Group 1 received cefotaxime 1 g intravenously plus metronidazole 500 mg intravenously preoperatively . Group 2 received cefuroxime 1.5 g intravenously plus metronidazole 500 mg intravenously preoperatively , followed by cefuroxime 750 mg intravenously plus metronidazole 500 mg intravenously eight hours and 16 hours postoperatively . MAIN OUTCOME MEASURES --Development of surgical wound infection ( as evidence d by the presence of pus ) , death , or discharge from hospital . RESULTS --Wound condition was scored on a five point scale on alternate days until discharge or for up to 20 days postoperatively . Wound infection rates were : group 1 , 32/453 ( 7.1 % ; 95 % confidence interval 4.7 % to 9.4 % ) ; group 2 , 33/454 ( 7.3 % ; 95 % confidence interval 4.9 % to 9.6 % ) . Death rates ( group 1 : 26/470 ( 5.5 % ) ; group 2 : 31/471 ( 6.6 % ] , the incidence of postoperative complications , the median duration of hospital stay ( 12 days ) , and antibiotic tolerance were all similar in the two groups . Pooled data from groups 1 and 2 showed that wound infections were more frequent when minor faecal contamination had occurred at operation and when the duration of operation exceeded 90 minutes ( greater than 90 min 11.2 % of cases ; less than 90 min 4.8 % ) and were associated with an extended hospital stay . CONCLUSIONS --A single preoperative dose of cefotaxime plus metronidazole is an efficacious as a three dose regimen of cefuroxime plus metronidazole in preventing wound infection after colorectal surgery and has practical advantages in eliminating the need for postoperative antibiotics Background Laparoscopic colectomy is associated with less overall morbidity and improved survival for patients with colonic cancers . There are unfortunately limited clinical reports on laparoscopic abdominoperineal resection . We therefore design ed this study to compare laparoscopic abdominoperineal resection with conventional open surgery , with emphasis on health – related issues from the patients ’ perspective in order to justify its role in the management of low rectal or anal canal tumours . Methods We carried out a non – r and omized , prospect i ve comparative study on a cohort of patients who underwent either laparoscopic or open abdominoperineal resection between March 1994 and December 2003 . Patient demographics , tumour characteristics , operative morbidity and mortality , as well as overall survival were considered . The st and ard endpoints of last follow – up date and deaths were used . Data was analyzed according to intention – to – treat principle . Results A total of 102 patients were recruited : 31 patients underwent conventional open abdominoperineal resection ( OAPR ) and 71 patients were treated laparoscopically . Patient demographics , median follow – up period , as well as tumour characteristics were similar between groups . The median operating time was similar among groups ( 145 min in laparoscopic group vs. 156 min in open group ; p=0.62 ) . Patients in the laparoscopic group had significantly less blood loss ( p=0.01 ) and fewer requirements for blood transfusion ( p=0.01 ) . Despite similar overall morbidity , the laparoscopic group had a reduced incidence of abdominal wound infections ( p=0.01 ) and chest infections ( p=0.01 ) . Overall survival was significantly better in the laparoscopic group ( p=0.01 ) . Conclusions Laparoscopic abdominoperineal resection confers definite health – related benefits the over open approach in terms of reduced septic complications and fewer requirements for blood transfusion . It should be considered the procedure of choice for patients with low rectal or anal canal tumour in whom sphincter excision proved inevitable Introduction : Colonic pouches have been used for 20 years to provide reservoir function after reconstructive proctectomy for rectal cancer . More recently coloplasty has been advocated as an alternative to a colonic pouch . However there have been no long-term r and omized , controlled trials to compare functional outcomes of coloplasty , colonic J-Pouch ( JP ) , or a straight anastomosis ( SA ) after the treatment of low rectal cancer . Aim : To compare the complications , long-term functional outcome , and quality of life ( QOL ) of patients undergoing a coloplasty , JP , or an SA in reconstruction of the lower gastrointestinal tract after proctectomy for low rectal cancer . Methods : A multicenter study enrolled patients with low rectal cancer , who were r and omized intraoperatively to coloplasty ( CP-1 ) or SA if JP was not feasible , or JP or coloplasty ( CP-2 ) if a JP was feasible . Patients were followed for 24 months with SF-36 surveys to evaluate the QOL . Bowel function was measured quantitatively and using Fecal Incontinence Severity Index ( FISI ) . Urinary function and sexual function were also assessed . Results : Three hundred sixty-four patients were r and omized . All patients were evaluated for complications and recurrence . Mean age was 60 ±12 years , 71 % were male . Twenty-three ( 7.4 % ) died within 24 months of surgery . No significant difference was observed in the complications among the 4 groups . Two hundred ninety-seven of 364 were evaluated for functional outcome at 24 months . There was no difference in bowel function between the CP-1 and SA groups . JP patients had fewer bowel movements , less clustering , used fewer pads and had a lower FISI than the CP-2 group . Other parameters were not statistically different . QOL scores at 24 months were similar for each of the 4 groups . Conclusions : In patients undergoing a restorative resection for low rectal cancer , a colonic JP offers significant advantages in function over an SA or a coloplasty . In patients who can not have a pouch , coloplasty seems not to improve the bowel function of patients over that with an SA AIM Analysis of a r and omized study of preoperative radiation therapy for operable carcinoma of the rectum with regard to late sequelae . Results of tumor control and survival , which have already been published in detail are summarized for comparison and for confirmation of the conclusions . PATIENTS AND METHODS Between January 1988 and October 1993 94 patients with operable carcinoma of the rectum were included in a r and omized trial . Fourty-seven patients were treated with 5 x 3.3 Gy ( field size 16 x 16 cm , 9 MeV photons ) 24 to 48 hours prior to surgery ; 46 patients did not receive preoperative irradiation . If risk factors ( T4-stage , R1/R2 resection , intraoperative tumor perforation ) were present , postoperative irradiation was performed after CT-planning . Total postoperative doses of 41.4 Gy ( preoperative irradiation ) or 59.8 Gy ( surgery only ) were applied with doses per fraction of 1.8 to 2.0 Gy . Local control , survival , and pattern of side effects were analyzed at 5 years after conclusion of the trial . RESULTS The frequency of local recurrence was markedly reduced by preoperative irradiation of R0-resected patients ( 24 % vs 13 % , p = 0.08 ) . The time to recurrence was delayed ( 1.9 vs 3 years ) . The 5-year actuarial survival rate was significantly higher in the preoperatively irradiated group compared to the not pre-irradiated group ( 40 % vs 28 % , p = 0.027 ) . Multivariate analysis revealed UICC-grading as the only independent parameter for local control ( p = 0.0003 ) , while preoperative irradiation ( p = 0.07 ) and T-stage ( p = 0.08 ) only displayed a trend . For patient survival , age ( p = 0.0003 ) . R-status ( p = 0.01 ) and UICC-score ( p = 0.001 ) were significant prognostic factors . Preoperative irradiation had a non-significant effect only ( p = 0.078 ) . Radiation-induced side effects with a LENT-SOMA score > 2 were observed neither during frequent follow-up nor at an additional examination of those patients still alive in 1998 ( n = 25 ) . Of 4 pre- and postoperatively irradiated patients with risk factors , 3 had side effects grade 1 or 2 , predominantly rectal changes , at 5 to 11 years after treatment . CONCLUSIONS A positive effect on tumor control and survival is achieved with preoperative irradiation with the doses used in this study , with moderate side effects HYPOTHESIS Use of prophylactic antibiotics in elective colorectal surgery is essential . Although single-dose prophylactic antibiotics are recommended , the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven . We conducted a multicenter , r and omized trial of a single dose vs 3 doses of the second-generation cephalosporin cefmetazole . DESIGN A prospect i ve , r and omized , multicenter trial in patients undergoing elective colorectal surgery . SETTING Seven major hospitals in Japan that offer cancer treatment . PATIENTS Patients with colorectal cancer treated from May 6 , 2004 , to April 25 , 2005 . INTERVENTIONS Patients were r and omized to 1 of 2 groups : a single-dose group given a single dose of cefmetazole just before skin incision and a 3-dose group given 2 additional doses of cefmetazole every 8 hours after the first dose just before skin incision . MAIN OUTCOME MEASURES Incidences of incisional surgical site infection ( SSI ) , organ or space SSI , and all other infectious complications within 30 days after surgery . RESULTS A total of 384 patients were enrolled . Seven patients were excluded because of additional surgery or the inability to tolerate mechanical preparation . The incidence of incisional SSI was higher in the single-dose group ( 27/190 or 14.2 % ) than in the 3-dose group ( 8/187 or 4.3 % ) ( P = .009 ) . Incidences of organ or space SSI and other postoperative infectious diseases did not differ significantly between the 2 groups . In multivariate analysis , antibiotic dose was the only significant factor related to the incidence of incisional SSI . CONCLUSION Three-dose cefmetazole administration is significantly more effective for prevention of incisional SSI than single-dose antibiotic administration . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00292708 OBJECTIVE The authors compared clinical bowel function and complications of a low anterior resection with either a straight or colonic J pouch anastomosis . SUMMARY BACKGROUND DATA Urgency and frequent bowel movements after rectal resection with a low anastomosis have been related to the loss of rectal reservoir function . Reconstruction with a colonic J pouch possibly can obviate some of this dysfunction . Earlier reports have been favorable , but they must be verified in r and omized trials . METHOD One hundred patients with rectal cancer in whom a sphincter-saving procedure was appropriate were r and omized to reconstruction with either a straight or a colonic J pouch anastomosis . RESULTS The incidence of symptomatic anastomotic leakage was lower in the pouch group ( 2 % vs. 15 % , p = 0.03 ) . Eighty-nine patients could be evaluated after 1 year . The pouch patients had significantly fewer bowel movements per 24 hours , and less nocturnal evacuations , urgency , and incontinence . Overall well-being owing to the bowel function was rated significantly higher by the pouch patients . CONCLUSION Reconstruction with a colonic J pouch was associated with a lower incidence of anastomotic leakage and better clinical bowel function when compared with the traditional straight anastomosis . Functional superiority was especially evident during the first 2 months PURPOSE To assess tolerance and efficacy of preoperative treatment with uracil/tegafur and radiotherapy ( RT ) followed by surgery and postoperative flurouracil (FU)/leucovorin ( LV ) in patients with rectal cancer . PATIENTS AND METHODS Patients ( n = 94 ) with potentially resectable tumors , ultrasound at stages T2N+ ( n = 4 ) , T3 ( n = 77 ) , T4 ( n = 13 ) were treated with UFT ( 400 mg/m2/d , 5 days a week for 5 weeks ) and concomitant RT to the pelvis ( 45 Gy ; 1.8 Gy/d over 5 weeks ) . Patients underwent surgery 5 to 6 weeks later followed by four cycles of FU/LV . Primary end points included downstaging , pathologic responses , and sphincter-preserving surgery . Secondary end points were recurrence-free survival and overall survival . RESULTS All patients received the full RT dose . Fifteen patients ( 16 % ) needed UFT dose reduction . Preoperative G3 + toxicities included diarrhea ( 14 % ) , leukopenia ( 1 % ) , thrombocytopenia ( 1 % ) , and nausea ( 4 % ) . The downstaging rate was 54 % , pathologic complete response ( pCR ) was 9 % and , in an additional 23 % , there were only residual microscopic foci . When cellular viability criteria were taken into account , the pCR was 15 % . From 43 patients with abdominoperineal resection indication , 11 ( 25 % ) had sphincter-preserving surgery performed . Postoperative scheduled chemotherapy dose was not administered to 24 % of patients because of G3 + toxicity ( diarrhea , 8 % ; mucositis , 9 % ; and leukopenia , 7 % ) . Patients with downstaging had significantly higher survival and recurrence-free survival rates than those without . At 3 years , actuarial patterns of failure were pelvic , 5 % and distant , 11 % . OS was 75 % . CONCLUSION UFT combined with RT is safe and effective . In resectable rectal cancer , if preoperative treatment is considered , this approach can be an option Background The Laparoscopic approach has been applied to colorectal surgery for many years ; however , there are only a few reports on laparoscopic low and ultralow anterior resection with construction of coloanal anastomosis . This study compares open versus laparoscopic low and ultralow anterior resections , assesses the feasibility and efficacy of the laparoscopic approach of total mesorectal excision ( TME ) with anal sphincter preservation ( ASP ) , and analyzes the short-term results of patients with low rectal cancer . Methods We analyzed our experience via a prospect i ve , r and omized control trail . From June 2001 to September 2002 , 171 patients with low rectal cancer underwent TME with ASP , 82 by the laparoscopic procedure and 89 by the open technique . The lowest margin of tumors was below peritoneal reflection and 1.5–8 cm above the dentate line ( 1.5–4.9 cm in 104 cases and 5–8 cm in 67 cases ) . The grouping was r and omized . Results Results of operation , postoperative recovery , and short-term oncological follow-up were compared between 82 laparoscopic procedures and 89 controls who underwent open surgery during the same period . In the laparoscopic group , 30 patients in whom low anterior resection was performed had the anastomosis below peritoneal reflection and more than 2 cm above the dentate line , 27 patients in whom ultralow anterior resection was performed had anastomotic height within 2 cm of the dentate line , and 25 patients in whom coloanal anastomosis was performed had the anastomosis at or below the dentate line . In the open group , the numbers were 35 , 27 , and 27 , respectively . There was no statistical difference in operation time , administration of parenteral analgesics , start of food intake , and mortality rate between the two groups . However , blood loss was less , bowel function recovered earlier , and hospitalization time was shorter in the laparoscopic group . Conclusion Totally laparoscopic TME with ASP is feasible , and it is a minimally invasive technique with the benefits of much less blood loss during operation , earlier return of bowel function , and shorter hospitalization Objective : The objective of this study was to clarify the incidence and risk factors for developing incisional surgical site infection ( SSI ) in both elective colon and rectal surgery . Summary Background Data : SSI is a frequent complication after elective colorectal resection . The National Nosocomial Infection Surveillance system surveys all colorectal surgeries together , without differentiating the type of colorectal surgery performed . However , rectal surgery may have a higher risk for SSI , and identifying risk factors that are more specific to each procedure would be more predictive . Methods : We conducted prospect i ve SSI surveillance of all elective colorectal resections performed by a single surgeon in a single institution from November 2000 to July 2004 . The data for colon and rectal surgeries were collected separately . The outcome of interest was incisional SSI . Univariate and multivariate analyses were performed to determine the predictive significance of variables in each type of surgery . Results : A total of 556 colorectal resections , consisting of 339 colon and 217 rectal surgeries , were admitted to the program . The incisional SSI rates in colon and rectal surgeries were 9.4 % and 18.0 % , respectively ( P = 0.0033 ) . Risk factors for developing incisional SSI in colon surgery were ostomy closure ( OR = 7.3 ) and lack of oral antibiotics ( OR = 3.3 ) , while in rectal surgery , risk factors were preoperative steroids ( OR = 3.7 ) , preoperative radiation ( OR = 2.8 ) , and ostomy creation ( OR = 4.9 ) . Conclusions : Colon and rectal surgeries differ with regard to incidence and risk factors for developing incisional SSI . SSI surveillance for such surgeries should be performed separately , as this should lead to more efficient identification of risk factors and a reduction in SSI Objective To analyze total mesorectal excision ( TME ) for rectal cancer by the laparoscopic approach during a prospect i ve nonr and omized trial . Summary Background Data Improved local control and survival rates in the treatment of rectal cancer have been reported after TME . Methods The authors conducted a prospect i ve consecutive series of 100 laparoscopic TMEs for low and mid-rectal tumors . All patients had a sphincter-saving procedure . Case selection , surgical technique , and clinical and oncologic results were review ed . Results The distal limit of rectal neoplasm was on average 6.1 ( range 3–12 ) cm from the anal verge . The mean operative time was 250 ( range 110–540 ) minutes . The conversion rate was 12 % . Excluding the patient who stayed 104 days after a severe fistula and reoperation , the mean postoperative stay was 12.05 ( range 5–53 ) days . The 30-day mortality was 2 % and the overall postoperative morbidity was 36 % , including 17 anastomotic leaks . Of 87 malignant cases , 70 ( 80.4 % ) had a minimum follow-up of 12 months , with a median follow-up of 45.7 ( range 12–72 ) months . During this period 18.5 % ( 13/70 ) died of cancer and 8.5 % ( 6/70 ) are alive with metastatic disease . The port-site metastasis rate was 1.4 % ( 1/70 ) : a rectal cancer stage IV presented with a parietal recurrence at 17 months after surgery . The locoregional pelvic recurrence rate was 4.2 % ( 3/70 ) : three rectal cancers stage III at 19 , 13 , and 7 postoperative months . Conclusions Laparoscopic TME is a feasible but technically dem and ing procedure ( 12 % conversion rate ) . This series confirms the safety of the procedure , while oncologic results are at present comparable to the open published series with the limitation of a short follow-up period . Further studies and possibly r and omized series will be necessary to evaluate long-term clinical outcome in cancer patients BACKGROUND Since 1977 , we have studied preoperative treatments using 5-fluorouracil ( 5-FU ) suppositories alone or in combination with radiation to reduce local recurrence and improve survival of patients with rectal cancer . PATIENTS AND METHODS We developed a novel preoperative therapy combining radiation , intraluminal hyperthermia , and 5-FU suppositories . Thirty-five patients with rectal cancer underwent surgery after this treatment , and 41 patients underwent surgery without pretreatment . RESULTS The patients who underwent preoperative combination treatment showed significant tumor reduction ; 2 achieved microscopically complete regression . In comparison with the patients who underwent surgery without pretreatment , the preoperative treatment group had a 16.7 % lower local recurrence rate ( 10.4 % versus 27.1 % ) and an improved survival rate ( 81.8 % versus 67.6 % ) . CONCLUSIONS Preoperative combination therapy is a promising modality for the patients with respectable advanced cancer in the lower rectum PURPOSE To assess the toxicity and the efficacy of preoperative radiotherapy with continuous infusion 5-fluorouracil ( 5-FU ) for locally advanced adenocarcinoma of the rectum . METHODS AND MATERIAL S Eligible patients had newly diagnosed localized adenocarcinoma of the rectum within 12 cm of the anal verge , Stage T3 - 4 , and were suitable for curative resection . Eighty-two patients were treated with radiotherapy-50.4 Gy in 28 fractions in 5.6 weeks , given concurrently with continuous infusion 5-FU , using either 96-h/week infusion at 300 mg/m(2)/day or 7-days/week infusion at 225 mg/m(2)/day . RESULTS The median age was 59 years ( range , 27 - 87 ) , and 67 % of patients were male . Pretreatment stages of the rectal cancer were T3 , 89 % and resectable T4 , 11 % , with endorectal ultrasound confirmation in 67 % of patients . Grade 3 acute toxicity occurred in 5 of 82 patients ( 6 % ; 95 % confidence interval [ CI ] , 2 - 14 % ) . Types of surgical resection were anterior resection , 61 % ; abdominoperineal resection , 35 % ; and other procedures , 4 % . There was no operative mortality . Anastomotic leakage after low anterior resection occurred in 3 of 50 patients ( 6 % ; 95 % CI , 1 - 17 % ) . The pathologic complete response rate was 16 % ( 95 % CI , 9 - 26 % ) . Pathologic Stages T2 or less occurred in 51 % . CONCLUSION Preoperative radiotherapy with continuous infusion 5-FU for locally advanced rectal cancer is a safe regimen , with a significant downstaging effect . It does not seem to lead to a significant increase in serious surgical complications A prospect i ve audit of the management of colorectal cancer was established to investigate factors associated with variation in survival observed within the former Wessex region ( population three million ) A prospect i ve audit of all large bowel cancer resections is being conducted in the adjacent Health Boards of Lothian and Borders . The results of surgery in 750 consecutive patients recruited during the first 2 years are presented . In this time , 249 ( 33.2 per cent ) patients presented as an emergency , 490 ( 65.3 per cent ) had resection of a colonic cancer , and 36 ( 4.8 per cent ) patients died within 30 days . Abdominal resection was performed in patients and intestinal continuity was restored in 646 ( 87.2 per cent ) . Of all anastomoses performed , 31 ( 4.8 per cent ) leaked ( 15 of 467 ( 3.2 per cent ) and 16 of 179 ( 8.9 per cent ) after resection of colonic and rectal cancers , respectively ) . Of the patients presenting with a rectal cancer , 251 ( 96.5 per cent ) underwent abdominal resection and intestinal continuity was restored in 179 ( 71.3 per cent ) . Five of 28 consultants were responsible for half of these patients . Patients treated by these five consultants were no more likely to undergo anastomosis , but when an anastomosis was performed it was less likely to leak ( four of 95 ( 4.2 per cent ) versus 12 of 84 ( 14.3 per cent ) ( χ2 = 4.63 , P<0.05 ) ) . The overall outcome of surgery appears to be improved when compared to previous similar audits . Considerable intersurgeon variation remains in the results of resection of rectal cancer Background The applicability of laparoscopic surgery in the treatment of colorectal diseases is still controversial . Early reports on laparoscopic-assisted colectomy in patients with colon cancer suggested that it minimizes surgical trauma , decreases perioperative complications , and leads to a more rapid recovery . To our knowledge , no previous studies have compared the laparoscopic vs the open approach in rectal cancer . The aim of this paper was to assess the results of laparoscopic techniques in patients with rectal cancer . Methods From March 1998 to February 2003 , all patients admitted to our unit with adenocarcinoma of the rectum were evaluated for surgery by the laparoscopic approach . Results A total of 220 patients with a mean age of 67.3 years were included in the study . One hundred thirty patients ( 59 % ) were treated with neoadjuvant chemoradiotherapy . In > 75 % of the patients , a surgical procedure with sphincter preservation was perfomed . The rate of conversion to the open approach was 20 % . Ten patients had intraoperative complications . Fifty-eight patients ( 26.3 % ) developed postoperative complications . The length of hospital stay was 6.8 days . The distribution of tumor stages was as follows : stage I , 16.81 % ; stage II , 33.6 % ; stage III , 26.36 % ; stage IV , 19.09 % . The mean number of lymph nodes was 13.8 . The incidence of local relapse was 5.3 % , with a follow-up of 18 months . Conclusion Laparoscopic surgery can be safely performed in patients with adenocarcinoma of the rectum with good short-term results . R and omized controlled trials are needed to confirm these results In a prospect i ve r and omised controlled trial , amoxycillin plus clavulanic acid was compared to a combination of cefotaxime and metronidazole as prophylactic antibiotics in 164 patients who underwent elective colorectal resectional surgery . Wound infection occurred in 15 patients ( 9.1 % ) and deep surgical infection in 4 ( 2.4 % ) . Seven cases of wound infection and 2 cases of deep infection occurred in the amoxycillin plus clavulanic acid arm , while 8 cases of wound infection and 2 cases of deep infection occurred in the cefotaxime plus metronidazole arm . Eighty-eight percent of infections occurred in patients who had low anterior resection or abdominoperineal resection of the rectum . Both the amoxycillin plus clavulanic acid and the combination of cefotaxime and metronidazole offer the same degree of protection against post-operative infection . The use of amoxycillin plus clavulanic acid as antibiotic prophylaxis is recommended because of its easier use and cheaper cost PURPOSE To compare , in a r and omized trial , 5-fluorouracil ( FU ) plus leucovorin ( LV ) ( FU+LV ) vs. oral uracil and tegafur ( UFT ) plus LV ( UFT+LV ) given concomitantly with preoperative irradiation in patients with cT3 - 4 or N+ rectal cancer . METHODS AND MATERIAL S A total of 155 patients were entered onto the trial . Patients received pelvic radiotherapy ( 4500 - 5,040 cGy in 5 to 6 weeks ) and chemotherapy consisting of two 5-day courses of 20 mg/m(2)/d LV and 350 mg/m(2)/d FU in the first and fifth weeks of radiotherapy ( 77 patients ) or one course of 25 mg/d oral LV and 300 mg/m(2)/d UFT for 4 weeks beginning in the second week of radiotherapy ( 78 patients ) . The primary endpoints were pathologic complete response ( pCR ) and resectability rate . Secondary endpoints included downstaging rate , toxicity , and survival . RESULTS Grade 3 - 5 acute hematologic toxicity occurred only with FU+LV ( leukopenia 9 % ; p = 0.02 ) . There were no differences in resectability rates ( 92.1 % vs. 93.4 % ; p = 0.82 ) . The pCR rate was 13.2 % in both arms . Tumor downstaging was more frequent with UFT+LV ( 59.2 % vs. 43.3 % ; p = 0.04 ) . Three-year overall survival was 87 % with FU+LV and 74 % with UFT+LV ( p = 0.37 ) . The 3-year cumulative incidences of local recurrence were 7.5 % and 8.9 % , respectively ( p = 0.619 ; relative risk , 1.46 ; 95 % confidence interval 0.32 - 6.55 ) . CONCLUSION Although this study lacked statistical power to exclude clinical ly significant differences between both groups , the outcome of patients treated with UFT+LV did not differ significantly from that of patients treated with FU+LV , and hematologic toxicity was significantly lower in the experimental arm Background Sphincter-preserving operations ( SPO ) for lower rectal cancer are on the rise . In the study reported here , we compared the oncologic outcomes of patients who underwent sphincter-preserving operations following preoperative chemoradiation for lower rectal cancer with the outcome for patients who underwent abdominoperineal resection ( APR ) . Methods This prospect i ve study included 87 patients who underwent proctectomy with curative intent for locally advanced rectal cancer that was located less than 6 cm from the anal verge . Forty-four patients had APR with no preoperative treatment . Forty-three patients underwent concurrent chemoradiation therapy ( CCRT ) consisting of preoperative 5-fluorouracil – based chemotherapy and pelvic radiation ( 4500–5040 cGy ) ; this was followed 6 weeks later by surgery ( SPO/CCRT ) . The oncologic outcomes between the two groups were compared , and factors affecting survival were evaluated . Results The median follow-up period was 56.2 months . The overall postoperative complication rates did not significantly differ between SPO/CCRT and APR ( 32.6 % versus 34.2 % ; p = 0.879 ) . Also , there were no significant differences in the overall recurrence rate ( 20.9 % versus 20.5 % ; p = 0.956 ) and 5-year overall survival rate ( 70.8 % versus 62.9 % ; p = 0.189 ) between the two groups . By multivariate analysis , only the pathologic N stage was significantly associated with overall survival ( p < 0.001 ) . Conclusions Sphincter-preserving operation with CCRT could be another option for the treatment of locally advanced lower rectal cancer in patients who are clinical ly considered for APR , with no deterioration of oncologic outcomes . For patients undergoing curative resection for lower rectal cancer , the pathologic N stage can provide valuable prognostic information about survival Objective : The aim of this r and omized multicenter trial was to assess the rate of symptomatic anastomotic leakage in patients operated on with low anterior resection for rectal cancer and who were intraoperatively r and omized to a defunctioning stoma or not . Summary Background Data : The introduction of total mesorectal excision surgery as the surgical technique of choice for carcinoma in the lower and mid rectum has led to decreased local recurrence and improved oncological results . Despite these advances , perioperative morbidity remains a major issue , and the most feared complication is symptomatic anastomotic leakage . The role of the defunctioning stoma in regard to anastomotic leakage is controversial and has not been assessed in any r and omized trial of sufficient size . Methods : From December 1999 to June 2005 , a total of 234 patients were r and omized to a defunctioning loop stoma or no loop stoma . Loop ileostomy or loop transverse colostomy was at the choice of the surgeon . Inclusion criteria for r and omization were expected survival > 6 months , informed consent , anastomosis ≤7 cm above the anal verge , negative air leakage test , intact anastomotic rings , and absence of major intraoperative adverse events . Results : The overall rate of symptomatic leakage was 19.2 % ( 45 of 234 ) . Patients r and omized to a defunctioning stoma ( n = 116 ) had leakage in 10.3 % ( 12 of 116 ) and those without stoma ( n = 118 ) in 28.0 % ( 33 of 118 ) ( odds ratio = 3.4 ; 95 % confidence interval , 1.6–6.9 ; P < 0.001 ) . The need for urgent abdominal reoperation was 8.6 % ( 10 of 116 ) in those r and omized to stoma and 25.4 % ( 30 of 118 ) in those without ( P < 0.001 ) . After a follow-up of median 42 months ( range , 6–72 months ) , 13.8 % ( 16 of 116 ) of the initially defunctioned patients still had a stoma of any kind , compared with 16.9 % ( 20 of 118 ) those not defunctioned ( not significant ) . The 30-day mortality after anterior resection was 0.4 % ( 1 of 234 ) and after elective reversal a defunctioning stoma 0.9 % ( 1 of 111 ) . Median age was 68 years ( range , 32–86 years ) , 45.3 % ( 106 of 234 ) were females , 79.1 % ( 185 of 234 ) had preoperative radiotherapy , the level of anastomosis was median 5 cm , and intraoperative blood loss 550 mL , without differences between the groups . Conclusion : Defunctioning loop stoma decreased the rate of symptomatic anastomotic leakage and is therefore recommended in low anterior resection for rectal cancer This prospect i ve study addresses the rate of male genital dysfunction following total mesorectal excision ( TME ) for rectal carcinoma using the anterior extramesorectal plane and its correlation with early urinary function , pelvic autonomic nerve preservation ( PANP ) , and intraoperative neurostimulation ( INS ) . A consecutive series of 44 men operated on by the same surgical team was analyzed . After excluding 18 patients considered to be impotent preoperatively , urogenital function was evaluated in 26 patients on the basis of the International Prostatic Symptom Score and International Index of Erectile Function . PANP was assessed with INS of parasympathetic nerves . PANP was complete in 21 patients ( 80.8 % ) . Deterioration of urinary function was observed in six patients ( 23.1 % ) at early follow-up . Postoperative erectile dysfunction assessed in seven patients ( 26.9 % ) was associated with micturition disturbances in four ( 57 % ) . Despite dissection in front of Denonvilliers ´ fascia , the incidence of erectile dysfunction was low in patients with nonanterior tumors ( 1/10 ) . INS results had higher sensitivity for predicting urinary dysfunction than for predicting erectile dysfunction ( 67 % vs. 43 % ) . Values for specificity and accuracy were 95 % and 90 % , and 89 % and 77 % , respectively . The correlation between the findings on INS and urinary function was good ( κ = 0.66 ) at a fair ( κ = 0.36 ) correlation for erectile function . Nerve-sparing TME using the anterior extramesorectal plane results in a justifiable rate of postoperative impotence in patients with nonanterior tumors . Patients with negative results on INS or early urinary dysfunction are at greater risk of erectile dysfunction To determine whether mechanical bowel preparation influences the incidence of anastomotic dehiscence following colorectal surgery , 186 patients undergoing elective left colonic or rectal resection were r and omized before surgery to bowel preparation ( n = 89 ) or no bowel preparation ( n = 97 ) . Surgical technique was st and ardized and no patient had a defunctioning colostomy . Seventeen patients were excluded ( seven with preparation , ten without ) . Indications for surgery in the remaining 169 patients were carcinoma ( 133 patients ) , diverticular disease ( 26 ) , inflammatory bowel disease ( six ) and miscellaneous conditions ( four ) . Operations performed were left colonic resection or reversal of Hartmann 's procedure ( 26 with preparation , 28 without ) and anterior resection ( 56 versus 59 ) . The overall morbidity rate ( 18 per cent ) was similar in the two groups . All seven clinical anastomotic leaks occurred after low anterior resection , in three of the 39 patients who had undergone bowel preparation and four of the 36 who had not ( P>0·9 ) . Two deaths occurred , both of patients who had received bowel preparation , one being secondary to anastomotic leakage . Bowel preparation does not influence outcome after elective colorectal surgery Between March 1987 and February 1990 , 1168 patients with resectable rectal cancer were recruited into a nationwide Swedish trial . Patients were r and omly allocated to receive either preoperative irradiation ( 25 Gy infive fractions over 1 week ) followed by surgery within 1 week , or surgery alone . In each group 454 patients underwent curative surgery . The groups were well matched for age , sex and surgical procedure . The postoperative mortality rates did not differ : 4 per cent after irradiation versus 3 per cent after surgery alone , but the postoperative mortality rate was significantly higher in patients treated with a two‐ rather than three‐ or four‐portal technique ( 15 versus 3 per cent , P < 0·001 ) . More perineal wound infections were found in patients receiving irradiation ( 20 versus 10 per cent , P < 0·001 ) . No difference in the incidence of anastomotic dehiscence or other postoperative complication was found between the groups . Preoperative radiotherapy with a short‐term high‐dose technique can be delivered without major acute adverse effects , provided the irradiation technique is optimized PURPOSE To prospect ively compare the rates of pathologic response , acute toxicity , and sphincter preservation with two different schedules of preoperative chemoradiotherapy in patients with cT3 mid-distal rectal cancer . METHODS AND MATERIAL S Patients with cT3 and /or N+ resectable rectal carcinoma were r and omized to receive one of the two following chemoradiotherapy regimens : cisplatin , 5-fluorouracil , and radiotherapy ( PLAFUR ) or raltitrexed , oxaliplatin , and radiotherapy ( TOMOX-RT ) . For PLAFUR , cisplatin ( 60 mg/m(2 ) ) was given on Days 1 and 29 , with a prolonged infusion of 5-fluorouracil ( 1,000 mg/m(2 ) ) on Days 1 - 4 and 29 - 32 , plus concurrent radiotherapy ( 50.4 Gy in 1.8-Gy fractions daily ) . For TOMOX-RT , raltitrexed ( 3 mg/m(2 ) ) and oxaliplatin ( 130 mg/m(2 ) ) was given on Days 1 , 19 , and 38 with the same radiotherapy regimen as used for PLAFUR . Surgery was performed 6 - 8 weeks after completion of chemoradiotherapy . All pathologic specimens were review ed by a design ated expert pathologist . The primary endpoint of this study was pathologic tumor downstaging ( defined as tumor regression grade 1 - 2 ) . Secondary endpoints included the incidence of ypT0 , clinical tumor downstaging , sphincter-saving surgery , and acute treatment-related toxicity . RESULTS Between 2002 and 2005 , 164 patients were accrued in 10 Italian centers , 83 patients in the PLAFUR arm and 81 in the TOMOX-RT arm . Overall , tumor regression grade 1 - 2 was observed in 76 patients ( 46.4 % ) and ypT0 in 49 ( 29.9 % ) . The tumor regression grade 1 - 2 rate was 41.0 % vs. 51.9 % ( p = 0.162 ) and the ypT0 rate was 24.1 % vs. 35.8 % ( p = 0.102 ) for the PLAFUR vs. TOMOX-RT arm , respectively . The overall rate of tumor regression grade 1 and ypN+ was 4.6 % . The occurrence of ypT downstaging was significantly greater in the TOMOX-RT arm ( p = 0.035 ) . Grade 3 - 4 acute toxicity occurred in 19 patients ( 11.6 % ) : 7.1 % in the PLAFUR arm vs. 16.4 % in the TOMOX-RT arm . Sphincter-saving surgery was performed in 143 patients ( 87.2 % ) overall : 87.9 % in the PLAFUR arm and 86.4 % in the TOMOX-RT arm . CONCLUSIONS Compared with the PLAFUR regimen , TOMOX-RT achieved a greater incidence of downstaging but was associated with a correspondingly greater rate of acute Grade 3 + toxicity . With longer follow-up , the local control and survival rates might offer additional guidance as to the choice of regimen Purpose Adequate oxygenation is necessary for anastomotic healing , and ischemia has been found to be one of the most important factors in anastomotic leakage . This study was design ed to assess the value of early postoperative intramucosal pH measurements for the prediction of anastomotic leakage in patients with colorectal anastomosis . Methods A prospect i ve study of 90 patients with rectal or sigmoid cancer with primary anastomosis was conducted . In all patients intramucosal pH was determined by using tonometry at the anastomotic and gastric levels during the first 24 and 48 hours postoperatively . Seven other variables also were tested by univariate and multivariate analysis for any association with anastomotic leakage . Results The rate of clinical anastomotic leakage was 6.6 percent . Multivariate analysis showed that only the intramucosal pH at the anastomosis was an independent factor for the development of anastomotic leakage . The risk of leakage was 22 times higher in patients with an anastomotic intramucosal pH < 7.28 in the first 24 hours after surgery . Conclusions Measurement of anastomotic intramucosal pH in the early postoperative period can more accurately predict the risk of anastomotic leakage and benefit those patients who would need additional measures to improve the viability of the anastomosis Background . From 1980 to 1987 , 849 patients with clinical ly resectable rectal adenocarcinoma were r and omized into a controlled clinical trial to evaluate the role of preoperative radiotherapy Background We present a prospect i ve observational multicentre study of 4834 consecutive cases undergoing laparoscopic colorectal procedures . Methods The study was initiated on 1 August 1995 , with centres from Germany , Austria and Switzerl and participating . All patients undergoing laparoscopic colorectal surgery were included , and no selection criteria were applied . Results Between August 1995 and April 2004 , the participating centres treated 4834 patients . Three thous and , one hundred and sixty-six operations were performed for benign indications , and 1668 for cancer , with most operations being done for diverticulitis ( 2019 , 41.8 % ) . The conversion rate was 5.6 % , and the overall morbidity was 20.1 % . Intra-operative complications occurred in 5.9 % , postoperative complications in 14.0 % , and the overall anastomotic leak rate was 3.1 % ( colon 2.6 % , rectum 11.9 % ) . The 30-day mortality rate was 1.3 % . Conclusions It has been our experience that laparoscopic surgery for colorectal disease is safe . Morbidity and mortality are comparable to those of conventional colorectal surgery Between October 1980 and December 1985 , 471 patients with a resectable rectal carcinoma entered a r and omized multicenter trial for comparison of pre- and postoperative irradiation . Two hundred thirty-six patients were allocated to receive high-dose fractionated preoperative irradiation ( total dosage , 25.5 Gy in five to seven days ) and 235 patients to receive postoperative irradiation to a very high dosage level with conventional fractionation ( 60 Gy in a total 8 weeks ) . The postoperative treatment was delivered only to a high-risk group of patients ( Astler-Coller stages B2 , C1 , and C2 ) . The preoperative irradiation was well tolerated , with no immediate irradiation-related complications and no increased postoperative mortality ( 3 % , 7 of 217 patients , compared to 5 % , 10 of 215 patients in the postoperatively irradiated group ) . More patients in the preoperative irradiation group had perineal wound sepsis after abdominoperineal resection and this prolonged the stay in hospital after surgery . In 50 % of the patients the postoperative treatment could not be commenced until more than 6 weeks after surgery . The postoperative treatment was not as well tolerated as the preoperative one . The local recurrence rate was statistically significantly lower after preoperative than after postoperative radiotherapy ( 12 % versus 21 % ; p = 0.02 ) . In both groups more patients developed a local recurrence if the bowel was perforated at surgery or if the resection line was microscopically close to the tumor . To date , with a minimum follow-up of 3 years and a mean follow-up of 6 years , there is no difference in survival rates between the two groups Purpose In a register study , the risk of anastomotic leakage correlated to the choice of circular stapling device with a 4 % difference between the two br and s used . Based on those data , a r and omised multicentre study was started to explore the risk of an anastomotic leakage based upon the surgical device . Methods Patients above 18 years with a rectal cancer , able to give informed consent , and scheduled for an anterior resection were eligible for the study . Perioperative r and omisation was to Ethicon ™ PROXIMATE ™ ILS ™ or Autosuture ™ Premium Plus CEEA ™ . Anastomotic leakage was defined as a clinical ly manifest leak . Results Five hundred twenty-nine patients were r and omised ( 58 % male ) . A leak occurred in 8.3 % . The anastomoses created by PROXIMATE ™ ILS ™ leaked in 25/265 ( 9.4 % ) anastomoses , and the Premium Plus CEEA ™ leaked in 19/260 ( 7.3 % ) , p = .419 . Conclusion No difference in the leak rate could be revealed . Several centres replaced one of the staplers by a new product , and the study was ended before the stipulated number of patients was reached . In the future , surgical devices may have to prove superiority in r and omised trials or be monitored in quality registers before they can be introduced into day to day surgical practice . The study was registered at Clinical Trials.gov : NCT00399009 PURPOSE : National Surgical Adjuvant Breast and Bowel Project Protocol R-03 was design ed to determine the worth of preoperative chemotherapy and radiation therapy in the management of operable rectal cancer . METHODS : Thus far , 116 patients of an eventual 900 with primary operable rectal cancer have been r and omized to receive multimodality therapy to begin preoperatively ( 59 patients ) or identical therapy beginning after curative surgery ( 57 ) . All patients received seven cycles of 5-fluorouracil (FU)/leucovorin ( LV ) chemotherapy . Cycles 1 and 4 through 7 used a high-dose weekly FU regimen . In Cycles 2 and 3 , FU and low-dose LV chemotherapy was given during the first and fifth week of radiation therapy ( 5,040 cGy ) . The preoperative arm ( Group 1 ) received the first three cycles of chemotherapy and all radiation therapy before surgery . The postoperative arm ( Group 2 ) received all radiation and chemotherapy after surgery . Primary study end points included disease-free survival and survival . Secondary end points included local recurrence , primary tumor response to combination therapy , tumor downstaging , and sphincter preservation . RESULTS : Overall treatment-related toxicity was similar in both groups . Although seven preoperative patients had events after r and omization that precluded surgery , eight events occurred during an equivalent follow-up period in the postoperative group . No patient was deemed inoperable because of progressive local disease . Sphincter-saving surgery was intended in 31 percent of Group 1 patients and 33 percent of Group 2 patients at the time of r and omization . Such surgery was actually performed in 50 percent of the preoperatively treated patients and 33 percent of the postoperatively treated patients . The use of protective colostomy in patients undergoing sphincter-sparing surgery and the development of perioperative complications in all surgical patients were similar in both groups . There was evidence of tumor downstaging in evaluable patients under-going preoperative therapy , with 8 percent of Group 1 patients having had a pathologic complete response . CONCLUSION : These data do suggest that the preoperative chemotherapy and radiation therapy regimen used are , at least , as safe and tolerable as st and ard postoperative treatment . There is presently a trend to tumor downstaging and sphincter preservation in the preoperative arm . Whether this arm will have greater or lesser survival and long-term toxicity awaits the completion of this relevant study PURPOSE To study the impact of preoperative radiation dose escalation and postoperative adjuvant chemotherapy on the outcome of tethered and fixed rectal carcinoma . METHODS AND MATERIAL S We have treated 156 patients with 3 consecutive preoperative chemoradiation protocol s with escalating treatment intensity . Schedule 1 consisted of 40 Gy radiation with concurrent 5-fluorouracil ( 5-FU ) infusion and mitomycin C. Schedule 2 used a s and wich design with preoperative ( 40 Gy ) and postoperative ( 18 Gy ) radiation with concomitant 5-FU infusion , leucovorin , and mitomycin C. In schedule 3 , the preoperative radiation dose was increased to 50 Gy and adjuvant 5-FU/leucovorin chemotherapy was added following surgery . There were 54 , 27 , and 75 patients treated in schedules 1 , 2 , and 3 , respectively . RESULTS The resectability was 91 % for schedule 1 and 100 % for both schedules 2 and 3 . A dose-response relationship was observed between the radiation dose and the tumor downstaging and local control . The pathological complete response ( T0N0M0 ) rates for schedules 1 , 2 , and 3 were 4 % , 15 % , and 25 % , respectively . The respective rates of tumor downstaging were 41 % , 33 % , and 68 % , respectively . The 5-year local relapse-free rates were 67 % for schedule 1 ( 40 Gy ) , 96 % for schedule 2 ( 58 Gy ) , and 92 % for schedule 3 ( 50 Gy ) ( p = 0.0011 ) . The addition of postoperative chemotherapy appeared to improve both the survival and the relapse-free survival . The 5-year survival was increased from 52 % to 84 % ( p = 0.0004 ) and the 5-year progression-free survival was improved from 48 % to 74 % ( p = 0.0008 ) . CONCLUSION Preoperative 5-FU infusion , leucovorin , mitomycin C , and 50-Gy pelvic radiation , followed by postoperative bolus 5-FU/leucovorin chemotherapy , appeared to be an effective treatment for tethered/fixed rectal cancers . However , its therapeutic efficacy could only be vali date d in r and omized studies Objective The study was carried out to evaluate the efficacy of the gentamycin collagen sponge placed in the pelvic cavity after excision of rectal cancer in view of postoperative complications and the risk of cancer recurrence . Methods A total of 229 patients were recruited into the study and r and omized into two groups : GRM(+ ) , in which a gentamycin collagen sponge was used , and GRM(− ) , without the sponge . Tumors were resected using a TME technique . In the GRM(+ ) group , the sponge was placed into the tumor bed . Results Analysis covered 218 patients for whom all follow-up data were available . There were fewer early postoperative complications in the GRM(+ ) group : 20.7 vs. 37.5 % ; p=0.044 . This effect was found mainly in patients with surgery lasting longer than 3 h. After 36 months ’ follow-up , the overall survival after R0 resection for the GRM(+ ) and GRM(− ) groups was : 88.66 vs. 73.96 % . There was significant reduction in the distant metastasis rate in favor of the GRM(+ ) group . Conclusion The use of the gentamycin collagen sponge after excision of rectal cancer is safe and reduces the rate of early postoperative complications . The reasons for the lower rate of distant metastasis in the GRM(+ ) group are not clear , but the patients enjoy significant survival benefits BACKGROUND The aim of the study was to assess both mortality and morbidity following resection of mid and low rectal cancers in a French prospect i ve multicentric study . PATIENTS From June to September 2002 , consecutive patients undergoing resection for cancer of the mid- or lower rectum were prospect ively included in a multicentric study . Both postoperative mortality and morbidity were recorded . Multivariate statistical analysis was performed in order to assess risk factors predictive of postoperative morbidity . RESULTS 238 patients with a mean age of 66 + /- 13 years ( range : 26 - 88 ) were included . Neoadjuvant radiotherapy was performed in 68 % of the patients . Total mesorectal excision was performed in 218 patients ( 92 % ) , of whom 151 ( 63 % ) had a sphincter saving procedure . Six patients died ( 2.5 % ) . Overall postoperative morbidity rate was 43 % , including anastomotic leakage ( 11 % ) and reoperation ( 5 % ) . Mean hospital-in-stay was 20 + /- 16 days ( range : 3191 ) . Four independent risk factors of morbidity were found : perioperative fecal contamination ( OR = 3.9 [ 1.1 ; 13.5 ] ) , mean operating time longer than 6 hours ( OR = 4.5 [ 1.7 ; 12.1 ] ) , ASA score > 2 ( OR = 3.2 [ 1.6 ; 7.9 ] ) , and smocking ( OR = 3.3 [ 1.2 ; 8.9 ] ) . CONCLUSIONS Resection of cancer involving the middle or lower rectum with sphincter saving procedures was possible in two-thirds of the patients and was associated with 2.5 % mortality and 43 % morbidity The consequences of leakage from low colorectal or coloanal anastomoses are reduced by the use of a loop stoma to divert the faecal stream . Controversy continues as to whether loop ileostomy ( LI ) or loop transverse colostomy ( LTC ) is the optimal method of defunctioning such anastomoses Objective Whether resection of the primary tumour is of benefit to patients with incurable rectal cancer ( RC ) remains a matter of debate . In this study we analyse prospect ively recorded data from a national cohort PURPOSE In 1992 , preoperative radiotherapy was considered in France as the st and ard treatment for T3 - 4 rectal cancers . The present r and omized trial compares preoperative radiotherapy with chemoradiotherapy . PATIENTS AND METHODS Patients were eligible if they presented a resectable T3 - 4 , Nx , M0 rectal adenocarcinoma accessible to digital rectal examination . Preoperative radiotherapy with 45 Gy in 25 fractions during 5 weeks was delivered . Concurrent chemotherapy with fluorouracil 350 mg/m2/d during 5 days , together with leucovorin , was administered during the first and fifth week in the experimental arm . Surgery was planned 3 to 10 weeks after the end of radiotherapy . All patients should receive adjuvant chemotherapy with the same fluorouracil/leucovorin regimen . The primary end point of the trial was overall survival . RESULTS A total of 733 patients were eligible . Grade 3 or 4 acute toxicity was more frequent with chemoradiotherapy ( 14.6 % v 2.7 % ; P < .05 ) . There was no difference in sphincter preservation . Complete sterilization of the operative specimen was more frequent with chemoradiotherapy ( 11.4 % v 3.6 % ; P < .05 ) . The 5-year incidence of local recurrence was lower with chemoradiotherapy ( 8.1 % v 16.5 % ; P < .05 ) . Overall 5-year survival in the two groups did not differ . CONCLUSION Preoperative chemoradiotherapy despite a moderate increase in acute toxicity and no impact on overall survival significantly improves local control and is recommended for T3 - 4 , N0 - 2 , M0 adenocarcinoma of the middle and distal rectum BACKGROUND / AIMS This report provides our experience in 103 patients with adenocarcinoma of the rectum along with a general overview of the use of circular stapler in rectal surgery . MATERIAL S AND METHODS Forty-two patients were r and omized to a rectal anastomosis using either the single ( SST ) or double stapling technique ( DST ) . RESULTS From February 1991 to the present , 61 consecutive patients were treated to a rectal anastomosis using the DST . Perioperative mortality was 4.7 percent unrelated to the use of staplers . Statistically significant differences were noted : the mean distal resection margin measured 25.3 mm for SST and 35.0 mm for DST ( p = 0.0274 ) , without doughnut rings . Anastomotic stricture occurred in 3 patients ( 25 % ) using the 28-mm cartridge and in 1 ( 1.4 % ) using the 31-mm cartridge , respectively ( p = 0.0082 ) . To evaluate the different stapling techniques with bacterial contamination , the drain fluid was examined for lysozyme activity . When the SST was used , statistically significant enzyme activity increased as compared with the DST . Clinical leaks were noted in 9.5 percent ( 2/21 ) of the SST and in 2.4 percent ( 2/82 ) of the DST . The median follow-up of patients in the r and omized study was 45 months ( range , 32 - 62 months ) . Of the patients who underwent a potentially curative resection , seven ( 17.9 percent ) developed a local recurrence , with no statistically significant differences in the stapling techniques of local recurrence and overall survival . CONCLUSIONS Our experience , and that reported in literature , suggests that the double stapling technique is useful for restorative resection of rectal cancers Objective A defunctioning transanal stent may theoretically reduce the leakage rate after anterior rectal resection . We present a r and omized open study with the aim of comparing the leakage rate after anterior resection with a loop ileostomy , a transanal stent , both or neither Objective The primary outcome was sphincter preservation . No benefit was found with chemoradiation . The aim of this report is to analyse postoperative complications , which were the secondary outcome A prospect i ve r and omised multicentre trial compared pre-operative radiotherapy followed by surgery with surgery alone for rectal cancer < or = 12 cm from the anal verge . Of 468 patients ( mean age 67 years , range 31 - 94 , 273 males ) who met the entry criteria , 228 were r and omised to radiotherapy ( 3 x 5 Gy over 5 days within 2 days of operation ) followed by surgery , and 239 to surgery alone . R and omisation was unknown in 1 patient . Follow-up to death or 5 years was achieved in 454 ( 97 % ) patients . 31 ( 7 % ) of the 468 patients died within 30 days of operation ( radiotherapy and surgery 21 [ 9 % ] , surgery alone 10 [ 4 % ] ; P < 0.05 ) . Cardiovascular and thromboembolic complications were more common after radiotherapy and surgery ( 30 , 13 % ) than after surgery alone ( 8 , 3 % ; P < 0.005 ) . Of the 280 patients who had curative surgery , 52 % of those who had radiotherapy and surgery and 56 % of those who had surgery alone survived 5 years ( P = 0.88 ) . 395 patients attended out patients clinics at least once . Local treatment failure was identified during follow-up in 82 patients [ 31/185 ( 17 % ) radiotherapy and surgery ; 51/210 ( 24 % ) surgery alone ; P < 0.05 ] . It occurred in 33 of the 258 patients who had a curative resection and attended out patients [ radiotherapy and surgery , 11/120 ( 9 % ) , surgery alone , 22/138 ( 16 % ) ; P = 0.08 ] . Long-term survival was unaffected , but long-term local recurrence was reduced by the addition of low-dose radiotherapy to surgery . Peri-operative mortality was , however , increased PURPOSE : This study was design ed to investigate incidence , treatment , and outcome for patients with colorectal cancer . METHODS : From 1984 to 1986 in Östergötl and , a county in Sweden with a defined population , a prospect i ve registration using a computerized protocol was undertaken . RESULTS : In the surgical departments 596 cases were diagnosed and 31 more cases were diagnosed in other departments , bringing the incidence to 53 cases per 100,000 inhabitants per year . Of the cases , 14 percent presented as emergencies . The resectability rate was 90 percent , and the rate of curative operations was 74 percent . Postoperative mortality within 30 days was 2.9 percent . Crude five-year survival for all patients was 40 percent , and the corrected survival rate was 53 percent . After curative resection the crude five-year survival rate was 53 percent , and the corrected survival rate was 70 percent . Prognosis was better for colon than for rectal cancer , 76 percentvs.59 percent corrected five-year survival rate . For rectal cancer the local recurrence rate was 20 percent after curative resection . CONCLUSIONS : The prognosis was improved compared with a previous study from the same area because of decreased postoperative mortality , increased rate of operations for cure , and an increased five-year corrected survival rate . Local recurrence after rectal cancer was still high but may be reduced with improved surgical technique Background The purpose of this study was to present our experience of laparoscopic total mesorectal resection , including ultralow resection and coloanal anastomosis . Material s and methods Between 1993 and 2005 , patients fit for general anesthesia , with resectable cancers , and with lower edge of tumor beyond 5 cm of the anal verge were subjected to laparoscopic anterior resection with sphincter preservation . Double stapling technique is used to establish bowel continuity . Results A total of 170 patients , 88 males and 82 females , were subjected to successful laparoscopic anterior resection , which included high anterior resection ( n=90 ) , low anterior resection ( n=52 ) , ultralow anterior resection ( n=20 ) , and coloanal anastomosis ( n=8 ) . The average age of patients was 58.4 years ( 12–90 years ) . Mean operating time was 130 min and mean hospital stay was 7 days . The morbidity was 13.5 % with nil mortality . With an average follow-up of 49 months ( range 9 years to 3 months ) , 9 patients developed local recurrence and 45 patients developed distant metastasis . Conclusion In selected cases , laparoscopic anterior resection is possible for all levels of rectal tumors , allowing sphincter preservation and maintaining oncological safety PURPOSE The potential advantage of high-dose preoperative radiotherapy to increase tumor response and improve the chance of sphincter preservation for low rectal cancer remains controversial . The aim of this trial was to evaluate the role of escalating the dose of preoperative radiation to increase sphincter-saving procedures . PATIENTS AND METHODS Patients with rectal carcinoma located in the lower rectum , staged T2 or T3 , Nx , or M0 with endorectal sonography , and not involving more than two-thirds circumference , were r and omly assigned to one of two groups : preoperative external-beam radiotherapy ( EBRT ; 39 Gy in 13 fractions over 17 days ) versus the same EBRT with boost ( 85 Gy in three fractions ) using endocavitary contact x-ray . RESULTS Between 1996 and 2001 , 88 patients were enrolled onto the study . A significant improvement was seen in favor of the contact x-ray boost for complete clinical response ( 24 % v 2 % ) and for a complete or near-complete sterilization of the operative specimen ( 57 % v 34 % ) . A significant increase in sphincter preservation was observed in the boost group ( 76 % v 44 % ; P = .004 ) . At a median follow-up of 35 months , there was no difference in morbidity , local relapse , and 2-year overall survival . CONCLUSION A dose escalation with endocavitary irradiation provides increased tumor response and sphincter preservation with no detrimental effect on treatment toxicity and early clinical outcome Abstract PURPOSE : The aim of this study was to compare the bowel function of sigmoid vs. descending colonic J-pouches after ultralow anterior resection for rectal cancer . METHODS : A prospect i ve , r and omized trial was conducted from March 1998 to September 1999 . Ninety-two consecutive patients undergoing ultralow anterior resection for cancers arising from 3 to 10 cm from the anal verge were recruited . Forty-eight patients were males ; the mean ages ( st and ard error of the mean ) for patients with sigmoid and descending colon pouches , respectively , were 65.2 ( 3.1 ) years and 62.3 ( 3.1 ) years . A total of 46 patients were r and omly assigned to each group . Two patients from each group were excluded ; abdominoperineal resection was performed for two patients in the sigmoid pouch group and one patient in the descending pouch group . One patient in the descending pouch group had a transanal resection of a benign polyp . Dukes staging and use of postoperative chemoradiotherapy were statistically similar in both groups . All patients underwent a st and ardized ultralow anterior resection . A defunctioning loop ileostomy was used routinely . Anorectal physiology and bowel function question naires were performed at six weeks after ileostomy closure and again at 6 and 12 months after surgery . RESULTS : Median follow-up was 12 ( range , 7 to 25 ) and 12 ( range , 6 to 25 ) months , respectively , for sigmoid and descending pouch groups . Median tumor and anastomotic heights , time to ileostomy closure , operative time , and postoperative stay were statistically similar in both groups . There were no significant differences in stool frequency , incontinence , urgency , use of pads and antidiarrheals , sensation of incomplete evacuation , and anorectal physiology results between groups ( P > 0.05 ) . CONCLUSION : Pouches made from sigmoid or descending colon give similar bowel function after ultralow anterior resection for rectal cancers BACKGROUND Survival rates after surgery for rectal cancer remain at about 40 % at 5 years from diagnosis . The aim of this study was to find out whether local recurrence rate could be reduced and survival increased by a moderately high dose of preoperative radiotherapy in patients with locally advanced , but otherwise operable , carcinoma of the rectum . METHODS We carried out a prospect i ve r and omised trial of surgery alone ( n = 140 ) versus surgery preceded by 40 Gy radiotherapy ( n = 139 ) given in 20 fractions of 2 Gy over 4 weeks . The patients , from 20 regional centres throughout the UK , were enrolled between 1981 and 1989 , and followed up for a minimum of 5 years or to death . FINDINGS 217 patients died , 114 of 140 allocated surgery alone and 103 of 139 allocated preoperative radiotherapy : median survival times were 24 months and 31 months , respectively . The hazard ratio for overall survival was 0.79 ( 95 % CI 0.60 - 1.04 , p = 0.10 ) . At 5 years ' follow-up 65 patients allocated surgery alone and 50 who received preoperative radiotherapy had local recurrence ( hazard ratio 0.68 [ 0.47 - 0.98 ] , p = 0.04 ) ; the corresponding numbers of patients with distant recurrence were 67 and 49 ( hazard ratio 0.66 [ 0.46 - 0.95 ] , p = 0.02 ) . There was a significant benefit of radiotherapy on disease-free survival ( hazard ratio 0.76 [ 0.58 - 1.0 ] , p = 0.05 ) . There was no increase in postoperative or late complications in the radiotherapy group . INTERPRETATION Our results provide further evidence that preoperative radiotherapy can reduce the rate of local recurrence of rectal cancer in patients with locally advanced disease . However , survival results are still equivocal , and so we must await the results of a meta- analysis of all radiotherapy trials from which precise and definitive results , particularly for survival , may be obtained PURPOSE Few reports on the long-term functional outcome of colonic J-pouch reconstruction have been published , and data comparing J-pouch and straight reconstruction are contradictory . This prospect i ve study compares the functional outcome of colonic J-pouch and straight anastomosis five years after low anterior resection for rectal cancer . METHODS Functional outcome was compared in 46 patients with J-pouch reconstruction ( J-group ) and 48 patients with straight anastomosis ( S-group ) . Clinical status was evaluated with a 17-item question naire inquiring about different aspects of bowel function . Reservoir function was evaluated by manovolumetry . The Fisher ’s exact test and Wilcoxon ’s rank-sum test were used to compare categoric and quantitative data , respectively . RESULTS Among patients with an ultralow anastomosis ( ≤4 cm from the anal verge ) , the number of bowel movements during the day ( ≥5 , 4.3 vs. 29.2 percent ; P = 0.028 ) and at night ( > 1/week , 4.3 vs. 33.3 percent ; P = 0.013 ) and urgency ( 4.3 vs. 33.3 percent ; P = 0.013 ) and soiling ( 21.7 vs. 50.0 percent ; P = 0.043 ) were less in the J-group than in the S-group . Among patients with a low anastomosis ( 5 to 8 cm from the verge ) , patients in the J-group had fewer bowel movements at night ( > 1/week , 0 vs. 20.8 percent ; P = 0.028 ) and less urgency ( 0 vs. 20.8 percent ; P = 0.028 ) . Reservoir function was better in the J-group than in the S-group in both the ultralow ( maximum tolerable volume ( mean ) , 101.7 vs. 76.3 ml ; P = 0.004 ; threshold volume ( mean ) , 46.5 vs. 30.4 ml ; P < 0.001 ; compliance ( mean ) , 4.9 vs. 2.5 ml/cm H2O ; P < 0.001 ) and low-anastomosis ( maximum tolerable volume , 120.4 vs. 97.9 ml ; P < 0.001 ; threshold volume , 58.3 vs. 40.8 ml ; P < 0.001 ; compliance , 5.2 vs. 3.1 ml/cm H2O ; P < 0.001 ) groups . CONCLUSIONS J-pouch reconstruction increased reservoir function and provided better functional outcome than straight anastomosis , even five years after surgery , especially in patients whose anastomosis is less than 4 cm from the anal verge BACKGROUND Laparoscopic total mesorectal excision ( TME ) is being used in rectal cancer more frequently . The aim of this study was to analyze the differences in short-term outcomes between open and laparoscopic TME . METHODS In this nonr and omized consecutive study , the short-term outcomes of 100 patients undergoing TME for proven rectal cancer were analyzed . RESULTS Two groups of 50 patients underwent an open or laparoscopic TME for rectal cancer . Both groups were comparable . Laparoscopic surgery took longer to perform ( 250 vs. 197.5 min , p < 0.01 ) , but was accompanied by less blood loss ( 350 vs. 800 ml , p < 0.01 ) . Enteric function recovered sooner after laparoscopy . The numbers of major and minor complications were comparable between both groups , although fewer patients had major complications in the laparoscopic group ( 6 vs. 15 patients , p = 0.03 ) . Hospital stay was shorter for patients who underwent a laparoscopic abdominoperineal resection ( 10 vs. 12 days , p = 0.04 ) . Median follow-up was 17 months for the laparoscopic group and 22 months for the open group . Survival analyses between the groups showed no statistical difference in disease-free and overall survival . CONCLUSION This study shows that laparoscopic TME for rectal cancer is a safe and feasible technique with some short-term benefits over open TME PURPOSE Three Phase II studies of preoperative radiotherapy and concurrent 5FU chemotherapy were undertaken . The primary endpoints were acute toxicity and pathologic complete response rate ( pCR ) . Secondary endpoints were local recurrence-free survival ( LRFS ) , disease-free survival ( DFS ) , and overall survival ( OS ) . METHODS AND MATERIAL S A total of 134 patients with adenocarcinoma of the rectum ( clinical T3/T4 or N1/N2 ) were treated . The initial cohort received 40 Gy in 20 fractions , the second 46 Gy in 23 fractions , and the third 50 Gy in 25 fractions . 5FU ( 225 mg/m2/day ) was given continuously throughout radiotherapy . A total of 121 patients underwent surgical resection . RESULTS Treatment was well tolerated . Grade 3/4 acute toxicity was observed in 13 % , 4 % , and 14 % of patients in the 40 Gy , 46 Gy , and 50 Gy cohorts , respectively ( p = 0.20 ) . pCR was documented in 15 % , 23 % , and 33 % of patients , respectively ( p = 0.07 ) . The 2-year actuarial LRFS was 72 % , 90 % , and 89 % ( p = 0.02 ) ; DFS was 62 % , 84 % , and 78 % ( p = 0.02 ) ; and OS was 72 % , 94 % , and 92 % , respectively ( p = 0.03 ) . CONCLUSIONS All treatment schedules were well tolerated . There was a trend toward increased pCR with higher doses . A statistically significant increase in LRFS , DFS , and OS was seen with radiation doses of 46 Gy and greater , but there was no difference between 46 Gy and 50 Gy Background Assessment of healing after low colorectal , colo-anal or ileo-pouch anal anastomosis is routinely performed with a water-soluble contrast enema ( WSCE ) prior to the reversal of the defunctioning stoma . Interpretation of these radiographs is sometimes difficult and imprecise . As these anastomoses are within the reach of a simple digital rectal examination ( DRE ) , this approach is proposed as an effective and accurate adjunct . Patients and methods This is a prospect i ve cohort study recruiting patients who had undergone a low colorectal , colo-anal or ileo-pouch anal anastomosis with a diversion stoma . Anastomotic healing was assessed with a DRE in the clinic followed by the conventional WSCE . Anastomotic defects on digital examination and leaks on WSCEs were studied . Results There were 195 patients recruited with a total of 202 paired assessment s from 182 patients over 45 months . Six months after closure of the study , 174 patients had their stomas reversed . Thirteen examinations with WSCE showed pathology but were normal on digital examination ( false positive rate of 6.4 % for WSCE ) . These patients had their stomas reversed with no subsequent problems . Seven patients had an abnormal DRE but had a normal enema study ( false negative rate of 3.5 % for WSCE ) . These were large defects with pus and allowed the tip of the examining finger through . Delayed reversal of the stomas in these patients probably avoided continuing pelvic sepsis . The DRE was accurate in all instances except in the detection of a minor fistula in three patients . The sensitivity of the DRE in the detection of anastomotic pathology was 98.4 % . Conclusion The DRE yields additional and reliable information compared with the conventional water-soluble enema study in the assessment of anastomotic healing prior to stoma closure . In the experienced surgeon , it yielded more useful clinical information than the enema study Functional results after rectal resection with straight coloanal anastomosis are poor . While most functional aspects are improved with coloanal J pouch anastomosis , it is still unclear whether this translates into better quality of life . The aim of this trial was to investigate health‐related quality of life as a primary endpoint in patients undergoing sphincter‐saving rectal resection The aim of this study was to compare loop ileostomy and loop transverse colostomy as the preferred mode of faecal diversion following low anterior resection with total mesorectal excision for rectal cancer To ascertain whether preoperative short-term radiotherapy can improve local tumor control and the long-term survival of patients with operable rectal cancer , a prospect i ve r and omised trial was performed from 1988 to 1993 . Ninety-three patients with rectal cancer were either directly treated with surgery ( n = 46 ) or underwent preoperative radiotherapy with 5 x 3.3 Gy irradiation and operation within 48 h ( n = 47 ) . If indicated ( T4 , UICC stage III ) patients also received postoperative irradiation . Comparison of the methods of operation ( abdominoperineal amputation versus anterior resection ) revealed no significant difference in 5-year survival rate ( P = 0.393 ) . Local control of R0-resected tumors was improved after preoperative irradiation ( P = 0.08 ) . The 5-year survival rate was significantly higher after preoperative short-term radiotherapy ( P = 0.027 ) . Preoperative radiotherapy is not an independent factor according to overall survival ( P = 0.078 ) and local recurrence ( P = 0.07 ) . In agreement with the results of other authors the present study indicates improved local tumor control of rectal cancer after preoperative radiation therapy . The 5-year survival rate was significantly better after preoperative radiotherapy than after surgery alone One of the most controversial discussion s on laparoscopic surgery deals with the question of whether to apply this technique to malignant disease and specifically to rectal cancer . The four major issues are the adequacy of oncologic resection , recurrence rates and patterns , long-term survival and quality of life . There is evidence , from nonr and omized studies , suggesting that margins of excision and lymph node harvest achieved laparoscopically reached comparable results to those known from conventional open resection . Our own experience of laparoscopic surgery on rectal cancer is based on 52 patients treated with curative intent . Focusing on the postoperative long-term run , we gained the following results : The median age of patients was 66.7 years and ranged from 42 - 88 . Anastomotic leakage was seen in 6.1 % of cases . In a median follow-up of 48 months ( 36 - 136 ) , we reached an overall 3-year survival rate of 93 % and a 5-year survival rate of 62 % . Local recurrence was 1.9 % , distant metastasis occurred in 11.5 % of cases . We saw no port-site metastasis . To evaluate functional results following laparoscopic surgery a matched pair analysis was carried out . Matching of patients after laparoscopic and conventional open surgery was performed according to sex , age , type of resection , time period of surgery , and stage of disease classified by UICC . Regarding bladder and sexual dysfunction , using the EORTC QLQ CR38 score we found no statistical significant difference between the examined groups . As far as can be seen , laparoscopic surgery in rectal carcinoma may achieve the same or , in selected patients , even better results than open surgery . However , at present no published study has shown much evidence . Many more studies are necessary to define the place of laparoscopic technique in rectal cancer surgery , regarding appropriate selection of patients and evaluating adjuvant or neoadjuvant treatment in combination with the laparoscopic approach BACKGROUND Preoperative radiotherapy is recommended for selected patients with rectal cancer . We evaluated the addition of chemotherapy to preoperative radiotherapy and the use of postoperative chemotherapy in the treatment of rectal cancer . METHODS We r and omly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy , preoperative chemoradiotherapy , preoperative radiotherapy and postoperative chemotherapy , or preoperative chemoradiotherapy and postoperative chemotherapy . Radiotherapy consisted of 45 Gy delivered over a period of 5 weeks . One course of chemotherapy consisted of 350 mg of fluorouracil per square meter of body-surface area per day and 20 mg of leucovorin per square meter per day , both given for 5 days . Two courses were combined with preoperative radiotherapy in the group receiving preoperative chemoradiotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy ; four courses were planned postoperatively in the group receiving preoperative radiotherapy and postoperative chemotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy . The primary end point was overall survival . RESULTS We enrolled 1011 patients in the trial . There was no significant difference in overall survival between the groups that received chemotherapy preoperatively ( P=0.84 ) and those that received it postoperatively ( P=0.12 ) . The combined 5-year overall survival rate for all four groups was 65.2 % . The 5-year cumulative incidence rates for local recurrences were 8.7 % , 9.6 % , and 7.6 % in the groups that received chemotherapy preoperatively , postoperatively , or both , respectively , and 17.1 % in the group that did not receive chemotherapy ( P=0.002 ) . The rate of adherence to preoperative chemotherapy was 82.0 % , and to postoperative chemotherapy was 42.9 % . CONCLUSIONS In patients with rectal cancer who receive preoperative radiotherapy , adding fluorouracil-based chemotherapy preoperatively or postoperatively has no significant effect on survival . Chemotherapy , regardless of whether it is administered before or after surgery , confers a significant benefit with respect to local control . ( Clinical Trials.gov number , NCT00002523 [ Clinical Trials.gov ] . ) PURPOSE : Because evacuation of effusion or collection could depend on the type of drainage , we compared the effects of closed suction drainage with passive drainage through tubes or undulated drains after abdominoperineal rectal excision for carcinoma on early and late perineal wound healing . METHODS : Of 234 consecutive patients undergoing abdominoperineal rectal excision for carcinoma between January 1983 and August 1990 , unsatisfactory hemostasis or gross intraoperative septic contamination were recorded in 48 patients who were not included in the trial . After rectal excision and closure of the perineum , the remaining 186 patients were r and omized to receive passive drainage ( PD ; n=96 ) or closed suction drainage ( SD ; n=90 ) . Eighteen patients were withdrawn because of protocol violation , and three were lost to follow-up , leaving 165 ( 89 PD and 76 SD ) patients for analysis . Preoperative factors ( sex , age , degree of obesity , weight loss , anemia , or presence of ascites ) , intraoperative and pathologic findings ( Dukes stage ) , and postoperative courses ( recurrence , late mortality ) were similar in both groups . All patients were followed up for 12 months or until death . RESULTS : The rate of perineums healed at one month was significantly lower ( P<0.05 ) in PD ( 55/89=61 percent ) compared with SD ( 54/72=75 percent ) patients . At three months , the rate of healed perineums no longer differed between the two groups ( 70/87=81 percentvs.60/72=84 percent ) . The number of vaginal fistulas , secondary reopenings , and perineums not healed at 12 months was similar in both groups . Median duration to complete healing was similar in both groups ( 23vs.21 days , respectively ) . On the other h and , three retained drains were seen in PD patients only . The median duration of hospital stay was identical in both groups ( 22 days ) . Seven patients died in the early postoperative period , including one in the PD group and six in the SD group . There was no significant difference in the number of late deaths ( 3vs.7 ) in PD and SD patients , respectively . CONCLUSION : These results suggest that closed suction drainage should be used after abdominoperineal rectal excision with satisfactory hemostasis or absence of gross intraoperative septic contamination BACKGROUND The use of protective stoma in anterior resection ( AR ) is controversial . Neoadjuvant therapy , TME and laparoscopy seem to increase the rate of anastomotic dehiscences ( a.d . ) . PATIENTS AND METHODS In a prospect i ve study , 219 patients were su bmi tted to elective open AR ( 109 patients ) , open AR+TME nerve-sparing ( 110 patients ) , 35 of which had intrasphinteric anastomosis . Fifty-five patients were treated by neoadjuvant therapy . Primary stoma was not performed . RESULTS We had 15 ( 6.8 % ) a.d . : 5 ( 2.3 % ) major and 10 ( 4.4 % ) minor . In the five major a.d . an immediate colostomy was performed with one death . In the 10 minor the a.d . was cured conservatively . CONCLUSIONS A protective stoma is necessary in less than 10 % of the patients treated with AR , so avoiding further surgery , mortality , morbidity and higher medical costs in most patients Objective To identify the risk factors for surgical site infection ( SSI ) in patients undergoing elective resection of the colon and rectum . Summary Background Data SSI causes a substantial number of deaths and complications . Determining risk factors for SSI may provide information on reducing complications and improving outcome . Methods The authors performed a prospect i ve study of 2,809 consecutive patients undergoing elective colorectal resection via laparotomy between February 1995 and December 1998 at a single institution . The outcome of interest was SSI , which was classified as being incisional or organ/space with or without clinical leakage . A likelihood ratio forward regression model was used to assess the independent association of variables with SSIs . Results The overall SSI , incisional SSI , and organ/space SSI with and without clinical anastomotic leakage rates were 4.7 % , 3 % , 2 % , and 0.8 % , respectively . Risk factors for overall SSI were American Society of Anesthesiology ( ASA ) score 2 or 3 ( odd ratio [ OR ] = 1.7 ) , male gender ( OR = 1.5 ) , surgeons ( OR = 1.3–3.3 ) , types of operation ( OR = 0.3–2.1 ) , creation of ostomy ( OR = 2.1 ) , contaminated wound ( OR = 2.9 ) , use of drainage ( OR = 1.6 ) , and intra- or postoperative blood transfusion ( 1–3 units , OR = 5.3 ; ≥4 units , OR = 6.2 ) . However , SSIs at specific sites differed from each other with respect to the risk factors . Among a variety of risk factors , only blood transfusion was consistently associated with a risk of SSI at any specific site . Conclusions In addition to ASA score and surgical wound class , blood transfusion , creation of ostomy , types of operation , use of drainage , sex , and surgeons were important in predicting SSIs after elective colorectal resection Background : Controversy continues to surround laparoscopic rectal resection for malignancy . A longer follow-up period is required to evaluate the long-term efficacy of the procedure and its impact on survival . Furthermore , no data from ongoing r and omized controlled trials are yet available . The aims of this study were to compare long-term outcomes for unselected patients undergoing either laparoscopic or open rectal resection for cancer . Methods : A series of 124 unselected consecutive patients with rectal cancer , who underwent surgery by the same surgical team , have been included in this study . Patients with T1N0 tumors underwent local excision , and emergency cases were excluded from the study . Written consent was su bmi tted by each patient , and inclusion in either group ( laparoscopic or open ) was left to the patient ’s choice . The laparoscopic approach was chosen by 81 patients , and 43 patients chose open surgery . All the patients underwent preoperative radiotherapy ( 5,040 cGy ) , performed in selected cases with chemotherapy ( for patients younger than 70 years ) . The following parameters were compared between the two groups : length of the surgical specimen , clearance of the margins of the specimen , number of lymph nodes identified , local recurrence rate , incidence of distant metastases , and survival probability analysis . The mean follow-up period for both groups was 43.8 months ( range , l–9 years ) . Results : We performed 60 laparoscopic and 27 open anterior resections , as well as 21 laparoscopic and 16 open abdomino perineal resections , respectively . No mortality occurred in either group . The mean length of the resected specimens was 24.3 cm in the laparoscopic group and 23.8 cm in the open group ( p = 0.47 ) . The mean tumor-free margin was 3.0 cm in the laparoscopic group and 2.8 cm in the open group ( p = 0.57 ) , and the mean number of lymph nodes identified was 10.3 in the laparoscopic group and 9.8 in the open group ( p = 0.63 ) . Of the 124 patients , 86 ( 52 laparoscopic and 34 open ) were included in out study . We excluded patients who underwent a palliative resection ( 6 laparoscopic and 6 open patients ) or conversion to open surgery ( n = 10 ) and patients who had undergone surgery in the past year ( n = 16 ) . One laparoscopic patient was lost to follow-up evaluation , whereas three laparoscopic patients and one open patient died of causes not related to cancer . No wound recurrence was observed . The local recurrence rate after laparoscopic resection was 20.8 % , as compared with 16.6 % after open resection ( p = 0.687 ) . Distant metastases occurred in 18.2 % of the patients in the laparoscopic group , as compared with 21.2 % in the open group ( p = 0.528 ) . Cumulative survival probability was 0.709 after laparoscopic resection after LR and 0.606 after open resection ( p = 0.162 ) , whereas for Dukes ’ stages A , B , and C in the laparoscopic group versus the open group , it was 0.875 vs 0.889 ( p = 0.392 ) , 0.722 vs 0.584 ( p = 0.199 ) , and 0.500 vs 0.417 ( p = 0.320 ) , respectively . At this writing 20 laparoscopic patients ( 62.5 % ) and 20 open patients ( 60.6 % ) are disease free ( p = 0.623 ) . Conclusions : Oncologic surgical principles were respected . Long-term outcome after laparoscopic resection of rectal cancer was comparable with that after conventional resection . We should wait to draw conclusive scientific statements until the completion of ongoing international radomized controlled trials PURPOSE Total mesorectal excision ( TME ) surgery in the treatment of rectal cancer has been shown to result in a reduction in the number of local recurrences in retrospective studies . Reports on improved local control after preoperative , hypofractionated radiotherapy ( RT ) have led to the introduction of a prospect i ve r and omized multicenter trial , in which the effect of TME surgery with or without preoperative RT were evaluated . Any benefit in regard to a reduced local recurrence rate and possible improved survival must be weighed against potential adverse effects in both the short-term and the long-term . The present study was undertaken to assess the acute side effects of short-term , preoperative RT in rectal cancer patients and to study the influence of five doses of 5 Gy on surgical parameters , postoperative morbidity and mortality in patients r and omized in the Dutch TME trial . PATIENTS AND METHODS We analyzed 1,530 Dutch patients entered onto a prospect i ve r and omized trial , comparing preoperative RT with five doses of 5 Gy followed by TME surgery with TME surgery alone , of which 1,414 patients were assessable . Toxicity from RT , surgery characteristics , and postoperative complications and mortality were compared . RESULTS Toxicity during RT hardly occurred . Irradiated patients had 100 mL more blood loss during the operation ( P < .001 ) and showed more perineal complications ( P = .008 ) in cases of abdominoperineal resection . The total number of complications was slightly increased in the irradiated group ( P = .008 ) . No difference was observed in postoperative mortality ( 4.0 % v 3.3 % ) or in the number of re interventions . CONCLUSION Preoperative hypofractionated RT is a safe procedure in patients treated with TME surgery , despite a slight increase in complications when compared with TME surgery only Abstract INTRODUCTION : Anastomotic leakage is a major problem in colorectal surgery and in particular in operations for low rectal cancer . The present study investigates the question whether a protective stoma can reduce the ( clinical and radiologic ) anastomotic leakage rate and /or the rate of leakage requiring surgery . METHODS : The investigation took the form of a prospect i ve multicenter study involving 75 German hospitals and was performed between January 1 , 1999 , and December 31 , 1999 . A comparison was made of the postoperative results of procedures performed with and those performed without a protective stoma in patients undergoing low anterior rectal resection . In addition , logistic regression using the target criteria , overall anastomotic leakage and anastomotic leakage requiring surgery , was applied . RESULTS : Among the 3,695 operations performed for carcinoma of the rectum or colon , 482 were low anterior resections . In 334 patients ( 69.3 percent ) no protective stoma was constructed , whereas 148 ( 30.7 percent ) received such protection . Age , American Society of Anesthesiologists physical status , and body mass index were identical in both groups . In the group receiving a protective stoma , however , neoadjuvant radiochemotherapy was more common , the tumors were lower— and thus the total mesorectal excision rate higher , the intraoperative complication rate was higher , and the duration of the operation was longer . The differences were all significant . The major criterion ( overall anastomotic leakage rate ) was identical in the two groups , but the rate of leakage requiring surgery was significantly lower in patients receiving a protective stoma ( P = 0.028 ) . The logistic regression revealed that use of a protective stoma is a predictor of protection against anastomotic leakage requiring surgery . The distance of the tumor from the anal verge and the duration of the operation are further predictors . CONCLUSION : The particular benefit of a covering stoma is reduction in the rate of leaks requiring surgery and thus in the severe consequences of an anastomotic leakage Purpose Preoperative radiochemotherapy for rectal cancer causes a high rate of moderate-to-severe toxicities and is associated with only moderate survival benefits . A simpler , safer , and more convenient treatment would be preferable . Preoperative tegafur suppositories ( 1,500 mg/day ) for at least 14 days were piloted . Methods A total of 129 patients with resectable rectal cancer were enrolled . The primary end points were pathologic response , adverse events , rate of sphincter-sparing surgery , recurrence , and survival . Results The total dose of tegafur ranged from 21 to 78 ( mean , 32 ) g. The anal sphincter was preserved in 60.5 percent with microscopic no residual tumor ( R0 ) . The overall morbidity rate was 32 percent . Wound infection occurred in 13.2 percent of cases and anastomotic leakage in 9 percent of cases . Pathologic responses were observed in 70 percent of patients , with a complete necrosis occurring in 3.9 percent , two-thirds or more necrosis in 6.2 percent , one-third or more but less than two-thirds necrosis in 18.6 percent , and less than one-third necrosis in 41.9 percent . The mean total dose that patients showing complete or two-thirds or more necrosis received was 42.8 ± 6.4 g ( P = 0.01 ) compared with 31.6 ± 1.2 g administered to patients showing less than two-thirds necrosis . Adverse events were observed in 15.6 percent of patients overall , and Grade III or IV events were observed in 2.3 percent of patients . During a median follow-up of 48 months , distant metastasis occurred in 14.7 percent of patients and local recurrence occurred in 6.2 percent of patients . The four-year , disease-free and overall survival rates were 67.6 and 80.1 percent , respectively . Conclusions Preoperative tegafur suppositories are associated with low toxicity and may lead to analsphincter-sparing surgery with acceptable postoperative complications and favorable local and distal control PURPOSE To assess toxicity and long-term results of preoperative chemoradiotherapy in rectal cancer . METHODS AND MATERIAL S Between 1989 and 1997 , as a phase II study , 66 patients with T3 M0 , rectal cancer received preoperatively a 45 Gy dose pelvic radiotherapy ( XRT ) combined with two 5-day chemotherapy courses ( CT ) of 5-Fluorouracil ( 5-FU ) and Leucovorin ( LV ) delivered the first and fifth week of XRT . For each CT course , LV:20 mg/m2/d1-d5 , . While the 5-FU dose was variable from 450 to 350 mg/m2/d first course and 370 to 350 mg/m2/d second course . Surgery was planned 3 weeks later . RESULTS XRT-CT was stopped in 1 patient due to progressive disease . CT was stopped in 1 patient due to toxicity . Grade s 2 and 3 diarrhea were observed in 8 and 3 patients , respectively . One patient died from acute diarrhea due to deviation from recommendations ; 60 patients went to surgery . Among the 58 patients operated on for cure , 5 had an R1-resection . After a 4.5-year median follow-up , the 5-year pelvic disease-free survival was 92 % for the whole group and 96 % in the R0-resection group . CONCLUSION Preoperative combined XRT-5-FU-LV is feasible if optimal XRT and patients are carefully managed . The recommended 5-FU daily dose is 350 mg/m2 for both CT courses . This approach is currently tested in a large EORTC phase III trial AIM There is some evidence of functional superiority of colonic J-pouch over straight coloanal anastomosis ( CAA ) in ultralow anterior resection ( ULAR ) or intersphincteric resection . On the assumption that colonic J-pouch anal anastomosis is superior to straight CAA in ULAR with upper sphincter excision ( USE : excision of the upper part of the internal sphincter ) for low-lying rectal cancer , we compare functional outcome of colonic J-pouch vs the straight CAA . METHODS Fifty patients of one hundred and thirty-three rectal cancer patients in whom lower margin of the tumors were located between 3 and 5 cm from the anal verge received ULAR including USE from September 1998 to January 2002 . Patients were r and omized for reconstruction using either a straight ( n = 26 ) or a colonic J-pouch anastomosis ( n = 24 ) with a temporary diverting-loop ileostomy . All patients were followed-up prospect ively by a st and ardized question naire ( Fecal Incontinence Severity Index ( FISI ) scores and Fecal Incontinence Quality of Life ( FIQL ) scales ) . RESULTS We found that , compared to straight anastomosis patients , the frequency of defecation was significantly lower in J-pouch anastomosis patients for 10 mo after ileostomy takedown . The FISI scores and FIQL scales were significantly better in J-pouch patients than in straight patients at both 3 and 12 mo after ileostomy takedown . Furthermore , we found that FISI scores highly correlated with FIQL scales . CONCLUSION This study indicates that colonic J-pouch anal anastomosis decreases the severity of fecal incontinence and improves the quality of life for 10 mo after ileostomy takedown in patients undergoing ULAR with USE for low-lying rectal cancer PURPOSE Colonic J-pouch has been constructed to overcome reservoir dysfunction after restorative rectal surgery , whereas no effort has been made for sphincter dysfunction . We conducted a prospect i ve , r and omized study comparing surgical and functional outcomes between side-to-end anastomosis and colonic J-pouch after low anterior resection in which the anastomosis was constructed from the abdomen . METHODS Fifty-six consecutive patients with middle-to-low rectal cancer undergoing low anterior resection were r and omly assigned to side-to-end or colonic J-pouch group preoperatively . Surgical outcomes of all the patients were recorded . Patients underwent functional evaluation , including anorectal manometry and functional assessment , preoperatively and then 3 months , 6 months , 1 year , and 2 years postoperatively . RESULTS Twenty-four patients in each group completed the study . The demographic data and preoperative functional assessment did not differ between the two groups . There was no significant difference in surgical outcomes with regard to anastomotic height ( 5 cm ) , blood loss , protective colostomy , operative time , complications , and adjuvant therapy . Anal pressures showed no significant change postoperatively and during the follow-up period ; there were no differences between the two groups . Temporal minor fecal incontinence was noted in the early postoperative period in both groups . With regard to bowel function , a significant reduction of volume of urgency and maximal tolerable volume was found postoperatively in both groups ; however , a faster recovery was noted in the colonic J-pouch group . Stool frequency increased significantly after surgery in both groups ; however , in contrast to rectal volume , a faster recovery was noted in the side-to-end group . CONCLUSIONS Anastomosis after low anterior resection for middle to low rectal cancer could be performed safely from the abdomen . It minimized sphincter injury and showed good continence preservation . On the other h and , the surgical outcomes and long-term functional results of side-to-end anastomosis were comparable with colonic J-pouch . Side-to-end anastomosis provides an easier , alternative way for reconstruction after restorative rectal surgery PURPOSE To assess the toxicity , pathologic response rates , type of surgery , and oncologic results in a prospect i ve Phase I-II trial using pure hyperfractionated radiotherapy ( RT ) preoperatively in locally advanced rectal cancer . METHODS AND MATERIAL S Between September 1997 and April 2000 , 50 patients with T3-T4 or N1 rectal cancers were treated preoperatively with 50 Gy ( 45 Gy to the pelvis and a 5-Gy tumor boost ) in 40 fractions of 1.25 Gy during 4 weeks . The pretreatment tumor stage as determined by CT and endorectal ultrasonography ( 80 % of patients ) included 1 Stage T2 ( 2 % ) , 45 T3 ( 90 % ) , and 4 T4 ( 8 % ) . Nodal involvement ( N1 ) was documented in 26 patients ( 52 % ) . Surgery was performed at a median interval of 45 days ( range 26 - 114 days ) after RT completion . Seventeen patients who presented with pT4 or pN1 and /or pM1 received 5-fluorouracil-based chemotherapy postoperatively . RESULTS All patients completed the RT schedule as planned . Severe acute toxicities included two Grade 3 skin reactions ( 4 % ) that did not require a break . The other acute toxicities were Grade 2 or less ( skin , diarrhea , urinary , rectal tenesmus , and fatigue ) . A complete pathologic response was observed in 7 patients ( 14 % ) , and microscopic residual cancer was found in 10 ( 20 % ) . Of the 20 patients presenting with tumor located < or = 6 cm from the anal verge , sphincter-saving surgery was performed in 14 ( 70 % ) . At 3 years , the actuarial locoregional control rate was 90.5 % , and the disease-free survival rate was 74.6 % . At a median follow-up of 32 months , 4 patients ( 8 % ) presented with severe late complications ( Grade 3 - 4 ) that might have been RT related ( one rectovaginal fistula , two chronic perineal fistulas , and one bilateral ureteral stenosis ) . CONCLUSION In locally advanced rectal cancer , preoperative hyperfractionated RT to a total dose of 50 Gy is feasible , with acceptable acute and late toxicity and an objective downstaging effect . In view of these results , this schedule might be used as a basis for additional investigation regarding RT dose escalation or the addition of concomitant chemotherapy BACKGROUND Laparoscopic-assisted surgery for colorectal cancer has been widely adopted without data from large-scale r and omised trials to support its use . We compared short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer to predict long-term outcomes . METHODS Between July , 1996 , and July , 2002 , we undertook a multicentre , r and omised clinical trial in 794 patients with colorectal cancer from 27 UK centres . Patients were allocated to receive laparoscopic-assisted ( n=526 ) or open surgery ( n=268 ) . Primary short-term endpoints were positivity rates of circumferential and longitudinal resection margins , proportion of Dukes ' C2 tumours , and in-hospital mortality . Analysis was by intention to treat . This trial has been assigned the International St and ard R and omised Controlled Trial Number IS RCT N74883561 . FINDINGS Six patients ( two [ open ] , four [ laparoscopic ] ) had no surgery , and 23 had missing surgical data ( nine , 14 ) . 253 and 484 patients actually received open and laparoscopic-assisted treatment , respectively . 143 ( 29 % ) patients underwent conversion from laparoscopic to open surgery . Proportion of Dukes ' C2 tumours did not differ between treatments ( 18 [ 7 % ] patients , open vs 34 [ 6 % ] , laparoscopic ; difference -0.3 % , 95 % CI -3.9 to 3.4 % , p=0.89 ) , and neither did in-hospital mortality ( 13 [ 5 % ] vs 21 [ 4 % ] ; -0.9 % , -3.9 to 2.2 % , p=0.57 ) . Apart from patients undergoing laparoscopic anterior resection for rectal cancer , rates of positive resection margins were similar between treatment groups . Patients with converted treatment had raised complication rates . INTERPRETATION Laparoscopic-assisted surgery for cancer of the colon is as effective as open surgery in the short term and is likely to produce similar long-term outcomes . However , impaired short-term outcomes after laparoscopic-assisted anterior resection for cancer of the rectum do not yet justify its routine use |
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